ACTERO PHARMA PVT. LTD. SY.NO. 407 (PART) AND 411, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA

DRAFT EIA REPORT

1. ENVIRONMENTAL IMPACT ASSESSMENT 2. ENVIRONMENT MANAGEMENT PLAN 3. COMPLIANCE OF TERMS OF REFERENCE 4. ANNEXURES

Project No. 0118‐21‐03 January 2018

M/s. Actero Pharma Pvt. Ltd. STUDIES AND DOCUMENTATION BY C/o. Hetero Drugs Limited TEAM Labs and Consultants Plot No: 7‐2‐A2 Hetero Corp, Industrial Estate, B‐115‐117 & 509, Annapurna Block, Sanathnagar, Hyderabad‐500018 Aditya Enclave, Ameerpet, Phone: 040‐23704923/23704924 Hyderabad‐500 038. E‐mail: [email protected]; Phone: 040‐23748 555/23748616, [email protected] Telefax: 040‐23748666

SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD, REGIONAL OFFICE, NALGONDA ACTERO PHARMA PVT. LTD. SY.NO. 407 (PART) AND 411, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA

1. ENVIRONMENTAL IMPACT ASSESSMENT REPORT

Project No. 0118‐21‐03 January 2018

M/s. Actero Pharma Pvt. Ltd. STUDIES AND DOCUMENTATION BY C/o. Hetero Drugs Limited TEAM Labs and Consultants Plot No: 7‐2‐A2 Hetero Corp, Industrial Estate, B‐115‐117 & 509, Annapurna Block, Sanathnagar, Hyderabad‐500018 Aditya Enclave, Ameerpet, Phone: 040‐23704923/23704924 Hyderabad‐500 038. E‐mail: [email protected]; Phone: 040‐23748 555/23748616, [email protected] Telefax: 040‐23748666

SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD, REGIONAL OFFICE, NALGONDA Actero Pharma Pvt. Ltd., Contents CONTENTS

Section Description Page No.

1.0 Introduction of The Project 1-1 1.1 Product Profile 1-3 1.2 Technology 1-4 1.3 Plant Location & Layout 1-4 1.4 Scope of EIA Studies 1-8

2 Process Description and Pollution control Facilities 2-1 2.1 Process Description 2-2 2.1.1 Process Description of Abiraterone Acetate 2-2 2.1.2 Process Description of Afatinib 2-6 2.1.3 Process Description of Anastrazole 2-12 2.1.4 Process Description of Bicalutamide 2-15 2.1.5 Process Description of Bendamustine HCl 2-17 2.1.6 Process Description of Bexarotene 2-20 2.1.7 Process Description of Bosutinib 2-23 2.1.8 Process Description of Capecitabine 2-28 2.1.9 Process Description of Carfilzomib 2-30 2.1.10 Process Description of Ceritinib 2-34 2.1.11 Process Description of Cyclophosphamide 2-37 2.1.12 Process Description of Dasatinib 2-39 2.1.13 Process Description of Docetaxel 2-41 2.1.14 Process Description of Enzalutamide 2-43 2.1.15 Process Description of Erlotinib HCl 2-48 2.1.16 Process Description of Gefitinib 2-50 2.1.17 Process Description of Gemcitabine HCl 2-52 2.1.18 Process Description of Ibrutinib 2-55 2.1.19 Process Description of Imatinib Mesylate 2-60 2.1.20 Process Description of Lapatanib 2-63 2.1.21 Process Description of Lenvatinib 2-66 2.1.22 Process Description of Olaparib 2-67 2.1.23 Process Description of Palbociclib 2-72 2.1.24 Process Description of Pazopanib 2-76 2.1.25 Process Description of Sorefinib 2-78 2.1.26 Process Description of Sunitinib 2-80 2.1.27 Process Description of Tamoxifene 2-82 2.2 Utilities 2-84 2.3 Water Requirement 2-84 2.4 Pollution Control Facilities 2-86 2.4.1 Water Pollution 2-86 2.4.1.1 Process Description and Technical Specification of Effluent Treatment System 2-91 2.4.2 Air Pollution 2-97 2.4.2.1 Emissions from Utilities 2-98 2.4.2.2 Emissions from Process 2-99 2.4.2.3 Diffuse Emissions 2-101 2.4.2.4 Fugitive Emissions 2-101 Actero Pharma Pvt. Ltd., Contents 2.4.3 Solvent Use and Recycle 2-102 2.4.4 Solid Waste 2-109 2.4.5 Noise Pollution 2-115 3.0 Baseline Environmental Status 3-1 3.1 Introduction 3-1 3.2 Land Environment 3-1 3.2.1 Physiography 3-1 3.2.2 Geology 3-5 3.2.3 Hydrogeology 3-7 3.2.4 Soils 3-9 3.3 Water environment 3-14 3.3.1 Surface Water Resources 3-14 3.3.1.1 Surface water Quality 3-14 3.3.1.2 Ground Water resources 3-15 3.3.1.3 Quality Of Ground Water 3-15 3.4 Air environment 3-20 3.4.1 Meteorology 3-20 3.4.2 Meteorological Station at Plant Site 3-23 3.4.3 Ambient air quality 3-26 3.4.4 Scope of field study 3-28 3.4.5 Description of sampling locations 3-30 3.4.6 Ambient Air Quality Status 3-32 3.4.7 Noise environment 3-34 3.4.8 Traffic Study 3-36 3.5 Socio economic environment 3-37 3.6 Demography 3-37 3.6.1 Population Distribution 3-38 3.6.1.1 Literacy 3-39 3.6.1.2 Employment/Occupation 3-39 3.6.1.3 Living standards and Infrastructure 3-42 3.6.2 Land Utilization 3-44 3.6.3 Project Economy 3-44 3.7 Flora and Fauna 3-45

4 Identification of Impacts 4.1 Identification of Impacts 4-1 4.1.1 Impact Networks 4-1 4.2 Prediction of Impacts 4-8 4.2.1 Air Environment 4-8 4.2.1.1 Details of Mathematical Modeling 4-9 4.2.1.2 Utility Emissions 4-12 4.2.1.3 Air Quality Predictions 4-13 4.2.1.4 Prediction of Concentration of Solvents in the Indoor Environment Due to 4-21 Solvent Loss and Fugitive Emissions 4.2.2 Water Environment 4-22 4.2.3 Noise Environment 4-23 4.2.3.1 Prediction of Impact on Noise Quality 4-23 4.2.4 Land Environment 4-24 4.2.5 Biological Environment 4-25 Actero Pharma Pvt. Ltd., Contents 4.2.6 Socio-economic Environment 4-26 4.2.7 Prediction of Impact on Vehicular Traffic 4-26

5 Analysis of Alternatives 5-1 5.1 Alternative sites 5-1 5.2 Alternative in Process 5-1 5.2.1 Alternatives in Technology 5-2 5.2.2 Alternatives in treatment/mitigation options 5-3

6 Environmental Monitoring 6-1 6.1.1 Introduction 6-1 6.1.2 Objectives 6-1 6.1.3 Methodology 6-1 6.1.4 Ambient Air Quality (AAQ) Monitoring 6-2 6.1.5 Water Quality Monitoring 6-3 6.1.6 Noise Level Monitoring 6-8 6.1.7 Responsibility of Monitoring And Reporting System 6-9 6.1.7.1 Work Zone Monitoring for Hazardous Chemicals 6-10 6.2 Environmental Monitoring Budget 6-10

7 Risk Assessment and Damage Control 7-1 7.0 Introduction 7-1 7.1 Objectives and Scope 7-1 7.2 Project Details 7-2 7.3 Process Description 7-10 7.4 Plant Facilities 7-10 7.4.1 Production Blocks 7-10 7.4.2 Utilities 7-10 7.4.3 Quality Control, R&D Lab 7-11 7.4.4 ETP and Solid Waste storage 7-11 7.4.5 Ware Houses 7-11 7.4.6 Tank Farm Area 7-11 7.4.7 Cylinders Storage Area 7-12 7.4.8 Administrative Office 7-12 7.4.9 House Keeping 7-12 7.4.10 Coal and Ash Storage 7-12 7.4.11 Facility Layout and Design 7-12 7.5 Hazard Analysis and Risk Assessment 7-16 7.5.1 Introduction 7-16 7.5.2 Hazard Identification 7-16 7.5.3 Fire & Explosion Index (F & EI) 7-20 7.5.3.1 Methodology 7-20 7.5.4 Hazard and Operability Study (HAZOP) 7-22 7.5.5 Hazard Factors 7-23 7.5.6 Common Causes of Accidents 7-24 7.6 Maximum Credible Accident and Consequence Analysis (MCACA) 7-25 7.6.1 Methodology 7-26 7.6.2 Identification of Vulnerable Areas 7-26 7.6.3 Representative Accident Scenarios 7-27 7.7 Consequence Analysis 7-28 7.7.1 Release Models and Source strength 7-28 Actero Pharma Pvt. Ltd., Contents 7.7.2 Results of Consequence Analysis 7-30 7.7.2.1 Analysis of Hazardous Scenarios 7-31 7.7.2.1.1 Heat radiation effects 7-31 7.7.2.1.2 Overpressure effects 7-32 7.7.3 Observations 7-32 7.7.4 Recommendations 7-32 7.7.5 Toxic management plan 7-33 7.7.6 Transportation 7-35 7.7.7 Control measures for accidental spillage of chemicals 7-38 7.8 Disaster Management Plan 7-40 7.8.1 Introduction 7-40 7.8.2 Objectives Of Emergency Management Plan (On-Site) 7-41 7.8.3 Scope Of ONSEP 7-42 7.8.4 Methodology Of Developing ONSET 7-42 7.8.5 Element Of ONSITE Emergency Plan 7-42 7.8.5.1 Emergencies Identified 7-436 7.8.5.2 Emergency Organization 7-43 7.8.5.3 Emergency Facilities 7-43 7.8.5.4 Emergency Procedures 7-46 7.8.5.5 Rescue and Rehabilitation 7-47 7.8.5.6 Emergency Responsibilities 7-48 7.8.6 Remedial Action 7-53 7.8.7 Basic Action In Emergencies 7-54 7.8.8 Fire Fighting Operation 7-54

8 Project Benefits 8-1 8.1 Introduction 8-1 8.2 Employment Potential 8-1 8.3 Corporate Social Responsibility 8-1

9 Environment Cost Benefit Analysis 9-1

10 Environment Management Plan 10-1 10.0 Introduction 10-1 10.1 Environment Management Plan 10-2 10.1.1 Construction Phase 10-2 10.1.2 Operation Phase 10-3 10.2 Sources of Pollution from Manufacturing Process 10-3 10.2.1 Water Pollution 10-3 10.2.1.1 Process Description and Technical Specification of Effluent Treatment System 10-5 10.2.2 Air Pollution 10-11 10.2.2.1 Emissions from Utilities 10-11 10.2.2.2 Emissions from Process 10-13 10.2.2.3 Diffuse Emissions 10-15 10.2.2.4 Fugitive Emissions 10-15 10.2.2.5 Odor Management 10-16 10.2.3 Solvent Use and Recycle 10-16 10.2.4 Solid Waste 10-19 10.2.5 Noise Pollution 10-20 10.3 Rainwater Harvesting 10-21 10.4 Occupational Safety and Health 10-24 Actero Pharma Pvt. Ltd., Contents 10.4.1 Medical Check-up 10-25 10.4.2 Handling of Toxic Chemicals/Materials 10-26 10.4.3 Treatment of Workers affected by Accidental Spillage of Chemicals 10-27 10.5 Prevention, maintenance and operation of Environment Control System 10-28 10.6 House Keeping 10-28 10.7 Socio Economic Environment 10-28 10.8 Transport systems 10-30 10.9 Reduce, Recovery and Reuse 10-30 10.10 Energy Conservation 10-31 10.11 Green Belt Development 10-31 10.12 Corporate Environmental Responsibility 10-34 10.13 Environment Management Cell 10-35 10.14 CREP Guidelines and Compliance 10-36 10.15 Other Management Practices 10-36 10.16 Cost Estimate for Environment Management Plan 10-37

11 Executive Summary 11-1 11.0 Introduction 11-1 11.1 Location of the project 11-1 11.2 Product Profile 11-2 11.3 Manufacturing Process 11-3 11.4 Utilities 11-3 11.5 Water Requirement 11-3 11.6 Baseline Environmental Data 11-4 11.7 Identification and Quantification of Impacts 11-4 11.7.1 Impacts on Air quality 11-4 11.7.2 Impacts on Water 11-5 11.7.3 Impacts on Noise quality 11-5 11.7.4 Impacts on Soil 11-5 11.7.5 Impacts on Ecology 11-6 11.8 Environmental Monitoring Programme 11-6 11.9 Additional Studies 11-6 11.10 Project Benefits 11-6 11.11 Environmental Management Plan 11-6 11.11.1 Liquid Effluents 11-6 11.11.2 Effluent Treatment System 11-7 11.11.3 Air pollution 11-8 11.11.4 Solvent Use and Recycle 11-8 11.11.5 Solid Waste 11-9 11.11.6 Noise Pollution 11-9 11.11.7 Occupational Safety and Health 11-9 11.11.8 Prevention, maintenance and operation of Environment Control Systems 11-9 11.11.9 Transport systems 11-10 11.11.10 Reduce, Recycle and Reuse 11-10 11.11.11 Green Belt Development 11-10 11.11.12 Post Project Monitoring 11-10 11.11.13 Environment Management Department 11-11

12.0 Disclosure of Consultants Engaged 12-1

Actero Pharma Pvt. Ltd., Contents List of Tables S.No Description Page. No. 1.1 Manufacturing Capacity 1-3 1.2 List of By-Product 1-4 2.1 Manufacturing Capacity 2-1 2.2 List of By-Product 2-2 2.3 Material Balance of Abiraterone Acetate 2-5 2.4 Material Balance of Afatinib 2-10 2.5 Material Balance of Anastrazole 2-14 2.6 Material Balance of Bicalutamide 2-16 2.7 Material Balance of Bendamustine HCl 2-19 2.8 Material Balance of Bexarotene 2-22 2.9 Material Balance of Bosutinib 2-25 2.10 Material Balance of Capecitabine 2-29 2.11 Material Balance of Carfilzomib 2-32 2.12 Material Balance of Ceritinib 2-36 2.13 Material Balance of Cyclophosphamide 2-38 2.14 Material Balance of Dasatinib 2-40 2.15 Material Balance of Docetaxel 2-42 2.16 Material Balance of Enzalutamide 2-46 2.17 Material Balance of Erlotinib HCl 2-49 2.18 Material Balance of Gefitinib 2-51 2.19 Material Balance of Gemcitabine HCl 2-54 2.20 Material Balance of Ibrutinib 2-58 2.21 Material Balance of Imatinib Mesylate 2-62 2.22 Material Balance of Lapatanib 2-65 2.23 Material Balance of Lenvatinib 2-67 2.24 Material Balance of Olaparib 2-70 2.25 Material Balance of Palbociclib 2-75 2.26 Material Balance of Pazopanib 2-77 2.27 Material Balance of Sorefinib 2-79 2.28 Material Balance of Sunitinib 2-81 2.29 Material Balance of Tamoxifene 2-83 2.30 List of Utilities 2-84 2.31 Total Water balance 2-84 2.32 Total Effluents generated and Mode of Treatment 2-86 2.33 Process Effluents Quantity and Quality – Product Wise 2-87 2.34 Process Effluents Quantity and Quality – Stage Wise 2-88 2.35 Details of Treatment Facilities 2-92 2.36 Technical Specifications of Effluent Treatment System 2-94 2.37 Technical Specifications of Biological Treatment Plant 2-95 2.38 Emission Details of Pollutants from Stack 2-98 2.39 Technical Specifications of Bag Filters – 8 TPH Coal Fired Boiler 2-98 2.40 Quantity and Mode of Treatment of Process Emissions 2-100 2.41 Technical Specifications of Two Stage Scrubber 2-101 2.42 Total Solvent Balance – Product Wise 2-102 2.43 Total Solvent Balance – Stage Wise 2-104 2.44 Solid Wastes Generated from Process – Stage Wise 2-110 2.45 Solid Waste Generated from Process – Product Wise 2-114 Actero Pharma Pvt. Ltd., Contents 2.46 Total Solid Waste Generated and Mode of Disposal 2-115 3.1 Chronological succession of the geological formations 3-5 3.2 Soil Analysis Data 3-12 3.3 Soil Test Results – Reference Tables 3-13 3.4 Water Analysis - Surface water 3-14 3.5 Locations of Ground water Sampling 3-16 3.6 Water Analysis Data – Ground Water 3-19 3.7 Meteorological data at IMD Station 3-21 3.8 Frequency Distribution of Wind Speeds and Wind Directions 3-24 3.9 National Ambient Air Quality Standards 3-29 3.10 Locations of Ambient Air Quality Monitoring Stations 3-30 3.11 Summary Ambient Air Quality Status 3-32 3.12 Effects on Human Beings at Different Noise Levels 3-36 3.13 Equivalent Noise levels in the Study Area 3-36 3.14 Population Distribution – Study Area 3-38 3.15 Literacy - Study Area 3-39 3.16 Employment - Study Area 3-40 3.17 Main workers study area 3-41 3.18 Land utilization Pattern 3-44 3.19 List of Plant Species Recorded 3-53 3.20 List of Fauna 3-56 3.21 List of AVES either spotted or reported or recorded 3-56 3.22 List of Reptiles either spotted or reported 3-57 3.23 List of Amphibians either spotted or reported from the study area 3-57 4.1 Salient Features of the ISCST3 Model 4-10 4.2 Emission Details of Pollutants from Stack 4-12 4.3 Maximum Predicted 24 hourly GLC’s 4-14 4.4 Predicted GLC’s at Monitoring Locations 4-14 4.5 Cumulative Concentrations at Various Villages and Reserved Forests 4-15 4.6 Solvent Loss and the Predicted Airborne Concentrations 4-22 4.7 Modified level of services for connecting roads 4-26 6.1 National Ambient Air Quality Standards 6-2 6.2 Indian Standard Drinking Water Specification-IS:10500:1991 6-4 6.3 Noise Level Standards (CPCB) 6-8 6.4 Environmental Monitoring Plan 6-8 6.5 Environmental Monitoring Budget 6-10 7.1 Manufacturing Capacity 7-3 7.2 List of By-Products 7-3 7.3 List of Raw Materials and Inventory 7-4 7.4 List of Utilities 7-11 7.5 Risk Control Measures 7-14 7.6 Applicability of GOI Rules to Storage/Pipeline 7-18 7.7 Physical Properties of Raw Materials and Solvents 7-19 7.8 Degree of Hazard for F&EI 7-21 7.9 Fire & Explosion Index for Tank farm 7-21 7.10 Failure Rate Data 7-25 7.11 Ignition Sources of Major Fires 7-25 7.12 General Failure Frequencies 7-27 7.13 Damage Due to Incident Radiation Intensities 7-29 Actero Pharma Pvt. Ltd., Contents 7.14 Radiation Exposure and Lethality 7-30 7.15 Damage Due to Peak Over Pressure 7-30 7.16 Heat Radiation Damage Distances – Tank Farm 7-31 7-17 Heat Radiation Damage Distances – Hydrogen Cylinders 7-32 7.18 List of Toxic/Carcinogenic chemicals and mode of Storage/Transport 7-33 7.19 Truck Incidents – Initiating and Contributing Causes 7-36 7.20 Transportation specific concerns 7-37 7.21 List of Fire Extinguishers 7-45 10.1 Total Effluents Generated and Mode of Treatment 10-4 10.2 Process Effluents Quantity and Quality – Product Wise 10-4 10.3 Details of Treatment Facilities 10-6 10.4 Technical Specifications of Effluent Treatment System 10-8 10.5 Technical Specifications of Biological Treatment Plant 10-9 10.6 Emission Details of Pollutants from Stack 10-12 10.7 Technical Specifications of Bag Filters – 8 TPH Coal Fired Boiler 10-12 10.8 Quantity and Mode of Treatment of Process Emissions 10-13 10.9 Technical Specifications of Two Stage Scrubber 10-14 10.10 Total Solvent Balance – Product Wise 10-16 10.11 Solid Waste and Mode of Disposal 10-19 10-12 Storm Water Management 10-22 10-13 Frequency of Health Monitoring 10-26 10-14 Activity Wise CSR – Budget (2018-19 to 2022-23) – Program 10-30 10.15 Recommended Plant Species to Develop Green Belt 10-31 10.16 Environmental Management Cost estimate 10-37 10.17 Item Wise Tentative Capital Cost Estimate for Environment Management 10-38 11.1 Manufacturing Capacity 11-2 11.2 List of By-products 11-3 11.3 List of Utilities 11-3 11.4 Water Balance 11-4 11.5 Total Effluent Generated and Mode of Treatment 11-7 Actero Pharma Pvt. Ltd., Contents List of Figures S.No Description Page. No. 1.1 Location of Location of M/s. Actero Pharma Pvt. Ltd., 1-6 1.2 Plant Layout of Location of M/s. Actero Pharma Pvt. Ltd., 1-7 2.1 Process Flow Diagram of Abiraterone Acetate 2-4 2.2 Process Flow Diagram of Afatinib 2-8 2.3 Process Flow Diagram of Anastrazole 2-13 2.4 Process Flow Diagram of Bicalutamide 2-15 2.5 Process Flow Diagram of Bendamustine HCl 2-18 2.6 Process Flow Diagram of Bexarotene 2-21 2.7 Process Flow Diagram of Bosutinib 2-24 2.8 Process Flow Diagram of Capecitabine 2-28 2.9 Process Flow Diagram of Carfilzomib 2-31 2.10 Process Flow Diagram of Ceritinib 2-35 2.11 Process Flow Diagram of Cyclophosphamide 2-37 2.12 Process Flow Diagram of Dasatinib 2-39 2.13 Process Flow Diagram of Docetaxel 2-41 2.14 Process Flow Diagram of Enzalutamide 2-44 2.15 Process Flow Diagram of Erlotinib HCl 2-48 2.16 Process Flow Diagram of Gefitinib 2-50 2.17 Process Flow Diagram of Gemcitabine HCl 2-53 2.18 Process Flow Diagram of Ibrutinib 2-57 2.19 Process Flow Diagram of Imatinib Mesylate 2-61 2.20 Process Flow Diagram of Lapatanib 2-64 2.21 Process Flow Diagram of Lenvatinib 2-66 2.22 Process Flow Diagram of Olaparib 2-69 2.23 Process Flow Diagram of Palbociclib 2-74 2.24 Process Flow Diagram of Pazopanib 2-77 2.25 Process Flow Diagram of Sorefinib 2-79 2.26 Process Flow Diagram of Sunitinib 2-80 2.27 Process Flow Diagram of Tamoxifene 2-82 2.28 Water Balance Flow Diagram 2-85 2.29 Schematic Diagram of Effluent Treatment System 2-93 2.30 Schematic diagram of Scrubbing system 2-100 2.31 Schematic Diagram of Solvent Recovery system 2-108 3.1 Actero Pharma Pvt. Ltd- Site Photographs 3-2 3.2 Base map of the study area 3-3 3.3 Forest map of the study area 3-4 3.4 Geological map of the study area 3-6 3.5 Hydrogeological Map of the study area 3-8 3.6 Land use and land cover map of the study area 3-10 3.7 Soil Sampling Locations 3-11 3.8 Drainage Pattern of the Study area 3-17 3.9 Water Sampling Locations 3-18 3.10 Wind Rose Diagram at Site 3-25 3.11 Ambient Air Quality Monitoring Locations 3-31 3.12 Graphs Showing the Results of Ambient Air Quality 3-33 3-13 Noise Sampling Locations 3-35 3.14 Peak Hour Traffic 3-37 Actero Pharma Pvt. Ltd., Contents 3.15 Population distribution of the study area 3-38 3.16 Literacy of Study Area 3-39 3.17 Employment –Study Area 3-41 3.18 Ecosystem wise status of various floral species 3-52 4.1 Impacts Network For Air Environment 4-2 4.2 Impacts Network For Noise Environment 4-3 4.3 Identification of Likely Impacts For Waste Water 4-4 4.4 Impacts Network For Land Environment 4-5 4.5 Impacts Network For Soil Micro Flora Fauna 4-6 4.6 Impact Network For Socio-Economic And Cultural Environment 4-7 4.7 Isopleths Showing 24 Hourly GLC’s of SPM 4-16 4.8 Isopleths Showing 24 Hourly GLC’s of PM10 4-17 4.9 Isopleths Showing 24 Hourly GLC’s of PM2.5 4-18 4.10 Isopleths Showing 24 Hourly GLC’s of SO2 4-19 4.11 Isopleths Showing 24 Hourly GLC’s of NOX 4-20 7.1 Plant Layout of Actero Pharma Pvt. Ltd. 7-13 7.2 Steps in Consequence Calculations 7-29 10.1 Schematic Diagram of Effluent Treatment System 10-7 10.2 Existing Two Stage Scrubbing System 10-14 10.3 Schematic Diagram of Solvent Recovery System 10-18 10.4 Rain Water Harvesting Schematic Diagram 10-22 10.5 Location of Storm Water Storage Tank 10.23 10.6 Green Belt Development of Actero Pharma Pvt. Ltd. 10-33 10.7 Organ gram of the Environment Management Cell 10-35

Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

1.0 INTRODUCTION

1.0 Introduction of the Project (Terms of Reference No. 2(ii) & 2(iii)) The pharmaceutical industry is an important component of health care systems throughout the world; it is comprised of many public and private organizations that discover, develop, manufacture and market medicines for human and animal health. The pharmaceutical industry is based primarily upon the scientific research and development (R&D) of medicines that prevent or treat diseases and disorders. Modern scientific and technological advances are accelerating the discovery and development of innovative pharmaceuticals with improved therapeutic activity and reduced side effects. Industrial chemicals are used in researching and developing active drug substances and manufacturing bulk substances and finished pharmaceutical products.

Chemical synthesis produces majority of drugs currently available in the market. Chemical synthesis consists of four steps - reaction, separation, purification, and drying. Large volume of solvents are used during chemical syntheses, extractions, and solvent interchanges. The bulk drug manufacturing process utilizes various process equipment and chemical methods. Sources of emissions include dryers, reactors, distillation units, storage and transfer of materials, filtration, extraction, centrifugation, and crystallization. Chemical synthesis consists of one or more batch reactions followed by separation and purification steps utilizing organic and inorganic reactants, solvents, and catalysts, and is solvent-intensive. Waste streams generated are numerous and complex due to the raw materials used and the varied nature of operations. Organic synthesis generates a mother liquor containing unconverted reactants, by- products, and residual product in a solvent or aqueous base, as well as acids, bases, metals, etc.

The scientific research and development in API manufacturing is focused on increasing the yields and reducing the toxicity of wastes and consumption of solvents, using alternative manufacturing methods etc. In this context the API manufacturing is viewed as an environmentally hazardous activity. Accordingly Ministry of Environment and Forests, GOI mandated prior environmental clearance for synthetic organic chemicals manufacturing units vide S.O.1533 dt. 14.9.2006.

1-1 Team Labs and consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

Actero Pharma Pvt. Ltd. proposes to establish a synthetic organic chemicals (Bulk Drugs & Intermediates) Unit of Production capacity 165 TPM in an area of 11.275 acres of land on lease from principle organization M/s. Dasami Lab Pvt. Ltd., for a lease period of 25 years at Sy No 407 (Part) and 411, Veliminedu (V), Chityal Mandal, Nalgonda District, Telangana. Prior environmental clearance has to be obtained from Ministry of Environment, Forest and climate change, vide SO 1533, dated September 14, 2006, for synthetic organic chemicals manufacturing activity. The terms of reference for the environmental impact assessment studies was obtained from MoEF&CC vide letter no. F.No. J-11011/59/2017-IA II (I) dated 26.05.2017 as part of environmental clearance process.

M/s. Actero Pharma Pvt. Ltd., is conscious of its responsibility towards the society in minimizing the pollution load due to the proposed synthetic organic chemicals manufacturing and accordingly decided to carry out the Environmental Impact Assessment to identify the negative and positive impacts and to delineate effective measures to control the pollution and to mitigate the environmental pollution. M/s. Actero Pharma Pvt. Ltd., has appointed Team Labs and Consultants for the preparation of Environmental Impact Assessment report.

Immediately after the receipt of the work order for the preparation of EIA report, the collection of primary (field data) and secondary (data available with various state and central government agencies) data has begun. Reconnaissance survey of the region was carried out during of February 2017, and various sampling locations to monitor environmental parameters have been identified. Subsequently, monitoring has commenced for collection of data on meteorology, ambient air quality, surface and ground water quality, soil characteristics, noise levels flora and fauna at the specified locations during March to June 2017. The other studies such as socio-economic profile, land use pattern etc are based on secondary data collected from various Government agencies and validated through the primary surveys. The Ambient air monitoring locations have been selected based on the initial Air dispersion Modeling carried out by using the meteorological data generated at India Meteorological Department (IMD).

1-2 Team Labs and consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

Field team of M/s. Team Labs and Consultants worked in the study area during March to June 2017 and base line data for various environmental components i.e., air, water, soil, noise and flora and fauna and socio economic status of people was collected in a circular area of 10 km radius by taking the industry site as the center point, to assess the existing environmental status as per the guidelines specified by Ministry of Environment, Forest and Climate Change (MoEF&CC), Government of India. This report presents the results of environmental impact assessment study along with the environmental management plan, necessary to avoid or mitigate the observed environmental impacts of the proposed synthetic organic chemicals manufacturing unit.

1.1 Product Profile (Terms of Reference No. 3(ii) & (iii)) The manufacturing capacity of proposed products is presented in Table 1.1 and the list of by-products is presented in Table 1.2. Table 1.1 Manufacturing Capacity S.No Name of Product CAS. No Capacity Kg/day TPM 1 Abiraterone Acetate 154229-19-3 16.7 0.5 2 Afatinib 850140-72-6 23.3 0.7 3 Anastrazole 120511-73-1 10 0.3 4 Bicalutamide 3543-75-7 33.3 1 5 Bendamustine HCl 153559-49-0 16.7 0.5 6 Bexarotene 90357-06-5 313.3 9.4 7 Bosutinib 380843-75-4 10 0.3 8 Capecitabine 154361-50-9 366.7 11 9 Carfilzomib 868540-17-4 16.7 0.5 10 Ceritinib 1032900-25-6 500 15 11 Cyclophosphamide 50-18-0 200 6 12 Dasatinib 302962-49-8 83.3 2.5 13 Docetaxel 114977-28-5 808.3 24.25 14 Enzalutamide 915087-33-1 33.3 1 15 Erlotinib HCl 183319-69-9 133.3 4 16 Gefitinib 184475-35-2 350 10.5 17 Gemcitabine HCl 122111-03-9 13.3 0.4 18 Ibrutinib 936563-96-1 8.3 0.25 19 Imatinib Mesylate 220127-57-1 50 1.5 20 Lapatanib 388082-78-8 533.3 16 21 Lenvatinib 417716-92-8 13.3 0.4 22 Olaparib 763113-22-0 8.3 0.25 23 Palbociclib 571190-30-2 6.7 0.2 24 Pazopanib 444731-52-6 75 2.25 25 Sorefinib 284461-73-0 800 24

1-3 Team Labs and consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

26 Sunitinib 341031-54-7 753.3 22.6 27 Tamoxifene 10540-29-1 366.7 11 Total Worst Case: 22 Products on campaign basis 5500 165

Table 1.2 List of By-products S. No Name of the Product Stage Name of the By Product Quantity (Kg/day) 1 Docetaxel I 2,2,2-Trichloro ethyl formate 355.6

1.2 Technology The technology for the product profile is indigenous based on organic chemistry. The facility shall have required infrastructure to manufacture multiple products. The product profile has been finalized based on the market demand and the technology compatibility. The synthesis involves reaction of fine chemicals in a solvent medium, followed by separation, purification and drying.

1.3 Plant Location & Layout The plant site of 11.275 acres is located at Survey No. 407 (Part) and 411, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana State. The site is located at the intersection of 17°13'34" (N) latitude and 79° 2'38" (E) longitude. The plant site elevation above mean sea level (MSL) is in the range of 329 - 338 m. The plant site is surrounded by open agricultural land in west direction, proposed expansion site of Dasami Lab Pvt. Ltd., in west direction, road connecting Pittampalli village to national highway in north direction and VSK Laboratories Pvt. Ltd. In south direction. The nearest habitation from the plant is Pittampalli village located at a distance of 2.1 km in southwest direction. The main approach road connecting to National Highway 9 - Hyderabad - Vijayawada Road adjacent to site in north direction. National Highway 9 - Hyderabad - Vijayawada is at a distance of 0.5 km in north direction. The nearest town Chityal is at a distance of 8.4 km in northeast direction. The nearest railway station Ramannapet is at a distance of 7.6 km in northeast direction and nearest airport is Rajiv Gandhi International Airport (Hyderabad) located at a distance of 65 km in northwest direction. Seasonal nala Chinna Vagu is flowing from northwest to southeast direction at a distance of 6.5 km in southwest direction. There are two reserve forests in the impact area of 10 km radius of the study area. Chityal RF at a distance of 6.1 km in east direction, Shivanenigudem RF at a distance of 9.1 km in northeast direction. There

1-4 Team Labs and consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report is no national park, wildlife sanctuary, ecologically sensitive area, biosphere reserve, tiger reserve, elephant reserve, critically polluted areas and interstate boundary within 10 km radius of the site. . The location map and site layout is as shown in Fig 1.1 and Fig 1.2.

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Fig 1.1 Location of M/s. Actero Pharma Pvt. Ltd. (Terms of Reference No. 4(ii))

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Fig 1.2 Plant Layout of M/s. Actero Pharma Pvt. Ltd. (Terms of Reference No. 4(vi) & (viii))

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1.4 Scope of EIA Studies

EIA study involves three basic components, viz. identification, prediction and evaluation of impacts. The brief scope of EIA study incroporating the terms of reference (TOR) obtained from MoEFCC is as follows:

• An intensive reconnaissance and preliminary collection of environmental information to plan field study.

• Field studies to collect preliminary information, particularly on the quality of the physical environment. Experienced scientists and engineers will collect the data.

• Base line data generation and characterization of air, water, soil, noise and vegetation in the ten kilometer radius area (impact zone) over a period of Three months.

• A thorough study of the process including provisions for pollution control, and environmental management that includes prediction of impacts and relevant mathematical modeling.

• Preparation of Environmental Monitoring Program.

• Preparation of Environmental Management Plan suggesting suitable methods for mitigating and controlling the pollution levels. Environmental Monitoring Plan is suggested for monitoring the pollution loads at various facilities in the premises and to ensure compliance with the statutory requirements.

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2.0 PROCESS DESCRIPTION AND POLLUTION CONTROL FACILITIES

Actero Pharma Pvt. Ltd. proposes to set up a Synthetic Organic Chemicals (Bulk Drugs & Intermediates) Unit of Production capacity 165 TPM in an area of 11.275 acres of land on lease from principle organization M/s. Dasami Lab Pvt. Ltd., for a lease period of 25 years at Sy No 407 (Part) and 411, Veliminedu (V), Chityal Mandal, Nalgonda District, Telangana. The proposed list of products and manufacturing capacity is presented in is presented in Table 2.1. List of By Products is presented in Table 2.2 Table 2.1 Manufacturing Capacity S.No Name of Product CAS. No Capacity Kg/day TPM 1 Abiraterone Acetate 154229-19-3 16.7 0.5 2 Afatinib 850140-72-6 23.3 0.7 3 Anastrazole 120511-73-1 10 0.3 4 Bicalutamide 3543-75-7 33.3 1 5 Bendamustine HCl 153559-49-0 16.7 0.5 6 Bexarotene 90357-06-5 313.3 9.4 7 Bosutinib 380843-75-4 10 0.3 8 Capecitabine 154361-50-9 366.7 11 9 Carfilzomib 868540-17-4 16.7 0.5 10 Ceritinib 1032900-25-6 500 15 11 Cyclophosphamide 50-18-0 200 6 12 Dasatinib 302962-49-8 83.3 2.5 13 Docetaxel 114977-28-5 808.3 24.25 14 Enzalutamide 915087-33-1 33.3 1 15 Erlotinib HCl 183319-69-9 133.3 4 16 Gefitinib 184475-35-2 350 10.5 17 Gemcitabine HCl 122111-03-9 13.3 0.4 18 Ibrutinib 936563-96-1 8.3 0.25 19 Imatinib Mesylate 220127-57-1 50 1.5 20 Lapatanib 388082-78-8 533.3 16 21 Lenvatinib 417716-92-8 13.3 0.4 22 Olaparib 763113-22-0 8.3 0.25 23 Palbociclib 571190-30-2 6.7 0.2 24 Pazopanib 444731-52-6 75 2.25 25 Sorefinib 284461-73-0 800 24 26 Sunitinib 341031-54-7 753.3 22.6 27 Tamoxifene 10540-29-1 366.7 11 Total Worst Case: 22 Products on campaign basis 5500 165

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Table 2.2 List of By Products S. No Name of the Product Stage Name of the By Product Quantity (Kg/day) 1 Docetaxel I 2,2,2-Trichloro ethyl formate 355.6

2.1 Process Description: (Terms of Reference No. 3 (viii))

The manufacturing process for the above mentioned products involves chemical synthesis utilizing mainly organic chemicals as raw materials in batch process. Typically, a series of chemical reactions are performed in multi-purpose reactors and the products are isolated by extraction, crystallization and filtration. The finished products are usually dried, and milled. The manufacturing process of each product, reaction scheme, material balance and flow diagram is presented in the following pages.

2.1.1 Process Description of Abiraterone Acetate

Reaction Schemes Stage - I:

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Stage-II:

Process Description: Stage-I: Dehydroepiandrosterone-3-acetate is reacted with trifluoromethanesulfonic anhydride in presence of triethyl amine in methylene chloride, followed by reacted with Diethyl(3-pyridyl)borane and methanol in presence of triphenylphosphine palladium chloride in tetrahydrofuran and then treated with sodium hydroxide in methanol to yield Abiraterone (Stage-I compound). Stage-II: Abiraterone is reacted with acetic anhydride in presence of pyridine in methylene chloride, acetonitrile and water to yield Abiraterone acetate (Pharma).The process flow diagram for Abiraterone acetate is presented in Fig 2.1 and material balance is presented in Table 2.3.

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Dehydroepiandrosterone-3-acetate Abiraterone Trifluoromethane sulfonic anhydride Trifluoromethane sulfonic acid Diethyl (3-pyridyl)borane Methoxy Triethylamine Diethylborane Sodium acetate Methylene chloride STAGE-I Triphenylphosphine Triphenylphosphine palladium chloride palladium chloride Methylene chloride Tetrahydrofuran Tetrahydrofuran Methanol Methanol Sodium hydroxide Waste Water Water

Abiraterone Acetic acid Acetic anhydride Methylene chloride Methylene chloride

Pyridine 4-Dimethylamino pyridine

4-Dimethylamino pyridine STAGE-II Acetonitrile

Acetonitrile Activated carbon

Activated carbon Waste Water Water

Abiraterone Acetate (Pharma)

Fig 2.1 Process Flow Diagram of Abiraterone Acetate

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Table 2.3 Material Balance for Abiraterone Acetate Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Dehydroepiandrosterone 54.2 Stage I Product 26.9 To Stage II -3-acetate Trifluoromethanesulfoni 46.3 Trifluoromethane 23.2 Organic residue c anhydride Sulfonic acid Diethyl (3- 24.1 Methoxy 7.7 Organic residue pyridyl)borane diethylborane Triethyl amine 15 Sodium acetate 6.3 To Waste Water Methylene chloride 800 MDC recovered 768.0 Recovered and reused (MDC) Triphenylphosphine 0.7 MDC Loss 6.4 Fugitive Loss palladium chloride Tetrahydrofuran (THF) 500 MDC to water 8 To Wastewater Methanol 5.3 MDC to residue 17.6 Solvent in Residue Sodium hydroxide 6.6 THF recovered 480 Recovered and reused Water 350 THF Loss 4 Fugitive Loss Hydrochloric acid 3.2 THF to water 5 To Wastewater Methanol 550 THF to residue 11 Solvent in Residue Methanol recovered 528 Recovered and reused Methanol Loss 4.4 Fugitive Loss Methanol to water 5.5 To Wastewater Methanol to residue 12.1 Solvent in Residue Dehydroepiandroster 28.7 Organic residue one-3-acetate Trifluoromethane 24.5 Organic residue sulfonic anhydride Diethyl (3-pyridyl) 12.8 Organic residue borane Methanol 2.8 To waste water triethylamine 15 To waste water Triphenylphosphine 0.7 Organic residue palladium chloride Sodium chloride 5.2 To waste water Water 351.6 To waste water Total Input 2355.4 Total Output 2355.4 Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage I Product 26.9 Abiraterone Acetate 16.6 Final product Acetic anhydride 7.9 Acetic acid 2.5 To waste water Methylene chloride 500 MDC recovered 480 Recovered & reused (MDC) Pyridine 56.4 MDC Loss 4 Fugitive loss 2-5 Team Labs and Consultants

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4-Dimethylamino 1.4 MDC to water 5 To waste water pyridine Acetonitrile 290 MDC to residue 11 Solvent in residue Activated carbon 3 Acetonitrile 278.4 Recovered & reused recovered Water 200 Acetonitrile Loss 2.3 Fugitive loss Acetonitrile to water 2.9 To waste water Acetonitrile to 6.4 Solvent in residue residue Stage I Product 12.1 Organic residue Acetic anhydride 3.6 Organic residue Pyridine 56.4 Organic residue 4-Dimethylamino 1.4 Organic residue pyridine Activated carbon 3 spent carbon water 200 To waste water Total Input 1085.6 Total Output 1085.6

2.1.2 Process Description of Afatinib dimaleate Reaction Schemes Stage I

Stage II

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Stage III

Process Description: Stage –I: N-(3-Chloro-4-fluorophenyl)-7-fluoro-6-nitroquinazolin-4-amine reacts with (S)-3- Hydroxy tetra hydrofuran and potassium tert-butoxide in presence of DMF and final washing with Methanol to give (S)-N-(3-chloro-4-fluorophenyl)-6-nitro-7-((tetrahydrofuran- 3- yl)oxy)quinazolin-4-amine. Stage–II: (S)-N-(3-chloro-4-fluorophenyl)-6-nitro-7-((tetrahydrofuran-3-yl)oxy)quinazolin- 4-amine is react with Fe Powder and ammonium chloride in presence of ethanol to give (S)- N4-(3-chloro- 4-fluorophenyl)-7-((tetrahydrofuran-3-yl)oxy)quinazoline-4,6-diamine. Stage –III: (S)-N4-(3-chloro-4-fluorophenyl)-7-((tetrahydrofuran-3-yl) oxy) quinazoline-4,6- diamine is reacted with Trans-4-dimethyl amino crotonic acid. HCl in presence of DMF and acetonitrile to give (S,E)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-((tetrahydrofuran-3- yl)oxy)quinazolin-6- yl)-4-(dimethylamino)but-2-enamide and further reacts with Maleic acid in presence of Ethyl acetate, Dichloromethane and Methanol to give Afatinib dimaleate. Schematic diagram of Afatinib dimaleate is shown in Fig 2.2 and material balance for Afatinib dimaleate is presented in Table 2.4.

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Fig 2.2 Process Flow Diagram of Afatinib dimaleate

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Table 2.4 Material Balance for Afatinib dimaleate Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) N-(3-Chloro-4- 23.9 Stage I Product 27.6 To Stage II fluorophenyl)-7-fluoro-6- nitroquinazolin-4-amine (S)-3-Hydroxy 6.3 Potassium fluoride 4 To Wastewater tetrahydrofuran Potassium tertiary 8 tert.butanol 5.1 To Wastewater butoxide Dimethyl formamide 200 DMF recovered 192 Recovered and reused (DMF) Hydrochloric acid 25 DMF Loss 1.6 Fugitive Loss Water 800 DMF to water 2 To Wastewater Methanol 50 DMF to residue 4.4 Solvent in Residue Sodium hydroxide 27.4 Methanol recovered 48 Recovered and reused Methanol Loss 0.4 Fugitive Loss Methanol to water 0.5 To Wastewater Methanol to residue 1.1 Solvent in Residue N-(3-Chloro-4- 1 Organic residue fluorophenyl)-7-fluoro- 6-nitroquinazolin-4- amine (S)-3-Hydroxy 0.3 Organic residue tetrahydrofuran Potassium tertiary 0.3 Organic residue butoxide Water 812.3 To waste water Sodium chloride 40 To waste water Total Input 1140.6 Total Output 1140.6 Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage I Product 27.6 Stage II Product 19.3 To Stage-III Fe Powder 15.2 Ammonia gas 7 To scrubber Ammonium Chloride 29.2 Hydrogen gas 0.1 Let into atmosphere safely Ethanol 275 Iron II Chloride 26.1 To Wastewater DM water 350 Ethyl acetate 240 Recovered and reused recovered Ethyl acetate 250 Ethyl acetate Loss 2 Fugitive Loss Tetrahydro furan (THF) 350 Ethyl acetate to water 2.5 To Wastewater Hexanes 325 Ethyl acetate to 5.5 Solvent in Residue residue Ethanol recovered 264 Recovered and reused

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Ethanol Loss 2.2 Fugitive Loss Ethanol to water 2.8 To Wastewater Ethanol to residue 6.1 Solvent in Residue THF recovered 336 Recovered and reused THF Loss 2.8 Fugitive Loss THF to water 3.5 To Wastewater THF to residue 7.7 Solvent in Residue Hexanes recovered 312 Recovered and reused Hexanes Loss 2.6 Fugitive Loss Hexanes to water 3.3 To Wastewater Hexanes to residue 7.2 Solvent in Residue Stage I Product 6.8 Organic residue Fe Powder 3.7 Inorganic residue water 351.9 To waste water Ammonium Chloride 7 To waste water Total Input 1622 Total Output 1622 Stage III Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage II Product 19.3 Afatinib dimaleate 23.3 Final Product Trans-4-dimethyl amino 8.5 Acetonitrile recovered Recovered and reused 86.4 crotonic acid Oxalyl chloride 9.8 Acetonitrile Loss 0.7 Fugitive Loss N- Methyl pyrrolidine 100 Acetonitrile to water 0.9 To Wastewater Dimethyl formamide 1.9 Acetonitrile to residue 2 Solvent in Residue Acetonitrile 90 Ethyl acetate 480 Recovered and reused recovered Ethyl acetate 500 Ethyl acetate Loss 4 Fugitive Loss DM Water 500 Ethyl acetate to water 5 To Wastewater Sodium carbonate solution 71.4 Ethyl acetate to 11 Solvent in Residue (35%) residue NaCl Solution (26%) 192.3 Cyclohexane recovered 192 Recovered and reused Carbon 5 Cyclohexane Loss 1.6 Fugitive Loss Cyclohexane 200 Cyclohexane to water 2 To Wastewater Methanol 45 Cyclohexane to residue 4.4 Solvent in Residue Maleic acid 12 DDM recovered 43.2 Recovered and reused Dichloromethane (DCM) 45 DCM Loss 0.4 Fugitive Loss Sodium hydroxide 1.3 DCM to water 0.5 To Wastewater DCM to residue 1 Solvent in Residue Methanol recovered 43.2 Recovered and reused Methanol Loss 0.4 Fugitive Loss Methanol to water 0.5 To Wastewater Methanol to residue 1 Solvent in Residue Stage II Product 7.1 Organic residue Trans-4-dimethyl 3.2 Organic residue

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amino crotonic acid Maleic acid 4.4 To Wastewater Oxalyl chloride 9.8 Organic residue N- Methyl pyrrolidine 100 Organic residue Dimethyl formamide 1.9 Organic residue Activated carbon 5 spent carbon Water 690.3 To waste water Sodium chloride 51.9 To waste water Sodium carbonate 25 To waste water Total Input 1801.4 Total Output 1801.4

2.1.3 Process Description of Anastrazole Reaction Schemes

CH3 O 2,2'-Azobisisobutyronitrile NC N H C CN N Na 3 + N Br + N Chloroform H3C CH3 CH3 O Sodiumtriazole N,N-Dimethylformamide 2,2'-(5-Methyl-1,3-phenylene) Bromosuccinamide M.W t: 91 -di(2-methylpropionitrile) M.W t: 178 M.W t: 226 N N N O

NH NaBr NC H C CN + + 3 M.Wt:103 H C O CH 3 CH 3 3 Pyrrolidine-2,5-dione Anastrozole (Pharma) M.W t: 99 M.W t: 293 Process Description:

Stage-I: 2,2'-(5-Methyl-1,3-phenylene)-di(2-methylpropionitrile) is reacted with N- Bromosuccinamide and 1,2,4-Sodiumtriazole in N,N-Dimethylformamide to give Anastrozole (Pharma). Schematic diagram of Anastrozole is shown in Fig 2.3 and material balance for Anastrozole is presented in Table 2.5.

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2,2'-(5-Methyl-1,3-phenylene -di(2-methylpropionitrile) Bromosuccinamide

2,2,'-Azobisisobutyronitrile Pyrrolidine-2,5-dione Diisopropylether Diisopropylether Chlorofom Chlorofom NaCl N,N- Dimethylformamide Water Diispropylether Sodiumtriazole

N,N- Dimethylformamide Condensation Toluene Diispropylether Activated Carbon Toluene

SodiumBiCarbonate Tertiary- Butyl Methyl Ether

Sulphuric Acid NaBr

NaCl Waste Water Activated Carbon

Tertiary- Butyl Methyl Ether

Water

Anastrozole (Pharma)

Fig 2.3 Process Flow Diagram of Anastrazole

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Table 2.5 Material Balance for Anastrazole Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 2,2'-(5-Methyl-1,3- 27.5 Anastrozole 10 Final Product phenylene-di(2- methylpropionitrile) N-Bromo Succinamide 21.7 Pyrrolidine-2,5-dione 3.4 Organic residue Sodium Triazole 11.1 Sodium Bromide 3.5 To Wastewater Sodium Chloride 45.0 Chloroform recovered 240 Recovered and reused Sodium Bicarbonate 60 Chloroform Loss 2 Fugitive Loss Sulphuric acid 2 Chloroform to residue 8 Solvent in Residue Chloroform 250 DIPE recovered 480 Recovered and reused Diisopropylether (DIPE) 500 DIPE Loss 4 Fugitive Loss Dimethyl Formamide 170 DIPE to residue 16.0 Solvent in Residue (DMF) Toluene 250 DMF recovered 163.2 Recovered and reused t-Butyl Methyl Ether 170 DMF Loss 1.4 Fugitive Loss (MTBE) Methanol 100 DMF to water 1.7 To Wastewater Activated carbon 5 DMF to residue 3.7 Solvent in Residue Water 1100 Toluene recovered 240 Recovered and reused Sodium hydroxide 2.2 Toluene Loss 2 Fugitive Loss Toluene to water 2.5 To Wastewater Toluene to residue 5.5 Solvent in Residue MTBE recovered 163.2 Recovered and reused MTBE Loss 1.4 Fugitive Loss MTBE to water 0.0 To Wastewater MTBE to residue 5.4 Solvent in Residue Methanol recovered 96 Recovered and reused Methanol Loss 0.8 Fugitive Loss Methanol to water 1 To Wastewater Methanol to residue 2.2 Solvent in Residue 2,2'-(5-Methyl-1,3- 19.8 Organic residue phenylene-di(2- methylpropionitrile) Activated carbon 5 spent carbon N-Bromo Succinamide 15.6 Organic residue Waste water 1101 To waste water Sodium Triazole 8 To waste water Sodium Chloride 48.2 To waste water Sodium Bicarbonate 60 To waste water Total Input 2714.4 Total Output 2714.4

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2.1.4 Process Description of Bendamustine HCl

Reaction Schemes

Stage-I: H N 2 N OC H NaOH 2 5 O 3 HCl 2 N O + + Hydrochloric acid + Sodium hydroxide Ethylene oxide CH3 M.W t: 3X36.5=109.5 M.W t: 40 Ethyl 4-(5-amino-1-methyl-1H- M.W t: 2X44=88 benzimidazol-2-yl)butanoate MW t: 261

Cl

C 2H 5ONa Sodiumethoxide Methylene chloride N N Cl OH M.Wt: 68 .HCl + H O N O 2 M.W t: 18X2=36 CH3 Bendamustine Hydrochloride (Pharma) MW t: 394.5 Process Description: Stage I: 1H-Benzimidazol-1-methyl-5-amino-2-butanoic acid ethyl ester is reacted with ethylene oxide then hydrochloric acid and Sodium hydroxide to give Bendamustine Hydrochloride (Pharma). Schematic diagram of Bendamustine Hydrochloride is shown in Fig 2.4 and material balance for Bendamustine Hydrochloride is presented in Table 2.6.

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Fig 2.4 Process Flow Diagram of Bendamustine HCl

Table 2.6 Material Balance for Bendamustine HCl Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) N-[4-Cyano-3- 23 Bicalatamide 33.3 Final Product (trifluoromethyl)phenyl]- 3-[4-fluorophenyl)thio]- 2-hydroxy-2- methylpropanamide Hydrogen Peroxide 2.9 Hydrogen gas 0.2 Let out into atmosphere safely 4-fluorothiophenol 10.9 Acetic acid recovered 139.2 Recovered and reused Acetic acid 145 Acetic acid Loss 1.2 Fugitive Loss Acetone 220 Acetic acid to water 1.5 To Wastewater Water 735 Acetic acid to residue 3.2 Solvent in Residue Acetone recovered 211.2 Recovered and

reused Acetone Loss 1.8 Fugitive Loss Acetone to water 2.2 To Wastewater Acetone to residue 4.8 Solvent in Residue N-[4-Cyano-3- 2.1 Organic residue (trifluoromethyl)phenyl]- 3-[4-fluorophenyl)thio]- 2-hydroxy-2- methylpropanamide 4-fluorothiophenol 1 Organic residue Waste water 735 To waste water Hydrogen peroxide 0.3 To waste water Total Input 1136.8 Total Output 1136.8

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2.1.5 Process Description of Bexarotene

Reaction Schemes Stage-I:

O Methyltriphenylphosphoniumbromide (357) H 3 C CH3 Pottassium hexam ethyldisilazide, Toluene OMe CH 3 2 KOH (112) H C CH 3 3 O Methanol Ethylacetate Methyl[4-(5,6,7,8-tetrahydro-3,5,5,8,8- pentamethyl-2-naphthalenyl)carbonyl]benzoate

M.Wt: 364

Triphenylphosphine Oxide CH2 H 3 C CH3 M.W t: 278 OH + KBr (119) CH 3 MeOK (70) H C CH O 3 3 Potassium m ethoxide H O (18) Bexarotene (Pharma) 2

M.Wt: 348

Process Description: Stage-1: Methyl[4-(5,6,7,8-tetrahydro-3,5,5,8,8-pentamethyl-2-naphthalenyl)carbonyl] benzoate is reacted with methyl triphenyl phosphoniumbromide in presence of potassium hexamethyldisilazide and potassium hydroxide in toluene, methanol and ethyl acetate to yield Bexarotene (Pharma). Schematic diagram of Bexarotene is shown in Fig 2.5 and material balance for Bexarotene in Table 2.7.

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Methyl[4-(5,6,7,8-tetrahydro-3,5,5,8,8-

pentamethyl-2-naphthalenyl)carbonyl]benzoate Triphenylphosphine Oxide Methyltriphenylphosphoniumbromide KBr

Pottassiumhexamethyldisilazide Potassium methoxide

KOH Methanol Toluene Ethylacetate Methanol Toluene Ethylacetate Activated carbon Activated carbon Waste Water Water

Bexarotene (Pharma)

Fig 2.5 Process Flow Diagram of Bexarotene

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Table 2.7 Material Balance for Bexarotene Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 1H-Benzimidazol-1- 18.3 Bendamustine 16.6 Final Product methyl-5-amino-2- Hydrochloride butanoic acid ethylester Ethylene Oxide (Gas) 6.2 Sodium methoxide 2.9 Carried along with methanol residue Acetic acid 50 MDC recovered 1536 Recovered and reused Hydrochloric acid 51.3 MDC Loss 12.8 Fugitive Loss Sodium Hydroxide 52.8 MDC to water 16 To Wastewater Methylene Chloride 1600 MDC to residue 35.2 Solvent in Residue (MDC) Acetone 250 Acetone recovered 240 Recovered and reused Methanol 200 Acetone Loss 2 Fugitive Loss Water 1500 Acetone to water 2.5 To Wastewater Activated Carbon 5 Acetone to residue 5.5 Solvent in Residue Methanol recovered Recovered and 192 reused Methanol loss 1.6 Fugitive Loss Methanol to waste 2 To Wastewater

water Methanol in residue 4.4 Solvent in Residue 1H-Benzimidazol-1- 7.3 Organic residue methyl-5-amino-2- butanoic acid ethylester Ethylene Oxide (Gas) 2.5 Organic residue Activated carbon 5 spent carbon Acetic acid 50 To waste water Waste water 1524.5 To waste water Sodium chloride 74.8 To waste water Total Input 3733.5 Total Output 3733.5

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2.1.6 Process Description of Bicalutamide

Reaction Schemes Stage-I:

CH 3 SH H O CF N 3 Ethyl acetate + O NC Hydrogen peroxide (34) F 2,3-Epoxy-2-methyl-N-[4-cyano- 4-Fluorothiophenol 3-(trifluoro-methyl)phenyl] propanamide M.Wt: 128

M.Wt: 270 O O H H3C OH CF N S 3 H + 2 O NC F M.Wt: 2

Bicalutamide (Pharma) M.Wt: 430

Process Description: Stage-1: 2,3-Epoxy-2-methyl-N-[4-cyano-3-(trifluoro-methyl)phenyl]propanamide is condensed with 4-Fluorothiophenol to give N-[4-Cyano-3-(trifluoromethyl) phenyl]-3-[(4- fluorophenyl)thio]-2-hydroxy-2-methylpropanamide. The N-[4-Cyano-3-(trifluoromethyl) phenyl]-3-[(4-fluorophenyl)thio]-2-hydroxy-2-methylpropanamide on oxidation in presence of Hydrogen peroxide gives Bicalutamide (Pharma). Schematic diagram of Bicalutamide is shown in Fig 2.6 and material balance for Bicalutamide is presented in Table 2.8.

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2,3-Epoxy-2-methyl-N- [4-cyano-3-(trifluoro-methyl) phenyl]propanamide

4-Fluorothiophenol

Ethyl acetate

Tert. Butyl ammonium bromide

Ethyl acetate Water

Sulphuric acid Condensation H 2 Hydrogen peroxide &

Oxidation Dichloromethane Dichloromethane

Activated carbon Waste water

Diisopropyl ether

Water

Bicalutamide (Pharma) Fig 2.6 Process Flow Diagram of Bicalutamide

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Table 2.8 Material Balance for Bicalutamide Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Methyl[4-(5,6,7,8- 409.6 Bexarotene 313.3 Final Product tetrahydro-3,5,5,8,8- pentamethyl-2- naphthalenyl)carbonyl] benzoate Methyltriphenyl 401.8 Triphenylphosphine 250.3 Organic residue phosphoniumbromide oxide Potassiumhexamethyl 126 Potassium Bromide 107.1 To waste water disilazide Potassium hydroxide 200 Potassium methoxide 63 Carried along with Methanol residue Toluene 940 Toluene recovered Recovered and 902.4 reused Methanol 5000 Toluene Loss 7.5 Fugitive Loss Ethyl acetate 4500 Toluene to water 9.4 To Wastewater Activated carbon 70 Toluene to residue 20.7 Solvent in Residue Water 3500 Ethyl acetate Recovered and 4320 recovered reused Hydrochloric acid 130.1 Ethyl acetate Loss 36 Fugitive Loss Ethyl acetate to water 45 To Wastewater Ethyl acetate to 99 Solvent in Residue

residue Methanol recovered Recovered and 4800 reused Methanol Loss 40 Fugitive Loss Methanol to water 50 To Wastewater Methanol to residue 110 Solvent in Residue Methyl[4-(5,6,7,8- 81.9 Organic residue tetrahydro-3,5,5,8,8- pentamethyl-2- naphthalenyl)carbonyl] benzoate Methyltriphenyl 80.4 Organic residue phosphonium bromide Potassiumhexamethyl 25.2 Organic residue disilazide Activated carbon 70 Spent carbon Water 3580.4 To waste water Potassium Chloride 266 To waste water Potassium hydroxide 200 To Neutralization Total Input 15277.5 Total Output 15277.5

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2.1.7 Process Description of Bosutinib

Reaction Schemes Stage-I:

Stage-II:

Stage-III:

Process Description: Stage-I: 7-(3-chloropropoxy)-6-methoxy-4-oxo-1,4-dihydroquinoline-3-carbonitrile undergoes chlorination in the presence of POCl3 to form 4-chloro-7-(3-chloropropoxy)-6- methoxyquinoline-3-carbonitrile.

Stage-II: 4-chloro-7-(3-chloropropoxy)-6-methoxyquinoline-3-carbonitrile condenses with 2,4- dichloro-5-methoxyaniline to form 7-(3-chloropropoxy)-4-((2,4-dichloro-5- methoxyphenyl)amino)-6-methoxyquinoline-3-carbonitrile.

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Stage-III: 7-(3-chloropropoxy)-4-((2,4-dichloro-5-methoxyphenyl)amino)-6- ethoxyuinoline -3- carbonitrile further reacts with N-methyl piperazine to form Bosutinib. Schematic diagram of Bosutinib is shown in Fig 2.7 and material balance for Bosutinib is presented in Table 2.9.

Fig 2.7 Process Flow Diagram of Bosutinib

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Table 2.9 Material Balance for Bosutinib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 7-(3-chloropropoxy)-6- 22.4 4-chloro-7-(3- 23.3 To Stage II methoxy-4-oxo-1,4- chloropropoxy)-6- dihydroquinoline-3- methoxyquinoline-3- carbonitrile carbonitrile phosphorous 11.7 Phosphorodichloridic 10.1 To Wastewater oxychloride acid 280 Toluene recovered Recovered and Toluene 268.8 reused DMF 10 Toluene Loss 2.2 Fugitive Loss 8% Sodium bi carbonate 187.5 Toluene to water 2.8 To Wastewater solution Water 60 Toluene to residue 6.2 Solvent in Residue DMF recovered Recovered and 9.6 reused DMF Loss 0.1 Fugitive Loss DMF to water 0.1 To Wastewater DMF to residue 0.2 Solvent in Residue 7-(3-chloropropoxy)-6- 0.4 Organic residue methoxy-4-oxo-1,4- dihydroquinoline-3- carbonitrile phosphorous 0.2 Organic residue oxychloride Water 232.5 To waste water Sodium bi carbonate 15 To waste water Total Input 571.6 Total Output 571.6 Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 4-chloro-7-(3- 23.3 7-(3-chloropropoxy)-4- 23.8 To Stage III chloropropoxy)-6- ((2,4-dichloro-5- methoxyquinoline-3- methoxyphenyl) carbonitrile amino)-6- methoxyquinoline-3- carbonitrile. 2,4-dichloro-5- 14.4 Hydrogen chloride 1.9 To scrubber methoxyaniline 2-(2′-Hydroxyphenyl) 10 Toluene recovered 230.4 Recovered and benzoxazole reused Toluene 240 Toluene Loss 1.9 Fugitive Loss Cat-C 1.2 Toluene to residue 7.7 Solvent in Residue Ethanol 145 Ethanol recovered 139.2 Recovered and 2-25 Team Labs and Consultants

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reused Sodium hydroxide 2 EthanolLoss 1.2 Fugitive Loss Hydrochloric acid 1.8 Ethanol to residue 4.6 Solvent in Residue 4-chloro-7-(3- 7.5 Organic residue chloropropoxy)-6- methoxyquinoline-3- carbonitrile 2-(2′-Hydroxyphenyl) 10 Organic residue benzoxazole 2,4-dichloro-5- 4.6 Organic residue

methoxyaniline Cat-C 1.2 Organic residue Waste Water 0.9 Carried along with organic residue Sodium chloride 2.9 Carried along with organic residue Total Input 437.7 Total Output 437.7 Stage-III Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 7-(3-chloropropoxy)-4- 23.8 Bosutinib 10 Final Product ((2,4-dichloro-5- methoxyphenyl)amino)- 6-methoxyquinoline-3- carbonitrile N-methyl piperazine 5.1 Hydrogen chloride 0.7 To scrubber Sodium iodide 6.4 DMF recovered 44.2 Recovered and reused Dichloromethane 1170 DMF Loss 0.4 Fugitive Loss (DCM) Sat.Sodium chloride 25 DMF to water 0.5 To Wastewater solution Sodium sulphate 6 DMF to residue 1 Solvent in Residue Carbon 1 Ethyl acetate 220.8 Recovered and recovered reused Hyflo 3 Ethyl acetate Loss 1.8 Fugitive Loss Ethyl acetate 230 Ethyl acetate to water 2.3 To Wastewater 5% ethyl acetate.HCl 34.5 Ethyl acetate to 5.1 Solvent in Residue residue Water 530 DCM recovered 1123.2 Recovered and reused Methanol 230 DCM Loss 9.4 Fugitive Loss Dimethyl formamide 46 DCM to water 11.7 To Wastewater (DMF) L-Cysteine 4.6 DCM to residue 25.7 Solvent in Residue Silica gel 6.9 Methanol recovered 220.8 Recovered and

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reused Ethanol 270 Methanol Loss 1.8 Fugitive Loss 8% Sodium bi carbonate 325 Methanol to water 2.3 To Wastewater solution Sodium hydroxide 2.6 Methanol to residue 5.1 Solvent in Residue Hydro chloric acid 2.4 Ethanol recovered 259.2 Recovered and reused EthanolLoss 2.2 Fugitive Loss Ethanolto water 2.7 To Wastewater Ethanol to residue 5.9 Solvent in Residue 7-(3-chloropropoxy)-4- 15 Organic residue ((2,4-dichloro-5- methoxyphenyl)amino)- 6-methoxyquinoline-3- carbonitrile N-methyl piperazine 3.2 Organic residue Activated carbon 1 spent carbon Water 830.2 To waste water Sodium iodide 6.4 To waste water Sodium Chloride 28.8 To waste water Sodium bi carbonate 26 To waste water 5% ethyl acetate.HCl 34.5 To waste water L-Cysteine 4.6 Inorganic residue Silica gel 6.9 Inorganic residue Sodium sulphate 6 Inorganic residue Hyflo 3 Inorganic residue Total Input 2922.3 Total Output 2922.3

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2.1.8 Process Description of Capecitabine

Reaction Schemes Stage-I:

NH2 F N O N 2 NaO H CH n-Pentylchloro form ate M ethanol 3 + + Sodium hydroxide O M .W t: 150.5 M .W t:8 0 AcO OAc O 2,3-di-o-acetyl-5-deoxy- CH 5-fluorocytidine H N O 3 F M .W t:329 N O N HCl 2CH 3 COONa CH 3 + + M .W t:164 O M .W t:36.5

H O OH Capecitabine (P h a rm a ) M .W t:359 Process Description: Stage-I: 2,3-di-o-acetyl-5-deoxy-5-fluorocytidine is condensed with n-Pentylchloroformate in Methylene dichloride to give Capecitabine (Pharma). Schematic diagram of Capecitabine is shown in Fig 2.8 and material balance for Capecitabine is presented in Table 2.10.

2,3-di-o-acetyl-5-deoxy- 5-fluorocytidine

n-Pentylchoroform ate M ethylenedichloride M ethylenedichloride Sodium acetate Pyridine

Methanol Condensation Pyridine

Sodium hydroxide & Methanol Cyclohexane

D eprotection E th y lacetate Cyclohexane

Sodium carbonate E th y laceta te

H ydrochloric acid Waste water A ctiv ated carb o n

Water

Capecitabine (Pharma) Fig 2.8 Process Flow Diagram of Capecitabine

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Table 2.10 Material Balance for Capecitabine Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 2,3-di-o-acetyl-5-deoxy- 460.3 Capecitabine 366.7 Final Product 5-fluorocytidine n-Pentyl Chloroformate 210.6 Hydrogen Chloride 37.3 To scrubber Sodium Hydroxide 111.9 Sodium Acetate 167.5 Inorganic Residue Sodium Bicarbonate 150 MDC recovered 4800 Recovered and reused Hydrochloric acid 27.6 MDC Loss 40 Fugitive Loss Methylene Chloride 5000 MDC to water 50 To Wastewater (MDC) Methanol 950 MDC to residue 110 Solvent in Residue Ethyl Acetate 2340 Methanol recovered 912 Recovered and reused Water 2500 Methanol Loss 7.6 Fugitive Loss Activated Carbon 60 Methanol to water 9.5 To Wastewater Methanol to residue 20.9 Solvent in Residue Ethyl acetate 2246.4 Recovered and recovered reused Ethyl acetate Loss 18.7 Fugitive Loss Ethyl acetate to water 23.4 To Wastewater Ethyl acetate to 51.5 Solvent in Residue residue 2,3-di-o-acetyl-5-deoxy- 124.3 Organic residue 5-fluorocytidine n-Pentyl Chloroformate 56.9 Organic residue activated carbon 60 spent carbon Waste water 2513.6 To waste water Sodium chloride 44.2 To waste water Sodium Bicarbonate 150 To waste water Total Input 11810.4 Total Output 11810.4

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2.1.9 Process Description of Carfilzomib Reaction Schemes Stage-I:

Stage-II:

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Process Description: Stage-1: Methyl ((S)-2-(2-chloroacetamido)-4-phenylbutanoyl)-L-leucyl-L-phenylalaninate is treated with Morpholine and potassium hydroxide in presence of tetrahydrofuran to give (S)-2-((S)-4-methyl-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamido)-3- phenylpropanoic acid (Stage-I compound).

