ENVIRONMENTAL IMPACT ASSESSMENT (EIA) REPORT...

ENVIRONMENTAL IMPACT ASSESSMENT (EIA)

REPORT FOR THE PROPOSED EXPANSION

AND MODIFICATION OF THE ACTIVE PHARMACEUTICAL

INGREDIENTS (API’S) AND INTERMEDIATES MANUFACTURING

INDUSTRY WITH R & D ACTIVITY.

At

Unit –II, Plot No. 33, 33A & 40 to 47, Raichur,

Industrial Growth Centre, Wadloor Road,

Chicksugur, Raichur Dist - 584134.

Project Proponents

M/s. Shilpa Medicare Limited.,

100% Export Oriented Unit, Unit –II,

Plot No. 33, 33A & 40 to 47, Raichur,

Industrial Growth Centre, Wadloor Road,

Chicksugur – 584134.

Environmental Consultants

M/s. SAMRAKSHAN

F- 4, I Floor, Swastik Manandi Arcade,

S C Road, Sheshadripuram,

Bangalore - 560 020.

Ph. : 080-41466009

E mail id – [email protected],

[email protected]

(December 2016 to February 2017)

mailto:[email protected]

ii

CONTENTS

Sl. No. Description Pg. No

FORM -1 1-15

EXECUTIVE SUMMARY 1-23

CHAPTER 1

INTRODUCTION

1.0 Purpose Of The Report 24

1.1 Identification Of The Project & Project Proponent 25

1.1.1 Introduction To The Project Proponent 25

1.1.2 Introduction To The Project 28

1.2 Brief Description Of Nature, Size, Location Of The Project & Its Importance To The Country, Region

28

1.2.1 Nature, Size & Location Of The Project 28

1.2.2 Need For The Project And Its Importance To The Country And/Region

32

1.2.3 Demand Supply Gap, Imports Vs Indigenous Production 33

1.2.4 Export Possibility 33

1.3 Scope Of Study – Details Of Regulatory Scoping Carried Out (As Per Terms Of Reference)

34

1.3.1 Scope Of Study 34

1.3.2 Components Of EIA Report 34

1.3.3 Terms Of Reference (ToR) 35

1.4 Generic Structure Of EIA Document: 50

CHAPTER 2

PROJECT DESCRIPTION

2.1 Type Of Project 52

2.2 Need For The Project 52

2.3 Location Of The Proposed Industry 52

2.4 Size Or Magnitude Of Operation 54

2.5 Proposed Schedule For Approval & Implementation 55

2.6 Proposed Layout Plan 55

2.7 Technology & Process Description 59

2.7.1 Products Manufactured 59

2.7.2 Detailed Manufacturing Process Description 61

2.7.3 Resource Optimization/Recycling And Re-Use Envisaged In The Industry

72

2.7.3.1 Solvent Recovery & Re-Use 72

iii

2.7.3.2 Storage Of Solvents 77

2.7.4 Raw Materials Required 81

2.7.4.1 Quantity Requirement 81

2.7.4.2 Source Of Supply Of Raw Materials & Marketing Area Of Final Products

100

2.7.4.2.1 Raw Materials Suppliers 100

2.7.4.3 Storage Facility For Raw Materials And Products 105

2.7.5 Machinery & Equipment Details 106

2.8 Project Description Including Drawings Showing Project Layout, Components Of Project, Schematic Representations Of The Feasibility Drawing Giving Information Important For EIA Purpose

127

2.8.1 Project Description Including Drawings Showing Project Layout, Components Of Project

127

2.8.2 Schematic Representations Of The Feasibility Drawing 128

2.9 Mitigation Measures Incorporated Into The Project To Meet Environmental Standards, Environmental Operating Conditions Or Other EIA Requirements (As Required By The Scope)

129

2.9.1 Water Demand And Wastewater/Effluent Discharge 129

2.9.1.1 Source Of Water Supply 129

2.9.1.2 Water Demand And Wastewater Discharge During Operation Phase

129

2.9.2 Product-Wise Water Consumption And Discharge 133

2.9.2. (A) Raw Material To Product And Product To Waste Generation Ratio For Each Product

139

2.9.2.1 Process Effluent Characteristics 142

2.9.2.2 Storage Facilities Provided For Industrial Effluents 142

2.9.2.3 Treatment Scheme For Wastewater 143

2.9.2.4 ETP Details: 146

2.9.3 Air Pollution Sources 149

2.9.3.1 Power 149

2.9.3.2 Air Pollution Sources 149

2.9.3.3 Noise Generation And Its Management 157

2.9.3.4 Solid Waste Generation And Management 157

2.9.3.5 Hazardous Raw Materials Used In The Manufacturing Process And Hazardous Waste Generation And Management

158

2.9.3.5.1 Hazardous Raw Materials 158

2.9.3.5.2 Hazardous Waste Generation And Management 159

2.9.3.5.3 Storage Facilities For Hazardous Waste 174

iv

2.9.4 Rainwater Harvesting & Groundwater Recharging 175

2.10 Assessment Of New & Untested Technology For The Risk Of Technological Failure

176

CHAPTER 3

DESCRIPTION OF THE ENVIRONMENT

3.1 Study Area, Period, Components & Methodology 177

3.2 Establishment Of Baseline 179

3.2.1 Meteorological Data 179

3.2.2 Temperature 181

3.2.3 Relative Humidity 181

3.2.4 Rainfall 181

3.2.5 Atmospheric Pressure 181

3.2.6 Wind 182

3.2.7 Inversion Height 187

3.2.8 Cloud Cover 187

3.3 Baseline Monitoring 187

3.3.1 Sampling And Analytical Techniques 187

3.3.2 Air Quality 190

3.3.2.1 Air Quality At All Location: 193

3.3.2.2 Observations 195

3.3.3 Noise Environment 195


3.3.4 Water Environment 197

3.3.4.1 Reconnaissance Survey 197

3.3.4.2 Surface Water 198

3.3.4.3 Ground Water 202


3.3.5 Soil And Geology 206

3.4 Ecology 209

3.4.1 Anticipated Impacts 209

3.4.2 Flora 210

3.4.3 Fauna 211

3.5 Socio-Economic Environment 212

3.6 Demographic Structure 213

3.6.1 Social Infrastructure Available 214

3.7 Connectivity 215

3.8 Base Maps Of All Environmental Components 220

v

CHAPTER 4

ANTICIPATED ENVIRONMENTAL IMPACTS &

MITIGATION MEASURES

4.1 Details Of Investigated Environmental Impacts Due To Project Location, Possible Accidents, Project Design, Project Construction, Regular Operations, Final Decommissioning Or Rehabilitation Of Completed Project

222

4.1.1 Environmental Impacts Due To Project Location, Possible Accidents, Project Design

222

4.1.2 Environmental Impacts Due To Project Construction, Regular Operations

224

4.2 Actions Likely To Affect The Environment 224

4.2.1 Air Environment 225

4.2.1.2 Air Environment 225

4.2.1.2.1 Construction Phase 225

4.2.1.2.2 Operation Phase 225

4.2.2 Noise Environment 225

4.2.2.1 Construction Phase 225

4.2.2.2 Operation Phase 225

4.2.3 Water Environment 225



4.2.4 Land And Biological Environment 226



4.2.5 Socio-Economic Environment 227


4.3 Measures For Minimizing & / Or Offsetting Adverse Impacts Identified & Mitigation Measures – Environmental Management Plan (EMP)

227

4.3.1 Introduction 227

4.3.2 Scope Of EMP 227

4.3.3 EMP During Construction Phase 228


4.3.3.2 Noise Environment 228

4.3.3.3 Water Environment 228

4.3.3.4 Land Environment 229

4.3.3.5 Management Measures For Flora And Fauna 229

4.3.3.6 Socio-Economic Environment 229

vi

4.3.4 EMP During Operation Phase 229


4.3.4.2 Noise Environment 231

4.3.4.3 Traffic Density And Its Impact 231

4.3.4.4 Water Consumption And Wastewater Treatment And Disposal Details

231

4.3.4.5 Land Environment 232

4.3.5 EMP Implementation Schedule 233

4.4 Irreversible & Irretrievable Commitments Of Environmental Components

234

4.5 Assessment Of Significance Of Impacts (Criteria For Determining Significance, Assigning Significance)

234

4.5.1 Impact Matrix 234

4.5.2 Environmental Impact Assessment 236

CHAPTER 5

ANALYSIS OF ALTERNATIVES (TECHNOLOGY & SITE)

5.1 Alternatives For Technology 240

5.1.1 Emission Control Techniques 240

5.1.2 Oxides Of Nitrogen Emissions From Boiler 241

5.2 Alternatives For Site 243

CHAPTER 6

ENVIRONMENTAL MONITORING PROGRAMME

6.1 Technical Aspects Of Monitoring The Effectiveness Of

Mitigation Measures (Including Measurement

Methodologies, Frequency, Location, Data Analysis,

Reporting Schedules, Emergency Procedures, Detailed

Budget & Procurement Schedules)

244

6.1.1 Measurement Methodology 244

6.1.2 Frequency, Location, Data Analysis, Reporting Schedules 244

6.1.3 Emergency Procedures 245

6.1.4 Detailed Budget & Procurement Schedules 247

CHAPTER 7

ADDITIONAL STUDIES

7.1 Introduction 248

7.2 HAZOP Analysis 248

7.3 Safety Precautions For The Handling Of Hydrogen Gas And

PD/Carbon

249

vii

7.4 Risk Assessment 250

7.4.1 Background 250


7.4.3 Objective & Scope 250

7.4.4 Hazard Identification 251

7.4.4.1 Exposure To Solvents 253

7.4.4.5.1 Fire & Explosing Index 260

7.4.5 Fire Hazards 268

7.4.5.1 Introduction To The Fire & Explosion Index (F & EI) 268

7.4.5.2 Procedure For Risk Analysis Calculations 269

7.4.5.3 Important Considerations 269

7.4.5.4 Calculation Of F & EI For The Storage Area Of

M/s. Shilpa Medicare Limited., 100% Export Oriented Unit,

270

7.4.6 Maximum Credible Accident (MCA) Analysis 271

7.4.6.1 Fire Damage 271

7.4.6.2 Properties Of Solvents/Fuels 273

7.4.7 Salient Features Of Risk Auditing And Assessment 274

7.4.7.1 Fire Protection 275

7.4.7.2 OHS (Occupational Health And Safety) 276

7.4.7.3 ER (Electrical Risk) 276

7.4.8 Process Safety Management 276

7.4.9 Electrical Risk Assessment 276

7.4.10 Fire Risk Assessment 277

7.4.11 Risk Analysis & Emergency Plan 277

7.4.12 Risk Management & Insurance Planning 277

7.4.13 Risk Management Training 278

7.4.14 General Guidelines To Be Adopted By The Unit For Minimizing Associated Risks At M/S. Shilpa Medicare Limited., 100% Export Oriented Unit,

278

7.4.15 Accident Reporting 279

7.4.15.1 Introduction 279

7.4.15.2 Action To Be Taken In The Event Of An Accident/Incident 280

7.4.15.3 Reports To Be Generated In The Event Of Accidents 280

7.4.15.4 The Reporting Of Injuries, Diseases And Dangerous

Occurrences Regulations

280

7.4.15.5 Responsibilities 281

7.4.15.6 Incident/Accident Reporting And Investigation Flow Chart 283

viii

For Work-Related Accidents/Incident And Near Misses

7.5 Air Pollution Dispersion Modeling Studies 284


7.5.2 Model Input Data 284

7.5.3 Meteorological Data 285

7.5.4 Presentation Of Results 285

7.5.5 Comments 302

7.6 Public Consultation 303

7.7 Social Impact Assessment, R&R Action Plans 304

CHAPTER 8

PROJECT BENEFITS

8.1 Improvements In The Physical Infrastructure, Social

Infrastructure

305

8.2 Tangible Benefits 305

8.3 Intangible Benefits 306

CHAPTER 9

ENVIRONMENTAL COST BENEFIT ANALYSIS


9.2 Uses Of CBA 307

9.3 Main Stages 308

9.4 Disadvantages 309

9.5 Discounting The Future 310

9.6 Cost-Benefit Analysis For M/s. Shilpa Medicare Limited.,

100% Export Oriented Unit,

311

CHAPTER 10

ENVIRONMENTAL MANAGEMENT PLAN (EMP)


10.2 Mitigation Measures 314

10.3 Environmental Management Plan (EMP) 315

10.4 Environmental Policy 321

10.5 Description Of The Administrative Aspects Of Ensuring That

Mitigative Measures Are Implemented & Their Effectiveness

Monitored, After Approval, Implementation And During

Operation

322

10.5.1 Environment Management Cell

322

ix

CHAPTER 11

SUMMARY & CONCLUSION

11.1 Overall Justification For Implementation Of The Project 324

11..2 Explanation Of How Adverse Effects Have Been Mitigated 325

CHAPTER 12

DISCLOSURE OF CONSULTANTS ENGAGED

12.1 The Names Of The Consultants Engaged With Their Brief

Resume & Nature Of Consultancy Rendered

327

x

LIST OF TABLES

Table no.

