PRE - FEASIBILITY REPORT

Transcription

1 PRE - FEASIBILITY REPORT For PROPOSED BULK DRUGS INTERMEDIATES MANUFACTURING UNIT at SY. NO: PARTS OF 318, 319 AND 321 LOCATED AT PALLEPAHAD VILLAGE, THURKAPALLY MANDAL, YADADRI - BHONGIR DISTRICT, TELANGANA STATE By VEDGIR LIFE SCIENCES HOUSE NO: /662/A, RAHAMATH NAGAR, YOUSUFGUDA, HYDERABAD TELANGANA STATE

2 Contents S. No. Description Page no. 1.0 Executive Summary Introduction of The Proposed Project Project Proponent Brief description of nature of the project Need for the project and its importance to the country and or region Demand-Supply Gap Employment Generation(Direct and Indirect) due to the project Project description Product and Production Capacity Raw materials required and Quantities Manufacturing Process Resource Utilize and Recycling Water Power Requirement Fuel Requirement Quantity of wastes to be generated Waste Water Generation and utilization Solid waste generation and Disposal Schematic representations of the feasibility drawing which give information of EIA purpose Site Analysis Connectivity Land Form, Land use and Land ownership Existing Infrastructure Soil classification Climatic data from secondary sources Social Infrastructure available Planning brief Proposed infrastructure Industrial Area Residential Area Green Belt: Social Infrastructure Water management Sewerage System Industrial Waste Management Rehabilitation and Resettlement (R&R) Plan 14

3 8.0 Project Schedule and Cost estimates Analysis of project 15 LIST OF TABLES Table No Description Page no. 3.1 Proposed Products and Quantities List of By-Products Water Requirement Details Wastewater generation and Treatment Method Solid and hazardous waste generation and Disposal 11 & 12 LIST OF FIGURES Figure No Description Page no. 1.1 Location Map Google Earth Map Showing Clarus Chem Pvt. Ltd. 7 LIST OF FLOW CHART Flow Chart No 3.1 Description Page no. Generalized Flow Chart for Bulk Drug Manufacturing 9

4 Pre Feasibility Report 1.0 EXECUTIVE SUMMARY Vedgir Life Sciences is a partnership firm and it is registered office at H.No /662/A, Rahamath Nagar, Yousufguda, Hyderabad Telangana Sate. S. No Parameter Description 1 Project Location Sy No: Parts of 318,319 & 321, Pallepahad(V), Thurkapally(M) Yadadri - Bhongiri District, Telangana State 2 Category of Project as per EIA Notification & 5(f) A Amendments 3 Project cost 18 Crores 4 Plot area 9.77 Acres ( Sq.m) 5 Proposed Products 6 Resources 7 Proposed Products List is mentioned in section 3.1 (I)Electricity 800 KVA Requirement Source of electricity Telangana State Southern Power Distribution Company Limited (TSSPDCL) D. G. Sets 250 KVA & 380 KVA 8 (II)Water consumption KLD Source of water Waste water generation Ground Water KLD 9 (III)Boiler 2 TPH & 5 TPH Coal Fired Boiler is Proposed 10 (IV)Fuel Coal MT /Day for proposed boiler Requirement 11 Mode of disposal Zero Liquid Discharge System 12 Solid waste generation Mentioned in Para of report 13 Nearest Highway State Highway (Pragnapur - Bhongir Road) 1.90 kms (E) 14 Nearest Railway Station Bhongir Railway Station kms (SSE) 15 Nearest Airport Rajiv Gandhi International Airport 58 kms (SW) Vedgir Life Sciences Page 1

5 Pre Feasibility Report 2.0 INTRODUCTION OF THE PROJECT The objective of this pre- feasibility study is to provide information for the proposed Bulk Drug Intermediates manufacturing unit of Vedgir Life Sciences located at Sy. No: Parts of 318, 319 and 321 Pallepahad Village, Thurkapally Mandal, Yadadri - Bhongir district, Telangana State. 2.1 Project Proponent Mr. S. Mohan Reddy is Managing Partner of the company having more than 30 years experience in Pharma Industry. 2.2 Brief description of nature of the project. Vedgir Life Sciences is proposing to manufacture Bulk Drug intermediates at Sy. No: Parts of 318, 319 and 321 Pallepahad Village, Thurkapally Mandal, Yadadri - Bhongir district, Telangana State. 2.3 Need for the project and its importance to the country and or region Vedgir Life Sciences is a Greenfield project intended to start a manufacturing unit of Bulk Drug Intermediates at Survey No: Parts of 318, 319 and 321 Pallepahad Village, Thurkapally Mandal, Yadadri Bhongir. Availability of the well-connected road and railway network for easy transportation of the construction equipments and materials, Raw materials and finished products. Easy availability of skilled and unskilled labor for construction of Plant and its operation. The Indian pharmaceutical industry currently tops the chart amongst India's sciencebased industries with wide ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian pharmaceutical industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent annually. it ranks very high amongst all the third world countries, in terms of technology, quality and the vast range of medicines that are manufactured. It ranges from simple headache pills to sophisticated antibiotics and complex cardiac compounds; almost every type of medicine is now made in the Indian pharmaceutical industry. Vedgir Life Sciences Page 2

