PRE-FEASIBILITY REPORT

Transcription

1 PRE-FEASIBILITY REPORT for PROPOSED EXPANSION OF EXISTING BULK DRUGS & BULK DRUG INTERMEDIATES MANUFACTUIRNG UNIT of M/s. TECHNO DRUGS & INTERMEDIATES PVT. LTD. Plot No. C-1/B/1914, GIDC Industrial Estate, Panoli , Taluka: Ankleshwar, Dist. Bharuch, Gujarat, INDIA. Prepared By: NABL Accredited Testing Laboratory ISO 9001:2008 Certified Company Aqua-Air Environmental Engineers P. Ltd. 403, Centre Point, Nr. Kadiwala School, Ring Road, Surat

2 CONTENTS Sr. No. Description Page No. 1. Executive Summary 2 2. Introduction of the Project/Background information 9 3. Project Description Site Analysis Planning Brief Proposed Infrastructure Rehabilitation and resettlement (R& R) Plan Project Schedule & Cost Estimates Analysis of Proposal (Final Recommendations) 51 1

3 1.0 EXECUTIVE SUMMARY 1.1 Company Profile M/s. Techno Drugs & Intermediates Pvt. Ltd. engaged in manufacturing bulk drugs and bulk drug intermediates manufacturing located at Plot No. C-1/B/1914, GIDC Industrial Estate, Panoli , Taluka: Ankleshwar, Dist: Bharuch, Gujarat. Now, company is going for expansion of existing manufacturing unit by increasing production capacity of existing products and addition of new products within existing premises. 1.2 Project Details List of Products along with Production Capacity Sr. No. Products LD50 CAS No. Production Quantity (Kgs/Month) Oral Oral Existing Total after (Rat) (Mouse) Proposed End Use Expansion 1 Alendronate Sodium 552 mg/kg 966 mg/kg Antiosteoporosis 2 Bisacodyl 4.3 g/kg 17.5 g/kg laxative 3 Bisphenol Intermediate mg/kg mg/kg 4 Chlorobutanol Anesthetic mg/kg mg/kg 5 Docusate laxative Sodium mg/kg mg/kg 6 Lidocaine Anesthetic mg/kg mg/kg 7 Lidocaine Anesthetic Hydrochloride mg/kg mg/kg 8 Meloxicam 83.5mg/ kg 470 mg/kg Non Sterodial anti inflamatory 9 Pyridine Nil Intermediate Hydrochloride mg/kg mg/kg 10 Riboflavin Nil Multivitamin Phosphate Sodium 11 Sodium Laxative 2

4 Picosulfate mg/kg mg/kg 12 Sodium Sulphite mg/kg 820 mg/kg 13 Treated Corn Starch mg/kg mg/kg 14 Trimetazidine Hydrochloride 15 Ibuprofen lysinate mg/kg 980 mg/kg mg/kg 300 mg/kg Nil Intermediate Nil Intermediate Beta Blocker Non Sterodial anti Inflamatory Antiosteoporosis 16 Risedronate Sodium 1700 mg/kg 1377 mg/kg 17 Sibutramine Anti-obesity HCL Monohydrate 18 Sodium Preservative Formaldehyde mg/kg mg/kg Sulfoxylate 19 Valproic Acid Intermediate mg/kg mg/kg 20 Sodium antiepileptic Valproate mg/kg mg/kg 21 Divalproex antiepileptic Sodium mg/kg mg/kg 22 Lamotrigine antiepileptic mg/kg mg/kg 23 Cetylpyridiniu Anti Becterial m Chloride mg/kg mg/kg Total Raw Materials Consumption Raw Material Consumption Quantity CAS No. (MT/MT) Alendronate Sodium 4 Amino butyric acid Phosphorous acid Phosphorous trichloride Caustic Lye Carbon Hyflow Bisacodyl 3

5 Bisphenol Acetic anhydride Solvent 7.92 Hyflow Carbon Bisphenol Phenol Pyridine-2-aldehyde Solvent Chlorobutanol Chloroform Acetone Catalyst Docusate Sodium Di-Octyl maleate Sodium metabisulfite Solvent 2.0 Hyflow Lidocaine Chloro Acetyl Chloride ,6 Xylidene Di-ethyl amine Solvent Hyflow Carbon Lidocaine Hydrochloride Lidocaine Base HCL Solvent Hyflow Carbon Meloxicam Ester Thiazole Solvent Solvent Carbon Hyflow Pyridine Hydrochloride Phosphoric Oxychloride Riboflavin Caustic

6 Riboflavin Phosphate Sodium Phosphoric Oxychloride Riboflavin Caustic Sodium Picosulfate Bisphenol Sulfamic acid Caustic Soda Flask Solvent Hyflow Carbon Sodium Sulphite Starch Sulphuric Acid Sodium Hydroxide Treated Corn Starch Starch Sulphuric Acid Sodium Hydroxide Trimetazidine Hydrochloride TrimethoxyBenzaldehyde Formic acid Piperazine Hydrochloric acid Solvent 1.8 Hyflow Carbon Ibuprofen lysinate Ibuprofen D,L Lysine Solvent 20.0 Hyflow Carbon Risedronate Sodium Phosphorous trichloride Phosphorous acid pyridine acetic acid Caustic Soda Flask Hyflow Carbon SibutramineHCl Monohydrate 1-[1-(4-Chlorophenyl)cyclobutyl]