Description Pg. No

1.0 Existing Products 30

1.1 The API’s & Intermediates Proposed To Be Manufactured 30

1.1 Terms Of Reference (Tor) 35

2.0 Co-Ordinates (Lat-Long) Of All Four Corners Of The Site 53

2.1 Total Cost Of The Project 55

2.2 Time Schedule For Completion Of The Proposed 55

2.3 Land-Use Pattern 55

2.4 List Of Surrounding Major Industries 56

2.5 Existing Products 59

2.6 API’s And Intermediates Are Proposed To Be Manufactured 59

2.7 Solvent Recovery 72

2.8 Quantity Of By-Products Generated In Kg 80

2.9 Raw Materials Requirement 81

2.10 Raw Material Suppliers 100

2.11 Details Of Storage Facilities 105

2.12 List Of The Machinery & Equipments 106

2.13 Water Consumption And Discharge 130

2.14 Sewage/Effluent Treatment And Discharge 131

2.15 Product-Wise Water Consumption And Effluent Discharge 133

2.15.A Raw Materials To Waste & Product To Waste Generation Ratio & Percentage

139

2.16 Effluent Characteristics For The Emerging Scenario 142

2.17 Air Pollution Sources, Fuel Consumption And Chimney Height

Details

150

2.18 Solid Waste Generation 158

2.19 Hazardous Raw Materials 158

2.20 Quantity Of Organic Process Residue Generation From Manufacturing Process.

160

2.22 Details Of Spent Carbon 163

2.22 Inorganic Salt Generation From The Process 166

2.23 Quantity Of Spent Catalyst Generation From Manufacturing Process 169

2.24 Summary Of The Total Quantity Of Hazardous Wastes: 171

2.25 Characteristics Of Hazardous Waste 172

xi

2.26 Storage Facilities For Hazardous Waste 174

2.27 Disposal Facilities For Hazardous Waste 174

3.1 Meteorological Data Of Bangalore For The Year 2016 180

3.2 Techniques Adopted/Protocols For Ambient Air Quality Monitoring 188

3.3 Protocol For Surface Water Quality Monitoring 188

3.4 Protocol For Ground Water Quality Monitoring 189

3.5 Equipments Used For Noise & Soil Monitoring 190

3.6 Ambient Air Sampling Stations 191

3.7 Air Quality Data Analysis Results 193

3.8 Table 3.8: Ambient Air Quality Standards – MoEF As Per The

Notification Dated 16th November 2009 For Industrial, Residential

& Rural Areas

194

3.9 Noise Level Monitoring Stations 196

3.10 Summary Of Noise Levels 196

3.11 Limits As Per Environmental Protection Rules, 1986 197

3.12 Water Sampling Stations 198

3.13 Surface Water Quality 199

3.14 Ground Water Quality 202

3.15 Observations 206

3.16 Soil Sampling Stations 207

3.17 Physico-Chemical Characteristics Of Soil 207

3.18 TLOCATION OF SAMPLING STATIONS 209

3.19 Flora In The Study Area 210

3.20 Fauna In The Study Area 211

3.21 Break-Up Of The Study Area 213

3.22 Distribution Of Population 213

3.23 Distribution Of Literates And Literacy Levels In The Study Area 214

3.24 List Of Infrastructural Facilities In The Surroundings 215

3.25 Connectivity From The Project Site 215

3.26 Existing Land Use Pattern 220

4.0 Air Quality Management During Operation Phase 230

4.1 Noise Management During Operation Phase 231

4.2 Water Quality Management During Operation Phase 232

4.3 Land Quality Management During Operation Phase 232

4.4 Implementation Schedule For EMP 233

4.5 Financial Allocation/Budgetary Provisions For Environmental

Management

233

4.6 Actions Likely To Affect Environment 234

xii

4.7 Environmental Impact Assessment During Construction Phase 236

4.7.1 Environmental Impact Assessment During Operation Phase 237

4.8 Impact Matrix 239

6.1 Monitoring Schedule For Environmental Parameters 244

6.2 Financial Allocation/Budgetary Provisions For Monitoring Program 247

7.1 Product Wise Solvents Recovered In Kg 251

7.2 Probable Hazards In The Plant 272

7.3 Severity Mapping 254

7.4 Degree Of Hazard 270

7.5 Preventive Systems Provided In The Plant 271

7.6 Damage Due To Incident Radiation Intensities 272

7.7 Radiation Exposure And Lethality 272

7.8 Properties Of Solvents And Fuels 273

7.9 Fire Protection System Proposed For M/S.Shilpa Medicare Limited, 100% EOU

274

7.10 Data Considered For Calculation Of GlC 285

7.11 Predicted Incremental Short-Term Concentrations Due To The

Proposed Project

286

7.12 Resultant Maximum 24 Hourly Concentrations 302

9.1 CBA For M/S. M/S.Shilpa Medicare Limited,100% EOU 311

10.1 Environmental Management Plan During Construction Phase 315

10.2 Environmental Management Plan During Operation Phase 317

10.3 Environmental Management Plan During Storage, Handling &

Transportation Of Raw Materials And Products

320

11.0 Measures Adopted To Mitigate The Impacts 325

xiii

LIST OF FIGURES Fig. No.

Description Pg. No

1.0 Location Map 29

2.0 Maps Showing Project Boundary & Project Site Location 53

2.1 Layout Plan 57

2.1 A Plant Photos. 58

2.2 Typical Solvent Recovery System 80

2.3 Feasibility & Environmental Assessment Process 128

2.4 Water balance chart 132

2.5 ETP Flow Chart For HTDS Flow Diagram 144

2.6 Proposed LTDS Effluent Diagram 145

2.7 Column scrubber 156

3.0 Topo Map Of The Study Area 178

3.1 Wind Rose Diagrams 183

3.2 Wind Rose Diagram – December to February (sampling period) 192

3.3 Location Of Sampling Stations 208

3.4 Google Map Showing Connectivity 216

3.5 Google Map Covering 1 Km Aerial Distance From The Project Site 217



3.8 Google Map Showing Land-Use Pattern 221

7.1 Suspended Particulate Matter (PM) Isotherms For The Proposed Project (Existing + Proposed)

288

7.2 Sulfur Di-Oxide (So2) Isotherms For Proposed Project (Existing + Proposed) 291

7.3 Oxides Of Nitrogen (NOx) Isotherms For Proposed Project (Existing + Proposed)

294

7.4 Carbon Monoxide (CO) Isotherms For Proposed Project (Existing + Proposed)

297

12.1 Organizational Chart Of Environmental Consultants 323

xiv

LIST OF ANNEXURE

Annexure Description

1 Hazop Analysis

Appended at the end

of the report

2 Environmental Policy

3 Authorization/Membership for the disposal of solid/hazardous waste in TSDF

4 Employees Heath Status Annual Report

5 Material Safety Data Sheet (MSDS)

A Copy of EC, CFE, CFO & Compliance report

B Project related drawings

M/s.Shilpa Medicare Limited, 100% EOU

Environmental Impact Assessment Report - 1 -

EXECUTIVE SUMMARY

1. INTRODUCTION

M/s. Shilpa Medicare Limited., 100% Export Oriented Unit, Unit –II, Plot No. 33, 33A & 40 to 47,

Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134, Raichur Dist, Karnataka

intends to expand and modify the Active Pharmaceutical Ingredients (APIs) & Intermediats

manufacturing industry with R & D activity in an existing industry at Unit –II, Plot No. 33, 33A &

40 to 47, Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134, Raichur Dist.

The plant is located at Unit –II, Plot No. 33, 33A & 40 to 47, Raichur, Industrial Growth

Centre, Wadloor Road, Chicksugur - 584134, Raichur Dist, Karnataka.

The Environmental Clearance has been obtained from MOEF for the Active

Pharmaceutical Ingredients (APIs) & Intermediates manufacturing industry with R & D

activity vide EC letter no F.No. J-11011/71/2007-IA II (I) Dated March 12th 2008, and also

Consent for Establishment has obtained from KSPCB and since then the industry is in

operation with valid Consent for Operation from KSPCB.

Now the proponents intend to Expand and Modify the existing Active Pharmaceutical Ingredients (APIs) & Intermediates manufacturing industry with R & D activity.

Existing products:

Table 1.0:- Existing products

S.NO Existing Product Name Manufacturing Qty as per EC in MT/Year

1 Ambroxyl Hcl 47

2 Anatrazole 0.1

3 Gemcitabine Hcl 0.1

4 Paclitaxel 0.1

5 Temozolabide 0.1

6 Bicalutamide 0.5

7 Irinotecon Hcl Trihydrate 0.1

8 3a,7B-Dihydroxy Cholanic Acid 60

9 Cisplatin (to be deleted) 0.1

10 Carboplatin (to be deleted) 0.35

11 Co-Enzyme Q10 (to be deleted) 18

12 Docetaxel (to be deleted) 0.1

13 Oxoplatin (to be deleted) 0.05 Total 126.8



2. PURPOSE OF STUDY Environmental Impact Assessment Report has been prepared for obtaining Environmental

Clearance for the production activities involving expand and modify the Active Pharmaceutical

Ingredients (APIs) & Intermediats manufacturing industry with R & D activity in an existing

industry of M/s. Shilpa Medicare Limited., as it falls under Category 5(f) and is included in the

category of the Environmental Impact Assessment Notification issued in September-2006 and

subsequent amendments.

3. EXTENT OF STUDY AND AREA COVERED

The broad scope of this EIA study includes detailed characterization of baseline environmental

parameters/attributes (ambient air, water, soil, noise) selected for study in an area of 10 km

radius from the proposed project site. This EIA is prepared, based on studies carried out during

December 2016 to Febraury 2017. The following are the salient tasks within the scope.

To assess the existing status of air, noise, water, land, biological and socio-economic

components of environment.

To identify and quantify significant impacts of various operations on environmental

components during construction & operation phases.

To evaluate proposed pollution control measures.

To prepare Environmental Impact Statement outlining additional control technologies to

be adopted for mitigation of adverse impacts on the environment and the surroundings.

In addition to the above, the report would discuss about the TOR laid down by State Level

Expert Appraisal Committee, Karnataka vide letter no. SEIAA 50 IND 2016 dated 09th

Janaury 2017.

4. METHOD OF STUDY

The study is carried out based on guidelines of MoEF and identifies the nature of activities

involved and the impacts caused on various environmental parameters. It subsequently suggests

mitigation measures to be executed for safeguarding against any environmental degradation.

Finally, it suggests methods of implementing the environmental management plan.



5. PROJECT PROPOSAL

The Environmnetal Clearance has been obtained from MOEF for the Active Pharmaceutical

Ingredients (APIs) & Intermediats manufacturing industry with R & D activity vide EC letter no

F.No. J-11011/71/2007-IA II (I) Dated March 12th 2008, and also Consent for Establishment has

obtained from KSPCB. Now the proponent intends to expand & modify Pharmaceutical

Ingredients (APIs) & intermediates manufacturing industry by keeping & expanding some

products with additional products. Some of the products will be deleted. The details of existing

products and proposed products is shown in below table 1.1.

Table: - 1.1 Existing Products

Sl.No. Existing Product Name Manufacturing Qty in MT/Annum.