Stage-2: (S)-2-((S)-4-methyl-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido) pentanamido)-3-phenylpropanoic acid is reacted with (S)-2-Amino--4-methyl-1-((R)-2- methyloxiran-2-yl)pentan-1-one 2,2,2-trifluoroacetate in presence of dimethyl formamide to yield Carfilzomib (Pharma). Schematic diagram of Carfilzomib is shown in Fig 2.9 and material balance for Carfilzomib is presented in Table 2.11.

M ethyl ((S)-2-(2-chloroacetam ido)- 4-phenylbutanoyl)-L-leucyl-L -p hen ylalan inate (S)-2-((S)-4-m ethyl-2-((S)-2-(2-m orpholino acetam ido)-4-phenylbutanam ido) M orp h oline pentanam ido)-3-phenylpropanoic acid

Potassium hydroxide Potassium chloride

Potassium Iodide Tetrahydrofuran H ydrochloric acid STAGE-I Methanol

Tetrahydrofuran Ethyl acetate Methanol Methylene chloride Ethyl acetate

Methylene chloride Waste Water Sodium chloride

Water Po

(S)-2-((S)-4-m ethyl-2-((S)-2-(2-m orpholino acetam ido)-4-phenylbutanam ido) p en tan am id o)-3-p h en ylp rop anoic acid

(S)-2-am ino-4-m ethyl-1-((R )-2-m ethyloxiran T riflu oroacetic acid -2-yl)pentan-1-one 2,2,2-trifluoroacetate

N,N,N',N'-Tetramethyl-O-(1H-benzo N,N,N',N'-Tetramethyl-O-(1H-benzo triazol-1-yl)u roniu m hexaflu oro triazol-1-yl)u roniu m hexaflu oro phosphate STAGE-II phosphate N ,N -D iisop rop yleth ylam in e N -H ydroxybenzotriazole N ,N -D iisop rop yleth ylam in e Dimethyl formamide N -H ydroxybenzotriazole

Sodium bicarbonate Dimethyl formamide

Ethyl acetate Ethyl acetate Methanol Methanol Water Waste Water

C arfilzom ib (Pharm a) Fig 2.9 Process Flow Diagram of Carfilzomib

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Table 2.11 Material Balance for Carfilzomib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Methyl ((S)-2-(2- 33.7 Stage I Product 23.4 To stage-II chloroacetamido)-4- phenylbutanoyl)-L- leucyl-L- phenylalaninate Morpholine 5.5 Potassium chloride 3.1 To Wastewater Potassium hydroxide 3.6 Methanol 1.3 To Wastewater Potassium Iodide 2.3 THF recovered 278.4 Recovered and reused Hydrochloric acid 6.2 THF Loss 2.3 Fugitive Loss Tetrahydrofuran (THF) 290 THF to water 2.9 To Wastewater Methanol 310 THF to residue 6.4 Solvent in Residue Ethyl acetate 290 MDC recovered 528 Recovered and reused Methylene chloride 550 MDC Loss 4.4 Fugitive Loss (MDC) Sodium chloride 50 MDC to water 5.5 To Wastewater Water 920 MDC to residue 12.1 Solvent in Residue sodium hydroxide 6.8 Methanol recovered 297.6 Recovered and reused Methanol Loss 2.5 Fugitive Loss Methanol to water 3.1 To Wastewater Methanol to residue 6.8 Solvent in Residue Ethyl acetate 278.4 Recovered and reused recovered Ethyl acetate Loss 2.3 Fugitive Loss Ethyl acetate to 2.9 To Wastewater water Ethyl acetate to 6.4 Solvent in Residue residue Methyl ((S)-2-(2- 11.8 Organic residue chloroacetamido)-4- phenylbutanoyl)-L- leucyl-L- phenylalaninate Morpholine 1.9 Organic residue Water 922.8 To waste water Potassium Iodide 2.3 To waste water Potassium hydroxide 1.2 To waste water Sodium chloride 59.9 To waste water Total Input 2468 Total Output 2468

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Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage I Product 23.4 Carfilzomib 16.7 Final Product (S)-2-Amino--4-methyl- 11.8 Trifluoro acetic acid 2.6 To Wastewater 1-((R)-2-methyloxiran- 2-yl)pentan-1-one 2,2,2- trifluoroacetate N,N,N′,N′-Tetramethyl- 80 DMF recovered 816 Recovered and reused O-(1H-benzotriazol-1- yl) uronium hexafluoro phosphate N,N-Dimethyl 850 DMF Loss 6.8 Fugitive Loss formamide N,N-Diisopropyl 80 DMF to water 8.5 To Wastewater ethylamine (DIPE) N-Hydroxy 80 DMF to residue 18.7 Solvent in Residue benzotriazole Sodium chloride 80 Ethyl acetate 960 Recovered and reused recovered Sodium bicarbonate 80 Ethyl acetate Loss 8 Fugitive Loss Ethyl acetate 1000 Ethyl acetate to 10 To Wastewater water Methanol 1100 Ethyl acetate to 22 Solvent in Residue residue Water 2500 Methanol recovered 1056 Recovered and reused Methanol Loss 8.8 Fugitive Loss Methanol to water 11 To Wastewater Methanol to residue 24.2 Solvent in Residue Stage I Product 10.3 Organic residue (S)-2-Amino--4- 5.2 Organic residue methyl-1-((R)-2- methyloxiran-2- yl)pentan-1-one 2,2,2- trifluoroacetate N,N,N′,N′- 80 Organic residue Tetramethyl-O-(1H- benzotriazol-1-yl) uronium hexafluoro phosphate DIPE 80 Organic residue N-Hydroxy 80 Organic residue benzotriazole Water 2500.4 To waste water Sodium bicarbonate 80 To waste water Sodium chloride 80 To waste water Total Input 5885.2 Total Output 5885.2 2-33 Team Labs and Consultants

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2.1.10 Process Description of Ceritinib Reaction Schemes

Stage-I:

Stage-II:

Process Description: Stage-I : 2-isopropoxy-5-methyl-4-(piperidin-4-yl)aniline dihydrochloride condensed with 2,5- dichloro-N-(2-(isopropylsulfonyl)phenyl)pyrimidin-4-amine in presence of Isopropyl alcohol to give 5-chloro-N2-(2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl)-N4-(2- (isopropylsulfonyl)phenyl)pyrimidine-2,4-diamine dihydrochloride.

Stage-II: 5-chloro-N2-(2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl)-N4-(2- (isopropylsulfonyl) phenyl)pyrimidine-2,4-diamine dihydrochloride de-saltification with 10% sodium hydroxide solution to give Ceritinib. Schematic diagram of Ceritinib is shown in Fig 2.10 and material balance for Ceritinib is presented in Table 2.12.

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Fig 2.10 Process Flow Diagram of Ceritinib

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Table 2.12 Material Balance for Ceritinib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 2-isopropoxy-5-methyl- 556.2 Stage I Product 890.3 To Stage II 4-(piperidin-4-yl) aniline dihydrochloride 2,5-dichloro-N-(2- 599.3 Hydrogen Chloride 51.5 To scrubber (isopropylsulfonyl) phenyl)pyrimidin-4- amine Isopropanol 4500 Isopropanol recovered 4320 Recovered and reused Sodium hydroxide 54.6 Isopropanol Loss 36 Fugitive Loss Hydrochloric acid 49.8 Isopropanol to residue 144 Solvent in Residue 2-isopropoxy-5-methyl- 102.9 Organic residue 4-(piperidin-4-yl) aniline dihydrochloride 2,5-dichloro-N-(2- 110.9 Organic residue (isopropylsulfonyl) phenyl)pyrimidin-4- amine Water 24.6 Carried along with organic residue Sodium chloride 79.7 Inorganic residue Total Input 5759.8 Total Output 5759.8

Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage I Product 890.3 Ceritinib 500 Final Product 10% NaOH solution 716.7 Hydrochloric acid 65.4 To Neutralization Acetone 2664 Acetone recovered 2557.4 Recovered and reused Water 1110 Acetone Loss 21.3 Fugitive Loss Acetone to water 26.6 To Wastewater Acetone to residue 58.6 Solvent in Residue Stage I Product 324.9 Organic residue Water 1787.2 To waste water Sodium Chloride 104.7 To waste water Total Input 5380.9 Total Output 5380.9

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2.1.11 Process Description of Cyclophosphamide Reaction Schemes

Stage-I:

Cl OH T riethyl am ine POCl H N + 3 + NH2 Dim ethyl form am ide Phosphoryl Water Cl chloride 3-Amino-1-propanol Bis(2-chloroethyl)am ine M.W t: 153.5 M.Wt: 75 M.Wt: 142 Cl O O P N 3 HCl NH + Cl Hydrochloric acid M.W t: 109.5 Cyclophosphamide (Pharma)

M.W t: 261

Process Description: Stage – I: Bis(2-chloroethyl)amine is condensed with Phosphoryl chloride and 3-Amino-1- propanol to yield Cyclophosphamide (Pharma). The process flow diagram and material balance for Cyclophosphamide is presented in Fig 2.11 and Table 2.13.

Bis(2-chloroethyl)am ine Phosphoryl chloride Hydrogenchloride 3-Amino-1-propanol Dimethyl formamide Triethyl am ine Activated carbon Dimethyl formamide Sodium hydroxide Waste water Activated carbon

Water

Cyclophosphamide (Pharma)

Fig 2.11 Process Flow Diagram of Cyclophosphamide

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Table 2.13 Material Balance for Cyclophosphamide Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Bis-(2-chloroethyl)amine 241.8 Cyclophosphamide 200 Final Product Hydrochloride Monohydrate Phosphorylchloride 261.4 THF recovered 1920 Recovered and reused 3-Amino-1-propanol 127.7 THF Loss 16 Fugitive Loss Tetrahydro Furan (THF) 2000 THF to water 20 To Wastewater Diisopropyl Ether 2500 THF to residue 44 Solvent in Residue (DIPE) Acetone 4900 DPE recovered 2400 Recovered and reused Ethanol 795 DIPE Loss 20 Fugitive Loss Triethylamine 370 DIPE to water 25 To Wastewater Activated Carbon 40 DIPE to residue 55 Solvent in Residue Water 4500 Acetone recovered 4704 Recovered and reused Sodium hydroxide 92 Acetone Loss 39.2 Fugitive Loss Acetone to water 49 To Wastewater Acetone to residue 107.8 Solvent in Residue Ethanol recovered 763.2 Recovered and reused Ethanol Loss 6.4 Fugitive Loss Ethanol to water 8 To Wastewater Ethanol to residue 17.5 Solvent in Residue TEA Recovered 355.2 Recovered and reused TEA loss 3 Fugitive Loss TEA to waste water 3.7 To Wastewater TEA to residue 8.1 Solvent in Residue Bis-(2-chloroethyl) 133 Organic residue amine Hydrochloride 3-Amino-1-propanol 70.2 Organic residue Activated carbon 40 spent carbon Waste water 4541.4 To waste water Sodium chloride 134.5 To waste water Phosphorylchloride 143.8 To waste water Total Input 15827.9 Total Output 15827.9

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2.1.12 Process Description of Dasatinib Reaction Schemes Stage-I:

O H 3 C N H Cl N N N S H H O N 2 Ethanol N N Cl + OH + Water CH3 1-(2-hydroxyethyl) M.Wt: 18 piperazine 2-(6-chloro-2-methylpyrimidin-4ylam ino) -N-(2-chloro-6-m ethyl phenyl)thiazole-5- M.Wt: 130 carboxam ide

M.W t: 394.5 CH 3 CH N 3 H N N N + HCl S N N H .Monohydrate M .W t: 36.5 O N Cl OH Dasatinib m onohydrate (Pharma)

M .W t: 506 Process Description: Stage-I: 2-(6-chloro-6-methylpyrimidin-4ylamino)-N—(2-chloro-6-methyl phenyl)thiazole- 5-carboxamide is condensed with 1-(2-hydroxyethyl)piperazine in the presence of water and ethanol to yield Dasatinib Monohydrate (Pharma).Schematic diagram of Dasatinib is shown in Fig 2.12 and material balance for dasatinib is presented in Table 2.14.

2-(6-chloro-2-methylpyrimidin- Dasatinib monohydrate 4ylamino)-N-(2-chloro-6-methyl phenyl)thiazole-5-carboxamide Hydrochloric 1-(2-hydroxyethyl)piperazine n-Butanol

n-Butanol Condensation Diisopropyl Diisopropyl ethylam ine Ethanol Ethanol Water Water

Dasatinib M onohydrate (Pharm a) Fig 2.12 Process Flow Diagram of Dasatinib

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Table 2.14 Material Balance for Dasatinib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 2-(6-chloro-6-methyl 129.9 Dasatinib 83.3 Final Product pyrimidin -4ylamino)- Monohydrate N-(2-chloro-6-methyl phenyl) thiazole-5- carboxamide 1-(2- 42.8 n-Butanol recovered 1737.6 Recovered and reused hydroxyethyl)piperazine n-Butanol 1810 n-Butanol Loss 14.5 Fugitive Loss Diisopropyl ethyl amine 70 n-Butanol to water 18.1 To Wastewater Ethanol 1500 n-Butanol to residue 39.8 Solvent in Residue Water 2190 Ethanol recovered 1440 Recovered and reused Sodium hydroxide 6.6 EthanolLoss 12 Fugitive Loss Ethanolto water 15 To Wastewater Ethanol to residue 33 Solvent in Residue 2-(6-chloro-6-methyl 64.9 Organic residue pyrimidin -4ylamino)- N-(2-chloro-6-methyl phenyl) thiazole-5- carboxamide 1-(2-hydroxyethyl) 21.4 Organic residue piperazine Diisopropyl ethyl 70 Organic residue amine Water 2190 To waste water Sodium chloride 9.6 To waste water Total Input 5749.3 Total Output 5749.3

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2.1.13 Process Description of Docetaxel

Cl CCH CO O O OCO CH CCl 3 2 2 2 2 3 Pd/C NHBOC O H 3 C 2H2 Zinc, Acetic acid C H O 6 5 O + Hydrogen H Methanol OH OCOCH M .W t: 4 H O 3

H 5 C 6 OCO 4,6-bis[[(2,2,2-trichloroethoxy) carbonyl]oxy]substituted docetaxel M .W t: 1158

H O O OH

NHBOC O H 3 C 2 Cl3 CCH2 OCOH C H O 6 5 O + 2,2,2-Trichloroethyl form ate H OH OCOCH M.Wt: 355 H O 3

H 5 C 6 OCO Docetaxel (Pharm a) M.W t: 807 Process Description:

Stage – I: 4,6-bis[[(2,2,2-trichloroethoxy)carbonyl]oxy]substituted docetaxel reduced with hydrogen gas in the presence of Pd/C, Zinc and acetic acid in methanol yield Docetaxel (Pharma).The process flow diagram and material balance for docetaxel is presented in Fig 2.13 and Table 2.15.

4,6-bis[[(2,2,2-trichloro ethoxy)carbonyl]oxy] substituted docetaxel Pd/C A cetic acid Hydrogen gas Hydrogen gas 2,2,2-Trichloroethylformate Pd/C Acetic acid

Zinc Methanol

Methanol Zinc Activated carbon Activated carbon C elite C elite

Docetaxel (pharm a) Fig 2.13 Process Flow Diagram of Docetaxel

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Table 2.15 Material Balance for Docetaxel Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 4,6-bis[[(2,2,2- 1784.4 Docetaxel 808.3 Final Product trichloroethoxy)carbon yl]oxy]substituted docetaxel Hydrogen gas 6.2 2,2,2-Trichloro ethyl 355.6 By Product formate Zinc 80 Acetic acid recovered 4800 Recovered and reused Pd/C 100 Acetic acid Loss 50 Fugitive Loss Acetic acid 5000 Acetic acid to waste 25 To waste water water Methanol 7500 Acetic acid to residue 125 Solvent in Residue Activated carbon 50 Methanol recovered 7200 Recovered and reused Celite 60 Methanol Loss 75 Fugitive Loss Water 1500 Methanol to waste 37.5 To waste water water Methanol to residue 187.5 Solvent in Residue 4,6-bis[[(2,2,2- 624.5 Organic residue trichloroethoxy)carbon yl]oxy]substituted docetaxel Hydrogen gas 2.2 Let out into atmosphere safely Pd/C 100 Organic residue Activated carbon 50 spent carbon Zinc 80 Inorganic residue Celite 60 Inorganic residue Water 1500 To wastewater Total Input 16080.6 Total Output 16080.6

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2.1.14 Process Description of Enzalutamide

Reaction Schemes

Stage-I:

Stage-II:

Stage-III:

Stage-IV:

Process Description: Stage – I: 2-fluoro-4-nitrobenzoic acid reacts with Thionyl chloride and Aq.Methyl amine in presence of Dichloromethane and dimethyl formamide to form N-methyl-2-fluoro-4- nitrobenzamide.

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Stage – II: N-methyl-2-fluoro-4-nitrobenzamide undergoes hydrogenation with 10% Pd/C in presence of methanol to form N-methyl-2-fluoro-4-aminobenzamide. Stage – III: N-methyl-2-fluoro-4-aminobenzamide is further reacts with Acetone cyanohydrin, anhydrous magnesium sulfate in presence of Ethyl acetate and DM water to form N-Methyl- 2-fluoro-4-(1,1-dimethyl-cyanomethyl)-aminobenzamide. Stage – IV: N-Methyl-2-fluoro-4-(1,1-dimethyl-cyanomethyl)-amino benzamide reacts with 4-Amino- 2-(trifluoromethyl)benzonitrile and thiophosgene in presence of dimethyl acetamide to form Enzalutamide. The process flow diagram and material balance for Enzalutamide is presented in Fig 2.14 and Table 2.16.

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Fig 2.14 Process Flow Diagram of Enzalutamide

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Table 2.16 Material Balance for Enzalutamide Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 2-Fluoro-4-nitrobenzoic acid 49.7 Stage I Product 43.1 To Stage-II 40% Aqueous Methyl amine 8.3 DMF recovered 4.8 Recovered and reused Thionyl chloride 35 DMF Loss 0.04 Fugitive Loss Dimethylformamide (DMF) 5 DMF to water 0.1 To Wastewater Dichloromethane (DCM) 770 DMF to residue 0.1 Solvent in Residue Water 315.3 DCM recovered 739.2 Recovered and reused Hexane 90 DCM Loss 6.2 Fugitive Loss Anhydrous Sodium sulfate 15 DCM to water 7.7 To Wastewater DCM to residue 16.9 Solvent in Residue Hexane recovered 86.4 Recovered and reused Hexane Loss 0.7 Fugitive Loss Hexane to residue 2.9 Solvent in Residue 2-Fluoro-4- 9.4 Organic residue nitrobenzoic acid Aqueous Methyl 1.6 To waste water amine Water 319.2 To waste water Hydrogen Chloride 21.5 To Scrubber Sulfur dioxide 18.8 To Scrubber Sodium sulfate 15 Inorganic residue Total Input 1288.4 Total Output 1293.6 Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage I Product 43.1 Stage II Product 33.3 To Stage-III Pd/C 2.5 Water 7.1 Carry along with organic residue Methanol 340 Methanol recovered 326.4 Recovered and reused Hexane 90 Methanol Loss 2.7 Fugitive Loss Carbon 3 Methanol to water 0 To Wastewater Hydrogen gas 1.3 Hexane recovered 86.4 Recovered and reused Hexane Loss 0.7 Fugitive Loss Hexane to water 0 To Wastewater Stage I Product 3.9 Organic residue Activated carbon 3 spent carbon Pd/C 2.5 Organic residue Hydrogen 0.1 Let out into atmosphere safely Total Input 479.9 Total Output 479.9

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Stage III Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage II Product 33.3 Stage III Product 33.3 To Stage-III Acetone cyanohydrin 16.8 Ethyl acetate 441.6 Recovered and reused recovered Anhydrous Magnesium 40 Ethyl acetate Loss 3.7 Fugitive Loss sulfate Ethyl acetate 460 Ethyl acetate to 4.6 To Wastewater water Water 85 Ethyl acetate to 10.1 Solvent in Residue residue Diisopropyl ether (DIPE) 65 DPE recovered 62.4 Recovered and reused Anhydrous Sodium sulfate 15 DPE Loss 0.5 Fugitive Loss DIPE to water 0.7 To Wastewater DIPE to residue 1.4 Solvent in Residue Stage II Product 9.5 Organic residue Acetone cyanohydrin 4.8 Organic residue Water 87.5 To waste water Magnesium sulfate 40 Inorganic residue Sodium sulfate 15 Inorganic residue Total Input 715.1 Total Output 715.1 Stage IV Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage III Product 33.3 Enzalutamide 33.3 Final product 4-Amino-2-(trifluoromethyl) 26.3 DMA recovered 168 Recovered and reused benzonitrile Thiophosgene 16.3 DMA Loss 1.4 Fugitive Loss Dimethyl acetamide (DMA) 175 DMA to water 1.8 To Wastewater Methanol 350 DMA to residue 3.9 Solvent in Residue Ethyl acetate 1050 Methanol recovered 336.0 Recovered and reused Hyflo 3 Methanol Loss 2.8 Fugitive Loss DM Water 250 Methanol to water 3.5 To Wastewater Isopropyl alcohol (IPA) 140 Methanol to residue 7.7 Solvent in Residue Carbon 3 Ethyl acetate 1008 Recovered and reused recovered Sodium hydroxide 5.7 Ethyl acetate Loss 8.4 Fugitive Loss Ethyl acetate to 10.5 To Wastewater water Ethyl acetate to 23.1 Solvent in Residue residue IPA recovered 134.4 Recovered and reused IPA Loss 1.1 Fugitive Loss IPA to water 1.4 To Wastewater IPA to residue 3.1 Solvent in Residue

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Stage III Product 16.4 Organic residue 4-Amino-2- 13 Organic residue (trifluoromethyl) benzonitrile Thiophosgene 8 Inorganic residue Activated carbon 3 Spent carbon water 252.5 To waste water Sodium chloride 8.3 To waste water Hyflo 3 Inorganic residue Total Input 2052.6 Total Output 2052.6

2.1.15 Process Description of Erlotinib HCL

Cl Tetrabutylmethyl ether.HCl O Sodium hydroxide CH3 O N H N + 2 CH3 O CH O N Methanol 3 -E th ynylb en ze na m in e 4-chloro-6,7-bis(2-m ethoxyethoxy) quinazolinone M.Wt: 117 M.Wt: 312

H N CH O CH 3 O N CH O .H C l 3 O N Erlotinib hydrochloride (Ph arm a) M.Wt: 429 Process Description: Stage – I: 4-chloro-6,7-bis(2-methoxyethoxy)Quinazolinone is condensed with 3-ethynyl benzenamine in presence of methanol to yield Erlotinibhydrochloirde. The process flow diagram and material balance for Thiodicard is presented in Fig 2.15 and Table 2.17.

4-chloro-6,7-bis(2-methoxyethoxy) Erlotinib Hydrochloride quinazolinone 3-Ethynylbenzenamine Ethanol

Ethanol n-Hexane

n-Hexane Chloroform

Chloroform Sodium hydroxide Condensation Sodium hydroxide Methanol Methanol n-Heptane

n-Heptane A ctivated Carbon

A ctivated Carbon t-butyl m ethyl ether t-butyl m ethyl ether t-butyl methyl ether hydrochloride t-butyl methyl ether hydrochloride Wastwater Water

Erlotinib H ydrochloride (Pharm a)

Fig 2.15 Process Flow Diagram of Erlotinib HCL

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Table 2.17 Material Balance for Erlotinib HCl Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 4-chloro-6,7-bis(2- 139 Erlotinib hydrochloride 133.3 Final Product methoxy ethoxy) Quinazolinone Ethynyl benzenamine 52 Methanol recovered 768 Recovered and reused Ethanol 4920 Methanol Loss 6.4 Fugitive Loss Methanol 800 Methanol to water 8.00 To Wastewater t-butylmethyl ether 7650 Methanol to residue 17.6 Solvent in Residue t-butylmethyl ether 70 t-butyl methy lether 7344 Recovered and .HCl recovered reused Activated Carbon 25 t-butyl methyl ether 61.2 Fugitive Loss Loss DM Water 2115 t-butyl methyl ether to 76.50 To Wastewater water t-butyl methyl ether to 168.3 Solvent in Residue residue Ethanol recovered 4723 Recovered and reused Ethanol Loss 39.4 Fugitive Loss Ethanol to water 49.20 To Wastewater Ethanol to residue 108.2 Solvent in Residue 4-chloro-6,7-bis(2- 41.6 Organic residue methoxy ethoxy) Quinazolinone Ethynylbenzenamine 15.6 Organic residue Activated carbon 25 Spent carbon t-butylmethylether Hcl 70 Organic residue Waste water 2115 To waste water Total Input 15770.47 Total Output 15770.47

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2.1.16 Process Description of Gefitinib Reaction Schemes

Stage-I:

Process Description: Stage – I: 4-Chloro-6-(3-morppholinopropoxy)-7-methoxyquinazoline is condensed with 3- Chloro-4-fluoro aniline in presence of sodium hydroxide to give Gefitinib (Pharma). The process flow diagram and material balance for Gefitinib is presented in Fig 2.16 and Table 2.18.

Fig 2.16 Process Flow Diagram of Gefitinib 2-50 Team Labs and Consultants

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Table 2.18 Material Balance for Gefitinib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 4-Chloro-6-(3- 501 Gefitinib 350 Final Product morppholinopropoxy)-7- hydrochloride methoxyquinazoline 3-Chloro-4-fluoro aniline 216.3 Sodium chloride 45.9 To Wastewater Ethanol 4720 water 2826.8 To Wastewater Methylene chloride (MDC) 3400 Ethanol recovered 4531 Recovered and reused Sodium hydroxide solution 59.5 Ethanol Loss 37.8 Fugitive Loss Methanol 2000 Ethanol to water 47.2 To Wastewater Ethyl acetate 1500 Ethanol to residue 103.8 Solvent in Residue Activated carbon 50 MDC recovered 3264 Recovered and reused Water 2800 MDC Loss 27.2 Fugitive Loss Hydrochloric acid 25.6 MDC to water 34 To Wastewater MDC to residue 74.8 Solvent in Residue Methanol recovered 1920 Recovered and reused Methanol Loss 16 Fugitive Loss Methanol to water 20 To Wastewater Methanol to residue 44 Solvent in Residue EA recovered 1440 Recovered and reused EA Loss 12 Fugitive Loss EA to water 15 To Wastewater EA to residue 33 Solvent in Residue 4-Chloro-6-(3- 236.4 Organic residue morppholino propoxy)-7-methoxy quinazoline 3-Chloro-4-fluoro 102.1 Organic residue aniline Activated carbon 50 spent carbon Sodium chloride 41 To waste water Total Input 15272.2 Total Output 15272.2

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2.1.17 Process Description of Gemcitabine HCl

Reaction Schemes

Stage-I:

PhOCO O NHCOCH3 OH Methanesulfonyl F 3H2O chloride (114.5) N + + Water Sodium bicarbonate F N O M.Wt: 54 OCOPh H Hydrochloric acid (36.5) 2-Deoxy-2,2-difluoropentofuranos N-acetyl cytosine Methanolic ammonia -3,5-dibenzoate (Anomeric mixture) M.Wt:153 M.Wt: 378

NH2

N

N O HO CH3COOH HCl + 2 C6H 5COOH + CH3SO3H + + O .HCl Acetic acid Benzoic acid Methane M.W t: 36.5 H F sulphonic acid M.Wt: 60 M.W t:244 M.Wt: 96 F OH Gemcitabine Hydrochloride (Pharma) M.W t:299.5

Process Description: Stage – I: 2-Deoxy-2,2-difluoropentofuranos-3,5-dibenzoate is reacted with methane sulfonyl chloride in presence of triethylamine and then condensed with N-acetyl cytosine followed by treated with Hydrochloric acid to give Gemcitabine hydrochloride (Pharma). The process flow diagram and material balance for Gemcitabine hydrochloride is presented in Fig 2.17 and Table 2.19.

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Fig 2.17 Process Flow Diagram of Gemcitabine HCl

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Table 2.19 Material Balance for Gemcitabine HCl Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 2-deoxy-2,2-difluoro 21.3 Gemcitabine 13.3 Final Product pentofuranos-3,5- dibenzoate Methane sulfonyl 6.5 Benzoic acid 10.9 To Wastewater chloride Methylene 245 Methane sulphonic acid 4.3 To Wastewater chloride(MDC) Triethylamine 10 Acetic acid 2.7 To Wastewater DM water 770 Toluene recovered 172.8 Recovered and reused Hydrochloric acid 23.5 Toluene Loss 1.4 Fugitive Loss Sodium bicarbonate 2.5 Toluene to water 1.8 To Wastewater Ethanol 410 Toluene to residue 4.0 Solvent in Residue N-Acetyl cytosine 8.6 Ethanol recovered 393.6 Recovered and reused Hexamethyl disilazine 30 Ethanol Loss 3.3 Fugitive Loss Trimethyl Chlorosilane 2.5 Ethanol to water 4.1 To Wastewater Toluene 180 Ethanol to residue 9 Solvent in Residue Trimethyl silyl trifluoro 35 Methanol recovered 91.2 Recovered and reused methane sulphonate Sodium chloride 17 Methanol Loss 0.8 Fugitive Loss Methanol 95 Methanol to water 1 To Wastewater Methanolic ammonia 166.7 Methanol to residue 158.8 Solvent in Residue (6%) Activated carbon 5.0 MDC recovered 235.2 Recovered and reused Sodium hydroxide 2.3 MDC Loss 2 Fugitive Loss MDC to water 2.5 To Wastewater MDC to residue 5.4 Solvent in Residue 2-deoxy-2,2-difluoro 4.5 Organic residue pentofuranos-3,5- dibenzoate N-Acetyl cytosine 1.8 Organic residue Triethylamine 10 Organic residue Hexamethyl disilazine 30 Organic residue Trimethyl chloro silane 2.5 Organic residue Trimethyl silyl trifluoro 35 Organic residue methane sulphonate Methane sulfonyl 1.4 Organic residue chloride Activated Carbon 5 spent carbon Water 768.7 To waste water Sodium bicarbonate 2.5 To waste water Sodium chloride 20.3 To waste water Ammonia Chloride 31.5 To waste water Total Input 2030.9 Total Output 2030.9

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2.1.18 Process Description of Ibrutinib Reaction Schemes Stage-I:

Stage-II:

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Stage-III:

Process Description: Stage – I: 3-(4-Phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine reacts with Diisopropyl azodicarboxylate and condense with tert-butyl (S)-3-hydroxypiperidine-1- carboxylate in presence of Triphenylphosphine to form tert-butyl (R)-3-(4-amino-3- (4- phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidine-1-carboxylate.Then further reacts with HCl to form (R)-3-(4-Phenoxyphenyl)-1-(piperidin-3-yl)- 1H-pyrazolo[3,4- d]pyrimidin-4-amine (Stage-I compound). Stage-II: (R)-3-(4-Phenoxyphenyl)-1-(piperidin-3-yl)-1H-pyrazolo[3,4-d]pyrimidin-4-amine is condense with Acryloyl chloride in presence of Dichloromethane to form Ibrutinib (Crude) (Stage-II compound). Stage-III: Ibrutinib (Crude) is purification with Dichloromethane and Methanol to form Ibrutinib (Pure) (Stage-III compound).The process flow diagram and material balance for Ibrutinib is presented in Fig 2.18 and Table 2.20.

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Fig 2.18 Process Flow Diagram of Ibrutinib

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Table 2.20 Material Balance for Ibrutinib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 3-(4-Phenoxyphenyl)-1H- 12.8 Stage I Product 12.2 To Stage I pyrazolo[3,4-d]pyrimidin-4- amine Diisopropyl 8.5 Diisopropyl hydrazine- 6.5 Organic residue azodicarboxylate 1,2-dicarboxylate Tert-butyl (S)-3- 8.5 Triphenylphosphine 8.8 Organic residue hydroxypiperidine-1- oxide carboxylate Triphenylphosphine 11.1 tert-butyl 4.3 Organic residue carbonochloridate Hydrochloric acid 1.5 THF recovered 168 Recovered and reused Tetrahydrofuran(THF) 175 THF Loss 1.4 Fugitive Loss Isopropyl alcohol (IPA) 25 THF to water 1.8 To Wastewater Ethyl acetate(EA) 720 THF to residue 3.9 Solvent in Residue Water 800 IPA recovered 24 Recovered and reused Sodium chloride 50 IPA Loss 0.2 Fugitive Loss Sodium carbonate 35 IPA to water 0.3 To Wastewater Anhydrous Sodium sulfate 50 IPA to residue 0.6 Solvent in Residue Sodium hydroxide 0.4 EA recovered 691.2 Recovered and reused EA Loss 5.8 Fugitive Loss EA to water 7.2 To Wastewater EA to residue 15.8 Solvent in Residue 3-(4-Phenoxyphenyl)- 3.2 Organic residue 1H-pyrazolo[3,4- d]pyrimidin-4-amine Diisopropyl 2.1 Organic residue azodicarboxylate tert-butyl (S)-3- 2 Organic residue hydroxypiperidine-1- carboxylate Triphenylphosphine 2.8 Organic residue Water 800.2 To waste water Sodium carbonate 35.0 To waste water Sodium chloride 50.6 To waste water Sodium sulfate 50 Inorganic residue Total Input 1897.8 Total Output 1897.8 Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage I Product 12.2 Stage II Product 9.1 To Stage -II Acryloyl chloride 3 DCM recovered 307.2 Recovered and reused Dichloromethane(DCM) 320 DCM Loss 2.6 Fugitive Loss

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Ethyl acetate 250 DCM water 3.2 To Wastewater Water 650 DCM to residue 7 Solvent in Residue Sodium chloride 45 Ethyl acetate recovered 240 Recovered and reused Sodium carabonate 5 Ethyl acetate Loss 2 Fugitive Loss Anhydrous sodium sulfate 20 Ethyl acetate to water 2.5 To Wastewater DBU 8 Ethyl acetate to residue 5.5 Solvent in Residue Citric acid 15 Stage I Product 4.3 Organic residue Sodium hydroxide 0.82 Acryloyl chloride 1.0 Organic residue DBU 8 Organic residue Citric acid 15 To waste water Water 650.4 To waste water Sodium chloride 46.2 To waste water Sodium carbonate 5 To waste water sodium sulfate 20 To waste water Total Input 1328.9 Total Output 1328.9 Stage III Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage II Product 9.1 Ibrutinib (Pure) 8.33 Final Product Dichloromethane(DCM) 45 DCM recovered 43.2 Recovered and reused Methanol 25 DCM Loss 0.4 Fugitive Loss DCM to residue 1 Solvent in Residue Methanol recovered 24 Recovered and reused Methanol to water 0.0 To Wastewater Methanol to residue 0.8 Solvent in Residue Stage II Product 0.72 Organic residue Total Input 79.05 Total Output 79.05

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2.1.19 Process Description of Imatinib Mesylate Reaction Schemes

Stage-I:

Stage-II:

Process Description: Stage – I: 4-(4-Methylpiperazinomethyl)benzoic acid dihydrochloride is reacted with thionylchloride in the presence of dimethylformamide and then condensed with N-(2- Methyl-5-aminophenyl)-4-(3-pyridyl)-2-pyrimidne amine to give Imatinib. Stage – II: Imatinib is reacted with methane sulfonic acid in the presence of methanol to give Imatinib mesylate. The process flow diagram and material balance for Imatinib mesylate is presented in Fig 2.19 and Table 2.21.

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Fig 2.19 Process Flow Diagram of Imatinib Mesylate

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Table 2.21 Material Balance for Imatinib Mesylate Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 4-(4-Methyl piperazino 82.6 Stage I Product 50.4 To Stage II methyl) benzoic acid Di HCl Thionyl Chloride 32 Hydrogen Gas 0.2 Let into atmosphere safely N-(2-Methyl-5- 75 Ammonium chloride 21.9 To Wastewater aminophenyl)-4-(3- pyridyl)-2-pyrimidne amine Ammonium hydroxide 57 Ammonium sulfate 13.5 Inorganic residue Dimethyl Formamide 2 Water 1504.4 To Wastewater Methanol 450 Methanol recovered 432 Recovered and reused Hexane 350 Methanol loss 3.2 Fugitive Loss Chloroform 500 Methanol to water 7.7 To Wastewater Water 1500 Methanol residue 7.2 Solvent in Residue Acetone 250 Chloroform recovered 480 Recovered and reused Isopropanol 320 Chloroform loss 5 Fugitive Loss Chloroform residue 15 Solvent in Residue n-Hexane recovered 336 Recovered and reused n-Hexane loss 2.5 Fugitive loss n-Hexane residue 11.6 Solvent in Residue Acetone recovered 237.5 Recovered and reused Acetone loss 5.5 Fugitive Loss Acetone to water 1 To Wastewater Acetone residue 6 Solvent in Residue IPA recovered 306.2 Recovered and reused IPA loss 10.2 Fugitive Loss IPA to wastewater 1.3 To Wastewater IPA residue 2.2 Solvent in Residue 4-(4-Methyl piperazino 51.2 Organic residue methyl) benzoic acid Di HCl N-(2-Methyl-5- 46.2 Organic residue aminophenyl)-4-(3- pyridyl)-2-pyrimidne amine Ammonium hydroxide 35 Inorganic residue Hydrogen chloride 12.2 To Scrubber Sulfur dioxide 10.7 To Scrubber Dimethyl Formamide 2.4 Organic residue Total Input 3618.1 Total Output 3618.1

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Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage I Product 50.4 Imatinib Mesylate 50.0 Final product Methanesulfonic acid 9.8 Methanol recovered 216.2 Recovered and reused Methanol 230 Methanol Loss 1.6 Fugitive Loss Water 70 Methanol to water 1.8 To Wastewater Activated Carbon 10 Methanol to residue 10.4 Solvent in Residue Stage I Product 8.6 Organic residue Activated carbon 10 Spent carbon Waste water 70 To waste water Methanesulfonic acid 1.7 To waste water Total Input 370.24 Total Output 370.24

2.1.20 Process Description of Lapatanib Reaction Schemes Stage-I:

Process Description:

Stage – I: 5-[4-({3-chloro-4-[(3-fluorophenyl)methoxy]phenyl}amino)quinazolin-6-yl]furan- 2-carbaldehyde is reacted with p-Toluene sulfonic acid and 2-(Methanesulfonyl) ethylamine in the presence of diisopropylethyl amine to give Lapatinibditosylate monohydrate. The process flow diagram and material balance for Lapatinibditosylate monohydrate is presented in Fig 2.20 and Table 2.22.

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Fig 2.20 Process Flow Diagram of Lapatanib

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Table 2.22 Material Balance for Lapatanib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 5-[4-({3-chloro-4-[(3- 533 Lapatinib ditosylate 533.33 Final Product fluorophenyl) methoxy] Monohydrate phenyl} amino) quinazolin-6-yl]furan-2- carbaldehyde 2-(Methanesulfonyl) 138.2 Acetic acid recovered 4483.8 Recovered and ethylamine reused p-Toluenesulfonic acid 387.1 Acetic acid loss 33.4 Fugitive Loss Diisopropylethyl amine 90 Acetic acid to 38.2 To Wastewater wastewater Acetic acid 4770 Acetic acid residue 214.7 Solvent in Residue Triacetoxy sodium 105 Tetrahydrofuran 1237 Recovered and borohydride recovered reused Sodium hydroxide 300 Tetrahydrofuran loss 33 Fugitive Loss Tetrahydrofuran 1330 Tetrahydrofuran to 13.3 To Wastewater wastewater Ammonium chloride 200 Tetrahydrofuran 46.6 Solvent in Residue residue Activated carbon 80 Organic Imurities 264.74 Organic residue Hydrogen gas 2 2-(Methanesulfonyl) 68.7 Organic residue ethylamine Water 6000 p-Toluenesulfonic 192.4 Organic residue acid hydrochloric acid 274 Diisopropylethyl 90 Organic residue amine Triacetoxy sodium 105 Organic residue borohydride Activated carbon 80 Spent carbon Hydrogen 1.1 Let into atmosphere safely Sodium Chloride 438.8 To Wastewater Water 6135 To Wastewater Ammonium chloride 200 To Wastewater Total Input 14209 Total Output 14209

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2.1.21 Process Description of Lenvatinib Reaction Schemes

Stage-I:

Process Description:

Stage – I: 4-Chloro-7-methoxy-6-quinolinecarboxamide undergoes condensation with 3- chloro-4- (3-cyclopropylureido)phenol in presence of dimethyl sulfoxide, potassium-t- butoxide acetone and DM water. The process flow diagram and material balance for Lenvatinib is presented in Fig 2.21 and Table 2.23.

Fig 2.21 Process Flow Diagram of Lenvatinib

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Table 2.23 Material Balance for Lenvatinib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 4-Chloro-7-methoxy-6- 8.69 Lenvatinib 13.3 Final Product quinoline carboxamide 3-chloro-4-(3- 8.3 Water 596.7 To Wastewater cyclopropylureido) phenol dimethyl sulfoxide 95 Acetone recovered 488.1 Recovered and reused Potassium-t-butoxide 4 Acetone loss 16.3 Fugitive Loss Acetone 510 Acetone to wastewater 2 To Wastewater sodium hydroxide 1 Acetone residue 3.6 Solvent in Residue water 595 DMSO recovered 90.3 Recovered and reused Hydrochloric acid 1.1 DMSO loss 0.5 Fugitive Loss DMSO in residue 4.3 Solvent in Residue 4-Chloro-7-methoxy-6- 1.3 Organic residue quinolinecarboxamide 3-chloro-4-(3-cyclo 1.2 Organic residue propylureido)phenol Sodium chloride 1.8 To Wastewater Potassium-t-butoxide 4 To Wastewater Water 595.5 To Wastewater Total Input 1223.3 Total Output 1223.3

2.1.22 Process Description of Olaparib Reaction Schemes Stage-I:

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Stage-II:

Stage-III:

Process Description: Stage – I: Dimethyl (3-oxo-1, 3-dihydroisobenzfuran-1-yl) phosphonate condensed with 2- Fluoro- 5-formylbenzonitrile, water and Hydrazine hydrate in presence of Triethyl amine to give 2-Fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl) methyl) benzoic acid. Stage-II: 2-Fluoro-5-((4-oxo-3,4-dihydrophthalazin-1-yl)methyl)benzoic acid undergoes condensation and protected with Boc piperazine and Hydrochloric acid in presence of N-

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Fig 2.22 Process Flow Diagram of Olaparib

Table 2.24 Material Balance for Olaparib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Dimethyl(3-oxo-1,3- 12.8 Stage I Product 11.8 To Stage II dihydroisobenzfuran-1- yl)phosphonate 2-Fluoro-5- 7.9 Water 442.8 To Wastewater formylbenzonitrile DM water 400 Dimtehyl Phosphite 4.3 Organic residue Hydrazine hydrate 2.6 Ammonia 0.7 To Scrubber Triethyl amine 10 DMF recovered 108.1 Recovered and reused Dimethyl 115 DMF loss 0.8 Fugitive Loss formamide(DMF) Sodium hydroxide Soln 30 DMF to wastewater 2.9 To Wastewater (15%) Hydrochloric acid (22%) 18.7 DMF residue 3.2 Solvent in Residue Dimethyl(3-oxo-1,3- 3.2 Organic residue dihydroisobenzfuran- 1-yl)phosphonate 2-Fluoro-5- 2.0 Organic residue formylbenzonitrile Triethyl amine 10 Organic residue Hydrazine hydrate 0.7 Inorganic residue Sodium Chloride 6.6 To Wastewater Total Input 596.9 Total Output 596.9

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Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage I Product 11.8 Stage II Product 8.6 To Stage III BOC Piperazine 7.4 Water 663.4 To Wastewater Conc.Hydrochloric acid 1.4 Tert-butyl carbon 3.2 Organic residue chloridate Hydroxibezotriazole 2.6 Methanol recovered 156.8 Recovered and reused (HOBt) N-methyl morpholine 3.7 Methanol loss 0.8 Fugitive Loss Ethylene dichloride 10.0 Methanol residue 2.4 Solvent in Residue (EDCI) Dichloromethane(MDC) 300 MDC recovered 288.0 Recovered and reused Ammonium bi 300 MDC loss 2.1 Fugitive Loss carbonate solution (5%) Brine solution (26%) 58 MDC residue 9.9 Solvent in Residue Methanol 160 n-Hexane recovered 105.6 Recovered and reused n-Hexane 110 n-Hexane loss 0.8 Fugitive Loss Water 335 n-Hexane residue 3.6 Solvent in Residue Sodium hydroxide 0.6 Stage I Product 4.8 Organic residue BOC Piperazine 3 Organic residue HOBt 2.6 Organic residue N-methyl morpholine 3.7 Organic residue EDCl 10 Organic residue Sodium Chloride 0.9 To Wastewater Brine 15 To Wastewater Ammonium bi 15 To Wastewater carbonate Total Input 1300.2 Total Output 1300.2 Stage III Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage II Product 8.6 Olaparib 8.3 Final Product Cyclopropane carbonyl 2.5 Methanol recovered 470.3 Recovered and reused chloride Dichloromethane 220 Methanol loss 12.4 Fugitive loss Triethylamine 10 Methanol to water 8.9 To Wastewater DM Water 360 Methanol residue 3.5 Residue Sodium hydroxide 0.8 MDC recovered 209 Recovered and reused Methanol 495 MDC loss 5.5 Fugitive loss MDC to wastewater 1.8 To Wastewater MDC residue 3.7 Residue Stage II Product 1.6 Organic residue Cyclopropane 0.5 Organic residue carbonyl chloride Triethylamine 10 Organic residue

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Sodium Chloride 1.1 To Wastewater Water 360.3 To Wastewater Total Input 1096.8 Total Output 1096.6

2.1.23 Process Description of Palbociclib Reaction Schemes Stage-I:

Stage-II:

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Stage-III:

Process Description: Stage – I: 6-Bromo-2-chloro-8-cyclopentyl-5-methyl pyrido[2,3-d] pyrimidin-7(8H)-one and Tert- butyl 4-(6-aminopyridin-3-yl) piperazine-1-carboxylate undergoes condensation in the presence of LiHMDS and Toluene to form Tert-butyl 4-(6-((6-bromo-8-cyclopentyl-5- methyl-7-oxo-7,8-dihydro pyrido[2,3d]pyrimidin-2-yl) amino)pyridin-3-yl)piperazine-1- carboxylate. Stage-II: Tert-butyl 4-(6-((6-bromo-8-cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3- d]pyrimidin-2-yl) amino) pyridin-3-yl) piperazine-1-carboxylate undergoes Condensation with 1-(Vinyloxy)butane in presence of Hydrochloric acid to form Tert-butyl 4-(6-((6- (1- butoxyvinyl)-8- cyclopentyl-5-methyl-7-oxo-7,8-dihydropyrido[2,3-d]pyrimidin-2-yl) amino) pyridin-3-yl)piperazine-1-carboxylate. Stage-III: Tert-butyl 4-(6-((6-(1-butoxyvinyl)-8-cyclopentyl-5-methyl-7-oxo-7,8- dihydropyrido [2,3-d]pyrimidin-2-yl)amino)pyridin-3-yl)piperazine-1-carboxylate undergoes deprotection with water in presence of Methane sulfonic acid & Tri ethyl amine to form Palbociclib. The process flow diagram and material balance for Palbociclib is presented in Fig 2.23 and Table 2.25.

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Fig 2.23 Process Flow Diagram of Palbociclib

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Table 2.25 Material Balance for Palbociclib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 6-Bromo-2-chloro -8- Cyclo 36.9 Stage I Product 33.4 To Stage II pentyl -5-methyl pyrido [2,3-d] pyrimidin -7(8H)- one Tert-butyl 4-(6- 30 Toluene recovered 190 Recovered and aminopyridin-3-yl) reused piperazine-1-carboxylate LiHMDS 50 Toluene loss 0.8 Fugitive loss Toluene 200 Toluene to water 0.4 To Wastewater 10% Ammonium chloride 200 Toluene residue 8.8 Residue solution Sodium hydroxide 2.3 Organic Impurities 81.5 Organic residue Water 180 Water 361 To Wastewater Ammonium chloride 20 To Wastewater Sodium chloride 3.3 To Wastewater Total Input 699.2 Total Output 699.2 Stage II Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage I Product 33.4 Stage II Product 18 To stage III 5.7 n-Butanol recovered 228 Recovered and Vinyl butyl ether reused Di isopropyl ethylalcohol 10 n-Butanol loss 7.2 Fugitive Loss Pd(dppf)cl2 in DCM 1.6 n-Butanol residue 4.8 Solvent in Residue 240 DiPEA recovered 8.3 Recovered and n-Butanol reused Sodium hydroxide 1 DiPEA loss 0.04 Fugitive Loss DiPEA residue 1.7 Solvent in Residue Stage I Product 16 Organic residue Vinyl butyl ether 2.7 Organic residue Pd(dppf)cl2 in DCM 1.6 Organic residue Water 0.5 Carried along with organic residue Sodium bromide 3.1 Inorganic residue Total Input 291.9 Total Output 291.94 Stage III Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) Stage II Product 18 Palbociclib 6.67 Final Product DM Water 600.5 2-Carboxyoxy-2- 1.8 Organic residue methyl propane Acetone 85 2-methyl-1-propene 0.8 Organic residue

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Methane Sulfonic acid 6.5 Acetone recovered 79.9 Recovered and reused Triethyl amine(TEA) 5 Acetone loss 1.2 Fugitive Loss Acetone towater 1.4 To Wastewater Acetone residue 2.6 Solvent in Residue Stage II Product 9 Organic residue Methane Sulfonic 6.5 Organic residue acid TEA 5 To Wastewater water 600.3 To Wastewater Total Input 715 Total Output 715

2.1.24 Process Description of Pazopanib Reaction Schemes

Stage-I:

CH3 CH 3 Dimethyl formamide H 3C N CH3 Triethyl amine (101) N N NH2 H N S + 2 O O N Hydrochloric acid (36.5)

N Cl 5-Amino-2-methyl Methanol benzene sulphonamide N-(2-chloropyrimidin-4-yl)-N,2,3- trimethyl-2H-indazol-6-amine M.W t: 186 M.W t: 287.5

CH3

H C N 3 CH N N 3 Triethylamine .HCl CH3 + N M.W t: 137.5 NH .HCl N N S 2 H O O Pazopanib Hydrochloride (Pharma) M.W t: 473.5

Process Description:

Stage –I: N-(2-Chloropyrimidin-4-yl)-N,2,3-trimethyl-2H-indazol-6-amine is condensed with 5-Amino-2-methylbenzene sulphonamide in presence of triethylamine in dimethylformamide and methanol to yield Pazopanib Hydrochloride (Pharma).The process flow diagram and material balance for Pazopanib Hydrochloride is presented in Fig 2.24 and Table 2.26.

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Fig 2.24 Process Flow Diagram of Pazopanib Table 2.26 Material Balance for Pazopanib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) N-(2- 56.2 Pazopanib HCl 75 Final product Chloropyrimidin-4- yl)-N,2,3-trimethyl- 2H-indazol-6-amine 5-Amino-2-Methyl 36.4 Triethylamine Hcl 21.8 To Wastewater Benzene sulphonamide Triethyl amine 19.8 Methanol recovered 945 Recovered and reused Dimethyl formamide 1500 Methanol loss 4 Fugitive Loss (DMF) Hydrochloric acid 57.1 Methanol to wastewater 28 To Wastewater Methanol 1000 Methanol residue 23 Solvent in Residue Activated carbon 35 DMF recovered 1413 Recovered and reused Water 800 DMF loss 12 Fugitive Loss Sodium hydroxide 56.3 DMF to wastewater 12 To Wastewater DMF residue 63 Solvent in Residue Organic Impurities 17.6 Organic residue Triethyl amine 3.8 To Wastewater Activated carbon 35 Spent carbon Sodium chloride 82.2 To Wastewater Water 825.3 To Wastewater Total Input 3560.8 Total Output 3560.6

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2.1.25 Process Description of Sorefinib Reaction Schemes Stage-I:

Process Description:

Stage –I: 4-(2-(N-Methylcarbamoyl)-4-pyridyloxy)aniline is condensed with 4-Chloro-3- (trifluoromethyl)phenyl isocyanate and reacted with P-Toluene sulfonic acid in presence of Carbonyldiimidazole and methylene chloride and methanol to yield SorafenibTosylate (Pharma).The process flow diagram and material balance for Sorafenib Tosylate is presented in Fig 2.25 and Table 2.27.

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Fig 2.25 Process Flow Diagram of Sorefinib Table 2.27 Material Balance for Sorefinib Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 4(2-(N-Methylcarbamoyl) - 445.78 Sorefinib 800 Final Product 4-pyridyloxy) aniline 4-Chloro-3-(trifuoro 357.9 1H-Imizadole 170.8 Organic residue methyl) phenyl isocyanate N.N’-Carbonyl 296.6 MDC recovered 3477 Recovered and diimidazole reused P-Tolene sulfonic acid 314.9 MDC loss 14.6 Fugitive loss Methylene chloride(MDC) 3660 MDC residue 168.4 Solvent in Residue 3330 Methanol recovered 3163.5 Recovered and Methanol reused Activated carbon 80 Methanol loss 59.9 Fugitive loss Water 1000.0 Methanol to water 1.7 To Waste water Methanol residue 104.9 Solvent in Residue 4(2-(N-Methyl 140 Organic residue carbamoyl )-4- pyridyloxy)aniline N.N’-Carbonyldi 93.1 Organic residue imidazole P-Toluene sulfonic acid 98.9 Organic residue Activated carbon 80 Spent carbon 4-Chloro-3-(trifuoro 112.4 Organic residue methyl) phenyl isocyanate Water 1000 To Waste water Total Input 9485.2 Total Output 9485.2

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2.1.26 Process Description of Sunitinib Malate Reaction Schemes

Stage-I:

Process Description:

Stage –I: 5-formyl-2,4-dimethyl-1H-pyrrole-3-carboxylicacid-(2-diethylamino-ethyl)-amide is condensed with 5-fluoro-1,3-dihydro-indol-2-one followed by treating with L(-)-Malic acid to give Sunitinb malate (Pharma).The process flow diagram and material balance for Sorafenib Tosylate is presented in Fig 2.26 and Table 2.28.

Fig 2.26 Process Flow Diagram of Sunitinib Malate

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Table 2.28 Material Balance for Sunitinib Malate Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 5-formyl-2,4-dimethyl-1H- 547 Sunitinib 753.3 Final Product pyrrole-3-carboxylic acid- (2-diethylamino-ethyl)- amide 5-fluoro-1,3-dihydro- 311.7 Water 525.5 To Wastewater indol-2-one Malic acid 276.6 Methanol recovered 3800 Recovered and reused Pyrrolidine 20 Methanol loss 16 Fugitive loss Acetonitrile 5000 Methanol to waste 20 To Wastewater water Methanol 4000 Methanol residue 164 Solvent in Residue Ethanol 3500 Ethanol recovered 3325 Recovered and reused Activated Carbon 70 Ethanol loss 63 Fugitive loss Water 500 Ethanol residue 112 Solvent in Residue Acetonitrile recovered 4750 Recovered and reused Acetonitrile loss 90 Fugitive loss Acetonitrile residue 160 Solvent in Residue 5-formyl-2,4-dimethyl- 171.8 Organic residue 1H-pyrrole-3- carboxylicacid-(2- diethylamino-ethyl)- amide Malic acid 86.9 Organic residue Pyrrolidine 20 Organic residue Activated carbon 70 To Spent carbon 5-fluoro-1,3-dihydro- 97.9 Organic residue indol-2-one Total Input 14225.3 Total Output 14225.3

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2.1.27 Process Description of Tamoxifene Reaction Schemes Stage-I:

Process Description:

Stage–I: 1-(4-hydroxyphenyl)-1, 2-diphenyl-1-butene is reacted with 2-chloro-N,N- diethylethanamine in the presence of triethyl amine in dimethyl formamide to yield Tamoxifen (Pharma).The process flow diagram and material balance for Tamoxifen is presented in Fig 2.27 and Table 2.29.

Fig 2.27 Process Flow Diagram of Tamoxifene

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Table 2.29 Material Balance for Tamoxifene Stage I Input Quantity Output Quantity Remarks (Kg/day) (Kg/day) 1-(4-hydroxyphenyl) - 342.3 Tamoxifen 366.67 Final Product 1,2-diphenyl-1-butene 2-chloro-N,N- 122.7 DMF recovered 3800 Recovered and reused diethylethanamine Triethyl amine (TEA) 110 DMF loss 28 Fugitive Loss Dimethyl formamide 4000 DMF to wastewater 108 To Wastewater (DMF) Activated carbon 50 DMF residue 64 Solvent in Residue n-Propanol 2690 n-Propanol recovered 2555.5 Recovered and reused Water 3230 n-Propanol loss 13.5 Fugitive Loss Sodium hydroxide 39.5 n-Propanol to 26.9 To Wastewater wastewater n-Propanol residue 94.2 Solvent in Residue TEA recovered 104.5 Recovered and reused TEA loss 0.6 Fugitive Loss TEA to wastewater 1.1 To Wastewater TEA residue 3.9 Solvent in Residue 1-(4-hydroxyphenyl)- 46.2 Organic residue 1,2-diphenyl-1-butene 2-chloro-N,N- 16.6 Organic residue diethylethanamine Activated carbon 50 Spent carbon Sodium Chloride 57.7 To Wastewater Water 3247.7 To Wastewater Total Input 10584.5 Total Output 10584.9

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2.2 Utilities

It is proposed to establish coal fired boilers of capacity of 2 x 8 TPH to meet steam requirement for process and ZLD system. The DG sets required for emergency power during load shut down is estimated at 5000 KVA and accordingly 1 x 1500, 2 x 1000, 3 x 500 kVA DG set are proposed. The list of utilities is presented in Table 2.30. Table 2.30 List of Utilities S.No Utility Capacity 1 Coal Fired Boilers (TPH) 2 x 8 2 DG Sets (KVA)* 1 x 1500 2 x 1000 1 x 500 *DG sets shall be kept as standby. 2.3 Water Requirement (Terms of Reference No. 3 (vii)) Water is required for process, scrubbers, washing, cooling tower makeup, steam generation and domestic purposes. The total water requirement is 312.82 KLD consisting of 206.82 KLD of fresh water and 106 KLD of recycled water. The required water shall be drawn from ground water in addition to reuse of treated wastewater. The water balance for daily consumption is presented in Table 2.31. Water balance flow diagram is presented in Fig 2.28. Table 2.31 Total Water Balance Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Effluent Process 45.32 51.4* Washings 5 5 Scrubber 3 3 Boiler Feed 40 20 52 8 Cooling Tower 80 86 143 23 RO/DM Plant 8.5 8.5 Domestic 15 2.5 12.5 Gardening 10 10 Gross Total 206.82 106 207.5 111.4 Total 312.82 318.9 * Process Effluents contains unreacted raw materials, water formed during reaction, soluble solvents, by-products etc.

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Fig 2.28 Water Balance Flow Diagram

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2.4 Pollution Control Facilities: Liquid Effluents, air emissions and solid wastes generated are the major pollutants from the process operations of bulk drug manufacturing. The pollution control measures proposed to treat/mitigate the emissions and effluents are described as follows.

2.4.1 Water Pollution: The effluents generated in the process, separation techniques and during purification contain organic residues and inorganic raw materials, solvents, and products. Hence the effluents contain both organic and inorganic salts in various quantities leading to high COD and TDS concentrations respectively. Effluents from process, washings, Scrubbing media, utility blow downs and domestic wastewater will be sent to the effluent treatment system. The treated effluent will be reused for cooling towers and boiler makeup. The total effluent generated and mode of treatment is presented in Table 2.32. The compiled characteristics of process effluents, stage wise for each product is presented in Table 2.33 and Table 2.34 respectively Table 2.32 Total Effluent Generated and Mode of Treatment Description Quantity Mode of Treatment (KLD) HTDS Effluents Process 51.4 Sent to Stripper. Stripper condensate shall be Washings 5 disposed to cement industries for co- Scrubber Effluent 3 processing/TSDF. Stripper bottom is sent to MEE RO/DM Rejects 8.5 followed by AFTD. Condensate from MEE shall be sent to biological treatment plant followed by RO. RO rejects are sent to MEE and permeate is reused in cooling towers and boiler make-up. Total - I 67.9 LTDS Effluents Boiler Blow downs 8 Sent to Biological Treatment System followed by Cooling Tower Blow 23 RO. RO permeate reused for cooling towers and downs boiler makeup. RO rejects are sent to MEE. Domestic 12.5 Total - II 43.5 Grand Total (I+II) 111.4

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Table 2.33 Process Effluents - Quality and Quantity - Product Wise S.No Name of Product Quantity (Kg/Day) Water TDS COD Total Input Effluent 1 Abiraterone Acetate 550 8.6 41.2 613 2 Afatinib 1650 154.1 45.8 2037 3 Anastrazole 1100 119.7 9.3 1226 4 Bicalutamide 735 0.3 5.2 739 5 Bendamustine HCl 1500 74.8 65.5 1670 6 Bexarotene 3500 372.7 138.3 4058 7 Bosutinib 590 86.4 21.4 1171 8 Capecitabine 2500 194.1 62.4 2791 9 Carfilzomib 3420 226.6 54.1 3698 10 Ceritinib 1110 104.6 44.1 1919 11 Cyclophosphamide 4500 278 181.8 4925 12 Dasatinib 2190 9.6 52.2 2233 13 Docetaxel 1500 3.4 64.2 1566 14 Enzalutamide 650 8.3 36.1 699 15 Erlotinib HCl 2115 3.2 215.5 2252 16 Gefitinib 2800 86.9 120.3 3030 17 Gemcitabine HCl 770 54.3 36.2 850 18 Ibrutinib 1450 156.8 18.8 1622 19 Imatinib Mesylate 1570 21.9 13.2 1608 20 Lapatanib 6000 638.8 64.3 6825 21 Lenvatinib 595 5.8 3.4 604 22 Olaparib 1095 38.6 13.4 1517 23 Palbociclib 781 23.3 12.7 991 24 Pazopanib 800 82.2 81.2 973 25 Sorefinib 1000 4.1 1.7 1006 26 Sunitinib 500 2.2 20 548 27 Tamoxifene 3230 57.7 186.6 3442 Total Worst Case: 22 Products on campaign basis 45315.6 2803.7 1576.5 51407.2

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Table 2.34 Effluent Generated and Characteristics from Process – Stage Wise 1.Abiraterone Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 350 8.6 34.6 402.7 21267 85958 II 200 2.2 6.6 212.6 10346 31169 Total 550 10.8 41.2 615.4 17493 67026 2.Afatinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 800 44 11.9 863.8 50892 13733 II 350 33.3 20.9 397.1 83767 52678 III 500 76.9 13 775.6 99140 16726 Total 1650 154.1 45.8 2036.6 75677 22467 3.Anastrozole Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 1100 119.7 9.3 1225.8 97622 7605 Total 1100 119.7 9.3 1225.8 97622 7605 4.Bicalutamide Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 735 0.3 5.2 738.9 353 7021 Total 735 0.3 5.2 738.9 353 7021 5.Bendamustine HCl Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 1500 74.8 65.5 1669.8 44776 39223 Total 1500 74.8 65.5 1669.8 44776 39223 6.Bexarotene Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 3500 372.7 138.3 4057.5 91862 34095 Total 3500 372.7 138.3 4057.5 91862 34095 7.Bosutinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 60 25.1 6.9 260.5 96375 26675 III 530 61.3 14.5 910.9 67250 15879 Total 590 86.4 21.4 1171.4 73727 18280 8.Capecitabine Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 2500 194.1 62.4 2790.6 69563 22346 Total 2500 194.1 62.4 2791 69563 22346

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9.Carfilzomib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 920 66.6 15.9 1005.1 66217 15789 II 2500 160 38.2 2692.6 59423 14185 Total 3420 226.6 54.1 3697.6 61270 14621 10.Ceritinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I II 1110 104.6 44.1 1918.5 54538 22983 Total 1110 104.6 44.1 1918.5 54538 22983 11.Cyclophosphamide Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 4500 278 181.8 4925.0 56449 36916 Total 4500 278 181.8 4925 56449 36916 12.Dasatinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 2190 9.6 52.2 2232.7 4306 23369 Total 2190 9.6 52.2 2232.7 4306 23369 13.Docetaxel Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 1500 2 64.2 1564.5 1278 41014 Total 1500 2 64.2 1564.5 1278 41014 14.Enzalutamide Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 315 2.4 4.6 330.9 7252 13902 II III 85 3.1 7.9 95.9 32326 82530 IV 250 8.3 23.6 278 29742 84842 Total 650 13.8 36.1 704.8 19533 51217 15.Erlotinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 2115 4.1 215.5 2252.8 1820 95678 Total 2115 4.1 215.5 2252.8 1820 95678 16.Gefitinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 2800 86.9 120.3 3029.9 28696 39692 Total 2800 86.9 120.3 3029.9 28696 39692

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17.Gemcitabine Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 770 54.3 36.2 850 63835 42554 Total 770 54.3 36.2 850 63835 42554 18.Ibrutinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 800 85.6 14 895 95660 15624 II 650 71.2 4.8 727.3 97903 6656 Total 1450 156.8 18.8 1622.3 96666 11604 19.Imatinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 1500 21.9 11.4 1536.2 14248 7391 II 70 2.2 1.8 74.0 29714 24851 Total 1570 24.1 13.2 1610.2 14959 8193 20.Lapatinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 6000 638.8 64.3 6825.2 93587 9428 Total 6000 638.8 64.3 6825.2 93587 9428 21.Lenvatinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 595 5.8 3.4 604.5 9521 5586 Total 595 5.8 3.4 604.5 9521 5586 22.Olaparib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 400 6.6 3.8 450.1 14621 8400 II 335 30.9 2.2 696.4 44421 3159 III 360 1.1 9.6 372.1 3014 25723 Total 1095 38.6 15.6 1518.7 25443 10241 23.Palbociclib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 180 23.3 1 384.8 60639 2531 III 601 2.4 11.8 609 3941 19303 Total 781 25.7 12.7 993.8 25892 12810 24.Pazopanib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 800 82.2 81.2 973 84448 83467 Total 800 82.2 81.2 973 84448 83467

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25.Sorefinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 1000 2.2 1.7 1003.9 2192 1659 Total 1000 2.2 1.7 1003.9 2192 1659 26.Sunitinib Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 500 2.2 20 547.7 4017 36517 Total 500 2.2 20 547.7 4017 36517 27.Tamoxifen Stage Quantity (Kg/Day) Concentration(mg/l) Water Input TDS COD Total Effluent TDS COD I 3230 57.7 186.6 3441.5 16777 54220 Total 3230 57.7 186.6 3441.5 16777 54220

2.4.1.1 Process Description and Technical Specification of Effluent Treatment System

The Effluent management system is developed to ensure `Zero Liquid Discharge’. Seggregation of effluents is an integral part that facilitates effective treatment of various effluent streams. The effluents are segregated into two streams; High COD/ TDS and Low COD/ TDS streams. The segregation is at source and is stream wise based on characteristics of effluents, i.e., concentration of less than 15000 mg/l of TDS and COD is considered as low TDS effluents, while the others are considered as high COD/TDS effluents.

The High TDS/ COD Effluents The treatment system for treating High TDS/ COD effluents consists of Equalization, Neutralization, Settling tank, Stripper, Multiple Effect Evaporator (MEE) followed by Agitated Thin Film Dryer (ATFD). The organic distillate from the stripper is sent to cement plants for co-incineration and aqueous bottom from stripper is sent to MEE followed by ATFD for evaporation. The condensate from the MEE and ATFD are sent to ETP (Biological). Salts from ATFD are disposed to TSDF.

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The Low TDS/ COD Effluents: These effluents along with the condensate from MEE and ATFD are treated in primary treatment consisting of equalization, neutralization, and primary sedimentation followed by secondary biological treatment consisting of aeration tank and clarifier.

