Consultant: M/s. SADEKAR ENVIRO ENGINEERS PVT. LTD.

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1 Pre - feasibility Report For Ria Organics Private Limited, D-26/2, Kurkumbh - MIDC, Taluka - Daund Dist. Pune, Maharashtra, India. Consultant: M/s. SADEKAR ENVIRO ENGINEERS PVT. LTD. Accredited by QCI NABET Lab. Recognized by MoEF, Govt. of India NABL Accredited Certificate No. T- 2190, Certified by ISO 9001:2008 Certified by BS OHSAS 18001: /404, Paradise Tower, Opp. Alok Hotel, Gokhale road, Naupada, Thane Telephone : / psadekar@yahoo.com / prs@sadekarenviro.com Web site:- April, Executive Summary Name of the Project Proponent : Mr. Mathew Kavalam

2 1. Executive Summary Address of the Industry : Ria Organics Private Limited D - 26/2 Kurkubh - MIDC, Taluka - Daund, Dist. - Pune, Maharashtra, India. Total Plot Area : 8,000 Sq.m. Green Belt Area : 1, Sq.m. Production Details (MT/M) : 42.8 T/A Sr. No. in the Schedule : 5(f) Project Category : B-1 Water Requirement :60 CMD Power Requirement 1. Connected Load : 759 KW 2. Power Demand : 380 kva Total Cost of the project : 14 Crores Pollution Load and Mitigation Measures The industry will take necessary precautionary measures in view of environmental protection by implementing efficient pollution control equipments like Scrubbers to control the process related air emissions, adequate stack height for boiler & DG set. The industry will setup a full-fledged ETP of 40 CMD capacity with Tertiary treatment scheme for treatment of waste water with RO of 20 CMD capacity & MEE of 10 CMD capacity will be installed to achieve zero discharge. The company will acquire membership of Maharashtra Enviro Power Ltd. - CHWTSDF at Ranjangaon, Pune for disposal of hazardous waste. The other non hazardous solid waste such as empty drums and paper bags etc. will be sold to recycler. Page 2

3 Total Quantum of Waste Water to be Generated : 30 CMD Quantity of Effluent from process & other operations : 25 CMD Quantity of Domestic Effluent : 5 CMD Effluent Treatment Plant In view of set up of proposed manufacturing plant the company will establish full-fledged effluent treatment plant of 60 CMD capacity comprising of tertiary treatment scheme for treatment of low COD effluent along with RO of 20 CMD capacity and MEE of 10 CMD capacity will be installed for treatment for high COD effluent. The proposed plant will be a zero liquid discharge plant. Effluent Characteristics Sr. No. Parameter Characteristics MPCB Limit Before Treatment After Treatment 1. ph to Oil & Grease 0-5 Nil Total Dissolved Solids Total Suspended Solids COD BOD(3 days at 27 0 C) Sulphates Note: All the parameters are expressed in mg/l except ph. Quantum of Waste to be Generated: Sr. No. Name of waste Quantity (T/A) Nature Type Disposal Hazardous Waste 1 ETP Sludge 3.0 Sludge Chemical Maharashtra Enviro Power Ltd. Ranjangaon, Pune Page 3

4 2 3 Spent carbon Distillation residues 1.0 Solid Organic 0.5 Sludge Organic Salt 4 Spent Oil 0.5 Liquid Organic Maharashtra Enviro Power Ltd. Ranjangaon, Pune Maharashtra Enviro Power Ltd. Ranjangaon, Pune Maharashtra Enviro Power Ltd. Ranjangaon, Pune Non - Hazardous Waste 1 Empty Drums 100 No. Solid -- Return to the Supplier/ Sale to Authorized party 2 Packing Waste Material 100 kg/m Solid -- Air Emission Control Return to the Supplier/ Sale to Authorized party Sr. Component Utilities Proposed to be installed No 1. Air Stack attached to Utilities Description various utilities with sufficient height Capacity Fuel Type & Quantit Stack Heigh t Page 4 Boiler 1 X 600 kg/hr Thermopac k 1 X 4,00,000 kilocal/hr. DG Set 1 X 320 KVA y FO 288 l/day FO l/day HSD 65 l/hr (will be operate d only during power failure) 31 (com mon stack for boiler & ther mopa ck) 14.5 from grou nd level Source of Fuel Local Vendor