1 Ambroxyl Hcl 47

2 Anatrazole 0.1


4 Paclitaxel 0.1

5 Temezdomide 0.1

6 Bicalutamide 0.5


8 3a,7B-Dihydroxy Cholanic Acid 60

9 Cisplatin 0.1

10 Carboplatin 0.35

11 Co-Enzyme Q10 18

12 Docetaxel Trihydrate 0.1

13 Oxoplatin 0.05

14

Total 126.8



Table: - 1.2 The API’s & Intermediates Proposed to Be Manufactured

S.NO Existing Product Name

Manufacturing Qty as per EC in

MT/Year

Proposed Product Name

Manufacturin g Qty in MT/Year

Applications

1 Ambroxyl Hcl 47 Ambroxol HCl 10 API

2 Anatrazole 0.1 Anasrozole 0.1 API

3 Gemcitabine Hcl

0.1 Gemcitabine HCl 0.1 API

4 Paclitaxel 0.1 Paclitaxel 0.1 API

5 Temozolabide 0.1 Temozolabide 0.1 API

6 Bicalutamide 0.5 Bicalutamide 0.5 API

7 Irinotecon Hcl Trihydrate

0.1 Docetaxel Trihydrate

0.1 API

8 3a,7B-Dihydroxy

Cholanic Acid

60 3a,7B-Dihydroxy Cholanic Acid

60 Intermediate

9 Cisplatin (to be deleted) 0.1

Bendamustine hcl 0.2 API

10 Carboplatin (to be deleted) 0.35

Bortzomib 0.005 API

11 Co-Enzyme Q10

(to be deleted) 18

Capacitabine 60 API

12 Docetaxel (to be deleted) 0.1

Imatinib 5 API

13 Oxoplatin (to be deleted) 0.05

Lenalidomide 0.5 API

14 Letrozole 0.05 API

15 PMD 0.25 API

16

Decitabine 0.01 API

17 Cytrabine 0.05 API

18 Cabazitaxel 0.01 API

19 Acebrophylline 10 API

20 Cloferabine 0.01 API

21 Melphalan 0.025 API

22 Cyclophosphamide 1 API

23 Tenfovir 50 API



24 PMK 0.25 API

25 Erlotonib 2 API

26 Emtricitabine 1 API

27 Dimethyl fumarate 12 API

28 Elvitegravir 1 API

29 Cobicistat 100 API

30 Busulfan 0.05 API

31 Zoledranic Acid 0.005 API

32 Tranexamic Acid 100 API

33 Sunitinib Malate 3 API

34 Sorafenib Tosylate 3 API

35 Abiraterone acetate

2 API

Total 126.8

422.415

Note: At any given time only 10 products will be manufactured on campaign basis.






Latitude: 16°18'38.31"N; Longitude: 77°21'23.81"E, 357 m above MSL.

The project well connected by NH-167 & SH 51 road at about 1 km. Therefore the project site is well connected by roadways. Yedlapur Railway Station is at a distance of about 8.69 km towards North West direction. Hence the raw materials and the other utilities required by the industry can be easily transported.



6. PROJECT AT GLANCE

Sl.No. Details

1 Project Expansion and Modification of Active Pharmaceutical Ingredients (APIs) & Intermediats manufacturing industry with R & D activity manufacturing industry – “M/s. Shilpa Medicare Limited.,”

2 Project developers M/s. Shilpa Medicare Limited., 100% Export Oriented Unit, Unit –II, Plot No. 33, 33A & 40 to 47, Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134, Raichur Dist, Karnataka.

3 Location of the site Unit –II, Plot No. 33, 33A & 40 to 47, Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134, Raichur Dist, Karnataka.

4 Constitution of the Organization

Public limited Company

5 Raw materials Details of the raw materials required by the industry is appended in Section 3.6.1, Chapter 3 of this report.

6 Product/s proposed to be manufactured with production capacities?

The following APIs are proposed to be manufactured

S.NO Proposed Product Name

Manufacturing Qty in MT/Year

1 Ambroxol HCl 10

2 Anasrozole 0.1

3 Gemcitabine HCl 0.1

4 Paclitaxel 0.1

5 Temozolabide 0.1

6 Bicalutamide 0.5



60

9 Bendamustine hcl 0.2

10 Bortzomib 0.005

11 Capacitabine 60

12 Imatinib 5

13 Lenalidomide 0.5

14 Letrozole 0.05

15 PMD 0.25

16 Decitabine 0.01

17 Cytrabine 0.05



18 Cabazitaxel 0.01

19 Acebrophylline 10

20 Cloferabine 0.01

21 Melphalan 0.025

22 Cyclophosphamide 1

23 Tenfovir 50

24 PMK 0.25

25 Erlotonib 2

26 Emtricitabine 1

27 Dimethyl fumarate 12

28 Elvitegravir 1

29 Cobicistat 100

30 Busulfan 0.05

31 Zoledranic Acid 0.005

32 Tranexamic Acid 100

33 Sunitinib Malate 3

34 Sorafenib Tosylate 3

35 Abiraterone acetate 2

422.415

7 Project cost? Rs.6040 Lakhs.

8 Total man power requirement during occupancy phase

Occupancy/Operational phase: Existing :- 350 Employess Afetr Expansion: - 600 employees and contract persons

9 Proposed trees to be planted?

Exisiting number of tree : 400 Trees proposed to be planted – 100

10 Species of trees to be planted?

Araka, Silver Oak, Wild Badam, Mango, Neem trees, Michelia champaca, Butea monosperma, Pongamia pinnata, Bauhinia purpurea, Cassia fistula, Alstonia scholaris, and several native species

11 Rain water harvesting tank details?

200 KL capacity of open pond

12 Elevation of the project site with respect to MSL?

357 m above MSL; Latitude: 16°18'38.31"N; Longitude: 77°21'23.81"E

13 Total area of the project? 84,984.SQM ( 21.0 Acres)

14 Ground water quality? Potabile, however it has be aceratined.

15 Noise levels? Noise levels is well within the ambient noise stnd. However it has to be acertained.



7. OVERALL JUSTIFICATION FOR IMPLEMENTATION OF THE PROJECT

Bulk drugs have become a part of our life for sustaining many of our day-to-day activities, preventing and controlling diseases. Bulk drugs manufacturing sector in India is well established and has recorded a steady growth in the overall Indian industrial scenario. The bulk drugs and allied industries have been amongst the fastest growing segments of the Indian industry.

The Indian Pharmaceutical Industry today is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. It is expected to reach a level of Rs 3200 billion by 2012. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously.

Playing a key role in promoting and sustaining development in the vital field of medicines, Indian Pharma Industry boasts of quality producers and many units approved by regulatory authorities in USA and UK. International companies associated with this sector have stimulated, assisted and spearheaded this dynamic development in the past years and helped to put India on the pharmaceutical map of the world.

India's pharmaceutical industry is the third largest in the world in terms of volume. Its rank is 14th in terms of value. India is also one of the top five active pharmaceutical ingredients (API)producers (with a share of about 6.5 per cent).

The pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, chemicals, tablets, capsules, orals and injectibles. .Between September 2008 and September 2009, the total turnover of India's pharmaceuticals industry was US $21.04 billion. The domestic market was worth US $12.26 billion. This was reported by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. As per a report by IMS Health India, the Indian pharmaceutical market reached US $10.04 billion in size in July 2010. A highly organized sector, the Indian Pharma Industry is estimated to be worth $4.5 billion, growing at about 8 to 9 percent annually.

The pharmaceutical industry in Karnataka contributes Rs. 350 crore in revenue to the State exchequer and provides employment for 12,000 people. Its growth rate is between 10-12 per cent as against the national pharma growth of 12-14 percent. Pharma products worth Rs. 2,000 crore are produced annually, which is 10 per cent of the national production. The exports sales are Rs.850 crore which is 8 per cent of Indian exports. International pharma majors have preferred many companies from the State. When large companies offer their services on contractual basis to global MNCs, they want to outsource drug production for the domestic market from quality small-medium manufacturers in State. Here the small-medium units ideally fit into slot as third party manufacturers and serve as major hubs for



pharmaceutical outsourcing. In fact, two of Indian pharma sectors top five brands, are already outsourced from Karnataka. The units have been recognised for stringent regulatory enforcement and known to manufacture quality products. Another added advantage favoring the State is that it is emerging as an investment destination. Hence the proponents have proposed the expansion and modification of the pharmaceutical industry - M/s. Shilpa Medicare Limited., 100% Export Oriented Unit, Unit –II, Plot No. 33, 33A & 40 to 47, Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134, Raichur Dist, Karnataka.

8. ENVIRONMENTAL EVALUATION

BASELINE STATUS

Three months data during the period of December 2016 to Febraury 2017has been collected for

environmental attributes like air, water, soil, noise, ecology, socio-economic etc. within a radius

of 10 km to assess the baseline environmental status of the proposed project area. Secondary

data from different government, semi-government and private agencies and sources are

collected, interpreted, compiled and presented to authenticate and draw a conclusion regarding

the baseline status of the environment in the study area.

PUBLIC AMENITIES

Water supply

Most of the villages in the study area are provided with basic civic amenities. Water supply source

in the villages within the study area is basically BWSSB & water in the form of well water, tap

water, tank water, tube well, hand pumps etc. are also found.

Transportation & communication

The study area has a well connected road network. The project well connected by NH-167 & SH 51 road at about 1 km. Therefore the project site is well connected by roadways. Yedlapur Railway Station is at a distance of about 8.69 km towards North West direction. Hence the raw materials and the other utilities required by the industry can be easily transported.



Electricity

Electricity is supplied to all main and remote places for various needs such as domestic, industrial

and agricultural requirements in the study area.

Health, medical and educational facility

Various health & medical facilities available within study area are Community Health Workers,

Primary Health Centre, Hospitals, Child Welfare Centre, and Dispensary & Subsidized Medical

Practitioner.

List of hospitals details are shown in below table 2.0

Table 2.0 hospital Facilities

Sl. No.

Hospital Distance from the industry (km)

Direction w.r.t. the industry

1 Primary Health Center, Ramadurga

30 West

2 Rajiv Gandhi Memorial Hospital

9 South

3 Government Hospital, Raichur 10.1 South

4 Chaitanya Hospital 11.8 South West

AIR ENVIRONMENT

The ambient air quality status around the proposed project area is characterized using the

following sources of data.

Ambient air quality monitoring data for selected locations within 10 km radius of study

area.

Meteorological data of the project location is obtained for the year 2016 from modeling

studies carried out using U.S. EPA AERMOD dispersion model, 1996 – 2016 Lakes

Environmental Software, Version 7.1.0

Existing air quality

To evaluate the baseline status of the ambient air quality, a short term survey was conducted at

six locations around the proposed project site including residential/rural/ and industrial area for

a period of 3 months from December 2016 to Febraury 2017. Ambient air quality standards –

MoEF as per the notification dated 16th November 2009 for industrial, residential & rural areas

were considered as the standard. During the study period, concentrations of SPM (PM10 & PM2.5),



SO2, NOx, CO etcwere measured. From the observations, it has been concluded that the

concentration of pollutants under consideration are within the specified limits of NAAQS for

industrial and residential areas.

Six locations were considered for studying baseline ambient air quality. A brief study report is

appended subsequently.

Table 3:- Ambient air quality

Sl. No.

Parameter 24 Hrs concentration (µg/m3) Monitoring station

At all locations

1 PM2.5, µg/m3 14.66-26.6 2 PM10, µg/m3 33-54.33 3 SO2, µg/m3 6.5-13.5

4 NOx, µg/m3 7.9-11.03 5 NH3, µg/m3 ND 6 Pb, µg/m3 ND 7 O3, µg/m3 10-14 8 C6H6, µg/m3

ND 9 Benzo(a) pyrene in particulate phase, ng/m3

10 As, ng/m3 <0.01

11 Ni, ng/m3

12 CO, mg/m3 0.1-0.5

13 HC, ppm ND 14 Volatile Organic Compounds

(VOCs), ppm

WATER ENVIRONMENT

Seven water samples (3 – surface & 6 - groundwater) were collected in the study zone such as

project site and surroundings & analyzed for their physico- chemical characteristics to evaluate

the existing status of water quality and assess the impact of the proposed project on water

environment.

The ground water analysis results indicate that few parameters like total hardness, TDS for the

groundwater samples is above the limiting standards laid down in Drinking Water Standards (IS:

10500-1991).



However, the required water for this industrial area is supplied by KIADB water supply sources

from river Kabini and therefore effect of ground water quality may not be relavent.

Existing water quality

Studies on the physico-chemical characteristics of the ground water samples in the study area

indicate that the area is free from any abnormalities with regard to its quality.

Water sampling & analysis was carried out for three surface water & Six groundwater samples

for physico-chemical analysis. The observations made are as follows.

Table 4: Characterization of ground water quality

Sl. no.

Parameter Surface water Ground water

1 pH 7.6 - 8.17 7.48 - 8.12

2 Total dissolved solids, mg/L 274 - 336 366 - 448

3 Total hardness, mg/L 125 - 135 150 – 700

4 Fluoride, mg/L 0.60 0.53 – 1.35

Note:

Sl.

No.

Code

No.