6 Pre Feasibility Report The Indian pharmaceutical sector is highly fragmented with more than 20,000 registered units. It has expanded drastically in the last two decades. The Pharmaceutical and Chemical industry in India is an extremely fragmented market with severe price competition and government price control The Pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals, and injectibles. There are approximately 250 large units and about 8000 Small Scale Units, which form the core of the pharmaceutical industry in India (including 5 Central Public Sector Units). The Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent between the same period!. The market is expected to grow to US$ 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size, as stated by Mr Arun Singh, Indian Ambassador to the US. Branded generics dominate the pharmaceuticals market, constituting nearly 80 per cent of the market share (in terms of revenues). India has also maintained its lead over China in pharmaceutical exports with a yearon-year growth of per cent to US$ billion in FY , according to data from the Ministry of Commerce and Industry. Imports of pharmaceutical products rose marginally by 0.80 per cent year-on-year to US$ 1, million. Overall drug approvals given by the US Food and Drug Administration (USFDA) to Indian companies have nearly doubled to 201 in FY from 109 in FY The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ billion US generics market. 2.4 Demand-Supply Gap. There is a quite considerable gap between supply and demand for, fine chemicals, bulk drugs and intermediates. Very few players are in the market who can offer continuous supply. The company wants to bridge this gap between demand and supply by expanding the production capacity and thereby, making good business. Company's marketing edge comes from its direct and close contact with the customers. Their products are major strength of their customers. Each stage of their product is been monitored /checked for their quality to ensure quality product Vedgir Life Sciences Page 3

7 Pre Feasibility Report reaches their customer. They plan to launch new products every year to satisfy the need of their customers as per the market demand. 2.5 Employment Generation (Direct and Indirect) due to the project Approximate employment generation due to proposed unit is 70. Apart from this there will be significant non estimated employment generation at the supplier firms and service industry providing services to the company. Company shall be giving preference to people from economically weaker sections for employment in various semi-skilled/unskilled jobs thereby contributing to their upliftment. 3.0 Project Description Vedgir Life Sciences is proposing to Manufacture Bulk Drug Intermediates with production capacity of TPM The Location map is shown at Figure and Google earth map showing Vedgir Life Sciences plant is shown at Figure The site central GPS - coordinates are Latitude: 17 35'49.28"N Longitude: 78 49'7.98"E The project site does not offer any negative impact on the local area, but rather has a positive impact on socio economic conditions of the habitants around it because of employment to locals. The Vedgir Life Science is 1.90 kms away from State Highway No 17 and kms from Bhongir Railway Station. Vedgir Life Sciences Page 4

8 Pre Feasibility Report FIGURE 1.1: LOCATION MAP Vedgir Life Sciences Vedgir Life Sciences Page 6

9 Pre Feasibility Report FIGURE 1.2: GOOGLE EARTH MAP SHOWING VEDGIR LIFE SCIENCES. Vedgir Life Sciences Page 7

10 PRE FEASIBILITY REPORT 3.1 Products, By-Products and their Production Capacities Vedgir Life Sciences to produce below mention products with Manufacturing Capacity of 75 TPM and the list of products are shown in Table 3.1 & 3.2. Table 3.1: Proposed Product and Quantity S. No Product Name Production capacity MT/ Month 1 Aceclofenac Certrizine Hydrochloride Domperidone Drotraverine Hydrochloride Emiticitabine Hydrochloride Esomeprazole Fexofenadine Hydrochloride Fluconazole Glycazide Ketoconazole Levetiracetam Loratidine Losartan Potassium Lansoprazole Montelukast Sodium Omeprazole Pantoprazole sodium Sertaline Hydrochloride Telmisartan Tramadol Hydrochloride Total (Worst combination of any 10 products at any given point of time) Vedgir Life Sciences Page 8