5 Scrubbers Plant Section & Height form ground Description Units level Process Scrubber - 4 m above roof level 2000 CFM Acidic Scrubber Salient features of the location of proposed project Sr. Particulars Details No. 1 Project Site Located in Notified Kurkumbh MIDC, Pune, Maharashtra 2 Co-ordinates Latitude: N Longitude: E 3 Nearest Highway The Pune - Solapur Highway (NH 9) plies at a distance (aerial) of 0.5 km to the South of the proposed project site 4 Nearest City Daund approximately 7 km (aerial distance) from the proposed project site 5 Nearest Railway station Daund railway station approximately 8.7 km (aerial distance) from the proposed project site 6 Nearest Airport Pune Airport approximately 74 km (aerial distance) from the proposed project site 7 Average Rainfall 710 to 750 mm 8 Average 10 o C to 24 o C in winter and 30 o C to 38 o C in summer Temperature 9 Average 65 to 95% Humidity 10 Archealogical Monument Not around 10 Km of the proposed project site Production Details The proposed project envisages production of Active Pharmaceutical Ingredients (API) as per the quantities detailed in the table below: Sr. No. Product Name Quantity (T/A) 1 Brexpiparazole Canagliflozin Crizotinib Linezolid Eletriptan Lapatinib Mirabegron Lornoxicam 2.0 Page 5

6 9 Pazopanib amiono thiophene Tofacitinib benzyl pyridine 12.0 Total 42.8 Utilities Requirement Area Statement Utility Quantity Source Water Requirement 60 MIDC Power Requirement 380 kva MSEDCL Sr.No. Particulars Area in (Sq.m) 1 Total Plot Area 8, Ground Coverage Area 4, Parking Area 9, Open Area 3, Green Belt Area 1,003.2 Environmental Management Plan Sr. No. Cost of environmental protection measures Recurring Cost per annum (Rs.) Capital Cost (Rs.) 1 Air Pollution Control 1,20,000/- 25,00,000/- 2 Water Pollution Control 12,20,000/- 1,45,00,000/- 3 Noise Pollution Control 15,000/- 5, 00,000/- 4 Environment Monitoring and Management 6,25,000/ Occupational health 1,30,000/- 2, 20, 000/- 6 Green Belt 60,000/- 5,00,000/- 7 Solid waste management 75,000/- 1,30,000/- 8 Total Cost 22,45,000/- 1,83,50,000/- 2. Introduction of the project/background information (i) Identification of project and project proponent Project Details Page 6

7 The proposed project is a green field project for manufacturing of API intermediates to the tune of 42.8 T/A. The proposed project will be setup in an area admeasuring 8,000 sq. m at plot no. D-16/2 in Notified Kurkumbh - MIDC, Pune, Dist - Pune, Maharashtra, India. As per EIA Notification 2006 & amendments till date the proposed project come under Schedule 5(f), category B1& require prior Environmental Clearance. About Project Proponent The project proponent viz. Ria Organics Pvt. Ltd. already has an API intermediate manufacturing facility in function at plot no. D-16/2, MIDC TTC, Navi Mumbai, Dist. - Thane, Maharashtra in the name of Modepro India Pvt. Ltd. Hence the details pertaining to Modepro are discussed below. Modepro is privately held ISO 9001:2000 certified company, which was established in 1993 primarily to manufacture pharmaceutical intermediates and fine chemicals. Modepro is a reliable partner to multinational companies engaged in the manufacture of Pharmaceuticals, Biotech, Agrochemicals & other specialty chemicals. Modepro has a team of highly qualified individuals having vast experience in various facets of chemical process development, process scale-up, chemical technology & manufacturing expertise, well trained in all process & safety requirements. Modepro provides cost effective solutions for our customer s diverse requirements. Modepro has a versatile plant with glass lined & stainless steel reactors, pressure reactors etc. capable of carrying out various different kinds of reactions under different conditions. Modepro s infrastructure is designed to carry out many types of processes in a safe manner. Modepro manufactures intermediates for several API s along with fine chemicals & Specialty chemicals also company is among the largest manufacturer of Thiophene products in India and have an extensive range of different thiophene products. Modepro has a successful track record in developing non-infringing processes and scaling them up from laboratory to kilo scale to commercial scale production. Modepro s expertise enables to successfully manage and develop a wide range of processes that conform to stringent quality and safety guidelines. Modepros s quality assurance & quality control departments are staffed with competent individuals with a thorough understanding of GMP requirements. Plant has been audited by Page 7