The treated effluents after biological treatment are subjected to tertiary treatment in a reverse osmosis (double RO) system. Permeate from RO is reused for cooling tower and rejects are sent to MEE followed by ATFD. Sludge from various units of Biological treatment are thickened in sludge handling system and sent to TSDF. Schematic diagram of effluent treatment system is presented in Fig 2.29. Details of treatment facilities are presented in Table 2.35. Technical specifications of effluent treatment system are presented in Table 2.36 and 2.37 respectively. Table 2.35 Details of Treatment Facilities S.No Facility Description Capacity (KLD) Designed Operating 1 Stripper 80 56.4 2 Multiple Effect Evaporator 100 86.4 3 Agitated Thin Film Dryer 10 6.7 4 Biological Treatment Plant 150 126.9 5 Reverse Osmosis Plant - I 150 126.9 6 Reverse Osmosis Plant - II 60 50.8

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Tank

Water

Tank Filters Holding Clarifier Storage Treated

to

Bed

Cake Press

TSDF Sludge Tank Filter Drying Aeration Sludge

&

Plant

Double RO Neutralization Equalization

Oil Rejects Water

Towers Skimmer

Sump Collection Recycle Cooling

To Screen Chamber

&

MEE to

To TDS

COD Ind./TSDF

Low

Distillate

Org. Cement

Effluent,

Rejects

Condensate DiagramFig 2.29 Schematic Effluentof Treatment System Organic Distillate DM/RO Scrubber

&

Thin TSDF

Effect

Dryer to

TDS/COD

tank Film Settling Stripper Evaporator Salts Agitated Multiple High Neutralization Equalization to

TSDF Sludge

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Table 2.36 Technical Specifications of Effluent Treatment System S.No Description Unit Value Stripper 1 Design Capacity KLD 80 2 Feed Rate Kg/hr 2000-4000 3 Specific Gravity of Feed ≈ 1.03 4 Initial Feed COD PPM 20000-60000 5 Feed Total Solid % 2.0-4.0 6 High Heating Temperature OC 95 – 100 7 High COD Condensate recovery LPH 50-100 8 Dry Saturated Steam requirement at 3.0Kg/cm2 (g) TPH 0.6-1.0 9 Cooling Water circulation rate for condenser m3/hr 1.0-2.0 10 Cooling Water Inlet Temperature OC 30 – 32 11 Cooling Water Outlet Temperature OC 38 – 40 12 Operating Condition Multiple Effect Evaporator (MEE) 1 Design Capacity KLD 100 2 Feed Rate Kg/hr 2000-5000 3 Feed Concentration mg/l 30000-90000 4 Feed Temperature OC 30 5 Initial Solids % 5.0-10.0 6 Solids in Concentrate % 35.0-40.0 7 Concentrate Output Kg/hr 400-600 8 Water Evaporation Rate Kg/hr 4000-5000 9 Designed Water Evaporation Rate Kg/hr 4000 10 Dry Saturated Steam requirement at 6.0Kg/cm2 (g) TPH 1.5-2.5 11 Cooling Water Circulation Rate at 30 – 32OC m3/hr 3.0-4.0 12 Cooling Water Inlet Temperature OC 30 – 32 13 Cooling Water Outlet Temperature OC 38 – 40 Agitated Thin Film Dryer (ATFD) 1 Designed Capacity KLD 10 2 Feed Rate Kg/hr 300-500 3 Initial Feed Solid Content % 35.0-40.0 4 Final Moisture in Dry Bag-gable Product % 2.0-3.0 5 Water Evaporation Rate Kg/hr 200-300 6 Designed Water Evaporation Kg/hr 250 7 Solid Output in Bag-gable form at 5 – 6% moisture Kg/hr 150-200 8 Dry Saturated Steam requirement at 6.0Kg/cm2 (g) Kg/hr 15.0-30.0 9 Cooling Water Circulation Rate at 30 – 32OC m3/hr 0.6-1.0 10 Cooling Water Inlet Temperature OC 30 – 32 11 Cooling Water Outlet Temperature OC 38 – 40

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Table 2.37 Technical Specifications of Biological Treatment Plant Biological Treatment Design Capacity : 150 m3/day Flow : 126.9 m3/day Peak flow : 264.2 m3/day BOD : 775 mg/l COD : 2093 mg/l Total Dissolved Solids : 416 mg/l BOD load : 102 kg/day COD load : 277 kg/day Total Dissolved Solids : 55 kg/day 1. Neutralization Tank Average flow : 13.3 m3/hr Hydraulic retention time : 12 hrs. at peak flow Volume : 160 m3 Tank : 2 no. Proposed based on Daily flow. 2.Aeration Tank - 1 BOD(yo) : 775 mg/l % of BOD removed : 80 BOD Load : 102.4 kg/day COD : 2093 mg/l COD Load : 277 kg/day Outlet BOD : 155 mg/l MLSS : 6000 mg/l F/M ratio : 0.18 Flow : 160 m3/day Volume of the Tank : 106.2 m3 Check for Detention time : 15.9 Hours (12 - 24) Assuming depth : 3.5 m (4.0+0.5 F.B) Area of the tank : 30.34 m2 Width of the tank : 5.51 m Length of the Tank : 2.75 m BOD5 load in the aeration tank : 102.41 Oxygen is required for every Kg of BOD5 to be : 2.00 kgs removed Oxygen requirement for aeration : 204.82 kg/day O2 in Air % : 0.21 % Density of Air : 1.20 Oxygen requirement : 50.00 m3/kg O2/day Air Required : 10241.15 m3/day : 251.63 cfm Consider 35% excess considering the air required in the equalization tank. Total air required : 339.69 Kg O2/day 3.Clarifier - 1 Design quantity : 160 m3/m2-day

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Surface loading rate of average flow : 12 m2 Surface area provided : 13.3 m length of the tank (2l=b) : 3.65 m (Say 4.0 m) Width of the tank : 1.83 m (Say 2.0 m) 4.Aeration Tank - 2 BOD(yo) : 110 mg/l % of BOD removed : 80 BOD Load : 14.5 kg/day COD : 220 mg/l COD Load : 29 kg/day Outlet BOD : 22 mg/l MLSS : 5500 mg/l F/M ratio : 0.18 Flow : 160.0 m3/day Volume of the Tank : 145.5 m3 Check for Detention time : 21.8 Hours (12 - 24) Assuming depth : 3.5 m (4.5+0.6 F.B) Area of the tank : 41.56 m2 Width of the tank : 6.45 m Length of the Tank : 3.22 m BOD5 load in the aeration tank : 14.52 Oxygen is required for every Kg of BOD5 to be : 2.00 kgs removed Oxygen requirement for aeration : 29.03 kg/day O2 in Air % : 0.21 % Density of Air : 1.20 Oxygen requirement : 50.00 m3/kg O2/day Air Required : 1451.68 m3/day : 35.67 cfm Consider 35% excess considering the air required in the equalization tank. Total air required : 48.15 Kg O2/day 5.Clarifier - 2 Design quantity : 160 m3/m2-day Surface loading rate of average flow : 12 m2 Surface area provided : 13.3 m length of the tank (2l=b) : 3.65 m (Say 4.0 m) Width of the tank : 1.83 m (Say 2.0 m) 6. Holding tank The flow from the each individual settling tank i.e., the supernatant liquid is let into the respective Pre-Filtration Tank, which has a minimum 8 hours holding capacity. This tank is provided to hold the treated effluent and give an even flow to the pressure sand filter. Average flow : 13.3 m3/hr Peak factor : 2 m3/hr Peak flow : 26.7 m3/hr Provide min 1.5 hours holding capacity. Hence required volume of the tank : 40 m3 2-96 Team Labs and Consultants

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7. Pressure Sand Filter: Vertical down flow type with graded/sand bed under drain plate with polysterene strains. Flow : 160 m3/day Rate of filtration assumed as : 15 m3/m2/hr Requirement of treated water for usage in 20 hrs : 8 m3/hr Dia of filter of 1 nos. : 824.26 mm Provide a Pressure Sand filter of 800 mm say 950 mm dia with sand as media over layer, under drain pipe, laterals face piping etc., 8. Activated Carbon Filter: Vertical down flow type with graded/sand bed under drain plate with polysterene strains. Flow : 160 m3/day Rate of filtration assumed as : 15 m3/m2/hr Requirement of treated water for usage in 20 hrs : 8 m3/hr Dia of filter of 1 nos. : 824.26 mm Provide activated carbon filter of 800 mm say 950 mm dia with sand as media over layer, under drain pipe, laterals face piping etc., 9. Reverse Osmosis -1: Design Capacity : 150 KLD Operating capacity : 126.9 KLD Recovery : 60% RO Permeate : 76.1 KLD RO rejects : 50.8 KLD 10. Reverse Osmosis - 2: Design Capacity : 60 KLD Operating capacity : 50.8 KLD Recovery : 60% RO Permeate : 30.5 KLD RO rejects : 20.3 KLD

2.4.2 Air Pollution The manufacturing process consists of reaction, separation and purification. The reaction is conducted in closed reactors, while the separation is conducted in centrifuge, filtration equipment etc. The purification would be conducted in reactors or filtration equipment. The transfer of materials will be through closed pipelines. Various sources of emissions are identified from process operations. The usage of boiler for steam generation and DG sets for emergency power back up also releases emissions.

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2.4.2.1 Emissions from Utilities The sources of air pollution are proposed 2 x 8 TPH Coal fired boiler and proposed DG sets of 1 x 1500 kVA, 2x 100 kVA, 3 x 500 kVA. The proposed air pollution control equipment for 2 x 8 TPH coal fired boilers is bag filter. DG sets shall be provided with

effective stack height based on the CPCB formula. The emission rates of SO2, NOx and PM from each stack are presented in Table 2.38. Technical specifications of Bag filters for 10 TPH boiler are presented in Table 2.39. Table 2.38 Emission Details of Pollutants from Stack S. Stack Connected to Stack Dia of Temp. of Exit Pollutant Emission No Ht stack at exhaust Velocity Rate (g/sec) 0 (m) top(m) gases ( C) (m/sec) PM SO2 NOx 1 2 x 8 TPH Coal Fired 30 0.9 130 6.05 0.6 0.7 0.25 Boilers 2 1 x 1500 kVA DG 12 0.2 180 10 0.02 0.03 0.5 set* 3 2 x 1000 kVA DG set* 7 0.2 170 10 0.09 0.25 0.38 4 3 X 500 kVA DG set* 5 0.2 200 6.8 0.002 0.025 0.04 *DG sets shall be kept as standby.

Table 2.39 Technical Specifications of Bag Filter – 8TPH Coal Fired Boiler S.No Application Unit Value 1 Boiler Capacity TPH 8 Fuel Coal 2 Gas Volume m3/hr@170 degC 22000 Gas Temperature Deg C 145 Outlet emission mg/Nm3 <50 Flange to flange pr. drop mmWC 130 Moisture Content % 8.5 No. of Bags 245 Filter area per bag m² 1.75 Total filter area m² 429

Air to cloth ratio m³/min/m² 1.14 3 Bags Diameter ID, mm 150 Length mm 3650 Material Nomex Max. operating temp. degC 190 4 Bag Cleaning Compressed air required Nm3/Hr 5-7 kg/cm2 No. pulse cum solenoid valve 10 Size of pulse valve NB 40

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5 Material of Construction Casing MS 6 Tube Sheet MS Cage MS Hopper MS 7 Terminal Points Dirty air Inlet of Poppet Valve, Flanged end Clean air Outlet of Bag Filter, Flanged end Dust discharge RALV Compressed air Inlet of Air Header Electricals Power Supply for Timer 230 V Ac

2.4.2.2 Emissions from Process

The manufacturing process consists of reaction, separation and purification. The reaction is conducted in closed reactors, while the separation is conducted in centrifuge, filtration equipment etc. The purification would be conducted in reactors or filtration equipment. The transfer of materials is through closed pipelines. Various sources of emissions are identified; a. Process Emissions: The process emissions contain Ammonia, Hydrogen, Hydrogen chloride, and Sulfur dioxide. Ammonia, Hydrogen chloride and Sulphur dioxide are sent to scrubber in series. Sodium chloride from Hydrogen chloride, ammonium chloride from ammonia, sodium bisulfate from sulfur dioxide scrubbing sent to ETP. Hydrogen gas is let out into atmosphere through a water column. The quantity of process emissions is presented in Table 2.40. Schematic diagram of Scrubbing system is presented in Fig 2.30. Technical Specifications of two stage scrubber is presented in Table 2.41

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Table 2.40 Quantity and Mode of Treatment of Process Emissions S.No Name of Stage Name of the Gas Quantity Mode of treatment Product (Kg/day) 1 Afatinib II Ammonia 7 To Scrubber Hydrogen 0.1 Let into atmosphere 2 Bicalutamide I Hydrogen 0.2 safely through water column 5 Bosutinib II Hydrogen Chloride 1.9 To Scrubber III Hydrogen Chloride 0.7 To Scrubber 6 Capecitabine I Hydrogen Chloride 37.3 To Scrubber 7 Ceritinib I Hydrogen Chloride 51.5 To Scrubber 8 Docetaxel I Hydrogen 2.2 Let into atmosphere safely through water column 9 Enzalutamide I Hydrogen Chloride 21.5 To Scrubber Sulfur Dioxide 18.8 To Scrubber II Hydrogen 0.12 Let into atmosphere 10 Imatinib I Hydrogen 0.20 safely through water column Hydrogen Chloride 12.18 To Scrubber Sulfur Dioxide 10.68 To Scrubber 11 Lapatanib I Hydrogen 1.12 Let into atmosphere safely through water column 12 Olaparib I Ammonia 0.67 To Scrubber

Fig 2.30 Schematic diagram of Scrubbing system

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Table 2.41 Technical Specifications of Two Stage Scrubber Type Packed Tower Scrubber Two Stage MOC PP/FRP 5 mm PP+8mm FRP Air Flow Rate 3000CFM Inlet Temp. 350C Inlet Gas Pressure Atmospheric Batch 24 Hrs Scrubbing medium for Ist Stage Water 10% NaOH Solution Scrubbing medium for IInd Stage Caustic Solution (or) Acid Blower MOC PPFRP Capacity 2500CFM Suction Pressure − 250mmWC Discharge Pressure 60mmWC HP/RPM 5HP/1900RPM Circulation System Flow Rate 15 M3/hr Head 30 Meters Motor Make FLP MOC PP Storage/ Recirculation Tank Capacity 3 KL Size 1700mm Dia X 2300mm Ht. MOC PP/FRP

2.4.2.3 Diffuse Emissions Diffuse emissions are released from various operations of manufacturing like centrifuge, drying, distillation, extraction etc. These emissions mainly contain volatile contents of the material sent for processing. The emissions are normally passed through vent scrubber before releasing into atmosphere to mitigate odor. The emissions from distillation are passed through condensers, which mitigate odor.

2.4.2.4 Fugitive Emissions

Fugitive emissions are anticipated from equipment leakage and transfer spills. The periodic maintenance program shall ensure integrity of equipment mitigating the equipment leakage. The spills however shall be managed by adopting the spill management scheme as mentioned in the respective MSDS. The fugitive emissions shall be reduced by closed transfer and handling of all hazardous solvents and chemicals. The ventilation system provided will reduce the health impact on 2-101 Team Labs and Consultants

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2.4.3 Solvent Use and Recycle (Terms of Reference No. B1) Solvents are used for extraction of products and as reaction medium. Solvents constitute major consumable material of synthetic organic chemical manufacturing, mainly used as reaction medium. The used solvents constitute major waste stream of synthetic organic chemical manufacturing. Hence it is proposed to recycle the solvents by distillation for reuse in process, thereby reducing the total solvent consumption in the plant and reducing the waste quantity to be disposed. The distillation columns are mainly provided to remove moisture and impurities from spent single solvents, and mixed solvents. The recycled single solvents are reused in the process, while the mixed solvents are sold to end users. Distillation process generates residues which are mainly organic in nature containing significant calorific value, and can be sent to cement plants for co-incineration as fuel. The total solvent balance product wise and stage wise is presented in Table 2.42 & Table2.43. Schematic diagram of solvent recovery system is presented in Fig 2.31. Table 2.42 Total Solvent Balance-Product wise S.No Name of product Quantity (Kg/Day) Solvent Recovered Fugitive To waste Residue Input loss water 1 Abiraterone 2640 2534.4 21.1 26.4 58.1 2 Afatinib 2330 2236.8 18.6 23.3 51.3 3 Anastrozole 1440 1382.4 11.5 5.2 40.9 4 Bicalutamide 365 350.4 2.9 3.7 8 5 Bendamustine HC 2053 1968 16.4 20.5 48 6 Bexarotene 10503 10022.4 83.5 104.4 292.7 7 Bosutinib 2621 2516.2 21 22.4 61.5 8 Capecitabine 8290 7958.4 66.3 82.9 182.4 9 Carfilzomib 4390 4214.4 35.1 43.9 96.6 10 Ceritinib 7164 6877.4 57.3 26.6 202.6 11 Cyclophosphamide 10565 10142.4 84.5 105.7 232.4 12 Dasatinib 3310 3177.6 26.5 33.1 72.8 13 Docetaxel 12500 12000 125 62.5 312.5 14 Enzalutamide 3535 3393.6 28.2 30.2 83 15 Erlotinib 13370 12835.2 107 133.7 294.1

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16 Gefitinib 11620 11155.2 93.0 116.2 255.6 17 Gemcitabine 1086.7 892.8 7.4 9.3 177.1 18 Ibrutinib 1560 1497.6 12.5 14.9 35 19 Imatinib 2100 2007.9 28 11.8 52.3 20 Lapatinib 6100 5720.7 66.6 51.5 261.2 21 Lenvatinib 605 578.3 16.8 2 7.8 22 Olaparib 1400 1337.8 22.4 13.5 26.4 23 Palbociclib 535 506.2 9.2 1.8 17.8 24 Pazopanib 2500 2358 16 40 86 25 Sorefinib 6990 6640.5 74.6 1.7 273.3 26 Sunitinib 12500 11875 169 20 436 27 Tamoxefin 6800 6460 42 136 162 Worst Case: 22 Products on 134407.7 128369.3 1198.6 1107.3 3732.4 campaign basis

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Table 2.43 Total Solvent Balance-Stage wise S.No Name of the product Stage Name of Solvent Quantity (Kg/Day) Total Recovered Fugitive To Residue Solvent loss waste water 1 Abiraterone I Methylene Chloride 800 768 6.4 8 17.6 Tetrahydrofuran 500 480 4 5 11 Methanol 550 528 4.4 5.5 12.1 II Methylene Chloride 500 480 4 5 11.0 Acetonitrile 290 278.4 2.3 2.9 6.4 2 Afatinib I Dimethyl formamide 200 192 1.6 2 4.4 Methanol 50 48 0.4 0.5 1.1 II Ethyl acetate 250 240 2 2.5 5.5 Ethanol 275 264 2.2 2.8 6.1 Tetrahydrofuran 350 336 2.8 3.5 7.7 Hexane 325 312 2.6 3.3 7.2 III Acetonitrile 90 86.4 0.7 0.9 2 Ethyl acetate 500 480 4 5 11 Cyclohexane 200 192 1.6 2 4.4 Dichloromethane 45 43.2 0.4 0.5 1.0 Methanol 45 43.2 0.4 0.5 1.0 3 Anastrozole I Chloroform 250 240 2 8 Diisopropyl ether 500 480 4 16 Dimethyl formamide 170 163.2 1.4 1.7 3.7 Toluene 250 240 2 2.5 5.5 t-butyl methyl ether 170 163.2 1.4 5.4 Methanol 100 96 0.8 1 2.2 4 Bicalutamide I Acetic acid 145 139.2 1.2 1.5 3.2 Acetone 220 211.2 1.8 2.2 4.8 5 Bendamustine HCL I Methylene chloride 1600 1536 12.8 16 35.2 Acetone 250 240 2 2.5 5.5 Methanol 203 192 1.6 2 7.3

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6 Bexarotene I Toluene 940 902.4 7.5 9.4 20.7 Methanol 5063 4800 40 50 173 Ethyl acetate 4500 4320 36 45 99 7 Bosutinib I Toluene 280 268.8 2.2 2.8 6.2 Dimethyl formamide 10 9.6 0.1 0.1 0.2 II Toluene 240 230.4 1.9 7.7 Ethanol 145 139.2 1.2 4.6 III Dimethyl formamide 46 44.2 0.4 0.5 1 Ethyl acetate 230 220.8 1.8 2.3 5.1 Dichloromethane 1170 1123.2 9.4 11.7 25.7 Methanol 230 220.8 1.8 2.3 5.1 Ethanol 270 259.2 2.2 2.7 5.9 8 Capecitabine I Methylene chloride 5000 4800 40 50 110 Methanol 950 912 7.6 9.5 20.9 Ethyl acetate 2340 2246.4 18.7 23.4 51.5 9 Carfilzomib I Tetrahydrofuran 290 278.4 2.3 2.9 6.4 Methylene chloride 550 528 4.4 5.5 12.1 Methanol 310 297.6 2.5 3.1 6.8 Ethyl acetate 290 278.4 2.3 2.9 6.4 II Dimethyl formamide 850 816 6.8 8.5 18.7 Ethyl acetate 1000 960 8 10 22 Methanol 1100 1056 8.8 11 24.2 10 Ceritinib I Isoproponal 4500 4320 36 144 II Acetone 2664 2557.4 21.3 26.6 58.6 11 Cyclophosphamide I Tetrahydrofuran 2000 1920 16 20 44 Diisopropyl ether 2500 2400 20 25 55 Acetone 4900 4704 39.2 49 107.8 Ethanol 795 763.2 6.4 8 17.5 Triethylamine 370 355.2 3 3.7 8.1 12 Dasatinib I n-butanol 1810 1737.6 14.5 18.1 39.8 Ethanol 1500 1440 12 15 33

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13 Docetaxel I Acetic acid 5000 4800 50 25 125 Methanol 7500 7200 75 37.5 187.5 14 Enzalutamide I Dimethyl formamide 5 4.8 0.1 0.1 Dichloromethane 770 739.2 6.2 7.7 16.9 Hexane 90 86.4 0.7 2.9 II Methanol 340 326.4 2.7 10.9 Hexane 90 86.4 0.7 2.9 III Ethyl acetate 460 441.6 3.7 4.6 10.1 Diisopropyl ether 65 62.4 0.5 0.7 1.4 IV Dimethyl acetamide 175 168 1.4 1.8 3.9 Methanol 350 336 2.8 3.5 7.7 Ethyl acetate 1050 1008 8.4 10.5 23.1 Isopropyl alcohol 140 134.4 1.1 1.4 3.1 15 Erlotinib I Methanol 800 768 6.4 8 17.6 t-butyl methyl ether 7650 7344 61.2 76.5 168.3 Ethanol 4920 4723.2 39.4 49.2 108.2 16 Gefitinib I Ethanol 4720 4531.2 37.8 47.2 103.8 Methylene Chloride 3400 3264 27.2 34 74.8 Methanol 2000 1920 16 20 44 Ethyl acetate 1500 1440 12 15 33 17 Gemcitabine I Toluene 180 172.8 1.4 1.8 4 Ethanol 410 393.6 3.3 4.1 9 Methanol 251.7 91.2 0.8 1 158.8 Methylene chloride 245 235.2 2 2.5 5.4 18 Ibrutinib I Tetrahydrofuran 175 168 1.4 1.8 3.9 Isopropyl alcohol 25 24 0.2 0.3 0.6 Ethyl acetate 720 691.2 5.8 7.2 15.8 II Dichloromethane 320 307.2 2.6 3.2 7 Ethyl acetate 250 240 2.0 2.5 5.5 III Dichloromethane 45 43.2 0.4 1.4 Methanol 25 24 0.2 0.8

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19 Imatinib I Methanol 450 432 3.2 7.7 7.2 Chloroform 500 480 5 15 Hexane 350 336 2.5 11.6 Acetone 250 237.5 5.5 1 6 Isopropanol 320 306.2 10.2 1.3 2.2 II Methanol 230 216.2 1.6 1.8 10.4 20 Lapatinib I Acetic acid 4770 4483.8 33.4 38.2 214.7 Tetrahydrofuran 1330 1236.9 33.3 13.3 46.6 21 Lenvatinib I Acetone 510 488.1 16.3 2 3.6 Dimethyl sulfoxide 95 90.3 0.5 4.3 22 Olaparib I Dimethyl formamide 115 108.1 0.8 2.9 3.2 II Methanol 160 156.8 0.8 2.4 Methylene chloride 300 288 2.1 9.9 n-Hexane 110 105.6 0.8 3.6 III Methanol 495 470.3 12.4 8.9 3.5 Methylene chloride 220 209 5.5 1.8 3.7 23 Palbociclib I Toluene 200 190 0.8 0.4 8.8 II n-butanol 240 228 7.2 4.8 Di isopropyl 10 8.3 1.7 ethylalcohol III Acetone 85 79.9 1.2 1.4 2.6 24 Pazopanib I Methanol 1000 945 4 28 23 Dimethyl formamide 1500 1413 12 12 63 25 Sorefinib I Methylene chloride 3660 3477 14.6 168.4 Methanol 3330 3163.5 59.9 1.7 104.9 26 Sunitinib I Methanol 4000 3800 16 20 164 Ethanol 3500 3325 63 112 Acetonitrile 5000 4750 90 160 27 Tamoxefin I Dimethyl formamide 4000 3800 28 108 64 n-propanol 2690 2555.5 13.5 26.9 94.2 Tri ethylamine 110 104.5 0.6 1.1 3.9

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Fig 2.31 Schematic Diagram of Solvent recovery System of Solvent recovery Diagram Schematic 2.31 Fig

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2.4.4 Solid Waste Solid wastes are generated from the process, solvent distillation, wastewater treatment and utilities. The effluent treatment system generates stripper distillate, ATFD salts and ETP sludge. The process operations generate process residue, filter media, used catalysts, activated carbon and inorganic residue. The recycling operation of distillation generates solvent residue and spent mixed solvents. The utilities i.e., coal fired boiler generates ash while DG sets generate waste oil and used batteries. All the wastes except coal ash are considered hazardous. The other non hazardous wastes are container, packing material, empty drums etc. The containers and drums are detoxified before disposing to authorized buyers. The hazardous wastes of process residue, stripper distillate, solvent residue, and activated carbon are sent to cement plants for co- incineration, thereby reducing the load on TSDF facility and reducing consumption of non renewable resource of coal in cement plant kilns. Mixed solvents shall be sent to authorized recyclers/cement plant for co-incineration while spent solvents are recovered within plant premises. The inorganic wastes, filter media, used catalysts, salts from ATFD, and ETP sludge are sent to TSDF facility located at Dundigal, Ranga Reddy district. The waste oil and used batteries are sold to authorized recyclers. Coal ash is sold to brick manufacturers in the local area. The process wastes are compiled for each product in Table 2.44. The stage wise generation process wastes is presented in Table 2.45. The quantity of solid waste generated in the plant and the disposal practice is presented in Table 2.46.

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Table 2.44 Solid Wastes Generated from Process –Stage Wise 1.Abiraterone Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 97.6 40.7 138.3 II 73.5 17.4 3 93.9 Total 171.1 58.1 3 232.2 2.Afatinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 6.6 5.5 12.1 II 6.8 3.7 26.4 36.9 III 121.9 19.4 5.0 146.3 Total 135.3 3.7 51.3 5.0 195.3 3.Anastrozole Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 38.8 40.9 5 84.7 Total 38.8 40.9 5 84.7 4.Bicalutamide Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 3.1 8 11.1 Total 3.1 8 11.1 5.Bendamustine HCl Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 9.8 48 5 62.8 Total 9.8 48 5 62.8 6.Bexarotene Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 437.8 292.7 70 800.5 Total 437.8 292.7 70 800.5 7.Bosutinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 0.7 6.4 7.1 II 25.9 1.2 12.3 39.4 III 18.2 20.5 42.8 1 82.5 Total 44.8 21.7 61.5 1 128.9

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8.Capecitabine Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 181.1 167.5 182.4 60 591 Total 181.1 167.5 182.4 60 591 9.Carfilzomib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 13.7 31.7 45.4 II 255.5 64.9 320.4 Total 269.2 96.6 365.8 10.Ceritinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 238.3 79.7 144 462.0 II 324.9 58.6 383.6 Total 563.3 79.7 202.6 845.6 11.Cyclophosphamide Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 203.2 232.4 40 475.7 Total 203.2 232.4 40 475.7 12.Dasatinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 156.3 72.8 229.2 Total 156.3 72.8 229.2 13.Docetaxel Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 724.5 140 312.5 50 1227 Total 724.5 140 312.5 50 1227 14.Enzalutamide Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 9.4 15 19.9 44.4 II 13.5 13.8 3 30.2 III 14.3 55 11.6 80.8 IV 29.4 11 37.7 3 81.2 Total 66.6 81 83 6 236.6 15.Erlotinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 127.1 294.1 25 446.3 Total 127.1 294.1 25 446.3

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16.Gefitinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 338.5 255.6 50 644.1 Total 338.5 255.6 50 644.1 17.Gemcitabine Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 75.1 177.1 5 257.3 Total 75.1 177.1 5 257.3 18.Ibrutinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 29.8 50 20.24 100 II 13.3 12.54 25.8 III 0.7 2.24 3 Total 43.8 50 35.02 128.8 19.Imatinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 99.8 48.5 41.99 190.4 II 8.6 10.35 10 28.9 Total 108.4 48.5 52.3 10 219.3 20.Lapatinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 720.9 261.2 80 1062.1 Total 720.9 261.2 80 1062.1 21.Lenvatinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 2.6 7.8 10.4 Total 2.6 7.8 10.4 22.Olaparib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 19.4 0.7 3.22 23.31 II 27.2 15.93 43.18 III 12 7.20 19.25 Total 58.7 0.7 26.35 85.74

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23.Palbociclib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 81.45 8.8 90.2 II 20.82 3.1 6.46 30.4 III 18.09 2.55 20.6 Total 120.36 3.1 17.81 141.2 24.Pazopanib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 17.6 86 35 138.6 Total 17.6 86 35 138.6 25.Sorefinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 615.2 273.3 80 968.4 Total 615.2 273.3 80 968.4 26.Sunitinib Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 278.6 97.9 436 70 882.5 Total 278.6 97.9 436 70 882.5 27.Tamoxifen Stage Quantity(Kg/Day) Organic residue Inorganic residue Solvent residue Spent Carbon Total I 62.8 162 50 274.8 Total 62.8 162 50 274.8

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Table 2.45 Solid Wastes Generated from Process – Product Wise S.No Name of Product Quantity (Kg/Day) Organic Inorganic Solvent Spent Total residue residue residue Carbon 1 Abiraterone Acetate 171.1 58.1 3 232.2 2 Afatinib 135.3 3.7 51.3 5 195.3 3 Anastrazole 38.8 40.9 5 84.7 4 Bicalutamide 3.1 8 11.1 5 Bendamustine HCl 9.8 48 5 62.8 6 Bexarotene 437.8 292.7 70 800.5 7 Bosutinib 44.8 21.7 61.5 1 128.9 8 Capecitabine 181.1 167.5 182.4 60 591 9 Carfilzomib 269.2 96.6 365.8 10 Ceritinib 563.3 79.7 202.6 845.6 11 Cyclophosphamide 203.2 232.4 40 475.7 12 Dasatinib 156.3 72.8 229.2 13 Docetaxel 724.5 140 312.5 50 1227 14 Enzalutamide 66.6 81 83 6 236.6 15 Erlotinib HCl 127.1 294.1 25 446.3 16 Gefitinib 338.5 255.6 50 644.1 17 Gemcitabine HCl 75.1 177.1 5 257.3 18 Ibrutinib 43.8 50 35 128.8 19 Imatinib Mesylate 108.4 48.5 52.3 10 219.3 20 Lapatanib 720.9 261.2 80 1062.1 21 Lenvatinib 2.6 7.8 10.4 22 Olaparib 58.7 0.7 26.4 85.7 23 Palbociclib 120.4 3.1 17.8 141.2 24 Pazopanib 17.6 86 35 138.6 25 Sorefinib 615.2 273.3 80 968.4 26 Sunitinib 278.6 97.9 436 70 882.5 27 Tamoxifene 62.8 162 50 274.8 Total Worst Case: 22 Products on campaign 5503 693.7 3732.4 650 10491 basis

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Table 2.46 Total Solid Waste Generated and Mode of Disposal S.No Description Units Quantity Mode of Treatment/Disposal

1 Ash from Boiler TPD 32 Sold to Brick manufactures and cement plants 2 Organic residue TPD 5.5 Sent to TDSF/Cement Plants for Co- incineration 3 Solvent Residue TPD 3.73 Sent to TSDF/Cement Industries 4 Spent Solvent KLD 115.5 Recovered within plant premises and reused 5 Mixed Solvent KLD 12.8 Sent to authorized recovery units/Cement plants for co- incineration 6 Stripper Distillate KLD 1.26 Sent to Cement Industries for Co- 7 Spent Carbon Kg/day 650 incineration. 8 Inorganic Residue TPD 0.7 Sent to TSDF 9 Evaporation salts TPD 3.07 Sent to TSDF 10 ETP Sludge Kg/day 180 Sent to TSDF 11 Detoxified containers No.s/Yr 800 Sold to authorized vendors 12 Waste oil KLPA 8.25 Sent to Authorized Recyclers 13 Used batteries No.s/Yr 20 Sent to Authorized Recyclers

2.4.5 Noise Pollution Noise is anticipated from motors, compressors, chillers, cooling towers and DG set. The DG set shall be kept in a separate enclosed room with acoustic enclosure. The motors and compressors shall be provided with guards and shall be mounted adequately to ensure the reduction of noise and vibration. The employees working in noise generating areas shall be provided with earmuffs. The employees shall be trained in the mitigation measures and personal protection measures to be taken to avoid noise related health impacts.

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CHAPTER 3.0 BASELINE ENVIRONMENTAL STATUS

3.1 Introduction Collection of base line data is an integral aspect of the preparation of Environmental Impact Assessment Report. Baseline data reflects the present status of environment before initiation of any activity of project. The possible effects due to proposed green field project Actero Pharma Pvt. Ltd., proposed expansion of sister company Dasami Lab Pvt. Ltd., (formerly known as Medchem Organics Pvt.Ltd.) and proposed expansion of the group company M/s. Hindys Lab Pvt. Ltd., which is located about 1.6 km away from the site are estimated and superimposed on the compiled baseline data subsequently to assess environmental impacts. The study was conducted in the impact area; 10 km radius area surrounding the project site, during March 06, 2017 – June 05, 2017. Studies were undertaken to generate baseline data of Micrometeorology, Ambient air quality (AAQ), Water Quality, Noise Levels, Flora and Fauna, Land Use and Land Cover, Soil quality and Socio-Economic status of the community were collected.

3.2 Land Environment Land and soil constitute basic components of physical environment. The location of industrial project may cause changes in land, land use, soil and denudational processes in different intensities contingent on sptial proximity of the activity and receptors. Land and soil may be altered within the vicinity of 5 km radius and to a lesser extent upto 10 km radial distance due to development of the project.

3.2.1 Physiography

The plant site of 11.275 acres is located at Survey No. 407 (Part) and 411, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana State. The site is located at the intersection of 17°13'34" (N) latitude and 79° 2'38" (E) longitude. The plant site elevation above mean sea level (MSL) is in the range of 329 - 338 m. The plant site is surrounded by open agricultural land in west direction, proposed expansion site of Dasami Lab Pvt. Ltd., in west direction, road connecting Pittampalli village to national highway in north direction and VSK Laboratories Pvt. Ltd. In south direction. The nearest habitation from the plant is Pittampalli village located at a distance of 2.1 km in southwest direction. The main approach road connecting to National Highway 9 - Hyderabad - Vijayawada Road

3-1 Team Labs and Consultants Actero Pharma Pvt. Ltd Environmental Impact Assessment Report adjacent to site in north direction. National Highway 9 - Hyderabad - Vijayawada is at a distance of 0.5 km in north direction. The nearest town Chityal is at a distance of 8.4 km in northeast direction. The nearest railway station Ramannapet is at a distance of 7.6 km in northeast direction and nearest airport is Rajiv Gandhi International Airport (Hyderabad) located at a distance of 65 km in northwest direction. Seasonal nala Chinna Vagu is flowing from northwest to southeast direction at a distance of 6.5 km in southwest direction. There are two reserve forests in the impact area of 10 km radius of the study area. Chityal RF at a distance of 6.1 km in east direction, Shivanenigudem RF at a distance of 9.1 km in northeast direction. There is no national park, wildlife sanctuary, ecologically sensitive area, biosphere reserve, tiger reserve, elephant reserve, critically polluted areas and interstate boundary within 10 km radius of the site. The slope of the region is from northwest to southeast and northeast. The area has mainly agricultural lands irrigated by canals / tube wells. The slope of the region is from northwest to southeast. The area has mainly agricultural lands irrigated by canals / tube wells. The site photographs are presented in Figures 3.1. The base map of the study area is presented in Figure 3.2. The Forest map of the study area is presented in Figure 3.3.

Fig 3.1 Site and Plant Photographs – Actero Pharma Pvt. Ltd.

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Figure 3.2 Base map of the study area

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Figure 3.3 Forest map of the study area

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3.2.2 Geology The need for understanding geology, soil and hydrogeology of the site area and its surroundings is due to rock/soil stability, contamination of soil due to discharge of chemicals and effluents, and impact on ground water due to abstraction of ground water.

The study area is underlain by various geological formations like Archaen Crystallines, Deccan Traps, Puranas, Laterites, and River Alluvia. The area is occupied by peninsular gneissic complex of the Archean age comprisssing pink and grey granites, granitic sanded gneisses, migmatities, pegmatites, quartz veins and dolerite dykes. They occur in the form of domes, scarpes, massive, columnar blocks and ‘tors’ etc. scattered over a flat undulating country. Both massive granites and gneisses are intruded positioned, dolerite dykes and quartzite and pegmatitic reefs.

The deccan trap constitute a number of layers of varying texture and thickness. The traps are weathered and vesicular. Weathered basalts have medium permeability and vesicular basalts have relatively high permeability. Small areas of basaltic strata are present as “outliers” in granitic terrain. Laterites are found capping the weathered basalts.

The Unconsolidated materials in granitic terrain consist of the “in-situ” weathered remains of parent bedrock for the most of the area. Those materials (including soils) present at the ground surface over upland areas and valley sides range in the thickness from few centimeters to 25m, the average thickness approximately 22m. In basaltic terrain, unconsolidated materials comprise lateritised clay, weathered basalt inter- trappean clays, and alluvial sediments. Thickness of weathered basalts capped by laterites range upto 30m. Whereas the thickness of weathered basalts exposed at the ground surface approximates to around 6m. Geological map of the study area is presented in Figure 3.4. Table 3.1 Chronological succession of the geological formations Geological Age Type of Formation Sub recent to recent Alluvium, Colluvium, soils and valley fills Lower Eocene Deccan Traps: Laterities, Basalts quartz veins and dolerite dykes. Upper Cretaceous Pre-Cambrains (Bhimas) Sandstones, Limestones and Shales. Archean Gneissic complex rocks, diorite, coarse grained Granite with doleritic dyke intrusions.

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Figure 3.4 Geological map of the study area

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3.2.3 Hydrogeology Hydrogeologically the study area can be grouped under hard rocks occupied by granite and granitic gneisses; the ground water occurs under confined conditions in the weathered mantle and under semi confined conditions in the joints, fractures, crevices etc. of the fresh rock below. It’s occurrence is controlled by the intensity and depth of weathering and by the presence of the joints and fractures, which vary from place to place. The open place available for water to accumulate in fresh rock is extremely limited, while the weathered zone, which is more porous carrying most of the water that is available for development. The depth to water table in wells is governed to a large extent by the topography, the water levels being shallow in wells located in valleys than those located on high grounds.

The open wells existing in the study area are tapping weathered zone and range in depth from 5 to 18 meters below ground level. Most of the wells fall within the depth range of 5 to 10 meters, and about 30 percent of wells fall within the depth range of 10 to 15 meters. The yield of dug wells with 10 to 15 m depth ranges from 80 to 180 KLD. The wells are capable of sustained yield of about 500 lpm with a draw down ranging from 1 to 6 meters. The yield of bore wells range from 4000 to 20000 liters/hour. In areas of massive and poorly weathered rocks the safe well yield is less than 1 ha.m/year. Lower values occur in uplands where the transitivity, effective available draw down and maximum area of zone of influence of pumping wells are low, conversely, highest values occur where those independent variables are highest. The site area exist dendritic drainage pattern, and any second order streams are not exists nearby site location. Hydrogeological Map of the study area is presented in Figure 3.5. The proposed project requires 206.382 KLD of water, which is abstracted from borewells within the site.

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Figure 3.5 Hydrogeological Map of the study area

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3.2.4 Soils Soil may be defined as a thin layer of earth’s crust that serves as a natural medium for the growth of plants. It is the unconsolidated mineral matter that has been subjected to and influenced by genetic and environmental factors such as parent materials, climate, organisms and physico-chemical action of wind, water and sunlight, all acting over a period of time. Soil differs from the parent materials in the morphological, physical, chemical and biological properties. Also soil differs among them in some or all the genetic or environmental factors, therefore, some soils are yellow, some are black, and some are coarse textured. They serve as a reservoir of nutrients for plants and crop and also provide mechanical anchorage and favorable tilth. Soils have seven general functions; providing the basis for food and biomass production; controlling and regulating environmental interactions - regulating water flow and quality; Storing carbon and maintaining the balance of gases in the air; providing valued habitats and sustaining biodiversity; preserving cultural and archaeological heritage; providing raw material; and providing a platform for buildings and roads.

The Soil characteristics include both physical and chemical parameters. M/s. Team Labs and Consultants field team carried out soil survey to assess the soil characteristics of the study area. The land use and land cover map of the study are shown in Fig 3.6. It may be noted that the land use land cover map reflects predominantly agricultural lands. The impact area also has a significant percentage of agriculture nature of the impact area, and also its dependence on tank for irrigation. Representative soil sampling was done at various locations and these locations are shown in Fig 3.7. Analytical data of soil samples is presented in Table 3.2.

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Figure 3.6 Land Use and Land Cover of the study area (Terms of Reference No. 5)

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Figure 3.7 Soil Sampling Locations

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Table 3.2 Soil Analysis Data Parameters units S-1 S-2 S-3 S-4 S-5 S-6 S-7 S-8 S-9 S-10 pH - 6.83 6.95 7.89 7.41 6.85 7.55 6.99 7.34 7.13 6.79 Electrical Conductivity (EC) dS/m 0.087 0.040 0.283 0.243 0.051 0.177 0.093 0.069 0.182 0.097 Bulk Density g/cc 1.18 1.25 1.33 1.25 1.25 1.11 1.11 1.25 1.18 1.18 Cation-Exchange Capacity (CEC) Cmol(+)/kg 3.23 1.12 2.19 3.48 4.59 4.17 5.34 3.83 4.53 4.13 Infiltration rate mm/hour 27 26 25 26 22 25 25 24 25 22 Porosity % 56 53 50 53 53 58 58 53 56 56 Water Holding Capacity (W.H.C) % 1.07 1.33 0.28 2.40 2.99 0.59 0.54 0.63 10.52 8.80 Moisture % 1.08 1.12 0.28 2.46 3.09 0.59 0.54 0.63 11.21 9.65 Organic Matter % 0.83 0.86 0.94 1.40 0.64 0.64 0.57 0.45 0.71 0.38 Carbonates % Nil Nil Nil Nil Nil Nil Nil Nil Nil Nil Sand % 53 53 58 52 52 54 56 56 54 55 Silt % 42 37 32 41 33 38 34 32 33 32 Clay % 5 10.5 10.5 7 15 8 10 12 13 13 Organic Carbon % 0.48 0.49 0.56 0.81 0.37 0.37 0.33 0.26 0.41 0.22 Nitrogen (as N) % 0.036 0.017 0.041 0.089 0.284 0.068 0.290 0.064 0.214 0.166 Carbon / Nitrogen Ration (C/N) - 13.31 28.79 13.50 9.09 1.30 5.39 1.14 4.04 1.92 1.33 Phosphorus (as P) % 0.4 0.7 0.76 0.42 0.42 0.32 0.4 0.35 0.47 0.45 Potassium (as K) mg/kg 334 239 253 348 388 384 372 352 310 344 Sodium (as Na) mg/kg 224 249 165 232 248 284 352 328 206 328 Calcium (as Ca) mg/kg 194 147 109 279 437 262 405 125 294 225 Magnesium (as Mg) mg/kg 49 47 85 20 38 75 98 104 164 82 Calcium/Magnesium ratio - 3.95 3.14 1.28 13.99 11.52 7.29 4.11 1.20 1.79 2.74 Sodium Absorption Ratio (SAR) - 4.03 5.04 3.39 3.72 3.16 0.88 4.40 6.22 2.74 5.28 Chlorides (as Cl) mg/kg 517 314 377 669 304 519 976 360 304 452 Sulphates (as SO4) mg/kg 10 9.3 7.8 27 30 25 19 34 37 41 Iron (as Fe) mg/kg 762 675 640 846 457 726 124 426 624 336 Manganese (as Mn) mg/kg 214 198 165 216 144 246 194 301 102 165 Zinc (as Zn) mg/kg 10 24 16 14 14 17 29 24 13 13 Texture - Sandy Sandy Sandy Sandy Sandy Sandy Sandy Sandy Sandy Sandy Loam Loam Loam Loam Loam Loam Loam Loam Loam Loam S1-Dasami Lab Pvt Ltd, S2-Actero Pharma Pvt Ltd, S3-Hindys Lab Pvt Ltd, S4-Pittampalli, S5-Bongocheruvu, S6-Velminedu, S7-Are gudem, S8-Peddakapati, S9- Morsugudem and S10- Gundrampalli

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The test results of soil samples collected in the impact area are interpreted referring to the book; “Interpreting soil test results”. The reference tables are presented in Table 3.3. The pH of soil samples ranges from Neutral to mildily alkaline. The cation exchange capacity of the soils is very low in all samples contributed mainly by Potassium exchangeable ions. The level of nitrogen of the soils is Very low to low. The calcium magnesium ratio of the samples reflects calcium is low(7 samples) to and magnesium low (3 samples). Bulk density of soil of impact varies from 1.11-1.33 g/cc among Sandy Loam. The porosity values range from 50-58 % among Sandy Loam (10 samples). Soil texture is predominantly Sandy loam. Table 3.3 Soil Test Results – Reference Tables General interpretation of pH Measured Rating for Cation Exchange Capacity pH Range Classification CEC (Cmol)+)/kg <4.5 Extremely Acidic Very low <6 * 4.51 -5.0 Very Strong Acidic Low 6-12 5.1-5.5 Strong Acid Moderate 12-25 5.6- 6.0 Moderately Acid High 25-40 6.1-6.5 Slightly acid Very High >40 6.6-7.3 Neutral Source: Metson (1961) 7.4-7.8 Mildily Alkaline * Soils with CEC less than three are often 7.9 -8.4 Moderately Alkaline low in fertility and susceptible to soil 8.5-9.0 Strongly Alkaline acidification. >9.0 Very Strongly Alkaline Source: Bruce and Rayment (1982). Ca/mg Ratio Base Saturation as a Criterion of Leaching Description Range (%BS) Rating <1 Ca Deficient 70-100 Very Weakly Leached 1-4 Ca (Low) 50-70 Weakly Leached 4-6 Balanced 30-50 Moderately Leached 6-10 Mg (Low) 15-30 Strongly Leached >10 Mg deficient 0-15 Very Strongly Leached Source: Eckert (1987) Source: Metson (1961) Rating of Total Nitrogen Extractable Potassium (K) Rating (% by W) Description K <0.05 Very low low <150 ppm* (< 0.4 meq/100 g soil) 0.05-0.15 Low medium 150–250 ppm (0.4–0.6 meq/100 g soil) 0.15-0.25 Modium high 250–800 ppm (0.6–2.0 meq/100 g soil) 0.25-0.50 High excessive >800 ppm (>2.0 meq/100 g soil) >0.5 Very High Source: Abbott (1989) Source: Bruce and Rayment (1982)

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3.3 Water Environment Industrial development of any region is contingent on the availability of sufficient water resources, as most of the process industries require water for process or cooling purposes. The potential for exploitation of ground water resources increases as development of new projects increases in industrial and agricultural areas. With the increasing industrialization and urbanization the possibilities of contamination of surface water and ground water sources are rapidly increasing. The water resources in the area broadly fall into following categories:

1. Surface Water resources: Streams and ponds, etc. 2. Ground Water resources: Accumulation in deeper strata of ground.

3.3.1 Surface Water Resources Seasonal nala Chinna Vagu is flowing from northwest to southeast direction at a distance of 6.5 km in southwest direction. There are a few surface water surface bodies like natural lakes and tanks in the study area. The drainage pattern of the impact area is dendritic and the flow is mainly into tanks which follow a chain linkage system draining ultimately in Chinna Vagu. The drainage pattern of the impact area is presented in Fig 3.8.

3.3.1.1 Surface Water Quality The sampling locations of ground water are presented in Figure 3.9. The analytical results of water samples drawn from various locations in the study area during monitoring are presented in Table 3.4. Table 3.4 Water Analysis Data –Surface Water Parameters SW-1 SW-2 Units Method of Analysis IS 2296:1982 Temperature 34 36 oC IS:3025 part 09:2002 NS Colour 1.0 1.0 Hazen IS:3025 part 04:2012 300 Turbidity 0.5 0.5 NTU IS:3025 part 10:2006 NS pH 6.63 6.67 - IS:3025 part 11:2006 6.5-8.5 Total Solids 738 722 mg/l IS:3025 part 15:2003 NS Total Dissolved Solids 727 709 mg/l IS:3025 part 16:2006 1500 Total Suspended Solids 11 13 mg/l IS:3025 part 17:2006 NS Total Hardness (as CaCO3) 370 410 mg/l IS:3025 part 21:2009 NS Calcium (as Ca) 86 78 mg/l IS:3025 part 40:2009 NS Magnesium (as Mg) 38 52 mg/l IS:3025 part 46:2009 NS Sodium (as Na) 109 88 mg/l IS:3025 part 45:2003 NS Sodium Absorption Ratio (SAR) 2.8 2.2 - -

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Potassium (as K) 4.6 4.6 mg/l IS:3025 part 45:2003 NS Total Alkalinity (as CaCO3) 170 175 mg/l IS:3025 part 23:2003 NS Chloride (as Cl) 253 248 mg/l IS:3025 part 32:2007 NS Sulphates (as SO4) 96 85 mg/l IS:3025 part 24:2009 600 Nitrate Nitrogen (as NO3) 35.4 45.1 mg/l IS:3025 part 34:2009 400 Silica (as SiO2) 7.5 6.5 mg/l IS:3025 part 35:2003 50 Fluoride (as F) 0.75 0.85 mg/l IS:3025 part 60:2008 NS Mineral Oil Nil Nil mg/l IS:3025 part 39:2013 NS Cyanide (as CN) <0.2 <0.2 mg/l IS:3025 part 27:2003 NS Copper (as Cu) 0.02 0 mg/l IS:3025 part 42:2009 1.5 Iron (as Fe) 0.26 0.25 mg/l IS:3025 part 53:2009 50 Zinc (as Zn) 0.19 0.21 mg/l IS:3025 part 49:2009 15 Dissolved Oxygen 4.5 4.3 mg/l Is:3025 Part 38:2003 4 Chemical Oxygen Demand 11 13 mg/l IS:3025 Part 58:2006 NS BOD 3 days at 27±10C 3.7 4.0 mg/l IS:3025 Part 44:2003 3 SW1- Velminedu and SW2- Pedda Kaparti. * All units are expressed in mg/l except for pH and other paramters where units are mentioned.

3.3.1.2 Ground Water Resources

Ground water is the accumulation of water below the ground surface, caused by rainfall and its subsequent percolation through pores and crevices. Percolated water accumulates till it reaches impervious strata consisting of confined clay or confined rocks. Occurrence of ground water is controlled by landform, structure and lithology. Ground water abstraction is by means of dug wells, dug cum driven wells, and bore wells. Every village has a number of traditional wells large and small. The state authorities have also provided tube wells fitted with hand pump for the drinking water requirement of villages in the study area. Presently the drinking water needs are mostly met from the ground water resources.

3.3.1.3 Quality of Ground Water The representative samples are collected from various dug wells and bore wells in the study area. The list of sample loations is presented in Table 3.5. The analytical results of water samples drawn from various locations in the study area are presented in Table 3.6. The map showing the locations of sample collection (Figure 3.9) is also presented.

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Table 3.5 Locations of Ground water Sampling Direction Form S. No Location Name Distance From Site (Km) site GW - 1 Dasami Lab Pvt. Ltd - - GW – 2 Actero Pharma Pvt. Ltd W - GW – 3 Hindys Lab Pvt. Ltd W 1.6 GW – 4 Pittampalli SW 2.2 GW – 5 Bongonicheruvu SW 3.2 GW – 6 Velminedu NW 2.7 GW – 7 Aregudem SE 2.5 GW – 8 Pedda Kaparti NE 3.1 GW - 9 Morsugudem SE 3.2 GW – 10 Gudempalli NW 6.2

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Figure 3.8 Drainage Pattern of the study area

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Figure 3.9 Water Sampling Locations (Ground water)

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Table 3.6 Water Analysis Data – Ground Water

Parameters GW- GW- GW- GW- GW- GW- GW- GW- GW- GW- Units Method of Analysis IS 1 2 3 4 5 6 7 8 9 10 10500:2012 Standard Temperature 33 33 33 34 32 31 37 36 36 34 oC IS:3025 part 09:2002 - Colour 1 1 1 1 1 1 1 1 1 1 Hazen IS:3025 part 04:2012 5 Turbidity <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 NTU IS:3025 part 10:2006 1 pH 7.62 7.21 7.42 6.98 7.83 7.63 7.78 7.06 7.06 7.79 - IS:3025 part 11:2006 6.5-8.5 Total Solids 717 657 596 687 372 337 355 740 1094 340 mg/l IS:3025 part 15:2003 NS Total Dissolved Solids 704 647 585 676 362 327 345 727 1081 330 mg/l IS:3025 part 16:2006 500 Total Suspended Solids 13 10 11 11 10 10 10 13 13 10 mg/l IS:3025 part 17:2006 NS Total Hardness (as CaCO3) 531 525 515 550 130 145 155 527 790 155 mg/l IS:3025 part 21:2009 200 Calcium (as Ca) 140 134 124 122 32 34 36 25 38 32 mg/l IS:3025 part 40:2009 75 Magnesium (as Mg) 52 46 36 60 12 15 16 113 169 18 mg/l IS:3025 part 46:2009 30 Sodium (as Na) 51 45 35 51 84 70 69 79 119 67 mg/l IS:3025 part 45:2003 NS Sodium Absorption Ratio 1.0 0.9 0.78 1.1 3.6 2.8 2.7 2.0 2.5 2.7 - - - (SAR) Potassium (as K) 15 9.0 7.2 2.7 14 3.6 13 7.2 11 4.9 mg/l IS:3025 part 45:2003 NS Total Alkalinity (as CaCO3) 336 330 320 370 115 125 125 200 300 125 mg/l IS:3025 part 23:2006 200 Chloride (as Cl) 141 135 125 106 85 74 82 243 365 74 mg/l IS:3025 part 32:2007 250 Sulphate (as SO4) 46 40 30 49 70 49 58 95 143 55 mg/l IS:3025 part 24:2009 200 Nitrate Nitrogen (as NO3) 38 32 22 44 4.9 5.0 5.6 32 48 4.6 mg/l IS:3025 part 34:2009 45 Silica (as SiO2) 19 16 13 21 4.2 4.6 4.1 12 18.7 3.6 mg/l IS:3025 part 35:2003 NS Fluoride (as F) 0.87 0.86 0.84 0.72 0.59 0.6 0.71 0.61 0.61 0.4 mg/l IS:3025 part 60:2008 1.0 Zinc (as Zn) 0.10 0.11 0.11 0.13 0.17 0.14 0.11 0.13 0.13 0.16 mg/l IS:3025 part 49:2009 5.0 GW1-Dasami Lab Pvt Ltd, GW2-Actero Pharma Pvt Ltd, GW3-Hindys Lab Pvt Ltd, GW4-Pittampalli, GW5-Bongocheruvu, S6-Velminedu, GW7-Are gudem, GW8-Peddakapati, GW9- Morsugudem and GW10- Gundrampalli

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3.4 Air Environment

3.4.1 Meteorology

Micro meteorological studies are simultaneously conducted with ambient air quality monitoring. Meteorology plays a vital role in effecting the dispersion of pollutants, once discharged into the atmosphere, their transport, dispersion and diffusion into the environment. The meteorological data is very useful for interpretation of the baseline information and for model study of air quality impacts also. Since meteorological data show wide fluctuations with time, meaningful interpretation can only be drawn from long term and reliable data. Such source of data is the Indian Meteorological Department (IMD), which maintains a network of meteorological stations at several important locations. The data recorded for IMD station at Nalgonda is summarized and the salient features of the summarized data are as follows in the Table 3.7.

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Table 3.7 Meteorological data at IMD Station

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3.4.2 Meteorological Station at Plant Site The micro meteorological data at the industry site is collected simultaneously with ambient air quality monitoring. The station was installed at height of 10 meters above the ground level and the same is located in such a way that there are no obstructions facilitating free flow of wind. Wind speed, wind direction, humidity, temperature and rainfall are recorded on hourly basis. Salient features of micro meteorological data collected are as follows:

1. Wind Direction and Speed: The hourly wind speed and wind direction observations are computed during various seasons of study period and the same are presented in Table 3.8 and the wind rose diagrams are presented in Figure 3.10. The following observations can be made from the collected data; • Calm period is observed to be 6.16 % during the time of monitoring. • The predominant wind direction is East. • Other than predominant wind directions wind was blowing in West and East southeast. • Mostly the wind speeds are observed to be in the range of 1-5 kmph and 5-10 kmph.

2. Temperature: (a) Maximum: 42.6 0C (b) Minimum: 22.2 0C (c) Average: 29.8 0C

3. Humidity: The daily relative humidity values are observed to range between 48 - 72%.

4. Rain Fall: (a) Maximum: 2.2 mm (b) Minimum: 0 mm (c) Mean: 0.6 mm

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Table 3.8 Frequency Distribution of Wind Speeds and Wind Directions Wind Speed in kmph Wind Direction Calm 1 - 5 5-10 10-15 >15 Total N 1.99 1.27 0.05 3.31 NNE 2.72 1.13 0.05 3.89 NE 1.63 1.18 0.05 2.85 ENE 1.95 0.91 0.23 3.08 E 8.06 7.74 1.81 0.05 17.66 ESE 4.53 4.21 0.41 0.05 9.19 SE 4.17 3.76 0.77 0.05 8.74 SSE 2.31 1.27 0.18 0.05 3.80 S 3.58 1.86 0.50 5.93 SSW 2.22 1.54 0.23 0.05 4.03 SW 1.90 1.59 0.18 0.05 3.71 WSW 2.45 1.72 0.59 0.09 4.85 W 4.53 4.62 1.27 0.14 10.55 WNW 3.08 2.31 0.68 6.07 NW 2.54 1.13 0.09 3.76 NNW 1.40 0.82 0.18 2.40 CALM 6.16 Total 6.16 49.05 37.05 7.25 0.50 100.00 (Data Period: March 06, 2017 – June 05, 2017)

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WIND ROSE PLOT: DISPLAY: Wind Speed Direction (blowing from)

NORTH

17.7%

14.2%

10.6%

7.08%

3.54%

WEST EAST

WIND SPEED (m/s)

>= 4.20 2.80 - 4.20 SOUTH 1.40 - 2.80 0.28 - 1.40 Calms: 6.16%

COMMENTS: DATA PERIOD:

Start Date: 3/6/2017 - 00:00 End Date: 6/5/2017 - 23:00 MODELER: M/s.Team Labs and Consultants, Hyderabad

CALM WINDS: TOTAL COUNT:

6.16% 2208 hrs.

AVG. WIND SPEED: PROJECT NO.:

1.36 m/s

WRPLOT View - Lakes Environmental Software Figure 3.10 Wind Rose Diagram at Site

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3.4.3 Ambient Air Quality Air pollution means the presence in the outdoor atmosphere of one or more or combinations thereof in such quantities and of such duration as are or may tend to be injurious to human, plant or animal life or property. Air pollutants include smoke, vapors, soot, fumes, gases, mist, odors, particulate matter, radioactive material or noxious chemicals. Air pollution produces a number of adverse effects including offensive smell, loss of atmospheric clarity, soiling of clothes, building and manufactured goods by smoke and dust. The hazards caused to man, animals, vegetation, environment and climate have been understood in the past decade. The effects of air pollution are briefly discussed below. a) Effect on man: Air borne spores, pollen grains, virus, bacteria, fungi, fur and hairs cause various allergic reactions, bronchial asthma, tuberculosis and other infections. Sulphur dioxide produces drying of the mouth, scratchy throat and smarting eyes. It also causes chest constriction, headache, vomiting and death from respiratory diseases. Sulphur trioxide, Nitrogen oxide and carbon monoxide diffuse in the blood stream. They combine with haemoglobin and reduce its oxygen carrying capacity. Nitrogen oxide in high concentration impairs the functioning of lungs by causing accumulation of water in the air spaces. Hydrocarbons have been reported to cause cancer in man. Hydrogen sulphide causes nausea and irritates eyes and throat. Ammonia attacks upper respiratory passages. Ozone causes dryness of mucous membrane of the mouth, nose and throat. It changes visual capacity, causes headache, pulmonary congestion and oedema. Arsines damage red cells in blood, kidney and cause jaundice. Suspended particles like ash, soot and smoke cause eye irritation, tuberculosis and possible cancer. Fine particles of various metals present in the air cause a number of diseases. Heavy dust fall is one of the major causes of asthma, cough and other diseases of lungs and throat. Lead can damage the brain of young children and may even cause death. It affects the normal functioning of the nervous system in adults. Cadmium is a respiratory poison and may cause high blood pressure and a number of heart diseases. Asbestos fibers have been associated in chronic lung diseases. b) Effect on animals: Air pollution causes wide spread damage to live-stock. The effect of air pollution on domestic animals living in or near industrial areas is similar to those of

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human beings. Live stocks ingest various fluorine compounds which fall on fodder crops causing abnormal calcification of bones and teeth. It results in lameness, loss of weight and frequent diarrhea. c) Effect on plants: Air pollution has serious harmful effects on plants. Sulphur dioxide causes chlorosis. It results in the death of cells and tissues. Forest trees are worst affected by sulphur dioxide pollutants. Fluorides damage leafy vegetables such as lettuce and spinach. Oxides of nitrogen and fluorides reduce crop yields. Photochemical smog bleaches and blazes foliage of plants. Hydrocarbons cause premature fall of leaves and flower buds, discolouration of sepals and curling of petals. Ozone damages cereals, fruits and cotton crops. It also causes premature yellowing and shedding of leaves. d) Effect on materials: The acid rain and photochemical smog affect metals and buildings. Acid rain pollutes the soil and water sources. Acidic products of the air pollutant cause disintegration of textile, paper. Many small industrial units and sources of locomotive pollutants have been sifted to save the famous marble structure, Taj Mahal at Agra. Hydrogen sulphide decolorizes silver and lead paints. Ozone oxidizes rubber goods. e) Aesthetic loss: Dust and smoke in the air do not allow us to have a clear view of nature’s beauty and man-made objects. Smoke and foul smells emitted by factories, automobiles, dirty drains and garbage dumps make the urban life discomfortable. Smoking in public places affects the health of not only the smoker but also the non- smoker. f) Change in Climate: A change in the earth’s climate due to atmospheric pollution is an alarming global concern. It has been observed that in the recent past, the level of CO2 in the atmosphere has increased from 290 ppm to 330 ppm. Approximately one fourth of this rise has occurred in the past decade. Rapid increase in population, deforestation and excessive burning of fossil fuel has been responsible for this increase. It is also predicted that this factor alone could lead to rise in global temperature, causing “Green House Effect” or “Global Warming”.

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Green House effect may be defined as the progressive warming up the earth surface due to blanketing effect of man made CO2 in the atmosphere. The thick CO2 layer functions like the glass panel of a green house preventing re-radiation of heat to outer space. A rise of global temperature by more than 2 or 3 degrees may lead to the melting of polar ice cap and glaciers. This will cause rise in ocean level and consequent flooding of costal towns and submersion of many oceanic islands. This would also affect the rainfall pattern and productivity of agricultural crops.

With the proposed project a range of different pollutants are released into the atmosphere that are dispersed and have a significant impact on neighborhood air environment. Thus collection of base line data of air environment occupies a predominant role in the impact assessment. The ambient air quality status across the study zone forms basis for prediction of the impacts due to the project.

The data required to assess air quality impacts in and around neighborhood is achieved by designing such a network, which encompasses micro meteorological conditions, quantity and quality of emissions, locations, during, resources / monitoring technology and operational criteria.

3.4.4 Scope of Field Study The scope of baseline status of the ambient air quality can be assessed through a well- designed ambient air quality stations network. Ambient air quality monitoring of the study area consisting of 10 km radius with the plant site as the center point was carried out during the study period. Ambient air quality was monitored at nine locations spread over entire study area. Figure 3.11 presents the locations of nine ambient air quality- monitoring stations. At each sampling station monitoring was carried out for 24 hours in a day for 2 days a week, and for three months. The major air pollutants monitored on

24 hourly basis are; PM10, PM2.5, Sulfur dioxide and Oxides of Nitrogen. Sampling and analysis of the above variables is according to the guidelines of Central Pollution Control Board. National Ambient Air Qualiy Standards is presented in Table 3.9.

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Table 3.9 National Ambient Air Quality Standards Pollutant Time Concentration in Ambient Air Weighted IRR ESA Methods of Measurement Average Sulphur Dioxide (SO2) Annual* 50 20 Improved west and Gaeke 24 Hours** 80 80 Ultraviolet fluorescence Nitrogen Dioxide (NO2) Annual* 40 30 Modified Jacob & Hochheiser 24 Hours** 80 80 (Nn-Arsenite) Chemiluminescence Particulate Matter (Size Less Annual* 60 60 Gravimetic than 10µm) or PM10 24 Hours** 100 100 TOEM Beta Attenuation Particulate Matter (Size Less Annual* 40 40 Gravimetic than 2.5µm) or PM2.5 24 Hours** 60 60 TOEM Beta Attenuation Ozone (O3) 8 hours** 100 100 UV Photometric 1 hour** 180 180 Chemilminescence Chemical Method Lead (Pb) Annual* 0.50 0.50 AAS /ICP method after sampling on EPM 2000 or 24 hours** 1.0 1.0 equivalent filter paper ED - XRF using Teflon filter. Carbon Monoxide (CO) 8 hours** 02 02 Non Dispersive Infra Red 1 hour** 04 04 Spectroscopy Ammonia (NH3) Annual* 100 100 Chemilminescence 24 hours** 400 400 Indophenol blue method Gas Chromotography based continuous analyzer Benzene (C6H6) Annual* 05 05 Absorption and Desorption followed by GC analysis Benzo (o) Pyrene(BaP) – Annual* 01 01 Solvent extraction followed by Particulate Phase only, HPLC/GC analysis Arsenic (As), Annual* 06 06 AAS/ICP method after sampling on EPM 2000 or equivalent filter paper Nickel (Ni), Annual* 20 20 AAS/ICP method after sampling on EPM 2000 or equivalent filter paper IRR - Industrial, Residential, Rural and Other Area, ESA- Ecological Sensitive Area (Notified by Central Government) G.S.No.826 (E) dated 16th November, 2009. Vide letter no. F. No. Q-15017/43/2007-CPW *Annual Arithmetic mean of minimum 104 measurements in a year at a particular site taken twice a week 24 hourly at uniform interval. **24 hourly/8/1 hourly monitored values as applicable, shall be complied with 98 percent of the time in a year.2% of time they may be exceeded the limits but not on two consecutive days of monitoring.

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3.4.5 Description of Sampling Locations The location of ambient air quality stations is contingent on the meteorological status of the area. Hence the micro meteorological data was collected before initiating the ambient air quality monitoring. Table 3.10 presents the ambient air quality locations and their distances and directions from the plant site.

Table 3.10 Locations of Ambient Air Quality Monitoring Stations S.No Location Direction Distance from Plant site (KM) AAQ-1 Dasami Lab Pvt. Ltd - - AAQ-2 Actero Pharma Pvt. Ltd W - AAQ-3 Hindys Lab Pvt. Ltd W 1.6 AAQ-4 Pittampalli SW 2.2 AAQ-5 Bongonicheruvu SW 3.2 AAQ-6 Velminedu NW 2.7 AAQ-7 Aregudem SE 2.5 AAQ-8 Pedda Kaparti NE 3.1 AAQ-9 Morsugudem SE 3.2 AAQ-10 Gudempalli NW 6.2

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Figure 3.11 Ambient Air Quality Monitoring Locations

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3.4.6 Ambient Air Quality Status The baseline data for ambient air quality is presented in Table 3.11. It may be noted that the monitoring values for VOC are below detectable limits at all Monitoring locations except at plant areas. The observed values are found to be within the prescribed NAAQ standards. Graphical representation of ambient air quality is presented in Figure 3.12. Table 3.11 Summary Ambient Air Quality Status Pollutant Maximum Minimum Mean 98 percentile 1) Location: Dasami Lab Pvt. Ltd PM10 56 36 46.69 56 PM2.5 24 15 18.81 24 SO2 12 9 10.46 12 NOx 12 9 10.08 12 VOC (in PPM) 1.2 0.4 0.66 1.1 HCl 0.2 0.1 0.15 0.2 2) Location: Actero Pharma Pvt. Ltd PM10 54 36 43.85 54 PM2.5 23 15 17.92 22.5 SO2 12 9 10.46 12 NOx 12 9 10.08 12 VOC (in PPM) BDL BDL BDL BDL HCl BDL BDL BDL BDL 3) Location: Hindys Lab Pvt. Ltd PM10 56 32 45.81 55 PM2.5 24 14 19.08 24 SO2 12 9 10.08 12 NOx 12 9 10.31 12 VOC (in PPM) 1.1 0.3 0.62 1.1 HCl 0.2 0.1 0.14 0.2 4) Location: Pittampalli PM10 49 34 40.96 48.5 PM2.5 140 13 13.5 14 SO2 11 9 9.65 11 NOx 11 9 9.88 11 VOC (in PPM) BDL BDL BDL BDL HCl BDL BDL BDL BDL 5) Location: Bongonicheruvu PM10 47 34 39 47 PM2.5 14 12 13.46 14 SO2 11 9 9.81 11 NOx 11 9 9.65 11 VOC (in PPM) BDL BDL BDL BDL HCl BDL BDL BDL BDL 6) Location: Velminedu PM10 46 34 38.88 46 PM2.5 17 11 13.5 17 SO2 11 9 9.65 11 NOx 11 9 9.96 11

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VOC (in PPM) BDL BDL BDL BDL HCl BDL BDL BDL BDL 7) Location: Aregudem PM10 44 34 38.42 44 PM2.5 18 12 14.04 18 SO2 10 9 9.5 10 NOx 11 9 9.62 11 VOC (in PPM) BDL BDL BDL BDL HCl BDL BDL BDL BDL 8) Location: Pedda Kaparti PM10 48 32 39.04 48 PM2.5 18 12 14.19 18 SO2 10 9 9.5 10 NOx 11 9 9.65 11 VOC (in PPM) BDL BDL BDL BDL HCl BDL BDL BDL BDL 9) Location: Morsugudem PM10 48 33 40.38 48 PM2.5 18 13 15.15 18 SO2 12 9 9.96 12 NOx 12 9 9.88 12 VOC (in PPM) BDL BDL BDL BDL HCl BDL BDL BDL BDL 10) Location: Gudempalli PM10 46 32 37.62 45 PM2.5 17 14 15.42 17 SO2 12 9 9.96 12 NOx 12 9 9.88 12 VOC (in PPM) BDL BDL BDL BDL HCl BDL BDL BDL BDL • Note: Pollutant concentrations exccept for VOC are presented in µg/m³ • BDL: Below detectable limit

100 80 NAAQ Standard 90 NAAQ Standard 70 80 Maximum Minimum 60 70

60 3 50 Maximum 50 40 Minimum , µg/m 40 2 so 30 30 20 20 10

PM10, µg/m3 10 0 0 AAQ-1 AAQ-2 AAQ-3 AAQ-4 AAQ-5 AAQ-6 AAQ-7 AAQ-8 AAQ-9 AAQ-10 AAQ-1 AAQ-2 AAQ-3 AAQ-4 AAQ-5 AAQ-6 AAQ-7 AAQ-8 AAQ-9 AAQ-10

AAQ Monitoring Locations AAQ Monitoring Locations

80 60 NAAQ Standard NAAQ Standard 50 60

40 Maximum Maximum

Minimum 40 Minimum 30 , µg/m3 2.5 NOX, µg/m3 PM 20 20

10

0 0 AAQ-1 AAQ-2 AAQ-3 AAQ-4 AAQ-5 AAQ-6 AAQ-7 AAQ-8 AAQ-9 AAQ-10 AAQ-1 AAQ-2 AAQ-3 AAQ-4 AAQ-5 AAQ-6 AAQ-7 AAQ-8 AAQ-9 AAQ-10 AAQ Monitoring Locations AAQ Monitoring Locations Figure 3.12 Graphs Showing the Results of Ambient Air Quality

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3.4.7 Noise Environment Noise is an unwanted sound without musical quality. Artificial noise and its impact on environment, grown apace with advancing human civilization. Noise pollution is equally hazardous to environment as air, water and other forms of pollution. Various noise measurement units have been introduced to describe, in a single number, the response of an average human to a complex sound made up of various frequencies at different loudness levels. The most common scale is, weighted decibel dB (A), and measured as the relative intensity level of one sound with respect to another sound (reference sound).