11 PRE FEASIBILITY REPORT Table 3.2: List of By-Products S.No Name of the Product 1 Aceclofenac 2 Emtricitabine 3 Fluconazole 3 Montelukast Sodium 4 Losartan Potassium 5 Omeprazole 6 Tramadol Hydrochloride Name of the By-Product t- Butanol TEA Hcl DMSO Diisopropyl amine HCl Succinimide Trityl chloride Sodium Sulphate Magnesium Sulphate Quantity In Kg/Day Raw materials required and Quantities All the raw materials required for manufacturing of above products will be sourced from local market. 3.3 Manufacturing Process The manufacturing process of bulk drugs and Intermediates consists of chemical synthesis extending to stages of processing involving different type of chemical reactions. The generalized Flow chart for bulk drug manufacturing is shown in Flow chart 3.1. Flow Chart 3.1: Generalized Flow Chart for Bulk Drug Manufacturing Vedgir Life Sciences Page 9

12 PRE FEASIBILITY REPORT 3.4 Resource Utilize & Recycling Water Water requirement of the project for domestic and industrial activity during operation phase will be KLD. The water requirement will be met through ground water sources. The detailed water requirement shown in below Table 3.3. Table 3.3: WATER REQUIREMENT DETAILS S.No Purpose Water Input In KLD 1 Process Washings Boiler make up Cooling towers make up Scrubbing system Domestic Gardening 5.00 Total Power Requirement Power requirement of proposed project will be made available through Telangana State Southern Power Distribution Company Limited (TSSPDCL). The total power requirement for the unit is 800 KVA respectively D.G. sets of 250 KVA & 380 KVA is proposed installed to meet the emergency power requirement of the plant Fuel Requirement The company proposed to install 2 TPH & 5 TPH Coal Fired Boiler and total fuel requirement of coal will be around MT /Day and it will be procured from local sources. 3.5 Quantity of wastes to be generated Waste Water Generation and utilization Total effluent generated in the project is KLD. The treated water will be reused for plant operations. The HTDS waste water from Process after neutralization taken for treatment in stripper followed by MEE and ATFD, vapor condensate collected and transferred to Vedgir Life Sciences Page 10

13 PRE FEASIBILITY REPORT Biological Treatment. LTDS waste water including domestic sewage, floor Washes, Utilities waste water taken along with Vapour Condensate from MEE & ATFD for Biological Treatment. Treated effluent from ETP sent to RO, RO permeate collected and RO rejects are sent to MEE followed by ATFD for evaporation and separation of salts. Evaporation salts collected and sent to TSDF. MEE & ATFD vapour condensates collected & reused along with RO permeate in plant operations. Unit Table 3.4: Wastewater generation and Treatment Method HTDS KLD LTDS KLD Effluent Generation in KLD Treatment Method Process HTDS Effluent sent to stripper Washings followed by MEE/ATFD system. Boiler Blow down LTDS effluents treated in ETP along Cooling towers with MEE/ATFD vapour condensate. Blow down Treated effluent is sent to RO, RO Scrubbing system permeate water is recycled and RO rejects taken for evaporation in MEE followed by ATFD to collect Domestic evaporation salts for disposal to TSDF, MEE Condensate collected and reused along with RO permeate. Total Solid waste generation and Disposal The types of Hazardous and non Hazardous wastes generated from the project, method of disposal is shown in below table 3.5. Table 3.5: Solid / Hazardous waste generation and Disposal Name of the Solid/ Quantity S. No Disposal Method Hazardous Wastes 1 Organic waste (Process Kgs/Day Sent to Cement Industries Residue) 2 Spent Carbon Kgs/Day Sent to Cement Industries 3 Solvent Distillation Residue Kgs/Day Sent to Cement Industries 4 Inorganic Waste Kgs/Day Sent to TSDF 5 MEE Salts Kgs/Day Sent to TSDF 6 Organic Evaporative Liquid ( 890 Kgs/Day Sent to Cement Industry from MEE Stripper) 7 ETP Sludge 200 Kgs/Day Sent to TSDF Vedgir Life Sciences Page 11