8 several European multinational companies for compliance to GMP for pharmaceutical intermediates based on the ICHQ7 standard. Our long-term relationships with multinational companies bear testimony to our strict adherence to Intellectual Property. We leverage best practices and technology to ensure confidentiality in our operations. We are committed to the health and safety of our employees, the welfare of our community and environment protection. We play a proactive role in creating awareness, imparting training and minimizing pollution. ii) Nature of the project The proposed project is for manufacturing of API intermediates. iii) Need of the project and its importance to country/region Active Pharmaceutical Industry is the backbone of the self-reliant Pharmaceutical industry in India, playing a significant role in improving the health standards of the people. Pharmaceutical manufacturers consisting of Bulk Drugs and drug intermediates in large, medium and small scale sectors in the country employ man power of above 45 lakhs both directly and indirectly. The growth and achievement of the Indian Drug Industry during the last five decades has been phenomenal and has been rated as one of the highest among the developing countries. The aim of the project is to manufacture of Bulk Drugs, which will be subsequently used in formulation in form of capsule, tablet, liquid orals or injectables etc. further it will be used for consumption. The project proponent is justifying the aim by serving to the country. iv) Employment generation (Direct and Indirect) due to the project Man power requirement for the proposed project will be 55 nos. involving 25 no. staff and 30 no. workers. 3. Project Description (i) Type of project The proposed project is a green field project for manufacturing of API intermediates (ii) Location map of the proposed project Page 8

9 Figure 1: Google Earth Imagery depicting Location of Ria Organics Pvt. Ltd. at Kurmumbh MIDC, Pune Latitude: N Longitude: E (iii) Details of alternate site considered The management of Ria Organics Pvt. Ltd. is already setting up an API manufacturing facility plot no. D-26 Kurkumbh MIDC which is a sister concern of Ria Organics Pvt. Ltd. hence with a view of ease of operations for setting up of proposed project the proposed site was selected in the vicinity of existing plant so feasibility of none other site was considered. Page 9

10 (iv) Size or magnitude of operation The magnitude wise salient aspects of the proposed project are as tabulated below: Sr.No. Particulars Detail/Magnitude 1 Project cost 14 crore 2 Production capacity 42.8 T/A 3 Total Plot Area 8,000 sq.m. 4 Water requirement 60 CMD 5 Power requirement 380 kva 6 Effluent generation 30 CMD 7 Fuel requirement FO: 592 l/day HSD: 65 l/hr (consumption as per power failure) 8 Waste generation ETP Sludge: 3.0 T/A Spent Carbon: 1.0 T/A Distillation Residues: 0.5 T/A Spent Oil: 0.5 T/A 9 Boiler capacities Boiler: 1X600 kg/hr Thermopack: 1X 4,00,000 kilocal/hr. (v) Process details (vi) Raw material details along with quantities The requirement of raw materials will be as detailed in the table below: Sr. No. Name of Raw Material Quantity 1 Triethyl amine 400 Kg. 2 Methanol 2000 Kg. 3 Methylene dichloride (MDC) 2000 Kg. 4 Tetrahydrofuran 2000 Kg. 5 Ethyl acetate 2000 Kg. 6 Toluene 2000 Kg. 7 Xylene 1000 Kg. 8 Dimethyl formamide 1000 Kg. 9 Dimethyl sulphoxide 500 Kg. 10 Diisopropyl ether 400 Kg. 11 Acetonitrile 600 Kg. 12 Isopropyl alcohol 600 Kg. Page 10