7 methylbutyl amine Hydrochloride Formaldehyde Hyflow Carbon Solvent Sodium Formaldehyde Sulfoxylate Sodium formaldehyde sulfoxylate technical Solvent Valproic Acid Dipropylmalonic acid Sodium Valproate Valproic acid Caustic Soda Flakes Hyflow Divalproex Sodium Valproic acid Caustic Lamotrigine Hydrazine Carboximidazole 2-Cyano(2,3 dichloro phenyl) methane Solvent Hyflow Carbon Cetylpyridinium Chloride Cetyl chloride Pyridine Hyflow Carbon Water Requirement, Waste Water Generation and Treatment Existing: Total raw water requirement is KL/day (Industrial: KL/day + Domestic: 8.0 KL/day + Gardening: 0.2 KL/day) which is met through GIDC water supply. Total waste water generation is 8.75 KL/day (Industrial: 1.25 KL/day + Domestic: 7.5 KL/day). Existing industrial waste water is treated in existing ETP plant and reused/recycled in utilities. Domestic waste water is disposed of through septic tank & soak pit. 6

8 Total after proposed expansion: Total raw water requirement will be is 41.1 KL/day (Industrial: 32.3 KL/day + Domestic: 8.6 KL/day + Gardening: 0.2 KL/day) which will also meet through GIDC water supply. Total waste water generation will be 10.4 KL/day (Industrial: 1.8 KL/day + Domestic: 8.6 KL/day). Total industrial wastewater generated will be sent to CETP of M/s. Panoli Enviro Technology Ltd., Panoli for further treatment and disposal after treatment in existing ETP within premises. Domestic waste water will be disposed of through septic tank & soak pit. 1.5 Air Pollution Source and Control Management Sr. No. Stack/Vent attached to Stack Height (meter) Stack Diameter (meter) Fuel name & Quantity Type of Emission APCM Existing 1. Boiler-I (750 Kg/hr) Proposed 2. Boiler-II (400 Kg/hr) - Stand By * Natural Gas (32.53 sm 3 /day * Natural Gas (32.53 sm 3 /day) PM SO 2 NOx -- PM SO 2 NOx 3. # D.G. Set (82 KVA) Diesel 200 Liter/Month PM SO 2 NOx -- * Common Stack # To be used in emergency only. 1.6 Hazardous/Solid Waste Generation and Disposal Mode SR. TYPE OF WASTE CATEGORY QUANTITY MODE OF DISPOSAL NO. NO. EXISTING TOTAL AFTER PROPOSED EXPANSION 1 Used Spent Oil MT/Month MT/Month Collection, Storage, Transportation & given to registered reprocessor. 7

9 2 Spent Carbon /High Flow 3 Distillation Residue 4 Discarded Containers /Barrels/Liners 5 Filters and Filter material Filter cloth MT/Month 0.56 MT/Month Collection, Storage, Transportation & sent MT/Month 1.66 MT/Month for co-processing in cement industries or sent for Incineration at CHWIF of M/s. BEIL, Ankleshwar MT/Month 0.17 MT/Month Collection, Storage, Transportation, Decontamination & sell to authorized Vendor MT/Month 0.17 MT/Month Collection, Storage, Transportation & Incineration at CHWIF of M/s. BEIL, Ankleshwar. 1.7 Green Belt Total 943 m 2 land area is available at site; out of this area about 145 m 2 (15.38 %) area is covered as greenbelt and other forms of greenery. 1.8 Power & Fuel Requirements Power Requirement Sr. No. Requirement Existing Total After Existing Proposed Expansion KVA 100 KVA DGVCL (GEB) D.G. Set - 1 no. 82 KVA capacity (emergency standby) Fuel Requirement Sr. No. Fuel Existing Requirement Source After Proposed Expansion DGVCL (GEB) D.G. Set - 1 no. 82 KVA capacity (emergency standby) Total After Proposed Expansion 1. Natural Gas sm 3 /day sm 3 /day 2. Diesel 200 Liter/Month 200 Liter/Month 8

10 2.0 INTRODUCTION OF THE PROJECT/BACKGROUND INFORMATION 2.1 Identification of the project and project proponent. In case of mining project, a copy of mining lease/letter of intent should be given. Identification of the project Proposed expansion of existing Bulk Drugs and Bulk Drug Intermediates manufacturing unit. Identification of the project proponent Mr. Sameer Ganghi Dr. Vipinchandra Gandhi 2.2 Brief description of nature of the Project Proposed expansion of existing Bulk Drugs and Bulk Drug Intermediates manufacturing unit. 2.3 Need for the project and its importance to the country and or region The demand for products intended to be manufactured is increasing in domestic as well as in international market. To meet this demand, company proposes expansion of existing manufacturing unit. The project will also save forex as certain products import will be reduced. This will also generate direct and indirect employment opportunity for various levels of people. 2.4 Demands-Supply Gap Based on our informal survey of the market with various manufacturers and traders, we have found that there is a big potential for the range of the products we are planning. 2.5 Imports vs. Indigenous production Based on the current cost of indigenous raw materials and the non availability of some materials, we will have to import some of raw materials as they are not available indigenously. This will make us very competitive against imported finished products and we may export our finished products in the international market. 9

11 2.6 Export possibility We shall explore possibility of export of our products. 2.7 Domestic/Export Markets Our products have good demand in local & international markets. We shall explore possibility of export of our products. 2.8 Employment Generation (Direct and Indirect) due to project. Company will give direct employment to local skilled and unskilled people based on qualification and requirement as per prevailing norms of state government In addition to direct employment, indirect employment shall generate ancillary business to some extent for the local population. 3.0 Project Description 3.1 Type of Project including interlinked and interdependent projects, if any. No interlinked project has been submitted. 3.2 Location (map showing general location, specific location and project boundary & project site layout) with coordinates. Map showing general location Techno Drugs & Intermediates Pvt. Ltd. 10