The impact of noise depends on its characteristics (instantaneous, intermittent or continuous in nature), time of day (day or night) and location of noise source. Table 3.12 shows the effects of different noise levels on human beings. The environmental impact of noise can have several effects varying from noise induced hearing loss to annoying depending on noise levels.

The assessment of noise pollution on neighborhood environment due to the plant area was carried out keeping in view, all the considerations mentioned above. The existing status of noise levels is measured at nine locations at various villages within the study area. Figure 3.13 presents noise level monitoring locations. The monitored noise levels are shown in Table 3.13. Noise levels are observed to be with in the prescribed limits of rural and residential areas.

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Figure 3.13 Noise Sampling Locations

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Table 3.12 Effects on Human Beings at Different Noise Levels Source Noise Effects Level B(A) Large Rocket Engine (near by) 180 Threshold of Pains Hydraulic Press ( 1 m ) 130 Jet take off (60 m) 120 Maximum vocal effort possible Automobile Horn (1m) 120 Construction Noise (3m) 110 Jet Take off (600 m) 110 Shout, Punch, Press, Circular Saw 100 Very annoying Heavy Truck (15m), Farm 90 Prolonged exposure Machinery Endangers Lathes, Sports Car, Noisy Machines hearing loss Automobile (15m) 80 Annoying Freeway Traffic (15m) 70 Telephone is difficult, intrusive Loud Conversations 60 Living Room in Home 50 Quiet Power Station (15m) 50 Bed Room in Home 40 Soft Whisper (5m) 30 Very quiet Tick of Wall clock (1m) 30 Low radio Reception 20 Whisper 20 Rattling of Leaves by Breeze 10 Barely audible 0 Threshold of hearing

Table 3.13 Equivalent Noise levels in the Study Area S.No. Location Equivalent Noise Levels dB(A) Leq day Leq night 1. Dasami Lab Pvt. Ltd 55 48 2. Actero Pharma Pvt. Ltd 53 36 3. Hindys Lab Pvt. Ltd 55 46 4. Pittampalli 44 34 5. Bongonicheruvu 46 35 6. Velminedu 45 35 7. Aregudem 44 34 8. Pedda Kaparti 46 36 9. Morsugudem 45 35 10. Gudempalli 45 35

3.4.8 Traffic Study Traffic study was conducted during three alternative days including a holiday to arrive at peal traffic hours. Peak traffic was observed during 8 – 9 AM and 6 – 7 PM consisting

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of mainly passangers traffic. Graphical representation of peak hour traffic is presented in Figure 3.14.

Peak Hour Traffic ‐ PCU (8:00‐9:00) Peak Hour Traffic ‐ PCU (18:00‐19:00)

5% 3%

10% 11%

8% 2‐Wheelers 2‐Wheelers

12% Buses Buses Mini Buses Mini Buses Trucks 8% Trucks 53% 3‐Wheelers 3‐Wheelers

5% Others 61% Others

10%

14%

Figure 3.14 Peak Hour Traffic

3.5 Socio Economic Environment Industrial development reflects in social development, i.e., growth in infrastructure facilities, growth in employment rates, increased demands for housing, and other amenities etc., which will have a bearing on the socio economic status.

Socio-economic survey is conducted to ascertain the existing socio-economic status to compare the same with the developments due to the project. Baseline data of demographic characteristics- occupational status, literacy, health status and the access to infrastructure facilities for social development in the project area has been studied from the secondary data collected from census department By M/s. Team Labs and Consultants.

Demographic characteristics of the study area falling within 10 km radius of the project site have been compiled to assess the pre-project socio-economic status. Secondary data has been collected from various government agencies i.e., chief planning officer, Yadradi Bhuvanagiri, Nalgonda districts and other government departments of forestry, irrigation etc., and Mandal Development Offices of the relevant government departments. Census 2011 was complied and presented as follows

3.6 Demography The study area falls under the following mandals of Chotuppal, Ramannapeta, in Yadradi Bhuvanagiri District and Chityala, Munugode, Narayanapur in Nalgonda

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District Telangana state. Study area comprises of 40 revenue villages and 8 hamlets apart from Tiruvuru Town.

3.6.1 Population Distribution The population distribution of the study area is presented in Table 3.14 The population density in the study area is less reflecting the rural nature and lack of irrigation facilities. The total population of the area is 134403 consisting of 68494 males and 65909 females. The population density in this area reflects the rural area. The population of the scheduled castes is 24072 consisting of 12195 males and 11877 females, while the scheduled tribe population is 1243 consisting of 680 males and 563 females, which is 17.91 and 0.92% of the total population respectively. Table 3.14 Population Distribution – Study Area Category km Total 0-3 3-5 5-7 7-10 Total Population 7431 9878 9062 108032 134403 Total Population – Male 3813 5016 4731 54934 68494 Total Population – Female 3618 4862 4331 53098 65909 Population <6 years 815 1026 851 10585 13277 Male <6 years 425 571 480 5515 6991 Females < 6years 390 455 371 5070 6286 Scheduled Caste Population 1192 1293 1780 19807 24072 Male – SC 594 656 934 10011 12195 Female – SC 598 637 846 9796 11877 Scheduled Tribe Population 95 50 92 1006 1243 Male – ST 51 26 53 550 680 Female – ST 44 24 39 456 563

Figure 3.15 Population distribution of the Study Area

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3.6.1.1 Literacy Census operations consider a literate as a person who is above six years old and who can write and read as per the census. Table 3.15 presents the literacy levels in the study area. The population below six years old is 13277 consisting of 6991 males and 6286 females, which is 9.88% of the study area population. The percentage of literacy level in the study area among males is 76.48 and 55.18 among females. It may be observed that the literacy level among females is comparatively less than males. Table 3.15 Literacy Study Area Category km Total 0-3 3-5 5-7 7-10 Total Population 7431 9878 9062 108032 134403 Total Population – Male 3813 5016 4731 54934 68494 Total Population – Female 3618 4862 4331 53098 65909 Population <6 years 815 1026 851 10585 13277 Male <6 years 425 571 480 5515 6991 Females < 6years 390 455 371 5070 6286 Total Literates 4052 5621 5322 64937 79932 Male –Literates 2435 3316 3263 38021 47035 Female – Literates 1617 2305 2059 26916 32897 Total Illiterates 3379 4257 3740 43095 54471 Male –Illiterate 1378 1700 1468 16913 21459 Female – Illiterate 2001 2557 2272 26182 33012

Female <6years Male 5.2% lliterate 19.9% Literates 35% Literates 24.5% lliterate 10.7%

<6years 4.7%

Figure 3.16 Literacy of Study Area

3.6.1.2 Employment/Occupation Work is defined as participation in any economically productive activity – Physical/ mental. The work force is classified into three categories: a) main workers, b) marginal

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workers and c) non-workers. Main workers are those who work for a substantial part of the year for a living such as salaried employees, agricultural labor etc. Marginal workers are those who worked the previous year but have not worked for a substantial part of this year. Non-workers constitute students, house wives, dependents, pensioners etc. Table 3.16 presents the population distribution for employment.

It may be observed that a majority of the study area population falls in the non worker category among 51.53 % of the total population and the marginal workers from about 6.59% of the total population. The male female difference is also significant in all the regions and in all the categories. There are few females among the workers where as there are more non workers and marginal workers among females. Table 3.16 Employment - Study Area Category km Total 0-3 3-5 5-7 7-10 Total Population 7431 9878 9062 108032 134403 Total Population – Male 3813 5016 4731 54934 68494 Total Population – Female 3618 4862 4331 53098 65909 Total Workers 3410 4904 4243 52590 65147 Total Workers – Male 2046 2822 2476 30425 37769 Total Workers – Female 1364 2082 1767 22165 27378 Total Main Workers 3073 4468 3884 44868 56293 Main workers – Male 1936 2712 2367 28129 35144 Main Workers – Female 1137 1756 1517 16739 21149 Total Marginal Workers 337 436 359 7722 8854 Marginal Workers – Male 110 110 109 2296 2625 Marginal Workers – Female 227 326 250 5426 6229 Total Non Workers 4021 4974 4819 55442 69256 Non Workers – Male 1767 2194 2255 24509 30725 Non Workers – Female 2254 2780 2564 30933 38531

The main workers are further classified into; Total cultivators: those who engage a single worker or his family member to cultivate land for payment in money, kind or share; Agricultural labor : those who work in other’s lands for wages; household workers: workers involved in manufacturing and processing industries in the house hold industries; and other services; Livestock, forestry, fishing and allied activities; Workers involved in mining and quarrying; Workers involved in manufacturing and processing industries in the house hold industries; non house hold industries; construction workers; workers in trade and commerce; workers involved in transport, storage and communication ; and other services: government employees, teachers, priests, artists etc.

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Table 3.17 presents the main workers distribution among the study area population. It may be observed that over 22.01% of the study area population is involved in cultivation or agriculture labor, followed by other services to the tune of 17.82% which is largely due to the proximity to Chityala. It may also be observed that the people involved in non household industry are significantly more reflecting on the industrial nature of the area. Significant differences are observed among the male and female workers, Female workers are found to be more in agricultural activity largely due to more percentage of females being agricultural labor.

Figure 3.17 Employment - Study Area

Table 3.17 Main workers Study Area Category km Total 0-3 3-5 5-7 7-10 Total Population 7431 9878 9062 108032 134403 Total Population – Male 3813 5016 4731 54934 68494 Total Population – Female 3618 4862 4331 53098 65909 Total Main Workers 3073 4468 3884 44868 56293 Main workers – Male 1936 2712 2367 28129 35144 Main Workers – Female 1137 1756 1517 16739 21149 Total Cultivators 702 795 448 7478 9423 Cultivators – Male 479 542 369 5481 6871 Cultivators- Female 223 253 79 1997 2552 Total Agriculture Labor 1328 1429 1643 15760 20160 Agriculture Labor – Male 580 476 453 5672 7181 Agriculture Labor – Female 748 953 1190 10088 12979 Total Household Workers 31 47 82 2602 2762

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Category km Total 0-3 3-5 5-7 7-10 Household Workers – Male 14 29 54 1696 1793 Household Workers – Female 17 18 28 906 969 Total Others 1012 2197 1711 19028 23948 Others – Male 863 1665 1491 15280 19299 Others – Female 149 532 220 3748 4649

3.6.1.3 Living Standards and Infrastructure Sustainable development of any area is dependent not only the population but also on the availability of infrastructure which leads to better living standards. The infrastructure facilities are essential in providing education, awareness, health, communication, potable water, transport etc. The standards of living are the sum of the availability of the infrastructure to the subject community, wide variations in terms of income, economic conditions and patterns of spending.

The infrastructure facilities available in the impact zone are reflecting the rural nature of the entire study area.

I. Educational Facilities The educational facilities available in the rural areas are meager, despite the proximity to urban area of Chityal. There are 39 primary schools, 34 middle schools and 26 high schools in the study area. There are two junior colleges in the area. The higher educational need of the population is met by Chityal, which has a number of private engineering colleges, PG colleges, junior colleges and degree colleges. The distict Head quater of Nalgonda caters to educational needs of surrounding areas ad fer as 23 kms away from Chityal.

II. Health facilities The medical and health facilities available in the impact zone are inadequate; there are one PHC, twentyone PHS and no child welfare centers in the entire area. The health needs of the population in this area are met by quacks and other semi qualified persons.

III. Availability of Potable Water The entire population in this area is dependent on ground water for drinking purposes. There are protected water supply schemes in all the villages. About 8 villages in the

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study area are dependent on tube wells, while the remaining villages are dependent on wells and hand pumps.

IV. Transport and Communication Transport is essentially provided by the Telangana State Road Transport Corporation (TSRTC). Most of the study area has excellent road network in all the villages except in one village, which has kacha roads. TSRTC bus facility is available for the all the villages. However it is observed that a number of private transport vehicles are observed in the area connecting them to Chityala.

V. Sources of Energy and Availability The primary source of energy in the study area is electricity, and the entire study area has electricity for agriculture and domestic purpose. The urban areas have LPG facility for their cooking purpose. A significant number of people in the urban area are also dependent on Kerosene for cooking purposes, which is contingent on the vagaries of public distribution system. A majority of the rural area is mostly dependent on Kerosene, dried cow dung cakes, wood from roadside trees for their domestic energy needs.

VI. Post and Telegraph facilities There are 14 post offices in the area and one post and Telegraph office in the study area. Phone facilities however are extended to some of the villages.

VII. Housing Census defines the house hold as a group of persons living together and sharing their meals from a common kitchen. The number of households in the impact zone is 27920, while the number of the houses is 21557. The density of the households is approximately four. The traditional houses made up of mud walls and covered by dry common grass and leaves of bourses are commonly found in the rural area, which are not considered pucca houses. The government has been augmenting the housing standards by constructing housing colonies for various weaker sections of the society.

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3.6.2 Land Utilization Land use patterns can be prepared on the basis of revenue records though it is not an exact indicator of the actual use of the land at a given time. Land use is presented under the heads of area under forest cover irrigated land, area under cultivation and cultivable wasteland in Table 3.18. Table 3.18 Land Utilization Pattern Category kms Total 0-3 3-5 5-7 7-10 Area, ha Forest 38 38 Canals 102 102 Waterfall 520 520 Land Under Miscellaneous Tree Crops etc 40 88 97 377.71 602.71 Culturable Waste Land 127 70 276 1172.13 1645.13 Tanks/Lakes 130 540 187 1193.94 2050.94 Barren & Un-cultivable Land 300 415 320 2419.98 3454.98 Permanent Pastures and Other Grazing Land 365 582 197 2747.67 3891.67 Area under Non-Agricultural Uses 761 681 587 2767.48 4796.48 Wells/Tube Wells 222 450.51 729.43 4143.82 5545.76 Fallows Land other than Current Fallows 3 1220 468 6767.44 8458.44 Current Fallows 19 992 1247 10166.5 12424.5 Net Area Sown 1732 1859 1496 13013.1 18100.1 Unirrigated Land 1402 3080.49 2294.57 23987.3 30764.3 Total 5101 9978 7899 69417 92395 It may be observed that a majority of the study area is Unirrigated Land, followed by Net Area Sown.

3.6.3 Project Economy

M/s. Actero Pharma Pvt. Ltd., proposed to expand its Bulk Drug & Intermediates Manufacturing Unit at Sy.No. 407 (Part) and 411, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana.

The proposed project will provide employment to 300 people. It will be spending approximately Rs. 67.5 Lakhs of rupees every month on salaries providing bread and succor to 300 families additionally. The proposed project will also generate indirect employment to the locals during construction phase in the order of 180 people for a period of 24-30 months. The employers will contribute to the provident fund, ESI and provide facilities as per the relevant labor act.

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The proximity of Chityala will provide access to the extensive medical facilities available apart from the ESI medical facilities to the employees and their families. An industrial Canteen is established by the company.

It may be concluded that satisfactory amenities are available for the population of the impact zone, while the amenities are available either within the village or at a minimum distance of 8 km. The area also has large tracts of waste lands which can be utilized for industrial development. The plant has been contributing to the industrial growth of the area, which in turn; generates employment, and improve the infrastructure facilities of the area by strengthening the same economically.

3.7 Flora and Fauna Biological environment includes the study of the relationships of organisms or groups of organisms to their environment. Ecology in essence is the study of the abiotic (non- living) and biotic (living) components, interaction of community and the environment and exchange of material (energy and nutrient) between living and non-living parts. A community includes all organisms in the given area interacting with the abiotic environment. The main aim of Conservation of Biodiversity is to ensure “No Net Loss”. The biodiversity-related Conventions are based on the premise that further loss of biodiversity is unacceptable. Biodiversity must be conserved to ensure it survives, continuing to provide services, values and benefits for current and future generations.

The following approach has been chosen by the IAIA to help achieve ‘no net loss’ of biodiversity:

• Avoidance of irreversible loss of biodiversity. • Seeking alternative solutions to minimize biodiversity losses. • Use of mitigation to restore biodiversity resources. • Compensation for unavoidable loss by providing substitutes of at least similar biodiversity value. • Looking for opportunities for enhancement.

This approach can be called “positive planning for biodiversity.” It helps achieve no net loss by ensuring the safety and survival of rare or endangered or endemic or threatened

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(REET) species. This approach has been adopted by the proposed project in the study under report.

Methodology The study area was carried out through belt transect method (100m X10m) by covering the various ecosystems of core and buffer zones in all the directions. A reconnaissance survey has been made randomly to observe the ecologically sensitive habitats during Pre Monsoon season 2017. General Interviews are made with local people on native animals and medicinal plants used frequently. The observed species recorded through photography and documentation in the field data sheets. No physical damage created to flora and fauna during the data collection. Survey Types used 1. Point quarter plot-less method (random sampling) for terrestrial vegetation 2. Belt transact method for trees, shrubs and herbs for quantification. 3. Indirect and direct evidences for faunal species in the sample plots. 4. Point count method for birds near aquatic bodies. 5. Interview with local villagers within the study area for past history for faunal migratory routes and ecosensitive habitats. Equipment / Instruments deployed ¾ Digital Camera (NIKON 42 X zoom) ¾ GPS ¾ Binoculars ¾ Field observation book Flora During belt transects, an area of 100 m X 10 m width was estimated for statistical analysis. List of floral species observed at each transect was documented. The number of sampling points are depends on the Area- Species graph. Species listed are compared with standard books (BSI, ZSI and IUCN) and noted the species required for conservation criteria. Fauna The observations on faunal species recorded through direct and indirect methods. Direct sightings for Mammals, Aves, Reptiles and Butterflies are listed out in the field note

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book and compared with secondary sources. Secondary data is also validated during personal interaction with local villagers. Scheduling of species represented as per Indian Wildlife Protection act (1972) and IUCN for each species and checked REET species. No quantitative analysis made for faunal species as most of species listed by secondary source. As the animals are migratory in nature, habitats used by protected, rare or sensitive species for breeding, nesting, foraging, migration are ascertained. Ecological parameters viz., abundance, density, frequency, Relative abundance (RA), Relative density (RD), Relative frequency (RF), Important value index (IVI), Shannon- Wiener diversity index were derived from the quantitative primary data collected during field survey. Importance Value Index (IVI): RD + RF +RA Species Diversity Shannon Diversity Index (H’) has been used for estimating the diversity among the core & buffer zones in order to know the species richness and dominance. H’= - ∑ Pi. ln Pi S= Number of individuals of one species Where Pi = ------N = Total number of all individuals in the sample and, ln is the logarithm to the base e Communities with less number of species with high level of dominance or low level of uniformity will have lower diversity. Thus it is a statistical function based on the richness and evenness components. Evenness and dominance are inversely related. This can be also calculated through Statistical Software “PAST”.

Rationale for Survey Method The proposed project site is an open land without any vegetation surrounded by barren lands. Most of the region is dry and xerophytic conditions. Vegetation is limited to pond side and road side. There are no major canals and Rivers, Reserve forests in the study area. The possible impacted regions are intensively studied. The new technologies adopted and wastes and other pollution related aspects are also considered to know the impact study. The impacts on the surrounding agricultural system are also studied and

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quantified. The sampling points are selected in all the directions and ecosystems along with the wind direction pattern.

Identification of Species Species of flora and fauna are identified through local field guides. Unidentified plant pictures are later confirmed by website and expert scientists from BSI, ZSI, forest officials etc.

Secondary data The key referral material is from Telangana state working plan data of the forest department. Certain published papers related to region in the recent years are also considered. Ground validation has done through elderly village people and personal field visits.

Desktop work Ahead of initiating the field surveys, details pertaining to the project collected and crosschecked with various online sources. Relevant maps of the study area on road network, drainage pattern, contour, forest type, forest cover etc are also observed. Existing baseline environmental conditions such as Air, Water, Soil and climatic conditions, site specific ecological sensitive zones are gathered. Area specific details of the study area are collected through Google earth. The total area is analyzed with GIS tools and no. of sampling points finalized through Area- Species graph and marked around 10 sampling points by covering the various ecosystems of core and buffer zones in all the directions.

Field observation Description of the project site environment: The project site is open land without any vegetation except natural grass and common weeds.

The proposed project falls in

™ 6D – Deccan Peninsula Deccan Plateau as per the Biogeography Classification of India. ™ Hot Semi arid type as per the India's Köppen climate classification.

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The vegetation of the study area falls under

9 5A: Southern tropical dry deciduous forests C3: Southern dry mixed deciduous forest; 9 6A: Southern tropical thorn forests DS1: Southern thorn scrub, 2S1: Secondary dry deciduous forest by revised classification of Indian forest types (Champion and Seth, 1968). These types of forests are seen throughout the Eastern Ghats and few parts of Western Ghats of the country.

The proposed project site does not encounter with any kind of forest types like Reserve Forest, Protected forest or un- classed Forest (declared Protected under “ The Indian Forest Act, 1927”) and “Forest (Conservation) Act, 1980 with Amendments Made in 1988”. (Source: Forest Department). Further no tree cutting is involved in the project as there is no vegetation at all within this project site. Thus no forest Clearance is required for the proposed development. There no Scheduled species recorded within the proposed construction site.

Wetland: No wetland notified under “The Ramsar Convention – 1971” or listed under “the National wetland Conservation Programme – 2009” is reported within 10 km from project boundary.

Ecology The project site has natural grasses and other herbaceous weed species. There is a good number of natural and plantation type vegetation maintained within the project site. However, certain weeds, natural creepers, herbs are present in the sampling sites. Except few common birds, no major fauna or breeding sites found within the site. There no migratory paths or boundary of any protected areas or ecological sensitive zones present in the proposed site. Herbs such as Tridax procumbance, Cassia occidentalis, Indigofera tinctoria, Crotalaria retusa, Crotan bonplantianum and Alternanthera sessilis and climbers and creepers such as Pergularia daemia, Evolvulous alsinoides, Cardiospermum halicacabum are very common.

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Overview of the area and plantation activities undertaken Near the office entrance more woody species such as Bauhinia purpurea, Nerium odoratum, Peltophorum pterocarpum, Polyalthia longifolia, Plumaria pendula, Pongamia pinnata which attract birds and other smaller mammals are present. Tall and broad leaved trees were grown towards the boundary wall to check the pollution dispersal rate. The ornamental plants maintained near the office premises attract more butterfly species. The plantation taken up with the plant unit and near roadside is enhancing the ecological values of the surroundings. The ground flora is also maintained well with typical grass species and creepers.

Ecology of plant site The plant site habitat boundary to 5 sq. km. urban and natural vegetation is found towards other directions. It is very clear that more manmade ecosystem is predominant in this zone. Most of the region is dry and xerophytic conditions. Vegetation is limited to pond side and road side. There are no major canals and Rivers, Reserve forests in the study area. The predominant species are Borassus flabellifer, Phoenix sylvestris, Prosopis juliflora, Acacia nilotica, Azadirachta indica, Ficus benghalensis, Tectona grandis, Casuarina equisetifolia, Leucaena leucocephala, Acacia auriculiformis, Tecoma stans, Dalbergia sisoo, Peltophorum pterocarpum, Thespecia populnea, Polyalthia longifolia, and Pongamia pinnata under natural vegetation.

The faunal composition generally with arboreal and semi arboreal based animals. Within the core zone common mongoose, Squirrels are sighted apart from few reptilian species. From the secondary source (local people working in the plant) it is also revealed that presence of common snakes exists here. Common bird species such as Herons, Paddy egrets, Green bee eaters, Indian rollers, Parakeets, White headed babblers, Weaver birds, Mynas, Black drangos, Crows, Sparrows are sighted here. Pea fowls are very common near the Reserve forest areas. Butterflies and dragonflies are fairly common near herbs and flowering shrubs.

Ecology of study area Habitat The buffer zone habitat from 5 sq. km radius of the project site to 10 sq km. Chityal RF at a distance of 6.0 km in east direction, Shivanenigudem RF at a distance of 9.0 km in

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northeast direction project site. This area is having few shrubs having xerophytic adaptation. Most of the region is barren and rocky. Hence vegetative survey mainly conducted on herbs and shrubs. The floral quantification has been done in Chityal RF at a distance of 6.0 km in east direction, Shivanenigudem RF at a distance of 9.0 km in northeast direction where quadrate method can be adopted. There are no endangered and endemic plants present in the buffer and core zones. There are no medicinal, timber / fuel wood, fodder and other socio-economic purposes. The vegetation at Non forest areas and RF’s were analyzed statistically at various points and recorded the diversity and density of individuals.

The faunal composition was also estimated based on the direct and indirect evidences. Tectona grandis, Cocos nucifera. Phoenix aculis, Borassus flabellifer, Azadirachta indica, Prosopis spicegera, Ficus sp, Acacia sp, Tribulus terrstris, Achyranthes aspera, Balanites aegyptiaca, Opuntia, are mainly restricted to waste and cultivable waste lands ands. Albizia procera, Albizia lebbeck, Delonix regia, Azadirachta indica, Peltoforum sp., Terminalia catappa, Psidium guava, Dalbergia sissoo and Tamarindus indica are predominant near villages.

Uncultivated Food Plant Uncultivated food-plants in the area include: Amarantus spinosus (tender shoots, leaves), Annona squamosa (fruits), Mangifera indica (fruits), Moringa oleifera (leaves, flowers, pods), Phoenix sylvestris (sap, pith, fruits), Pithecolobium dulce (fruits), Syzigium cumini (fruits), Tamarindus indica (tender leaves, fruits), Zizyphus mauritiana & Z. oenoplia (fruits).

Medicinal Plants Medicinal Plants in the area comprises of Achyranthes aspera (roots, seeds), Alternanthera sessilis (plant), Azadirachta indica (leaves, seeds), Calotropis gigantea (latex), Tridax procumbance (leaves), Euphorbia hirta (plant), Leucas aspera (leaves), Melia azedarach (leaves, seeds), Pongamia pinnata (seeds), Sida acuta (roots, leaves), Solanum surratense (roots), Typha angustata (seed-fibre), Vernonia cinerea (roots, leaves, seeds), Vitex negundo (leaves).

Quantitative analysis The study area is mainly focused through secondary data validation from primary observations. Checklist is prepared and marked the species noticed during rapid

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assessment. 10 sampling points are finalized through Area-Species graph. And the quantitative analysis done based on the methodology adopted for various species.

The habit wise and ecosystem wise status of various floral species observed are given here graphically.

Figure 3.18 ecosystem wise status of various floral species

Fauna Throughout the study area, there no direct evidence of wild animal species observed. From the secondary source (local people near villages) it is also revealed that presence of common snakes exists here. Common bird species such as Paddy egrets, Green bee eaters, Indian rollers, Parakeets, common babblers, Weaver birds, Mynas, Black drangos, Crows, Sparrows are sighted here.

Endemic, Threatened and Endangered Species From the present survey it appears that none of the terrestrial species are under endangered and threatened species, and not listed in the Schedule I of the Indian Wildlife (Protection) Act, 1972 as amended in 1991.

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Table 3.19 List of Plant Species Recorded S.No. Botanical Name Common name Family Habit Status 1 Acacia auriculiformis Australia thumma Mimosaceae Tree Dominant 2 Acacia chundra* Mimosaceae Tree Sparse 3 Acacia leucophloea Thella thumma Mimosaceae Tree Sparse 4 Acacia nilotica Nalla tumma Mimosaceae Tree Common 5 Albizia amara* Konda sigara Leguminosae Tree Common 6 Annona squamosa Sithaphalam Annonaceae Tree Common 7 Azadirachta indica Vepa Meliaceae Tree Dominant 8 Balanites aegyptiaca Adavi velaga Zygophyllaceae Tree Dominant 9 Bauhinia purpurea* Kanchana u Leguminosaae Tree Dominant 10 Bauhinia racemosa* Are Caesalpiniaceae Tree Sparse 11 Bauhinia variagata* Mandari Caesalpiniaceae Tree Sparse 12 Borassus flabellifer Taati / Taadi Palmae Tree Common 13 Butea frondosa * Moduga Leguminosae Tree common 14 Cassia siamea Seema tangedu Leguminosae Tree Common 15 Ceiba pentandra Malvaceae Tree Sparse 16 Chukrasia tabularis Konda vepa Meliaceae Tree Rare 17 Cocos nucifera Coconut Araceae Tree Common 18 Dalbergia sissoo Sisso or seesum Caesalpiniaceae Tree Dominant 19 Decalepis hahiltonii Maredu kommulu Periplocaceae Tree Rare 20 Delonix regia Chittikesaram Leguminosae Tree Common 21 Dendrocalamus strictus* Sanna vedru Graminae Tree Sparse 22 Eucalyptus globulus Neelagiri Myrtaceae Tree Common 23 Ficus benghalensis Marri Moraceae Tree Dominant 24 Ficus hispida Bommedu Moraceae Tree Common 25 Ficus microcape Moraceae Tree Dominant 26 Ficus racemosa Medi Moraceae Tree Dominant 27 Ficus religiosa Raavi Moraceae Tree Dominant 28 Leucaena leucocephala Subabul Mimosaceae Tree Dominant 29 Limonia acidissima* Velaga Rutaceae Tree Rare 30 Mangifera indica Mamidi Anacardiaceae Tree Common 31 Morinda tinctoria Thogaru Rubiaceae Tree Common 32 Nerium odoratum Ganneru Apocynaceae Tree Dominant 33 Peltophorum pterocarpum Kondachinta Leguminosae Tree Dominant 34 Phoenix sylvestris Eetha Araceae Tree Dominant 35 Phyllanthus emblica Usiri Euphorbiaceae Tree Common 36 Pithecellobium dulce Seema chinta Mimosaceae Tree Dominant 37 Plumeria rubra Erra devaganneru Apocynaceae Tree Sparse 38 Polyalthia longifolia Ashoka Annonaceae Tree Dominant 39 Polyalthia pendula Asoka Annonaceae Tree Sparse 40 Pongamia pinnata Ganuga Fabaceae Tree Dominant 41 Prosopis juliflora English tumma Mimosaceae Tree Common 42 Randia uliginosa Nalla manga Rubiaceae Tree Sparse 43 Samanea saman Nidrabhangi Mimosaceae Tree Sparse 44 Syzygium cumini Neradu Myrtaceae Tree Sparse 45 Tamarindus indica Chinta Leguminosae Tree Common 46 Tecoma stans Patcha turai Bignoniaceae Tree Dominant 47 Tectona grandis Teak Verbenaceae Tree Dominant 48 Terminalia bellirica Tani Combretaceae Tree Rare

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S.No. Botanical Name Common name Family Habit Status 49 Thespecia populnea Ganga Raavi Malvaceae Tree Dominant 50 Thevetia neriifolia Pacha ganneru Apocynaceae Tree Rare 51 Trema orientalis Boggu chettu Ulmaceae Tree Rare 52 Vitex negundo* Vaavili Verbenaceae Tree Sparse 53 Wrightia tinctoria Akupala, Tellapala Apocynaceae Tree Sparse 54 Ziziphus jujube Regu Rhamnaceae Tree Sparse 55 Ziziphus mauritiana Regu Rhamnaceae Tree Common 56 Agave americana Gitta nara Asparagaceae Shrub Rare 57 Aloe vera Kithanara Tiliaceae Shrub Sparse 58 Caesalpinia bonducella Caesalpinaceae Shrub Sparse 59 Calotropis gigantea Tella Jilledu Asclepiadaceae Shrub Dominant 60 Cassia auriculata Leguminosae Shrub Dominant 61 Dodonaea viscose* Bandedu Sapindaceae Shrub Common 62 Erythroxylon monogynum Dedaraaku Erythroxylaceae Shrub Common 63 Euphorbia cactus Jemudu Euphorbiaceae Shrub Common 64 Grewia hirsuta Jana Tiliaceae Shrub Common 65 Ipomoea carnea Rubber mokka Convolvulaceae Shrub Common 66 Ixora coccinea Ramabanam Rubiaceae Shrub Common 67 Jatropha glandulifera Yerranepalamu Euphorbiaceae Shrub Common 68 Lantana camara Lantana Verbenaceae Shrub Common 69 Opuntia elatior Nagamullu Cactaceae Shrub Common 70 Phoenix acaulis Chitteetha Palmae Shrub Sparse 71 Plumbago zeylanica* Chitramulam Plumbaginaceae Shrub Common 72 Randia dumetorum Rubiaceae Shrub Common 73 Xanthium strumarium Marula-Mathangi Asteraceae Shrub Sparse 74 Ipomoea aquatica Thooti Koora Convolvulaceae Hydrophyte Common 75 Typha angustata Jammu Typhaceae Hydrophyte Common 76 Abutilon indicum Thuthuru Benda Malvaceae Herb Dominant 77 Acalypha indica Euphorbiaceae Herb Common 78 Achyranthes aspera Uttareni Amaranthaceae Herb Dominant 79 Aerva lanata Konda Pindi Amaranthaceae Herb Common 80 Ageratum conyzoides Vasavi Asteraceae Herb Common 81 Alternanthera sessilis Ponaganti kura Amaranthaceae Herb Dominant 82 Amaranthus spinosus* Mulla thotakoora Amaranthaceae Herb Common 83 Amaranthus viridis Chilakathotakoora Amaranthaceae Herb Sparse 84 Andrographis echioides Chalavala puri Acanthaceae Herb Common kada 85 Argemone mexicana Bhrama dandi Papaveraceae Herb Common 86 Asparagus racemosus* Pilliteegalu Asperagaceae Herb Sparse 87 Barleria prionitis Acanthaceae Herb Sparse 88 Blumea mollis* Kukkapogaku Asteraceae Herb Sparse 89 Boerhavia diffusa Atukamaamidi Nyctaginaceae Herb Common 90 Boerhavia erecta Nyctaginaceae Herb Common 91 Cassia occidentalis Adavi Chennangi Leguminosae Herb Dominant 92 Cassia tora Tagarisa Caesalpiniaceae Herb Dominant 93 Catharanthus roseus Billaganneru Apocynaceae Herb Common 94 Cleome gynandra* African cabbage Cleomaceae Herb Sparse 95 Cleome viscosa Yerri Vaminta Cleomaceae Herb Sparse 96 Colocasia esculenta Atuka tiga Araceae Herb Sparse

3-54 Team Labs and Consultants ActeroPharma Pvt.Ltd Environmental Impact Assessment Report

S.No. Botanical Name Common name Family Habit Status 97 Indigofera tinctoria Leguminosae Herb Common 98 Crotalaria retusa Leguminosae Herb Sparse 99 Crotan bonplantianum Bhu thulasi Euphorbiacea Herb Common 100 Cynodon dactylon Garika Poaceae Herb Sparse 101 Cyperus castaneus Poaceae Herb Common 102 Datura stramonium * Tella Ummetta Solanaceae Herb Common 103 Dioscorea oppositifolia Adda dumpa Dioscoreaceae Herb Sparse 104 Eclipta alba Gunta galijru Asteraceae Herb Common 105 Euphorbia antiquorum * Bontha Jemudu Euphorbiaceae Herb Common 106 Euphorbia hirta Nanubalu Euphorbiaceae Herb Common 107 Euphorbia tirucalli* Tirucalli Euphorbiaceae Herb Common 108 Hyptis suaveolens Maha beera Lamiaceae Herb Common 109 Leucas aspera Tummi Lamiaceae Herb Common 110 Leucas cephalotes Thummi Lamiaceae Herb Common 111 Mimosa pudica * Atthi pathi Leguminosae Herb Dominant 112 Oldenlandia umbellata Chiru veru Rubiaceae Herb Common 113 Oxalis corniculata Indian Sorrel Oxalidaceae Herb Common 114 Parthenium hysterophorus Congress Grass Asteraceae Herb Dominant 115 Pavonia zeylanica* Karubenda Malvaceae Herb Common 116 Phyllanthus amanus* Nela Usiri Euphorbiaceae Herb Common 117 Physalis minima Budda bhushada Solanaceae Herb Rare 118 Sida acuta Bala Malvaceae Herb Sparse 119 Sida cordata Bala Malvaceae Herb Common 120 Solanum surattense Nela Vakudu Solanaceae Herb Common 121 Sphaeranthus indicus* Bodasaramu Asteraceae Herb Common 122 Tephrosia purpurea Vempala Leguminosae Herb Dominant 123 Tridax procumbens Asteraceae Herb Dominant 124 Tribulus terrestris Zygophyllaceae Herb Dominant 125 Triumfetta rhomboidea Marla Benda Taccaceae Herb Common 126 Urena lobata Pedda benda Malvaceae Herb Common 127 Vanda tessellata Kodikalla chettu Orchidaceae Herb Sparse 128 Vernonia cinerea* Sahadevi Asteraceae Herb Common 129 Ziziphus nummularia Nela regu Rhamnaceae Herb Dominant 130 Cymbopogon citratus Poaceae Grass Rare 131 Cyperus flavidus* Cyperaceae Grass Common 132 Cyperus rotundus Cyperaceae Grass Common 133 Digitaria ciliaris Poaceae Grass Common 134 Zizania latifolia Poaceae Grass Common 135 Abrus precatorius Guriginja Leguminosae Climber Common 136 Acacia caesia Kirintha Mimosaceae Climber Common 137 Cardiospermum halicacabum Sapindaceae Climber Rare 138 Cissus quadrangularis Nalleru Vitaceae Climber Sparse 139 Clitoria ternatea* Sanku-Pushpamu Leguminosae Climber Sparse 140 Coccinia grandis Cucurbitaceae Climber Common 141 Daemia extensa Asclepidaceae Climber Sparse 142 Desmodium triflorum* Munta Mandu Leguminosae Climber Common 143 Dioscorea hispida* Dioscoreaceae Climber Rare 144 Dioscorea pentaphylla Adavi Dioscoreaceae Climber Common gunusuthega

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S.No. Botanical Name Common name Family Habit Status 145 Evolvulous alsinoides Vishnukrantha Convolvulaceae Climber Common 146 Hemidesmus indicus Sugandhipala Asclepiadaceae Climber Common 147 Ipomoea macrantha* Convolvulaceae Climber Common 148 Ipomoea nil Convolvulaceae Climber Common 149 Ipomoea obscura* Macha aku Convolvulaceae Climber Rare 150 Tinospora cordifolia* Tippa tiga Menispermaceae Climber Rare (* indicates Secondary data) Table 3.20 List of Fauna Scientific Name Common Name Family I - WPA Funambulus Three striped palm Sciuridae palmarum squirrel* Bendicota bengalensis Indian mole rat Muridae Bendicota indica Bandicoot rat Muridae Mus booduga Little Indian Field mouse Muridae Mus musculus House Mouse Muridae Rattus rattus House rat Muridae Herpestes javanicus Common Indian Herpestidae Mongoose Schedule II Part II (* indicates Pirmary data)

Table 3.21 List of AVES either spotted or reported or recorded Scientific name Common Name Family IWLP Elanus caeruleus Black Shouldered Accipitridae IV Haliastur indus Brahminy Kite Accipitridae IV Milvus migrans Black kite* Accipitridae IV Acrocephalus agricola Paddy field Acrocephalidae IV Apus affinis House Swift* Apodidae IV Cypsiurus balasiensis Asian Palm Swift Apodidae IV Ardeola grayii Pond Heron* Ardeidae IV Bubulcus ibis Cattle Egret* Ardeidae IV Egretta garzetta Little Egret* Ardeidae IV Ceryle rudis Pied Kingfisher* Cerylidae IV Charadrius hiaticula Ringed Plover Charadriidae IV Vanellus indicus Red wattled Charadriidae IV Cisticola juncidis Streaked Fantail Cisticolidae IV Streptopelia orientalis Spoted dove* Columbidae IV Streptopelia turtur Turtle Doves Columbidae IV Coraciiformesas benghalensis Indian Roller* Coraciiformesidae IV Corovus macrorhynchos Jungle Crow* Corvidae IV Dendrocitta formosae Grey Treepie Corvidae IV Centropus sinensis Crow Pheasant Cuculidae IV Eudynamys scolopacea Asian Koel Cuculidae IV Dicrurus macrocercus Black Drongo* Dicruridae IV Euodice malabarica White Throated Estrildidae IV Lonchura atricapilla Black Headed Estrildidae IV Lonchura punctulata Spotted Munia* Estrildidae IV

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Merops orientalis Small Bee eater* Meropidae IV Nyctyornis athertoni Blue tailed Bee Meropidae IV Saxicoloides fulicata Indian Robin* Muscicapidae IV Cinnyris asiaticus Purple Sunbird* Nectariniidae IV leptocoma zeylonica Purple Rumped Nectariniidae IV Passer domesticus House Sparrow* Passeridae IV Phalacrocorax niger Little Cormorant* Phalacrocorax IV Francolinus pondicerianus Grey Patridge Phasianidae IV Psittacula eupatria Alexandrine Psittacidae IV Psittacula krameri Rose ringed Psittacidae IV Pycnonotus cafer Red Vented Bulbul Pycnonotidae IV Acridotheres tristis Common Myna* Sturnidae IV Gracupica contra Asian Pied starling Sturnidae IV Turdoides caudata Common Babbler* Timaliidae IV (* indicates Pirmary data)

Table 3.22 List of Reptiles either spotted or reported S. No. Scientific Name Common Name IUCN IWPA 1. Ahaetulla nasutus Green whip snake LC 2. Ptyas mucosus Common Rat snake LC II 3. Amphiesma stolata Buffstriped keelback LC 4. Trimeresurus gramineus Green pit viper LC IV 5. Typhlops hypomethes Common blind snake LC IV 6. Enhydris enhydris Common Water Snake LC 7. Mabuya carinata Common Skink* LC 8. Calotes rouxi Forest Calottes* LC 9. Calotes versicolor Common garden LC 10. Hemimidactylus brooki House gecko* LC 11. Hemidactylus forenatus Southern House Gecko LC (* indicates Pirmary data)

Table 3.23 List of Amphibians either spotted or reported from the study area. S. No. Scientific Name Common Name IUCN IWPA 1. Bufo melanosticus Common toad * LC Sch-IV 2. Rana hexadactyla Commn green frog LC Sch-IV 3. Rana leptodactyla Small forg LC Sch-IV 4. Rana tigrina Bullfrog* LC Sch-IV 5. Rhacophorus maculatus Common Tree Frog LC Sch-IV LC means Least Concern

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CHAPTER 4.0 ANTICIPATED ENVIRONMENTAL IMPACTS

4.1 Identification of Impacts Identification of Impacts is one of the basic analytical steps of EIA for subsequent prediction and evaluation of impacts. Impact is a change in baseline due to interaction of a development activity with environment, or interaction of environment with development activity, or change in baseline due to a man made emergency. The impacts were assessed for construction stage, operation stage and emergency cases. Initially the assessment was done to identify impacts due to the proposed development activity using net work method which mainly follows cause condition and effect relationship. The interaction of project activity on the environment was assessed by posing questions related to each aspect of project activity envisaged as part of expanding the plant. The proposed API manufacturing site is adjacent to the proposed expansion of sister company M/s. Dasami Lab Pvt. Ltd and proposed expansion of the group company M/s. Hindys Lab Pvt. Ltd., which is located about 1.6 km away from the site was also considered for air quality impact predictions to assess cumulative impact.

4.1.1 Impact Networks The purpose of identifying the impacts is that it aids in making appropriate decision to mitigate the adverse consequences if any. It may be pointed out that the distinction between magnitude and importance of impact should be appreciated. Thus the degree of extensiveness and scale of impacts and the consequences based on value judgments are generalized while identifying impacts; as it is imperative that the impact will normally lead to a chain of reactions. The construction of network charts brings out to certain extent the appropriate levels of risks that may occur due to the interventions while interacting with hydrological, biological and social systems. Figure 4.1 to 4.6 present the identified impacts for various components of environment viz. air, noise, water, land and socio economic aspects. In the above-mentioned Figure the lines mean - - "has an effect on."

4-1 Team Labs and Consultants Actero Pharma Pvt. Ltd Environmental Impact Assessment Report

on

Faunal

Socio Heat

and of

on

Climatic Changes Impacts Environment

Flora Release Impacts Cultural

Soil,

on

on

Land

Environment

Impacts Agricultural Air

Water, Particulates For Deposition

Project

on Network

Visibility Impacts Impacts Aesthetic Impacts 4.1

Pollutants

Fig in Air

on

on

Output

of Health

Quality

Change Air Impacts Impacts Human Release Economic

Tertiary Impacts Impacts Primary Impacts Secondary

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Socio

Birds,

on of

Environment Population

Impacts Cultural Migration Reptiles Level

Environment

Noise

Output

Noise

Emission

For Work

Project

Ambient Efficiency

on

Noise in

and Network

Impacts Change Impacts

4.2

Fig on

Output Risks

Primary Impacts Impacts Health Economic Impacts Secondary Tertiary Impacts

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Fauna

Dynamics

and

in

Health Community Flora Shift Water

Quality

Water

of of

its

Economic &

Land Crops Imbalances Ground Wastewater

Pattern Socio Fertility Tables Direct For

Impacts Ecosystem

Flora

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of

of to

Aquatic Water

Bodies

Fauna

of Water

and in Group

Project

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in

of

Resources Deleterious Identification from Shift Change Water Population 4.3

Water Effects Fig

of

existing

Soil

Group to

Organisms Direct

in

community in

Texture Shift plant Ecological Desired Imbalances Injurious Change Ecosystem

Land

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Water

Land and

Live

Land on

on Deposition

Flora Land on Waste

Socio Stock

on on of

Fauna

on

Impacts Sludge Environment

Substances Particulate Impact Disposal Impacts Cultural

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in

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Impacts 4.4

of

Fig on

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Output on

in

Land Impacts Texture Landscape Impacts Permeability Change Disturbance Economic

Tertiary Impacts Primary Impacts Impacts Secondary

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Flora Sensitive

Waste

PH

Micro Solid Other Fauna

Matter

and

Flora Organic

Productivity

Biota of

and

Micro

Soil

Soil Matrix

Fertility Project

Acidification Native Nitrifying

For Soil

Wastewater Soil

Soil Mineralization

in

Affect Network

Reduction Impacts Decomposition 4.5

Fixing

Fig Emission

Air Nitrogen

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Risk Aesthetic

for

Facilities Demand Infrastructure

Facilities

and Human

on

Health for

Effect Building

Recreational on

Materials, Facilities Monuments Demand

Effect Communication

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Savings Income

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4-7 Team Labs and Consultants Actero Pharma Pvt. Ltd Environmental Impact Assessment Report

4.2 Prediction of Impacts The identified impacts are assessed by posing questions related each activity of proposed project and their interaction with environment. The statutory limits of ambient air quality, noise, emissions and discharges as mandated by the MoEF&CC was considered to classify the quantifiable impacts as acceptable or not acceptable. However there are few impacts that cannot be quantified, which need to be qualitatively assessed. There are a number of methods for qualitatively assessing the impacts to arrive at the significance of impact. The qualitative assessment of impacts require characterization with respect to its magnitude, geographic extent, duration, frequency, reversibility, probability of occurrence, confidence rating and impact rating. The manual published by MOEF&CC prescribes the following process for determining the significance of impact; first, an impact is qualified as being either negative or positive. Second, the nature of impacts such as direct, indirect, or cumulative is determined using the impact network. Third, a scale is used to determine the severity of the effect; for example, an impact is of low, medium, or high significance. Accordingly it was proposed to quantify the impacts which are a direct result of the activities contingent on availability of reliable prediction tools. In case the quantification is not feasible, a subjective assessment of the impact significance being low, medium or high was proposed.

4.2.1 Air Environment The sources of air pollution in the proposed activity are utility emissions, process emission, emissions from pollution control facilities, storages. The direct impact of utility emissions consisting of particulate matter, sulfur dioxide, and oxides of nitrogen results in change in criteria air contaminants in ambient air quality. The process emissions and other emissions are toxic and may result in change in health of the receptors both flora, and fauna including humans. The adoption of adequate mitigation measures shall reduce the impact to low levels. The storage of chlorinated solvents may also lead to diffuse emissions unless adequate mitigation measures like breather valves, double lined storage and condensers are adopted. All these emissions impact air quality negatively, resulting in health impacts indirectly. These impacts have medium significance in case mitigation measures are in place, and shall have high significance in

4-8 Team Labs and Consultants Actero Pharma Pvt. Ltd Environmental Impact Assessment Report case of anthropogenic and natural emergencies as well as in case no mitigation measures are proposed. The change in ambient air quality due to the utility emissions of proposed green field project of the sister company M/s. Actero Pharma Pvt. Ltd., and the proposed expansion of the sister company M/s. Hindys Lab Pvt. Ltd., located at a distance of 1.6 km from the present site were considered for prediction by using air quality impact prediction model. The impacts due to the proposed project shall be felt mainly within the plant area and the immediate surroundings as the utilities shall have air pollution control equipment.

4.2.1.1 Details of Mathematical Modeling A large number of different mathematical models for dispersion calculations are in practice in many parts of the world. Most of the models for prediction of downwind concentrations are based on Gaussian dispersion. The principle behind the Gaussian dispersion models is Gaussian probability distribution of concentration in both vertical and horizontal cross wind directions about the plume central line.

Predictions of ground level concentrations of the pollutants were carried out based on site meteorological data collected during the study period. For calculation of predicted ground level concentrations, ISCST3 model of Lakes Environmental based on USEPA, ISCST3 algorithms, was used; as it’s based on more sophisticated algorithm incorporating deposition, better algorithm for area sources, etc.

Brief History of the ISC Models The ISC3 models are based on revisions to the algorithms contained in the ISC2 models. The latter came about as a result of a major effort to restructure and reprogram the ISC models that began in April 1989, and was completed in March 1992. The reprogramming effort was largely motivated by the need to improve the quality, reliability, and maintainability of the code when numerous "bugs" were discovered after the implementation of the revised downwash algorithms for shorter stacks. However, the goals of the reprogramming effort also included improving the user interface by modifying the input file structure and the output products.

4-9 Team Labs and Consultants Actero Pharma Pvt. Ltd Environmental Impact Assessment Report

Overview of New Features in the ISC3 Models The ISC3 models include several new features. A revised area source algorithm and revised dry deposition algorithm have been incorporated in the models. The ISC3 models also include an algorithm for modeling impacts of particulate emissions from open pit sources, such as surface coal mines. The Short Term model includes a new wet deposition algorithm, and also incorporates the COMPLEX1 screening model algorithms for use with complex and intermediate terrain. When both simple and complex terrain algorithms are included in a Short Term model run, the model will select the higher impact from the two algorithms on an hour-by-hour, source-by-source, and receptor by- receptor basis for receptors located on intermediate terrain, i.e., terrain located between the release height and the plume height.

Some of the model input options have changed and newer input options have been added as a result of the new features contained in the ISC3 models. The source deposition parameters have changed somewhat with the new dry deposition algorithm, and there are new source parameters needed for the wet deposition algorithm in the Short Term model. There are also new meteorology input requirements for use of the new deposition algorithms. The option for specifying elevation units has been extended to source elevations and terrain grid elevations, in addition to receptor elevations.

The utility programs, STOLDNEW, BINTOASC, and METLIST have not been updated. While they may continue to be used as before, they are not applicable to the new deposition algorithms in the ISC3 models. The salient features of the ISCST3 model are presented below in Table 4.1. Table 4.1 Salient Features of the ISCST3 Model S.No Item Details 1 Model name ISCST3 (Based on USEPA algorithm) 2 Source Types Point, Area, Volume, Open Pits 3 Dispersion Equation Steady State Gaussian Plume Equation 4 Diffusion Parameters Pasquill Gifford Co-efficient 5 Plume Rise Briggs Equation 6 Time Average 1 hr to Annual/Period Has Short Term and Long Term modeling options 7 Deposition Both Dry and Wet Deposition 8 Application Input Data: (i) Source Data Stack co-ordinates (ii) Receptor Data Grid interval, number of receptors, receptor elevations

4-10 Team Labs and Consultants Actero Pharma Pvt. Ltd Environmental Impact Assessment Report

(iii) Meteorological Hourly meteorological data i.e. wind speed, direction, Data ambient temperature, stability and mixing heights

Model Formulation The model uses the following steady state Gaussian plume equation. The basic equation for calculating the concentration of pollutants for any point in x, y, z co- ordinates is given below:

2 2 C(x,y,z,H) = Q/2π σy σz U exp[-1/2(y/σy) ] x [exp{-1/2(z-h/σz) } 2 + exp{-1/2 (z+H/σz) }] Where C= Concentration of pollutants in mg/cu m Q= Strength of emissions in g/sec. H= Effective Height (m), i.e., physical height + plume raise y, z= diffusion coefficients in y and z directions in m. U= average wind velocity in m/sec. The following assumptions are made in Gaussian dispersion model.

This model assumes no diffusion in the down wind direction and thus applicable to a plume and not a puff of pollutant. The dispersion parameter values used for horizontal dispersion coefficient and vertical dispersion coefficients are those given in the “Work book of atmospheric dispersion estimates”. These dispersion coefficients assume a sampling time of about 10 min., the height values of interest to be in the lowest several hundred meters of the atmosphere, a surface corresponding to the open country. The stacks are tall enough to be free from building turbulence so that no aerodynamic down wash occurs. The given stability exists from ground level to well above the top of the plume.

The Gaussian dispersion model has been tested extensively for its validity and found to be reasonably applicable for different atmospheric conditions. BIS has also adopted this basic plume dispersion model. Hence the same model is adopted for predictions of downwind concentrations of pollutants in this report.

Meteorological Data Data recorded by the weather monitoring station at site on wind speed, direction, solar isolation, temperature and cloud cover at one hourly interval for three months i.e. One full season has been used for computations.

4-11 Team Labs and Consultants Actero Pharma Pvt. Ltd Environmental Impact Assessment Report

Mixing Height The mixing heights for ambient air quality predictions are adopted from Atlas of Hourly Mixing Height and Assimilative Capacity of Atmosphere in India by S.D Attri, Siddartha Singh, B. Mukhopadhya and A.K Bhatnagar, Published by Indian Metrological Department, New Delhi. 2008. The mixing heights range from 300 to 1450 m during summer season. There is no record of inversion for this area (Reference: Atlas of Hourly Mixing Height and Assimilative Capacity of Atmosphere in India by S.D Attri, Siddartha Singh, B. Mukhopadhya and A.K Bhatnagar, Published By Indian Metrological Department, New Delhi. 2008). There is no record of inversion in this area as observed from the IMD data.

4.2.1.2 Utility Emissions The sources of air pollution from proposed projects are Boilers and DG sets. The major

pollutants generated from the fuel combustion are SO2, NOx and Particulate Matter. Based on fuel analysis and combustion details the emission rates of above pollutants are

calculated. The emission rates of SO2, NOx and Particulate Matter from each stack are presented in Table 4.2. Table 4.2 Emission Details of Pollutants from Stack Stack Connected to Stack Diameter Temp. of Exit Pollutant Emission Ht, m of stack exhaust Velocity, Rate, g/sec at top, m gases, 0C m/sec PM SO NO 2 x Actero Pharma Pvt. Ltd. Proposed 2 x 8 TPH CFB 30 0.9 130 6.05 0.6 0.7 0.25 1 x 1500 kVA DG set 12 0.2 180 10 0.02 0.03 0.5 2 x 1000 kVA DG sets 7 0.2 170 10 0.09 0.25 0.38 Dasami Lab Pvt Ltd Existing 1 x 5TPH CFB 30 1.3 180 8 0.5 0.87 1.2 1 x 3800KVA DG Set* 4 0.1 200 10 0.19 0.14 0.27 Proposed 2 x 10 TPH CFB 35 1.5 180 10 0.85 1.8 2.1 3 x 1000KVA DG set* 10 0.15 150 12.5 0.01 0.02 0.03 Hindys Lab Pvt Ltd. Existing 1 x 2 TPH CFB 15 1 180 4.5 0.11 0.4 0.45 1 x 250 kVA DG Set* 3 0.1 200 10 0.028 0.09 0.18 Proposed 2 x 8 TPH CFB 30 0.9 130 6.05 0.6 0.7 0.25 1 x 1500 kVA DG set* 12 0.2 180 10 0.02 0.03 0.5

4-12 Team Labs and Consultants Actero Pharma Pvt. Ltd Environmental Impact Assessment Report

2 x 1000 kVA DG set* 7 0.2 170 10 0.09 0.25 0.38 3 x 500 kVA DG set* 5 0.2 200 6.8 0.002 0.025 0.04 CFB - Coal Fired Boilers *DG sets will be used during load shut down by TSPDCL.

Effective stack height calculation for proposed 10 TPH and 8 TPH Coal Fired Boiler On SPM Basis - Coal Fired Boiler Boiler Capacity TPH 10.0 8.0 Coal Consumption Kg/hr 1860 1488 Coal Consumption TPD 44.64 35.71 Ash Generation @ 45% of coal consumption TPH 0.84 0.67 Fly ash (5% of total Ash) TPH 0.04 0.03 Stack Height Calculated (SPM) H= 74*(Q0.27) m 31.4 29.6

On SO2 Basis - Coal Fired Boiler Sulphur Content in Coal % (by wt. Max.) 0.45% 0.45% Coal Consumption TPD 44.64 35.71 Coal Consumption Kg/hr 1860 1488 SO2 Emission Rate Kg/hr 16.74 13.39 SO2 Emission Rate gms/Sec 4.65 3.72 0.3 Stack Height Calculated (SO2) H= 14*(Q ) m 32.6 30.5 Hence it is proposed to provide a 35 m height stack for the 10 TPH coal fired boiler and 30 m height stack for the 8 TPH coal fired boiler

4.2.1.3 Air Quality Predictions (Terms of Reference No. 7(i)) Predictions of ground level concentrations of the pollutants were carried out based on site meteorological data collected during the study period. For calculation of ground level concentrations a grid of 10 km X 10 km with a receptor interval of 400 meters is considered.

The composition of particulate matter was obtained from USEPA AIRCHIEF AP-42 and the same was considered in determining the source concentration of PM10 and

PM2.5 for prediction purpose. The predicted maximum 24 hourly ground level concentrations of Suspended Particulate Matter, PM10, PM2.5, SO2 and NOx and distance of occurrence during different seasons of study period are presented in Table 4.3.

It may be observed that the annual predicted maximum 24 hourly GLC’s of PM, PM10,

3 PM2.5, SO2 and NOx are 6.05, 1.74, 1.17, 8.38 and 9.26μg/m respectively and the maximum values are observed at a distance of 1.8 km in northwest direction.

However it may be noted that the predicted values of the SO2 and NOx are based on

4-13 Team Labs and Consultants Actero Pharma Pvt. Ltd Environmental Impact Assessment Report the assumption that the DG sets are used constantly, where as the DG set usage is only during load shut down from TRANSCO.

The GLC’s are also predicted at air quality monitoring locations and the predicted GLC’s are presented in Tables 4.4 and the cumulative concentrations at various villages are tabulated in Table 4.5. It may be observed from the table that the predicted results show that the incremental rise over existing base line status of ambient air quality is within the limits prescribed by National Ambient Air Quality standards (NAAQ), and hence the impact due to the proposed project is low on ambient air quality. Hence the control measures and height of stack is sufficient to disperse the pollutants into the atmosphere and keeping the baseline levels within the prescribed limits. The predicted ground level concentrations are graphically displayed for SPM, PM10, PM2.5, SO2, and NOx respectively in Figure 4.7 – 4.11.

Table 4.3 Maximum Predicted 24 hourly GLC’s S.No Parameter Predicted GLC, μg/m3 Distance, km Direction 1 SPM 6.05 1.8 NW 2 PM10 1.74 1.8 NW 3 PM2.5 1.17 1.8 NW 4 SO2 8.38 1.8 NW 5 NOX 9.26 1.8 NW

Table 4.4 Predicted GLC’s at Monitoring Locations Monitoring Distance, Predicted GLC, μg/m3 S.No Direction Location Km SPM PM10 PM2.5 SO2 NOx 1 Hindys Lab Pvt. Ltd. W 1.6 2.100 0.840 0.378 2.436 3.100 2 Pittampalli SW 2.2 0.192 0.077 0.035 0.223 0.283 3 Bongonicheruvu SW 3.2 0.173 0.069 0.031 0.201 0.255 4 Velminedu NW 2.7 0.387 0.155 0.070 0.449 0.571 5 Aregudem SE 2.5 0.264 0.106 0.048 0.306 0.390 6 Pedda Kaparti NE 3.1 0.506 0.202 0.091 0.587 0.747 7 Morsugudem SE 3.2 0.283 0.113 0.051 0.328 0.418 8 Gudempalli NW 6.2 0.103 0.041 0.019 0.119 0.152 Reserved Forest 1 Chityal RF E 6.0 0.451 0.181 0.081 0.524 0.666 2 Shivanenigudem RF NE 9.0 0.072 0.029 0.013 0.083 0.106

4-14 Team Labs and Consultants Actero Pharma Pvt. Ltd Environmental Impact Assessment Report

Table 4.5 Cumulative Concentrations at Various Villages and Reserved Forests Baseline Cumulative Distance, Predicted GLC, μg/m3 Station Concentration, μg/m3 Concentration, μg/m3 km PM10 PM2.5 SO2 NOx PM10 PM2.5 SO2 NOx PM10 PM2.5 SO2 NOx Hindys Lab Pvt. Ltd. 1.6 54 23 12 12 1.16 0.52 3.36 4.28 55.16 23.52 15.36 16.28 Pittampalli 2.2 49 14 11 11 0.08 0.03 0.22 0.28 49.08 14.03 11.22 11.28 Bongonicheruvu 3.2 47 14 11 11 0.07 0.03 0.20 0.26 47.07 14.03 11.20 11.26 Velminedu 2.6 46 17 11 11 0.15 0.07 0.45 0.57 46.15 17.07 11.45 11.57 Aregudem 2.4 44 18 10 11 0.11 0.05 0.31 0.39 44.11 18.05 10.31 11.39 Pedda Kaparti 3.1 48 18 10 11 0.20 0.09 0.59 0.75 48.20 18.09 10.59 11.75 Morsugudem 3.2 48 18 12 12 0.11 0.05 0.33 0.42 48.11 18.05 12.33 12.42 Kommaiguda 6.1 46 17 12 12 0.04 0.02 0.12 0.15 46.04 17.02 12.12 12.15 Reserved Forest Chityal RF 6.0 - - - - 0.18 0.08 0.52 0.67 0.18 0.08 0.52 0.67 Shivanenigudem RF 9.0 - - - - 0.03 0.01 0.08 0.11 0.03 0.01 0.08 0.11

4-15 Team Labs and Consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

PROJECT TITLE:

2 .39

2.39 2.39 2.39 3.60 2.39 54 23 2 2.3 1NPOL1 . 9 3 9

2.39 -8000 -6000 -4000 -2000 0 2000 4000 6000 8000

-10000 -8000 -6000 -4000 -2000 0 2000 4000 6000 8000 10000

PLOT FILE OF HIGH 1ST HIGH 24-HR VALUES FOR SOURCE GROUP: ALL ug/m^3

2.387 3.598 5.054 6.510

COMMENTS: SOURCES: COMPANY NAME:

5 M/s.Actero Pharma Pvt. Ltd

RECEPTORS: MODELER: WIND ROSE PLOT: DISPLAY: Wind Speed Direction (blowing from)

NORTH

M/s.Team Labs and 372

298 100 223 149

74

Counsultants WEST EAST

WIND SPEED (m/s) OUTPUT TYPE: SCALE: >= 4.20 2. 80 - 4. 20 1:136,481 SOUTH 1. 40 - 2. 80 0. 28 - 1. 40 Calms: 6.16%

COMMENTS: DATA PERIOD: COMPANY NAME:

Start Date: 3/6/2017 - 00:00 M/s.Actero Pharma Pvt. Ltd End Date: 6/5/2017 - 23:00 MODELER: M/s.Team Labs and Consultants, Hyderabad CALM WINDS: TOTAL COUNT:

6.16% 2208 hrs. CONC 0 5 km AVG. WIND SPEED: PRO JE CT NO.: 1.36 m/s

WRPLOT View - Lakes Environmental Software

MAX: PROJECT NO.:

6.50959 ug/m^3

ISC-AERMOD View - Lakes Environmental Software Figure 4.7 Isopleths Showing 24 Hourly GLC’s of SPM

4-16 Team Labs and Consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

PROJECT TITLE:

0.59

9

5

.

0

0 0 .59 .5 9 0.97 0 0.59 0. .78 0.97 78 0.97 .59 0.59 0.78 54 23 0 0.59 1NPOL1 -8000 -6000 -4000 -2000 0 2000 4000 6000 8000

-10000 -8000 -6000 -4000 -2000 0 2000 4000 6000 8000 10000

PLOT FILE OF HIGH 4TH HIGH 24-HR VALUES FOR SOURCE GROUP: ALL ug/m^3

0.585 0.779 0.973 1.167 1.361 1.555 1.749

COMMENTS: SOURCES: COMPANY NAME:

5 M/s.Actero Pharma Pvt. Ltd

RECEPTORS: MODELER: WIND ROSE PLOT: DISPLAY: Wind Speed Direction (blowing from)

NORTH

M/s.Team Labs and 372

298 100 223 149

74

Counsultants WEST EAST

WIND SPEED (m/s) OUTPUT TYPE: SCALE: >= 4.20 2.80 - 4.20 1:136,413 SOUTH 1.40 - 2.80 0.28 - 1.40 Ca lms: 6.1 6%

COMMENTS: DATA PERIOD: COMPANY NAME:

Start Date: 3/6/2017 - 00:00 M/s.Actero Pharma Pvt. Ltd End Date: 6/5/2017 - 23:00 MO DE LER: M/s.Team Labs and Consultants, Hyderabad

CALM WINDS: TOTAL COUNT:

6.16% 2208 hrs. CONC 0 5 km AVG. WIND SPEED: PROJECT NO.: 1.36 m/s

WRPLOT View - Lakes Environmental Software

MAX: PROJECT NO.:

1.74924 ug/m^3

ISC-AERMOD View - Lakes Environmental Software Figure 4.8 Isopleths Showing 24 Hourly GLC’s of PM10

4-17 Team Labs and Consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

PROJECT TITLE:

0.43

0.43 0.43 0.43 0.52 0.52 0.52 0.65 0.52 0.43 0.52 54 23 0 NPOL1 . 0.4 1 4 3 3

0.43 -8000 -6000 -4000 -2000 0 2000 4000 6000 8000

-10000 -8000 -6000 -4000 -2000 0 2000 4000 6000 8000 10000

PLOT FILE OF HIGH 1ST HIGH 24-HR VALUES FOR SOURCE GROUP: ALL ug/m^3

0.426 0.522 0.652 0.782 0.912 1.042 1.172

COMMENTS: SOURCES: COMPANY NAME:

5 M/s.Actero Pharma Pvt. Ltd

RECEPTORS: MODELER: WIND RO SE PLO T: DISPLAY: Wind Spe ed Direction (blowing from)

NORTH

M/s.Team Labs and 372

298 100 223 149

74

Counsultants WEST EAST

WIND SPEED (m/s) OUTPUT TYPE: SCALE: >= 4.2 0 2.80 - 4. 20 1:136,413 SOUTH 1.40 - 2. 80 0.28 - 1. 40 Calms: 6.16%

COMMENTS: DA TA P ER I OD : COMPANY NAME:

Start Date: 3/6/2017 - 00:00 M/s.Actero Pharma Pvt. Ltd End Date: 6/5/2017 - 23:00 MODELER: M/s.Team Labs and Consultants, Hyderabad CA L M WI N D S : TOTAL COUNT:

6.16% 2208 hrs. CONC 0 5 km AVG. WIND SPEED: PROJECT NO.: 1.36 m/s

WRPLOT View - Lakes Environmental Software

MAX: PROJECT NO.:

1.17173 ug/m^3

ISC-AERMOD View - Lakes Environmental Software Figure 4.9 Isopleths Showing 24 Hourly GLC’s of PM2.5

4-18 Team Labs and Consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

Figure 4.10 Isopleths Showing 24 Hourly GLC’s of SO2

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Figure 4.11 Isopleths Showing 24 Hourly GLC’s of NOX

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4.2.1.4 Prediction of Concentration of Solvents in the Indoor Environment Due to Solvent Loss and Fugitive Emissions

A simple Box Model (EVAPMOD) was used to calculate the solvent concentration in the indoor environment. The methodology adopted was to calculate the concentration for the product group which has the largest amount of solvent losses.