11 13 N-Methyl-2-pyrrolidone (NMP) 500 Kg. 14 Acetic acid 600 Kg. 15 Trifluoroacetic acid 400 Kg. 16 Con Hydrochloric acid 400 Kg. 17 Sulphuric acid 400 Kg. 18 Nitric acid (70%) 300 Kg. 19 Thioglycolic acid 500 Kg. 20 Acetic anhydride 200 Kg. 21 Morpholine 200 Kg. 22 Potassium carbonate 400 Kg. 23 Potassium hydroxide 400 Kg. 24 Sodium hydroxide 400 Kg. 25 Sodium bicarbonate 400 Kg. 26 Ammonium chloride 200 Kg. 27 Caesium carbonate 200 Kg. 28 Sodium tert-butxide 400 Kg. 29 Sodium metabisulphite 400 Kg. 30 Sodium triacetoxyborohydride 600 Kg. 31 3,4- Difluoro nitrobenzene 600 Kg. 32 Methyl chloroformate 600 Kg. 33 R- Glycidyl butyrate 400 Kg. 34 N-butyl lithium 300 Kg. 35 Methane sulphonyl chloride 400 Kg. 36 Sodium azide 200 Kg % Pd/ C 50 Kg. 38 Palladium acetate 200 Kg. 39 tri-tert-butylphosphonium tetaphenyl borate 100 Kg. 40 Diisopropyl azodicarboxylate (DIAD) 10 Kg. 41 Triphenyl phosphene (TPP) 50Kg. 42 2,6-Dichlorobenzaldehyde 400 Kg. 43 Quinoline 200 Kg. 44 Copper powder 10 Kg. Page 11

12 45 Piperazine 200 Kg. 416 (S)-1-(2,6-Dichloro-3-fluorophenyl)ethanol 400 Kg Nitropyridin-3-ol 400 Kg. 48 N-Bromosuccinimide 200 Kg. 49 N-Boc-4-hydroxy piperidine 200 Kg Bromo-1H-pyrazole 200 Kg. 51 Isopropyl magnesium chloride LiCl complex (1.3 M) 200 Kg Methoxy-4,4,5,5-tetramethyl-1,3,2-dioxaborolane 100 Kg Ethyl benzene amine 300 Kg. 54 tert- Butyl nitrite 200 Kg. 55 Dimethyl sulphate 300 Kg. 56 2,4-Dichloropyrimidine 400 Kg. 57 Methyl iodide 200 Kg Methylbuta-1,3-diene 200 Kg. 59 Phenylmethanamine 300 Kg. 60 Formaldehydde (37 %) 300 Kg. 61 Hydrogen Peroxide 400 Kg. 62 Methyl amine (40%) 300 Kg Chloro-7H-pyrrolo[2,3-d]pyrimidine 400 Kg Methylbenzene-1-sulfonyl chloride 400 Kg Fluorophenylboronic acid 200 Kg bromothiophene 300 Kg. 67 1,2-dimethoxyethane 200 Kg. 68 Charcoal 100 Kg. 69 Hexane 600 Kg. 70 Tetrakistriphenylphosphine 200 Kg bromo-2-methylbenzoic acid 200 Kg. 72 Oxalylchloride 300 Kg. 73 Aluminium chloride 300 Kg. 74 Triethylsilane 200 Kg. 75 BF 3.Etherate 200 Kg. 76 Ethyl-4-chloroacetoacetate 200 Kg. Page 12

13 77 Thiourea 200 Kg. 78 Ethanol 500 Kg. 79 Benzylcyanide 300 Kg nitrobenzylcyanide 300 Kg. 81 Sodiumborohydride 200 Kg. Mode of transport of Raw Materials: By Road, Sea & Air Mode of transport of Products: By Road, Sea & Air (vii) Resource optimization/recycling and reuse The proposed project envisages resources optimization measures such as recovery of mother liquor from the process for reuse. Recycled water will be used for utilities, domestic flushing and gardening activity. (viii) Availability of various utilities The requirement of water, power & its source are as given in the following table: Utility Quantity Source Water Requirement 60 MIDC Power Requirement 280 kva MSEDCL The equipment/machinery to be installed is given in the table below: Sr.No. Name of Equipment Material of Construction Capacity Quantity 1 Reactor PP/FRP 1000 L 2 Nos 2 Reactor MSGL 630 L 4 Nos 3 Reactor MSGL 2000 L 7 Nos 4 Reactor MSGL 3000 L 1 Nos 5 Reactor MSGL 4000 L 1 Nos 6 Reactor SS 1000 L 3 Nos 7 Reactor SS 2000 L 4 Nos 8 Reactor SS 3000 L 1 Nos 9 Reactor SS 4000 L 2 Nos 10 Steam Boiler 600 kg/hr 1 Nos Thermic Fluid Heater 4 Lakh/Kilo Caleries/hr 1 Nos Scrubber Acidic 2000 CFM 1 System Page 13