12 Specific location and project boundary (Google Map) 11

13 Plot Layout 12

14 3.3 Details of alternate sites considered and the basis of selecting the proposed site, particularly the environmental considerations gone into should be highlighted. Major factors involved in the selection of site are listed below: Site is very well connected by road and rail Proximity to common effluent treatment and hazardous/solid waste disposal facilities Availability of sufficient land free from cultivation Availability of water for industrial use Availability of power evacuation facilities Efficient transport facilities within the industrial estate and to & fro the city area. Environment-friendly zone. Uninterrupted power supply. 3.4 Size or Magnitude of Operation Reference: Section-1.0, Sub-section 1.2, Pages No. 2-3 of this report. 3.5 Project Description with process details (a schematic diagram/flow chart showing the project layout, components of the project, etc. should be given) For list of Products along with Production Capacity and Raw Materials Consumption Refer Section-1.0, Sub-section 1.2, Pages No. 2-6 of this report. For Plot Layout Refer: Section-3.2, Pages No. 12 of this report. Brief Manufacturing Process Description Alendronate Sodium Process Description: 4-amino butyric acid is mixed with phosphorous acid and phosphorous trichloride at controlled temperature. The ph is adjusted with sodium hydroxide and filtered to get Alendronate sodium. 13

15 Chemical Reaction: + 4-Amino Butyric Acid M.W: Phosphorous acid MW: Phosphorous Trichloride MW: Caustic MW: H20 Water MW: 18 3HCl + Hydrochloric acid MW H 2 O Alendronate Sodium Trihydrate MW: Mass Balance: Input 4 Amino butyric acid Phosphorous acid Phosphorous trichloride Caustic Lye Process Water Wash water Scrubbing Carbon Hyflow TOTAL Kgs Output Product Drying Loss Solid Waste Water reuse for product Ml + Washing TOTAL Kgs

16 Bisacodyl Process Description: Bisphenol is reacted with acetic anhydride to form Bisacodyl. Chemical Reaction: Solvent + + H 2 O BISPHENOL MW: Mass Balance: ACETIC ANHYDRIDE MW: BISACODYL MW: Input Kgs Output Kgs Bisphenol Product Acetic anhydride Drying Loss Solvent ML + Solvent Process Water Solid Waste Hyflow Solvent Recovery Carbon Reuse Water Wash Water TOTAL TOTAL

17 Bisphenol Process Description: Phenol is condensed with Pyridine-2-Aldehyde in a suitable solvent to give Bisphenol. Chemical Reaction: H 2 O PHENOL MW:94.11 PYRIDINE -2- ALDEHYDE MW: BISPHENOL MW: Mass Balance: Input Kgs Output Kgs phenol Product Pyridine-2-aldehyde Drying Loss Solvent ML + Washing Wash Water Solvent Recovery TOTAL TOTAL

18 Chlorobutanol Process Description: Acetone is added to chloroform and heated at 80 deg. C. On completion of reaction the product is crystallized, filtered and dried. Chemical Reaction: Base CHCl3 + H3CCOCH3 + ½ H 2 O CHLOROFORM ACETONE MW MW CHLOROBUTANOL HEMIHYDRATE MW: Mass Balance: Input Kgs Output Kgs Chloroform Product Acetone Drying Loss Process Water Solid Water Catalyst Ml + Washing Wash water Reuse Water Solvent Recovery TOTAL TOTAL

19 Docusate Sodium Process Description: Charge Di-octyl maleate and sodium bisulfite in a reactor and reflux. Evaporate the sample to give Docusate Sodium. Chemical Reaction: + Na 2 O 5 S 2 + H 2 O DI-OCTYL MALEATE MW:340 Sodium Metabisulfite MW: Na 2 SO 3 DOCUSATE SODIUM MW: Sodium Sulfite Mass Balance: Input Kgs Output Kgs Di-octyl maleate Product Sodium metabisulfite Drying Loss Solvent ML + Washing Process Water Solid Waste Wash water Solvent Recovery Hyflow TOTAL TOTAL

20 Lidocaine Process Description: 2,6-Xylidene is reacted with chloroacetyl chloride and di-ethyl amine to give Lidocaine. Chemical Reaction: 2,6-Xylidine MW: Chloroacetyl Chloride MW: 113 Di-ethylamine MW: HCl LIDOCAINE MW: Mass Balance: Input Kgs Output Kgs Chloroacetyl Chloride Product ,6 Xylidene Drying Loss Di-ethyl amine Solvent Recovery Solvent ML + Solvent Wash water Solid Waste Hyflow Carbon TOTAL TOTAL

21 Lidocaine Hydrochloride Process Description: Lidocaine base is reacted with IPA HCl to form Lidocaine HCl. Chemical Reaction: \ + HCl + H 2 O IPA/HCl LIDOCAINE BASE MW: MW 36.5 MW: 18 LIDOCAINE HCL MW:288.8 Mass Balance: Input Kgs Output Kgs Lidocaine Base Product HCL Drying Loss Solvent ML + Solvent Wash water Solid Waste Hyflow ML + Washing Carbon TOTAL TOTAL

22 Meloxicam Process Description: Ester is condensed with 2-amino-5-methyl thiazole in an appropriate solvent to give Meloxicam. Chemical Reaction: ESTER MW: CH N S + + H 2 N 2-Amino-5-Methyl thiazo Solvent O OH S N O MELOXICAM MW: H CON CH 3 N S CH 3 + ISOPROPYL ALCOHOL MW:60.09 Mass Balance: Input Kgs Output Kgs Ester Product Thiazole Drying Loss Solvent Solvent Recovery Solvent Solid Waste Wash water Ml + Washing Carbon Hyflow TOTAL TOTAL