General Box Model: Indoor air pollution models developed and used by USEPA and others consider the conservation of air contaminant mass in a volume or "box" of workroom air. Airborne concentrations are derived by solving the following general equation (Jay jock, 1988):

C = (Ain - Aout) / Volume of Box ------(1) Where C = Concentration at time ti (assume C=0 @ t0 = 0)

Ain = Mass of contaminant that went into the box during time interval ti - t0

Aout = Mass of contaminant that left the box during time interval ti - t0 The diffusion coefficient and the generation rate of the contaminant were calculated to arrive at the airborne concentration in the environment.

For the General Ventilation Model, the overall estimate of the airborne concentration of a contaminant is obtained by use of following equation.

5 Cv = (1.7*10 ) Ta*G M*Q*m

Where: C v = Contaminant concentration in workplace (ppm) Ta = Ambient temperature of the air (°K) G = Vapor generation rate (gm/sec) M = Molecular Weight (gm/gm-mole) Q = Ventilation rate (ft3/min) m = Mixing factor (dimensionless)

Higher solvent loss and the predicted airborne concentrations of the various solvents are tabulated in the Table 4.6.

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Table 4.6 Solvent Loss and the Predicted Airborne Concentrations S.No Name of Solvent Fugitive Air borne Solvent TLV Loss Conc. (ppm) (ppm) 1 Acetic acid 84.55 41.8 10 2 Acetone 87.28 44.5 1000 3 Acetonitrile 93.04 67.1 40 4 Chloroform 7.00 1.7 50 5 Cyclohexane 1.60 0.6 300 6 Dichloro Methane 137.80 48.1 50 7 Diisopropyl ether 24.52 7.1 250 8 Dimethyl acetamide 1.40 0.5 10 9 Dimethyl formamide 51.01 20.7 10 10 Dimethyl sulfoxide 0.48 0.2 50 11 Ethanol 167.28 107.8 1000 12 Ethyl acetate 104.72 35.2 400 13 Hexane 7.26 2.5 50 14 Isoproponal 47.56 23.5 400 15 Methanol 81.01 75.1 200 16 n-butanol 21.68 8.7 100 17 n-propanol 13.45 6.6 200 18 t-butyl methyl ether 62.56 21 50 19 Tetrahydrofuran 59.77 24.6 200 20 Toluene 15.92 5.1 200

4.2.2 Water Environment The water environment of the proposed project consists of abstraction of water from bore wells, and generation of wastewater from process, utilities and domestic usage. The total fresh water required of quantity after expansion is 206.82 KLD. The abstraction of ground water for industrial use shall have negative and direct impact with medium significance as the plant shall be a competing user for farmers in the surrounding area. The effluent generation in the plant may have a direct negative impact with high significance, on both ground and surface water regimes, if mitigation measures are not adopted and the effluents are disposed without treatment. The release of effluents may change ground water quality, change in run off quality, change in ground water and surface water interaction, change in channel morphology leading to deterioration of production levels of both terrestrial and aquatic flora and fauna, resulting in higher concentrations of chemicals in food chain. The treated effluent from proposed project shall be reused completely for utility makeup water. Hence the impact of wastewater shall be for the duration of plant operation, with negative impact due to ground water

4-22 Team Labs and Consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

abstraction. The mitigation measure shall hence ensure that the impact is of low significance.

4.2.3 Noise Environment

The project activities that have an impact on noise environment are operation of motors, pumps, compressors, DG sets resulting in direct impact of increasing ambient noise levels both within the plant area and outside. Excessive noise will trigger health risks such as headaches, depression, deafness and retardation of sensory mechanisms in the impact area population. The incremental noise levels due to these activities were predicted and the values reflect low impact outside the premises. The increase in noise levels shall have low impact, restricted to within site area due to its low magnitude and occasional frequency. The incremental noise levels however shall have direct negative impact on the noise levels, with low significance due to mitigation measures and also due to absence of sensitive receptors within 500 m of the sources.

4.2.3.1 Prediction of Impact on Noise Quality The sound pressure level generated by noise source decreases with increasing distance from the source due to wave divergence. An additional decrease in sound pressure levels also occurs with increasing distance from the source due to atmospheric effect or interaction with the objects in the transmission path. This is due to excess attenuation. The sound pressure level is also affected by medium of travel and environmental conditions. The propagation model has been devised to take into account these factors and predict the noise levels at various distances round a single or a multiple source. The model uses the following formula as a basis for such predictions.

(Lob) = (Lr) - (Ldiv) - (Latm) Where (Lob) = Observed noise level at a distance R from source (Lr) = Noise level of source measured at reference distance r (Ldiv) = Loss due to divergence at distance R from source = 20 log (R/r) (Latm) = Attenuation due to atmosphere at distance R from the source. = a x R/100, where a is atmospheric attenuation coefficient in dB (A)/100m. For hemispherical wave divergence in a homogenous loss free atmosphere (Latm) = 0. The total impact of all sources at particular place is then estimated by adding as the contribution of noise from each of the following sources as follows;

4-23 Team Labs and Consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

i i=n (Lob) /10 (Leq) = 10 log Σ {10 } i=1 Where n = total number of sources

The calculated noise levels are further super imposed (logarithmically) on the background noise levels. The model assumes that the noise spectrum is mainly centered on a spectrum of 1000 Hz and attenuation due to building materials is also at the same frequency.

The major sources of noise generation are DG sets, soot blowing of boiler, compressors and motors, which emit noise level of maximum 90 dB (A) - 110 dB (A) at a reference distance of 1m from the source. The predicted cumulative noise levels due to the source and the existing level as calculated from the logarithmic model without noise attenuation ranged between 55 and 75 Db (A) at distances ranging between 70 to 135 m which falls within the plant boundary. The impact of noise on the population in the surrounding area will be negligible, as the nearest habitation is at least 500 m away from the site.

4.2.4 Land Environment The proposed project plan involves construction of additional production blocks, enhancement of treatment system and storage. There is no alteration of terrain, and may lead to additional sealing of land due to increased foot print. The proposed project shall also result in increased generation of solid waste, mainly process residue and solvent residue which will be sent to cement plants as auxiliary fuel for co-processing. Handling of hazardous waste has a potential to contaminate soil, ground water, land capability and permeability of soil. However as long as it is not affecting the soil quality chemistry and sedimentation, the impact is not an undesirable one. The impact on land environment is mainly due to accidental spillages of chemicals, effluents and wastes. The project has neutral impact on land environment, terrain and soils as the impacts if any are restricted to within the site with negligible magnitude and is felt mainly during project work only. The operational phase impacts shall be low due to effective implementation of mitigative measures in handling, storing and transferring wastes, effluents and chemicals. It may however be noted that significant negative impacts may occur due to accidental releases of chemicals, effluents and wastes on soil.

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4.2.5 Biological Environment

The ecological factors that are considered most significant as far as the impact on flora and fauna concerned are:

1. Whether there shall be any reduction in species diversity?

2. Whether there shall be any habitat loss or fragmentation?

3. Whether there shall be any additional risk or threat to the rare or endangered or endemic or threatened (REET) species?

4. Whether there shall be any impairment of ecological functions such as

(i) disruption of food chains,

(ii) decline in species population and or

(iii) Alterations in predator-prey relationships?

5. Whether it is possible to attain the global objectives of ‘no net loss’ of biodiversity?

6. Whether it is possible to improve the biological diversity through the proposed activity?

There is no direct threat to any rare or endangered or threatened biological species as indicated by the baseline data, due to the proposed project, as the proposed construction area has sparse vegetation. Chityal RF is at a distance of 6.0 km in east direction, Shivanenigudem RF at a distance of 9.0 km in northeast direction. The project is not going to cause any fragmentation of habitat or disruption of food cycles or destruction of breeding grounds or blockade of migratory routes. The major impacts of the project are mainly during construction and subsequently on account of atmospheric pollution. The industry is required to limit its emissions as per the NAAQ of 2009. It has to strictly adhere to the conditions stipulated by the regulatory bodies. The project authorities are going to take all steps and measures in order to strictly comply with National Ambient Air Quality Standards of 2009. The project may not have impacts on terrestrial flora and fauna. Further, as there are no rare or endangered or threatened (RET) species within the impact area, the project does not pose any direct threat to the survival of any rare species. Hence, the proposed project activity is unlikely to pose any additional threat to REET species in the impact area. It may be concluded that the impacts are indirect, and positive due to increasing the density of green belt, and of low significance.

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4.2.6 Socio-economic Environment The proposed project envisages additional employment to 300 people, with an annual salary outlay of Rs. 67.5 lakhs which will have a direct positive impact. The site is about 6.1 km from Chityala town, which has adequate infrastructure with respect to housing, education, transport, health and civic amenities, and hence the additional influx of 300 people may have low impact on infrastructure availability. The impact on health was assessed by air quality impact predictions and was observed to be within prescribed NAAQ standards. There will be medium significant, direct negative impact due to community expectations and public safety concern as the unit handles, and produces hazardous chemicals. The proposed CSR activities from the company shall also enhance the public approval for the project and ensure improvement in infrastructure in the surrounding villages. The overall impact due to this project shall be positive, both direct and indirect with high significance.

4.2.7 Prediction of Impact on Vehicular Traffic As the plant is located adjacent to the national highway there will not be any unauthorized shop or settlements along the road connecting the plant site. The traffic density of the connecting road is low mainly consisting of local transport, commercial and passenger vehicle traffic. Raw materials and finished products are transported by road using road trucks. The additional traffic generated due to the proposed project shall be 20-25 truck trips per day. There will be marginal increase in the traffic density.

The traffic study for the both the units of the connecting road revealed that the peak traffic volume in PCU is 0.046 during 6 to 7 PM and the level of service of the connecting road remains A, after expansion also. Modified level of service for connecting roads considering the additional truck trips for both the unit for proposed project is presented in Table 4.7 Table 4.7 Modified level of services for connecting roads Road Existing Existing Additional Modified Modified Modified volume, volume/ volume Volume volume/ Los & PCU/hr Capacity Capacity performance Site – NH 9 69 0.038 95 164 0.046 A (Excellent)

4-26 Team Labs and Consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

5.0 ANALYSIS OF ALTERNATIVES

Actero Pharma Pvt. Ltd. proposes to set up a Synthetic Organic Chemicals (Bulk Drugs & Intermediates) Unit of Production capacity 165 TPM in an area of 11.275 acres of land on lease from principle organization M/s. Dasami Lab Pvt. Ltd., for a lease period of 25 years at Sy No 407 (Part) and 411, Veliminedu (V), Chityal Mandal, Nalgonda District, Telangana.

Analysis of alternatives was undertaken to assess sites, process, technology and treatment options. The site was selected as it is taken on lease from principle organization M/S. Dasami Lab Pvt. Ltd., adjacent to national highway to reduce the transportation risk, located at a distance of 2.1 km from nearest habitation will reduce the level of impacts due to proposed project. The objective of this assessment is to identify best available technology not entailing excessive costs, and to reduce pollution loads by optimizing both raw material and resource consumption.

5.1 Alternative Sites Three different sites were assessed before finalizing this site. The other sites were located in Dhothigudem Village and Lakkaram Village, Choutuppal. The site in Dhothigudem village area was avoided as availability of ground water is not sufficient for project and Lakkaram site was avoided as it was near to Choutuppal town. The present site is selected as it is located adjacent to sister company Dasami Lab Pvt. Ltd. which is involved in manufacturing of Bulk drugs and intermediates, thereby significantly reducing transport of raw materials and also facilitating synergic activity of both units.

5.2 Alternative in Process

The process mass intensity was mainly contributed by water and solvents. Solvents are used as a medium of reaction for all the stages of process. The material balance of each stage of the product was reviewed and it was observed that the solvent usage is ranging from 50 to 7500 kg/day. Solvents like Methanol, Ethyl Acetate, Isopropyl alcohol, Tetrahydrofuran, Methylene dichloride, Toluene etc. was observed to be used in the manufacturing process of various products. The management agreed to conduct

5-1 Team Labs And Consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report research in identifying the potential solvents from the list of preferred solvents as per green chemistry principles, i.e., water, methanol, ethanol, propanol, ethyl acetate etc.

The usage of water is mainly for washings of product and equipment. The alternatives assessed are conducting campaign manufacturing in a planned manner to avoid washing frequently and to utilize washing streams in first wash of downstream equipment. Both the alternatives were chosen for implementation. The usage of high pressure water jet in place of fill and vacate method of washing is chosen as the best alternative of equipment washing. The product washings will be optimized by agitating the wash product thereby reducing number of washings. It is also proposed to reuse lean washings of product in the first wash of the product.

The management proposed to assess process mass intensity of each stage of manufacturing and evaluate the best options of reducing the process mass intensity by reducing usage of water and solvents in addition to improving the yields of reaction.

5.2.1 Alternatives in Technology Active Pharma Ingredients manufacturing is mainly batch process, with usage of day tanks, reactors, and centrifuge, filters and dryers, wherein each stage of process involves different type equipment which are potential sources of diffuse emissions. Hence the alternatives were reviewed for charging the material into reactors to drying of product. Manual charging of material shall be completely avoided to reduce diffuse emissions and loss into atmosphere of raw materials.

Design of reactors will be made with minimal number of nozzles at reactor top. The constant flux cooling jacket reactors and double limpet coil cooling system reactors are proposed for regulating the process temperature without altering the jacket temperature for quick cooling of reaction mass to avoid diffuse emissions and loss of media. The technologies identified for adoption are dip pipe provision for transfer of liquid materials from day tanks to reactors to avoid static electricity, Air operated Diaphragm (AOD) pumps for transfer of materials from drums, powder transfer systems for solids and transfer by pipeline. The identified alternative for filter and dryers was Agitated Nutche Filter and Dryer (ANFD) which serves the purpose of both

5-2 Team Labs And Consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report filtration and drying thereby reducing the transfer of material from one equipment reflecting in reduced diffuse emissions. It is proposed to enhance the solvent recovery system by installing fractional distillation columns in place of simple distillation to increase the purity of recovered solvents, which can be reused in process, thereby reducing the consumption of solvents used and diffuse emissions. Seamless pipes will be used for piping with less number of bends and flanges to avoid loss of material and fugitive emissions. Double mechanical sealed flanges will be provided in solvents transfer pipelines, and PTFE pumps will be provided for transfer of corrosive material transfer and charging.

5.2.2 Alternatives in treatment/mitigation options The emission sources in the proposed expansion project are utilities, storages, process and effluent treatment system. The alternatives assessed for air pollution control equipment to the boilers are cyclone, multicone cyclone, scrubbers, bag filter and electro static precipitator. Bag filters are selected as the optimum technology for low pressure boilers to ensure particulate emission concentration of 115 mg/Nm3. The alternatives assessed for mitigating emissions from process are scrubbing systems for process gas mitigation, various mitigation measures for diffuse emissions; double stage scrubbing system is identified as the best alternative by using water in primary scrubber and acid or basic media in the secondary scrubber. Diffuse emissions are mitigated by using condensers for storages, while thermal insulation, and nitrogen blanketing are identified for storage of low boiling solvents. Double condensers are proposed to mitigate both diffuse and process emissions and the alternatives of medium assessed were RT water, cold water, chilled brine. Cold water and chilled brine were identified as the best medium to mitigate VOC concentration in ambient air. It is proposed to connect the vents of effluent storage tanks to the scrubbing system to mitigate VOC concentration.

Zero liquid discharge based effluent treatment system was selected after assessing various physical, chemical and biological technologies. The concentration of effluents is lean compared to pesticide and dyes sector, from multiple streams with various concentrations of COD and TDS. Accordingly a complex system involving chemical

5-3 Team Labs And Consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report precipitation, physical separation and filtration by RO and biological treatment was identified considering the inadequacy of a single and simple technology to treat the complex wastes from API manufacturing, to ensure reuse of treated wastewater. The adoption of zero liquid discharge based treatment system however observed to be a source of solid waste as the organic and inorganic components are separated as either stripper condensate and or Multiple Effect Evaporator (MEE) and Agitated Thin Film dryer (ATFD) salts. The management identified this aspect and proposed to identify alternative solid waste treatment/disposal methods, and accordingly proposed to assess the feasibility of disposing the stripper condensate for co-incineration in cement plants.

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6.0 ENVIRONMENTAL MONITORING

6.1.1 Introduction

The environmental monitoring programme provides such information on which management decision may be taken during construction and operation phases. It provides basis for evaluating the efficiency of mitigation and pollution control measures and suggest further actions that need to be taken to achieve the desired effect. The monitoring includes: (i) Visual observations; (ii) Monitoring of environmental parameters at specific locations; (iii) Sampling and regular testing of these parameters.

6.1.2 Objectives The objectives of the environmental monitoring programme are: • Evaluation of the efficiency of mitigation and pollution control measures; • Updating of the actions and impacts on baseline data; • Adoption of additional mitigation measures if the present measures are insufficient; • Generating the data, which may be incorporated in environmental management plan in future projects.

6.1.3 Methodology

Monitoring methodology covers the following key aspects: • Components to be monitored; • Parameters for monitoring of the above components; • Monitoring frequency; • Monitoring standards; • Responsibilities for monitoring; • Direct responsibility, • Overall responsibility; • Monitoring costs.

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Environmental monitoring of the parameters involved and the threshold limits specified are discussed below for the proposed synthetic organic chemicals - APIs (Bulk drug manufacturing) unit of M/s. Actero Pharma Pvt. Ltd.

6.1.4 Ambient Air Quality (AAQ) Monitoring

Ambient air quality parameters recommended are PM10, PM2.5, Oxides of Nitrogen

(NOX) and Sulphur Dioxide (SO2). These are to be monitored at designated locations starting from the commencement of construction activity. Data should be generated at all identified locations in accordance to the National Ambient Air Quality Standards (Table 6.1) location, duration and the pollution parameters to be monitored and the responsible institutional arrangements are detailed out in the Environmental Monitoring Plan. Table 6.1 National Ambient Air Quality Standards S.No Pollutant Time Concentration in Ambient Air Weighted Industrial, Ecological Methods of Average Residential, Sensitive Area Measurement Rural and (Notified by Other Area Central Government) 1 Sulphur Dioxide Annual* 50 20 Improved west and (SO2) GaekeUltraviolet 24 Hours** 80 80 fluorescence 2 Nitrogen Annual* 40 30 Modified Jacob & Dioxide (NO2) Hochheiser (Nn-Arsenite) 24 Hours** 80 80 Chemiluminescence 3 Particulate Annual* 60 60 Gravimetic Matter (Size TOEM Less than 10 24 Hours** 100 100 Beta Attenuation µm) or PM10 4 Particulate Annual* 40 40 Gravimetic Matter (Size TOEM Less than 24 Hours** 60 60 Beta Attenuation 2.5µm) or PM2.5 5 Ozone (O3) 8 hours** 100 100 UV Photometric Chemilminescence 1 hour** 180 180 Chemical Method 6 Lead (Pb) Annual* 0.50 0.50 AAS /ICP method after sampling on EPM 2000 or 24 hours** 1.0 1.0 equivalent filter paper ED-XRF using Teflon filter. 7 Carbon 8 hours** 02 02 Non Dispersive Infra Red Monoxide (CO) (NDIR) 1 hour** 04 04 Spectroscopy

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8 Ammonia Annual* 100 100 Chemilminescence (NH3) 24 hours** 400 400 Indophenol blue method Gas Chromotography based continuous analyzer 9 Benzene (C H ) Annual* 05 05 6 6 Absorption and Desorption followed by GC analysis 10 Benzo (o) Annual* 01 01 Solvent extraction Pyrene(BaP) – followed by HPLC/GC Particulate analysis Phase only, 11 Arsenic (As), Annual* 06 06 AAS/ICP method after sampling on EPM 2000 or equivalent filter paper 12 Nickel (Ni), Annual* 20 20 AAS/ICP method after sampling on EPM 2000 or equivalent filter paper *Average Arithmetic mean of minimum 104 measurement in a year taken for a week 24 hourly at uniform interval. **24 hourly/8 hourly values should meet 98 percent of the time in a year

6.1.5 Water Quality Monitoring The physical and chemical parameters recommended for analysis of water quality relevant are pH, total solids, total dissolved solids, total suspended solids, oil and grease, COD, chloride, lead, zinc and cadmium. The location, duration and the pollution parameters to be monitored and the responsible institutional arrangements are detailed in the Environmental Monitoring Plan. The monitoring of the water quality is to be carried out at all identified locations in accordance to the Indian Standard Drinking Water Specification – IS 10500: 1991 (stated in Table 6.2)

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Table 6.2 Indian Standard Drinking Water Specifications – IS: 10500:1991 S. No Substance or Requirement Undesirable Methods Remarks Characteristics (Desirable Effect Outside of Test Limit) the Desirable (Ref. To Limit IS) Source Source Alternate Absence of Absence Permissible Permissible Limit in the

ESSENTIAL CHARACTERISTICS 1 Colour, Hazen 5 Above 5, 25 3025 Extended to 25 only if units, Max. consumer (Part 4) toxic substances are not acceptance 1983 suspected, in absence of decreases alternate sources 2 Odour Unobjectionable - - 3025 a) Test cold and when (Parts5): heated 1984 b) Test at several dilutions 3 Taste Agreeable - - 3025 Test to be conducted only (Part 7& 8) after safety has been 1984 established 4 Turbidity NTU, 5 Above 5, 10 3025 - Max. consumer (Part 10) acceptance 1984 decreases 5 pH Value 6.5 to 8.5 Beyond this No 3025 - range, the water relaxation (Part 11) will affect the 1984 mucous membrane and/or water supply system 6 Total hardness 300 Encrustation in 600 3025 - (as CaCO3) water supply (Part 21) mg/l, Max structure and 1983 adverse effects on domestic use 7 Iron (as Fe) 0.3 Beyond this 1 32 of 3025 : - mg/l, Max limit 1964 taste/appearan ce are affected, has adverse effect on domestic uses and water supply struc- tures, and promotes iron bacteria 8 Chlorides (as 250 Beyond this 1000 3025 - CI) mg/l, Max limit, taste, (Part 32) corrosion and 1988 palatibility are affected 9 Residual, free 0.2 - - 3025 To be applicable only chlorine, mg/l, (Part 26) when water is

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S. No Substance or Requirement Undesirable Methods Remarks Characteristics (Desirable Effect Outside of Test Limit) the Desirable (Ref. To Limit IS) Source Source Alternate Absence of Absence Permissible Permissible Limit in the

Min 1986 chlorinated. Tested at consumer end. When protection against viral infection is required, it should be Min 0.5 mg/l DESIRABLE CHARACTERISTICS 1 Dissolved 500 Beyond this 2000 3025 - solids mg/l, palatability (Part 16) Max decreases and 1984 may cause gastro intestinal irritation 2 Calcium (as Ca) 75 Encrustation in 200 3025 - mg/l, Max water supply (Part 40) structure and 1991 adverse effects on domestic use 3 Magnesium (as 30 Encrustation to 100 16, 33, 34 of - Mg), mg/l, Max water supply IS 3025: 1964 structure and adverse effects on domestic use 4 Copper (as Cu) 0.05 Astringent 1.5 36 of 3025: - mg/l, Max taste, 1964 discoloration and corrosion of pipes, fitting and utensils will be caused beyond this 5 Manganese (as 0.1 Beyond this 0.3 35 of 3025: - Mn) mg/l, Max limit 1964 taste/appearan ce are affected, has adverse effects on domestic uses and water supply structures 6 Sulphate (as 200 Beyond this 400 3025 May be extended up to 200 SO4) mg/l, causes gastro (Part 24) 400 provided (as Mg) Max intestinal irrita- 1986 does not exceed 30 tion when magnesium or sodium are present 7 Nitrate (as 45 Beyond this, 100 3025 (Part -

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S. No Substance or Requirement Undesirable Methods Remarks Characteristics (Desirable Effect Outside of Test Limit) the Desirable (Ref. To Limit IS) Source Source Alternate Absence of Absence Permissible Permissible Limit in the

NO2) mg/l, may cause 34) 1988 Max methaemoglobi nemia 8 Fluoride (as F) 1 Fluoride may 1.5 23 of 3025: - mg/l, Max be kept as low 1964 as possible. High fluoride may cause fluorosis 9 Phenolic 0.001 Beyond this, it 0.002 54 of 3025: - compounds (As may cause 1964 C6H5OH) mg/l, objectionable Max taste and odour 10 Mercury (as 0.001 Beyond this, the No (see Note) To be tested when Hg) mg/l, Max water becomes relaxation Mercury ion pollution is suspected toxic analyzer 11 Cadmium (as 0.01 Beyond this, the No (See note) To be tested when Cd), mg/l, Max water becomes relaxation pollution is suspected toxic 12 Selenium (as 0.01 Beyond this, the No 28 of 3025: To be tested when Se), mg/l, Max water becomes relaxation 1964 pollution is suspected toxic 13 Arsenic (As As) 0.05 Beyond this, the No 3025 To be tested when mg/l, max water becomes relaxation (Part 37) pollution is suspected toxic 1988 14 Cyanide (As 0.05 Beyond this No 3025 To be tested when CN), mg/l, Max limit, the water relaxation (Part 27) pollution is suspected becomes toxic 1986 15 Lead (as Pb), 0.05 Beyond this No (see note) To be tested when mg/l, Max limit, the water relaxation pollution is suspected becomes toxic 16 Zinc (As Zn). 5 Beyond this 15 39 of 3025: To be tested when Mg/l, Max limit it can 1964) pollution is suspected cause astringent taste and an opalescence in water 17 Anionic 0.2 Beyond this 1 Methylene- To be tested when detergents (As limit it can blue pollution is suspected MBAS) mg/l, cause a light extraction Max froth in water method 18 Chromium (As 0.05 May be No 38 of 3025: To be tested when Cr6+) mg/l, carcinogenic relaxation 1964 pollution is suspected Max above this limit 19 Poly nuclear - May be - - - aromatic carcinogenic hydrocarbons above this limit

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S. No Substance or Requirement Undesirable Methods Remarks Characteristics (Desirable Effect Outside of Test Limit) the Desirable (Ref. To Limit IS) Source Source Alternate Absence of Absence Permissible Permissible Limit in the

(as PAH) g/1, Max 20 Mineral oil 0.01 Beyond this 0.03 Gas - mg/l, Max limit un- Chromatogr desirable taste aphic and odour after method chlorination take place 21 Pesticides Absent Toxic 0.001 - - mg/l, Max 22 Radioactive materials: 58 of - 3025:01964 23 a) Alpha - - 0.1 - - emitters Bq/l, Max 24 Beta emitters - - 1 - - pci/1, Max 25 Aluminium (as 200 Beyond this 600 13 of - Al), mg/l, Max limit taste 3025:1964 becomes unpleasant 26 Aluminium (as 0.03 Cumulative 0.2 31 of 3025: - Al), mg/l, Max effect is 1964 reported to cause dementia 27 Boron, mg/l, 1 - 5 29 of 3025: - Max 1964 Source: Indian Standard Drinking Water Specification-IS10500:1991

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6.1.6 Noise Level Monitoring The measurements for monitoring noise levels would be carried out at all designated locations in accordance to the Ambient Noise Standards formulated by Central Pollution Control Board (CPCB) in 1989 (refer Table 6.3) Sound pressure levels would be monitored on twenty-four hour basis. Noise should be recorded at a “A” weighted frequency using a “slow time response mode” of the measuring instrument. The location, duration and the noise pollution parameters to be monitored and the responsible institutional arrangements are detailed in the Environmental Monitoring Plan (Table 5.3) Table 6.3 Noise level standards (CPCB) Type Noise level for Day Noise level for Industrial area 75 70 Commercial area 65 55 Residential area 55 45 Silence zone 50 40 Day time - 6.00 am - 9.00 pm (15 hours)

The monitoring plan along with the environmental parameters and the time frame is presented in the Table 6.4. Table 6.4 Environmental Monitoring Plan (Terms of Reference No. 7 (xii)) S. Particulars Monitoring Standards Duration Important monitoring No Frequency of parameters Sampling Ambient Air Quality Monitoring 1 Industry Quarterly Air (Prevention 24 hrs PM10, PM2.5, SO2, NOx, & Main Gate, Pittampalli and Control of VOC and Veliminedu villages Pollution) Rules, 2 Work Place Monitoring : Quarterly CPCB, 1994 8 hr SPM, VOC Production blocks 8 locations, Solvent Tankfarm , and ETP area Stack Emissions Monitoring 1 Utility Stacks : 2 nos. Quarterly Air (Prevention -- PM, SO2, Nox , Coal fired boilers, and 6 and Control of recommended methods no.s DG sets. Pollution) of CPCB. CPCB, 1994 Water Quality Monitoring 1 Process water Daily Water Quality Grab pH, TDS, SS, BOD, COD standards by and Oil & Grease CPCB Hardness, , chlorides, using APHA or BIS analytical methods. 2 Effluents Stream wise Quarterly Grab pH, TDS, SS, BOD, COD using APHA or BIS analytical methods.

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3 Treated effluent before Daily Grab pH, TDS, TSS, COD, disposal Marine outfall BOD and Oil and Grease using APHA or BIS analytical methods. Noise Quality Monitoring 1 Noise Levels at 3 Quarterly Noise standards 24 hrs Equivalent Noise levels Locations within plant by CPCB in dB(A) site and 2 locations outside the plant site , Pittampalli and Veliminedu villages villages Soil Quality Monitoring 1 Soil - 3 locations within Once a year pH, EC, CEC, Lead, the site; storage area, near Moisture, Texture, Bulk production blocks (8no.s) Density etc. and ETP area.

6.1.7 Responsibility of Monitoring And Reporting System The overall responsibility of monitoring the above parameters shall lie with the management of Actero Pharma Pvt. Ltd. The maintenance/environment wing shall be responsible for day to day monitoring of effluent, raw water and treated water quality. The Ambient air quality, Stack emissions, soil, noise and water quality shall be monitored by either third party or by the Environment management division of the unit.

Records shall be maintained for the analysis of raw effluents and treated effluents, ambient air quality data, stack emissions monitoring results, micro- meteorological data and noise levels. These records are not only required for the perusal of the Pollution Control Board authorities but also to derive at the efficiencies of the pollution control equipment as the objective of the project proponent is not only compliance with statutory regulations, but also a serious commitment towards clean environment.

The industry shall maintain the records as per the hazardous waste regulations and EPA regulations and apply for the annual consents for air and water, and renewal of authorization for the storage of hazardous waste as per Hazardous Waste (Handling & Management) Rules, 1989. The records of hazardous waste manifest will be maintained.

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Reporting system provides the necessary feedback for project management to ensure quality of the works and that the management plan in implementation. The rationale for a reporting system is based on accountability to ensure that the measures proposed as part of the Environmental Management Plan get implemented in the project.

6.1.7.1 Work Zone Monitoring for Hazardous Chemicals (Terms of Reference No. Sp. TOR (4))

Periodic Workzone monitoring is carried out to review the indoor toxic chemicals concentration. The periodicity of monitoring is dependent on the concentrations i.e., below or above TLV values.

6.2 Environmental Monitoring Budget The environmental budget for the various environmental management measures in the EMP is detailed in Table 6.5. There are several other environmental issues that have been addressed as part of good engineering practices, the costs for which have been accounted for in the Engineering Costs. Moreover, since environmental enhancements have not been finalized at this stage, the table projects the typical costs unit wise. Table 6.5 Environmental Monitoring Budget Particulars Monitoring Unit Cost Annual Cost Frequency Rs. Rs. Ambient Air Quality Monitoring Monthly 4500 162000 Work Place Monitoring Monthly 2000 240000 Stack Emissions Monitoring Monthly 2700 64800 DG Set Stack Emissions Monitoring Quarterly 2700 64800 Process water Daily 500 165000 Effluents - Stream wise Quarterly 600 4800 Treated effluent (ETP water) Daily 600 198000 Noise Level Monitoring Quarterly 1000 20000 Soil Quality Once a year 2000 20000 Total (Rs.) 939400

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7.0 RISK ASSESSMENT AND DAMAGE CONTROL

7.0 Introduction This chapter presents the risk assessment study results for the plant operations, transport and storage of raw materials, and identifies maximum credible accident scenarios to draw the emergency management plan addressing various credible scenarios identified.

7.1. Objectives and Scope The production of Synthetic Organic chemicals (bulk drug and intermediates) involves usage of many chemicals which are both hazardous and toxic in nature. The risks associated with the chemical industry are commensurate with their rapid growth and development. Apart from their utility, chemicals have their own inherent properties and hazards. Some of them can be flammable, explosive, toxic or corrosive etc. The whole lifecycle of a chemical should be considered when assessing its dangers and benefits. In order to ensure the health and safety of persons at or near the facilities, Govt. has approved some regulations. The regulation requires Employers to consult with employees in relation to: - Identification of major hazards and potential major accidents - Risk assessment - Adoption of control measures - Establishment and implementation of a safety management system - Development of the safety report

The involvement of the employees in identification of hazards and control measures enhances their awareness of these issues and is critical to the achievement of safe operation in practice. In order to comply with regulatory authorities, M/s Actero Pharma Pvt. Ltd., have entrusted Team Labs and Consultants, Hyderabad to review and prepare Hazard analysis and Risk assessment for their facility along with an approach to on-site emergency preparedness plan as required under the acts and rules. (Manual on emergency preparedness for chemical hazards, MOEF, New Delhi). In this endeavor, the methodology adopted is based on;

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• visualizing various probable undesirable events which lead to major accidents • detailed and systematic assessment of the risk associated with each of those hazards, including the likelihood and consequences of each potential major accident event; and • identifying the technical and other control measures that are necessary to reduce that risk to a level that is as low as reasonably practicable

The strategy to tackle such emergencies, in-depth planning and person(s) or positional responsibilities of employees for implementation and coordination of timely and effective response measures are described in onsite detail in Emergency Plan.

7.2 Project Details

The plant site of 11.275 acres is located at Survey No. 407 (Part) and 411, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana State. The site is located at the intersection of 17°13'34" (N) latitude and 79° 2'38" (E) longitude. The plant site elevation above mean sea level (MSL) is in the range of 329 - 338 m. The plant site is surrounded by open agricultural land in west direction, proposed expansion site of Dasami Lab Pvt. Ltd., in west direction, road connecting Pittampalli village to national highway in north direction and VSK Laboratories Pvt. Ltd. In south direction. The nearest habitation from the plant is Pittampalli village located at a distance of 2.1 km in southwest direction. The main approach road connecting to National Highway 9 - Hyderabad - Vijayawada Road adjacent to site in north direction. National Highway 9 - Hyderabad - Vijayawada is at a distance of 0.5 km in north direction. The nearest town Chityal is at a distance of 8.4 km in northeast direction. The nearest railway station Ramannapet is at a distance of 7.6 km in northeast direction and nearest airport is Rajiv Gandhi International Airport (Hyderabad) located at a distance of 65 km in northwest direction. Seasonal nala Chinna Vagu is flowing from northwest to southeast direction at a distance of 6.5 km in southwest direction. There are two reserve forests in the impact area of 10 km radius of the study area. Chityal RF at a distance of 6.1 km in east direction, Shivanenigudem RF at a distance

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report of 9.1 km in northeast direction. There is no national park, wildlife sanctuary, ecologically sensitive area, biosphere reserve, tiger reserve, elephant reserve, critically polluted areas and interstate boundary within 10 km radius of the site. The manufacturing capacities of the proposed bulk drug and intermediates is presented in Table 7.1 and Table 7.2 Chemical inventory is presented in Table 7.3 Table 7.1 Manufacturing Capacity S.No Name of Product CAS. No Capacity Kg/day TPM 1 Abiraterone Acetate 154229-19-3 16.7 0.5 2 Afatinib 850140-72-6 23.3 0.7 3 Anastrazole 120511-73-1 10 0.3 4 Bicalutamide 3543-75-7 33.3 1 5 Bendamustine HCl 153559-49-0 16.7 0.5 6 Bexarotene 90357-06-5 313.3 9.4 7 Bosutinib 380843-75-4 10 0.3 8 Capecitabine 154361-50-9 366.7 11 9 Carfilzomib 868540-17-4 16.7 0.5 10 Ceritinib 1032900-25-6 500 15 11 Cyclophosphamide 50-18-0 200 6 12 Dasatinib 302962-49-8 83.3 2.5 13 Docetaxel 114977-28-5 808.3 24.25 14 Enzalutamide 915087-33-1 33.3 1 15 Erlotinib HCl 183319-69-9 133.3 4 16 Gefitinib 184475-35-2 350 10.5 17 Gemcitabine HCl 122111-03-9 13.3 0.4 18 Ibrutinib 936563-96-1 8.3 0.25 19 Imatinib Mesylate 220127-57-1 50 1.5 20 Lapatanib 388082-78-8 533.3 16 21 Lenvatinib 417716-92-8 13.3 0.4 22 Olaparib 763113-22-0 8.3 0.25 23 Palbociclib 571190-30-2 6.7 0.2 24 Pazopanib 444731-52-6 75 2.25 25 Sorefinib 284461-73-0 800 24 26 Sunitinib 341031-54-7 753.3 22.6 27 Tamoxifene 10540-29-1 366.7 11 Total Worst Case: 22 Products on campaign basis 5500 165

Table 7.2 List of By-products S. No Name of the Product Stage Name of the By Product Quantity (Kg/day) 1 Docetaxel I 2,2,2-Trichloro ethyl formate 355.6

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Table 7.3 List of Raw Materials and Inventory (Terms of Reference No. 3(iv) & (3(v)) S.No Name of the Raw Material Maximum Physical Type of Mode of Mode of storage Form Hazard Storage Transport (Kgs) 1 (S)-2-Amino--4-methyl-1-((R)-2-methyloxiran-2- 164 Solid Irritant Bags By Roads yl)pentan-1-one 2,2,2-trifluoroacetate 2 (S)-3-Hydroxy tetrahydrofuran 44 Liquid Irritant Drums By Roads 3 1-(2-hydroxyethyl)piperazine 300 Liquid Irritant Drums By Roads 4 1-(4-hydroxyphenyl)-1,2-diphenyl-1-butene 2396 Liquid Flammable Drums By Roads 5 1H-Benzimidazol-1-methyl-5-amino-2-butanoic 128 Solid Irritant Bags By Roads acid ethylester 6 2-(2′-Hydroxyphenyl)benzoxazole 70 Powder Irritant Bags By Roads 7 2-(6-chloro-6-methyl pyrimidin -4ylamino)-N- 909 Irritant By Roads (2-chloro-6-methyl phenyl) thiazole-5- carboxamide 8 2-(Methanesulfonyl) ethylamine 968 Liquid Flammable Drums By Roads 9 2,2'-(5-Methyl-1,3-phenylene-di(2- 193 Liquid Flammable Drums By Roads methylpropionitrile) 10 2,3-di-o-acetyl-5-deoxy-5-fluorocytidine 3222 Liquid Carcinogenic Drums By Roads 11 2,4-dichloro-5-methoxyaniline 101 Irritant By Roads 12 2,5-dichloro-N-(2-(isopropylsulfonyl) 4195 Irritant By Roads phenyl)pyrimidin-4-amine 13 2-chloro-N,N-diethylethanamine 859 Irritant By Roads 14 2-deoxy-2,2-difluoro pentofuranos-3,5- 149 Crystalline Combustible Bags By Roads dibenzoate 15 2-Fluoro-4-nitrobenzoic acid 348 Solid Irritant Bags By Roads 16 2-Fluoro-5-formylbenzonitrile 55 Solid Irritant Bags By Roads 17 2-isopropoxy-5-methyl-4-(piperidin-4-yl) aniline 3893 Crystalline Corrosive Bags By Roads dihydrochloride 18 3-(4-Phenoxyphenyl)-1H-pyrazolo[3,4- 90 Liquid Flammable Drums By Roads d]pyrimidin-4-amine 19 3-Amino-1-propanol 894 Viscous Corrosive Drums By Roads 20 3-chloro-4-(3-cyclopropylureido)phenol 58 Liquid Toxic Drums By Roads

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

21 3-Chloro-4-fluoro aniline 1514 Powder Toxic By Roads 22 4(2-(N-Methylcabamoyl)-4-pyridyloxy)aniline 3120 Liquid Flammable Drums By Roads 23 4-(4-Methylpiperazino methyl) benzoic acid 578 Solid Irritant Bags By Roads dihydrochloride 24 4,6-bis[[(2,2,2-trichloroethoxy)carbonyl] 6000 Liquid Flammable Drums By Roads oxy]substituted docetaxel 25 4-Amino-2-(trifluoromethyl)benzonitrile 184 Solid Irritant Bags By Roads 26 4-Chloro-3-(trifuoromethyl)phenyl isocyanate 2505 Powder Irritant Bags By Roads 27 4-Chloro-6-(3-morppholinopropoxy)-7- 3506 Liquid Flammable Drums By Roads methoxyquinazoline 28 4-chloro-6,7-bis(2-methoxy ethoxy) 970 Liquid Flammable Drums By Roads Quinazolinone 29 4-Dimethylamino pyridine 10 Crystalline Toxic HDPE Bags By Roads 30 4-Chloro-7-methoxy-6-quinolinecarboxamide 61 Solid Carcinogenic Bags By Roads 31 4-fluorothiophenol 76 Liquid Flammable Drums By Roads 32 5-[4-({3-chloro-4-[(3- 3729 Liquid Flammable Drums By Roads fluorophenyl)methoxy]phenyl} amino)quinazolin-6-yl]furan-2-carbaldehyde 33 5-Amino-2-Methyl Benzene sulphonamide 255 Solid Non hazard Bags By Roads 34 5-fluoro-1,3-dihydro-indol-2-one 2182 Crystalline Combustible Bags By Roads 35 5-formyl-2,4-dimethyl-1H-pyrrole-3- 3829 Solid Corrosive Bags By Roads carboxylicacid-(2-diethylamino-ethyl)-amide 36 6-Bromo-2-chloro -8-Cyclopentyl-5- 258 Solid Corrosive Bags By Roads methylpyrido[2,3-d] pyrimidin-7(8H)-one 37 7-(3-chloropropoxy)-6-methoxy-4-oxo-1,4- 157 Liquid Flammable Drums By Roads dihydroquinoline-3-carbonitrile 38 Acetic acid 15000 Liquid Flammable Storage Tanks By Roads 39 Acetic anhydride 55 Liquid Flammable Drums By Roads 40 Acetone 30000 Liquid Flammable Storage Tanks By Roads 41 Acetone cyanohydrin 118 Liquid Toxic Drums By Roads 42 Acetonitrile 8000 Liquid Flammable Drums By Roads 43 Acryloyl chloride 20 Solid Corrosive Bags By Roads 44 Activated carbon 4466 Solid Flammable Bags By Roads

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45 Ammonium bi carbonate 1050 Solid Irritant Bags By Roads 46 Ammonium Chloride 1647 Solid Corrosive Bags By Roads 47 Ammonium hydroxide 396 Liquid Toxic Drums By Roads 48 Anhydrous Magnesium sulfate 280 Crystalline Combustible Bags By Roads 49 Anhydrous Sodium sulfate 700 Granules Non-Hazard Bags By Roads 50 Bis-(2-chloroethyl)amine Hydrochloride 1693 Powder Irritant Bags By Roads 51 BOC Piperazine 52 Crystalline Irritant Bags By Roads 52 Carbon 84 Solid Non-Hazard Bags By Roads 53 Celite 3500 Liquid Flammable Drums By Roads 54 Chloroform 5250 Liquid Carcinogenic Drums By Roads 55 Citric acid 105 Liquid Combustible Drums By Roads 56 Cyclohexane 1400 Liquid Flammable Drums By Roads 57 Cyclopropane carbonyl chloride 17 Liquid Flammable Drums By Roads 58 1,8-Diazabicyclo[5.4.0]undec-7-ene 56 Liquid Toxic Drums By Roads 59 Dehydroepiandrosterone-3-acetate 379 Solid Non-Hazard Bags By Roads 60 Di isopropyl ethylalcohol 70 Liquid Flammable Drums By Roads 61 Dichloromethane 30000 Liquid Carcinogenic Storage Tanks By Roads 62 Diethyl (3-pyridyl)borane 169 Solid Irritant Bags By Roads 63 Diisopropyl azodicarboxylate 60 Liquid Carcinogenic Drums By Roads 64 Diisopropylether 8000 Liquid Flammable Drums By Roads 65 Diisopropyl ethyl amine 490 Liquid Flammable Drums By Roads 66 Dimethyl formamide 30000 Liquid Flammable Storage Tanks By Roads 67 Dimethyl sulfoxide 665 Liquid Flammable Drums By Roads 68 Dimethyl(3-oxo-1,3-dihydroisobenzfuran-1- 89 Solid Corrosive Bags By Roads yl)phosphonate 69 Dimethylacetamide 1225 Liquid Carcinogenic Drums By Roads 70 Ethylene dichloride 70 Liquid Toxic Drums By Roads 71 Ethanol 30000 Liquid Flammable Storage Tanks By Roads 72 Ethyl acetate 30000 Liquid Flammable Storage Tanks By Roads 73 Ethyl acetate.HCl 242 Liquid Flammable Drums By Roads 74 Ethylene Oxide (Gas) 50 Gas Flammable Cylinders By Roads 75 Ethynylbenzenamine 364 Liquid Toxic Drums By Roads

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

76 Hexane 6195 Liquid Flammable Drums By Roads 77 Hexamethyl disilazine 210 Liquid Flammable Drums By Roads 78 Hydroxybenzotriazole 18 Solid Flammable Bags By Roads 79 Hydrazine hydrate 18 Liquid Flammable Drums By Roads 80 Hydrochloric acid 4799 Liquid Corrosive Drums By Roads 81 Hydrogen gas 50 Gas Flammable Cylinders By Roads 82 Hydrogen Peroxide 20 Liquid Corrosive Drums By Roads 83 Hyflo 42 Solid Non - Bags By Roads Flammable 84 Isopropanol 30000 Liquid Flammable Storage Tanks By Roads 85 L-Cysteine 32 Crystalline Non hazard Bags By Roads 86 Lithium bis(trimethylsilyl)amid 350 Solid Flammable Bags By Roads 87 Maleic acid 2020 Solid Combustible Bags By Roads 88 Methanesulfonic acid 114 Liquid Non - Drums By Roads Flammable 89 Methane sulfonyl chloride 45 Liquid Toxic Drums By Roads 90 Methanol 30000 Liquid Flammable Storage Tanks By Roads 91 Methanolic ammonia 1167 Liquid Flammable Drums By Roads 92 Methyl ((S)-2-(2-chloroacetamido)-4- 236 Powder toxic Bags By Roads phenylbutanoyl)-L-leucyl-L-phenylalaninate 93 Methyl[4-(5,6,7,8-tetrahydro-3,5,5,8,8- 2867 Solid Irritant Bags By Roads pentamethyl-2-naphthalenyl)carbonyl] benzoate 94 Methyltriphenyl phosphoniumbromide 2812 Powder Irritant Bags By Roads 95 Morpholine 39 Liquid Flammable Drums By Roads 96 N- Methyl pyrrolidine 700 Liquid Carcinogenic Drums By Roads 97 N-(2-Chloropyrimidin-4-yl)-N,2,3-trimethyl-2H- 394 Solid Irritant Bags By Roads indazol-6-amine 98 N-(3-Chloro-4-fluorophenyl)-7-fluoro-6- 167 Liquid Flammable Drums By Roads nitroquinazolin-4-amine 99 N-(2-Methyl-5-aminophenyl)-4-(3-pyridyl)-2- 522 Solid Flammable Bags By Roads pyrimidne amine 100 N,N,N′,N′-Tetramethyl-O-(1H-benzotriazol-1-yl) 83 Solid Flammable Bags By Roads uronium hexafluoro phosphate

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101 N,N-Diisopropylethylamine 5950 Liquid Flammable Drums By Roads 102 N,N-Dimethyl formamide 560 Liquid Flammable Drums By Roads 103 N.N’-Carbonyldiimidazole 2076 Solid Corrosive Bags By Roads 104 N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[4- 161 Powder Irritant Bags By Roads fluorophenyl)thio]-2-hydroxy-2- methylpropanamide 105 N-Acetyl cytosine 60 Liquid Irritant Drums By Roads 106 N-Bromo Succinamide 152 Solid Corrosive Bags By Roads 107 n-Butanol 6000 Liquid Flammable Drums By Roads 108 n-Hexane 770 Liquid Flammable Drums By Roads 109 N-Hydroxybenzotriazole 560 Solid Flammable Bags By Roads 110 N-methyl morpholine 26 Liquid Flammable Drums By Roads 111 N-methyl piperazine 36 Liquid Corrosive Drums By Roads 112 n-Pentyl Chloroformate 1474 Solid Flammable Bags By Roads 113 n-Propanol 8000 Liquid Flammable Drums By Roads 114 Oxalyl chloride 68 Liquid Toxic Drums By Roads 115 Pd/C 717 Solid Irritant Bags By Roads 116 Pd(dppf)cl2 in DCM 11 Solid Carcinogenic By Roads 117 phosphorous oxychloride 82 Liquid Corrosive Drums By Roads 118 Phosphorylchloride 1830 Liquid Toxic Drums By Roads 119 Potassium hydroxide 1425 Solid Corrosive Bags By Roads 120 Potassium Iodide 16 Solid Irritant Bags By Roads 121 Potassium tertiary butoxide 84 Solid Flammable Bags By Roads 122 Potassiumhexamethyl disilazide 882 Liquid Irritant Drums By Roads 123 p-Toluenesulfonic acid 2752 Liquid Flammable Drums By Roads 124 Pyridine 395 Liquid Flammable Drums By Roads 125 Pyrrolidine 140 Liquid Flammable Drums By Roads 126 Sodium chloride solution 2561 Solid Corrosive Bags By Roads 127 Silica gel 48 Beads Non- Bags By Roads Flammable 128 Methyl amine 23 Liquid Corrosive Drums By Roads 129 Sodium Bicarbonate 2335 Crystalline Irritant Bags By Roads 130 Sodium carbonate 430 Crystalline Irritant Bags By Roads

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131 Sodium hydroxide 5745 Liquid Corrosive Drums By Roads 132 Sodium iodide 45 Crystalline Irritant Bags By Roads 133 Sodium sulphate 42 Granules Non-Hazard Bags By Roads 134 Sodium Triazole 78 Powder Carcinogenic HDPE Bags By Roads 135 Sulphuric acid 14 Liquid Corrosive Drums By Roads 136 t-Butyl Methyl Ether 8500 Liquid Flammable Drums By Roads 137 t-butylmethylether .HCl 490 Liquid Flammable Drums By Roads 138 tert-butyl (S)-3-hydroxypiperidine-1-carboxylate 59 Solid Irritant Bags By Roads 139 Tert-butyl 4-(6-aminopyridin-3-yl) piperazine-1- 210 Crystalline Irritant Bags By Roads carboxylate 140 Tetrahydrofuran 6000 Liquid Flammable Drums By Roads 141 Thionyl chloride 469 Liquid Toxic Drums By Roads 142 Thiophosgene 114 Liquid Toxic Drums By Roads 143 Toluene 30000 Liquid Flammable Storage Tanks By Roads 144 Trans-4-dimethyl amino crotonic acid 60 Solid Corrosive Bags By Roads 145 Triacetoxy sodium borohydride 735 Solid Flammable Bags By Roads 146 Triethyl amine 3848 Liquid Flammable Drums By Roads 147 Trifluoromethanesulfonic anhydride 324 Liquid Corrosive Drums By Roads 148 Trimethyl Chlorosilane 18 Liquid Flammable Drums By Roads 149 Trimethyl silyl trifluoro methane sulphonate 245 Liquid Flammable Drums By Roads 150 Triphenylphosphine 77 Solid Irritant Bags By Roads 151 Triphenylphosphine palladium chloride 5 Crystalline Irritant Bags By Roads 152 Vinyl butyl ether 40 Liquid Flammable Drums By Roads 153 Zinc 2800 Solid Flammable Bags By Roads

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

7.3 Process Description The manufacturing process for all the products is presented in Chapter 2. (Page No. 2-2 to 2-83) of the report.

7.4 Plant Facilities The manufacturing facility shall be provided with 1) Production blocks 6) Tank farm area 2) Utilities 7) Cylinder Storage 3) Quality Control, R&D lab 8) Administrative Office 4) Effluent Treatment plant 9) Solvent recovery area 5) Warehouses 10) Coal and Ash Storage Area

The production facilities shall be designed for proper handling of materials and machines. Safety of operators, batch repeatability and process parameter monitoring shall be the major points of focus in the design of facility. The current Good Manufacturing Practices (GMP) guidelines shall be incorporated as applicable to synthetic organic chemicals manufacturing facilities.

7.4.1 Production Blocks: The Production blocks will consist of SS and glass lined reactors, storage tanks, shell & tube heat exchangers, evaporators, vacuum pumps, packed columns, Agitated Nutche Filter and Dryers, crystallizers, layer separators etc. The area shall be provided with proper concealed drainage facility and all process facilities shall be performed under protective environment.

7.4.2 Utilities: It is proposed to establish coal fired boilers of capacity of 2 x 8 TPH to meet steam requirement for process and ZLD system. The DG sets required for emergency power during load shut down is estimated at 5000 KVA and accordingly 1 x 1500, 2 x 1000, 3 x 500 kVA DG set are proposed. The list of utilities is presented in the following Table 7.4.

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

Table 7.4 List of Utilities S.No Utility Capacity 1 Coal Fired Boilers (TPH) 2 x 8 2 DG Sets (KVA)* 1 x 1500 2 x 1000 1 x 500 *DG sets will be used during load shut down periods only 7.4.3 Quality Control, R&D Lab The QC department shall comprise of an in-process lab with instruments like HPLC, GC etc. It will be maintained by highly qualified and trained people. The activities include: • In-process quality check during manufacturing • Validation of facilities • Complaint handling Also a process development laboratory shall be provided for in-house process development, initial evaluation of process technology in case of technology transfer, back- up for production department to address any issues arising during commercial production

7.4.4 ETP and Solid waste storage The total effluents segregated into two streams High COD/ TDS and Low COD/ TDS streams based on source of generation. These effluents are treated in Zero Liquid Discharge system and the treated effluents are reused for cooling towers and boiler make- up.

7.4.5 Ware Houses: The plant shall have sufficient storage facility for safe handling of raw materials. All solid raw materials shall be stored in marked areas with proper identification. Liquid raw materials and solvents like which are available in drums will be stored according to material compatibilities and flammability. Adequate fire fighting facilities shall be provided as per NFPA norms.

7.4.6 Tank Farm Area: A separate tank farm area shall be provided for storing liquid raw materials, especially solvents with high inventory and also for toxic, corrosive chemicals. Dykes shall be

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report provided to ensure safety in case of tank failure. Acid proof lining for the dykes shall be provided for acid storage tanks. Condensers for low volatile solvent storage tanks vents.

7.4.7 Cylinders storage Area: Gas cylinders storage should conform to SMPV-Unfired rules-1981. Hydrogen cylinders should be stored in approved Gas Storage pad. Chained and capped when not in use. Operational cylinder should be firmly secured. Pressure regulator, metal piping, non- return valve, and safe residue bleed off arrangement should be incorporated in installation design. Strict hot work control and display of danger signs should be ensured.

7.4.8 Administrative Office: An Administrative office shall be provided at the entrance of the factory to ensure the entry of authorized personnel only into the premises.

7.4.9 House Keeping: A regular house keeping schedule with adequate preventive maintenance shall be ensured so that the plant is consistently maintained as per GMP standards.

7.4.10 Coal and Ash Storage: Coal will be stored under covered shed with water sprinkler system in emergency. Ash silos will be provided for storage and handling of ash generated from combustion of coal.

Water sprinkling system shall be installed on stocks of coal in required scales to prevent spontaneous combustion and consequent fire hazards. The stack geometry shall be adopted to maintain minimum exposure of stock pile areas towards predominant wind direction

7.4.11 Facility layout and design: The layout of all the various areas required for the facility, as mentioned above is considered. In laying out the above areas, isolation of the various process areas from the utilities and non-process areas is considered in view of both containment and cGMP. A tentative plant layout is shown in Fig 7.1.

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Fig 7.1 Plant Layout of Actero Pharma Pvt. Ltd.

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Table 7.5 Risk Control Measures Significant Risks Control Measures Solvent Tank Farm and Chemical Tank Farm Fire/ Explosion • Solvent Tank Farm licensed by PESO. • Restrict inventory to licensed quantities in Solvent Tank Farm. • Fenced Solvent Tank Farm. • Fenced Solvent Tank Farm capable of being locked when not in use. • Access Control and control of visitors • Control of ignition sources. • All electrical equipment and fittings to be flameproof as per area classification. • Provision of foam cover to cover the largest dyke area • Water spray cooling arrangements for all tanks • Fire hydrants and fire monitors • Solvent Storage Tanks to have N2 blanketing • Earthrite system for earthing of tankers carrying solvents. • Spark arresters on vehicles • Wetting of road and tyres before unloading • NO dry grass inside the fenced area • No parking inside/ near the tank farm. • No obstruction on the road for free movement of fire tender. • No solvent pumping in night shift – Daytime operations only.

Loss of Containment • Dykes for all tanks (Dyke capacity to be min. 110% of tank capacity and Spillage and dyke distance from tank to be min half the tank height). • Tanker unloading area (road) to be dyked. • Availability of the Spill control kit.

Injury at the time of • Provision of PPE to stores personnel. loading/ unloading • Operations by trained stores personnel only.

Bulk Materials Store (liquid chemicals) Drum Yard and Special Chemicals Store Fire/ Explosion • Fenced area, Access Control and control of visitors • Building capable of being locked when not in use. • Control of ignition sources. • Control of inventory to minimum possible • Segregation of materials. • Smoke/ Heat detection system (non-electricity based) • No water based fire fighting setup around the store. • Adequate CAUTION displays • Fire hydrants and fire monitors • Provision of foam • No electrical installation inside the Store • Adequate natural light and ventilation. • Daily night inspection by Shift Manager.

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Significant Risks Control Measures • No dry grass inside the fenced area • Emergency exit.

Loss of Containment • Arrangements of drums in rows of two (two levels max) and a gap Spillage of at least 2 feet between rows and from the walls all around. • Storage in open area on hard impervious floor surrounded by a dyke/ sill. (For Bulk Materials Store and New Solvent Drum Shed) • Availability of the Spill control kit

Ergonomics – Poor • Provision of PPE to stores personnel. posture leading to • Loading/ unloading only by trained stores personnel. illness/ injury.

Injury at the time of loading/ unloading Raw Materials Warehouse, Finished Goods Warehouse, Packing Materials Warehouse, and Engineering Store Fire • Access Control and control of visitors • Fenced area • Building capable of being locked when not in use. • Control of ignition sources. • Control of inventory to optimal levels • Segregation of flammable materials. • Segregation of materials. • Battery charging not to be done inside the warehouse except for penicillin warehouse, that too during daytime only. • Installation of Smoke/ Heat detectors • Adequate hydrant points outside/around the building • NO dry grass in open areas. • Daily night inspection by Shift Manager. • Emergency exit. • Availability of DCP, Foam and CO2 fire extinguishers, Spill Control kit. Spillage • Availability of the Spill control kit Falling Objects • Mandatory head and foot protection when inside the warehouse.

Ergonomics – Poor • Provision of other PPE to stores personnel. posture leading to • Loading/ unloading only by trained stores personnel. illness/ injury. Injury at the time of loading/ unloading

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

7.5 Hazard Analysis and Risk Assessment 7.5.1 Introduction. Hazard analysis involves the identification and quantification of the various hazards (unsafe conditions) that exist in the plant. On the other hand, risk analysis deals with the identification and quantification of risks, the plant equipment and personnel are exposed to, due to accidents resulting from the hazards present in the plant.

Hazard and risk analysis involves very extensive studies, and requires a very detailed design and engineering information. The various hazard analysis techniques that may be applied are hazard and operability studies, fault-tree analysis, event-tree analysis and failure and effects mode analysis.

Risk analysis follows an extensive hazard analysis. It involves the identification and assessment of risks; the neighboring populations are exposed to as a result of hazards present. This requires a thorough knowledge of failure probability, credible accident scenario, vulnerability of population's etc. Much of this information is difficult to get or generate. Consequently, the risk analysis is often confined to maximum credible accident studies.

In the sections below, the identification of various hazards, probable risks, maximum credible accident analysis, consequence analysis are addressed which gives a broad identification of risks involved in the plant.

7.5.2 Hazard Identification (Terms of Reference No. 3(ix)) The Hazard identification process must identify hazards that could cause a potential major accident for the full range of operational modes, including normal operations, start-up, and shutdown, and also potential upset, emergency or abnormal conditions. Employers should also reassess their Hazard identification process whenever a significant change in operations has occurred or a new substance has been introduced. They should also consider incidents, which have occurred elsewhere at similar facilities including within the same industry and in other industries.

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Hazard identification and risk assessment involves a critical sequence of information gathering and the application of a decision-making process. These assist in discovering what could possibly cause a major accident (hazard identification), how likely it is that a major accident would occur and the potential consequences (risk assessment) and what options there are for preventing and mitigating a major accident (control measures). These activities should also assist in improving operations and productivity and reduce the occurrence of incidents and near misses.

The chemical and process industries have been using a variety of hazard identification techniques for many years, ranging from simple screening checklists to highly structured Hazard and Operability (HAZOP) analysis. Each technique has its own strengths and weaknesses for identifying hazards. It is impossible to compare hazard identification techniques and come to any conclusion as to which is the best. Each technique has been developed for a specific range of circumstances taking many factors into account including the resources required to undertake the analysis, expertise available and stage of the process. While HAZOP is primarily a tool for hazard identification, the HAZOP process can also include assessment of the causes of accidents, their likelihood and the consequences that may arise, so as to decide if the risk is acceptable, unacceptable or requires further study. Moreover, a formal guidance for applying this technique is available. Collaboration between management and staff is fundamental to achieving effective and efficient hazard identification and risk assessment processes.

After identifying hazards through a qualitative process, quantification of potential consequences of identified hazards using simulation modeling is undertaken. Estimation of probability of an unexpected event and its consequences form the basis of quantification of risk in terms of damage to property, environment or personnel. Therefore, the type, quantity, location and conditions of release of a toxic or flammable substance have to be identified in order to estimate its damaging effects, the area involved, and the possible precautionary measures required to be taken.

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

Considering operating modes of the facility, and based on available resources the following hazard identification process chosen are: a) Fire Explosion and Toxicity Index (FETI) Approach; b) HAZOP studies; c) Maximum Credible Accident and Consequence Analysis (MCACA); d) Classification of Major Hazard Substances; e) Manufacture Storage and Import of Hazardous Chemical Rules, 1989 (GOI Rules, 1989); f) Identification of Major Hazardous Units.

The physical properties of solvents used in the process are presented in Table 6.2 which forms the basis for identification of hazards during storage and interpretation of the Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 (GOI Rules, 1989)

The interpretation of “The Manufacture Storage and Import of Hazardous chemicals” issued by the Ministry of Environment and Forests, GOI, which guides the preparation of various reports necessary for safe handling and storage of chemicals shows that the present project requires preparation of safety reports before commencing operation and risk assessment is not mandatory. The applicability of various rules is presented in Table 7.6. Table 7.6 Applicability of GOI Rules to Storage/Pipeline S.No Name of Chemical Inventory Threshold Quantity (T) Applicable KL For Application of Rules Rules 5,7-9, 13-15 10 - 12 1 Acetic acid 15 1500 10000 4 (1) (a), (2), 5,15 2 Acetone 30 1500 10000 4 (1) (a), (2), 5,15 3 Dichloromethane 30 1500 10000 4 (1) (a), (2), 5,15 4 Dimethyl Formamide 30 1500 10000 4 (1) (a), (2), 5,15 5 Ethanol 30 1500 10000 4 (1) (a), (2), 5,15 6 Ethyl Acetate 30 1500 10000 4 (1) (a), (2), 5,15 7 Isopropyl alcohol 30 1500 10000 4 (1) (a), (2), 5,15 8 Methanol 30 1500 10000 4 (1) (a), (2), 5,15 9 Toluene 30 1500 10000 4 (1) (a), (2), 5,15

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

Table 7.7 Physical Properties of Raw Materials and Solvents S.No Name of Raw material TLV Toxicity Level Flammable Limit Chemical Class (ppm) LD50 LD50 LC 50 (As per MSIHC Rules) Oral Dermal (mg/1) LEL UEL FP BP Class (As per (mg/kg) (mg/kg) (%) (%) (OC) (OC) Petroleum Classification 1 Acetic acid 10 3310 1060 88 4 19.9 39 118 C Flammable/Corrosive 2 Acetone 1000 5800 20000 5540 2.6 13 <-20 56.2 B Flammable 3 Acetonitrile 40 3800 988 1000 3 17 2 81.6 B Flammable 4 Chloroform 50 908 20000 47702 ------61 --- Toxic 5 Dichloro methane 50 670 2800 2270 6 11.4 13 40 B Carcinogenic 6 Diethyl ether 400 1213 14268 2600 1.7 36 -40 34.6 B Flammable 7 Diisopropyl ether 250 8470 14480 162000 1 21 -28 67 C Flammable 8 Dimethyl formamide 10 2800 1500 15 2.2 16 58 153 C Flammable 9 Dimethyl sulfoxide 50 14500 5000 40250 1.8 63 95 189 B Non-Hazard 10 Ethanol 1000 1720 1025 20000 2.1 11.5 -4 77 B Flammable 11 Ethylacetate 400 5620 18000 2500 2.1 11.5 -4 77 B Flammable 12 Hexane 50 28710 2000 >20 1 8.1 -22 69 B Flammable 13 Isopropyl alcohol 400 5045 12800 100000 2 12.7 12 82.4 B Flammable 14 Methanol 200 5628 15800 64000 5.5 36.5 11 64.5 A Flammable 15 n-Butanol 100 2733 2000 --- 2.3 8.0 14 83 B Flammable 16 Methyl t-butyl ether 50 4000 10000 23576 1.6 15.1 -33 55.2 C Flammable 17 Tetrahydrofuran 200 1650 2000 2160 1.5 12.4 -21.5 66 B Flammable 18 Toluene 200 636 12124 313 1.2 8 4 110.6 B Flammable 19 Triethylamine 5 730 580 7.1 1.2 9.3 -11 90 B Flammable

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

7.5.3 Fire & Explosion Index (F & EI): 7.5.3.1 Methodology Dow Chemical Company issued a guideline for hazard determination and protection. By this method a chemical process unit is rated numerically for hazards. The numerical value used is the Fire and Explosion Index (F&EI) which is most widely used for hazard evaluation in chemical process industries.

The guide applies to process unit only and not to auxiliary units such as power generating stations, plant water systems, control rooms, fired heaters, structural requirements, corrosive nature of material handled and personal safety equipment. These are regarded as basic features that do not vary according to the magnitude of the fire and explosion hazard involved. The guide also does not cover the processing and handling of explosives such as dynamite, TNT etc.

Computation of F&EI

The F&EI is calculated as a product of Material factor, General process hazard factor, and special process hazard factor The Material factor is a measure of the intrinsic rate of potential energy release from fire or explosion of most hazardous material or mixture of materials present in significant quantity, whether it is raw material, intermediate, product, solvent etc, by combustion or chemical reaction. “In significant quantity” here means such quantity that the hazard represented by the material actually exists. The National Fire Protection Agency of USA (NFPA) have specified standard values for material factor which should be used for F&EI calculations and are available in Dow’s Hazard Classification Guide. In case it is not readily available, it can be calculated using the heat of combustion, flammability indices etc.

General process hazards are factors that play a primary role in determining the magnitude of loss of incident. It takes into account the nature of the reaction, ventilation of the unit, accessibility of the unit, drainage facilities etc., Special process hazards are factors that contribute primarily to the probability of a loss of incident. They consist of

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report specific process conditions that have shown themselves to be major causes of fire and explosion incidents. It takes into account toxicity of the material, operating pressure, operation near flammable range, quantity of material, joints and packing, use of hot oil exchange system etc., The F&EI index is calculated as a product of Material factor, General process hazard factor, and Special process hazard factor.

Hazard Ranking The hazard ranking based on F&EI value is presented in Table 7.8.

Table 7.8 Degree of Hazard for F&EI F&EI Index Range Degree of Hazard 1 – 60 Light 61 – 96 Moderate 97 – 127 Intermediate 128 – 158 Heavy 159 & above Severe

The estimated values of F&EI and hazard ranking are given in the Table 7.9. The radius of exposure is determined by 0.26 meter x respective F&EI. The estimated values of F&EI reflect light hazard in view of the low volume of chemicals.