14 Air Handling Unit As per room volume 8 System Chilled Water Unit 80 TR@7 C 1 Set Brine Chilled Unit 20 TR@ 20 C 1 Set FBD SS 120 KG 4 Nos Blender SS 750 KG 1 Nos Shifter SS R 1 Nos Multimill SS 1 Nos Cooling Tower PP/FRP 200 TR 4 Nos High Vacuum Pump 4 Nos Ejector System 5 System HVD SS Column Height 15 Mtr. 1 System (ix) Waste generation & management The waste generation details & its management will be as shown in the following table: Sr. No. Name of waste Quantity T/A Nature Type Disposal Hazardous Waste 1 ETP Sludge 3.0 Sludge Chemical 2 3 Spent carbon Distillation residues 1.0 Solid Organic 0.5 Sludge Organic Salt 4 Spent Oil 0.5 Liquid Organic Maharashtra Enviro Power Ltd. Ranjangaon, Pune Maharashtra Enviro Power Ltd. Ranjangaon, Pune Maharashtra Enviro Power Ltd. Ranjangaon, Pune Maharashtra Enviro Power Ltd. Ranjangaon, Pune Non - Hazardous Waste 1 Empty Drums 100 No./month Solid -- Return to the Supplier/ Sale to Authorized party 2 Plastic Bags 100 kg/month Solid -- Return to the Supplier/ Sale to Authorized party Page 14

15 (x) Schematic representation of the feasibility drawing of EIA RESOURCE CONSUMPTION (WATER) POWER CONSUMPTION RAW MATERIAL PRODUCTION ACTIVITY WASTE GENERATION FINISHED PRODUCTS POLLUTION ABATEMENT EMPLOYMENT MARKET ECONOMY Page 15

16 4. Site Analysis (i) Connectivity The main/primary highway connecting the Kurkumbh MIDC to various parts of the country is Mumbai - Solapur Highway (NH 9) where as the access to the project site can be gained by the connecting roads developed by the MIDC. (ii) Land Form, Land Use and Land ownership Land Form The projected affected area in large is a plateau type of land form. Land Use The proposed project being located in the MIDC area which is exclusively meant for industrial developmental activities, immediate surroundings of the proposed project plot prevail industrial type of land use whereas currently the proposed project plot is a barren land. Land ownership The plot no. D-26/2 is in possession of Ria Organics Pvt. Ltd. (iii) Topography Generally the topographic features are an exhibit of settings of any area considered on a very large scale hence the topography of Pune Districrt in general is discussed. Pune District lies in the Bhima and Nira basins. It has a shape of triangle with its base in Sahyadri mountains on the west and its apex in the extreme South-East corner near Nira River. Taking into consideration the height from sea level, rainfall, soil patter etc. it is divided into three zones viz. Western Zone, Central Zone and Eastern Zone. The Sahyadri ranges are spread from North to South in the district. (iv) Existing land use pattern The inner 5 km radial study area prevail three land use patterns viz. Industrial Area, Human Settlements & Agricultural/Croplands where as the outer 10 km radial study area has Agricultural & Human settlements land use pattern. (v) Existing Infrastructure The industry will develop all the necessary infrastructures within the proposed plant for production of API intermediates & Fine Chemicals; however the MIDC has developed following infrastructure for the industrial cluster. Road: MIDC has developed internal Tar roads with varying widths for access to various industrial units. Page 16