Name of the Station

1 GW 1 Project site

2 GW 2 Chiksugur (downwind direction)

3 GW 3 Hanumandoddi

4 GW 4 Yermaras

5 GW 5 Hospet

6 GW 6 Shaktinagar

7 SW 1 Krishna river upstream

8 SW2 Krishna river downstream

9 SW3 Konad Halla



NOISE ENVIRONMENT

Existing noise level

Noise level monitoring was conducted at six locations within the study area representing

industrial & residential areas. From the observations, it may be concluded that the noise levels

are within the prescribed limit specified by the statutory authorities for industrial areas.

Table 5: Details of noise level monitoring

Sl.

No.

Code

No.

Name of the Station Lowest

dB (A)

Highest dB (A)

1 N 1 Project site 40.7 49.0

2 N 2 Chiksugur (downwind direction)

31.5 43.8

3 N 3 Hanumandoddi 37.8 46.4

4 N 4 Yermaras 37.3 47.5

5 N 5 Hospet 38.3 48.6

6 N 6 Shaktinagar 41.8 45.8

Note:

N 1 Project site

N 2 Chiksugur (downwind direction)

N 3 Hanumandoddi

N 4 Yermaras

N 5 Hospet

N 6 Shaktinagar

SOIL ENVIRONMENT

The results of the analysis show that the nature of the soil is neutral.

The soil in the study area has pH in the range of 7.69 – 9.35 & conductivity in the range of 79.0 – 189.0 µs/cm. Potassium, Nitrogen & Phosphorous were in the range of 0.01-0.17 %, 0.07– 0.078 %, 0.007-0.018%.



FLORA & FAUNA

There are naturally growing plants, vegetation & grasses. Land within the study zone is

moderately dry, barren with patches of green fields surrounding the rural village settings. Tree

species attaining moderate to considerable height are found to be present in sparsely distributed

area. The biodiversity of vegetation in the area is not very high due to intense agro ecosystem.

BIOLOGICAL ENVIRONMENT

The biological environment is another important component on which impact of the industrial

activity needs to be studied. The terrestrial and aquatic life forms of flora and fauna constitute

the biological environment. Adequate measures will be undertaken for mitigating & controlling

all the sources of pollution & hence no adverse impact on the biological environment is envisaged

due to the proposed project activities and operations. Moreover, a considerable area of

56,066.06 sq m (i.e. 65.9 % of total plot area) of the proposed project site would be covered by

green-belt. It will also nullify or stabilize the impact of pollutants which may remain beyond the

scope of pollution impact assessment.

The fauna found in the region does not show much diversity as there is no suitable habitat for

the occurrence of ecologically important fauna in the area. The wild life species in the study area

includes few mammals, like common fox, hare, reptiles, common jackal, wolf, bats and domestic

animals.

SOCIO-ECONOMIC ENVIRONMENT

The proposed project is exapansion and modification of the Active Pharmaceutical Ingredients

(APIs) & Intermediates manufacturing industry with R & D activity in an existing industry. During

the construction phase, local people will be employed providing direct and indirect

employments. Thus, a positive impact is envisaged on socio-economic environment of the

locality.

9. ENVIRONMENTAL MANAGEMENT PLAN

CONSTRUCTION PHASE

During construction phase, all precautionary measures for controlling emissions, soil erosion and

noise reduction will be undertaken. The effect due to construction will be of temporary nature

and will have no permanent effect on the environment.



OPERATION PHASE

Environmental impacts associated with the operation phase are detailed in the following

sections.

AIR EMISSIONS

Sources of air pollution

The sources of air pollution in the proposed industry are

Process section – proposed to be provided with column scrubbers & stack of adequate heights.

Boilers – proposed to be provided with stack of adequate height.

DG set – proposed to be provided with stack of adequate height.

Impact on air quality

No adverse impact on air environment is envisaged due to the proposed project, as adequate measures are proposed to be adopted.

Pollutants in the form of oxides of nitrogen, sulfur & SPM from generator, boiler & acid mist/VOCs

from the process sections are considered. Adequate stack heights for DG & boilers are proposed

to mitigate emissions & hence no adverse impact is envisaged on existing environment.



Table 6: Air pollution sources, fuel consumption and chimney height details

SI. no.

Stack attached to Fuel used

Fuel consumption

Number of

stacks

Stack height

Air pollution control unit

Predicted emissions

Existing

1 Process section(scrubbers)

(Production block & Finishing block 5 nos each)

- - 15 3 m ARL for each

Packed column scrubbers – 15 no.s

Acid mist/ VOCs

1 Steam boilers – 6 TPH + 10 TPH– 1 no each

Coal/ Furnace oil / Husk

1303.06 kgs/Hr

1 32 m AGL (common stack for the 2 boilers)

Mechanical dust collectors/ multicyclone - 2 no.s

SO2, NOx, SPM

2 D.G. sets - 625 kVA – 3 no.s

HSD 125 L/hr 3 6 m ARL for each DG set

Stack SO2, NOx, SPM

Proposed

1 D.G. set new install -750 KVA-1 no.s

HSD 150 L/hr 1 6 m ARL For each DG set

stack SO2, NOx, SPM

2 Process section (Newly insttalled thermic flueid) 6 lakh kilo kalaries-1 no’s

FO/LDO 71 kgs/Hr 1 14 m AGL

(combined stack)

Stack SO2, NOx, SPM



SOURCE OF WATER POLLUTION

WASTEWATER TREATMENT AND DISPOSAL DETAILS

The treatment methods and the final disposal of each type of wastewater generated is appended in the table 7.0 below

Table: -7 Sewage/wastewater treatment and discharge

Type of wastewater

Source Quantity, KLD Treatment Re-use of treated

wastewater

Low strength

Process Effluent, Washing effluent & Domestic waste water

130.5 Treated in Effluent treatment palnt followed by Reverse Osmosis. Domestic waste is treated in ETP at the stage of Biological treatment.

cooling tower make-up & Boiler feed water etc.

High strength

Process Effluent, R&D Effluent,

Scrubber wastes, LSWW ETP RO (38.25 KLD )

reject & Shipa Medicare Unit –I

effluent.

84.75 KLD = 58.75 KLD

from this unit + 26 KLD From

Unit-I

Treated in Effluent treatment plant followed by MEE.

High strength

DM plant/ Softner rejects &

Cooling tower bleed off.

50 KLD Treated in High rate Solids contact clarifier tank (HRSCC).

Note: - Additional 26 KLD Effluent from Shilpa Medicare Unit – I will be added to

this Unit for further treatment and disposal and we have the permission for the same.

Impact on water environment

No adverse impact on the water environment is envisaged as adequate treatment

facilities & disposal options are envisaged for the wastewater. Also since the water supply

is from KIADB Water Supply, no adverse impact on the water balance of the area and

changes in Groundwater level and its characteristics is anticipated.



NOISE

Sources of noise

The main sources of noise at present are movement of vehicles on the roads. From the

proposed project, it is envisaged that the DG sets & the process activities will be the

additional source of noise near the project site.

Impact on noise level

Computations based on data and analysis, the distance of noise sources from the project

site and the attenuation due to green belt reveals that the noise level in the study area

will remain practically unchanged. Thus, no impact on existing noise level is foreseen in

the surrounding industrial and residential areas due to the proposed project activities and

operations. Since the proposed industry is located in notified industrial area and also due

to the fact that the proposed industry is to be involved in the Bulk drugs & Intermediates

manufacturing industry, the industry will not have any bearing on the sound generation

and impacts due to the same.

SOLID WASTE

Solid waste management

The solid waste generated from the industry is of 2 types – domestic garbage & hazardous

waste. The total quantity of waste generated with disposal options are detailed below.

Domestic garbage

Table 8: Solid waste generation & management

Total no. of employees 600

Assuming per capita solid waste generation rate as 0.2 kg/capita/day

Quantity of solid waste generated 120 kg/day

Organic solid waste : 60 % of the total waste 72 kg/day

Inorganic solid waste : 40 % of the total waste 48 kg/day

Disposal of domestic solid waste The domestic wastes are segregated at source, collected in bins and composted.



Hazardous solid waste

The quantities of hazardous waste generated from various processes are shown in the

following table 9.

Table 9: Summary of the total quantity of hazardous wastes:

Sl. No.

Source Quantity of hazardous waste generated

Category according to Schedule I of hazardous waste categories

Treatment/ Disposal

kg/month kg/annum

1 Process residue 723.5 8682.4 28.1 Send to Co processing industries in cement industries.

2 Inorganic salt from Process

8073.295 kg 96879.54 kg 34.3 Send to TSDF (Treatment Storage & Disposal Facility), Bangalore

3 Spent Carbon 211.36 2536.3 28.2 Send to Co processing industries in cement industries

4 Spent catalyst 875.4

11,800.8

28.2 Sent to manufacturer/ reprocessor for recycle and reuse.

5 Waste oil from DG set & boiler

150 L/Month 1800 L/annum

5.1 Handed over to KSPCB authorized recyclers/re-processors

6 Spent Solvent 51940 L/month 623288 L/annum

20.2

Solvent distillation inhouse/Send to authorized spent solvent re-processors for recover & re-use.

7 Distillation residue

1.5 MT/month 20.3 MT/annum

20.3 Send to Co processing industries in cement industries

8 Salt from Multiple effect Evaporation System

32739 kg/monh (26739 kg from unit-2 + 6000 from unit-1)

393 Tons/annum

34.3 Send to TSDF (Treatment Storage & Disposal Facility), Bangalore/ Co processing industries.



9 ETP Sludge 3000 kg 36000 kg 34.4 Send to TSDF (Treatment Storage & Disposal Facility), Bangalore/ Co processing industries.

10 Discarded Containers/ liners /barrels

500 No’s/month 6000 no’s/annum


11 Used Batteries -- 05 Hand over to authorized re – cyclers.

12 E-Waste 5 kg 60 kg Handed over to KSPCB authorized recyclers/re-processors.



10. ENVIRONMENTAL EVALUATION

10.1 Environmental impacts and management plan

Environmental management plan during operation phase

Table 10 ENVIRONMENTAL MANAGEMENT PLAN DURING OPERATION PHASE

Sl. no.

Environmental components

Predicted impacts

Probable source of impact Mitigation measures Remarks

1 Ambient air quality

Minor negative impact.

Process of manufacture of APIs & Intermediates

Particulate and gaseous emissions from DG set and boilers & Thermic Fluid heater

Manufacturing process involves closed operations in various controlled reactors.

The process area will be provided with abundant natural light and ventilation and high roofs to disperse the fumes/gases to the outside atmosphere; preventing the increase of ground level concentrations (GLC’S) as it gets dispersed.

Packed column scrubbers are proposed to neutralize and control dust and fumes from the process section.

The treated waste gases and fumes will be let out through stacks of 5 m height ARL.

The emissions from DG & boiler will be let out through stacks of heights 3 m ARL and 32 m AGL respectively.

DG sets will be used only during power failure.



2 Noise Minor negative impact near noise generation sources inside the premises.

Operation of machineries during the manufacturing process.

Handling and conveying of raw materials and semi-finished components to different areas of operations

Operation of DG set.

The conveying system shall be maintained by following routine and periodic maintenance to reduce noise generation in material handling.

DG set with prebuilt acoustic enclosure as per CPCB norms will be installed in dedicated utility area, where the access will be restricted. Also the use of PPE (ear plugs) will be mandatory in this area.

Green belt at the project boundary will further act as noise barrier and help in attenuation of noise.

-

3 Water quality No significant adverse impact

Discharge of domestic sewage and industrial effluent

Domestic sewage will be mixed with low strength wastewater stream & re-used for cooling tower make-up water etc.

The effluent generated from the industry will be treated in ETP followed by RO & MEE.

Water conservation measures will be encouraged.

4 Land No negative impact

Discharge of wastewater.

Storage and disposal of solid wastes.

The treated wastewater will be re-used for cooling tower make-up water etc.

The domestic solid wastes are segregated at source, collected in bins and composted and inert portion will be handed over to authorized recyclers.

-

5 Socio-economic Overall positive impact

Employment opportunities

Locally available man power will be utilized to the maximum possible extent.

-



10.2 POST-PROJECT MONITORING PLAN

A comprehensive monitoring program is suggested in below table 11.0

Table: - 11 monitoring schedule for environmental parameters

Sl. No

Particulars

Monitoring frequency

Duration of monitoring

Important parameters for monitoring

I Air quality

a Ambient air monitoring

1. Project premises Once in a month 24 hourly sample RSPM, SPM, SO2, NOx

2. Stack monitoring Once in a month Grab SPM, SO2, NOx, HC, CO

II Water and wastewater quality

b Water quality

i. Groundwater at two locations (up-gradient and down-gradient)

Once in a month Grab As per KSPCB requirements

c Wastewater quality

i. Low strength & high strength wastewater streams (raw & treated)


III Soil quality

1. Within project premises at 1 location

Once in a year Composite sample As per KSPCB requirements

2. Ecological preservation and up-gradation

Seasonal Visual observations

Survival rate

IV Noise monitoring

1. Project premises Once in a year Day and night As per KSPCB requirements

V Hazardous waste monitoring

1. Hazardous waste characterization

Annually Day and night As per KSPCB requirements

CONCLUSION

The overall impact of the project is beneficial as the impacts on air, noise, water, soil and

biological environment are not significant and socio-economic impacts are predominantly

positive. All the relevant safety norms & precautionary measures would be incorporated in the

system, to ensure that the project is environmentally viable.