The fire and explosion index evaluation can be very useful in developing plant layouts or adding equipment and buildings to existing plants. Evaluation of the F&EI calculations and layout considerations will result a safe, operable, maintainable and cost-effective arrangement of equipment and buildings. Table 7.9 Fire & Explosion Index for Tank farm S. Name of Solvent Fire & Radius of Degree of No. Explosion Index Exposure (m) Hazard (F1*F2*MF) F&EIx0.26 1 Acetic acid 71.58 18.61 Moderate 2 Acetone 76.78 19.96 Moderate 3 Dichloromethane 93.62 24.34 Moderate 4 Dimethyl Formamide 83.22 21.64 Moderate 5 Ethanol 64.48 16.76 Moderate 6 Ethyl Acetate 75.28 19.57 Moderate 7 Isopropyl alcohol 77.35 20.11 Moderate 8 Methanol 74.17 19.28 Moderate 9 Toulene 86.82 22.57 Moderate

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F& E index value calculated considering the maximum storage capacity of chemical and values are found to be moderate for all other solvents storage reflecting the threshold limits as prescribed in MSHC rules.

7.5.4 Hazard and Operability Study (HAZOP) Hazard and Operability Study (HAZOP) is a highly structured and detailed technique, developed primarily for application to chemical process systems. A HAZOP can generate a comprehensive understanding of the possible ‘deviations from design intent’ that may occur. However, HAZOP is less suitable for identification of hazards not related to process operations, such as mechanical integrity failures, procedural errors, or external events. HAZOP also tends to identify hazards specific to the section being assessed, while hazards related to the interactions between different sections may not be identified. However, this technique helps to identify hazards in a process plant and the operability problems. It is performed once the engineering line diagrams of the plant are made available. It is carried out during or immediately after the design stage. The purpose of the study is to identify all possible deviations from the way the design/operation is expected to work and all the hazards associated with these deviations. A multi- disciplinary team was constituted with chemical, mechanical and instrumentation engineers, R&D chemist and production manager. It is important to keep the team small enough to be efficient, while retaining a sufficient spread of skills and disciplines for all aspects of the study to be covered comprehensively. The group discussion is facilitated by a Chairman and the results of the discussion are recorded by a Secretary. Every investigation must be led by Chairman who is familiar with the HAZOP study technique, which is primarily concerned with applying, controlling the discussions and stimulating team thinking.

The preparative work for HAZOP studies consisted of four stages i.e., obtaining the data, converting into usable form, planning the sequence of the study and arranging the necessary meetings. The documents referred to for the study include process description, process flow diagrams, P&I diagrams plant layout, operating manuals including startup

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& shutdown, safety instructions etc., The parameters such as temperature, pressure, flow, level were investigated for deviation and hazard situations are identified.

Some basic definitions of terms frequently used in HAZOP studies are deviation, causes, consequences and guide words etc., Deviations are departures from the design intent which are discovered by systematically applying the guide words. Causes are the reasons why deviations might occur. Consequences are the reasons why deviations should they occur. Guide words are simple words used to understand a particular plant section in operating condition in order to guide and simulate the creative thinking process and so discover deviations. NO, less, more, as well as, part of, reverse, other than are guide words used.

Potential problems as represented by the consequences of the deviation should be evaluated as they arise and a decision reached on whether they merit further consideration or action. Except for major risk areas where a fully quantitative assessment is required this decision is made semi-quantitatively on the consequence (usually scaled as trivial, important or very probable).

7.5.5 Hazard Factors A study of past accident information provides an understanding of failure modes and mechanisms of process and control equipment and human systems and their likely effects on the overall plant reliability and safety. Some of the major contributing factors for accidents in chemical industries are: S. No Contributing Factor Percent Loss 1 Equipment design faults 41 2 Process design faults 10 3 Operator errors 31 4 Maintenance deficiencies 12 5 Material hazards 6

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7.5.6 Common Causes of Accidents Engineering and Instrumental Based on the analysis of past accident information, common causes of major chemical plant accidents are identified as: • Poor house keeping • Improper use of tools, equipment, facilities • Unsafe or defective equipment facilities • Lack of proper procedures • Improving unsafe procedures • Failure to follow prescribed procedures • Jobs not understood • Lack of awareness of hazards involved • Lack of proper tools, equipment, facilities • Lack of guides and safety devices • Lack of protective equipment and clothing

Failures of Human Systems An assessment of past chemical accidents reveals human factor to be the cause for over 60% of the accidents while the rest are due to other plant component failures. This percentage will increase if major accidents alone are considered for analysis. Major causes of human failures reported are due to:

• Stress induced by poor equipment design, unfavorable environmental conditions, fatigue, etc. • Lack of training in safety and loss prevention. • Indecision in critical situations. • Inexperienced staff being employed in hazardous situations.

Often, human errors are not analyzed while accident reporting and accident reports only provide information about equipment or component failures. Hence, a great deal of uncertainty surrounds analysis of failure of human systems and consequent damages. The number of persons/materials are potentially exposed to a specific hazard zone is a function of the population density and distribution near the accident location. The failure rate data and ignition sources of major fires are presented in the following Tables 7.10 and 7.11.

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Table 7.10 Failure Rate Data S.No Item International Data 1. Process Controllers 2.4 x 10-5 hr-5 2. Process control valve 2.0 x 10-6 hr-1 3. Alarm 2.3 x 10-5 hr-1 4. Leakage at biggest storage tank 5.0 x 10-5 yr-1 5. Leakage of pipe line 1 x 10-7 m-1 yr-1 6. Human Failure 1 x 10-4 (demand)-1

Table 7.11 Ignition Sources of Major Fires S.No Ignition Source Percent 1. Electrical (wiring of motors) 23% 2. Smoking 18% 3. Friction 10% 4. Over heated material 8% 5. Burner flames 7% 6. Combustion sparks 5% 7. Spontaneous ignition 4% 8. Cutting & welding 4% 9. Exposure (fires jumping into new areas) 3% 10. Mechanical sparks 2% 11. Molten substances 1% 12. Chemical actions 1% 13. Static sparks 1% 14. Lightening 1% 15. Miscellaneous 1%

7.6 Maximum Credible Accident and Consequence Analysis (MCACA) The potential hazards due to flammable and toxic nature of the raw materials, process streams and products can be quantified. However, it is necessary to carry out a hazard analysis study to visualize the consequences of an unexpected release from chemical plant, which consists of a number of process units and tank farm facilities. The present study provides quantified picture of the potential hazards and their consequences.

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7.6.1 Methodology MCACA aims at identifying the unwanted hazardous events, which can cause maximum damage to plant and personnel. At the first instance, all probable accident scenarios are developed. Scenarios are generated based on properties of chemicals, physical conditions under which reactions occur or raw materials stored, as well as material strength of vessels and conduits, in-built valves and safety arrangements, etc. Creating a scenario does not mean that it will occur, only that there is a reasonable probability that it could. A scenario is neither a specific situation nor a specific event, but a description of a typical situation that covers a set of possible events or situations. The following steps are involved in identifying the maximum credible accident scenarios. a. A detailed study of the process and plant information including process flow diagrams and piping & instrumentation diagrams. b. Hazard classification of chemicals, operations and equipment. c. Identification of representative failure cases of vessels and the resulting release scenarios d. Establishment of credibility of visualized scenarios based on past accident data.

7.6.2 Identification of Vulnerable Areas The unit operations in the process and storage areas involve mass and energy transfer operations to effect the necessary physical changes. Nature of chemicals and the operating conditions create special hazardous situations. In the present case the chemicals handled are flammable and toxic in nature. With these factors in mind a thorough examination of the process information is carried out and a list of inventories of the hazardous chemicals is prepared to identify the hazardous situations. Based on the raw material consumptions determined from the pilot scale studies, experience in handling commercial scale processes and logistics in procurement of raw materials, the inventories to be maintained for each of the raw material and its mode of storage is determined. High inventory liquid raw materials like solvents are usually stored in tank farms, while solids and other low inventory liquids are stored in ware house based on compatibility,

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7.6.3 Representative Accident Scenarios A study of past accidents, which took place in similar process units and the present plant, provides reasons and course of accidents and there by focusing on most critical areas. A thorough examination of engineering details indicated many possible scenarios like gasket leak, pinholes in pipes and vessels apart from rupture of pipelines and vessels and catastrophic failure of vessels resulting in a pool. Heat radiation damage distances for Pool fire was considered.

Failure Frequency: The release scenarios considered above can be broadly divided in to two categories (i) Catastrophic failures which are of low frequency and (ii) Ruptures and leaks which are of relatively high frequency

Vapor or liquid release from failure of gasket, seal and rupture in pipe lines and vessels fall in second category whereas catastrophic failure of vessels and full bore rupture of pipe lines etc., fall in to first category. Typical failure frequencies are given in Table 7.12.

Table 7.12 General Failure Frequencies Item Mode of failure Failure frequencies Pressure Vessel Serious leak 1.0*10-5/Year Catastrophic 3.0*10-6/Year Pipe lines =50 mm dia Full bore rupture 8.8*10-7/m.year Significant leak 8.8*10-6/m.year >50 mm =150 mm dia Full bore rupture 2.6*10-7/m.year Significant leak 5.3*10-6/m.year >150 mm dia Full bore rupture 8.8*10-8/m.year Significant leak 2.6*10-6/m.year hose Rapture/Failure 4.0*10-5/hr Unloading arm Rapture/Failure 3.0*10-8/hr Check valve Failure on demand 1.0*10-4/on demand motor operated valve Failure on demand 1.0*10-3/ on demand Flange Leak 3.0*10-4/ Year Pump seal Leak 5.0*10-3/ Year

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Gasket failure Failure 5.0*10-5/ Year Process safety valve(PSV) Lifts heavily 4.0*10-3/ Year Blocked 1.0*10-3/ Year Lifts lightly 6.0*10-2/ Year

7.7 Consequence Analysis The accidental release of hazardous chemicals leads to subsequent events, which actually cause the damage. The damages are of three types. 1) Damage due to heat radiation. 2) Damage due to Over pressure effects subsequent to explosion 3) Damage due to toxic effects The type of damage and extent of damage depends on nature of chemical, the conditions of release, atmospheric conditions and the subsequent events. The sequence of probable events following the release of a hazardous chemical is schematically shown in Figure 7.2. The best way of understanding and quantifying the physical effects of any accidental release of chemicals from their normal containment is by means of mathematical modeling. This is achieved by describing the physical situations by mathematical equations for idealized conditions and by making corrections for deviation of the practical situations from ideal conditions. In the present study ALOHA software from USEPA. These models for various steps are described in the following sub-sections.

7.7.1 Release Models and Source strength This depends on the nature of failure of the unit and the content of the unit and operating temperature and pressure of the unit. The release may be instantaneous due to total failure of storage unit or continuous due to leakage or rupture of some component of the storage facility. The material discharged may be gas or liquid or the discharge could be manifested through two phase flow. The models that are used to calculate the quantity of liquid/vapor released are:

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Fig 7.2 Steps in Consequence Calculations The following criteria tables present heat radiation intensities (Table 7.13), radiation exposure and lethality (Table 7.14), and damage due to peak over pressure is presented in Table 7.15. Table 7.13 Damage Due to Incident Radiation Intensities S. No Incident Type of Damage Intensity Radiation Damage to Equipment Damage to the People (KW/m2) 1 37.5 Damage to process Equipment 100% lethality in 1 min. 1% lethality in 10 sec. 2 25.0 Minimum energy required 50 % lethality in 1min. to ignite wood at indefinitely long Significant injury in 10 sec. exposure without a flame 3 19.0 Maximum thermal radiation --- intensity allowed n thermally unprotected adjoining equipment. 4 12.5 Minimum energy to ignite with 1% lethality in 1 min. a flame, melts plastic tubing

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5 4.0 -- Causes pain if duration is longer than 20 sec, however blistering is unlikely ( First degree burns) 6 1.6 -- Causes no discomfort on Longer exposure Source: Techniques for Assessing Industrial Hazards by World Bank

Table 7.14 Radiation exposure and lethality Radiation Intensity Exposure Time 1% Lethality Degree Burns (KW/m2) (seconds) 1.6 -- 0 No Discomfort even after longer exposure 4.5 20 0 1st 4.5 50 0 1 st 8.0 20 0 1 st 8.0 50 <1 3 rd 8.0 60 <1 3 rd 12.0 20 <1 2 nd 12.0 50 8 3 rd 12.5 -- 1 -- 25.0 -- 50 -- 37.5 -- 100 --

Table 7.15 Damage Due to Peak Over Pressure Human Injury Structural Damage Peak Over Type of Damage Peak over Type of Damage Pressure (bar) Pressure (bar) 5 – 8 100% lethality 0.3 Heavy (90%Damage) 3.5 – 5 50% lethality 0.1 Repairable (10%Damage) 2 – 3 Threshold lethality 0.03 Damage of Glass 1.33 – 2 Severe Lung damage 0.01 Crack of Windows 1 – 11/3 50% Eardrum rupture - - Source : Marshall, V.C.(1977)’ How lethal are explosives and toxic escapes.

7.7.2 Results of Consequence Analysis The damages due to the accidental release of chemicals are of three types. a) Damage due to heat radiation b) Damage due to Over pressure effects subsequent to explosion c) Damage due to Toxic effects

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7.7.2.1 Analysis of Hazardous Scenarios The hazardous chemicals involved are stored within the threshold limits of storage and hence few representative chemicals mainly solvents were studied.

7.7.2.1.1 Heat radiation effects (Terms of Reference No. Sp. TOR (13)) When a non-boiling liquid spills, it spreads into a pool. The size of the pool depends on the availability of the bund and obstacles. The heat load on objects outside a burning pool of liquid is calculated with the heat radiation model. The average heat radiation intensity, the diameter-to-height ratio dependent on the burning liquid, geometric view, distance from the fire, relative humidity of air, horizontal or vertical orientation of the object radiated with respect to fire are factored. All storage tanks in tank-farm area are provided with dykes. For each of the hazardous chemicals involved various scenarios such as pipe line leaks of 5mm or pipeline ruptures or catastrophic vessel ruptures of the inventories as outlined have been considered and damage distances for Lower Flammability Limits (LFL) and heat radiation effects for the three levels of intensity are calculated and presented in Table 7.16 . Heat radiation damage distances for most of the scenarios are not occurring in the case of release from 25 mm holes at a height of 0.1 m from the bottom of the tank for one hour, in the storage tanks. In case of pipeline leaks, 5 mm leaks are considered for 15 mm and 50 mm pipe sizes. The release rates from 5 mm leaks are observed to be low, and these leaks have low incident hazard. The concentration of the flammable material in the vapor cloud was found to be below the lower flammability limits. Table 7.16 Heat Radiation Damage Distances – Tank Farm (Pool Fire) S.No Name of Raw material Tank Diameter Height Release Heat radiation damage Capacity (m) (m) Rate distances in m for KW/m2 (KL) (Kg/sec) 37.5 12.5 4.0 1 Dichloromethane 30 3.1 4.0 2.07 <10 <10 12 2 Dimethyl Formamide 30 3.1 4.0 0.41 <10 <10 <10 3 Ethanol 30 3.1 4.0 0.38 <10 <10 <10 4 Methanol 30 3.1 4.0 0.38 <10 <10 <10 5 Acetone 30 3.1 4.0 0.38 <10 <10 <10 6 Isopropyl alcohol 30 3.1 4.0 0.38 <10 <10 <10 7 Acetic acid 15 2.3 3.8 0.43 <10 <10 <10

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8 Ethyl Acetate 30 3.1 4.0 0.40 <10 <10 <10 9 Toulene 30 3.1 4.0 0.40 <10 <10 11

Table 7.17 Heat Radiation Damage Distance – Hydrogen Cylinders S. Scenario Release Storage Tank Details Heat radiation damage No. Description Rate distances in m for KW/m2 Kg/sec Height Diameter Storage 37.5 12.5 4.0 (m) (m) Pressure 1 Hydrogen Gas 5.42 0.87 0.27 350 Bar <10 12 20 Cylinder (50Kg)

7.7.2.1.2 Overpressure effects:

When an unignited gas cloud mixes with air and reaches the flammable range and if the cloud ignites wither a flash fire or flash fire explosion can occur. Since the burning time is shorter, instead of heat radiation from a flash fire, peak overpressure as a function of distance from the centre of the cloud is derived. In case of pipeline leaks, damage distances due to overpressure effects are not observed. The values are found to be similar as there are no pressurized storage tanks in the tank farm, and the over pressure distances are contingent on the tank capacity.

7.7.3 Observations:

From the previous incident records published in literature and hydrocarbon release data bases, it has been observed that pinhole leaks contribute highest percentage where as the second cause is small sized leaks of 25 mm diameter in tank farm. Accordingly the consequence analysis was carried out for 25 mm sized leaks in the tank farm.

7.7.4 Recommendations:

The following are the recommendations to minimize the hazards and improve the safety of the proposed plants. Plants of this nature, which handle a variety of chemicals, face problems of fire and vapor cloud explosions. It has been observed that the damage distances are more or less confined to the plant area only. Taking precautionary safety measures as outlined below can further minimize these effects.

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• In view of hazardous nature of operations, it is recommended to adopt best practices with respect to design, operation and maintenance. • It is recommended that all flammable areas and process area be maintained free of ignition sources. Ensure that sources of ignition, such as pilot lights, electrical ignition devices etc., at strategic locations like solvent storage areas are avoided. • All electrical fittings involved in and around the pipeline and operation system should conform to flame/explosion proof regulations. • Strict hot work control and display of danger signs should be ensured. • It is recommended to provide one fire hydrant point in the tank-farm area to take care of any emergency. Installation of fire water hydrant net work is suggested. • It is suggested to provide fire extinguishers in process plant at solvent storage area and the vents of solvent tanks to be provided with PESO approved flame arrestors. • Fire protection equipment should be well maintained so that it is available when required. They should be located for quick accessibility. Provide carbon dioxide fire extinguishers and DCP extinguishers for Electrical fires. • It is suggested to have a periodical review of safety awareness and safety training requirements of plant employees with respect to hazards present in the plant. • In general, all pipelines carrying flammable liquids/vapor are periodically checked for their integrity. Spillages have to be avoided and disposal should be done quickly.

7.7.5 Toxic Management Plan (Terms of Reference No. Sp. TOR (14)) The list of chemicals identified to have toxic or carcinogenic nature is presented in Table 7.18. Table 7.18 List of Toxic/Carcinogenic Chemicals and Mode of Storage/Transport S.No Name of Raw Material Maximum Physical Type of Mode of storage Form Hazard Storage (Kgs) 1 2,3-di-o-acetyl-5-deoxy-5- 3222 Liquid Carcinogenic Drums fluorocytidine 2 3-chloro-4-(3- 58 Liquid Toxic Drums cyclopropylureido)phenol

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3 3-Chloro-4-fluoro aniline 1514 Powder Toxic 4 4-Dimethylamino pyridine 10 Crystalline Toxic HDPE Bags 5 4-Chloro-7-methoxy-6- 61 Solid Carcinogenic Bags quinolinecarboxamide 6 Acetone cyanohydrin 118 Liquid Toxic Drums 7 Ammonium hydroxide 396 Liquid Toxic Drums 8 Chloroform 5250 Liquid Carcinogenic Drums 9 1,8-Diazabicyclo[5.4.0]undec-7- 56 Liquid Toxic Drums ene 10 Dichloromethane 30000 Liquid Carcinogenic Storage Tanks 11 Diisopropyl azodicarboxylate 60 Liquid Carcinogenic Drums 12 Dimethylacetamide 1225 Liquid Carcinogenic Drums 13 Ethylene dichloride 70 Liquid Toxic Drums 14 Ethynylbenzenamine 364 Liquid Toxic Drums 15 Methane sulfonyl chloride 45 Liquid Toxic Drums 16 Methyl ((S)-2-(2-chloroacetamido 236 Powder toxic Bags )-4-phenylbutanoyl)-L-leucyl-L- phenylalaninate 17 N- Methyl pyrrolidine 700 Liquid Carcinogenic Drums 18 Oxalyl chloride 68 Liquid Toxic Drums 19 Pd(dppf)cl2 in DCM 11 Solid Carcinogenic 20 Phosphorylchloride 1830 Liquid Toxic Drums 21 Sodium Triazole 78 Powder Carcinogenic HDPE Bags 22 Thionyl chloride 469 Liquid Toxic Drums 23 Thiophosgene 114 Liquid Toxic Drums

Handling: Storage & handling in compliance with MSDS. The transfer of solvents shall be mainly by closed pipeline systems, while solvents are transferred from drums by using air operated diaphragm pumps in closed hoods. Solid phase raw materials are charged by using closed hoppers to avoid dust emissions and hazard of static electricity. SOP’s for better operational control.

Engineering Control Measures: All the operations filtration and drying is conducted in closed conditions. Forced dry ventilation system to hoods. Vent condensers in series to reactors, distillation columns, driers and centrifuge to mitigate atmospheric emissions of toxics. Solvents with low boiling point will be stored in double limpet coil storage tanks with coolant circulation.

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Vents of secondary condensers connected to vacuum pumps followed by tertiary condenser. Common headers connecting all the process vents and the same are connected to scrubbers. Low boiling solvents tanks are connected with reflux condensers to minimise the loss. The transfer pumps shall be provided with mechanical seals.

Personnel Protective Equipment: Personal protective equipment shall be provided to all employees including contract employees. All the employees shall be provided with gumshoe, helmet, masks, goggles. The other equipment like ear muffs, gloves, respirators, aprons etc., will be provided to employees depending on the work area allocated to them. The PPE selection shall strictly follow the prescribed guidelines of MSDS.

Health Monitoring of Employees: The pre employment screening and periodic medical examination shall follow the guidelines of factories act. The pre employment screening shall obtain medical history, occupational history followed by physical examination and baseline monitoring for specific exposures. Frequency of Health Monitoring Occupation Type of evaluation Frequency Process Physical Height Once a year for area Observation Weight regular Eyes Color vision employees. Detailed Test Hearing Ability; Physical Status Half yearly for General Condition; Previous Accidents contract Skin Infections; Any Physical Handicap employees Clinical Lungs; Heart; Hydrocele; Central Nervous Observation System; Liver functioning; Diabetes; Any operations undergone; Symptoms of communicable and other contagious disease and Medical fitness Noise Area Audiometry Annually

7.7.6 Transportation (Terms of Reference No. 7(iii) All the raw materials and finished products are transported by road. Dedicated parking facility will be provided for transport vehicles. The plant is located near national highway, and there will not be any unauthorized shop or settlements along the road connecting the plant site. There will be 20-25 truck trips per day to the factory. Safety

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Transportation of raw materials may result in accidents due to high speed collision, low speed collision, overturning and non-accident-initiated release. The initiating and contributing causes are presented in Table 7.19 Table 7.19 Truck Incidents – Initiating and Contributing Causes Human Errors Equipment Failures System or Procedural External Events Failures Driver Non-dedicated trailer Driver incentives Vandalism/ Impairment Sabotage Speeding RR crossing guard Driver training Rain Driver Overtired Failure Carrier selection Fog Contamination Leaking Valve Container Specification Wing Overfilling Leaking Fitting Route selection Flood/washout

Other Vehicle's Brake Failure Emergency response Fire at rest Driver training areas/parking areas Taking Tight Insulation/Thermal Speed Enforcement Earthquake Protection Failure Unsecured Load Relief device failure Driver rest periods Existing accident Tire failure Maintenance Inspection Soft shoulder Overpressure Time of day Restrictions Material defect Steering failure Sloshing High center of gravity Corrosion; Bad Weld; Excessive Grade Poor Intersection design Suspension system

The scenarios presented for storages are calculated for transport related incidents/accidents and presented in Table 7.20.

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Table 7.20 Transportation Specific Concerns Concern Road Spill on Water Over or near a body of water Unconfined Pools In an undisturbed flat area BELVE-Induced catastrophic vessel Possible if sufficient quantity in car with small leak to failure feed fire or if double tank trailer or burning fuel leak Toxic products of combustion or Dependent on material and whether ignition occurs reaction

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7.7.7 Control Measures for Accidental Spillage of Chemicals Name of the Storage Details Hazard Rating Systems Type of Hazards Involved Persons Control Measures Chemical Stored Quantity Pressure/ TLV STEL FP Effected (KL) Temp (PPM) (PPM) (OC) Acetone 30 NTP 1000 500 -20 Highly flammable liquid Operators Keep away from and vapor. Maintenance heat/sparks/open flames/hot Causes serious eye Technicians surfaces. - No smoking. irritation. Avoid breathing dust/ fume/ May cause drowsiness or gas/ mist/ vapors/ spray. IF IN dizziness. EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Safety board’s displayed on the tank. Effective ventilation must be provided. For accidental contact if you feel unwell, seek medical advice immediately. Handling of Acetone with Safety gloves and protective clothing Dimethyl 30 NTP 10 58 Flammable liquid and Operators Avoid exposure - obtain special Formamide vapor Maintenance instructions before use. Harmful in contact with Technicians Avoid contact with skin and eyes. skin Avoid inhalation of vapor or mist. Causes serious eye Keep away from sources of irritation ignition - No smoking. Take Harmful if inhaled measures to prevent the buildup of electrostatic charge. Wear respiratory protection. Avoid breathing vapors’, mist or gas. Ensure adequate ventilation. Methanol 20 NTP 1000 1000 14 Highly flammable liquid Operators Keep away from and vapor. Maintenance heat/sparks/open flames/hot Technicians surfaces. Use personal protective

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equipment. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Remove all sources of ignition. Evacuate personnel to safe areas. Dichloromethane 20 NTP 50 13 Limited evidence of a Operators Do not breathe carcinogenic effect. Maintenance gas/fumes/vapour/spray. Technicians Avoid contact with skin and eyes Wear suitable protective clothing and gloves. Store in cool place. Keep container tightly closed in a dry and well-ventilated place. Containers which are opened must be carefully resealed and kept upright to prevent leakage Toluene 20 NTP 200 4 Highly flammable liquid Operators Keep away from and vapor. Maintenance heat/sparks/open flames/hot May be fatal if swallowed Technicians surfaces. - No smoking. and enters airways. Avoid breathing dust/ fume/ Causes skin irritation gas/ mist/ vapours/ spray. May cause drowsiness or Use personal protective equipment dizziness. as required. May cause damage to IF SWALLOWED: Immediately organs through prolonged call a POISON CENTER or or repeated exposure doctor/ physician. Do NOT induce vomiting. Use personal protective equipment. Avoid breathing vapors, mist or gas. Ensure adequate ventilation

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7.8 Disaster Management Plan (Terms of Reference No. 7(xiii)

7.8.1 Introduction A disaster is a catastrophic situation in which suddenly, people are plunged into helplessness and suffering and, as a result, need protection, clothing, shelter, medical and social care and other necessities of life.

Disasters can be divided into two main groups. In the first, are disasters resulting from natural phenomena like earthquakes, volcanic eruptions, storm surges, cyclones, tropical storms, floods, avalanches, landslides, and forest fires. The second group includes disastrous events occasioned by man, or by man's impact upon the environment. Examples are armed conflict, industrial accidents, radiation accidents, factory fires, explosions and escape of toxic gases or chemical substances, river pollution, mining or other structural collapses, air, sea, rail and road transport accidents and can reach catastrophic dimensions in terms of human loss.

There can be no set criteria for assessing the gravity of a disaster in the abstract since this depends to a large extent on the physical, economic and social environment in which it occurs. However, all disasters bring in their wake similar consequences that call for immediate action, whether at the local, national or international level, for the rescue and relief of the victims. This includes the search for the dead and injured, medical and social care, removal of the debris, the provision of temporary shelter for the homeless, food, clothing and medical supplies, and the rapid re- establishment of essential services.

An emergency may be said to begin when operator at the plant or in charge of storage of hazardous chemicals cannot cope up with a potentially hazardous incident, which may turn into an emergency. The emergencies could be a major fire or explosion or release of toxic gas or a combination of them.

The proposed plant will store fuels, which are flammable in nature, and the storage will be as per the Controller of Explosives and OISD norms. The hierarchy of the employees is

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report yet to be determined and the project is still in the initial stages of designing. Hence a tentative disaster management plan is prepared to be suitably modified before commissioning of the plant.

7.8.2 Objectives of Emergency Management Plan (ON-SITE) (Terms of Reference No. 7(xiii) A quick and effective response during emergency can have tremendous significance on whether the situation is controlled with little loss or it turns into a major emergency Therefore, the objectives of this Onsite Emergency Plan (ONSEP);

During Emergency: Is to provide basic guidance to the personnel for effectively combating such situations to minimize loss of life, damage to property and loss of property.

• To localize the emergency and if possible eliminate it; • To minimize the consequences of an emergency; • To prevent spreading of the damage in other areas; • To give necessary warning to plant personnel and neighborhood; • To maximize resource utilization and combined efforts towards the emergency operations; • To mobilize internal resources and utilize them in the most effective way; • To arrange rescue of persons, transport and treatment of causalities; • To seek necessary help from industries in neighborhood or local authorities; • To provide information to government agencies and to provide information to public.

During Normal Time:

• To keep the required emergency equipment in stock at right places and ensure their working condition; • To keep the concerned personnel fully trained in the use of emergency equipment; • Preserving records, evidence of situation for subsequent emergency etc.

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7.8.3 Scope of ONSEP This ONSEP is prepared for industrial emergencies like fires, explosions, toxic releases, asphyxia and does not cover natural calamities and societal disturbances related emergencies (like strikes, bomb threats, civil Commissions etc). Also, the scope of this ONSEP is limited to onsite emergencies and does not include measures for off site Emergency Management. Necessary information with regards to Off Site Emergency Management will be furnished to district authorities.

7.8.4 Methodology of Developing ONSEP The consideration in preparing this Emergency Plan includes the following steps: • Identification and assessment of hazards and risks; • Identifying, appointment of personnel & Assignment of Responsibilities; • Identification and equipping Emergency Control Center; • Identification of Assembly, Rescue points, Medical Facilities; • Formulation of plan and of emergency sources; • Training, Rehearsal & Evaluation; • Action on Site.

Earlier, a detailed Hazard Analysis and Risk Assessment were carried out for the plant facilities and the hazards are quantified. The likely locations of hazards and consequences are evaluated, duly following the standard procedure.

7.8.5 Elements of Onsite Emergency Plan Important elements considered in this plan are: • Identification of emergencies • Emergency organization • Emergency facilities • Emergency procedures • Communications during emergency • Rescue, Transport and Rehabilitation

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• Roles and responsibilities of key personnel and essential employees • Mutual aid.

7.8.5.1 Emergencies Identified Spillage, pool fire, are the possible emergencies in the pipelines, fire near storage, DG set, and Transformers are the other possible emergencies.

The other emergencies are asphyxiation of persons, apart from risks due to cyclonic conditions, earth quake, lightning, floods (natural calamities), sabotage, bombing (social and other reasons) etc. which are not under the management control.

Priority of protection in the event of an emergency is; Life and safety of personnel, preservation of property, restoration of normalcy.

7.8.5.2 Emergency Organization The project employs a total of 300 people in 3 shifts. The general shift will be for the administrative employees, while the three shifts of 8 hours each are for technical employees. Key personnel and essential employees are identified and are assigned emergency responsibilities.

Security personnel, all operators, fitters, electricians etc. in the shifts are designated essential employees. During emergencies, their services are drafted for essential operations.

7.8.5.3 Emergency Facilities a) Emergency Control Center (ECC) It is a location where all key personnel like Chief Coordinator, Emergency controller, maintenance coordinator can assemble and monitor aspects related to emergency and take decisions related to emergency. The office room is designated as ECC. In case if this area is affected, zone security room is designated as alternative ECC.

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The following information and facilities would be maintained at the ECC in Plant Control room: Latest copy of Onsite Emergency Plan and Offsite Emergency Plan (as provided by District Emergency Authority) • Intercom Telephone; • P& T Telephone; • Telephone directories (internal and P&T); • Factory Layout, site plan; • P&I diagrams, electrical connections plans indicating locations of hazardous inventories, sources of safety equipment, hydrant layout, location of pump house, road plan, assembly points, vulnerable zones, escape routes; • Hazard chart; • Emergency shutdown procedures for generators and fuel supply system; • Nominal roll of employees; • List and addresses of key personnel; • List and addresses of emergency coordinators; • List and addresses of first aid providers; • List and addresses of employees trained in fire fighting; • List and addresses of qualified trained persons; • Material safety data sheets of raw materials; • Duties of key personnel; • Important addresses and telephone numbers including those of fuel supplying company, government agencies, neighboring industries and other sources of help, outs side experts; The following emergency equipment is made available at alternate ECC (Security point): • Fire proximity suit/Gloves/Helmets; • Hand tools suitable for pipe lines (non sparking type); • Gaskets;

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• Teflon tape; • Gas Explosimeter; • Flame proof torches/batteries; • 1/2 crow bar; • Spade; • Manila rope; • Spark arrestor; • Spare fan belt for truck; • First aid box; • Special fire fighting information related to Hydrocarbon fuels; • Public address megaphone, hand bell, Emergency torch. b) Assembly points Office room is identified as Assembly point and is in a low intensity fire affected zone. Additionally the following places in plan are designated as safe assembly points: Time office, and green belt area near the main road. The locations of assembly points would be reviewed later. c) Fire fighting Facilities The fire fighting facilities which shall be provided are presented in Table 7.21. Table 7.21 List of Fire Extinguishers S.No Description of Item Quantity 1. DCP 10 kg 80 Nos. 2. Foam 50 ltrs 50 Nos. 3. CO2 22.5 kg 30 Nos. 4. CO2 6.8 kg 25 Nos. 5. ABC Soda Acid 5 kg 40 Nos. 6. ABC Soda Acid 1 kg 40 Nos. 7. Fire Buckets with stand 50 Nos. d) Location of First aid Boxes The first aid boxes will be located at the following places: preparation areas, administrative office, time office, and will be under the charge of security coordinator.

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report e) Emergency siren Emergency siren will be provided with 0.5 km range of audibility and the location will be time office. The siren will operate on regular supply and also on emergency electrical supply. Shift electrical engineer of plant on receipt of information from shift incharge, is authorized to operate the siren. f) Emergency escapes Emergency escapes in the plant area and floor wise emergency escapes will be conspicuously marked. g) Wind sock Wind socks to observe the wind directions will be installed on the top of Turbine Plant house.

7.8.5.4 Emergency Procedures a) Procedure for Raising Emergency alarm Whenever and whoever notices an emergency or a situation with a potential emergency should forthwith raise alarm by calling on the available communication network or shouting or approaching the shift incharge, furnishing details. Anybody noticing fire should inform the plant control room immediately. The shift electrical engineer at control room informs the site controller. b) Control Room staff If an emergency is reported then plant control room staff must, request for the location, nature and severity of emergency and obtain the caller's name, telephone number, and inform the shift incharge or site controller who ever are available in the shift. c) Emergency communication The following communications will be used during emergencies; P&T Telephones, intercom, walkie-talkies, hand bell and siren. If any of the equipment is not working, runners would be engaged to send the communication.

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Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report d) Warning/Alarm Communication of emergency Emergency siren would be operated to alert all other employees on the orders of manager (electrical). The emergency is communicated by the Emergency siren mode of wailing for 3 minutes. When the emergency has been brought under control, the Emergency controller will direct plant control staff giving an 'all clear signal', by way of normal siren (continuously for 3 minutes).

7.8.5.5 Rescue and Rehabilitation Emergency vehicle will be made available round the clock under the charge of manager (electrical) who is emergency coordinator. Security personnel are trained in rescue operations. Persons rescued would be taken to First aid centre for further medical attention or Safe Assembly Points as per the condition of the rescued person. a) Transport Vehicles and Material Trucks The transport vehicles and vehicles with materials would immediately withdraw to outside the factory. Security guard of the shift is responsible for this. Transport vehicles would wait at the security at the main entrance to provide emergency transport. This is ensured by security coordinator. b) Mock drill Occasional mock drill is essential to evaluate that the ONSEP is meeting the objectives. Adequate training is given to all staff members before conducting the mock drill. Mock drills will be initiated with table top exercise, followed by pre-informed mock drills, and few uninformed mock drills in the first phase. Functional exercises (communication, Emergency shut down, fire fighting at different locations, rescue etc.) are carried out in the second phase.

Mock drills will familiarize the employees with the concept and procedures and help in evaluating their performance. These scheduled and unscheduled mock drills are conducted during shift change, public holidays, in night shift once in 6 months.

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Response time, strict adherence to discharge of responsibilities, difficulties and inconsistencies experienced are recorded and evaluated. Fire officer will assists Emergency coordinator in designing and extending such mock drills and in evaluating the response. c) Review The Emergency plan is reviewed periodically to evaluate the effectiveness, and during change in organizational structure, isolation of equipment for longer duration, and during increase in inventory of fuel and other chemicals. Manger Electrical and Emergency coordinator initiates and authorizes such review as and when required, and the changes if any will be duly informed to all the employees concerned.

7.8.5.6 Emergency Responsibilities I. Chief Coordinator The chief coordinator shall be General manger and Alternate is Manager Electrical. • He is overall incharge of emergency operations. • He reaches emergency control center as soon as he receives emergency information. • He coordinates with emergency controller, maintenance coordinator. • He provides necessary resources required at the emergency site. • He will inform the inspector of factories, and other statutory authorities. • Prepares accident report/investigation. • Arranges for keeping records of chronological events and orders an investigation report and preserves evidence. • Gives a public statement if necessary.

II. Emergency controller - Shift in charge On receiving the message about emergency; • He will assume charge as chief coordinator till general manger arrives at scene and takes charge as a chief coordinator.

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• Takes actions to minimize the consequences and directs emergency management and fire control/other causes with available personnel to put off or to reduce the consequences. • On the arrival of chief coordinator, he will hand over the charge of Chief coordinator and assists him. • He will identify the need of evacuating any personnel in the vicinity of the affected zone. • Exercises operational control of the installation and outside the affected area and directs emergency operations. • Declares emergency and orders plant control room for operation of emergency siren. • Continuously reviews and assesses possible development to determine most probable courses of events. • Initiates suspension of all work permits during the period of major emergency for safe guarding the plant and other personnel.

III. Incident Controller The Supervisor assumes the role of incident controller in the following instances of emergencies. • Protects himself and proceeds to site quickly. • Assess the magnitude of the incident. • Initiates the emergency procedure to secure the safety of the workers and minimise damage to installation and property. • He will undertake all possible steps for safe isolation of plant systems, first aid and fire fighting. • He keeps in touch with plant control room till emergency controller arrives at the scene of emergency, • Organizes essential employees present in the shift.

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• Ensures that adequate personal protective equipment is available foe essential employees. • Arranges for search of causalities. • Arranges evacuation of non-essential workers to assemble at designated assembly points. • During the fire fighting operations seeks help from electrical/mechanical maintenance personnel for isolation of machine/section involved in fire as the need arises. • Once the situation is under control, guides different persons for salvage and cleanup operations. • Assists in assessing the loss, preparation of accident report with the assistance of security officer and senior officials of respective departments present during the accident, investigates the fire with a view to find out causative factors ad action needed to prevent recurrence.

IV. Communicator – production supervisor • The Control Room Shift Electrical Engineer assumes the role of Communicator and passes the information related to emergency to Incident Controller and Chief Coordinator. • Other vulnerable installation in the plant is alerted about the emergency. • On the Instructions from chief coordinator, neighboring installations are alerted about the emergency. • On the instructions from Chief Coordinator, mutual assistance is called from neighboring industries. • On the instructions from Chief Coordinator, seeks help form fire brigade. • Provides emergency Telephone rosters are provided in Plant control room and Fire Station.

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V. Maintenance Coordinator Dy. Manager Mechanical shall assume the role of maintenance coordinator. His responsibilities include; • Protecting him self. • Reaching the emergency spot. • Arranging all resources for assisting Emergency controller to mitigate the Emergency scene, with respect to maintenance requirements. • Assisting Emergency controller in arranging the needed containment measures. • Undertaking post emergency maintenance work upon termination of emergency. • Ensuring availability of adequate quantities of protective equipment and other emergency materials, spare parts etc at Emergency control center. • Ensuring upkeep of fire systems, emergency lighting in order.

VI. Resource Coordinator Shift in charge shall assume the responsibility of resource coordinator. • Arranges first aid, rescue acts, ambulance, attendance roster checking and security. • Interacts with chief coordinator for all emergency operations. • Assists chief coordinator with necessary data and coordinates the emergency activities. • Maintains liaison with civil administration and mutual aid agencies - neighboring industrial management. • Ensures availability of humanitarian needs and maintenance of rehabilitation center. • Ensures emergency transport facility. • Mobilizes extra medical help from outside if necessary. • Maintains first aid and medical emergency requirements.

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• Keeps list of qualified first aid providers and seeks their assistance. • Ensures availability of necessary cash for rescue/rehabilitation and emergency expenditure. • Coordinates mutual aid. • Participates in reviewing Emergency plan and arranges revision if required.

VII. Security Coordinator. The production supervisor will assume the responsibilities of security coordinator, and his responsibilities are; • On receipt of fire call from plant control he prepares for fire fighting and collects necessary equipment. • Organizes rescue of persons trapped in work areas. • Assists administration coordinator in organizing Mock drills, evaluation and debriefing. • During normal situations keeps the fire fighting capabilities in fully ready condition by maintaining equipment. • Organizes fire drills on periodic basis and evaluates the same. • Arranges to clear off unconnected persons and trucks from the vicinity and off the main gate. • Instructs security guards posted on duty in the nearby industries to cordon off the affected section and to control the crowd at the scene of fire. • Arranges to control law and order till local authorities for Law and order till police arrive at site. • Post security guard at the scene of fire to check for possible re-ignition, after the emergency is over. • Assists Resource coordinator in organizing Mock Drills, evaluation and debriefing. • VIII. Person Noticing Fire

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Any employee on noticing fire will take the following steps; • Takes protection • Raises alarm – shouts fire! Fire!! Fire!!! Or other emergency. • Informs Shift Incharge, or at the control room over telephone giving clear message about the exact location of fire and names of equipment/machinery involved in fire. • If Telephone is not working, quickly goes to either Plant Control Room and informs.

IX. Trained Fire Fighting Person The employees trained in fire fighting will take the following steps in the event of fire apart from following the instructions of security coordinator apart from; • Protects self • Raises alarm • Attempts to put out the fire using fire extinguishers. • If necessary, operates fixed fire fighting equipment. • Stands by in safety for further instructions.

7.8.6 Remedial Action The cause of emergency is identified and action is taken from operation point of view such as isolating or shutdown etc.

I. Failure of pipelines: feeding into the pipeline is stopped. Isolate the leaking pipeline by closing the relevant valves. Transfer the material present to other pipelines. Shutdown the pump. Close the suction and discharge valves of the pump

II. Personal Protection: The people, who are assigned to the rescue operations, must wear suitable personnel protective equipment such as self-contained breathing apparatus and fire suit. They should remain in the incident area as

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long as he can safely stay there. In spite of the wearing safety protective equipment if he is unable to stay in the contaminated area, he should leave immediately.

7.8.7 BASIC ACTION IN EMERGENCIES Immediate action is the most important factor in emergency control because the first few seconds count, as fires develop and spread very quickly unless prompt and efficient action is taken. • Take immediate steps to stop leakage/fire and raise alarm simultaneously. • Initiate action as per fire organization plan or disaster management plan, based on gravity of the emergency. • Stop all operations and ensure closure and isolation valves. • All effort must be made to contain leakage/fire. • Saving of human life shall get priority in comparison to stocks/assets. • Plant personnel with specific duties should assemble at the nominated place. • All vehicles except those required for emergency use should be moved away from the operating area, in an orderly manner by the predetermined route. • Electrical system except for control supplies, utilities, lighting and fire fighting system should be isolated. • If the feed to the fire cannot be cut off, the fire must be controlled and not extinguished. • Start water spray system at areas involved or exposed to fire risks to avoid domino effects. • In case of leakage of chemicals without fire and inability to stop the flow, take all precautions to avoid source of ignition. • Block all roads in the adjacent area and enlist police support for the purpose if warranted.

7.8.8 FIRE FIGHTING OPERATIONS Enlist support of local fire brigade and neighboring industries. • Fire fighting personnel working in or close to unignited vapor clouds or close to fire must wear protective clothing and equipment including safety harness and manned lifeline. They must be protected continuously by water sprays. Water

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protection for fire fighters should never be shut off even though the flames appear to have been extinguished until all personnel are safely out of the danger area.

• Exercise care to ensure that static charge is not generated in vapor cloud. For this purpose solid jet of water must be avoided, instead fog nozzles must be used.

• Fire fighters should advance towards a fire in down wind direction.

• If the only valve that can be used to stop the leakage is surrounded by fire, it may be possible to close it manually. The attempt should be directed by trained persons only. The person attempting closure should be continuously protected by means of water spraying (thorough fog nozzles), fire entry suit, water jet blanket or any other approved equipment. The person must be equipped with a safety harness and manned lifeline.

• Any rapid increase in pressure or noise level of should be treated as a warning of over pressurization. In such case all personnel should be evacuated immediately.

• In case of any emergency situation, it is of paramount importance to avoid endangering human life in the event of fire, involving or seriously exposing plant equipment.

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8.0 PROJECT BENEFITS

8.1 Introduction

Actero Pharma Pvt. Ltd. proposes to set up a Synthetic Organic Chemicals (Bulk Drugs & Intermediates) Unit of Production capacity 165 TPM in an area of 11.275 acres of land on lease from principle organization M/s. Dasami Lab Pvt. Ltd., for a lease period of 25 years at Sy. No 407 (Part) and 411, Veliminedu (V), Chityal Mandal, Nalgonda District, Telangana.

8.2 Employment Potential

The proposed expansion will provide employment to 300 people. It will be spending approximately Rs. 67.5 Lakhs of rupees every month on salaries providing bread and succor to 300 families additionally. The proposed project will also generate indirect employment to the locals during construction phase in the order of 180 people for a period of 24-30 months. The employers will contribute to the provident fund, ESI and provide facilities as per the relevant labour act.

8.3 Corporate Social Responsibility

The management proposes to spend 2.5% of the capital cost and 2% of profits during operation towards social development activities in the surrounding villages. The objective is to obtain a social licence from the stake holders who are likely to be affected due to the proposed manufacturing activities.

Tax Income The proposed capital expenditure of Rs. 35 crores includes GST on various equipment and services to the tune of Rs. 4.5 crores. The provision of employment also directly contributes to additional income tax and also indirectly contributes to additional GST due to various transactions. The operation of the expansion project also results in additional GST from revenue, additional income tax on profits and from employee salaries.

8-1 Team Labs And Consultants Actero Pharma Lab Pvt. Ltd. Environmental Impact Assessment Report

9.0 ENVIRONMENT COST BENEFIT ANALYSIS

The TOR letter F.No. J-11011/59/2017-IA II (I) dated 26.05.2017, does not mention Environment Cost Benefit Analysis and hence the same was not conducted.

9-1 Team Labs And Consultants ACTERO PHARMA PVT. LTD. SY.NO. 407 (PART) AND 411, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA

2. ENVIRONMENT MANAGEMENT PLAN

Project No. 0118‐21‐03 January 2018

M/s. Actero Pharma Pvt. Ltd. STUDIES AND DOCUMENTATION BY C/o. Hetero Drugs Limited TEAM Labs and Consultants Plot No: 7‐2‐A2 Hetero Corp, Industrial Estate, B‐115‐117 & 509, Annapurna Block, Sanathnagar, Hyderabad‐500018 Aditya Enclave, Ameerpet, Phone: 040‐23704923/23704924 Hyderabad‐500 038. E‐mail: [email protected]; Phone: 040‐23748 555/23748616, [email protected] Telefax: 040‐23748666

SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD, REGIONAL OFFICE, NALGONDA Actero Pharma Pvt. Ltd. Environment Management Plan

10.0 ENVIRONMENT MANAGEMENT PLAN

10.0 Introduction Environmental protection is an issue that no organization can neglect and hope to survive. The by-products of civilization are being dumped upon the environment to a degree that the environment finds difficult to assimilate. The key to the success of the integrated approach to pollution prevention and control is the management and operation of the organization. Effective committed management delivers a successful industry. As total commitment to the environment, not just for compliance with legal or regulatory compliance will be the essence of environment management of an industry. Many companies have recognized the benefits of implementing an effective environmental management system.

Environmental management plan can be effectively implemented to mitigate the pollution levels by observing the following;

1. Pollution will be prevented or reduced at the source, 2. Pollution that cannot be prevented will be recycled in an environmentally safe manner, 3. Pollution that cannot be prevented or recycled will be treated in environmentally safe manner, and 4. Disposal and other releases into the environment will be used “only as a last resort” and will be conducted in an environmentally safe manner.

The management plan is drawn in consultation with the project proponents with reference to various potential monitored, identified and predicted in the previous chapters. And the necessary measures to be taken for the mitigation and control of the same presented, various pollution control measures adopted which are present in the proposed project and measures identified for adoption are discussed in the Environmental Impact Assessment Report of the same are presented in appendix of the Environmental Impact Assessment Report. Review of the process is the essential component of Environmental Management M/s. Actero Pharma Pvt. Ltd. has been conducting experiments to optimize the consumption of raw materials and to increase the purity of the product.

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Actero Pharma Pvt. Ltd. Environment Management Plan

10.1 Environment Management Plan 10.1.1 Construction Phase

The potential of pollution during construction phase due to transport of construction materials will be less compared to operational stage. However industry will ensure that pollution potential in the construction phase is at a minimum. Wherever applicable, detailed procedures will be developed for control of pollution during project execution phase for proposed project. Separate rooms will be provided for labors and casual workers. The following measures are to be adopted to minimize pollution load during construction phase

Sanitation Considering the standards of hygiene, the workers involved in construction will be provided temporary toilets, and drinking water. The toilets will be attached to septic tank so as to minimize the percolation and to control the subsequent impact on the environment. These facilities will be properly designed and maintained to ensure minimum environmental impact.

Noise The site is located in a place where habitation is minimum and at distance of 2.1 Km. Thus there will be insignificant impact due to noise on the inhabitants. The construction workers on site will be provided with personal protective equipment like earmuffs whenever for those who work near noise generating equipment/sources.

Wastes from Construction Equipment Construction activity involves a number of operations that utilize equipment like DG sets, dozers, cranes etc. These equipment are a source of emissions and solid wastes. Proactive maintenance to mitigate emissions, while the hazardous solid wastes of waste oils and used batteries are sent to authorized recyclers. Spillage is avoided and spill control measures are adopted to minimize contamination of soil and ground water resources. The empty containers of paints, thinners etc shall be sold to authorized buyers.

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10.1.2 Operation Phase During operation stage the major pollution from the proposed unit is from liquid effluents from process, utilities and domestic facilities, and air pollution from utilities and or combustion of fuels/wastes. The effluent treatment system will convert most of the liquid effluents to solids by way of evaporation of salts and ETP sludge. The environment management plan is drawn in consultation with the project authorities, R&D experts of Actero Pharma Pvt. Ltd. and other technical consultants involved in preparing the project plan. The management, mitigation and enhancement measures identified for significant impact sources are presented as follows;

10.2 Sources of Pollution from Manufacturing Process: The major contributions of pollution from proposed API unit are effluent generation from process, utilities and domestic sources and gaseous emission from process and utilities. The water pollution is due to the effluent generated from process, washings, scrubbings, utility blow downs and domestic sources. The air pollution is caused due to process operation and combustion of both fuels and solid/gaseous wastes. The treatment of effluents and recovery operations of solvents generate salts and residues respectively, in addition to residues from process operations, which are considered hazardous wastes. The quantities and quality of effluents, emissions and solid wastes are identified and quantified in the environmental impact assessment study. The environment management measures proposed are described as follows;

10.2.1 Water Pollution (Terms of Reference No. 3(vi) & 7(iv))

The effluents generated in the process, separation techniques and during purification contain organic residues and inorganic raw materials, solvents, and products. Hence the effluents contain both organic and inorganic salts in various quantities leading to high COD and TDS concentrations respectively. Effluents from process, washings, Scrubbing media, utility blow downs and domestic wastewater will be sent to the effluent treatment system. The treated effluent will be reused for cooling towers and boiler makeup. The total effluent

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Actero Pharma Pvt. Ltd. Environment Management Plan generated and mode of treatment is presented in Table 10.1. The compiled characteristics of process effluents for each product is presented in Table 10.2. Table 10.1 Total Effluents Generated and Mode of Treatment Description Quantity Mode of Treatment (KLD) HTDS Effluents Process 51.4 Sent to Stripper. Stripper condensate shall be disposed to Washings 5 cement industries for co-processing/TSDF. Stripper Scrubber Effluent 3 bottom is sent to MEE followed by AFTD. Condensate RO/DM Rejects 8.5 from MEE shall be sent to biological treatment plant followed by RO. RO rejects are sent to MEE and permeate is reused in cooling towers and boiler make-up. Total - I 67.9 LTDS Effluents Boiler Blow downs 8 Sent to Biological Treatment System followed by RO. RO Cooling Tower Blow 23 permeate reused for cooling towers and boiler makeup. downs RO rejects are sent to MEE. Domestic 12.5 Total - II 43.5 Grand Total (I+II) 111.4

Table 10.2 Process Effluents Quantity and Quality – Product Wise S.No Name of Product Quantity (Kg/Day) Water Input TDS COD Total Effluent 1 Abiraterone Acetate 550 8.6 41.2 613 2 Afatinib 1650 154.1 45.8 2037 3 Anastrazole 1100 119.7 9.3 1226 4 Bicalutamide 735 0.3 5.2 739 5 Bendamustine HCl 1500 74.8 65.5 1670 6 Bexarotene 3500 372.7 138.3 4058 7 Bosutinib 590 86.4 21.4 1171 8 Capecitabine 2500 194.1 62.4 2791 9 Carfilzomib 3420 226.6 54.1 3698 10 Ceritinib 1110 104.6 44.1 1919 11 Cyclophosphamide 4500 278 181.8 4925 12 Dasatinib 2190 9.6 52.2 2233 13 Docetaxel 1500 3.4 64.2 1566 14 Enzalutamide 650 8.3 36.1 699 15 Erlotinib HCl 2115 3.2 215.5 2252 16 Gefitinib 2800 86.9 120.3 3030 17 Gemcitabine HCl 770 54.3 36.2 850 18 Ibrutinib 1450 156.8 18.8 1622 19 Imatinib Mesylate 1570 21.9 13.2 1608 20 Lapatanib 6000 638.8 64.3 6825 21 Lenvatinib 595 5.8 3.4 604

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22 Olaparib 1095 38.6 13.4 1517 23 Palbociclib 781 23.3 12.7 991 24 Pazopanib 800 82.2 81.2 973 25 Sorefinib 1000 4.1 1.7 1006 26 Sunitinib 500 2.2 20 548 27 Tamoxifene 3230 57.7 186.6 3442 Total Worst Case: 22 Products on campaign 45315.6 2803.7 1576.5 51407.2 basis

10.2.1.1 Process Description and Technical Specification of Effluent Treatment System (Terms of Reference No. 7(iv) & Sp. TOR (5)) The Effluent management system is developed to ensure `Zero Liquid Discharge’. Seggregation of effluents is an integral part that facilitates effective treatment of various effluent streams. The effluents are segregated into two streams; High COD/ TDS and Low COD/ TDS streams. Effluents generated from Process, washings, Scrubbers, DM/RO Rejects are considered as High COD/TDS. Blow downs from boiler, cooling towers and wastewater from domestic usage are considered as Low COD/TDS stream.

The High TDS/ COD Effluents The treatment system for treating High TDS/ COD effluents consists of equalization, neutralization, settling tank, stripper, multiple effect evaporator (MEE) followed by agitated thin film dryer (ATFD). The organic distillate from the stripper is sent to cement plants for co-incineration and aqueous bottom from stripper is sent to MEE followed by ATFD for evaporation. The condensate from the MEE and ATFD are sent to Effluent treatment plant based on biological treatment. Salts from ATFD are disposed to TSDF.

The Low TDS/ COD Effluents: These effluents along with the condensate from MEE and ATFD are treated in primary treatment consisting of equalization, neutralization, and primary sedimentation followed by secondary biological treatment consisting of aeration tank and clarifier.

The treated effluents after biological treatment are subjected to tertiary treatment in a reverse osmosis (double RO) system. Permeate from RO is reused for cooling towers and boiler make-up while rejects are sent to MEE followed by ATFD. Sludge from various units

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Actero Pharma Pvt. Ltd. Environment Management Plan of Biological treatment are thickened in sludge handling system and sent to TSDF. Schematic diagram of effluent treatment system is presented in Fig 10.1. Details of treatment facilities are presented in Table 10.3. Technical specifications of effluent treatment system are presented in Table 10.4 and 10.5 respectively.

Table 10.3 Details of Treatment Facilities S.No Facility Description Capacity (KLD) Designed Operating 1 Stripper 80 56.4 2 Multiple Effect Evaporator 100 86.4 3 Agitated Thin Film Dryer 10 6.7 4 Biological Treatment Plant 150 126.9 5 Reverse Osmosis Plant - I 150 126.9 6 Reverse Osmosis Plant - II 60 50.8

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Tank

Water

Tank Filters Holding Clarifier Storage Treated

to

Bed

Cake Press

TSDF Sludge Tank Filter Drying Aeration Sludge

&

Plant

Double RO Neutralization Equalization

Oil Rejects Water Towers

Skimmer

Sump Collection Recycle Cooling

To Screen Chamber

&

MEE to

To TDS

COD Ind./TSDF

Low

Distillate

Org. Cement

Effluent,

Rejects

Condensate Organic Distillate Fig 10.1 Schematic Diagram of Effluent Treatment System Fig 10.1 Schematic Diagramof Effluent Treatment DM/RO Scrubber

&

Thin TSDF

Effect

Dryer to

TDS/COD

tank Film Settling Stripper Evaporator Salts Agitated Multiple High Neutralization Equalization to

TSDF Sludge

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Actero Pharma Pvt. Ltd. Environment Management Plan

Table 10.4 Technical Specifications of Effluent Treatment System S.No Description Unit Value Stripper 1 Design Capacity KLD 80 2 Feed Rate Kg/hr 2000-4000 3 Specific Gravity of Feed ≈ 1.03 4 Initial Feed COD PPM 20000-60000 5 Feed Total Solid % 2.0-4.0 6 High Heating Temperature OC 95 – 100 7 High COD Condensate recovery LPH 50-100 8 Dry Saturated Steam requirement at 3.0Kg/cm2 (g) TPH 0.6-1.0 9 Cooling Water circulation rate for condenser m3/hr 1.0-2.0 10 Cooling Water Inlet Temperature OC 30 – 32 11 Cooling Water Outlet Temperature OC 38 – 40 12 Operating Condition Multiple Effect Evaporator (MEE) 1 Design Capacity KLD 100 2 Feed Rate Kg/hr 2000-5000 3 Feed Concentration mg/l 30000-90000 4 Feed Temperature OC 30 5 Initial Solids % 5.0-10.0 6 Solids in Concentrate % 35.0-40.0 7 Concentrate Output Kg/hr 400-600 8 Water Evaporation Rate Kg/hr 4000-5000 9 Designed Water Evaporation Rate Kg/hr 4000 10 Dry Saturated Steam requirement at 6.0Kg/cm2 (g) TPH 1.5-2.5 11 Cooling Water Circulation Rate at 30 – 32OC m3/hr 3.0-4.0 12 Cooling Water Inlet Temperature OC 30 – 32 13 Cooling Water Outlet Temperature OC 38 – 40 Agitated Thin Film Dryer (ATFD) 1 Designed Capacity KLD 10 2 Feed Rate Kg/hr 300-500 3 Initial Feed Solid Content % 35.0-40.0 4 Final Moisture in Dry Bag-gable Product % 2.0-3.0 5 Water Evaporation Rate Kg/hr 200-300 6 Designed Water Evaporation Kg/hr 250 7 Solid Output in Bag-gable form at 5 – 6% moisture Kg/hr 150-200 8 Dry Saturated Steam requirement at 6.0Kg/cm2 (g) Kg/hr 15.0-30.0 9 Cooling Water Circulation Rate at 30 – 32OC m3/hr 0.6-1.0 10 Cooling Water Inlet Temperature OC 30 – 32 11 Cooling Water Outlet Temperature OC 38 – 40

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Actero Pharma Pvt. Ltd. Environment Management Plan

Table 10.5 Technical Specifications of Biological Treatment Plant Biological Treatment Design Capacity : 150 m3/day Flow : 126.9 m3/day Peak flow : 264.2 m3/day BOD : 775 mg/l COD : 2093 mg/l Total Dissolved Solids : 416 mg/l BOD load : 102 kg/day COD load : 277 kg/day Total Dissolved Solids : 55 kg/day 1. Neutralization Tank Average flow : 13.3 m3/hr Hydraulic retention time : 12 hrs. at peak flow Volume : 160 m3 Tank : 2 no. Proposed based on Daily flow. 2.Aeration Tank - 1 BOD(yo) : 775 mg/l % of BOD removed : 80 BOD Load : 102.4 kg/day COD : 2093 mg/l COD Load : 277 kg/day Outlet BOD : 155 mg/l MLSS : 6000 mg/l F/M ratio : 0.18 Flow : 160 m3/day Volume of the Tank : 106.2 m3 Check for Detention time : 15.9 Hours (12 - 24) Assuming depth : 3.5 m (4.0+0.5 F.B) Area of the tank : 30.34 m2 Width of the tank : 5.51 m Length of the Tank : 2.75 m BOD5 load in the aeration tank : 102.41 Oxygen is required for every Kg of BOD5 to : 2.00 kgs be removed Oxygen requirement for aeration : 204.82 kg/day

O2 in Air % : 0.21 % Density of Air : 1.20 Oxygen requirement : 50.00 m3/kg O2/day Air Required : 10241.15 m3/day : 251.63 cfm Consider 35% excess considering the air required in the equalization tank. Total air required : 339.69 Kg O2/day 3.Clarifier - 1 Design quantity : 160 m3/m2-day Surface loading rate of average flow : 12 m2

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Actero Pharma Pvt. Ltd. Environment Management Plan

Surface area provided : 13.3 m length of the tank (2l=b) : 3.65 m (Say 4.0 m) Width of the tank : 1.83 m (Say 2.0 m) 4.Aeration Tank - 2 BOD(yo) : 110 mg/l % of BOD removed : 80 BOD Load : 14.5 kg/day COD : 220 mg/l COD Load : 29 kg/day Outlet BOD : 22 mg/l MLSS : 5500 mg/l F/M ratio : 0.18 Flow : 160.0 m3/day Volume of the Tank : 145.5 m3 Check for Detention time : 21.8 Hours (12 - 24) Assuming depth : 3.5 m (4.5+0.6 F.B) Area of the tank : 41.56 m2 Width of the tank : 6.45 m Length of the Tank : 3.22 m BOD5 load in the aeration tank : 14.52 Oxygen is required for every Kg of BOD5 to : 2.00 kgs be removed Oxygen requirement for aeration : 29.03 kg/day O2 in Air % : 0.21 % Density of Air : 1.20 Oxygen requirement : 50.00 m3/kg O2/day Air Required : 1451.68 m3/day : 35.67 cfm Consider 35% excess considering the air required in the equalization tank. Total air required : 48.15 Kg O2/day 5.Clarifier - 2 Design quantity : 160 m3/m2-day Surface loading rate of average flow : 12 m2 Surface area provided : 13.3 m length of the tank (2l=b) : 3.65 m (Say 4.0 m) Width of the tank : 1.83 m (Say 2.0 m) 6. Holding tank The flow from the each individual settling tank i.e., the supernatant liquid is let into the respective Pre-Filtration Tank, which has a minimum 8 hours holding capacity. This tank is provided to hold the treated effluent and give an even flow to the pressure sand filter. Average flow : 13.3 m3/hr Peak factor : 2 m3/hr Peak flow : 26.7 m3/hr Provide min 1.5 hours holding capacity. Hence required volume of the tank : 40 m3 7. Pressure Sand Filter:

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Actero Pharma Pvt. Ltd. Environment Management Plan

Vertical down flow type with graded/sand bed under drain plate with polysterene strains. Flow : 160 m3/day Rate of filtration assumed as : 15 m3/m2/hr Requirement of treated water for usage in 20 hrs : 8 m3/hr Dia of filter of 1 nos. : 824.26 mm Provide a Pressure Sand filter of 800 mm say 950 mm dia with sand as media over layer, under drain pipe, laterals face piping etc., 8. Activated Carbon Filter: Vertical down flow type with graded/sand bed under drain plate with polysterene strains. Flow : 160 m3/day Rate of filtration assumed as : 15 m3/m2/hr Requirement of treated water for usage in 20 hrs : 8 m3/hr Dia of filter of 1 nos. : 824.26 mm Provide activated carbon filter of 800 mm say 950 mm dia with sand as media over layer, under drain pipe, laterals face piping etc., 9. Reverse Osmosis -1: Design Capacity : 150 KLD Operating capacity : 126.9 KLD Recovery : 60% RO Permeate : 76.1 KLD RO rejects : 50.8 KLD 10. Reverse Osmosis - 2: Design Capacity : 60 KLD Operating capacity : 50.8 KLD Recovery : 60% RO Permeate : 30.5 KLD RO rejects : 20.3 KLD

10.2.2 Air Pollution (Terms of Reference No. 3(vi))

The manufacturing process consists of reaction, separation and purification. The reaction is conducted in closed reactors, while the separation is conducted in centrifuge, filtration equipment etc. Purification would be conducted in reactors or filtration equipment. The transfer of materials will be through closed pipelines. Various sources of emissions are identified from process operations. The usage of boiler for steam generation, power and DG sets for emergency power back up are also a source of emissions.

10.2.2.1 Emissions from Utilities (Terms of Reference No. 7(v) The sources of air pollution are proposed 2 x 8 TPH Coal fired boiler and proposed DG sets of 1 x 1500 kVA, 2x 100 kVA, 3 x 500 kVA. The proposed air pollution control equipment

10-11 Team Labs and Consultants

Actero Pharma Pvt. Ltd. Environment Management Plan for 2 x 8 TPH coal fired boilers is bag filter. DG sets shall be provided with effective stack height based on the CPCB formula. The emission rates of SO2, NOx and PM from each stack are presented in Table 10.6. Technical specifications of Bag filters for 10 TPH boiler is presented in Tables 10.7 Table 10.6 Emission Details of Pollutants from Stack S. Stack Connected to Stack Dia of Temp. of Exit Pollutant Emission No Ht stack at exhaust Velocity Rate (g/sec) 0 (m) top(m) gases ( C) (m/sec) PM SO2 NOx 1 2 x 8 TPH Coal Fired 30 0.9 130 6.05 0.6 0.7 0.25 Boilers 2 1 x 1500 kVA DG set* 12 0.2 180 10 0.02 0.03 0.5 3 2 x 1000 kVA DG set* 7 0.2 170 10 0.09 0.25 0.38 4 3 X 500 kVA DG set* 5 0.2 200 6.8 0.002 0.025 0.04 *DG sets will be used during load shut down by TRANSCO.

Table 10.7 Technical Specifications of Bag Filter - 8TPH Coal Fired Boiler S.No Application Unit Value 1 Boiler Capacity TPH 8 Fuel Coal 2 Gas Volume m3/hr@170 degC 22000 Gas Temperature Deg C 145 Outlet emission mg/Nm3 <50 Flange to flange pr. drop mmWC 130 Moisture Content % 8.5 No. of Bags 245 Filter area per bag m² 1.75 Total filter area m² 429

Air to cloth ratio m³/min/m² 1.14 3 Bags Diameter ID, mm 150 Length mm 3650 Material Nomex Max. operating temp. degC 190 4 Bag Cleaning Compressed air required Nm3/Hr 5-7 kg/cm2 No. pulse cum solenoid valve 10 Size of pulse valve NB 40 5 Material of Construction Casing MS 6 Tube Sheet MS Cage MS Hopper MS 7 Terminal Points

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Actero Pharma Pvt. Ltd. Environment Management Plan

Dirty air Inlet of Poppet Valve, Flanged end Clean air Outlet of Bag Filter, Flanged end Dust discharge RALV Compressed air Inlet of Air Header Electricals Power Supply for Timer 230 V Ac

10.2.2.2 Emissions from Process

The source of process emissions are reactors, where gaseous products are released, or excess gaseous raw material used in production, which mainly contain inorganic gases. The other emissions from process operations and effluent treatment system are mainly known as diffuse emissions containing dusts, fumes and volatile organic compounds. The VOCs from among the diffuse emissions are the main cause of odour in the plant area and its neighborhood. Spillage, leakage and accidental releases are the causes of fugitive emissions, releasing solids, liquids and fumes of volatile organic compounds resulting in soil and ground water contamination in addition to odour in the plant area. a. Process Emissions: The process emissions contain Ammonia, Hydrogen, Hydrogen chloride, and Sulfur dioxide. Ammonia, Hydrogen chloride and Sulphur dioxide are sent to scrubber in series. Sodium chloride from Hydrogen chloride, ammonium chloride from ammonia, sodium bisulfate from sulfur dioxide scrubbing sent to ETP. Hydrogen gas is let out into atmosphere through a water column. The quantity of process emissions is presented in Table 10.8. Schematic diagram of Scrubbing system is presented in Fig 10.2. Technical Specifications of two stage scrubber is presented in Table 10.9 Table 10.8 Quantity and Mode of Treatment of Process Emissions S.No Name of Stage Name of the Gas Quantity Mode of treatment Product (Kg/day) 1 Afatinib II Ammonia 7 To Scrubber Hydrogen 0.1 Let into atmosphere safely 2 Bicalutamide I Hydrogen 0.2 through water column 5 Bosutinib II Hydrogen Chloride 1.9 To Scrubber III Hydrogen Chloride 0.7 To Scrubber 6 Capecitabine I Hydrogen Chloride 37.3 To Scrubber 7 Ceritinib I Hydrogen Chloride 51.5 To Scrubber

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Actero Pharma Pvt. Ltd. Environment Management Plan

8 Docetaxel I Hydrogen 2.2 Let into atmosphere safely through water column 9 Enzalutamide I Hydrogen Chloride 21.5 To Scrubber Sulfur Dioxide 18.8 To Scrubber II Hydrogen 0.12 Let into atmosphere safely 10 Imatinib I Hydrogen 0.20 through water column Hydrogen Chloride 12.18 To Scrubber Sulfur Dioxide 10.68 To Scrubber 11 Lapatanib I Hydrogen 1.12 Let into atmosphere safely through water column 12 Olaparib I Ammonia 0.67 To Scrubber

Fig 10.2 Existing Two Stage Scrubbing System

Table 10.9 Technical Specifications of Two Stage Scrubber Type Packed Tower Scrubber Two Stage MOC PP/FRP 5 mm PP+8mm FRP Air Flow Rate 3000CFM Inlet Temp. 350C Inlet Gas Pressure Atmospheric Batch 24 Hrs Scrubbing medium for IstStage Water 10% NaOH Solution Scrubbing medium for IIndStage Caustic Solution (or) Acid Blower MOC PPFRP Capacity 2500CFM Suction Pressure − 250mmWC Discharge Pressure 60mmWC HP/RPM 5HP/1900RPM Circulation System Flow Rate 15 M3/hr

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Actero Pharma Pvt. Ltd. Environment Management Plan

Head 30 Meters Motor Make FLP MOC PP Storage/ Recirculation Tank Capacity 3 KL Size 1700mm Dia X 2300mm Ht. MOC PP/FRP

10.2.2.3 Diffuse Emissions

Emissions are also released from various operations of manufacturing like drying, distillation, extraction etc. These emissions mainly contain volatile contents of the material sent for processing. The emissions are normally passed through vent scrubber before releasing into atmosphere to mitigate odor. The emissions from distillation are passed through condensers, which mitigate odor. Vent condensers in series to reactors, distillation columns, driers and centrifuge etc. are provided to mitigate VOC emissions release. Other vents are connected to common headers and scrubbers. The transfer pumps shall be provided with double mechanical seals. The transfer of solvents will be mainly by closed pipeline systems, while drum transfer is by using air operated diaphragm pumps in closed hoods. The charging of solid raw materials shall be by powder transfer system to avoid dust emissions, safety and hazard of static electricity. Safety relief valves rupture disc, Breather provided to reactors, thermal insulation, vent condenser and nitrogen blanketing provide for bulk storage tanks. Thermal insulation and condensers will be provided for storage tanks of low boiling point solvents. The reactor or solvent storage tank vents when not use shall be kept closed.