17 Water: The scheme is sourced from main lake at Varvand near Kurkumbh MIDC. Water consumption of the proposed unit will be 60 CMD. Electricity: The to the MIDC is sourced from MSEDCL. The power requirement of the proposed unit will be 280 kva. Fire Safety: A fire station was deemed necessary keeping in mind the planned development of Kurkumbh MIDC. MIDC had allotted a plot of 4,800 sq. ft. for construction of fire station accordingly a full-fledged fire station has been constructed in an area of 543 sq. ft. & has been put into operation w.e.f 21 st July, Common Effluent Disposal Facility: MIDC has commissioned a common effluent treatment plant of 1 MLD capacity on plot no. AM-4 Kurkumbh MIDC which is having current load of 0.37 MLD. (vi) Soil Classification The soil characterization of Daund Taluka is as follows: The major soil types in the taluka are namely coarse sallow soil, medium black soil and deep black soil. 60 % percent area in the taluka is covered by coarse shallow soil. It is confined to south and central parts of the taluka. (vii) Climatic Data (Secondary data) The project affected area & Daund Taluka in large show marked seasonal variations viz. Winter, Summer and Rainy seasons, mostly experiencing semi arid climate characterized by dryness during major part of the year. The climate from January to April is comparatively dry. The relative humidity is high in July, August and September. The region receives rainfall from southwest monsoon which is generally confined from June to September. The average annual rainfall ranges between 500 mm to 750 mm. The mean annual maximum temperature is recorded during May ( C) while mean annual minimum temperature recorded during January is ( C). The maximum summer temperature is C and minimum winter temperature is C. 5. Planning Brief The proposed project of Ria Organics Pvt. Ltd. is located in notified Kurkumbh MIDC. The total plot area is 8,000 sq.m. The proposed infrastructure of the industry will be used for manufacturing of API intermediates. The power supply will be taken from MSEDCL and water supply will be provided by MIDC. Demarcated storage area will be made available for storage of hazardous waste, raw material, finished product. All the necessary safety and fire fighting measures like Fire Hydrant System, Sprinklers, Fire Detector System, Fire Extinguishers will be made available. Page 17

18 6. Proposed Infrastructure (i) Industrial Area: Notified Kurkumbh MIDC, Dist Pune, Maharashtra (ii) Residential Area: Not Applicable (iii) Green Belt: Green belt will be developed in an area of 1, sq.m. (iv) Social Infrastructure: The necessary infrastructure such as Roads, Electricity & Water supply, Common effluent treatment facility, Dedicated Fire station, Green Belt etc. are made available by MIDC. (v) Connectivity: The main/primary highway connecting the Kurkumbh MIDC to various parts of the country is Mumbai - Solapur Highway (NH 9) where as the access to the project site can be gained by the connecting roads developed by the MIDC. (vi) Drinking Water Management: The water requirement for the proposed project will be around 60 CMD which will be sourced by MIDC. (vii) Sewarage System: Domestic waste water will be sent to septic tank and the over flow of septic tank will be connected to aeration tank of ETP. (viii) Industrial Waste Management: The hazardous waste will be disposed off to Maharashtra Enviro Power Ltd. Ranjangaon, Pune - CHWTSDF. (ix) Solid waste management: The municipal solid waste generated will be disposed off through local municipal body. (x) Power Requirement & Supply/Source: The power requirement for the proposed project will be 280 kva which will be sourced through MSEDCL. 7. Rehabilitation and Resettlement (R& R) Plan The proposed project is coming up in Notified Kurkumbh MIDC which is exclusively meant for industrial developmental activities. Moreover the plot D-26/2 is a vacant land which is in custody of project proponent hence the rehabilitation and resettlement aspects are not applicable. 8. Project Schedule & Cost Estimates (i) Time schedule for the project The proposed schedule for approval & implementation is as follows: Sr. No. Description Time Cost in % 1. Obtaining all statutory permission with respect to industry 22 Months 0.85 % Page 18

19 2. Design and Engineering Plan 2 Months 4.0 % 3. Factory Set Up 20 Months % 4. Testing and Commissioning 6 Months 1.0 % 5. Actual Starting 26 Months 2.0 % (ii) Estimated cost of project The estimated cost of the proposed project is 14 crore. 9. Analysis of proposal The proposed project will generate direct and indirect employment opportunities to local people and will help in betterment of the living standard of locals. As, the industry has the export market it will add to the net foreign exchange earning of the country. The industry is committed to manufacture and supply of finished products to achieve enhanced customer satisfaction by establishing and maintaining quality management system. The safety related measures such as regular medical checkups, safety training program s, mock drill will be conducted in the industry. In view of the above points it is concluded that the project proposal will not have any significant negative impact on the environment and people on the other hand the proposed project will have positive impact by improving the socio economic aspects with employment generation. Page 19

Consultant: M/s. SADEKAR ENVIRO ENGINEERS PVT. LTD.

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