23 Pyridine Hydrochloride Process Description: First react phosphoric oxychloride with water and converted into phosphoric monochloride and liberate the HCL gas by hydrolysis. After the isolated of phosphoric monochloride reacted with Riboflavin in present of Sodium Hydroxide & water and converted to Riboflavin phosphate sodium and Pyridine HCl. Chemical Reaction: + 2H2O POHO2Cl + 2HCl Phosphoricoxychloride (POCl3) + O=PCl₃ + 2H₂O + POH2O2Cl caustic & H2O C 5 H 5 N HCl + C 17 H 2 20N 4 O 6 Sodium Phosphate Riboflavin Pyridine Hydrochloride Riboflavin Mass Balance: Input (Kg) Phosphoric Oxychloride (POCl3) Output (Kg) POH2O2Cl 2H2O Total HCl Input (Kg) Riboflavin Output (Kg) Pyridine Hydrochloride POH2O2Cl Riboflavin phosphate sodium Caustic 40 HCl H2O 18 Total

24 Riboflavin Phosphate Sodium Process Description: First react phosphoric oxychloride with water and converted into phosphoric monochloride and liberate the HCL gas by hydrolysis. After the isolated of phosphoric monochloride reacted with Riboflavin in present of Sodium Hydroxide & water and converted to Riboflavin phosphate sodium and Pyridine HCl. Chemical Reaction: + 2H2O POHO2Cl + 2HCl Phosphoricoxychloride (POCl3) + O=PCl₃ + 2H₂O + POH2O2Cl caustic & H2O C 17 H 20 N 4 O 6 + C5H 5 5 N HCl Riboflavin Sodium Phosphate Riboflavin Mass Balance: Input (Kg) Phosphoric Oxychloride(POCl3) 2H2O Total Output (Kg) POH2O2Cl 36 2HCl Input (Kg) Riboflavin Output (Kg) Riboflavin phosphate sodium POH2O2Cl HCl Caustic 40 Pyridine Hydrochloride H2O 18 Total

25 Sodium Picosulfate Process Description: Bisphenol on reaction with Sulfamic acid gives Sodium Picosulfate. Methanol is reused after distillation. Excess of Ethyl acetate and Sulfamic acid are re-used. Chemical Reaction: NaOH Solvent BISPHENOL MW: Mass Balance: SULFAMIC ACID MW: Sodium Picosulfate + NH3 + NH 3 +3 H 2 O Input Kgs Output Kgs Bisphenol Product Sulfamic acid Drying Loss Caustic Soda Flask Solid Waste Solvent Ml + Washing Wash Water Solvent Recovery Hyflow Carbon TOTAL TOTAL

26 Sodium Sulphite Process Description: As per process we had received technical starch and add Sulphuric Acid for breaking chain. After breaking of polymer chain reaction mass take in Caustic solution which is reacted with Sulphuric acid and this Sulphuric & Sodium Hydroxide solution converted in Aq. Sodium sulphite. After concentration and evaporation of water final get the dried sodium sulphite. Chemical Reaction: + Sulphuric Acid Sodium Sulphite + Starch (C6H10O5)n Mass Balance: Input (Kg) Starch Sulphuric Acid Sodium Hydroxide 2H2O Total Output (Kg) 100 Sodium Sulphite 10 Starch 20 Water

27 Treated Corn Starch Process Description: As per process we had received technical starch and add Sulphuric Acid for breaking chain. After breaking of polymer chain reaction mass take in Caustic solution which is reacted with Sulphuric acid and this Sulphuric & Sodium Hydroxide solution converted in Aq. Sodium sulphite and Treated Corn Starch. Chemical Reaction: Chemical Reaction: + Sulphuric Acid + Sodium Sulphite Mass Balance: Input (Kg) Starch Sulphuric Acid Sodium Hydroxide 2H2O Total Output (Kg) 100 Treated Corn Starch 10 Water 20 Sodium Sulphite

28 Trimetazidine Hydrochloride Process Description: Trimethoxy Benzaldehyde is reacted with Piperazine in presence of formic acid to form the base. The base is reacted with IPA-HCl to form Trimetazidine Hydrochloride. Chemical Reaction: MW:44 + HCOOH HCL Trimethoxybenzaldehyde Formic acid Piperazine MW:196 W:46.03 MW: IPA/HCL TRIMETAZIDINE DIHYDROCHLORIDE MW: H 2 O Mass Balance: Input Kgs Output Kgs Trimethoxy Benzaldehyde Product Formic acid Drying Loss Piperazine ML + Washing Hydrochloric acid Solid Waste Solvent Solvent Recovery Wash Water Hyflow Carbon TOTAL TOTAL

29 Ibuprofen lysinate Process Description: Ibuprofen is treated with Lysine in a solvent and suitable reaction conditions to give Ibuprofen Lysinate. Chemical Reaction: IBUPROFEN MW: solvent D,L-Lysine MW: Ibuprofen lysinate MW : 353 Mass Balance: Input Kgs Output Kgs Ibuprofen Product D,L Lysine Drying Loss Solvent ML + Solvent Wash water Solid Waste Hyflow Ml + Washing Carbon TOTAL TOTAL

30 Risedronate Sodium Process Description: 3-Pyridine Acetic Acid, Phosphorous Acid And Phosphorous Trichloride and caustic are reacted together to give Risedronate sodium. Chemical Reaction: + + Phosphorous Trichloride MW: Phosphorous acid MW:82 3-Pyridine Acetic acid MW NaOH + + Caustic + H 2 O.2.5 H 2 O + 3HCl Risedronate Sodium MW: Mass Balance: Input Phosphorous trichloride Kgs Output Product Kgs Phosphorous acid Drying Loss pyridine acetic acid Solvent Recovery Caustic Soda Flask Solid Waste Process water ML + Washing Solvent Wash Water Hyflow Carbon TOTAL TOTAL