CHAPTER 1

INTRODUCTION

1.0 PURPOSE OF THE REPORT

Amendment of the Environmental Impact Notification No. S.O. 60(E) dated 27.01.1994, issued by

the MoEF, Govt. of India has made mandatory under Schedule-I of EIA notification for 30 different

activities to obtain NOC (No Objection Certificate) from the State Pollution Control Board and

Environmental Clearance from the Ministry of Environment & Forests, Govt. of re Public

HearinIndia. This amendment to the EIA Notification is effective from 14.09.2006. It is in this

context that all such activities need to prepare Environmental Impact Assessment (EIA) report

and also appear befog to ascertain the response of Public for the project based on the general

and specific conditions in the said notification.






The Environmnetal Clearance has been obtained from MOEF for the Active Pharmaceutical

Ingredients (APIs) & Intermediats manufacturing industry with R & D activity vide EC letter no

F.No. J-11011/71/2007-IA II (I) Dated March 12th 2008, and also Consent for Establishment has

obtained from KSPCB. Now the proponent intends to expand & modify Pharmaceutical

Ingredients (APIs) & intermediates manufacturing industry by keeping & expanding some

products with additional products. Some of the products will be deleted.



1.1 IDENTIFICATION OF THE PROJECT & PROJECT PROPONENT 1.1.1 INTRODUCTION TO THE PROJECT PROPONENT M/s. Shilpa Medicare Limited., 100% Export Oriented Unit, Unit –II, Plot No. 33, 33A & 40 to 47, Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134, Raichur Dist, Karnataka intends to expand and modify the Active Pharmaceutical Ingredients (APIs) & Intermediats manufacturing industry with R & D activity in an existing industry at Unit –II, Plot No. 33, 33A & 40 to 47, Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134, Raichur Dist.

The proposed industry M/s. Shilpa Medicare Limited., is a Public Limited company. Shilpa

Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur,

Karnataka- India. The commercial production in the SML was started in November 1989. We

initially started producing Trimethoprim IP/BP with in-house developed technology. During the

first year of its operation, the Company had expanded the production facilities to manufacture

Trimethoprim apart from selling on its own, for other reputed Companies like Eskayef Limited,

Bombay Drugs and Pharmas Limited, Bombay Drug House Ltd., US Vitamins Ltd, Sandoz India Ltd

etc. for their export commitments.

Near 1992, the Company had further enhanced its operations by inducting new production

facilities for manufacture of Sodium Methoxide. The technology for the Sodium Methoxide was

also developed in house. About the same time, the Company secured export business from Stellar

Exports Limited, Glaxo Limited and Deepak Nitrite Limited for Trimethoprim. Since then Shilpa

Medicare Limited has started exporting on its own. The Company thus started manufacturing for

both export and domestic markets since 1992.

The Company then embarked upon an expansion project which involved the addition of one

more bulk drugs to its existing product range viz; Norfloxcin and expansion of the production

capacity of the existing products of the Company viz; Sodium Methoxide and Trimethoprim. The

Company also developed a process for drug intermediate- 1-methyl amino-1-methylthio- 2-nitro

ethane, used in the manufacture of Ranitidine, which is an anti-ulcer drug. In November 1993,

Shilpa Medicare was converted into a Public Limited Company. The Company was listed on

Bombay Stock Exchange on Jun 19, 1995 and National Stock Exchange (NSE) on Dec 03,

2009.Subsequently; Shilpa Medicare has gained World Health Organization-Good Manufacturing

Practices (GMP) Certificate recognition. In our relentless efforts for growth-Shilpa Medicare

successfully set up a 100% EOU project in FY10 incurring a capital expenditure of nearly Rs.1000

million.



Today, we have carved a niche for ourselves in the exceedingly competitive and quality-conscious

field of pharmaceuticals manufacturing. We aim to be amongst global leaders in generic APIs &

pharmaceutical products manufacturers, finding innovative ways to make affordable medicines

accessible to every section of the society. SML is committed to its mission of achieving affordable

healthcare, which shall be available to more and more people globally. ‘Global access to

affordable healthcare’- is how we see ourselves contributing to the field of medicine.

We are dealing with high-quality Active Pharmaceutical Ingredients (APIs), Intermediates,

Formulations, New Drug Delivery Systems, Peptides / Biotech products and Specialty Chemicals

etc. utilizing sophisticated technology meticulously in order to comply with international

standards/specifications. Today we are among the world’s leading suppliers of Oncology/non-

Oncology APIs and intermediates. Further to consolidation in field of generic APIs and

Formulations, we are striving for achieving excellence by putting our relentless efforts in field of

Novel Drug Delivery Systems (NDDS) and peptides/biotechnology, along with widening our focus

to other therapy areas. We aim for ensuring affordable healthcare without compromising quality

standards.

We are ISO 14001: 2004 certified organization and committed to implement, maintain and

improve the environmental management system so as to assure its conformity with our stated

environmental policy. We offer a broad and integrated portfolio of products and services

(CRAMS) to the global pharmaceutical industry. In recognition of our outstanding performance

we have been awarded time to time, with awards like ‘Best Entrepreneur Award’ and ‘Star Export

House’ by Ministry of Commerce and Industry, Govt. of India and National Energy Conservation

Award-2012 by President of India.

Being proactive in approach, we continuously seek out avenues and first available opportunities

for development of new products drawing strength from our zeal to provide affordable

healthcare to everyone. Our state-of-the-art infrastructure, more than 2 decades of experience,

and rigorous across-the-board quality standards all contribute to our commitment- Quality

Healthcare at a price which everyone can afford. Being Shilpa Medicare companies, our vision

and business plans are shared by our subsidiary organizations:

Loba Fienchem

Raichem Life Sciences

Nu Therapeutics

Reva Pharma

http://www.loba.co.at/

http://www.raichemlifesciences.com/



At Shilpa in our state of art facilities, we bring on board the expertise and passion for excellence

of our competent team to develop quality pharmaceuticals while building value to our partners

and stakeholders. We are known as a successful and reliable partner within the pharmaceutical

domain. Buyers within the country and from across the borders count on our fast track integrated

development plans. Shilpa Medicare’s skilled team and certified manufacturing capabilities have

proved to be significant differentiator among discerning buyers in the highly regulated markets

of US and Europe. Besides exporting to USA, Canada, Australia, Japan and European Countries

viz.,Germany, Switzerland, Netherlands, Belgium, Spain, Greece, Cyprus, Italy, United Kingdom

etc., we also cater to South American Countries like Mexico, Brazil, and Columbia etc.; African

Countries like Kenya, Nigeria and West Indies etc. and Asian Countries like Singapore, Taiwan,

China, Malaysia, Thailand, etc.

Shilpa Medicare’s facilities have received key regulatory approvals for its facilities as well as for

the products from EDQM, UK-MHRA, TGA, USFDA, PMDA and KFDA. With diverse regulatory

recognized manufacturing set ups and excellent scientific manpower, Shilpa has been on a

consistent growth path, thus defining us: Shilpa Medicare-“Where growth is a habit”.

At Shilpa Medicare, we make every effort to create an environment of openness and

transparency. We believe in maintaining the trust and respect of all of our stakeholders and

customers by acting with integrity at all times. Our ultimate goal is to help all levels of society in

living healthier lives.

Raichur Unit-II Unit-II of Shilpa Medicare Ltd. Is a 100% Export Oriented API Unit. This unit is also well connected

to state highway as being located just adjacent to Hyderabad-Raichur state highway. This unit is

cerified by ISO 14001:2004 and approved of WHO-GMP/EUGMP.

This unit has expertise in :

Isolation, purification, separation techniques.

Asymmetric synthesis.

Chiral technology.

Reduction reaction.s

Customized synthesis/CRAMS activities. Now the company proposes to obtain Environmental Clearance from SEIAA for M/s. Shilpa

Medicare Limited., 100% Export Oriented Unit, Unit –II, Plot No. 33, 33A & 40 to 47, Raichur,

Industrial Growth Centre, Wadloor Road, Chicksugur - 584134, Raichur Dist, Karnataka intends

to expand and modify the Active Pharmaceutical Ingredients (APIs) & Intermediats

manufacturing industry with R & D activity in an existing industry.



1.1.2 INTRODUCTION TO THE PROJECT






“M/s. Shilpa Medicare Limited.,” has entered into a lease agreement with KIADB & a copy of the

lease deed is submitted earlier during ToR time.

“M/s.Shilpa Medicare Limited, 100% EOU” is located at latitude of 16°18'38.31"N; Longitude: 77°21'23.81"E at an elevation of 357 m above MSL.

The project well connected by NH-167 & SH 51 road at about 1 km. Therefore the project site is

well connected by roadways. Yedlapur Railway Station is at a distance of about 8.69 km towards

North West direction. Hence the raw materials and the other utilities required by the industry

can be easily transported.

1.2 BRIEF DESCRIPTION OF NATURE, SIZE, LOCATION OF THE PROJECT & ITS IMPORTANCE TO

THE COUNTRY, REGION

1.2.1 NATURE, SIZE & LOCATION OF THE PROJECT

M/s. Shilpa Medicare Limited., 100% Export Oriented Unit, Unit –II, is located at Unit –II, Plot No.

33, 33A & 40 to 47, Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134,

Raichur Dist.

The locations of the Project site is as below in fig 1.0.



Fig 1.0 LOCATION MAP

Source: - https://www.google.co.in/maps/

The proposed project is manufacturing of Active Pharmaceutical Ingredients (APIs) & Intermediats manufacturing industry with R & D activity in an existing industry.

The APIs & intermediates manufacturing industry with R&D activity proposed to be manufactured are provided in below table 1.0.



Table 1.0:- Existing Products

Sl.No. Existing Product Name Manufacturing Qty in MT/Annum

1 Ambroxyl Hcl 47

2 Anatrazole 0.1


4 Paclitaxel 0.1

5 Temezdomide 0.1

6 Bicalutamide 0.5


8 Cisplatin 0.1

9 Carboplatin 0.35

10 Co-Enzyme Q10 18


12 Oxoplatin 0.05


60

14 Total 126.8

Table: - 1.1 The API’s & Intermediates Proposed to Be Manufactured

S.NO Existing Product Name

Manufacturing Qty as per CFO

in MT/Year


Manufacturing Qty in

MT/Year

1 Ambroxyl Hcl 47 Ambroxol HCl 10

2 Anatrazole 0.1 Anasrozole 0.1

3 Gemcitabine Hcl 0.1 Gemcitabine HCl 0.1

4 Paclitaxel 0.1 Paclitaxel 0.1

5 Temozolabide 0.1 Temozolabide 0.1

6 Bicalutamide 0.5 Bicalutamide 0.5

7 Irinotecon Hcl Trihydrate

0.1 Docetaxel Trihydrate

0.1



60

9 Cisplatin (To be deleted )

0.1 Bendamustine hcl 0.2

10 Carboplatin (To be deleted )

0.35 Bortzomib 0.005

11 Co-Enzyme Q10 (To be deleted )

18 Capacitabine 60



12 Docetaxel Trihydrate

(To be deleted )

0.1 Imatinib 5

13 Oxoplatin (To be deleted )

0.05 Lenalidomide 0.5

14 Letrozole 0.05

15 PMD 0.25

16

Decitabine 0.01

17 Cytrabine 0.05

18 Cabazitaxel 0.01


20 Cloferabine 0.01

21 Melphalan 0.025


23 Tenfovir 50

24 PMK 0.25

25 Erlotonib 2

26 Emtricitabine 1


28 Elvitegravir 1

29 Cobicistat 100

30 Busulfan 0.05






2

Total 126.8

422.415

Note: The above products will be manufactured on campaign basis only.



1.2.2 NEED FOR THE PROJECT AND ITS IMPORTANCE TO THE COUNTRY AND/REGION

Bulk drugs have become a part of our life for sustaining many of our day-to-day activities, preventing and controlling diseases. Bulk drugs manufacturing sector in India is well established and has recorded a steady growth in the overall Indian industrial scenario. The bulk drugs and allied industries have been amongst the fastest growing segments of the Indian industry.