10.2.2.4 Fugitive Emissions (Terms of Reference No. 7(vi) Fugitive emissions are anticipated from equipment leakage and transfer spills. The periodic maintenance program shall ensure integrity of equipment mitigating the equipment leakage. The spills however shall be managed by adopting the spill management scheme as mentioned in the respective MSDS, spill control kit shall be provided in storage, and production blocks. The fugitive emissions shall be reduced by closed transfer and handling of all hazardous solvents and chemicals. The ventilation system provided will reduce health

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Actero Pharma Pvt. Ltd. Environment Management Plan

impact on the employees by way of dilution of work room air and also dispersion of contaminated air.

10.2.2.5 Odour Management (Terms of Reference No. Sp. TOR (6))

Odour is caused mainly by diffuse and fugitive emissions of low boiling organic chemicals/ compounds releasing volatile organic compounds. The above mentioned measures for mitigation and control of diffuse and fugitive emissions shall reduce release of VOC’s into atmosphere and the resultant odour.

10.2.3 Solvent Use and Recycle Solvents are used for extraction of products and as reaction medium. Solvents constitute major consumable material of synthetic organic chemical manufacturing, mainly used as reaction medium. The used solvents constitute major waste stream of synthetic organic chemical manufacturing. Hence it is proposed to recycle the solvents by distillation for reuse in process, thereby reducing total solvent consumption in the plant and reducing the waste quantity to be disposed. The distillation columns are mainly provided to remove moisture and impurities from spent single solvents, and mixed solvents. The recycled single solvents are reused in the process, while the mixed solvents are sold to end users. Distillation process generates residues which are mainly organic in nature containing significant calorific value, and can be sent to cement plants for co-incineration as fuel. The total solvent balance product wise and stage wise is presented in Table 10.10. Schematic Diagram of solvent recovery system is presented in Fig 10.3. Table 10.10 Total Solvent Balance – Product Wise S.No Name of product Quantity (Kg/Day) Solvent Recovered Fugitive To waste Residue Input loss water 1 Abiraterone 2640 2534.4 21.1 26.4 58.1 2 Afatinib 2330 2236.8 18.6 23.3 51.3 3 Anastrozole 1440 1382.4 11.5 5.2 40.9 4 Bicalutamide 365 350.4 2.9 3.7 8 5 Bendamustine HC 2053 1968 16.4 20.5 48 6 Bexarotene 10503 10022.4 83.5 104.4 292.7 7 Bosutinib 2621 2516.2 21 22.4 61.5 8 Capecitabine 8290 7958.4 66.3 82.9 182.4

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Actero Pharma Pvt. Ltd. Environment Management Plan

9 Carfilzomib 4390 4214.4 35.1 43.9 96.6 10 Ceritinib 7164 6877.4 57.3 26.6 202.6 11 Cyclophosphamide 10565 10142.4 84.5 105.7 232.4 12 Dasatinib 3310 3177.6 26.5 33.1 72.8 13 Docetaxel 12500 12000 125 62.5 312.5 14 Enzalutamide 3535 3393.6 28.2 30.2 83 15 Erlotinib 13370 12835.2 107 133.7 294.1 16 Gefitinib 11620 11155.2 93.0 116.2 255.6 17 Gemcitabine 1086.7 892.8 7.4 9.3 177.1 18 Ibrutinib 1560 1497.6 12.5 14.9 35 19 Imatinib 2100 2007.9 28 11.8 52.3 20 Lapatinib 6100 5720.7 66.6 51.5 261.2 21 Lenvatinib 605 578.3 16.8 2 7.8 22 Olaparib 1400 1337.8 22.4 13.5 26.4 23 Palbociclib 535 506.2 9.2 1.8 17.8 24 Pazopanib 2500 2358 16 40 86 25 Sorefinib 6990 6640.5 74.6 1.7 273.3 26 Sunitinib 12500 11875 169 20 436 27 Tamoxefin 6800 6460 42 136 162 Worst Case: 22 Products on 134407.7 128369.3 1198.6 1107.3 3732.4 campaign basis

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Actero Pharma Pvt. Ltd. Environment Management Plan

Fig 10.3 Schematic Diagram of Solvent Recovery SystemFig 10.3 Schematic Diagram of Solvent Recovery

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Actero Pharma Pvt. Ltd. Environment Management Plan

10.2.4 Solid Waste (Terms of Reference No. 3(vi) & 7(vii)) Solid wastes are generated from process, solvent distillation, wastewater treatment and utilities. Process residue contains mainly unreacted raw materials and byproducts. These are collected from the reactors and other process equipment and stored in drums. Solvent residue is generated from distillation units, the residues are tarry substances with good calorific value, and are stored in drums. The other major waste is salts from multiple effect evaporator and agitated thin film dryer section of effluent treatment system. These salts are stored in HDPE lined bags. All solid waste storage containers/drums/bags are labeled showing the source, nature of hazard and type of wastes. All the hazardous wastes are stored in a closed shed with fire safety measures, and the shed is provided with a leachate collection facility connected to effluent conveyance lines. The stripper distillate, process residue and solvent residue are sent to cement plants for co-incineration based on acceptability. If these wastes are not suitable for co-incineration, the same is sent to TSDF facility. Mixed solvents shall be sent to authorized recyclers /cement plant for co-incineration while spent solvents are recovered within plant premises. The evaporation salts are sent to TSDF. Filter media, activated carbon and catalysts are sent to TSDF. Waste oil and used batteries from the DG sets are sent to authorized recyclers. The sludge from effluent treatment plant is considered hazardous and the same is sent to TSDF. Coal ash is sold to brick manufacturers in the local area. The other solid wastes expected from the unit are containers, empty drums which are returned to the product seller or sold to authorize buyers after detoxification. The quantity and disposal plan for the solid wastes is presented in Table 10.11. Table 10.11 Solid Waste and Mode of Disposal S.No Description Units Quantity Mode of Treatment/Disposal

1 Ash from Boiler TPD 32 Sold to Brick manufactures and cement plants 2 Organic residue TPD 5.5 Sent to TDSF/Cement Plants for Co- incineration 3 Solvent Residue TPD 3.73 Sent to TSDF/Cement Industries 4 Spent Solvent KLD 115.5 Recovered within plant premises and reused 5 Mixed Solvent KLD 12.8 Sent to authorized recovery units/Cement plants for co-incineration 6 Stripper Distillate KLD 1.26 Sent to Cement Industries for Co- 7 Spent Carbon Kg/day 650 incineration.

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Actero Pharma Pvt. Ltd. Environment Management Plan

8 Inorganic Residue TPD 0.7 Sent to TSDF 9 Evaporation salts TPD 3.07 Sent to TSDF 10 ETP Sludge Kg/day 180 Sent to TSDF 11 Detoxified containers No.s/Yr 800 Sold to authorized vendors 12 Waste oil KLPA 8.25 Sent to Authorized Recyclers 13 Used batteries No.s/Yr 20 Sent to Authorized Recyclers

10.2.5 Noise Pollution Noise is anticipated from motors, compressors, chillers, cooling towers and DG set. The DG set shall be kept in a separate enclosed room with acoustic enclosure. The motors and compressors shall be provided with guards and shall be mounted adequately to ensure the reduction of noise and vibration. The employees working in noise generating areas shall be provided with earmuffs. The employees shall be trained in the mitigation measures and personal protection measures to be taken to avoid noise related health impacts.

Measures to Control Noise Pollution The following engineering control measures are identified for implementation to reduce noise levels/exposure; • The walls of turbine room will be built with noise absorbing materials. • The control room of the power plant will be acoustically enclosed. • The noise generating sources like motors and compressors will be provided with Casings and guard to reduce noise levels • Attenuating screens will be placed between operators and noise sources. • Adequate spacing between noise sources and operators will be provided. In free field conditions the sound levels roughly varies with the square of the distance. • Reflected noise is reduced by use of absorbent materials on roofs, walls and floors. • Proactive periodic maintenance to correct vibrations and other imbalances. • Training would be imparted to plant personnel to generate awareness about the damaging effects of noise. • Personal protective equipment: ear plugs and muffs consisting of fine glass wool, ear muffs consisting of ear cups with a soft seal, fitted with a spring or adjustable headband. Comfort, maintenance and cleaning are important aspects of use.

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Actero Pharma Pvt. Ltd. Environment Management Plan

• Plantation of tall as well as short trees around the plant area will protect the outside environment from any noise and dust nuisance. • It is possible to reduce the noise levels by 3-5 dB (A) per 30-m width of the green belt.

10.3 Rainwater Harvesting (Terms of Reference No. 7(x) Rain water harvesting shall be adopted by providing rain water harvesting structures along the drains, storm water storage sump and tanks. Storm water drains are provided with rain water harvesting structures which will act as flow dissipaters and also as infiltration trenches. Filtration points shall ensure percolation of water and enhance the ground water table. The site area will be provided with 15 nos. of rain water harvesting structures. The roof water shall be collected in 1 x 100 KL capacity sump connected to down spouts of the roofs, and the collected water shall be reused for process and green belt development. The storm water from open areas, and green belt area, and the overflow of the roof water storage sump shall be collected in a storm water storage tank in southeast part of the site and reused for plant and process. The storage pond shall have a capacity of 1000 m3. These measures shall ensure reuse of stored storm water for about 28 days of plant operation. The storm water is quantified using rational formula, for a rainfall intensity of 854.6 mm, with constant of 0.5 for open area and 0.3 for green belt area. The total water that can be stored is in the order of 5751 m3/year. The storage tank and the sump shall get refilled during intense rain fall periods, and the stored water shall be reused mainly during monsoon and post monsoon seasons. The location of storm water storage tank, roof water storage sump is presented in Fig. 10.4 and storm water management is presented in Table 10.12. The schematic diagram for rain water harvesting structure is presented in Fig 10.5.

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Actero Pharma Pvt. Ltd. Environment Management Plan

Fig 10.4 Rain Water Harvesting Schematic Diagram

Table 10.12 Storm Water Management Land Use Area Vol./hr after Vol./hr before Difference in in Ha development development Discharges (KL) C=0.8 (KL) C=0.6 (KL) Roof Area 0.92 293.5 220.2 73.4 Road Area 1.38 440.3 330.2 110.1 Open Area 2.29 275.2 550.4 -275.2 TOTAL 4.59 -91.73 *C=0.3 after development of greenery Area of Catchment, ‘A’ 4.49 Ha Run off Coefficient, ‘C’ 0.5 Maximum intensity of rainfall, ‘I’ 854.6 mm/year Therefore Q 19172 m3/year Storm water Storage (30% run off) 5751 m3/year Water requirement 206.8 KLD No of days usage (Storm water) 28 Storm water storage pond 1000 m2 Storm water storage pond Depth 1.5 m Total Storm water storage pond Capacity 1500 m3

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Actero Pharma Pvt. Ltd. Environment Management Plan

Fig 10.5 Location of Storm Water Storage Tank

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Actero Pharma Pvt. Ltd. Environment Management Plan

10.4 Occupational Safety and Health (Terms of Reference No. 8(iii) Many worker health and safety hazards are posed by synthesis operations. They include safety hazards from moving machine parts, pressurized equipment and pipes, heavy manual handling of materials and equipment, steam, hot liquids, heated surfaces and hot workplace environments, confined spaces and hazardous energy sources (e.g., electricity); and high noise levels.

Acute and chronic health risks may result from worker exposures to hazardous chemicals during synthesis operations. Chemicals with acute health effects can damage the eyes and skin, be corrosive or irritating to body tissues, cause sensitization or allergic reactions or be asphyxiants, causing suffocation or oxygen deficiency. Chemicals with chronic health effects may cause cancer, or damage the liver, kidneys or lungs or affect the nervous, endocrine, reproductive or other organ systems. Worker exposure to chemicals can occur during manufacturing when chemicals spill, leak, or discharge from the process system and contaminate areas where workers are present. The most frequently reported industrial exposure occurs during the transfer of materials. The entry of workers into systems, equipment, or enclosures that are contaminated may occur inadvertently, but routine servicing, nonscheduled maintenance, and process monitoring appear to be the kind of activities with potential for significant exposure. Health and safety hazards may be controlled by implementing appropriate control measures (e.g., process modifications, engineering controls, administrative practices, personal and respiratory protective equipment).

The process modification shall be a constant exercise of the Research and development wing of the organization, resulting in reduced pollution loads, and increased yields. The measures proposed are selection of alternative solvents/routes of synthesis, avoidance of hazardous chemicals usage, and application of green chemistry principles.

The engineering controls for reducing occupational hazards are provision of scrubbers, condenser systems for process equipment, piping systems, insulation to reactors, usage of

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Actero Pharma Pvt. Ltd. Environment Management Plan transfer pumps with mechanical seals, AOD pumps, trolleys for transfer of drums or bags, closed hoods for charging raw materials, dip pipe provision for solvent and liquid raw material charging, level indicators, pressure and temperature indicators, barrier guards on moving machine parts, optimization of chemical inventory, control switches and emergency stop devices to mitigate and avoid physical, chemical, electrical and mechanical hazards.

Work practices proposed for improving occupational safety are induction training programs, safety training programs, rotation of workers, implementation of proactive maintenance schedule, provision of standard operating procedures for all plant operations, access to MSDS for all employees, access to emergency numbers of contact, and avoidance of crowded work place, and provision of occupational safety centre.

Personal protective equipment shall be provided to all the employees including contract employees. All the employees shall be provided with gumshoe, helmet, masks, and goggles. The other equipment like ear muffs, gloves, respirators, aprons etc., will be provided to employees depending on the work area allocated to them. The PPE selection shall strictly follow the prescribed guidelines of MSDS. The budget allocated for personal protective equipment is Rs. 19.4 lakhs and Rs. 25.5 lakhs for health checkup.

Work Practices: Safety training classes are conducted to all the employees periodically to educate and train them with regard to proper operation and steps to be taken during emergencies. Work permit system is being strictly implemented. Dedicated ambulance is provided round the clock. The industry has an arrangement with hospitals for referral cases.

10.4.1 Medical Check-up (Terms of Reference No. 8(ii) M/s Actero Pharma Pvt. Ltd. Will have a medical program of pre employment screening, periodic medical examination, emergency treatment, non emergency treatment, and record keeping and review. The pre employment screening and periodic medical examination shall follow the guidelines of factories act. The pre employment screening shall obtain medical history, occupational history followed by physical examination and baseline monitoring for

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Actero Pharma Pvt. Ltd. Environment Management Plan specific exposures. The frequency of periodic medical examination and type of evaluation is presented in Table 10.13. Table 10.13 Frequency of Health Monitoring Occupation Type of evaluation Frequency Process Physical Height Once a year area Observation Weight for all Eyes Color vision Detailed Test Lung Functioning test, Hearing Ability; Physical Status, General Condition; Previous Accidents, Skin Infections; Any Physical Handicap Clinical Heart; Hydrocele; Central Nervous System; Liver Observation functioning; Diabetes; Any operations undergone; Symptoms of communicable and other contagious disease and Medical fitness Noise Audiometry Annually prone areas

The plant shall have an occupational health centre to provide emergency and non emergency treatment, by way of emergency first aid on site, liaison with local hospitals and specialists, arranging decontamination of victims, arranging transport of victims to hospitals, and to transfer medical records, and to provide details of incident and medical history to next care provider. The occupational health centre shall be supervised by a qualified physician. The occupational health centre shall maintain the health records and shall analyse the records for any common symptoms and common health problems which may be due to exposure to chemicals, and or due to other occupational hazards.

10.4.2 Handling of Toxic Chemicals/Materials The engineering controls proposed for reducing occupational hazards in handling of toxic chemicals are as follows; ¾ Separate Storage area with environmental controls ¾ Dispensing of material in isolated dispensing booth with cross ventilation ¾ Transfer of toxic powders by Power Transfer System (PTS) ¾ Level Indicators, sensors, pressure & Temperature indicators provision to reactors ¾ Transfer by dedicated pipe line ¾ Dump tank system in case of overflow

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Actero Pharma Pvt. Ltd. Environment Management Plan

¾ Transfer by using AOD pumps in case of Drum transfer ¾ Vents connected to common scrubbers.

Administration Controls for handling of toxic chemicals are as follows; ¾ All chemicals are stored based on respective MSDS ¾ Periodic health check-up tuned to Toxic chemicals handled. ¾ All employees are provided with respiratory protection ranging from nose mask to full body suit to prevent toxic chemicals impacting respiratory system of employees. ¾ Personal Protective Equipment (PPE) based on requirement and suitability.

10.4.3 Treatment of Workers affected by Accidental Spillage of Chemicals The following is the standard procedure followed in Plant; ¾ On receiving message of casualty at ECC, Ambulance is sent to the plant / location of occurrence. ¾ Give topmost priority to the “personal Safety of employees”. Prevention of life is the number priority and people must be removed from the danger area and shifted for medical treatment as early as possible. ¾ The casualty is rendered first aid by trained first aiders. ¾ The casualty then shifted to OHC in Ambulance for further treatment. ¾ Medical aid is administered by FMO / Manager- OHC at OHCS. ¾ On the Company Manager – Occupational Health assessment, the casualty is transported in Ambulance to defined hospitals for further treatment.

Toxic release gas: ¾ Check wind direction of wind sack installed at highest point. ¾ Wear appropriate / necessary PPE if moving near gas leakage area. ¾ Rescue operators must wear SCBA set before entering the affected section. ¾ Monitoring of the emission levels in the immediate vicinity by on-duty Environment Protection Manager (Dragger Tubes / PID instrument / Gas detector tubes) ¾ Water curtains to be started immediately to control drift of gases away from leak spot.

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Actero Pharma Pvt. Ltd. Environment Management Plan

¾ Contaminated water is to be diverted to effluent treatment plant. Coordination with ETP personnel is a must.

10.5 Prevention, maintenance and operation of Environment Control System The pollution control equipment, and the effluent treatment systems and effluents will be monitored periodically and will be checked for its performance and pro-active maintenance will be adopted. The environmental monitoring results will be evaluated to identify the problems/under performance of the equipment. Necessary steps will be taken to rectify the identified problems/defects. The management agrees that the evaluation of the performance of pollution control measures and occupational safety measures to arrive at their efficiency and proposes to adopt new measures for efficient pollution control which will be a regular exercise.

All pollution control equipments are adequately designed and operating staff of the pollution control equipment have good experience in the operation and maintenance of the equipment. Standby equipment provided for all critical equipment to ensure continuous operation of pollution control equipment and preventive maintenance is done as per the schedule to avoid breakdown. Characteristics of influent and effluent are monitored on daily basis by the industry and air emissions and effluent characteristics on monthly basis by third party.

10.6 House Keeping Good house-keeping practices will be adopted. Floor washing is avoided and wet mopping will be adopted to minimize liquid waste generation. Paper waste is minimized by adopting intra office network. Sufficient workspace and proper lighting will be provided.

10.7 Socio Economic Environment (Terms of Reference No. 11(i) The proposed project provides an opportunity for the local people to get employment directly or indirectly and helps in the up liftment of the socioeconomic status of the area. The project proponents propose to involve in social activities of the stakeholders/surrounding community by planning the betterment of neighbouring social conditions through awareness

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Actero Pharma Pvt. Ltd. Environment Management Plan and welfare programs will ensure an improved relation, useful in the long run. Many of the beneficiaries of such programs shall include own employees as well. The goodwill of the local populace can never be ignored. Another important facet of social environment identified by the project proponents is a green appearance, hence the management will develop a green belt towards aesthetic beautification as the same is necessary to be considered as a responsible, social neighbour. Aurobindo Pharma Limited spent Rs. 80 cores in year 2018-19 and 2022-23 on CSR activities. The budget allocated for funding corporate social responsibility activity is as follows;

1. Social Investment Funding: 2% of the profits of the unit are spent on socio economic development programs in consultation with revenue authorities and public representative annually. 2.5% of the capital cost i.e., Rs. 80 crores shall be spent additionally during 2018-2023. The investment on CSR activity shall benefit the stake holders within the impact area. 2. Local Content: About 300 no. of employees are from the surrounding villages. Local produce like rice, vegetables, milk etc is procured from surrounding villagers by the canteen. 3. Capacity building: Skill development, and provision of infrastructural facilities for drinking water, education and health. 4. Payment of Taxes: Presently the organization is paying about Rs. 2.8 crores per year towards various central and state taxes. The amount will increase to about Rs. 4.2 crores per year after execution.

The programs identified by the management as part of corporate social responsibility program are presented in Table 10.14. The development programs are identified from schedule VII of companies act 2013.

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Table 10.14 Activity Wise CSR – Budget (2018-19 to 2022-23) – Program S.No Name of Village Activity Total Health School Portable Dental Plantation Rs. Camps Infrastructure RO Plant Camp Lakhs Cost (in Rs.Lakhs) 1 Veliminedu 6 6 4 16 2 Pittam Palli 4 6 6 16 3 Gundrampalli 2 7 3 12 5 Yepuru 4 5 8 17 5 Peripalli 6 6 7 19 Total 10 18 20 19 13 80

10.8 Transport systems All the raw materials and finished products are transported by road. There will be 20-25 additional truck trips per day to the factory due to proposed project. Traffic signs are placed in the battery limit. The drivers of the vehicles will be provided with TREM cards and will be explained the measure to be adopted during various emergencies. Drivers transporting hazardous chemicals are periodically trained.

10.9 Reduce, Recovery and Reuse (Terms of Reference No. 7(vii) It is the endeavor of the project authorities to increase the yields of the products through constant research and development activity. The development activity shall concentrate on increasing the yields, using less quantity of raw material, using alternative solvents with low hazards adopting green chemistry principles. The solvents shall be recycled for reuse in the process by distillation. The mother liquors from the first crop shall be reused for process. The cleaning cycles will be reduced by adopting appropriate production plan with minimum changeovers of the product. Hydro jets or high pressure cleaning shall be adopted for washing the reactors to minimize washing effluents. It is proposed to use third and fourth washing water for first and second washing of the reactor and centrifuges. Step down The steam condensate shall be reused for boiler feed. A cross functional team shall constantly evaluate various options of reduce, reuse and recycle for water conservation, reduction in wastewater generation, effluent segregation, reuse of wastes, alternate treatment methods, leakage/spillage control, avoidance of overflow and contamination. As part of the above

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exercise the proponent identified few compounds which can be recovered as byproducts and sold. It is also proposed to explore recovery of various salts from MEE salts, and from process effluents to reduce effluent loads, and quantity of solid waste.

10.10 Energy Conservation It is proposed to use screw compressors (Air/Refrigeration) for energy efficiency (10 – 12% saving), evaporative condensers in the chilling circuit to reduce overall power, Cooling tower fan control to switch off at times not required (Low temp), energy efficient pumps to conserve energy.

10.11 Green Belt Development (Terms of Reference No. 7(ix) It is proposed to provide green belt in an area of 3.75 acres, covering the boundary of the site as part of environment management plan. Native species shall be identified for plantation and the guidelines issued by CPCB for development of green belt shall be followed. The green belt shall enhance environmental quality through mitigation of fugitive emissions, attenuation of noise levels, balancing eco-environment, consumption of treated effluent, prevention of soil erosion, and creation of aesthetic environment. The list of recommended plant species are presented in Table 10.15 and green belt plan presented in Fig. 10.6.

Table 10.15 Recommended Plant Species to Develop Green Belt S.No Latin Name Common Name 1 Abutilon indicum Botla benda 2 Achras sapota Sapota 3 Actinodaphne angustifolia Tali 4 Balanites roxburgii Gara 5 Bambusa arundinacia Mulla bongu 6 Bambusa vulgaris Bamboo 7 Caesolpinia pulcherrima Sankesula 8 Calistemon ctrinus Bottle brush 9 Dendrocoloums Strictus Saadaranapuveduru 10 Emblica Officinalis Amalakama 11 Erythring Variegata Moduga 12 Nyctanthus Arbor-tristis Sepali 13 Ouginia Oojeinensis Tella Moduga 14 Peltophorum Pterocarpum Copper Pod Tree 15 Phoenix Sylvestris Peddaetta 16 Ficus Benghalensis Peddamarri

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17 Ficus Benjamina Pimpri 18 Ficus Hispida Vettiyati 19 Ficus Religiosa Raavi chettu 20 Garcinia indica Murgal 21 Gardenia Jasminoides Anant 22 Hibiscus-rosa-Sinensis Dasanamu 23 Juniperus Communis Common JUniper 24 Lagerstroemia Parviflora Chinagoranta 25 Lagerstroemia Specicosa Varagoogu 26 Mallotus Phillippensis Sinduri 27 Mammea Suriga Surampunnagamu 28 Mangifera Indica Maamidi Chettu 29 Saraca Asoka Asokamu 30 Sesbania Grandiflora Arise-Chetta

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Fig 10.6 Green Belt Development of Actero Pharma Pvt. Ltd.

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10.12 Corporate Environmental Responsibility (Terms of Reference No. 9(i) The Management of Actero Pharma Pvt. Ltd., commits to operate all its units in an environmentally friendly manner, while protecting health and safety of its employees. The management is committed to prevention of pollution, injury and ill-health to its employees. Actero Pharma Pvt. Ltd., will comply applicable laws and other requirements.

Broad guidelines of Policy

¾ Ensure that all our activities are carried out to avoid & control all foreseeable risks to the health and safety of all people involved in the operations. ¾ Protect the natural environment by prevention of pollution. ¾ Optimize the use of resources through reduction, reuse, recycling, continuous research and using efficient technologies. ¾ Comply with all applicable Health, safety & Environment laws, regulations and other requirements applicable our business. ¾ Continually evaluate and improve the processes by setting the objective in the direction to minimize hazards & environmental impacts arising out of operations. ¾ Provide safe working environment to everyone in our premises with necessary infrastructure. ¾ Inculcate Health, safety & Environment awareness across the organization through recognition, training and development.

¾ Seek involvement of our employees and all stake holders in improving the operations to ensure clean environment, safety & healthy work place for all.

The management is dedicated to the continual improvement of the Health, safety & Environment performance across our operations. We are of the firm belief that all our employees identify and share this commitment, which would go a long way in earning the confidence of our customers, stakeholders and the society

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10.13 Environment Management Cell (Terms of Reference No. 9(iii)& 9(iv)) AGM Operations, Deputy Manager – EH&S will take the final responsibility for environmental Management and Safety control. The Environmental Manager and staff will supervise the day-to-day activities of the environmental management and control. The organ gram of the Environment management cell is presented in Fig 10.7

Fig 10.7 Organ gram of the Environment Management Cell

Records shall be maintained for the analysis of raw effluents and treated effluents, ambient air quality data, stack emissions monitoring results, micro- meteorological data and noise levels. These records are not only required for the perusal of the pollution control board authorities but also to derive at the efficiencies of the pollution control equipment as the objective of the project proponent is not only compliance with statutory regulations, but also a serious commitment towards clean environment.

The industry shall be regularly maintaining the records as per the hazardous waste regulations and EPA regulations and is applying for the annual consents for air and water, and renewal of authorization for the storage of hazardous waste.

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10.14 CREP Guideline and Compliance CREP Guideline Compliance Segregation of waste streams Segregation of waste streams at source Detoxification and treatment of high COD waste High COD waste streams are neutralized and streams detoxified as present practice Management of solid waste Hazardous waste is sent to TSDF. Minimum scale of production to afford cost of Production capacities optimized. pollution control Long term strategies for reduction in waste Reduction of waste generation by increasing the yields is a major R&D activity. Control of air pollution Scrubbers provided to all vents and air emission of reactions apart from Bag filters to boilers. Self – regulation by industry through regular Third party monitoring conducted quarterly monitoring and environmental auditing Optimizing the inventory of hazardous Storage of chemicals optimized for one week. chemicals

10.15 Other Management Practices The industry will maintain records as per the hazardous waste regulations and EPA regulations and apply for the annual consents for air and water, and renewal of authorization for the storage of hazardous waste as per Hazardous Waste (Handling & Management) Rules, 1989 and subsequent amendments. The records of hazardous waste manifest will be maintained.

The industry shall obtain the consent for operation (CFO) as required under section 25/26 of the Water Act, 1974 and under section 21/22 of Air Act, 1981 before trial production and commissioning from the Sate Pollution Control Board. The CFO will be renewed each year by the industry. The industry will obtain the necessary permissions under Hazardous Waste (Management and Handling) Rules 1989, and Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989, issued by the Ministry of Environment and Forests, New Delhi. The industry will submit environmental statement every year before September 30, and monthly water cess returns. The management ensures that it will comply with all the directions and regulations issued by the Ministry of Environment and Forests, New Delhi, State and Central Pollution Control Boards. The Consent for Establishment, Consent for

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Operation will be displayed in a conspicuous location for the information of the inspecting authorities of different departments.

10.16 Cost Estimate for Environment Management Plan (Terms of Reference No. 7(xi) It is estimated that the total capital cost for implementing the Environment Management plan is Rs. 10 crores, while the recurring costs for the same is Rs. 7.88 crores/year. The cost estimate is presented in Table 10.16. The item wise tentative capital cost estimate for environment management measures is presented in Table 10.17

Table 10.16 Environmental Management Cost estimate S.No Description Capital Recurring Cost 1 Air pollution Control 275.3 30 2 Water pollution Control 650 601.6 3 Noise pollution Control 7.4 1 4 Environment Monitoring and Management 7.6 5.2 5 Occupational Health 25.5 12 6 Green Belt 8 4 7 Others (S. Waste) 26 134.2 Total (Lakhs) 1000 788 Note: Value in Rs. Lakhs

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Table 10.17 Item Wise Tentative Capital Cost Estimate for Environment Management S.No Description Cost (Rs. Lakhs) I Air pollution Bag Filter 90 Scrubbers 60 Condensors 36 Vaccum pumps 42 Spill control kits 0.32 Closed Hoods and AOD pumps 6 Dust Collectos 12 Coal handling system 12 Ash handling system 17 Total - I 275.3 II Safety Breather Valves 1 Rupture disks 1.4 Trolleys 0.5 Fire hydrant system 1 Gas detection system 3 Safety releif valves 3.75 Fire extinguishers 0.8 Fire buckets 0.04 Total - II 11.49 III Occupational safety Ocuupational safety and health centre with facilities 3.5 Self contained breathing apparatus 5.04 Personal protective equipment 3 Eye wash and body wash showers 2.5 Total - III 14.04 IV Water Effluent treatment system 550 Storm water drains 20 Storm water storage tank 32 Rain water harvesting structures 8.5 Fire hydrant storage tank 5.5 Effluent and sewage transfer lines 34 Total - IV 650 V Noise Acoustic enclosures 2.4 Guards, casing, attenuating screens 2.5 Vibration control pads 1.5 Others 1 Total - V 7.4 VI Solid waste Storage area for hazardous waste 18.5

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Detoxification area 2.5 Ash handling system 5 Total - VI 26 VII Green Belt 8 Total - VIII 8 VIII Environmental monitoring Laboratory 5.5 Monitoring equipment 2.1 Total - VIII 7.6 Total (I+II+III+IV+V+VI+VII+VIII) 1000

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CHAPTER 11.0 EXECUTIVE SUMMARY

11.0 Introduction Pharmaceutical Chemicals are used for the benefit of human and animal health. The scale of manufacturing of active pharma ingredients is less compared to other synthetic organic chemicals, which are used for the manufacture of consumer products, dyes etc. India is a major producer of active pharma ingredients contributing to wellbeing of both human and animal population of the world.

Actero Pharma Pvt. Ltd. proposes to establish a synthetic organic chemicals (Bulk Drugs & Intermediates) Unit of Production capacity 165 TPM in an area of 11.275 acres of land on lease from principle organization M/s. Dasami Lab Pvt. Ltd., for a lease period of 25 years at Sy No 407 (Part) and 411, Veliminedu (V), Chityal Mandal, Nalgonda District, Telangana. Prior environmental clearance has to be obtained from Ministry of Environment, Forest and climate change, vide SO 1533, dated September 14, 2006, for synthetic organic chemicals manufacturing activity. The terms of reference for the environmental impact assessment studies was obtained from MoEF&CC vide letter no. F.No. J-11011/59/2017-IA II (I) dated 26.05.2017 as part of environmental clearance process.

11.1 Location of the Project: The plant site of 11.275 acres is located at Survey No. 407 (Part) and 411, Veliminedu Village, Chityal Mandal, Nalgonda District, Telangana State. The site is located at the intersection of 17°13'34" (N) latitude and 79° 2'38" (E) longitude. The plant site elevation above mean sea level (MSL) is in the range of 329 - 338 m. The plant site is surrounded by open agricultural land in west direction, proposed expansion site of Dasami Lab Pvt. Ltd., in east direction, road connecting Pittampalli village to national highway in north direction and VSK Laboratories Pvt. Ltd., in south direction. The nearest habitation from the plant is Pittampalli village located at a distance of 2.1 km in southwest direction. The main approach road NH-9 with pittamapalli village is adjacent to site in north direction. National Highway 9 - Hyderabad - Vijayawada is at a distance of 0.5 km in north direction. The nearest town Chityal is at a distance of 8.4 km in northeast direction. The nearest railway station Ramannapet is at a distance of 7.6 km in northeast direction and

11-1 Team Labs and consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report nearest airport is Rajiv Gandhi International Airport (Hyderabad) located at a distance of 65 km in northwest direction. Seasonal nala Chinna Vagu is flowing from northwest to southeast direction at a distance of 6.5 km in southwest direction. There are two reserve forests in the impact area of 10 km radius of the study area. Chityal RF at a distance of 6.1 km in east direction, Shivanenigudem RF at a distance of 9.1 km in northeast direction. There is no national park, wildlife sanctuary, ecologically sensitive area, biosphere reserve, tiger reserve, elephant reserve, critically polluted areas and interstate boundary within 10 km radius of the site.

11.2 Product Profile The manufacturing capacity of proposed products is presented in Table No. 11.1 and the list of by-products is presented in Table 11.2. Table 11.1 Manufacturing Capacity S.No Name of Product CAS. No Capacity Kg/day TPM 1 Abiraterone Acetate 154229-19-3 16.7 0.5 2 Afatinib 850140-72-6 23.3 0.7 3 Anastrazole 120511-73-1 10 0.3 4 Bicalutamide 3543-75-7 33.3 1 5 Bendamustine HCl 153559-49-0 16.7 0.5 6 Bexarotene 90357-06-5 313.3 9.4 7 Bosutinib 380843-75-4 10 0.3 8 Capecitabine 154361-50-9 366.7 11 9 Carfilzomib 868540-17-4 16.7 0.5 10 Ceritinib 1032900-25-6 500 15 11 Cyclophosphamide 50-18-0 200 6 12 Dasatinib 302962-49-8 83.3 2.5 13 Docetaxel 114977-28-5 808.3 24.25 14 Enzalutamide 915087-33-1 33.3 1 15 Erlotinib HCl 183319-69-9 133.3 4 16 Gefitinib 184475-35-2 350 10.5 17 Gemcitabine HCl 122111-03-9 13.3 0.4 18 Ibrutinib 936563-96-1 8.3 0.25 19 Imatinib Mesylate 220127-57-1 50 1.5 20 Lapatanib 388082-78-8 533.3 16 21 Lenvatinib 417716-92-8 13.3 0.4 22 Olaparib 763113-22-0 8.3 0.25 23 Palbociclib 571190-30-2 6.7 0.2 24 Pazopanib 444731-52-6 75 2.25 25 Sorefinib 284461-73-0 800 24 26 Sunitinib 341031-54-7 753.3 22.6 27 Tamoxifene 10540-29-1 366.7 11 Total Worst Case: 22 Products on campaign basis 5500 165

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Table 11.2 List of By-products S. No Name of the Product Stage Name of the By Product Quantity (Kg/day) 1 Docetaxel I 2,2,2-Trichloro ethyl formate 355.6

11.3 Manufacturing Process Chemical synthesis produces majority of API’s currently in the market. Chemical synthesis consists of four process steps - reaction, separation, purification, and drying. Large volumes of solvents are used during chemical syntheses as medium, extractions, and solvent interchanges. The manufacturing process of the above mentioned molecules involve various types of reactions like acetylyzation, protection, deprotection, hydrolysis etc. The manufacturing process of all the compounds, reactions involved, material balance are presented in chapter 2 of EIA report.

11.4 Utilities It is proposed to establish coal fired boilers of capacity of 2 x 8 TPH to meet steam requirement for process and ZLD system. The DG sets required for emergency power during load shut down is estimated at 5000 KVA and accordingly 1 x 1500, 2 x 1000, 3 x 500 kVA DG set are proposed. The list of utilities is presented in Table 11.3. Table 11.3 List of Utilities S.No Utility Capacity 1 Coal Fired Boilers (TPH) 2 x 8 2 DG Sets (KVA)* 1 x 1500 2 x 1000 1 x 500 *DG sets will be used during load shut down by TRANSCO.

11.5 Water Requirement Water is required for process, scrubbers, washing, cooling tower makeup, steam generation and domestic purposes. The total water requirement is 312.82 KLD consisting of 206.82 KLD of fresh water and 106 KLD of recycled water. The required water shall be drawn from ground water in addition to reuse of treated wastewater. The water balance for daily consumption is presented in Table 11.4.

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Table 11.4 Water Balance Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Effluent Process 45.32 51.4* Washings 5 5 Scrubber 3 3 Boiler Feed 40 20 52 8 Cooling Tower 80 86 143 23 RO/DM Plant 8.5 8.5 Domestic 15 2.5 12.5 Gardening 10 10 Gross Total 206.82 106 207.5 111.4 Total 312.82 318.9 * Process Effluents contains unreacted raw materials, water formed during reaction, soluble solvents, by-products etc

11.6 Baseline Environmental Data The baseline data was collected in the study area during the months of March to June 2017 for 3 co located units i.e., Actero Pharma Pvt. Ltd., Dasami Lab Pvt. Ltd., and Hindys Lab Pvt. Ltd. The baseline data includes collection of Samples of ground water, surface water and soil, monitoring of ambient air quality, noise levels, ecological status and meteorological parameters. The analytical results show that the values are within the prescribed limits for air quality. The ground water quality is observed to be above the limits for potable purpose when compared to the prescribed standards of IS: 10500 – 2012 at few locations.

11.7 Identification and Quantification of Impacts The impact assessment report has identified various sources of pollution and quantified the pollution loads due to proposed project. It has also identified the technologies to be adopted for the mitigation and control of the same. The sources of pollution are air emissions from utilities and process; liquid effluents from process, utilities and domestic usage; solid wastes from process, treatment systems and utilities; and noise pollution from utilities, and process equipment.

11.7.1 Impacts on Air quality: The impacts on air quality shall be due to the emissions from, Coal Fired Boilers and standby DG sets. The incremental concentrations are quantified using ISC-AERMOD model based on ISCST3 Algorithm. The results indicate marginal increase in ambient air quality concentration. The predicted values for SPM,

3 PM10, PM2.5, SO2 and NOx are 6.05, 1.74, 1.17, 8.38 and 9.26 μg/m respectively and he

11-4 Team Labs and consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report maximum values are observed at a distance of 1.8 km from the center of plant site in northwest direction, and the cumulative values of baseline air quality combined with predicted values are found to be within the prescribed limits of National Ambient Air Quality Standards. The mitigative and control measures of air pollution shall ensure that the impact on air quality is local – within the site area and its surroundings. The fugitive and diffuse emissions were quantified and a box model was used to predict air borne concentrations, and the results indicate the work room concentrations less than threshold limit values (TLV) for various solvents.

11.7.2 Impacts on Water: Water is essentially used for process and utilities and domestic purposes. The required water is drawn from ground water in the order of 206.82 KLD in addition to reuse of treated wastewater in the order of 106 KLD. No impact on water quality is expected due to discharge of effluents as zero liquid discharge is envisaged, which ensures reuse of treated wastewater for cooling towers and boiler makeup. There is no usage of treated wastewater for on land irrigation.

11.7.3 Impacts on Noise quality: The noise levels may increase due to motors, compressors, DG set and other activities. The major source of noise generation is DG sets which emit noise levels of above 90 dB (A) at a reference distance of 1m from the source. The predicted cumulative noise levels (as calculated by the logarithmic model without noise attenuation) ranged between 55 and 75 dB (A) at distances of 70 to 135 m. The increase in noise levels shall have neutral impact, restricted to within site area.

11.7.4 Impacts on Soil: The solid wastes generated from process, utilities and effluent treatment plant may have significant negative impacts if disposed indiscriminately. The total solid waste will be stored separately in Hazardous waste storage area. Solid waste will be sent to cements plants for co-incineration based on calorific value or sent to TSDF. The operational phase impacts shall be neutral due to effective implementation of mitigative measures in handling, storing and transferring of solid wastes, effluents and chemicals, and development of green belt.

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11.7.5 Impacts on Ecology: There are no endangered species of flora and fauna in the impact area. The impact on biological environment is neutral with the effect confined mainly to the site area.

11.8 Environmental Monitoring Programme

It is proposed to monitor Ambient Air Quality (AAQ) for PM10, PM2.5, SO2 and NOX, work room for VOC concentrations, stack emissions for boiler and DG sets, noise levels on quarterly basis. Water, treated wastewater are monitored on daily basis, while Soil analysis is done once in a year.

11.9 Additional Studies Risk assessment was conducted and the heat radiation damage distances of pool fire in the tank farm was limited to 12m for a heat radiation of 4 KW/m2, and the same was within the plant premises.

11.10 Project Benefits The proposed project will provide employment to 300 people. The proposed project will also generate indirect employment to the locals during construction phase in the order of 180 people for a period of 24-30 months. The project shall have positive impact on socioeconomic environment due to provision of employment both direct and indirect and proposed CSR activities.

11.11 Environment Management Plan The management plan is drawn in consultation with project proponents and technical consultants after evaluating various mitigation and control measures to address the impacts identified, predicted and monitored. The impacts during construction stage are temporary and less significant, the management plan for impacts identified during operation stage is described as follows;

11.11.1 Liquid Effluents The effluent generated from the proposed project is mainly from process, washings, scrubbers, cooling towers and boiler blow downs, RO/DM rejects from pre-treatment of water and domestic wastewater. The effluents from process, washings, scrubber and RO/DM rejects are considered as HTDS stream, while utility blow downs and domestic

11-6 Team Labs and consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report wastewater are considered LTDS stream. It is proposed to treat HTDS effluents from process and washing in stripper followed by MEE and ATFD, and MEE and ATFD in the case of effluents from RO/DM backwash and scrubber. All LTDS effluent along with condensate from MEE and ATFD shall be treated in Biological treatment followed by RO system. RO Rejects are sent to MEE and permeate is used for cooling towers and boilers as make up. Total Effluent generated and mode of treatment is presented in Table 11.5. Table 11.5 Total Effluent Generated and Mode of Treatment Description Quantity Mode of Treatment (KLD) HTDS Effluents Process 51.4 Sent to Stripper. Stripper condensate shall be Washings 5 disposed to cement industries for co- Scrubber Effluent 3 processing/TSDF. Stripper bottom is sent to MEE RO/DM Rejects 8.5 followed by AFTD. Condensate from MEE shall be sent to biological treatment plant followed by RO. RO rejects are sent to MEE and permeate is reused in cooling towers and boiler make-up. Total - I 67.9 LTDS Effluents Boiler Blow downs 8 Sent to Biological Treatment System followed by Cooling Tower Blow downs 23 RO. RO permeate reused for cooling towers and Domestic 12.5 boiler makeup. RO rejects are sent to MEE. Total - II 43.5 Grand Total (I+II) 111.4

11.11.2 Effluent Treatment System The Effluent management system is developed to ensure `Zero Liquid Discharge’. Segregation of effluents is an integral part that facilitates effective treatment of various effluent streams. The effluents are segregated into two streams; High COD/ TDS and Low COD/ TDS streams.

The High TDS/ COD Effluents The treatment system for treating High TDS/ COD effluents consists of Equalization, Neutralization, Settling tank, Stripper, Multiple Effect Evaporator (MEE) followed by Agitated Thin Film Dryer (ATFD). The organic distillate from the stripper is sent to cement plants for co-incineration and aqueous bottom from stripper is sent to MEE followed by ATFD for evaporation. The condensate from the MEE and ATFD are sent to ETP (Biological). Salts from ATFD are disposed to TSDF.

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The Low TDS/ COD Effluents: These effluents along with the condensate from MEE and ATFD are treated in primary treatment consisting of equalization, neutralization, and primary sedimentation followed by secondary biological treatment consisting of aeration tank and clarifier.

The treated effluents after biological treatment are subjected to tertiary treatment in a reverse osmosis (RO) system. Permeate from RO is reused for cooling tower and boiler make-up and rejects are sent to MEE followed by ATFD. Sludge from various units of Biological treatment are thickened in sludge handling system and sent to TSDF.

11.11.3 Air Pollution The sources of air pollution are proposed 2 x 8 TPH Coal fired boiler and proposed DG sets of 1 x 1500 kVA, 2x 100 kVA, 3 x 500 kVA. The proposed air pollution control equipment for 2 x 8 TPH coal fired boilers is bag filter. DG sets shall be provided with effective stack height based on the CPCB formula.

The process emissions contain Ammonia, Hydrogen, Hydrogen chloride, and Sulfur dioxide. Ammonia, Hydrogen chloride and Sulphur dioxide are sent to scrubber in series. Sodium chloride from Hydrogen chloride, ammonium chloride from ammonia, sodium bisulfate from sulfur dioxide scrubbing sent to ETP. Hydrogen gas is let out into atmosphere through a water column.

Emissions are also released from various operations of manufacturing like centrifuge, drying, distillation, extraction etc. These emissions mainly contain volatile contents of the material used for processing. It is proposed to provide vent condensers in series to reactors, distillation columns, driers and centrifuge etc. to mitigate VOC emissions release. Other vents are connected to common headers and scrubbers.

11.11.4 Solvent Use and Recycle Solvents are used for extraction of products and as reaction medium. Used solvents are recovered by distillationfor reuse. Residues from distillation columns and mixed solvents shall be sent to TSDF for incineration or cement plants for co-incineration. If any of the distilled spent solvents are not reused due to statutory reasons the same shall be sold to end users.

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11.11.5 Solid Waste Solid wastes are generated from process, solvent distillation, effluent treatment system, DG sets and boilers. Stripper distillate, process residue and solvent residue are sent to cement plants for co-incineration based on acceptability as the same contain significant calorific value and are predominantly organic in nature. If these wastes are not suitable for co-incineration, the same are sent to TSDF facility. The evaporation salts from ATFD , and sludge from ETP are sent to TSDF for landfill. Waste oil and used batteries from the DG sets are sent to authorized recyclers. Other solid wastes expected from the unit are containers, empty drums which are returned to the product seller or sold to authorized buyers after detoxification. Coal ash from boiler is sold to brick manufacturers.

11.11.6 Noise Pollution Noise is anticipated from motors, compressors, centrifuges and DG sets. DG sets shall be provided with acoustic enclosure. Engineering controls like acoustic enclosures, barriers, shields, and anti vibrating pads are provided to ensure reduction of noise levels and vibration. Employees working in noise generating areas shall be provided with appropriate personnel protective equipment.

11.11.7 Occupational Safety and Health

Direct exposure to chemicals or its raw materials may affect health of employees. Direct exposure to hazardous materials is eliminated by providing closed handling facilities. Personal Protective Equipment (PPE) i.e., hand gloves, safety goggles, safety shoes, safety helmets, respiratory masks etc. are provided to all the employees working in the plant. Company has a policy of providing PPEs to all personnel including contract workers. Periodic medical checkup in addition to checkup during recruitment is adopted to monitor health status of employees.

11.11.8 Prevention, maintenance and operation of Environment Control Systems

The pollution control equipment, and the effluent treatment system is monitored periodically to estimate their efficiency and performance potential as part of adoptive management. Proactive maintenance and monitoring program for all equipment and machinery is adopted to identify the problems/under performance of the equipment. Necessary measures will be adopted to rectify the identified problems/defects. The

11-9 Team Labs and consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report management agrees that the results of monitoring will be reviewed periodically to adopt new measures if necessary, for efficient pollution control.

11.11.9 Transport systems All the raw materials and finished products are transported by road. Dedicated parking facility is provided for transport vehicles. There will be 20-25 truck trip per day to the factory for transporting raw materials and products. Traffic signs will be placed in the battery limit. The drivers of vehicles will be provided with TREM cards of chemicals and materials to be transported, and will be explained the measure to be adopted during various emergencies

11.11. 10 Reduce, Recycle and Reuse A number of measures are proposed to achieve high yields and reduce generation of wastes. It shall be endeavor of the R&D team to improve yields through constant research and development activities. The solvents shall be recycled for reuse in the process after distillation. Mother liquors from the first crop shall be reused for process. The steam condensate shall be reused for boiler feed. Treated wastewater from sewage treatment plant is reused for greenbelt development. It is also proposed to explore recovery of various salts from MEE salts, and from process effluents to reduce effluent loads, and quantity of solid waste.

11.11.11 Green Belt Development It is proposed to provide green belt in an area of 3.75 acres, covering the boundary of the site as part of environment management plan. Native species shall be identified for plantation and guidelines issued by CPCB for development of green belt shall be followed. The green belt shall enhance environmental quality through mitigation of fugitive emissions, attenuation of noise levels, balancing eco-environment, prevention of soil erosion, and creation of aesthetic environment.

11.11.12 Post Project Monitoring Environmental monitoring for water, air, noise and solid waste quality will be conducted periodically either by proponent or third party. The frequency of monitoring and the quality parameters shall be as suggested by the Ministry of Environment and Forests and Climate Change, Government of India.

11-10 Team Labs and consultants Actero Pharma Pvt. Ltd. Environmental Impact Assessment Report

11.11.13 Environment Management Department The Environment Management Cell of the project shall be headed by the AGM operations, followed by Dy. Manager (EH&S), Junior executives, Managers, Chemists and fitters.

11-11 Team Labs and consultants Actero Pharma Lab Pvt. Ltd. Environmental Impact Assessment Report

CHAPTER 12.0 DISCLOSURE OF CONSULTANTS ENGAGED

Declaration by Experts Contributing to the EIA

I, hereby, certify that I was a part of the EIA team in the following capacity that developed the above EIA.

EIA coordinator:

Name: G.V. Reddy

Signature and Date: January 10, 2017

Period of involvement: January 2018

Contact information: Team Labs and Consultants, B115 - 117, 509, Aditya Enclave, Ameerpet, Hyderabad 500038.

Functional area experts: S. Functional Name of the Involvement Signature and No. areas expert/s (period and task**) date Period of involvement : January 2017 till date 1 AP T.Ravi kiran Site visit, Design of AAQ network, supervision of AAQ monitoring, Compilation of emissions and characteristics, assessment of impacts due to the proposed expansion, identification of mitigation measures, preparation of EMP for AP, Preparation of monitoring plan for AP. 2 WP G.V.Reddy Site visit, identification of monitoring stations, supervision of sampling, Characterization of effluent streams, segregation of effluent streams, ZLD for effluent treatment, assessment of impacts due to the proposed expansion, identification of mitigation measures, preparation of EMP for WP, Preparation of monitoring plan for WP. 3 SHW G.V.Reddy Site visit, Characterization of solid wastes, storage, and disposal plan for various solid wastes, assessment of

12-1 Team Labs and consultants

Actero Pharma Lab Pvt. Ltd. Environmental Impact Assessment Report

impacts due to the proposed expansion, identification of mitigation measures, preparation of EMP for SHW. 4 SE K. Nanaji Site visit, primary and secondary data collection of the impact area, assessment

of impacts due to the expansion prooject on socio economic status and prooject economy, preparation of CSR plan, Preparation of SE part of EIA report. 5 EB I. Sivarama Site visit, primary and secondary data Krishna collection related to ecology and biodiversity, assessment of impaacts based on IAIA guidelines, preparation of mitigation measures, preparation of green belt plan and cost estimate, preparation of EB part of EIA report. 6 HG G.V.A. Identification of water sheds of the area Ramakrishna by preparing the drainage map, assessment of ground water potential of the site and impact area, preparation of rain water harvesting plan, assessment of impacts due to ground water abstraction and mitigation measures. 7 SC D. Sundar Rao Identification of soil sampling locations and characterization of the soils,

interpretation of soil analysis reports, assessment of impacts due to spillages, accidental releases of chemicals, effluents etc., and mitigation measures. 8 AQ M. Srinivasa Assisting AP FAE in identifying the AAQ Reddy monitoring stations by providing normal climatological and other historical data, Identification of Micrometeorological data monitoring station, supervision of met data collection usinng Automatic weather station, Preparation of emission details, Air quality impact prediction modeling, Calculation of work room concentrations of solvents using box model, Assessment of results and preparation of isopleths, assisting the AP FAE and EIA coordinator in preparation of EMP.

12-2 Team Labs and consultants

Actero Pharma Lab Pvt. Ltd. Environmental Impact Assessment Report

9 LU G.V.A. Preparation of land use land cover map Ramakrishna using satellite imagery, ground truth study, assessing the impacts due to expansion. Preparation of FAE report. 10 RH D. Sadasivudu Site visit, assessment of hazop reports, identification of sources of hazards, assessment of storages proposed in comparison with statutory regulations and calculation of FETI to assess the scope of risk assessment, preparation of isopleths for various scenarios as part of consequence analysis, identification of mitigation measures preparation of disaster management plan.

Declaration by the Head of the accredited consultant organization/ authorized person I, G.V. Reddy hereby, confirm that the above mentioned experts prepared the EIA report for M/s. Actero Pharma Pvt. Ltd. I also confirm that the consultant organization shall be fully accountable for any mis-leading information mentioned in this statement.

Signature:

Name: G.V. Reddy Designation: Director Name of the EIA consultant organization: Team Labs And Consultants NABET Certificate No: S. No. 141 of List ‘A’ – Accredited EIA Consultant Organizations complying with Version 3 of the Scheme - as on Rev. 61 January 05, 2018

12-3 Team Labs and consultants

STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

5(f):STANDARD TERMS OF REFERENCE FOR CONDUCTING ENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETIC ORGANIC CHEMICALS INDUSTRY (DYES & DYE INTERMEDIATES; BULK DRUGS AND INTERMEDIATES EXCLUDING DRUG FORMULATIONS; SYNTHETIC RUBBERS; BASIC ORGANIC CHEMICALS, OTHER SYNTHETIC ORGANIC CHEMICALS AND CHEMICAL INTERMEDIATES) AND INFORMATION TO BE INCLUDED IN EIA/EMP REPORT

A. STANDARD TERMS OF REFERENCE

1) Executive Summary 2) Introduction i. Details of the EIA Consultant including NABET accreditation ii. Information about the project proponent iii. Importance and benefits of the project 3) Project Description i. Cost of project and time of completion. ii. Products with capacities for the proposed project. iii. If expansion project, details of existing products with capacities and whether adequate land is available for expansion, reference of earlier EC if any. iv. List of raw materials required and their source along with mode of transportation. v. Other chemicals and materials required with quantities and storage capacities vi. Details of Emission, effluents, hazardous waste generation and their management. vii. Requirement of water, power, with source of supply, status of approval, water balance diagram, man-power requirement (regular and contract) viii. Process description along with major equipments and machineries, process flow sheet (quantative) from raw material to products to be provided ix. Hazard identification and details of proposed safety systems. x. Expansion/modernization proposals: c. Copy of all the Environmental Clearance(s) including Amendments thereto obtained for the project from MOEF/SEIAA shall be attached as an Annexure. A certified copy of the latest Monitoring Report of the Regional Office of the Ministry of Environment and Forests as per circular dated 30th May, 2012 on the status of compliance of conditions stipulated in all the existing environmental clearances including Amendments shall be provided. In

181 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

addition, status of compliance of Consent to Operate for the ongoing Iexisting operation of the project from SPCB shall be attached with the EIA-EMP report. d. In case the existing project has not obtained environmental clearance, reasons for not taking EC under the provisions of the EIA Notification 1994 and/or EIA Notification 2006 shall be provided. Copies of Consent to Establish/No Objection Certificate and Consent to Operate (in case of units operating prior to EIA Notification 2006, CTE and CTO of FY 2005-2006) obtained from the SPCB shall be submitted. Further, compliance report to the conditions of consents from the SPCB shall be submitted. 4) Site Details i. Location of the project site covering village, Taluka/Tehsil, District and State, Justification for selecting the site, whether other sites were considered. ii. A toposheet of the study area of radius of 10km and site location on 1:50,000/1:25,000 scale on an A3/A2 sheet. (including all eco-sensitive areas and environmentally sensitive places) iii. Details w.r.t. option analysis for selection of site iv. Co-ordinates (lat-long) of all four corners of the site. v. Google map-Earth downloaded of the project site. vi. Layout maps indicating existing unit as well as proposed unit indicating storage area, plant area, greenbelt area, utilities etc. If located within an Industrial area/Estate/Complex, layout of Industrial Area indicating location of unit within the Industrial area/Estate. vii. Photographs of the proposed and existing (if applicable) plant site. If existing, show photographs of plantation/greenbelt, in particular. viii. Landuse break-up of total land of the project site (identified and acquired), government/ private - agricultural, forest, wasteland, water bodies, settlements, etc shall be included. (not required for industrial area) ix. A list of major industries with name and type within study area (10km radius) shall be incorporated. Land use details of the study area x. Geological features and Geo-hydrological status of the study area shall be included. xi. Details of Drainage of the project upto 5km radius of study area. If the site is within 1 km radius of any major river, peak and lean season river discharge as well as flood occurrence frequency based on peak rainfall data of the past 30 years. Details of Flood Level of the project site and maximum Flood Level of the river shall also be provided. (mega green field projects) xii. Status of acquisition of land. If acquisition is not complete, stage of the acquisition process and expected time of complete possession of the land. xiii. R&R details in respect of land in line with state Government policy.

182 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

5) Forest and wildlife related issues (if applicable): i. Permission and approval for the use of forest land (forestry clearance), if any, and recommendations of the State Forest Department. (if applicable) ii. Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineating the forestland (in case of projects involving forest land more than 40 ha) iii. Status of Application submitted for obtaining the stage I forestry clearance along with latest status shall be submitted. iv. The projects to be located within 10 km of the National Parks, Sanctuaries, Biosphere Reserves, Migratory Corridors of Wild Animals, the project proponent shall submit the map duly authenticated by Chief Wildlife Warden showing these features vis-à-vis the project location and the recommendations or comments of the Chief Wildlife Warden-thereon. v. Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the State Government for conservation of Schedule I fauna, if any exists in the study area. vi. Copy of application submitted for clearance under the Wildlife (Protection) Act, 1972, to the Standing Committee of the National Board for Wildlife. 6) Environmental Status i. Determination of atmospheric inversion level at the project site and site-specific micro- meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall. ii. AAQ data (except monsoon) at 8 locations for PM10, PM2.5, SO2, NOX, CO and other parameters relevant to the project shall be collected. The monitoring stations shall be based CPCB guidelines and take into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests. iii. Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in the NAQQM Notification of Nov. 2009 along with - min., max., average and 98% values for each of the AAQ parameters from data of all AAQ stations should be provided as an annexure to the EIA Report. iv. Surface water quality of nearby River (100m upstream and downstream of discharge point) and other surface drains at eight locations as per CPCB/MoEF&CC guidelines. v. Whether the site falls near to polluted stretch of river identified by the CPCB/MoEF&CC, if yes give details. vi. Ground water monitoring at minimum at 8 locations shall be included. vii. Noise levels monitoring at 8 locations within the study area. viii. Soil Characteristic as per CPCB guidelines. ix. Traffic study of the area, type of vehicles, frequency of vehicles for transportation of materials, additional traffic due to proposed project, parking arrangement etc.

183 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

x. Detailed description of flora and fauna (terrestrial and aquatic) existing in the study area shall be given with special reference to rare, endemic and endangered species. If Schedule-I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared and furnished. xi. Socio-economic status of the study area. 7) Impact and Environment Management Plan i. Assessment of ground level concentration of pollutants from the stack emission based on site-specific meteorological features. In case the project is located on a hilly terrain, the AQIP Modelling shall be done using inputs of the specific terrain characteristics for determining the potential impacts of the project on the AAQ. Cumulative impact of all sources of emissions (including transportation) on the AAQ of the area shall be assessed. Details of the model used and the input data used for modelling shall also be provided. The air quality contours shall be plotted on a location map showing the location of project site, habitation nearby, sensitive receptors, if any. ii. Water Quality modelling - in case of discharge in water body iii. Impact of the transport of the raw materials and end products on the surrounding environment hall be assessed and provided. In this regard, options for transport of raw materials and finished products and wastes (large quantities) by rail or rail-cum road transport or conveyor- cum-rail transport shall be examined. iv. A note on treatment of wastewater from different plant operations, extent recycled and reused for different purposes shall be included. Complete scheme of effluent treatment. Characteristics of untreated and treated effluent to meet the prescribed standards of discharge under E(P) Rules. v. Details of stack emission and action plan for control of emissions to meet standards. vi. Measures for fugitive emission control vii. Details of hazardous waste generation and their storage, utilization and management. Copies of MOU regarding utilization of solid and hazardous waste in cement plant shall also be included. EMP shall include the concept of waste-minimization, recycle/reuse/recover techniques, Energy conservation, and natural resource conservation. viii. Proper utilization of fly ash shall be ensured as per Fly Ash Notification, 2009. A detailed plan of action shall be provided. ix. Action plan for the green belt development plan in 33 % area i.e. land with not less than 1,500 trees per ha. Giving details of species, width of plantation, planning schedule etc. shall be included. The green belt shall be around the project boundary and a scheme for greening of the roads used for the project shall also be incorporated. x. Action plan for rainwater harvesting measures at plant site shall be submitted to harvest rainwater from the roof tops and storm water drains to recharge the ground water and also to

184 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

use for the various activities at the project site to conserve fresh water and reduce the water requirement from other sources. xi. Total capital cost and recurring cost/annum for environmental pollution control measures shall be included. xii. Action plan for post-project environmental monitoring shall be submitted. xiii. Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency Management Plan including Risk Assessment and damage control. Disaster management plan should be linked with District Disaster Management Plan. 8) Occupational health i. Plan and fund allocation to ensure the occupational health & safety of all contract and casual workers ii. Details of exposure specific health status evaluation of worker. If the workers' health is being evaluated by pre designed format, chest x rays, Audiometry, Spirometry, Vision testing (Far & Near vision, colour vision and any other ocular defect) ECG, during pre placement and periodical examinations give the details of the same. Details regarding last month analyzed data of above mentioned parameters as per age, sex, duration of exposure and department wise. iii. Details of existing Occupational & Safety Hazards. What are the exposure levels of hazards and whether they are within Permissible Exposure level (PEL). If these are not within PEL, what measures the company has adopted to keep them within PEL so that health of the workers can be preserved, iv. Annual report of heath status of workers with special reference to Occupational Health and Safety. 9) Corporate Environment Policy i. Does the company have a well laid down Environment Policy approved by its Board of Directors? If so, it may be detailed in the EIA report. ii. Does the Environment Policy prescribe for standard operating process / procedures to bring into focus any infringement / deviation / violation of the environmental or forest norms / conditions? If so, it may be detailed in the EIA. iii. What is the hierarchical system or Administrative order of the company to deal with the environmental issues and for ensuring compliance with the environmental clearance conditions? Details of this system may be given. iv. Does the company have system of reporting of non compliances / violations of environmental norms to the Board of Directors of the company and / or shareholders or stakeholders at large? This reporting mechanism shall be detailed in the EIA report

185 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

10) Details regarding infrastructure facilities such as sanitation, fuel, restroom etc. to be provided to the labour force during construction as well as to the casual workers including truck drivers during operation phase. 11) Enterprise Social Commitment (ESC) i. Adequate funds (at least 2.5 % of the project cost) shall be earmarked towards the Enterprise Social Commitment based on Public Hearing issues and item-wise details along with time bound action plan shall be included. Socio-economic development activities need to be elaborated upon. 12) Any litigation pending against the project and/or any direction/order passed by any Court of Law against the project, if so, details thereof shall also be included. Has the unit received any notice under the Section 5 of Environment (Protection) Act, 1986 or relevant Sections of Air and Water Acts? If so, details thereof and compliance/ATR to the notice(s) and present status of the case. 13) A tabular chart with index for point wise compliance of above TOR.

B. SPECIFIC TERMS OF REFERENCE FOR EIA STUDIES FOR SYNTHETIC ORGANIC CHEMICALS INDUSTRY (DYES & DYE INTERMEDIATES; BULK DRUGS AND INTERMEDIATES EXCLUDING DRUG FORMULATIONS; SYNTHETIC RUBBERS; BASIC ORGANIC CHEMICALS, OTHER SYNTHETIC ORGANIC CHEMICALS AND CHEMICAL INTERMEDIATES)

1. Detailsonsolvents to be used,measuresfor solventrecovery and for emissions control. 2. Details of process emissions from the proposed unit and its arrangement to control. 3. Ambient air quality data should include VOC, otherprocess-specificpollutants* like NH3*, chlorine*, HCl*, HBr*, H2S*, HF*,etc.,(*-asapplicable) 4. Work zone monitoring arrangements for hazardous chemicals. 5. Detailed effluent treatment scheme including ssegregation of effluent streams for units adopting 'Zero' liquid discharge. 6. Action plan for odour control to be submitted. 7. A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearly that they co-process organic solid/hazardous waste generated. 8. Authorization/Membership for the disposal of liquid effluent in CETP and solid/hazardous waste in TSDF, if any. 9. Action plan for utilization of MEE/dryers salts. 10. Material Safety Data Sheet for all the Chemicals are being used/will be used. 11. Authorization/Membership for the disposal of solid/hazardous waste in TSDF.

186 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

12. Details of incinerator if to be installed. 13. Risk assessment for storage and handling of hazardous chemicals/solvents. Action plan for handling & safety system to be incorporated. 14. Arrangements for ensuring health and safety of workers engaged in handling of toxic materials.