31 Sibutramine HCl Monohydrate Process Description: 1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutylamine Hydrochloride is reacted with formaldehyde in presence of, formic acid and sodium bicarbonate to form Sibutramine hydrochloride monohydrate. Chemical Reaction: [1-(4-Chlorophenyl)cyclobutyl]-3- methylbutylamine Hydrochloride MW:292 FORMALDEHYDE MW:30.03 Formic acid NAHCO 3 Mass Balance: Sibutramine Hydrochloride MW: H 2 O Input Kgs Output Kgs 1-[1-(4-Chlorophenyl) Product cyclobutyl]-3-methylbutyl amine Hydrochloride Formaldehyde Drying Loss Wash Water ML + Washing Hyflow Solid Waste Carbon Solvent Recovery Solvent TOTAL TOTAL

32 Sodium Formaldehyde Sulfoxylate Process Description: Sodium formaldehyde sulfoxylate technical is recrystallized, dried and pulverized to Sodium formaldehyde sulfoxylate pure. Chemical Reaction: SODIUM FORMALDEHYDE SULFOXYLATE TECHNICAL MW:118.1 SODIUM FORMALDEHYDE SULFOXYLATE PURE MW:118.1 Mass Balance: Input Kgs Output Kgs Sodium formaldehyde Product sulfoxylate technical Solvent Drying Loss Wash Water Solvent Recovery ML + Wash Water TOTAL TOTAL

33 Valproic Acid Process Description: DipropylMalonic acid is heated to boiling to give valproic acid. Chemical Reaction: Heat + CO 2 DIPROPYL MALONIC ACID MW : VALPROIC ACID MW: MW: 44 Mass Balance: Input Kgs Output Kgs Dipropyl malonic acid Product Wash Water Drying Loss ML + Wash water TOTAL TOTAL

34 Sodium Valproate Process Description: Valproic acid is dissolved in suitable solvent and ph is adjusted to get Sodium valproate. Chemical Reaction: Heat + NaOH + H 2 O VALPROIC ACID MW: SODIUM VALPROATE MW: 166 Mass Balance: Input Kgs Output Kgs Valproic acid Product Caustic Soda Flakes Drying Loss Wash water ML + Wash Hyflow TOTAL TOTAL

35 Divalproex Sodium Process Description: Valproic acid is dissolved in suitable solvent and ph is adjusted to give Divalproex sodium. Chemical Reaction: Heat 2 + NaOH + H 2 O VALPROIC ACID MW: DIVALPROEX SODIUM MW:310.4 Mass Balance: Input Kgs Output Kgs Valproic acid Product Caustic Drying Loss Wash water ML + Wash TOTAL TOTAL

36 Lamotrigine Process Description: Hydrazine Carboximidazole 2-Cyano(2,3 dichloro phenyl) methane and Process water is added in methanol at C. Temperature is raised up to 74±5 C to attain reflux and maintained for 5 hours. Reaction mass is given carbon treatment and maintained for 1 hour at 74±5 C. Reaction mass is further filtered, cooled to C and maintained for 2 hours, cooled to 10±5 C and maintained for 2 hours. Wet cake is centrifuged, dried and milled to get Lamotrigine. Chemical Reaction: Methanol/H 2 O Hydrazine Carboximidazole 2- Cyano(2,3 dichloro phenyl) methane MW:256 Heat LAMOTRIGINE MW:256.1 Mass Balance: Input Kgs Output Kgs Hydrazine Product Carboximidazole 2- Cyano(2,3 dichloro phenyl) methane Solvent Drying Loss Wash water ML + Wash Hyflow Solid Waste Carbon Solvent Recovery TOTAL TOTAL

37 Cetylpyridinium Chloride Process Description: Cetyl Chloride is reacted with Pyridine to form Cetyl Pyridinium Chloride which is purified to give pure Cetyl Pyridinium Chloride. Chemical Reaction: + + H 2 O CETYL CHLORIDE MW PYRIDINE MW: WATER MW 18 CETYLPYRIDINIUM CHLORIDE MW: Mass Balance: Input Kgs Output Kgs Cetyl chloride Product Pyridine Drying Loss Solvent ML + Solvent Solvent Solid Waste Water Washing Ml + washing Hyflow Carbon TOTAL TOTAL Raw Material required along with estimated quantity, likely source, marketing area of final product/s, mode of transport of raw material and Finished product. For raw materials along with consumption quantities - Reference: Section-1.0, Sub-section 1.3, Pages No. 3-6 of this report. We will procure raw materials (as and when require) as much as possible from domestic market. 36