The Indian Pharmaceutical Industry today is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. It is expected to reach a level of Rs 3200 billion by 2012. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously.

Playing a key role in promoting and sustaining development in the vital field of medicines, Indian Pharma Industry boasts of quality producers and many units approved by regulatory authorities in USA and UK. International companies associated with this sector have stimulated, assisted and spearheaded this dynamic development in the past years and helped to put India on the pharmaceutical map of the world.

India's pharmaceutical industry is the third largest in the world in terms of volume. Its rank is 14th in terms of value. India is also one of the top five active pharmaceutical ingredients (API) producers (with a share of about 6.5 per cent).

The pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, chemicals, tablets, capsules, orals and injectibles. .Between September 2008 and September 2009, the total turnover of India's pharmaceuticals industry was US $21.04 billion. The domestic market was worth US $12.26 billion. This was reported by the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. As per a report by IMS Health India, the Indian pharmaceutical market reached US $10.04 billion in size in July 2010. A highly organized sector, the Indian Pharma Industry is estimated to be worth $4.5 billion, growing at about 8 to 9 percent annually.

The pharmaceutical industry in Karnataka contributes Rs. 350 crore in revenue to the State exchequer and provides employment for 12,000 people. Its growth rate is between 10-12 per cent as against the national pharma growth of 12-14 percent. Pharma products worth Rs. 2,000 crore are produced annually, which is 10 per cent of the national production. The exports sales are Rs.850 crore which is 8 per cent of Indian exports. International pharma majors have preferred many companies from the State. When large companies offer their services on contractual basis to global MNCs, they want to outsource drug production for the domestic market from quality small-medium manufacturers in State. Here the small-medium units ideally fit into slot as third party manufacturers and serve as major hubs for



pharmaceutical outsourcing. In fact, two of Indian pharma sectors top five brands, are already outsourced from Karnataka. The units have been recognised for stringent regulatory enforcement and known to manufacture quality products. Another added advantage favoring the State is that it is emerging as an investment destination. Hence the proponents have proposed the expansion and modification of the pharmaceutical industry - M/s. Shilpa Medicare Limited., 100% Export Oriented Unit, Unit –II, Plot No. 33, 33A & 40 to 47, Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134, Raichur Dist, Karnataka. 1.2.3 DEMAND SUPPLY GAP, IMPORTS VS INDIGENOUS PRODUCTION

Indian pharmaceutical companies supply almost all the country's demand for API and nearly 70

per cent of demand for bulk drugs. The imports of pharmaceuticals are estimated at 10 to 12

percent of the total market. The major suppliers are Switzerland, China, USA, Germany, Italy,

Denmark, France, and UK. Imports include raw materials and finished products. Some major

pharmaceuticals which are imported include Provitamins and Vitamins, Cortisones,

Hydrocortisone, Insulin, Penicillin, Osetrogen, Progesterone and other hormones, Erythromycin

and other ANTIBIOTICS, Antisera & other blood fraction, and Glycosides.

The imports are from Switzerland, US and Germany primarily consist of finished medicament in

dosage forms for retail sales.

1.2.4 EXPORT POSSIBILITY

The size of the domestic pharmaceutical market is larger than export market. However, owing to the growth of global generics market, stringent price controls in the domestic market, and better margins, the export market is growing much faster than the domestic market.

India exports pharmaceuticals to numerous countries around the world, including to the U.S., Germany, France, Russia and UK. The Indian pharmaceutical industry ranks 17th with respect to exports value of bulk actives and dosage. Exports constitute nearly 40 per cent of the production, with bulk drugs 45 per cent.

According to the Pharmaceutical Export Promotion Council (Pharmexcil), the pharmaceutical exports in 2007-08 stood at US $6.68 billion against US $5.73 billion in 2006-07, recording a growth rate of 16 per cent. The industry has been clocking export growth rate, recording 18 per cent, 23 per cent and 17 per cent growth rates during 2006-07, 2005-06, and 2004-05,



respectively. The overall pharmaceutical exports are estimated to increase at a CAGR of 30-32 percent and reach US $ 18.3 billion in 2010 - 11.

India exports to over 200 countries. Pharmaceutical exports clocked a CAGR of 10.3 per cent to US$ 15.5 billion during 2014–15 from US$ 10.4 billion during 2010–11. The US is the largest importer of Indian products. Exports to the UK grew at 11.9 per cent between 2009 and 2010, and 2013 and 2014. India has the highest number of plants approved by the United States Food and Drug Administration (USFDA) outside the US. Around 584 Indian companies/sites are registered with the USFDA. Several plants have also obtained regulatory approvals from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; the Medicines Control Council (MCC) in South Africa; and the Therapeutic Goods Administration (TGA) in Australia. India has one of the lowest manufacturing cost in the world. Manufacturing cost in India is approximately 35–40 per cent of that in the US as installation and workforce costs are low.

1.3 SCOPE OF STUDY – DETAILS OF REGULATORY SCOPING CARRIED OUT (AS PER TERMS OF

REFERENCE)

The purpose of EIA/EMP is to critically analyze the environmental impacts due to Construction

and Operation of project with respect to effluent transportation, treatment and disposal of

treated effluent, disposal of sludge and mitigation measures to reduce the pollution and to

delineate an Environmental Management Plan along with recommendations and suggestions.

ToRs have been considered for prepeation of Environment Impact Assessment studies for the

project.

1.3.1 SCOPE OF STUDY

Collecting baseline data on different environmental parameters for the period from

December 2016 to Febraury 2017.

Impact assessment and suggestion of mitigation measures to minimize the impacts.

Preparation of Environmental Management Plan and Environmental Monitoring Plan

Primary and secondary data collection for preparing EIA/ EMP Report.

Submission and presentation of salient features of EIA/EMP report to the EAC for

getting Environmental Clearance.

1.3.2 COMPONENTS OF EIA REPORT

Depending on nature, location and scale of the project, EIA report contains the following

components:



Air Environment

Noise Environment

Water Environment

Land Environment

Biological Environment

Socio-Economic and Health Environment

Environmental Monitoring Program

Environment Management Plan.

1.3.3 TERMS OF REFERENCE (TOR)

Terms of Reference (TOR) prescribed by the State Level Expert Appraisal Committee, Karnataka,

vide letter no. SEIAA 50 IND 2016 dated 09-01-2017 for the preparation of project report for the

proposed expansion and modification of the Active Pharmaceutical Ingredients (APIs) &

Intermediats manufacturing industry with R & D activity in an existing industry of M/s. Shilpa

Medicare Limited., 100% Export Oriented Unit, Unit –II is tabulated below table 1.1.

Table 1.2: Terms of Reference (TOR)

Sl. No.

Description Details provided in Chapter/Section

1. Executive summary of the project

2. Introduction

(i) Details of the EIA Consultant including NABET accreditation.

Chapter -12.

(ii) Information about the project proponent.

Section 1.1.1, Chapter – 1

(iii) Importance and benefits of the project.


3. Project Description.

(i) Cost of project and time of completion.

Section 2.4, Chapter – 2

(ii) Products with capacities for the proposed project.

Section 1.2.1, Table 1.0 Chapter – 1

(iii) If expansion project, details of existing products with capacities and whether adequate land is available for expansion, reference earlier EC if any.

The Environmental Clearance has been obtained

from MOEF for the Active Pharmaceutical

Ingredients (APIs) & Intermediates manufacturing

industry with R & D activity vide EC letter no F.No. J-

11011/71/2007-IA II (I) Dated March 12th 2008, and



also Consent for Establishment has obtained from

KSPCB. Now the proponent intends to expand &

modify Pharmaceutical Ingredients (APIs) &

intermediates manufacturing industry by keeping &

expanding some products with additional products.

Some of the products will be deleted.


(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.

Section 2.9, 2.9.2, 2.9.3, 2.9.3.5 Chapter – 2

(vii) Requirement of water, power, with source of supply, status of approval, water balance diagram, man-power requirement (regular and contract).

Section 2.9, 2.9.2, 2.9.3.1, 2.5 & Fig 2.4,

Chapter -2.

Occupancy/Operational phase: 600 employees

(viii) Process description along with major equipments and machineries, process flow sheet (quantitative) from raw material to products to be provided.

Section 2.7 & 2.7.2 Chapter – 2

(ix) Hazard identification and details of proposed safety systems.

Section 2.9.3.5.2 Chapter – 2

(x) Expansion/ modernization proposals.


a) Copy of all the Environmental Clearance 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 operation of the project from SPCB shall be attached with the EIA-EMP report.

Copy of Environmental Clearance and compliance report is attached as annexure -A



EC b) 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 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. c) Comparative statement of existing and the proposed capacity, products, use of natural resource, waste generation, pollution potential, etc.,

The project has been accorded with Consent for Establishment from KSPCB for Herbal Extract products during the year 2008 from MoEF and since then the industry is running with valid CFO. Now the proponents intend to expand and modify the Active Pharmaceutical ingredients (API) & Intermediates. Copy of EC, CFE, CFO & Compliance report of the same is appended as annexure - A

4. Site Details:

(i) Location of the project site covering village, taluk/Tehsil, District and State, justification for selecting the site, whether other site were considered.

Fig. 3.1, Chapter -3 & Executive Summary.

(ii) A topo sheet 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 environ mentally sensitive places)

Fig. 3.1, Chapter -3 & Annexure-B

(iii) Details w.r.t option analysis for selection of site.

Chapter -5.

(iv) Co-ordinates (lat-long) of all four corners of the site.

Table 2.0, Chapter-2.

(v) Google map-Earth downloaded of the project site.

Fig 2.0, Chapter -2.

(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.

Fig 2.1, Chapter -2.



(vii) Photographs of the proposed and existing (if applicable) plant site. If existing, show photographs of plantation/greenbelt, in particular.

Fig 2.1A, Chapter -2.

(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)

Section 2.6, Chapter -2.

(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.

Table 2.4, Chapter-2.

(x) Geological features and Geo-hydrological status of the study area shall be included.

Section 3.3.5, Chapter-3.

(xi) Details of Drainage of the project up to 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)

NA, as the proposed project is located in designated industrial area.

(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.

“M/s. Shilpa Medicare Limited.,” has entered into a lease agreement with KIADB & a copy of the lease deed is submitted earlier during ToR time.

(xiii) R and R details in respect of land in line with state Government policy.

Section 7.7, Chapter-7.

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)

NA, no forest is located within 10 km.



(iii) Status of Application submitted for obtaining the stage 1 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 1 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 micrometeorological data using temperature, relative humidity, hourly wind speed and direction and rainfall.

Section 3.2, Chapter-3.

(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 predominant wind direction, population zone and sensitive receptors including reserved forests.

Detailed in chapter -3 , Section – 3.3.2.1, Table -3.7

(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

Detailed in chapter -3 , Section – 3.3.2.1, Table -3.7



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 and CC guidelines.

The effluent generated from the project will be treated in zero liquid discharge plant.

(v) Whether the site falls near to polluted stretch of river identified by the CPCB/MoEF and CC, if yes give details.

No, NA

(vi) Ground water monitoring at minimum at 8 locations shall be included.

Detailed in chapter -3 , Section – 3.3.4

(vii) Noise levels monitoring at 8 locations within the study area.

Detailed in chapter -3 , Section - 3.2.2.4.3

(viii) Soil characteristics as per CPCB guidelines.

Detailed in chapter -3 , Section – 3.3.3

(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.,

Detailed in chapter -4 , Section – 4.3.5.1

(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-1 fauna are found within the study area, a wildlife conservation plan shall be prepared and furnished.

Detailed in chapter -3 , Section – 3.4.2 & 3.4.3.

(xi) Socio-economic status of the study area.

Detailed in chapter -3 , Section – 3.5.

7. Impact and Environment Management Plan:

(i) Assessment of ground level concentration of pollutants from the stack emission based onsite-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

AAQ monitoring was conducted to assess the baseline air quality status of the study area. GLC of AAQ were estimated using industrial source complex (ISCST3) USEPA, Lakes Environmental complex terrain dispersion model based on a steady state Gaussian plume dispersion designed for point sources and short term modeling as per MOEF guidelines for the expansion project. The estimated AAQ were within permissible limits. The details are furnished in EIA report chapter 7 under section 7.5.3 Impact of air quality.



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.

We are not discharging effluent to any water body.

(iii) Impact of the transport of the raw materials and end products on the surrounding environment shall 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.

Detailed in Chapter 2, Section 2.7.4.