14 PRE FEASIBILITY REPORT 8 SPCB Authorized Agencies Used Oils 500 Ltrs/Annum for Reprocessing/Recycling 9 After Detoxification sent to Containers liners 300 No s / Month outside agencies 10 Send back to suppliers for Used Lead Acid Batteries 4 No s/ Annum buyback of New Batteries 11 Ash from boiler Sent to Brick Manufacturers 3.6 Schematic representations of the feasibility drawing which give information of EIA purpose. The applicability of the S.O.1533 for the proposed project was explored by considering different possibilities & provision made in the said notification. Considering the products & project location of the proposed project it is noticed that the proposed project falls under Category 5 (f) A of the Schedule-I of EIA Notification S.O As per the provision of the SO 1533, it is necessary to get Environmental Clearance by applying to MoEF&CC along with the Environmental Impacts Assessment Study Report for the proposed project prior to commissioning of the project activities. Therefore the EIA is required to conduct to comply with provisions of SO 1533 made for Category 5(f) A of schedule I of the notification. 4.0Site Analysis 4.1 Connectivity Vedgir Life Sciences located at Sy. No: Parts of 318, 319 and 321 Pallepahad Village, Thurkapally Mandal, Yadadri - Bhongir district, Telangana State. The nearest habitation from the site is Pallepahad Village at a distance of 0.50 kms (NNW). The nearest railway station is Bhongir Railway Station at a distance of kms (SSE) from the site. The nearest airport is Rajiv Gandhi International Airport at a distance of 58 kms The Nearest road ways State Highway No kms Vedgir Life Sciences Page 12

15 PRE FEASIBILITY REPORT 4.2 Land Form, Land use and Land ownership. The land use of the Area of 9.77 Acres ( Sq.m) will be permanently changed to industrial purpose. 4.3 Existing Infrastructure. The Proposed project is a Greenfield project which is 1.90 kms away from SH-17 and Mandal head quarter Turkapally is 6.00 kms (NNE) from the project site. 4.4 Soil classification The predominant soils in the district are Red sandy soil, Sandy Loam Soil and black soil. 4.5 Climatic data from secondary sources. Temperature Maximum: 44.5 o C Minimum: 10.6 o C Normal annual rainfall : mm 4.6 Social Infrastructure available. Well developed social infrastructure facilities are available at nearby Habitations. 5.0 Planning Brief Proposed plant activities will be started after getting statutory clearance form related authorities. The project will be completed within two years. Further project management will take care of all the rules and regulation of statutory authority and provide the control measure and devices to achieve the standard norms 6.0 Proposed Infrastructure 6.1 Industrial Area The infrastructure and other facilities are already well developed in Turkapally, which is a Mandal head quarter. 6.2 Residential Area The employees who will work in the industry are from nearby villages and hence no proposal for residential area for employees. Vedgir Life Sciences Page 13

16 PRE FEASIBILITY REPORT 6.3 Green Belt: % of Green Belt will be developed and maintained. 6.4 Social Infrastructure: Facilities like road and communication are good; Banks, ATM's and medical facilities are also adequate. Amenities: Education- schools including middle, secondary and higher secondary schools, social welfare hostels. Medical and Health- Community Health Centre & Primary Health center are available in Turkapally which is 6.50 kms NNE of proposed project site. Power and water- All the villages are electrified and drinking water facilities are extended to all villages. Rail and Road- The project site is very well connected by road through State Highway No. 17 and nearest railway station is Bhongir. 6.5 Water management Water requirement will be met through ground water. 6.6 Sewerage System: There will be no discharge of industrial effluent as company proposing Zero Liquid Discharge (ZLD) system. The treated effluent will be reused. 6.7 Industrial Waste Management: Due to proposed project, the effluent from cooling and Plant/Equipment washing will be generated and treated in the well designed Effluent Treatment Plant. The treated effluent will be reused. 7.0 Rehabilitation and Resettlement (R & R) Plan Rehabilitation & Resettlement (R & R) plan is not applicable to this proposed project. 8.0 Project Schedule & Cost Estimates Proposed project activities will be started after getting statutory clearance form related authorities. The project will be completed within two years. Vedgir Life Sciences Page 14

17 PRE FEASIBILITY REPORT Proposed activity will provide benefits to the local people in terms of financial and social welfare. The project cost for proposed Project is Crores will be used for constructing additional building, Equipments & misc. 9.0 Analysis of proposal (Final Recommendations) Local people will get direct financial benefit by way of employment. Local people will get some contracts of supply and services to get indirect income. Company will contribute in improving education and health facilities in nearby area. Vedgir Life Sciences Page 15