38 3.7 Resource optimization/recycling and reuse envisaged in the project, if any, should be briefly outlined. Resource optimization/recycling and reuse shall be envisaged. 3.8 Availability of water, its source, energy/power requirement and source should be given. Raw water requirement is met through GIDC water supply. And will meet through the same source after proposed expansion. Power & Fuel Requirement Reference: Section-1.0, Sub-section 1.8, Page No. 8 of this report. 3.9 Quantity of wastes to be generated (liquid and solid) and scheme for their management/disposal. Reference: Form-I, Annexure-4, 5 & Schematic representations of the feasibility drawing which give information of EIA purpose. ACTIVITIES OVERVIEW OF E. I. A. STUDIES SOURCE OF INFORMATION RECONNAISSANCE SURVEY OF EXISTING PLANT MONITORING OF AIR, WATER & SOIL QUALITY & NOISE LEVELS. DATA ON METEOROLOGY SOCIO-ECONOMIC STATUS & BASIC AMENITIES. SITE VISITS BY AND INTERVIEWS WITH LOCALS INTRODUCTION BASELINE ENVIRONMENTAL STATUS SOCIOECONOMIC STATUS & INFRASTRUCTURE PROPOSED PLANT ANNUAL REPORT MARKET ASSESSMENT FINANCIAL REPORT PROJECT REPORT ENVIRONMENTAL INFORMATION CENTRE CENTRAL GROUND WATER BOARD GUJARAT POLLUTION CONTROL BOARD (GPCB) PUBLIC HEALTH ENGINEERING DEPT. AGRICULTURE DEPARTMENT FOREST DEPARTMENT IRRIGATION DEPARTMENT EMPLOYMENT EXCHANGE HEALTH CENTER CENSUS DEPT. INDIAN METEOROLOGICAL DEPT. IDENTIFICATION & ASSESSMENT OF IMPACTS EVALUATION OF IMPACTS BY MATRIX METHOD DESCRIPTION OF EFFLUENT TREATMENT PLAN, AIR POLLUTION CONTROL, HAZARDOUS WASTE MANAGEMENT, GREEN BELT DEVELOPMENT MONITORING PROGRAM 4.0 Site Analysis IMPACTS METHODOLOGY OF IMPACT ASSESSMENT ENVIRONMENTAL MANAGEMENT PLAN FACILITY DESCRIPTION CONSEQUENCE ANALYSIS PREPARATION OF DISASTER MANAGEMENT PLAN RISK ANALYSIS STUDIES & DISASTER MANAGEMENT PLAN SAFETY, HEALTH & ENVIRONMENTAL POLICY, GUIDELINES BY DIRECTOR GENERAL OF FACTORY SAFETY, MINISTRY OF LABOR. 37

39 4.1 Connectivity Site is very well connected by road and rail. Availability of water, power, etc. 4.2 Land Form, Land Use and Land Ownership (Courtesy: Environmental Information Center, New Delhi) 4.3 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 forests, national park, wild life sanctuary, eco sensitive areas, water bodies (distance from HFL of the river), CRZ. In case of the notified industrial area, a copy of the Gazette notification should be given. 38

40 (Courtesy: Environmental Information Center, New Delhi) AREAS UNDER DIFFERENT LANDUSE SR. NO. LANDUSE CLASSIFICATION AREA WITHIN 10 KM OF PROJECT LOCATION 1 Agriculture Fallow Land Habitation, Settlement Marshy Land Miscellaneous Land Degraded Vegetation Water Open & Barren Land River Total (Courtesy: Environmental Information Center, New Delhi) PERCENTAGE OF TOTAL AREA CRZ Clearance is not applicable. 39

41 4.4 Existing Infrastructure Site is very well connected by road and rail Proximity to common effluent treatment and hazardous/solid waste disposal facilities Availability of sufficient land free from cultivation Availability of water for industrial use Availability of power evacuation facilities Efficient transport facilities within the industrial estate and to & fro the city area. Environment-friendly zone. Uninterrupted power supply. 40

42 4.5 Soil Classification Soil Characteristics under project area are as below Table; Map ping Cate gory Area in (Sq km) Description Taxono my1 Taxono my2 Class Sub_Cla ss Soil Unit (Order) Physiogr aphy Depth Erosion Drainage Surf ace Text ure ph Salinit y/alk alinity Calc areo usne ss Fertility B C Very deep, moderately well drained, fine soils on very gently sloping basalic interfluves with slight erosion; associated with deep well drained, calareous fine soils with slight erosion 0.12 Very deep, moderately well drained, fine soils on very gently sloping basaltic interfluves with moderate erosion; associated with very deep, well drained, fine soils with moderate erosion Fine, montrm orilloniti c, hyperth ermic Typic Chromu sterts Fine, montmo rillonitic, hyperth ermic Typic Chromu sters Fine, montmo rillonitic (calcare ous) hyperth ermic Vertic Ustochr epts Fine, montmo rillonitic, hyperth ermic Vertic Ustochr epts Soils of west coast (soils of Gujarat plain) Soils of west coast (soils of Gujarat plain) Soils of interfluv es Soils of interfluv es Vertisol/ Inceptisol Vertisol/ Inceptisol Very Gently sloping Very Gently sloping Very Deep- Deep Very Deep Slight Moderat e Mod. Well Mod. Well Fine Neutral Nil Calca reou s Medium Fine Neutral Nil Nil Medium 41

43 D G Very deep, moderately well drained, fine soils on nearly level alluvial plain with slight erosion and slight salinity; associated with deep, moderately well drained calcareous fine soils with slight erosion and slight salinity Very deep, moderately well drained, fine soils on very gently sloping alluvial plain with moderate erosion; associated with very deep, moderately well drained, fine soils on nearly level lands with slight erosion. Fine, montmo rillonitic, isohyper thermic Vertic Ustrope pts Fine, montmo rillonitic, hyperth ermic Typic Chromu sters Fine, montmo rillonitic (calcare ous), isohyper thermic Vertic Ustrope pts Fine, montmo rillonitic, hyperth ermic Vertic Ustochr epts Soils of west coast (soils of Gujarat plain) Soils of west coast (soils of Gujarat plain) Soils of alluvial plains Soils of alluvial plains Inceptisol Nearly level alluvial Vertisol Very gently sloping V.Deep- Deep Very Deep Slight Sligt- Mod. Mod. Well Mod. Well Fine Slightly alkalin e Fine Soil Slightly alkalin e Slight Salinit y Calca reou s Medium Nil Nil Medium 42