(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.

Detailed in Section 2.9.2.3, Chapter -2.

(v) Details of stack emission and action plan for control of emissions to meet standards.

Detailed in Chapter 2, Section 2.9.3.2.

(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.

No Fly ash is generated from the industry.



(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.

Considerable area of 56066.06 sq m (i.e. 65.9 % of total plot area) of the proposed project site would be covered by green-belt. It will also nullify or stabilize the impact of pollutants which may remain beyond the scope of pollution impact assessment.

(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 use for the various activities at the project site to conserve fresh water and reduce the water requirement from other sources.

Detailed in Chapter 2, Section 2.9.4.

(xi) Total capital cost and recurring cost/annum for environmental pollution control measures shall be included.

Detailed in Chapter, Table 4.5.

(xii) Action plan for post-project environmental monitoring shall be submitted.

Detailed in Chapter – 6.

(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 should be linked with District Disaster Management plan.

Detailed in Chapter – 7, Section 7.4.7

8. Occupational health:

I. Plan und allocation to ensure the occupational health and safety of all contract and casual workers.

Detailed in Chapter – 7, Section 7.4.7.2

II. Details of exposure specific health status evaluation of worker if the worker health is being evaluated by pre designed format, chest x rays, Audiometry, Spirometry, vision testing (Far and near vision, color vision and any other ocular defect) ECG, during pre-placement and periodical

Employees are being examined by a team of doctors. Pre-employment medical checkup is being done for employees. Medical checkup is being done as per general and systemic parameters. All the Employees are found good condition of health.



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.

Detailed is appended in annexure -4

III. Details of existing occupational and 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.

There is a likelihood of employees being exposed to respiratory, contact, and Noise hazards due to accidental exposure to substances. All these hazards are being periodically monitored, all exposure level are within the limits PEL. Fallowing systems are in place to maintain values below PEL. 1. All the process reactors & distillation units are

provided with primary condensers circulated with water at 32 DEGC & are designed for Delta Tof 5 DEGC , sub coolers with Chilled water circulation of +10 DEG C with a Delta T of 50C, to avoid the escape of solvents into the environment and also to have the effective recoveries of 98% during distillation

2. The solid liquid separation is done under the closed condition using the special Equipment like ANFD , and The vacuum pumps are connected with Post condensers to avoid solvent vapour emission to the environment

3. Further all the Centrifuges are provided with Nitrogen Blanketing and the mother liquors are collected in tanks & pumped in closed system to ML Tanks & further to Recovery systems

4. Effective ventilation system is provided in all the work places with sufficient air changes

5. All the vents are provided with flame arrestors & further to dump tanks with over pressure & under pressure relief Valves , to avoid any leaks to working environment

6. Adequate & specific PPE are provided to avoid personal Contact while handling Chemical substances

Noise levels in all work areas are found bellow the PEL , Effective periodic maintenance is ensured and acoustic enclosures are in place



IV. Annual report of health status of workers with special reference to Occupational health and safety.

No special reference made to any of the workers. Annual Report attached as anneure-4

9. Corporate Environmental 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.

Detailed in Chapter –10, Section 10.4.

II.Does the Environment policy prescribed 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.

No

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.

Detailed in Chapter –10, Section 10.5.1.

IV.Does the company have system of reporting of non-compliances/ violations of shareholders or stakeholders at large? This reporting mechanism shall be detailed in the EIA report.

The reporting of non-compliance to the top management (Board of Directors of the company and/or shareholders or stakeholders) will be through lower management, Middle management of the project.

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.

Detailed in Chapter –4, Section 4.1.1.

11. Enterprise Social Commitment (ESC) 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. Socioeconomic development activities need to be elaborated upon.

Shilpa Medicare Ltd., has defined CSR policy, & the company has allocated the funds as required under the Companies act. Number of socioeconomic development activities have been undertaken by the company for the benefit of the public (stakeholders) around the vicinity of the company in Karnataka.



Company has contributed to the following activities to promote social activities

Ambedkar Jayanti

karnataka state Police officers Welfare Fund



National Education Trust

DSS Aqssociation for Celebration Ambedkar Jayathi


towards Badmainton Club

Karnatataka Day

Social activites

Civil & Fabrication Work for Cool Water plant at Polepally Jadcherla

the prime Miniter National relief Fund

SL N College for Sponsorship Manthan

Shri Manik Prabhu Academy Blind Trust

Orphanage Childern Fees

Hanuman Temple Flooring Wal

Flooring Granite Hanuman Temple

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 Environmental (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.

NO

13. A tabular chart with index for point wise compliance of above TOR.

Detailed in chapter -1, Section 1.3.3

B. Specific terms of reference for EIA studies for synthetic organic chemicals industry (Dyes and Dyes intermediates; Bulk drugs and intermediates excluding drug formulations; Synthetic rubbers; Basic organic chemicals, other synthetic organic chemicals and chemical intermediates)



1. Details on solvents to be used, measures for solvent recovery and for emissions control.

Detailed in chapter -2, Section 2.7.3

2. Details of process emissions from the proposed unit and its arrangement to control.

Detailed in chapter -2, Section 2.9.3.2

3. Ambient air quality data should include VOC, other process-specific pollutants* like NH3, chlorine, HCL, HBr, H2S, HF, etc.,(*-as applicable)


4. Work zone monitoring arrangements for hazardous chemicals.

1. Only sealed containers handled. 2. The hazardous chemicals are stored at

temperatures as per the prescribed storage condition

3. All containers provided with secondary containment.

4. Hazard identification & first aid methods ensured on labels.

5. High volume substances handled in closed conditions.

6. Local exhaust ventilation scrubber used while charging chemicals to the reactors.

7. Specific and adequate protection provided through PPE

8. VOC is monitored periodically 9. Adequate ventilation provided to all work

places.

5. Detailed effluent treatment scheme including segregation of effluent streams for units adopting ‘Zero’ liquid discharge.


6. Action plan for odor control to be submitted.

1. All the possible sources of leaks will be identified and plugged immediately with an effective Preventive maintenance schedule & Preventive maintenance schedule is in place, as per the protocol & check list is defined for each equipment & is maintained in order.

2. Odour control mechanism will be installed to bring down odorous particles for effective treatment

3. All the condensers are designed to take the vapour load during the reaction reflux & distillation & adequate cooling water by



Cooling towers is provided & standby circulation pumps are provided & further Existing Cooling system has adequate capacity to supply chilled water to the sub condensers to enhance condensation of vapours.& in case of any break down , standby chiller is provided.

7. A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearly that solid/hazardous waste generated.

NA, we are not giving any solid/hazardous waste to cement industry.

8. Authorization/Membership for the disposal of liquid effluent in CETP and solid/hazardous waste in TSDF, if any.

Authorization/Membership for the disposal of solid/hazardous waste in TSDF is enclosed as annexure-3

9. Action plan for utilization of MEE/dryers salts.

The segregation of the sulphate salts generating effluent is being made, and MEE & ATFD is run on campaign basis, to get the pure sodium sulphate which contributes to 45% of the salts, we have plans to dispose this to the vendors. Proposal for investing about Rs.1.3 crores is being finalized for achieving the above objective.

10. Material Safety Data Sheet for all the Chemicals are being used/will be used.

Material Safety Data Sheet for all the Chemicals is enclosed as annexure- 5

11. Authorization/membership for the disposal of solid/hazardous waste in TSDF.

Authorization/Membership for the disposal of solid/hazardous waste in TSDF is enclosed as annexure-3

12. Details of incinerator if to be installed. No, NA.

13. Risk assessment for storage and handling of hazardous chemicals/solvents. Action plan for handling and safety system to be incorporated.

Detailed in chapter -7, Section 7.4

1 14. Arrangements for ensuring health and safety of workers engaged in handling of toxic materials.

Detailed in chapter -7, Section 7.4

Additional TORs for EIA studies: 1. Quantification of the each product and

raw material. Detailed in Chapter -2 section 2.7.4

2. Explore the possibility to remove chloroform and Sulphur dioxide.

Presently Chloroform and Sulphur dioxide are not used in process.

3. No. of products and No. of reactors provided with justification.

Detailed in Chapter -2 section 2.7.5



4. Material balance and mass balance for all the products.

Detailed in Chapter -2 section 2.7.2

5. Raw material to product and product to waste generation ratio for each product to be given.

Detailed in Chapter -2 section 2.7.2 (A)

6. Impact on the adjacent Industry/agriculture land due to this activity.

Worst case scenario analysis has revealed that there is no Impact on the adjacent Industries, Refer Dwg. Detailed in section 7.4.4.1 and , Dow Fire & Explosive Index for one worst case Reduction process , and Hydrogenation Process is detailed in section 2.7.4.5, Chapter-2 and Severity mapping for Solvent tank farm Detailed in section 7.4.4.1

7. Greenbelt details with design to be provided.

The industry is designed with utmost consideration to the environment. A total area of 58,755.16 sq m i.e. 65.9 % of the total plot area is reserved exclusively for green-belt/landscape development.

8. Storage and safety measures taken in the hydrogenation process to be explained in EIA.

1. Considering the Hazardous nature of the

process the Unit is Separated from the Main

manufacturing block

2. Prior to the start of the process , the integrity of the Reactor is checked & certified

3. Before starting the hydrogenation Process inertisation is ensured by alternating cycles of Vacuum & Nitrogen

4. The system is Provided with safety relief Valve & Rupture Disk , Both these connected to a dump tank with water seal , the dump tank is provided with the flame arrester

5. High Pressure & High Temperature alarms are Provided on the equipment

6. Sensitive Hydrogen leak Detectors are provided near the reactor and Manifold

7. Flash Back arrestor in the manifold to the reactor

8. Close system sampling is done & the system is flushed with the water

9. Evacuation of Hydrogen is done through the dump tank gradually in over one hour

10. Filtration is done in the closed Pressure nutch filter & is done with the nitrogen pressure

9. Raney nickel is to be replaced with palladium/carbon in the hydrogenation process.

The Developed Process is robust & safe & safe The Process of Reduction of CN Group to CH2 NH2 is found to be catalyst sensitive and found working with smoothly with Raney Nickle Catalyst ,



The experiments Conducted in our R&D has demonstrated that PD/Charcoal is not suitable catalyst , the reaction is incomplete & is not progressing However efforts will be made to eliminate the Raney nickle with other low volume catalysts , where ever suitable .

10. Unit performance of the treatment plants available.

Unit performance of the Effluent plant:

S. No

Name of the Equipment

Designed efficiency %

Present Efficiency %

1 Stripper COD Stripping

95% 95%

2 Multiple Effect evaporator

98% 98%

3 Aeration Tank-1

50 to 55 %

53%

4 Aeration Tank-2

75 to 78 %

75%

5 Aeration Tank-3

95 to 96 %

95%

6 HRCC secondary clarifier

5 % 5%

7 UF Ro permeate to Reject

70 % 70%

11. In the monitoring protocols of the ambient air, VOC to be incorporated.

In the monitoring protocols of the ambient air, VOC is incorporated and detailed in section 3.3.2.1, Chapter -2.

12. Solvent storage and solvent recovery scheme to be explained.

Detailed in chapter – 2, section 2.7.3.2.

13. Green chemistry adopted in the process to be highlighted.

The Company is investing in Continuous Flow reactors about 3 crores is being invested &is exploring the possibility of Minimizing the waste generating during the reaction by way of losses , & recycling the all the recyclable materials , Like catalysts & byproducts

14. List of banned chemicals to be provided

with alternative chemicals to replace the banned chemicals.

We are not using any banned chemicals.



1.4 GENERIC STRUCTURE OF EIA DOCUMENT:

This EIA report presents the existing baseline scenario and the assessment and evaluation of the

environmental impacts that may rise during the construction and operational phases of the

project. This report also highlights the Environmental Monitoring Program during the

construction and operation phases of the project and the post project monitoring program. In

terms of the EIA Notification of the MoEF dated 14th September 2006 as amended Dec. 2009, the

generic structure of the EIA document will be as under:

Chapter 1: Introduction

Introductory information is presented in this Chapter. The introduction provides a Background

to the project and describes the objective of this document. This Chapter also includes the outline

of the project and its proponent. The purpose and organization of the report is also presented in

this chapter.

Chapter 2: Project Description

This Chapter includes Project Description and Infrastructure Facilities delineating all industrial

and environmental aspect of the industry of M/s. Shilpa Medicare Limited., 100% Export Oriented

Unit, Unit –II Construction and operation phase activities as well as process details of proposed

scenario. This Chapter gives information about storage and handling, water and wastewater

quantitative details, air pollution and control system, sludge storage facility, utilities, greenbelt

and safety measures for proposed plant.