***

187 ACTERO PHARMA PVT. LTD. SY.NO. 407 (PART) AND 411, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA

3. COMPLIANCE OF TERMS OF REFERENCE

Project No. 0118‐21‐03 January 2018

M/s. Actero Pharma Pvt. Ltd. STUDIES AND DOCUMENTATION BY C/o. Hetero Drugs Limited TEAM Labs and Consultants Plot No: 7‐2‐A2 Hetero Corp, Industrial Estate, B‐115‐117 & 509, Annapurna Block, Sanathnagar, Hyderabad‐500018 Aditya Enclave, Ameerpet, Phone: 040‐23704923/23704924 Hyderabad‐500 038. E‐mail: [email protected]; Phone: 040‐23748 555/23748616, [email protected] Telefax: 040‐23748666

SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD, REGIONAL OFFICE, NALGONDA

STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

5(f):STANDARD TERMS OF REFERENCE FOR CONDUCTING ENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETIC ORGANIC CHEMICALS INDUSTRY (DYES & DYE INTERMEDIATES; BULK DRUGS AND INTERMEDIATES EXCLUDING DRUG FORMULATIONS; SYNTHETIC RUBBERS; BASIC ORGANIC CHEMICALS, OTHER SYNTHETIC ORGANIC CHEMICALS AND CHEMICAL INTERMEDIATES) AND INFORMATION TO BE INCLUDED IN EIA/EMP REPORT

A. STANDARD TERMS OF REFERENCE

1) Executive Summary 2) Introduction i. Details of the EIA Consultant including NABET accreditation ii. Information about the project proponent iii. Importance and benefits of the project 3) Project Description i. Cost of project and time of completion. ii. Products with capacities for the proposed project. iii. If expansion project, details of existing products with capacities and whether adequate land is available for expansion, reference of earlier EC if any. iv. List of raw materials required and their source along with mode of transportation. v. Other chemicals and materials required with quantities and storage capacities vi. Details of Emission, effluents, hazardous waste generation and their management. vii. Requirement of water, power, with source of supply, status of approval, water balance diagram, man-power requirement (regular and contract) viii. Process description along with major equipments and machineries, process flow sheet (quantative) from raw material to products to be provided ix. Hazard identification and details of proposed safety systems. x. Expansion/modernization proposals: c. Copy of all the Environmental Clearance(s) including Amendments thereto obtained for the project from MOEF/SEIAA shall be attached as an Annexure. A certified copy of the latest Monitoring Report of the Regional Office of the Ministry of Environment and Forests as per circular dated 30th May, 2012 on the status of compliance of conditions stipulated in all the existing environmental clearances including Amendments shall be provided. In

181 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

addition, status of compliance of Consent to Operate for the ongoing Iexisting operation of the project from SPCB shall be attached with the EIA-EMP report. d. In case the existing project has not obtained environmental clearance, reasons for not taking EC under the provisions of the EIA Notification 1994 and/or EIA Notification 2006 shall be provided. Copies of Consent to Establish/No Objection Certificate and Consent to Operate (in case of units operating prior to EIA Notification 2006, CTE and CTO of FY 2005-2006) obtained from the SPCB shall be submitted. Further, compliance report to the conditions of consents from the SPCB shall be submitted. 4) Site Details i. Location of the project site covering village, Taluka/Tehsil, District and State, Justification for selecting the site, whether other sites were considered. ii. A toposheet of the study area of radius of 10km and site location on 1:50,000/1:25,000 scale on an A3/A2 sheet. (including all eco-sensitive areas and environmentally sensitive places) iii. Details w.r.t. option analysis for selection of site iv. Co-ordinates (lat-long) of all four corners of the site. v. Google map-Earth downloaded of the project site. vi. Layout maps indicating existing unit as well as proposed unit indicating storage area, plant area, greenbelt area, utilities etc. If located within an Industrial area/Estate/Complex, layout of Industrial Area indicating location of unit within the Industrial area/Estate. vii. Photographs of the proposed and existing (if applicable) plant site. If existing, show photographs of plantation/greenbelt, in particular. viii. Landuse break-up of total land of the project site (identified and acquired), government/ private - agricultural, forest, wasteland, water bodies, settlements, etc shall be included. (not required for industrial area) ix. A list of major industries with name and type within study area (10km radius) shall be incorporated. Land use details of the study area x. Geological features and Geo-hydrological status of the study area shall be included. xi. Details of Drainage of the project upto 5km radius of study area. If the site is within 1 km radius of any major river, peak and lean season river discharge as well as flood occurrence frequency based on peak rainfall data of the past 30 years. Details of Flood Level of the project site and maximum Flood Level of the river shall also be provided. (mega green field projects) xii. Status of acquisition of land. If acquisition is not complete, stage of the acquisition process and expected time of complete possession of the land. xiii. R&R details in respect of land in line with state Government policy.

182 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

5) Forest and wildlife related issues (if applicable): i. Permission and approval for the use of forest land (forestry clearance), if any, and recommendations of the State Forest Department. (if applicable) ii. Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineating the forestland (in case of projects involving forest land more than 40 ha) iii. Status of Application submitted for obtaining the stage I forestry clearance along with latest status shall be submitted. iv. The projects to be located within 10 km of the National Parks, Sanctuaries, Biosphere Reserves, Migratory Corridors of Wild Animals, the project proponent shall submit the map duly authenticated by Chief Wildlife Warden showing these features vis-à-vis the project location and the recommendations or comments of the Chief Wildlife Warden-thereon. v. Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the State Government for conservation of Schedule I fauna, if any exists in the study area. vi. Copy of application submitted for clearance under the Wildlife (Protection) Act, 1972, to the Standing Committee of the National Board for Wildlife. 6) Environmental Status i. Determination of atmospheric inversion level at the project site and site-specific micro- meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall. ii. AAQ data (except monsoon) at 8 locations for PM10, PM2.5, SO2, NOX, CO and other parameters relevant to the project shall be collected. The monitoring stations shall be based CPCB guidelines and take into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests. iii. Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in the NAQQM Notification of Nov. 2009 along with - min., max., average and 98% values for each of the AAQ parameters from data of all AAQ stations should be provided as an annexure to the EIA Report. iv. Surface water quality of nearby River (100m upstream and downstream of discharge point) and other surface drains at eight locations as per CPCB/MoEF&CC guidelines. v. Whether the site falls near to polluted stretch of river identified by the CPCB/MoEF&CC, if yes give details. vi. Ground water monitoring at minimum at 8 locations shall be included. vii. Noise levels monitoring at 8 locations within the study area. viii. Soil Characteristic as per CPCB guidelines. ix. Traffic study of the area, type of vehicles, frequency of vehicles for transportation of materials, additional traffic due to proposed project, parking arrangement etc.

183 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

x. Detailed description of flora and fauna (terrestrial and aquatic) existing in the study area shall be given with special reference to rare, endemic and endangered species. If Schedule-I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared and furnished. xi. Socio-economic status of the study area. 7) Impact and Environment Management Plan i. Assessment of ground level concentration of pollutants from the stack emission based on site-specific meteorological features. In case the project is located on a hilly terrain, the AQIP Modelling shall be done using inputs of the specific terrain characteristics for determining the potential impacts of the project on the AAQ. Cumulative impact of all sources of emissions (including transportation) on the AAQ of the area shall be assessed. Details of the model used and the input data used for modelling shall also be provided. The air quality contours shall be plotted on a location map showing the location of project site, habitation nearby, sensitive receptors, if any. ii. Water Quality modelling - in case of discharge in water body iii. Impact of the transport of the raw materials and end products on the surrounding environment hall be assessed and provided. In this regard, options for transport of raw materials and finished products and wastes (large quantities) by rail or rail-cum road transport or conveyor- cum-rail transport shall be examined. iv. A note on treatment of wastewater from different plant operations, extent recycled and reused for different purposes shall be included. Complete scheme of effluent treatment. Characteristics of untreated and treated effluent to meet the prescribed standards of discharge under E(P) Rules. v. Details of stack emission and action plan for control of emissions to meet standards. vi. Measures for fugitive emission control vii. Details of hazardous waste generation and their storage, utilization and management. Copies of MOU regarding utilization of solid and hazardous waste in cement plant shall also be included. EMP shall include the concept of waste-minimization, recycle/reuse/recover techniques, Energy conservation, and natural resource conservation. viii. Proper utilization of fly ash shall be ensured as per Fly Ash Notification, 2009. A detailed plan of action shall be provided. ix. Action plan for the green belt development plan in 33 % area i.e. land with not less than 1,500 trees per ha. Giving details of species, width of plantation, planning schedule etc. shall be included. The green belt shall be around the project boundary and a scheme for greening of the roads used for the project shall also be incorporated. x. Action plan for rainwater harvesting measures at plant site shall be submitted to harvest rainwater from the roof tops and storm water drains to recharge the ground water and also to

184 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

use for the various activities at the project site to conserve fresh water and reduce the water requirement from other sources. xi. Total capital cost and recurring cost/annum for environmental pollution control measures shall be included. xii. Action plan for post-project environmental monitoring shall be submitted. xiii. Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency Management Plan including Risk Assessment and damage control. Disaster management plan should be linked with District Disaster Management Plan. 8) Occupational health i. Plan and fund allocation to ensure the occupational health & safety of all contract and casual workers ii. Details of exposure specific health status evaluation of worker. If the workers' health is being evaluated by pre designed format, chest x rays, Audiometry, Spirometry, Vision testing (Far & Near vision, colour vision and any other ocular defect) ECG, during pre placement and periodical examinations give the details of the same. Details regarding last month analyzed data of above mentioned parameters as per age, sex, duration of exposure and department wise. iii. Details of existing Occupational & Safety Hazards. What are the exposure levels of hazards and whether they are within Permissible Exposure level (PEL). If these are not within PEL, what measures the company has adopted to keep them within PEL so that health of the workers can be preserved, iv. Annual report of heath status of workers with special reference to Occupational Health and Safety. 9) Corporate Environment Policy i. Does the company have a well laid down Environment Policy approved by its Board of Directors? If so, it may be detailed in the EIA report. ii. Does the Environment Policy prescribe for standard operating process / procedures to bring into focus any infringement / deviation / violation of the environmental or forest norms / conditions? If so, it may be detailed in the EIA. iii. What is the hierarchical system or Administrative order of the company to deal with the environmental issues and for ensuring compliance with the environmental clearance conditions? Details of this system may be given. iv. Does the company have system of reporting of non compliances / violations of environmental norms to the Board of Directors of the company and / or shareholders or stakeholders at large? This reporting mechanism shall be detailed in the EIA report

185 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

10) Details regarding infrastructure facilities such as sanitation, fuel, restroom etc. to be provided to the labour force during construction as well as to the casual workers including truck drivers during operation phase. 11) Enterprise Social Commitment (ESC) i. Adequate funds (at least 2.5 % of the project cost) shall be earmarked towards the Enterprise Social Commitment based on Public Hearing issues and item-wise details along with time bound action plan shall be included. Socio-economic development activities need to be elaborated upon. 12) Any litigation pending against the project and/or any direction/order passed by any Court of Law against the project, if so, details thereof shall also be included. Has the unit received any notice under the Section 5 of Environment (Protection) Act, 1986 or relevant Sections of Air and Water Acts? If so, details thereof and compliance/ATR to the notice(s) and present status of the case. 13) A tabular chart with index for point wise compliance of above TOR.

B. SPECIFIC TERMS OF REFERENCE FOR EIA STUDIES FOR SYNTHETIC ORGANIC CHEMICALS INDUSTRY (DYES & DYE INTERMEDIATES; BULK DRUGS AND INTERMEDIATES EXCLUDING DRUG FORMULATIONS; SYNTHETIC RUBBERS; BASIC ORGANIC CHEMICALS, OTHER SYNTHETIC ORGANIC CHEMICALS AND CHEMICAL INTERMEDIATES)

1. Detailsonsolvents to be used,measuresfor solventrecovery and for emissions control. 2. Details of process emissions from the proposed unit and its arrangement to control. 3. Ambient air quality data should include VOC, otherprocess-specificpollutants* like NH3*, chlorine*, HCl*, HBr*, H2S*, HF*,etc.,(*-asapplicable) 4. Work zone monitoring arrangements for hazardous chemicals. 5. Detailed effluent treatment scheme including ssegregation of effluent streams for units adopting 'Zero' liquid discharge. 6. Action plan for odour control to be submitted. 7. A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearly that they co-process organic solid/hazardous waste generated. 8. Authorization/Membership for the disposal of liquid effluent in CETP and solid/hazardous waste in TSDF, if any. 9. Action plan for utilization of MEE/dryers salts. 10. Material Safety Data Sheet for all the Chemicals are being used/will be used. 11. Authorization/Membership for the disposal of solid/hazardous waste in TSDF.

186 STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

12. Details of incinerator if to be installed. 13. Risk assessment for storage and handling of hazardous chemicals/solvents. Action plan for handling & safety system to be incorporated. 14. Arrangements for ensuring health and safety of workers engaged in handling of toxic materials.

***

187 Actero Pharma Pvt. Ltd. TOR Compliances

Compliance of Terms of Reference Compliance of Standard TOR for “Synthetic Organic Chemicals Industry (dyes and dye intermediates; bulk drugs and intermediates excluding drug formation; synthetic rubber; basic organic chemicals, other synthetic organic chemicals and chemical intermediates” Issued by MoEF&CC for EIA/EMP report for Projects/Activates requiring Environmental Clearance Under EIA Notification, 2006

TOR Letter No: F.No.J-11011/59/2017-IA. II (I) Date: 26.05.2017 S.No Compliance of Terms or Reference Response A. STANDARD TERMS OF REFERENCE 1 Executive Summary Included in EIA report. 2 Introduction i. Details of the EIA Consultant including EIA Consultants: NABET accreditation Team Labs and Consultants List of QCI/NABET Consultants: S.No.141 (Rev. 61 - January 05, 2018) ii. Information about the project proponent Presented in Chapter 1 of EIA report at Page No. 1-2 iii. Importance and benefits of the project Presented in Chapter 1 of EIA report at Page No. 1-2 3 Project Description i. Cost of project and time of completion. Cost of Project for Proposed Expansion is 35 crores. ii. Products with capacities for the proposed Presented in Chapter 1 of EIA report at project. Page No. 1-3 iii. If expansion project, details of existing Not Applicable. The present proposal is products with capacities and whether a green filed project. adequate land is available for expansion, reference of earlier EC if any. iv. List of raw materials required and their source Presented in Chapter 7 of EIA report at along with mode of transportation. Page No. 7-4 to 7-9 v. Other chemicals and materials required with Presented in Chapter 7 of EIA report at quantities and storage capacities Page No. 7-4 vi. Details of Emission, effluents, hazardous Presented in Chapter 10 Chapter 10. waste generation and their management. Effluents: 10-4 to 10-11 Emissions: 10-11 to 10-15 Hazardous Waste: 10-19 to 10-20. vii. Requirement of water, power, with source of Total water required: 312.82 KLD supply, status of approval, water balance Fresh water: 206.82 KLD diagram, man-power requirement (regular Recycled water: 106 KLD* and contract) Detailed water balance is presented in Chapter 2 of EIA Report at Page No. 2- 84 viii. Process description along with major Presented in Chapter 2 of EIA Report at equipments and machineries, process flow Page No. 2-2 to 2-83 sheet (quantative) from raw material to products to be provided ix. Hazard identification and details of proposed Presented in Chapter 7 of EIA report at safety systems. Page No. 7-16 to 7-19. x. Expansion/modernization proposals: Page 1

Actero Pharma Pvt. Ltd. TOR Compliances

a. Copy of all the Environmental Not Applicable Clearance(s) including Amendments thereto obtained for the project from MOEF/SEIAA shall be attached as an Annexure. A certified copy of the latest Monitoring Report of the Regional Office of the Ministry of Environment and Forests as per circular dated 30th May, 2012 on the status of compliance of conditions stipulated in all the existing environmental clearances including Amendments shall be provided. In addition, status of compliance of Consent to Operate for the ongoing existing operation of the project from SPCB shall be attached with the EIA-EMP report. b. In case the existing project has not Not Applicable obtained environmental clearance, reasons for not taking EC under the provisions of the EIA Notification 1994 and/or EIA Notification 2006 shall be provided. Copies of Consent to Establish/No Objection Certificate and Consent to Operate (in case of units operating prior to EIA Notification 2006, CTE and CTO of FY 2005-2006) obtained from the SPCB shall be submitted. Further, compliance report to the conditions of consents from the SPCB shall be submitted. 4 Site Details i. Location of the project site covering village, Actero Pharma Pvt. Ltd. Taluka/Tehsil, District and State, Justification Sy No 407 (Part) and 411, Veliminedu for selecting the site, whether other sites were (V), Chityal Mandal, Nalgonda District, considered. Telangana. Total land area: 11.275 acres. ii. A topo sheet of the study area of radius of Presented in Chapter 1 of EIA report at 10km and site location on 1:50,000/1:25,000 Page No. 1-6. scale on an A3/A2 sheet. (including all eco- sensitive areas and environmentally sensitive places) iii. Details w.r.t. option analysis for selection of Actero Pharma Pvt. Ltd. proposes to site establish a synthetic organic chemicals (Bulk Drugs & Intermediates) Unit of Production capacity 165 TPM in an area of 11.275 acres of land on lease from principle organization M/s. Dasami Lab Pvt. Ltd., for a lease period of 25 years at Sy No 407 (Part) and 411, Veliminedu (V), Chityal Mandal, Nalgonda District, Telangana.

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iv. Co-ordinates (lat-long) of all four corners of S.No Latitude Longitude the site. 1 17°13'34" 79° 2'38" v. Google map-Earth downloaded of the project Enclosed at Annexure - I site. vi. Layout maps indicating existing unit as well Plant layout is presented in Chapter 1 as proposed unit indicating storage area, plant of EIA report at Page No. 1-7 area, greenbelt area, utilities etc. If located within an Industrial area/Estate/Complex, layout of Industrial Area indicating location of unit within the Industrial area/Estate. vii. Photographs of the proposed and existing (if Photographs of Plant site is presented applicable) plant site. If existing, show in Chapter 3 of EIA report at Page No. Photographs of plantation/greenbelt, in 3-2 particular. viii. Land use break-up of total land of the project Plant layout is presented in Chapter 1 site (identified and acquired), government/ of EIA report at Page No. 1-7 private - agricultural, forest, wasteland, water bodies, settlements, etc shall be included. (not required for industrial area) ix. A list of major industries with name and type Land use and Land Cover map of the within study area (10km radius) shall be study area is presented in Chapter 3 of Incorporated. Land use details of the study EIA report at Page No. 3-10. area x. Geological features and Geo-hydrological Presented in Chapter 3 of EIA report at status of the study area shall be included. Page No. 3-5 to 3-8 xi. Details of Drainage of the project upto 5km Drainage pattern of the impact area is radius of study area. If the site is within 1 km presented in Chapter 3 of EIA report at radius of any major river, peak and lean Page No. 3-17 season river discharge as well as flood occurrence Frequency based on peak rainfall data of the past 30 years. Details of Flood Level of the Project site and maximum Flood Level of the river shall also be provided. (mega green field projects) xii. Status of acquisition of land. If acquisition is Actero Pharma Pvt. Ltd. obtained not complete, stage of the acquisition process 11.275 acres of land on lease from and expected time of complete possession of principle organization M/s. Dasami the land. Lab Pvt. Ltd., for a lease period of 25 years at Sy No 407 (Part) and 411, Veliminedu (V), Chityal Mandal, Nalgonda District, Telangana. xiii. R&R details in respect of land in line with Not Applicable. state Government policy. 5 Forest and wildlife related issues (if applicable): i. Permission and approval for the use of forest Not Applicable land (forestry clearance), if any, and recommendations of the State Forest Department. (if applicable) ii. Land use map based on High resolution Actero Pharma Pvt. Ltd. obtained satellite imagery (GPS) of the proposed site 11.275 acres of land on lease from

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Actero Pharma Pvt. Ltd. TOR Compliances

delineating the forestland (in case of projects principle organization M/s. Dasami involving forest land more than 40 ha) Lab Pvt. Ltd., for a lease period of 25 years at Sy No 407 (Part) and 411, Veliminedu (V), Chityal Mandal, Nalgonda District, Telangana. iii. Status of Application submitted for obtaining Not Applicable the stage I forestry clearance along with latest status shall be submitted. iv. The projects to be located within 10 km of the There are no National Parks, National Parks, Sanctuaries, Biosphere Sanctuaries, Biosphere Reserves, Reserves, Migratory Corridors of Wild Migratory Corridors of Wild Animals Animals, the project proponent shall submit within the impact area of 10 km. the map duly authenticated by Chief Wildlife Warden showing these features vis-à-vis the project location and the recommendations or comments of the Chief Wildlife Warden- thereon. v. Wildlife Conservation Plan duly authenticated Not Applicable by the Chief Wildlife Warden of the State Government for conservation of Schedule I fauna, if any exists in the study area. vi. Copy of application submitted for clearance Not Applicable under the Wildlife (Protection) Act, 1972, to the Standing Committee of the National Board for Wildlife. 6 Environmental Status i. Determination of atmospheric inversion level Site-specific micrometeorological data at the project site and site-specific presented in Chapter 3 of EIA report at micrometeorological data using temperature, Page No. 3-20 to 3-25 relative humidity, hourly wind speed and direction and rainfall. ii. AAQ data (except monsoon) at 8 locations for AAQ data presented in Chapter 3 of PM10, PM2.5, SO2, NOX, CO and other EIA report at Page No. 3-30 to 3-33 parameters relevant to the project shall be collected. The monitoring stations shall be based CPCB guidelines and take into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests. iii. Raw data of all AAQ measurement for 12 AAQ data is presented in Chapter 3 of weeks of all stations as per frequency given in EIA report at Page No. 3-32 to 3-33 the NAQQM Notification of Nov. 2009 along with - min., max., average and 98% values for each of the AAQ parameters from data of all AAQ stations should be provided as an annexure to the EIA Report. iv. Surface water quality of nearby River (100m Surface water Monitoring locations upstream and downstream of discharge point) presented in Chapter 3 of EIA report at and other surface drains at eight locations as Page No. 3-14. per CPCB/MoEF&CC guidelines.

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Actero Pharma Pvt. Ltd. TOR Compliances

v. Whether the site falls near to polluted stretch No. of river identified by the CPCB/MoEF&CC, if Sy No 407 (Part) and 411, Veliminedu yes give details. (V), Chityal Mandal, Nalgonda District, Telangana. vi. Ground water monitoring at minimum at 8 Ground Monitoring locations presented locations shall be included. in Chapter 3 of EIA report at Page No. 3-15 to 3-19. vii. Noise levels monitoring at 8 locations within Noise levels monitoring is presented in the study area. Chapter 3 of EIA report at Page No. 3- 34 to 3-36 viii. Soil Characteristic as per CPCB guidelines. Soil Characteristics is presented in Chapter 3 of EIA report at Page No. 3-9 to 3-13 ix. Traffic study of the area, type of vehicles, The additional traffic generated due to frequency of vehicles for transportation of the proposed project shall be 20 - 25 materials, additional traffic due to proposed truck trips per day. project, parking arrangement etc. x. Detailed description of flora and fauna Flora and Fauna of the Impact area is (terrestrial and aquatic) existing in the study presented in Chapter 3 of EIA report at area shall be given with special reference to Page No. 3-45 to 3-57 rare, endemic and endangered species. If Schedule-I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared and furnished. xi. Socio-economic status of the study area. Socio-Economic status of the impact area is presented in Chapter 3 of EIA report at Page No. 3-37 to 3-44 7 Impact and Environment Management Plan i. Assessment of ground level concentration of Predictions of ground level pollutants from the stack emission based on concentrations using ISC-AERMOD site-specific meteorological features. In case using ISCST3 model is of the pollutants the project is located on a hilly terrain, the presented in Chapter 4 of EIA report at AQIP Modelling shall be done using inputs of Page No. 4-13 to 4-20. the specific terrain characteristics for determining the potential impacts of the The additional traffic generated due to project on the AAQ. Cumulative impact of all the proposed project shall be 20-25 sources of emissions (including truck trips per day. There will be transportation) on the AAQ of the area shall marginal increase in the traffic density. be assessed. Details of the model used and the Emissions considered from transport of input data used for modelling shall also be vehicles as line source. provided. The air quality contours shall be plotted on a location map showing the location of project site, habitation nearby, sensitive receptors, if any. ii. Water Quality modelling - in case of discharge Not applicable in water body Total effluent generated sent to “Zero Liquid Discharge“System iii. Impact of the transport of the raw materials There will be 20-25 truck trips per day. and end products on the surrounding Truck transport Incidents and concerns environment shall be assessed and provided. are presented in Chapter 7 of EIA In this regard, options for transport of raw report at Page No. 7-36.

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Actero Pharma Pvt. Ltd. TOR Compliances

materials and finished products and wastes (large quantities) by rail or rail-cum road transport or conveyor cum- rail transport shall be examined. iv. A note on treatment of wastewater from Quantity, quality of effluent generated different plant operations, extent recycled and from different operation is presented in reused for different purposes shall be Chapter 10 Chapter 10 of EIA report at included. Complete scheme of effluent Page No. 10-4 to 10-6. treatment. Characteristics of untreated and treated effluent to meet the prescribed Effluent Treatment System (ZLD) is standards of discharge under E (P) Rules. presented in Chapter 10 of EIA report at Page No. 10-6 to 10-11. v. Details of stack emission and action plan for Presented in Chapter 10 Chapter 10 of control of emissions to meet standards. EIA report at Page No. 10-12. vi. Measures for fugitive emission control Presented in Chapter 10 of EIA report at Page No. 10-15. vii. Details of hazardous waste generation and Presented in Chapter 10 of EIA report their storage, utilization and management. at Page No. 10-19 to 10-20. Copies of MOU regarding utilization of solid Reduce, reuse and recycled concept is and hazardous waste in cement plant shall presented in waste-minimization, also be included. EMP shall include the Energy conservation is presented in concept of waste-minimization, Chapter 10 of EIA report at Page No. recycle/reuse/recover 10-30. Techniques, Energy conservation, and natural resource conservation. viii. Proper utilization of fly ash shall be ensured Ash generated from 2 x 8 TPH coal as per Fly Ash Notification, 2009. A detailed fired is 32 TPD and same sold to brick plan of action shall be provided. manufactures and cement plants ix. Action plan for the green belt development It proposed to provide green belt in an plan in 33 % area i.e. land with not less than area of 3.75 acres. Layout showing 1,500 trees per ha. Giving details of species, green belt development is presented in width of plantation, planning schedule etc. Chapter 10 at Page No. 10-33. shall be included. The green belt shall be around the project boundary and a scheme for greening of the roads used for the project shall also be incorporated. x. Action plan for rainwater harvesting measures Presented in Chapter 10 of EIA report at plant site shall be submitted to harvest at Page No. 10-21. rainwater from the roof tops and storm water ZLD system helps in reduction of fresh drains to recharge the ground water and also water consumption by using 33.88% of to use for the various activities at the project total water requirement. site to conserve fresh water and reduce the water requirement from other sources. xi. Total capital cost and recurring cost/annum Total Capital Cost: Rs. 35 crores for environmental pollution control measures EMP Cost estimate: Rs. 1000 Lakhs shall be included. Recurring Cost on EMP: Rs. 788 Lakhs/annum. Details are presented in Chapter 10 at Page no. 10-36 to 10- 39 xii. Action plan for post-project environmental Presented in Chapter 6 of EIA report at monitoring shall be submitted. Page No. 6-2 to 6-9

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Actero Pharma Pvt. Ltd. TOR Compliances

xiii. Onsite and Offsite Disaster (natural and Man- Disaster Management Plan is presented made) Preparedness and Emergency in Chapter 7 of EIA report at Page Management Plan including Risk Assessment No.7-40. and damage control. Disaster management plan should be linked with District Disaster Onsite and Offsite Disaster is presented Management Plan. in Chapter 7 of EIA report at Page No.7-41. 8 Occupational Health i. Plan and fund allocation to ensure the Total: 44.9 Lakhs/annum occupational health & safety of all contract PPE: 19.4 Lakhs/annum and casual workers Health Check-up: 25.5 Lakhs/annum ii. Details of exposure specific health status Medical health check-up is presented in evaluation of worker. If the workers' health is Chapter 10 of EIA report at Page No. being evaluated by pre designed format, chest 10-25 to 10-26. x rays, Audiometry, Spirometry, Vision testing (Far & Near vision, colour vision and any Medical examination report of other ocular defect) ECG, during pre employees is enclosed at Annexure – placement and III. Periodical examinations give the details of the same. Details regarding last month analyzed data of above mentioned parameters as per age, sex, duration of exposure and department wise. iii. Details of existing Occupational & Safety Presented in Chapter 10 of EIA report Hazards. What are the exposure levels of at Page No. 10-30 to 10-33. hazards and whether they are within Permissible Exposure level (PEL). If these are Suitable PPE will be prescribed to the not within PEL, what measures the company employees working in area where the has adopted to keep them within PEL so that conc. Exceeds PEL values. health of the workers can be preserved, Simultaneously the project and R&D team will be consulted to suggest mitigative measures and or engineering control measures.

The focus shall always be in ensuring concentration within PEL by adopting engineering controls as when requires. iv. Annual report of heath status of workers with Not Applicable special reference to Occupational Health and Safety. 9 Corporate Environment Policy i. Does the company have a well laid down Corporate Environment Policy is Environment Policy approved by its Board of presented in Chapter 10 of EIA report Directors? If so, it may be detailed in the EIA at Page No. 10-34. report. ii. Does the Environment Policy prescribe for Environment engineer is responsible to standard operating process / procedures to bring to focus to higher management in bring into focus any infringement / deviation case of deviation/ violation of the / violation of the environmental or forest environmental or forest norms / norms / conditions? If so, it may be detailed in conditions. the EIA. iii. What is the hierarchical system or Environment Management Cell is Page 7

Actero Pharma Pvt. Ltd. TOR Compliances

Administrative order of the company to deal presented in Chapter 10 of EIA report with the environmental issues and for at Page No. 10-35. ensuring compliance with the environmental clearance Conditions? Details of this system may be given. iv. Does the company have system of reporting of No non compliances / violations of environmental norms to the Board of Directors of the company and / or shareholders or stakeholders at large? This reporting mechanism shall be detailed in the EIA report 10 Details regarding infrastructure facilities such as Presented in Chapter 10 of EIA report sanitation, fuel, restroom etc. to be provided to the at Page No. 10-2. labour force during construction as well as to the casual workers including truck drivers during operation phase. 11 Enterprise Social Commitment (ESC) i. Adequate funds (at least 2.5 % of the project Corporate Social Responsibilities – cost) shall be earmarked towards the Budget is presented in Chapter 10 of Enterprise Social Commitment based on EIA report at Page No. 1-40. Public Hearing issues and item-wise details along with time bound action plan shall be included. Socio-economic development activities need to be elaborated upon. 12 Any litigation pending against the project and/or No Individual Court case against the any direction/order passed by any Court of Law Project. against the project, if so, details thereof shall also be included. Has the unit received any notice under the Section 5 of Environment (Protection) Act, 1986 or relevant Sections of Air and Water Acts? If so, details thereof and compliance/ATR to the notice(s) and present status of the case. 13 A tabular chart with index for point wise compliance Enclosed at Compliance of Terms of of above TOR. Reference along with EIA & EMP. A. STANDARD TOR 1 Details on solvents to be used, measures for solvent Details of solvents used and balance is recovery and for emissions control. presented in Chapter 2 of EIA report at Page No. 2-102 to 2-108. 2 Details of process emissions from the proposed unit Detail of process emission and mode of and its arrangement to control. treatment is presented in Chapter 10 of EIA report at Page No. 10-13 to 2-15. 3 Ambient air quality data should include VOC, other AAQ data is presented in Chapter 3 of process-specific pollutants* like NH3*, chlorine*, EIA report at Page No. 3-32 to 3-33 HCl*, HBr*, H2S*, HF*,etc., (*-as applicable) 4 Work zone monitoring arrangements for hazardous Presented in Chapter 6 of EIA report at chemicals. Page No. 6-10. 5 Detailed effluent treatment scheme including Details of Effluent Treatment System segregation of effluent streams for units adopting (ZLD) are presented in Chapter 10 of 'Zero' liquid discharge. EIA report at Page No. 10-6 to 10-11. 6 Action plan for odour control to be submitted. Presented in Chapter 10 of EIA report Page 8

Actero Pharma Pvt. Ltd. TOR Compliances

at Page No. 10-16. 7 A copy of the Memorandum of Understanding Enclosed at Annexure - IV signed with cement manufacturers indicating clearly that they co-process organic solid/hazardous waste generated. 8 Authorization/Membership for the disposal of liquid Enclosed at Annexure - V effluent in CETP and solid/hazardous waste in TSDF, if any. 9 Action plan for utilization of MEE/dryers salts. Salts generated from MEE/ATFD sent to TSDF. 10 Material Safety Data Sheet for all the Chemicals are Enclosed at Annexure – VI being used/will be used. 11 Authorization/Membership for the disposal of Enclosed at Annexure - V solid/hazardous waste in TSDF. 12 Details of incinerator if to be installed. Not Applicable. Organic waste sent to TSDF/cements plant for co- incineration. 13 Risk assessment for storage and handling of Presented in Chapter 7 of EIA report at hazardous chemicals/solvents. Action plan for Page No.7-33 to 7-34. handling & safety system to be incorporated. 14 Arrangements for ensuring health and safety of Presented in Chapter 10 of EIA report workers engaged in handling of toxic materials. at Page No. 10-24. B. ADDITIONAL TOR 1 A plan for implementation of Zero Liquid Discharge Effluent Treatment System (ZLD) is shall be submitted presented in Chapter 10 of EIA report at Page No. 10-6 to 10-11. 2 Layout Plan earmarking space for Green belt of 10 m It proposed to provide green belt in an width along the periphery of the unit shall be area of 3.75 acres. Layout showing submitted. Total 33 % of the area of the unit shall be green belt development is presented in ensured for green cover with trees. Chapter 10 at Page No. 10-33. 3 Draft EIA/EMP report shall be submitted to SPCB for conduct of public hearing. The points raised during the Public hearing/ public consultation shall be properly addressed in the Final EIA/EMP report

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ACTERO PHARMA PVT. LTD. SY.NO. 407 (PART) AND 411, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA

4. ANNEXURES

Project No. 0118‐21‐03 January 2018

M/s. Actero Pharma Pvt. Ltd. STUDIES AND DOCUMENTATION BY C/o. Hetero Drugs Limited TEAM Labs and Consultants Plot No: 7‐2‐A2 Hetero Corp, Industrial Estate, B‐115‐117 & 509, Annapurna Block, Sanathnagar, Hyderabad‐500018 Aditya Enclave, Ameerpet, Phone: 040‐23704923/23704924 Hyderabad‐500 038. E‐mail: [email protected]; Phone: 040‐23748 555/23748616, [email protected] Telefax: 040‐23748666

SUBMITTED TO TELANGANA STATE POLLUTION CONTROL BOARD, REGIONAL OFFICE, NALGONDA

SIGMA-ALDRICH sigma-aldrich.com SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Version 6.0 Revision Date 31.03.2016 Print Date 08.01.2018 GENERIC EU MSDS - NO COUNTRY SPECIFIC DATA - NO OEL DATA

SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifiers Product name : (S)-(+)-3-Hydroxytetrahydrofuran

Product Number : 296686 Brand : Aldrich REACH No. : A registration number is not available for this substance as the substance or its uses are exempted from registration, the annual tonnage does not require a registration or the registration is envisaged for a later registration deadline. CAS-No. : 86087-23-2 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, Manufacture of substances 1.3 Details of the supplier of the safety data sheet Company : Sigma-Aldrich Chemical Pvt Limited Industrial Area, Anekal Taluka Plot No 12, 12 Bommasandra - Jigani Link Road 560100 BANGALORE INDIA

1.4 Emergency telephone number Emergency Phone # : +91 98802 05043

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008 Skin irritation (Category 2), H315 Eye irritation (Category 2), H319 Specific target organ toxicity - single exposure (Category 3), Respiratory system, H335 For the full text of the H-Statements mentioned in this Section, see Section 16. 2.2 Label elements Labelling according Regulation (EC) No 1272/2008 Pictogram

Signal word Warning

Hazard statement(s) H315 Causes skin irritation. H319 Causes serious eye irritation. H335 May cause respiratory irritation.

Aldrich - 296686 Page 1 of 7

Precautionary statement(s) P261 Avoid breathing vapours. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Supplemental Hazard none Statements 2.3 Other hazards This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

SECTION 3: Composition/information on ingredients 3.1 Substances Synonyms : (S)-(+)-Tetrahydro-3-furanol

Formula : C4H8O2 Molecular weight : 88.11 g/mol CAS-No. : 86087-23-2

Hazardous ingredients according to Regulation (EC) No 1272/2008 Component Classification Concentration (S)-(+)-Tetrahydro-3-furanol CAS-No. 86087-23-2 Skin Irrit. 2; Eye Irrit. 2; STOT <= 100 % SE 3; H315, H319, H335

For the full text of the H-Statements mentioned in this Section, see Section 16.

SECTION 4: First aid measures 4.1 Description of first aid measures General advice Consult a physician. Show this safety data sheet to the doctor in attendance. If inhaled If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician. In case of skin contact Wash off with soap and plenty of water. Consult a physician. In case of eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. If swallowed Do NOT induce vomiting. Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. 4.2 Most important symptoms and effects, both acute and delayed The most important known symptoms and effects are described in the labelling (see section 2.2) and/or in section 11 4.3 Indication of any immediate medical attention and special treatment needed No data available

SECTION 5: Firefighting measures 5.1 Extinguishing media Suitable extinguishing media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

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5.2 Special hazards arising from the substance or mixture Carbon oxides 5.3 Advice for firefighters Wear self-contained breathing apparatus for firefighting if necessary. 5.4 Further information Use water spray to cool unopened containers.

SECTION 6: Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Use personal protective equipment. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Remove all sources of ignition. Evacuate personnel to safe areas. Beware of vapours accumulating to form explosive concentrations. Vapours can accumulate in low areas. For personal protection see section 8. 6.2 Environmental precautions Prevent further leakage or spillage if safe to do so. Do not let product enter drains. 6.3 Methods and materials for containment and cleaning up Contain spillage, and then collect with an electrically protected vacuum cleaner or by wet-brushing and place in container for disposal according to local regulations (see section 13). Keep in suitable, closed containers for disposal. 6.4 Reference to other sections For disposal see section 13.

SECTION 7: Handling and storage 7.1 Precautions for safe handling Avoid contact with skin and eyes. Avoid inhalation of vapour or mist. Keep away from sources of ignition - No smoking.Take measures to prevent the build up of electrostatic charge. For precautions see section 2.2. 7.2 Conditions for safe storage, including any incompatibilities Store in cool place. Keep container tightly closed in a dry and well-ventilated place. Storage class (TRGS 510): Combustible liquids 7.3 Specific end use(s) Apart from the uses mentioned in section 1.2 no other specific uses are stipulated

SECTION 8: Exposure controls/personal protection 8.1 Control parameters 8.2 Exposure controls Appropriate engineering controls Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday. Personal protective equipment Eye/face protection Safety glasses with side-shields conforming to EN166 Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). Skin protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands.

The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

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Body Protection Impervious clothing, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Respiratory protection Where risk assessment shows air-purifying respirators are appropriate use (US) or type ABEK (EN 14387) respirator cartridges as a backup to enginee protection, use a full-face supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Control of environmental exposure Prevent further leakage or spillage if safe to do so. Do not let product enter drains.

SECTION 9: Physical and chemical properties 9.1 Information on basic physical and chemical properties a) Appearance Form: clear, liquid Colour: colourless b) Odour No data available c) Odour Threshold No data available d) pH No data available e) Melting point/freezing No data available point f) Initial boiling point and 80 °C at 20 hPa - lit. boiling range g) Flash point 79 °C - closed cup h) Evaporation rate No data available i) Flammability (solid, gas) No data available j) Upper/lower No data available flammability or explosive limits k) Vapour pressure No data available l) Vapour density No data available m) Relative density 1.103 g/cm3 at 25 °C n) Water solubility No data available o) Partition coefficient: n- No data available octanol/water p) Auto-ignition No data available temperature q) Decomposition No data available temperature r) Viscosity No data available s) Explosive properties No data available t) Oxidizing properties No data available 9.2 Other safety information No data available

SECTION 10: Stability and reactivity 10.1 Reactivity No data available

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10.2 Chemical stability Stable under recommended storage conditions. 10.3 Possibility of hazardous reactions No data available 10.4 Conditions to avoid Heat, flames and sparks. 10.5 Incompatible materials Strong oxidizing agentsStrong oxidizing agents, Acid chlorides, Acid anhydrides 10.6 Hazardous decomposition products Hazardous decomposition products formed under fire conditions. - Carbon oxides Other decomposition products - No data available In the event of fire: see section 5

SECTION 11: Toxicological information 11.1 Information on toxicological effects Acute toxicity No data available(S)-(+)-Tetrahydro-3-furanol Skin corrosion/irritation No data available((S)-(+)-Tetrahydro-3-furanol) Serious eye damage/eye irritation No data available((S)-(+)-Tetrahydro-3-furanol) Respiratory or skin sensitisation No data available((S)-(+)-Tetrahydro-3-furanol) Germ cell mutagenicity

No data available((S)-(+)-Tetrahydro-3-furanol) Carcinogenicity IARC: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC. Reproductive toxicity No data available((S)-(+)-Tetrahydro-3-furanol) Specific target organ toxicity - single exposure Inhalation - May cause respiratory irritation.((S)-(+)-Tetrahydro-3-furanol) Specific target organ toxicity - repeated exposure No data available Aspiration hazard No data available((S)-(+)-Tetrahydro-3-furanol)

Additional Information RTECS: Not available

To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.((S)-(+)-Tetrahydro-3-furanol)

SECTION 12: Ecological information 12.1 Toxicity No data available

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12.2 Persistence and degradability No data available

12.3 Bioaccumulative potential No data available 12.4 Mobility in soil No data available((S)-(+)-Tetrahydro-3-furanol) 12.5 Results of PBT and vPvB assessment This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher. 12.6 Other adverse effects

No data available

SECTION 13: Disposal considerations 13.1 Waste treatment methods Product This combustible material may be burned in a chemical incinerator equipped with an afterburner and scrubber. Offer surplus and non-recyclable solutions to a licensed disposal company. Contaminated packaging Dispose of as unused product.

SECTION 14: Transport information 14.1 UN number ADR/RID: - IMDG: - IATA: - 14.2 UN proper shipping name ADR/RID: Not dangerous goods IMDG: Not dangerous goods IATA: Not dangerous goods 14.3 Transport hazard class(es) ADR/RID: - IMDG: - IATA: - 14.4 Packaging group ADR/RID: - IMDG: - IATA: - 14.5 Environmental hazards ADR/RID: no IMDG Marine pollutant: no IATA: no 14.6 Special precautions for user No data available

SECTION 15: Regulatory information 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006. 15.2 Chemical safety assessment For this product a chemical safety assessment was not carried out

SECTION 16: Other information Full text of H-Statements referred to under sections 2 and 3. H315 Causes skin irritation. H319 Causes serious eye irritation. H335 May cause respiratory irritation.

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Further information Copyright 2016 Sigma-Aldrich Co. LLC. License granted to make unlimited paper copies for internal use only. The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Sigma-Aldrich Corporation and its Affiliates shall not be held liable for any damage resulting from handling or from contact with the above product. See www.sigma- aldrich.com and/or the reverse side of invoice or packing slip for additional terms and conditions of sale.

Aldrich - 296686 Page 7 of 7

SIGMA-ALDRICH sigma-aldrich.com SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Version 6.0 Revision Date 30.03.2016 Print Date 08.01.2018 GENERIC EU MSDS - NO COUNTRY SPECIFIC DATA - NO OEL DATA

SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifiers Product name : 1-(2-Hydroxyethyl)piperazine

Product Number : H28807 Brand : Aldrich REACH No. : A registration number is not available for this substance as the substance or its uses are exempted from registration, the annual tonnage does not require a registration or the registration is envisaged for a later registration deadline. CAS-No. : 103-76-4 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, Manufacture of substances 1.3 Details of the supplier of the safety data sheet Company : Sigma-Aldrich Chemical Pvt Limited Industrial Area, Anekal Taluka Plot No 12, 12 Bommasandra - Jigani Link Road 560100 BANGALORE INDIA

1.4 Emergency telephone number Emergency Phone # : +91 98802 05043

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008 Skin irritation (Category 2), H315 Eye irritation (Category 2), H319 Specific target organ toxicity - single exposure (Category 3), H335 For the full text of the H-Statements mentioned in this Section, see Section 16. 2.2 Label elements Labelling according Regulation (EC) No 1272/2008 Pictogram

Signal word Warning

Hazard statement(s) H315 Causes skin irritation. H319 Causes serious eye irritation. H335 May cause respiratory irritation.

Aldrich - H28807 Page 1 of 7

Precautionary statement(s) P261 Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Supplemental Hazard none Statements 2.3 Other hazards - none

SECTION 3: Composition/information on ingredients 3.1 Substances Synonyms : 2-Piperazinoethanol Piperazine-1-ethanol

Formula : C6H14N2O Molecular weight : 130.19 g/mol CAS-No. : 103-76-4 EC-No. : 203-142-3

Hazardous ingredients according to Regulation (EC) No 1272/2008 Component Classification Concentration 2-Piperazin-1-ylethanol CAS-No. 103-76-4 Skin Irrit. 2; Eye Irrit. 2; STOT <= 100 % EC-No. 203-142-3 SE 3; H315, H319, H335

For the full text of the H-Statements mentioned in this Section, see Section 16.

SECTION 4: First aid measures 4.1 Description of first aid measures General advice Consult a physician. Show this safety data sheet to the doctor in attendance. If inhaled If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician. In case of skin contact Wash off with soap and plenty of water. Consult a physician. In case of eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. If swallowed Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. 4.2 Most important symptoms and effects, both acute and delayed The most important known symptoms and effects are described in the labelling (see section 2.2) and/or in section 11 4.3 Indication of any immediate medical attention and special treatment needed No data available

SECTION 5: Firefighting measures 5.1 Extinguishing media Suitable extinguishing media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

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5.2 Special hazards arising from the substance or mixture Carbon oxides, Nitrogen oxides (NOx) 5.3 Advice for firefighters Wear self-contained breathing apparatus for firefighting if necessary. 5.4 Further information No data available

SECTION 6: Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Use personal protective equipment. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. For personal protection see section 8. 6.2 Environmental precautions Do not let product enter drains. 6.3 Methods and materials for containment and cleaning up Soak up with inert absorbent material and dispose of as hazardous waste. Keep in suitable, closed containers for disposal. 6.4 Reference to other sections For disposal see section 13.

SECTION 7: Handling and storage 7.1 Precautions for safe handling Avoid contact with skin and eyes. Avoid inhalation of vapour or mist. Normal measures for preventive fire protection. For precautions see section 2.2. 7.2 Conditions for safe storage, including any incompatibilities Store in cool place. Keep container tightly closed in a dry and well-ventilated place. Handle and store under inert gas. Storage class (TRGS 510): Combustible liquids not in Storage Class 3 7.3 Specific end use(s) Apart from the uses mentioned in section 1.2 no other specific uses are stipulated

SECTION 8: Exposure controls/personal protection 8.1 Control parameters 8.2 Exposure controls Appropriate engineering controls Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday. Personal protective equipment Eye/face protection Safety glasses with side-shields conforming to EN166 Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). Skin protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands.

The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

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Body Protection Impervious clothing, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Respiratory protection Where risk assessment shows air-purifying respirators are appropriate use (US) or type ABEK (EN 14387) respirator cartridges as a backup to enginee protection, use a full-face supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Control of environmental exposure Do not let product enter drains.

SECTION 9: Physical and chemical properties 9.1 Information on basic physical and chemical properties a) Appearance Form: liquid Colour: light yellow b) Odour No data available c) Odour Threshold No data available d) pH No data available e) Melting point/freezing No data available point f) Initial boiling point and 246 °C - lit. boiling range g) Flash point 135 °C - closed cup h) Evaporation rate No data available i) Flammability (solid, gas) No data available j) Upper/lower No data available flammability or explosive limits k) Vapour pressure No data available l) Vapour density No data available m) Relative density 1.061 g/cm3 at 25 °C n) Water solubility No data available o) Partition coefficient: n- No data available octanol/water p) Auto-ignition No data available temperature q) Decomposition No data available temperature r) Viscosity No data available s) Explosive properties No data available t) Oxidizing properties No data available 9.2 Other safety information No data available

SECTION 10: Stability and reactivity 10.1 Reactivity No data available

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10.2 Chemical stability Stable under recommended storage conditions. 10.3 Possibility of hazardous reactions No data available 10.4 Conditions to avoid No data available 10.5 Incompatible materials Strong oxidizing agentsStrong oxidizing agents, Strong acids, Copper, Chlorinated solvents 10.6 Hazardous decomposition products Hazardous decomposition products formed under fire conditions. - Carbon oxides, Nitrogen oxides (NOx) Other decomposition products - No data available In the event of fire: see section 5

SECTION 11: Toxicological information 11.1 Information on toxicological effects Acute toxicity LD50 Oral - Guinea pig - 3,720 mg/kg(2-Piperazin-1-ylethanol) Remarks: Behavioral:Somnolence (general depressed activity). Behavioral:Muscle weakness. Behavioral:Muscle contraction or spasticity. Inhalation: No data available(2-Piperazin-1-ylethanol) Skin corrosion/irritation Skin - Rabbit(2-Piperazin-1-ylethanol) Serious eye damage/eye irritation Eyes - Rabbit(2-Piperazin-1-ylethanol) Respiratory or skin sensitisation Germ cell mutagenicity

No data available(2-Piperazin-1-ylethanol) Carcinogenicity IARC: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC. Reproductive toxicity No data available(2-Piperazin-1-ylethanol) Specific target organ toxicity - single exposure Inhalation - May cause respiratory irritation.(2-Piperazin-1-ylethanol) Specific target organ toxicity - repeated exposure No data available Aspiration hazard No data available(2-Piperazin-1-ylethanol)

Additional Information RTECS: TL6825000

To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.(2-Piperazin-1-ylethanol)

SECTION 12: Ecological information 12.1 Toxicity

Toxicity to fish LC50 - Pimephales promelas (fathead minnow) - 6,410 mg/l - 96 h(2- Aldrich - H28807 Page 5 of 7

Piperazin-1-ylethanol) 12.2 Persistence and degradability No data available

12.3 Bioaccumulative potential No data available 12.4 Mobility in soil No data available(2-Piperazin-1-ylethanol) 12.5 Results of PBT and vPvB assessment PBT/vPvB assessment not available as chemical safety assessment not required/not conducted 12.6 Other adverse effects

No data available

SECTION 13: Disposal considerations 13.1 Waste treatment methods Product Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed professional waste disposal service to dispose of this material. Contaminated packaging Dispose of as unused product.

SECTION 14: Transport information 14.1 UN number ADR/RID: - IMDG: - IATA: - 14.2 UN proper shipping name ADR/RID: Not dangerous goods IMDG: Not dangerous goods IATA: Not dangerous goods 14.3 Transport hazard class(es) ADR/RID: - IMDG: - IATA: - 14.4 Packaging group ADR/RID: - IMDG: - IATA: - 14.5 Environmental hazards ADR/RID: no IMDG Marine pollutant: no IATA: no 14.6 Special precautions for user No data available

SECTION 15: Regulatory information 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006. 15.2 Chemical safety assessment For this product a chemical safety assessment was not carried out

SECTION 16: Other information Full text of H-Statements referred to under sections 2 and 3. H315 Causes skin irritation. H319 Causes serious eye irritation. H335 May cause respiratory irritation.

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Further information Copyright 2016 Sigma-Aldrich Co. LLC. License granted to make unlimited paper copies for internal use only. The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Sigma-Aldrich Corporation and its Affiliates shall not be held liable for any damage resulting from handling or from contact with the above product. See www.sigma- aldrich.com and/or the reverse side of invoice or packing slip for additional terms and conditions of sale.

Aldrich - H28807 Page 7 of 7

SIGMA-ALDRICH sigma-aldrich.com SAFETY DATA SHEET according to Regulation (EC) No. 1907/2006 Version 6.1 Revision Date 06.02.2017 Print Date 08.01.2018 GENERIC EU MSDS - NO COUNTRY SPECIFIC DATA - NO OEL DATA

SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifiers Product name : 1,8-Diazabicyclo[5.4.0]undec-7-ene

Product Number : 139009 Brand : Aldrich REACH No. : A registration number is not available for this substance as the substance or its uses are exempted from registration, the annual tonnage does not require a registration or the registration is envisaged for a later registration deadline. CAS-No. : 6674-22-2 1.2 Relevant identified uses of the substance or mixture and uses advised against Identified uses : Laboratory chemicals, Manufacture of substances 1.3 Details of the supplier of the safety data sheet Company : Sigma-Aldrich Chemical Pvt Limited Industrial Area, Anekal Taluka Plot No 12, 12 Bommasandra - Jigani Link Road 560100 BANGALORE INDIA

1.4 Emergency telephone number Emergency Phone # : +91 98802 05043

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008 Corrosive to metals (Category 1), H290 Acute toxicity, Oral (Category 3), H301 Skin corrosion (Category 1B), H314 Chronic aquatic toxicity (Category 3), H412 For the full text of the H-Statements mentioned in this Section, see Section 16. 2.2 Label elements Labelling according Regulation (EC) No 1272/2008 Pictogram

Signal word Danger

Hazard statement(s) H290 May be corrosive to metals. H301 Toxic if swallowed. H314 Causes severe skin burns and eye damage. H412 Harmful to aquatic life with long lasting effects. Aldrich - 139009 Page 1 of 7

Precautionary statement(s) P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection. P301 + P310 IF SWALLOWED: Immediately call a POISON CENTER/doctor. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310 Immediately call a POISON CENTER/doctor.

Supplemental Hazard none Statements 2.3 Other hazards This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

SECTION 3: Composition/information on ingredients 3.1 Substances Synonyms : DBU 2,3,4,6,7,8,9,10-Octahydropyrimidol[1,2-a]azepine

Formula : C9H16N2 Molecular weight : 152.24 g/mol CAS-No. : 6674-22-2 EC-No. : 229-713-7

Hazardous ingredients according to Regulation (EC) No 1272/2008 Component Classification Concentration 1,8-Diazabicyclo[5.4.0]undec-7-ene CAS-No. 6674-22-2 Met. Corr. 1; Acute Tox. 3; <= 100 % EC-No. 229-713-7 Skin Corr. 1B; Aquatic Chronic 3; H290, H301, H314, H412

For the full text of the H-Statements mentioned in this Section, see Section 16.

SECTION 4: First aid measures 4.1 Description of first aid measures General advice Consult a physician. Show this safety data sheet to the doctor in attendance. If inhaled If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician. In case of skin contact Take off contaminated clothing and shoes immediately. Wash off with soap and plenty of water. Take victim immediately to hospital. Consult a physician. In case of eye contact Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician. If swallowed Do NOT induce vomiting. Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. 4.2 Most important symptoms and effects, both acute and delayed The most important known symptoms and effects are described in the labelling (see section 2.2) and/or in section 11 4.3 Indication of any immediate medical attention and special treatment needed No data available Aldrich - 139009 Page 2 of 7

SECTION 5: Firefighting measures 5.1 Extinguishing media Suitable extinguishing media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. 5.2 Special hazards arising from the substance or mixture Carbon oxides, Nitrogen oxides (NOx) 5.3 Advice for firefighters Wear self-contained breathing apparatus for firefighting if necessary. 5.4 Further information No data available

SECTION 6: Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Wear respiratory protection. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. For personal protection see section 8. 6.2 Environmental precautions Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Discharge into the environment must be avoided. 6.3 Methods and materials for containment and cleaning up Soak up with inert absorbent material and dispose of as hazardous waste. Keep in suitable, closed containers for disposal. 6.4 Reference to other sections For disposal see section 13.

SECTION 7: Handling and storage 7.1 Precautions for safe handling Avoid contact with skin and eyes. Avoid inhalation of vapour or mist. For precautions see section 2.2. 7.2 Conditions for safe storage, including any incompatibilities Store in cool place. Keep container tightly closed in a dry and well-ventilated place. Containers which are opened must be carefully resealed and kept upright to prevent leakage. Store under inert gas. Sensitive to carbon dioxide Air sensitive. Storage class (TRGS 510): Non-combustible, acute toxic Cat.3 / toxic hazardous materials or hazardous materials causing chronic effects 7.3 Specific end use(s) Apart from the uses mentioned in section 1.2 no other specific uses are stipulated

SECTION 8: Exposure controls/personal protection 8.1 Control parameters 8.2 Exposure controls Appropriate engineering controls Avoid contact with skin, eyes and clothing. Wash hands before breaks and immediately after handling the product. Personal protective equipment Eye/face protection Tightly fitting safety goggles. Faceshield (8-inch minimum). Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). Aldrich - 139009 Page 3 of 7

Skin protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands.

The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

Full contact Material: butyl-rubber Minimum layer thickness: 0.3 mm Break through time: 480 min Material tested:Butoject® (KCL 897 / Aldrich Z677647, Size M)

Splash contact Material: Nitrile rubber Minimum layer thickness: 0.11 mm Break through time: 30 min Material tested:Dermatril® (KCL 740 / Aldrich Z677272, Size M)

data source: KCL GmbH, D-36124 Eichenzell, phone +49 (0)6659 87300, e-mail [email protected], test method: EN374 If used in solution, or mixed with other substances, and under conditions which differ from EN 374, contact the supplier of the CE approved gloves. This recommendation is advisory only and must be evaluated by an industria situation of anticipated use by our customers. It should not be construed as offering an approval for any specific use scenario.

Body Protection Complete suit protecting against chemicals, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Respiratory protection Where risk assessment shows air-purifying respirators are appropriate use (US) or type ABEK (EN 14387) respirator cartridges as a backup to enginee protection, use a full-face supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Control of environmental exposure Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Discharge into the environment must be avoided.

SECTION 9: Physical and chemical properties 9.1 Information on basic physical and chemical properties a) Appearance Form: clear, liquid Colour: yellow b) Odour unpleasant c) Odour Threshold No data available d) pH 12.8 at 10 g/l at 20 °C

e) Melting point/freezing Melting point/range: -69.99 °C point f) Initial boiling point and 80 - 83 °C at 0.8 hPa - lit. boiling range g) Flash point 116 °C h) Evaporation rate No data available i) Flammability (solid, gas) No data available j) Upper/lower Upper explosion limit: 6.5 %(V) Aldrich - 139009 Page 4 of 7

flammability or Lower explosion limit: 1.1 %(V) explosive limits k) Vapour pressure 5.3 mmHg at 37.7 °C l) Vapour density No data available m) Relative density 1.018 g/mL at 25 °C n) Water solubility No data available o) Partition coefficient: n- log Pow: < -2.2 octanol/water p) Auto-ignition No data available temperature q) Decomposition No data available temperature r) Viscosity No data available s) Explosive properties No data available t) Oxidizing properties No data available 9.2 Other safety information No data available

SECTION 10: Stability and reactivity 10.1 Reactivity No data available 10.2 Chemical stability Stable under recommended storage conditions. 10.3 Possibility of hazardous reactions No data available 10.4 Conditions to avoid No data available 10.5 Incompatible materials acids, Acid chlorides, Acid anhydrides, Oxidizing agents, Chloroformates 10.6 Hazardous decomposition products Hazardous decomposition products formed under fire conditions. - Carbon oxides, Nitrogen oxides (NOx) Other decomposition products - No data available In the event of fire: see section 5

SECTION 11: Toxicological information 11.1 Information on toxicological effects Acute toxicity LD50 Oral - Rat - > 215 - < 681 mg/kg(1,8-Diazabicyclo[5.4.0]undec-7-ene) Skin corrosion/irritation No data available(1,8-Diazabicyclo[5.4.0]undec-7-ene) Serious eye damage/eye irritation No data available(1,8-Diazabicyclo[5.4.0]undec-7-ene) Respiratory or skin sensitisation No data available(1,8-Diazabicyclo[5.4.0]undec-7-ene) Germ cell mutagenicity

No data available(1,8-Diazabicyclo[5.4.0]undec-7-ene)

Aldrich - 139009 Page 5 of 7

Carcinogenicity IARC: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC. Reproductive toxicity No data available(1,8-Diazabicyclo[5.4.0]undec-7-ene) Specific target organ toxicity - single exposure No data available(1,8-Diazabicyclo[5.4.0]undec-7-ene) Specific target organ toxicity - repeated exposure No data available Aspiration hazard No data available(1,8-Diazabicyclo[5.4.0]undec-7-ene)

Additional Information RTECS: Not available

Material is extremely destructive to tissue of the mucous membranes and upper respiratory tract, eyes, and skin., Cough, Shortness of breath, Headache, Nausea(1,8-Diazabicyclo[5.4.0]undec-7-ene)

SECTION 12: Ecological information 12.1 Toxicity

Toxicity to fish LC50 - Leuciscus idus (Golden orfe) - 100.0 - 220.0 mg/l - 96.0 h(1,8- Diazabicyclo[5.4.0]undec-7-ene)

Toxicity to daphnia and EC50 - Daphnia magna (Water flea) - 50 mg/l - 48 h(1,8- other aquatic Diazabicyclo[5.4.0]undec-7-ene) invertebrates

Toxicity to algae EC50 - Desmodesmus subspicatus (green algae) - > 100 mg/l - 72 h(1,8- Diazabicyclo[5.4.0]undec-7-ene) 12.2 Persistence and degradability Biodegradability (OECD Test Guideline 302)

12.3 Bioaccumulative potential Does not bioaccumulate. 12.4 Mobility in soil No data available(1,8-Diazabicyclo[5.4.0]undec-7-ene) 12.5 Results of PBT and vPvB assessment This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher. 12.6 Other adverse effects Harmful to aquatic life with long lasting effects.

No data available

SECTION 13: Disposal considerations 13.1 Waste treatment methods Product Offer surplus and non-recyclable solutions to a licensed disposal company. Contaminated packaging Dispose of as unused product. Aldrich - 139009 Page 6 of 7

SECTION 14: Transport information 14.1 UN number ADR/RID: 3267 IMDG: 3267 IATA: 3267 14.2 UN proper shipping name ADR/RID: CORROSIVE LIQUID, BASIC, ORGANIC, N.O.S. (1,8-Diazabicyclo[5.4.0]undec-7-ene) IMDG: CORROSIVE LIQUID, BASIC, ORGANIC, N.O.S. (1,8-Diazabicyclo[5.4.0]undec-7-ene) IATA: Corrosive liquid, basic, organic, n.o.s. (1,8-Diazabicyclo[5.4.0]undec-7-ene) 14.3 Transport hazard class(es) ADR/RID: 8 IMDG: 8 IATA: 8 14.4 Packaging group ADR/RID: II IMDG: II IATA: II 14.5 Environmental hazards ADR/RID: no IMDG Marine pollutant: no IATA: no 14.6 Special precautions for user No data available

SECTION 15: Regulatory information 15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006. 15.2 Chemical safety assessment For this product a chemical safety assessment was not carried out

SECTION 16: Other information Full text of H-Statements referred to under sections 2 and 3. H290 May be corrosive to metals. H301 Toxic if swallowed. H314 Causes severe skin burns and eye damage. H412 Harmful to aquatic life with long lasting effects. Further information Copyright 2016 Sigma-Aldrich Co. LLC. License granted to make unlimited paper copies for internal use only. The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. Sigma-Aldrich Corporation and its Affiliates shall not be held liable for any damage resulting from handling or from contact with the above product. See www.sigma- aldrich.com and/or the reverse side of invoice or packing slip for additional terms and conditions of sale.

Aldrich - 139009 Page 7 of 7

Material Safety Data Sheet Bis(triphenylphosphine)palladium(II) chloride, 15% Pd

MSDS# 03477 Section 1 - Chemical Product and Company Identification MSDS Name: Bis(triphenylphosphine)palladium(II) chloride, 15% Pd Catalog Numbers: AC197320000, AC197320010, AC197320050 Synonyms: Dichlorobis(triphenylphosphine)palladium(II). Acros Organics BVBA Company Identification: Janssen Pharmaceuticalaan 3a 2440 Geel, Belgium Acros Organics Company Identification: (USA) One Reagent Lane Fair Lawn, NJ 07410 For information in the US, call: 800-ACROS-01 For information in Europe, call: +32 14 57 52 11 Emergency Number, Europe: +32 14 57 52 99 Emergency Number US: 201-796-7100 CHEMTREC Phone Number, US: 800-424-9300 CHEMTREC Phone Number, Europe: 703-527-3887 Section 2 - Composition, Information on Ingredients ------CAS#: 13965-03-2 Chemical Name: Bis(triphenylphosphine)palladium(II) chloride %: 100 EINECS#: 237-744-2 ------Hazard Symbols: None listed Risk Phrases: None listed Section 3 - Hazards Identification EMERGENCY OVERVIEW Caution! Hygroscopic (absorbs moisture from the air). The toxicological properties of this material have not been fully investigated. May cause eye, skin, and respiratory tract irritation. Target Organs: No data found. Potential Health Effects Eye: May cause eye irritation. The toxicological properties of this material have not been fully investigated. Skin: May cause skin irritation. The toxicological properties of this material have not been fully investigated. May cause irritation of the digestive tract. The toxicological properties of this substance have not been fully Ingestion: investigated. May cause respiratory tract irritation. The toxicological properties of this substance have not been fully Inhalation: investigated. Chronic: No information found. Section 4 - First Aid Measures Flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Get Eyes: medical aid. Flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Get Skin: medical aid if irritation develops or persists. Wash clothing before reuse. Never give anything by mouth to an unconscious person. Get medical aid. Do NOT induce vomiting. If

Ingestion: conscious and alert, rinse mouth and drink 2-4 cupfuls of milk or water. Remove from exposure and move to fresh air immediately. If not breathing, give artificial respiration. If Inhalation: breathing is difficult, give oxygen. Get medical aid. Notes to Physician: Section 5 - Fire Fighting Measures As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH General (approved or equivalent), and full protective gear. During a fire, irritating and highly toxic gases may be Information: generated by thermal decomposition or combustion. Extinguishing Use water spray, dry chemical, carbon dioxide, or appropriate foam. Media: Autoignition Not available Temperature: Flash Point: 100 deg C ( 212.00 deg F) Explosion Limits: Not available Lower: Explosion Limits: Not available Upper: NFPA Rating: health: 1; flammability: 1; instability: 0; Section 6 - Accidental Release Measures General Use proper personal protective equipment as indicated in Section 8. Information: Vacuum or sweep up material and place into a suitable disposal container. Clean up spills immediately, Spills/Leaks: observing precautions in the Protective Equipment section. Avoid generating dusty conditions. Provide ventilation. Section 7 - Handling and Storage Wash thoroughly after handling. Use with adequate ventilation. Minimize dust generation and accumulation. Avoid Handling: breathing dust, mist, or vapor. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation. Store in a tightly closed container. Store in a cool, dry, well-ventilated area away from incompatible substances. Storage: Store protected from moisture. Section 8 - Exposure Controls, Personal Protection +------+------+------+------+ | Chemical Name | ACGIH | NIOSH |OSHA - Final PELs| |------|------|------|------| | Bis(triphenylphosph|none listed |none listed |none listed | | ine)palladium(II) c| | | | | hloride | | | | +------+------+------+------+

OSHA Vacated PELs: Bis(triphenylphosphine)palladium(II) chloride: None listed Engineering Controls: Facilities storing or utilizing this material should be equipped with an eyewash facility and a safety shower. Use adequate ventilation to keep airborne concentrations low. Exposure Limits Personal Protective Equipment Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA's eye and face Eyes: protection regulations in 29 CFR 1910.133 or European Standard EN166. Skin: Wear appropriate protective gloves to prevent skin exposure. Clothing: Wear appropriate protective clothing to prevent skin exposure. Follow the OSHA respirator regulations found in 29 CFR 1910.134 or European Standard EN 149. Use a Respirators: NIOSH/MSHA or European Standard EN 149 approved respirator if exposure limits are exceeded or if irritation or other symptoms are experienced. Section 9 - Physical and Chemical Properties

Physical State: Crystals Color: yellow Odor: Not available pH: Not available Vapor Pressure: Not available Vapor Density: Not available Evaporation Rate: Not available Viscosity: Not available Boiling Point: Not available Freezing/Melting Point: Not available Decomposition Temperature: Solubility in water: insoluble Specific Gravity/Density: Molecular Formula: C36H30Cl2P2Pd Molecular Weight: 701.89 Section 10 - Stability and Reactivity Stable at room temperature in closed containers under normal storage and handling Chemical Stability: conditions. Conditions to Avoid: Dust generation, moisture, excess heat. Incompatibilities with Other Strong oxidizing agents. Materials Hazardous Decomposition Hydrogen chloride, phosphine, carbon monoxide, oxides of phosphorus, oxides of Products phosphorus, carbon dioxide. Hazardous Polymerization Has not been reported. Section 11 - Toxicological Information RTECS#: CAS# 13965-03-2: None listed LD50/LC50: RTECS: Not available. Bis(triphenylphosphine)palladium(II) chloride - Not listed as a carcinogen by ACGIH, IARC, NTP, or CA Carcinogenicity: Prop 65. Section 12 - Ecological Information Not available Section 13 - Disposal Considerations Dispose of in a manner consistent with federal, state, and local regulations. Section 14 - Transport Information US DOT Shipping Name: Not regulated as a hazardous material Hazard Class: UN Number: Packing Group: Canada TDG Shipping Name: Not available Hazard Class: UN Number: Packing Group:

Section 15 - Regulatory Information European/International Regulations European Labeling in Accordance with EC Directives Hazard Symbols:Not available Risk Phrases:

Safety Phrases: S 24/25 Avoid contact with skin and eyes. WGK (Water Danger/Protection) CAS# 13965-03-2: 0 Canada Canadian WHMIS Classifications: Not available This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all of the information required by those regulations. CAS# 13965-03-2 is not listed on Canada's Ingredient Disclosure List. US Federal TSCA CAS# 13965-03-2 is not listed on the TSCA Inventory. It is for research and development use only. Section 16 - Other Information MSDS Creation Date: 2/19/1999 Revision #6 Date 7/20/2009

The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantibility or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall the company be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential, or exemplary damages howsoever arising, even if the company has been advised of the possibility of such damages. ------ACTERO PHARMA PVT. LTD. SY.NO. 407 (PART) AND 411, VELIMINEDU VILLAGE, CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA

STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants QCI: MoE&F OM, List A-1, S.No.25. (An ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 Certified Organization) B-115, Annapurna Block, Aditya Enclave Ameerpet, Hyderabad-500 038. Phone: 040-23748 555/616, Telefax: 040-23748666 Email: [email protected]