44 H J Very deep, moderately well drained, fine soils on neraly level alluvial plain with slight erosion; associated with very deep moderately well drained, calcareous, fine soils on gently sloping lands with severe erosion 1.36 Very deep, moderately well drained, fine soils on very gently sloping alluvial plain with moderate erosion and moderate salinity; associated with very deep, moderately well drained calcareous, fine soils with moderate erosion Fine, montmo rillonitic, hyperth ermic Typic Chromu sterts Fine, montmo rillonitic, isohyper thermic Typic Chromu sterts Fine, montmo rillonitic (calcare ous), hyperth ermic Typic Chromu sterts Fine, montmo rillonitic, (calcare ous), hyperth ermic Udic Chromu sterts Soils of west coast (soils of Gujarat plain) Soils of west coast (soils of Gujarat plain) Soils of alluvial plains Soils of alluvial plains Vertisol Vertisol Nearly level aluvial Very gently sloping Very Deep Very Deep Slight- Severe Moderat e Mod. Well Mod. Well Fine Soil Fine Soil Slightly alkalin e Slightly alkalin e Nil Nil Low- Medium Mode rate Nil Low- Medium 43

45 K L 7.83 Moderately deep, moderately well drained, fine soils on nearly level alluvial plain with slight erosion and moderate salinity; associated with very deep, moderately well drained, calcareous, fine soils with slight erosion and slight salinity 1.31 Very deep, moderately well drained, fine soils on nearly level alluvial plain with slight erosion and moderate salinity; associated with very deep, imperfectly drained, calcareous, very fine soils with slight erosion and moderate salinity Fine, montmo rillonitic, isohyper thermic Typic Chromu sterts Fine, montmo rillonitic, isohyper thermic Typic Chromu sterts Fine, montmo rillonitic, (calcare ous), isohyper thermic Udic Chromu sterts Veryfine, montmo rillonitic (calcare ous), isohyper thermic Udit Chromu sterts Soils of west coast (soils of Gujarat plain) Soils of west coast (soils of Gujarat plain) (Courtesy: Environmental Information Centre, New Delhi) Soils of alluvial plains Soils of alluvial plains Vertisol Vertisol Nearly level Nearly level Mod. Deep- V.Deep Very Deep Slight Erosion Slight Erosion Well- Mod. Weel Drained- Fine Soils Fine Soils- V.Fin e Soils Slightly alkalin e Slightly alkalin e Mode rate Mode rate Nil Nil Medium Medium 44

46 SOIL CHARACTERISTICS MAP (Courtesy: Environmental Information Centre, New Delhi) 4.6 Climatic data from secondary sources. Climatic data from primary & secondary sources will be incorporated in EIA Study. 4.7 Social infrastructure available. Depending on the growth of the company the required social infrastructure will be provided. 5.0 Planning Brief 5.1 Planning Concept (type of industries, facilities, transportation etc.) Town and Country planning/development authority classification. Proposed expansion of existing Bulk Drugs and Bulk Drug Intermediates manufacturing unit. 45

47 5.2 Population Projection Population data will be incorporated in EIA report. 5.3 Land use planning (breakup along with green belt etc.) Industrial Area (Processing Area) Processing Area (Plant facilities, R&D, ETP Area and Engineering/Utility Services) = 400 m 2 (approx.) Residential Area (Non Processing Area) Non Processing Area (Green belt, Raw material storage area, finished storage area, Administration Building, Parking, road and open area) = 543 m 2 (approx.) 5.4 Assessment of Infrastructure Demand (Physical& Social) Employment will be as per prevailing norms of state government for skilled and unskilled people. Social Welfare shall be done. Cordial relation with the industry shall be established and representation shall be made to villagers for help for creation of facilities related to health, education, etc. 46

48 5.5 Amenities/Facilities Details of amenities available in study area Taluka Village Educational Medical Drinking Water Post & Telegraph Communication Approach to Village Nearest Town Power Supply Ankleshwar Bharan P(2) CWC, PHS T, W PO BS PR, KR Kosamba- 8 EA Amboli P(2) -(- 5 KMS.) W, TK PO, Phone BS PR, KR Ankleshwar-1 EA Boidara P(2) -(- 5 KMS.) T, W PO, Phone BS PR, KR Ankleshwar-1 EA Nangal P(2) CHW T, W PO, Phone BS PR, KR Ankleshwar-6 EA Hajat P(2), Ac -(- 5 KMS.) T, W PO, Phone BS PR, KR Ankleshwar-12 EA Adol P(2) PHS, FPC, CHW T, W PO BS PR, KR Ankleshwar-11 EA Umarwada P(3), O PHS, RP T, W, HP PO, Phone BS PR, KR Ankleshwar-6 EA Safipura UNINHABITED Kapodara P(2),O PHS, CHW, FPC T, W PO, Phone BS PR Ankleshwar-7 EA Bhadkodara P(2) CHW T, W PO, Phone -(- 5 KMS.) PR, KR Ankleshwar-7 EA Piraman P(3), Tr, O PHS T, W PO, Phone BS PR, KR Ankleshwar-1 EA Kosamadi P(6), O PHS, RP(3) T, W, HP PO, Phone BS PR, KR Ankleshwar-12 EA Bakrol P(2) CHW T, W, HP -(-5 KMS) BS PR, KR Ankleshwar-8 EA Sanjali P(2), O CHW T, W PO, Phone BS, RS PR, KR Ankleshwar-10 EA Alonj P(2), O CHW T, W, HP PO BS PR, KR Ankleshwar-15 EA Piludara P(2) -(10+ KMS) T, W PO, Phone BS PR Ankleshwar-13 EA Telva P(2), Ac, O CHW T, W -(-5KMS) BS PR Ankleshwar-16 EA Pardi Idris P(2) CHW T, W Po BS PR, KR Ankleshwar-12 EA Adadara P(2) CHW T, W -(-5 KMS.) BS PR Kosamba-7 EA Utiyadara P(2) -(-5 KMS) T, W -(-5 KMS) BS PR Kosamba-3 EA Karmali P(2),O -(-5 KMS) T, W Phone BS PR Ankleshwar-13 EA Ravidra P(2), O PHC, CHW T, W PO, Phone BS PR Ankleshwar-10 EA P(3), H, O H, MH, CWC, PHS, D, T, W PTO, Phone BS, RS PR Ankleshwar-10 EA FPC, NH, RP, SMP, Panoli CHW Kharod P(3), H, O CWC, PHC, CHW T, W PO, Phone BS PR, KR Ankleshwar-10 EA Bhadi P(2), O -(-5 KMS) T, W PO BS PR, KR Ankleshwar-12 EA Mangrol Hathuran P(3), Ac(3) PHS T, W, TK, TW, C PO, Phone BS, RS PR, KR Kosamba-5 EA Nana Borsara P, Ac -(5-10 kms) T, W, TK -(-5 KMS.) -(-5KMS) KR Kosamba-5 EA 47

49 Dhamdod P, Ac, O CHW T, W, TK PO BS PR, KR Kosamba-5 EA Nandvav P, Ac(2) PHS, CHW T,W, TK, C, N PO BS PR, KR Kosamba-10 EA Moti Pardi P, Ac CWC, CHW T, W, TK, C -(5-10 Kms) BS PR, KR Kosamba-16 Dinod P PHS, FPC, CHW T, W, TK PO BS KR Kosamba-8 EA Boridara P CHW T, W, TK PO BS KR Kosamba-15 EA Mahuej P, Ac(2), O PHS T, W, TW, TK, C PO, Phone BS PR, KR Surat-31 EA Hansot Ghodadara P(2), O CHW T, W, TK, C PO BS PR, KR Ankleshwar-8 EA Valia Kondh P(4), H, O PHS, D, FPC, RP, CHW T, W PO BS PR, KR Ankleshwar-12 EA (Courtesy: Census Dept., GOI) ABBREVIATIONS 1. Education P-Primary Elementary School H-Matriculation or Secondary O-Other Educational Institution PUC-Higher Secondary/Intermediate/pre-University/junior Collage AC Adult literacy class TR Training center 2. Medical Facilities RP-Registered Private Practitioner PHS-Primary Health Centre FPC-Family Planning Centre D- Dispensary CHW - Community Health Worker/Health Worker H - Hospital NH - Nursing Home MH - Maternity Home PHC - Public Health Centre CWC - Child Welfare Centre TB - T.B Clinic O Others 3. Drinking Water T-Tap Water HP-Hand Pump TK-Tank Water W-Well Water R-River Water C-Canal N - Nallah S Spring 4. Post & Telegraph PO-Post Office PTO-Post & Telegraph Phone-Telephone Communication 5. Transportation RS- Railway Station BS-Bus Station NW-Navigable Waterway 6. Approach to Village PR-Pucca Road KR-Kuccha Road 7. Power Supply EA-Electricity for all purposes EAG - Electricity for Agriculture ED - Electricity for domestic EO - Electricity for other purpose like Industrial, Commercial etc. 48

50 6.0 Proposed Infrastructure 6.1 Industrial Area (Processing Area) Processing Area (Plant facilities, R&D, ETP Area and Engineering/Utility Services) = 400 m 2 (approx.) 6.2 Residential Area (Non Processing Area) Non Processing Area (Green belt, Raw material storage area, finished storage area, Administration Building, Parking, road and open area) = 543 m 2 (approx.) 6.3 Green Belt Total 943 m 2 land area is available at site; out of this area about 145 m 2 (15.38 %) area is covered as greenbelt and other forms of greenery. 6.4 Social Infrastructure Water Supply by GIDC. Power supply by DGVCL and D.G. Sets (emergency standby) 6.5 Connectivity (Traffic and Transportation Road/ Rail/Metro/ Water ways etc.) Major factors involved in the selection of site are listed below: Site is very well connected by road and rail Proximity to common effluent treatment and hazardous/solid waste disposal facilities Availability of sufficient land free from cultivation Availability of water for industrial use Availability of power evacuation facilities Efficient transport facilities within the industrial estate and to & fro the city area. Environment-friendly zone. Uninterrupted power supply. 49

51 6.6 Drinking water Management (Source & Supply of water) Total water requirement is and shall be met through GIDC water supply. 6.7 Sewerage System Sewage pipes are laid in entire premises for the removal and disposal of mainly non-harmful liquid wastes from offices, canteen and domestic waste to be came from different sections of unit. These liquid wastes are sent to septic tank & soak pit. The same system will be followed after proposed expansion. 6.8 Solid Waste Management Reference: Section-1.0, sub-section 1.6, Page No. 7-8 of this report. 6.9 Power Requirement & Supply/Source Reference: Section-1.0, sub-section 1.8, Page No. 8 of this report. 7.0 Rehabilitation and Resettlement (R& R) Plan 7.1 Policy to be adopted (central/state) in respect of the project affected including home oustees, land oustees and landless laborers (a brief outline to be given) Proposed expansion activity will be carried out within GIDC, Panoli, Taluka: Ankleshwar so there is no habitation on proposed project area, so R & R policy is not applicable to this project. There shall not be displacement of any population in proposed expansion project. Proposed expansion project will likely boost the commercial and economical status of the locality up to some extent. 8. Project Schedule & Cost Estimates 8.1 Likely date of start of construction and likely date of completion (Time schedule for the project to be given). We shall start construction after getting EC and shall start operation after applying for CCA. 50

52 8.2 Estimated Project cost along with analysis in terms of economic viability of the project. Total capital investment for the proposed expansion project is Rs. 2.0 crores. 9. Analysis of Proposal (Final Recommendations) 9.1 Financial and social benefits with special emphasis on the benefit to be local people including tribal population, if any, in the area. Employment will be as per prevailing norms of state government for skilled and unskilled people for the proposed project. Social Welfare shall be done. Cordial relation with the industry shall be established and representation shall be made to villagers for help for creation of facilities related to health, education, etc. 51