Chapter 3: Description of the Environment

This Chapter provides Baseline Environmental Status of Environmental components (Primary

data) delineating meteorological details of the project site and surrounding area.

Chapter 4: Anticipated Environmental Impacts & Mitigation Measures

This Chapter presents the analysis of impacts on the environmental and social aspects of the

project as a result of establishment of plan and thereby suggesting the mitigation measures.



Chapter 5: Analysis of Alternatives

This chapter includes the justification for the selection of the project site from Environmental

point of view as well as from economic point of view so that the technology will be affordable to

the member units of the industrial area.

Chapter 6: Environmental Monitoring Plan

This chapter will include the technical aspects of monitoring, the effectiveness of mitigation

measures which will include the measurement methodologies, frequency, location, data analysis,

reporting schedules etc.,

Chapter 7: Additional Studies

This chapter will detail about the Public Consultation sought regarding the project. It will also

identify the risks of the Project in relation to the general public and the surrounding environment

during construction and operation of the plant and thereby presents Disaster Management Plan.

Chapter 8 & 9: Project Benefits & Environmental Cost Benefit Analysis.

The realization of the project activity is envisaged to impart benefits to the areas in concern. This

Chapter will identify the benefits from the project and summarize them.

Chapter 10: Environmental Management Plan

It is the key Chapter of the report and presents the mitigation plan, covers the institutional and

monitoring requirements to implement environmental mitigation measures and to assess their

adequacy during project implementation.

Chapter 11: Summary and Conclusion

This chapter summarizes the information given in Chapters in this EIA/EMP report and the

conclusion based on the environmental study, impact identification, mitigation measures and the

environmental management plan.

Chapter 12: Disclosure of the Consultant

Names of consultants engaged in the preparation of the EIA/EMP report along with their brief

resume and nature of Consultancy rendered are included in this Chapter.



2.1 TYPE OF PROJECT

The main activity of the industry is manufacturing of Active Pharmaceutical Ingredients (APIs) &

Intermediats manufacturing industry with R & D activity.

2.2 NEED FOR THE PROJECT

The need for the project is detailed in Section 1.2.2, Chapter 1 of this report.

2.3 LOCATION OF THE PROPOSED INDUSTRY

The Expansion and Modification of Active Pharmaceutical Ingredients (APIs) & Intermediats

manufacturing industry with R & D activity manufacturing industry is located at Unit –II, Plot No.

33, 33A & 40 to 47, Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134,

Raichur Dist, Karnataka. Google map is appended as fig 2.1A.

CHAPTER 2

PROJECT DESCRIPTION



Fig 2.0: Maps showing project boundary & project site location

Note:

Latitude: 16°18'38.31"N; Longitude: 77°21'23.81"E 357 m above MSL;

Table: - 2.0 Co-ordinates (lat-long) of all four corners of the site

Sl.No. Directions Co- ordinates

1 North East Latitude: 16°18'44.22"N; Longitude: 77°21'23.67"E

2 North West Latitude: 16°18'42.20"N; Longitude: 77°21'19.34"E

3 South East Latitude: 16°18'33.56"N; Longitude: 77°21'27.26"E

4 South West Latitude: 16°18'35.91"N; Longitude: 77°21'17.73"E



2.4 SIZE OR MAGNITUDE OF OPERATION

The industry “M/s. Shilpa Medicare Limited., 100% Export Oriented Unit, Unit –II” is a Large scale industrial unit with a total capital investment of Sixty Crores Forty Lakhs only. The total production capacity proposed is 422.415 MT/Annum.



The total production capacity is 4,22,415 kg/annum.

The total capital investment on the project is Rs. 60.40 Crores only; the details of which are

appended in the following table 2.1.

Table: 2.1 - Total Cost of theproject

Sl. no.

Cost of Rs. (Lakhs)

1 Building 1000.00

2 Plant & machinery 5000.00

3 Pollution control systems 40.00

Rupees TOTAL 6040.00

2.5 PROPOSED SCHEDULE FOR APPROVAL & IMPLEMENTATION

The time schedule for completion of the proposed project is given in the following table 2.2.

Table 2.2:- time schedule for completion of the proposed

Particulars Time schedule

Approval May, 2017

Civil works July, 2017

Erection & installation of machinery October, 2017

Completion March, 2018

2.6 PROPOSED LAYOUT PLAN

The proposed layout plan clearly demarcating various units within the plant and the boundaries

with land use pattern is provided in fig 2.1 and table 2.3 respectively.

Table 2.3:- Land-use pattern

Sl. No.

Particulars Existing Area (SQM)

Proposed Area (SQM)

After Expansion

(SQM)

Area in percentage

(%)

1 Total plot area 84,984.00 - 84,984.00 100

2 Ground coverage area 16769.9 2689.1 19459 22.89

3 Landscape/Green-belt area

58755.16 - 56066.06 65.9

4 Hard paved area 9458.94 - 9458.94 11.21

5 Built-up area 25803.4 5124.1 30927.5 -



“M/s. Shilpa Medicare Ltd.,” has entered into a lease agreement with KIADB & a copy of the lease deed is is submitted earlier during ToR time. SITE BEARINGS: The proposed project site is surrounded by vacant plots/industries in all

directions. Details are shown in the below table.

Table 2.4: List of surrounding major industries

List of Surrounding Major Industries

Sl.No. Name of the Industry Type of Industry Direction Distance in Km

1 Raichem Medicare (P) Ltd Pharmaceutical North 0.5

2 Trimax industry (P) ltd Pharmaceutical North west

0.5

3 Vibrant pharma Bulk drug industry South 0.4

4 Surana Industry Iron industry(Closed) East 0.5

5 Laksmi venkateswara ginning & presser

ginning & pressing mill West Adjacent

The proposed layout plan of the project with various components is appended as fig 2.1.



Fig. 2.1: Layout plan



Fig. 2.1 A Plant Photos.



2.7 TECHNOLOGY & PROCESS DESCRIPTION

2.7.1 PRODUCTS MANUFACTURED

The following APIs & intermediates are proposed to be manufactured is detailed in table 2.5 & 2.6.

Table 2.5: Existing Products

Sl.No. Existing Product Name Manufacturing Qty in MT/Annum

1 Ambroxyl Hcl 47

2 Anatrazole 0.1


4 Paclitaxel 0.1

5 Temezdomide 0.1

6 Bicalutamide 0.5


8 Cisplatin 0.1

9 Carboplatin 0.35

10 Co-Enzyme Q10 18


12 Oxoplatin 0.05


60

14 Total 126.8

Table: - 2.6 The API’s & Intermediates Proposed To Be Manufactured

S.NO Existing Product Name Manufacturing Qty as per CFO in

MT/Year


Manufacturing Qty in MT/Year

1 Ambroxyl Hcl 47 Ambroxol HCl 10

2 Anatrazole 0.1 Anasrozole 0.1

3 Gemcitabine Hcl 0.1 Gemcitabine HCl 0.1

4 Paclitaxel 0.1 Paclitaxel 0.1

5 Temozolabide 0.1 Temozolabide 0.1

6 Bicalutamide 0.5 Bicalutamide 0.5

7 Irinotecon Hcl Trihydrate 0.1 Docetaxel Trihydrate 0.1



60

9 Cisplatin (To be deleted )

0.1 Bendamustine hcl 0.2



10 Carboplatin (To be deleted )

0.35 Bortzomib 0.005

11 Co-Enzyme Q10 (To be deleted )

18 Capacitabine 60

12 Docetaxel Trihydrate (To be deleted )

0.1 Imatinib 5

13 Oxoplatin (To be deleted )

0.05 Lenalidomide 0.5

14 Letrozole 0.05

15 PMD 0.25

16

Decitabine 0.01

17 Cytrabine 0.05

18 Cabazitaxel 0.01


20 Cloferabine 0.01

21 Melphalan 0.025


23 Tenfovir 50

24 PMK 0.25

25 Erlotonib 2

26 Emtricitabine 1


28 Elvitegravir 1

29 Cobicistat 100

30 Busulfan 0.05





35 Abiraterone acetate 2

Total 126.8

422.415



2.7.2 DETAILED MANUFACTURING PROCESS DESCRIPTION

The manufacturing process for typical product proposed to be produced is described with stoichiometric and gravimetric balances along with process description and material balance flow charts as under.

The manufacturing process for all the products proposed to be produced is submitted during TOR time in pre feasibity report.

REACTION SCHEME

1.Ambroxol HCl



PROCESS FLOW CHART

2-amino-3,5-dibromo benzaldehyde 342 kg

Trans -4- amino cyclohexanol

214 kg

Methanol

2565 kg

Sodium borohydride

65 kg

Water 400 kg

Carbon 4 kg

SS Reactor

Centrifuge

SS Reactor

Acetone

2376 kg Carbon 4 kg

Drier

Ambroxol HCl 500 kg

Filter

GL Reactor

Hydrochloric acid 128 kg

1st stage

Ambroxol HCl base 458 kg

Centrifuge

2nd stage

Distillation

Solvent methanol recovered from reaction

2536 kg

loss 29 kg

Process wastewater 562 kg

Solvent acetone recovered from

reaction 2347 kg

loss

49.0 kg

Slurry

Water

20 kg


Mother liquor

Centrifuge

Dillute Hcl 81 kg

Ambroxol HCl



PROCEDURE

The process involves 2 steps.

1st stage 2-amino-3,5-dibromobenzaldehyde is condensed with trans-4-amino cyclohexanol in the presence of solvent methanol to get trans-4-[(2-amino-3,5-dibromobenzyl)amino] cyclohexanol of ambroxol hydrochloride. The above trans-4-[(2-amino-3,5-dibromobenzyl)amino] cyclohexanol on reaction with sodium borohydride & in the presence of water forms ambroxol HCl base. 2nd stage Ambroxol base is converted into crude ambroxol HCl in the presence of acetone and carbon which is then purified to get ambroxol HCl pharma grade. HCl is used for pH adjustment. Cycle time

Particulars Time (hrs)

1st stage 2nd stage

Reaction 24 – 26 10 - 12

Isolation and centrifugation 4 – 6 4 - 6

Solvent recovery 8 – 10 8 – 10

Total process time 36 – 42 22 - 28

Materail Balance

Stage - I

Input Qty/batch (kg)

Reactors Output Qty/batch (kg)

2 amino 3,5 dibromo benzaldehyde

342 SS Reactor

Output from 1st stage 458

Solvent methanol

recovered from reaction 2536

Trans -4- amino cyclohexanol 214 loss 29

Sodium borohydride 64

Methanol 2565

Water 400 Process wastewater 562

Total input 3585 Total output 3585



Stage - II



Output from 1st stage 458 SS Reactor

Ambroxol HCl 500

Acetone 2376 Carbon 4

Hydrochloric acid 128 Solvent acetone


loss 29

Carbon 4 GL Reactor

Diluted HCl 81

Water 20 Process wastewater 25

Total input 2986 Total output 2986

Applications Ambroxol is a secretolytic agent used in the treatment of respiratory diseases associated with viscid or excessive mucus. It is the active ingredient of Mucosolvan, Lasolvan or Mucoangin. The substance is a mucoactive drug with several properties including secretolytic and secretomotoric actions that restore the physiological clearance mechanisms of the respiratory tract which play an important role in the body’s natural defence mechanisms. It stimulates synthesis and release of surfactant by type II pneumocytes. Surfactants acts as an anti-glue factor by reducing the adhesion of mucus to the bronchial wall, in improving its transport and in providing protection against infection and irritating agents. Ambroxol is indicated as “secretolytic therapy in bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport. It promotes mucus clearance, facilitates expectoration and eases productive cough, allowing patients to breathe freely and deeply. Ambroxol also provides pain relief in acute sore throat. Pain in sore throat is the hallmark of acute pharyngitis. Sore throat is usually caused by a viral infection. The infection is self limited and the patient recovers normally after a few days. What is most bothering for the patient is the continuous pain in the throat maximized when the patient is swallowing. The main goal of treatment is thus to reduce pain. The main property of Ambroxol for treating sore throat is the local anaesthetic effect, described first in the late 1970s, but explained and confirmed in more recent work. Ambroxol is a very potent inhibitor of the neuronal Na+ channels. This property led to the development of a lozenge containing 20 mg of ambroxol. Many state-of-the-art clinical studies have demonstrated the efficacy of Ambroxol in relieving pain in acute sore throat, with a fast onset of action and a long duration of effect of at least 3 hours. Additional anti-inflammatory properties of Ambroxol are of clinical relevance since treatment lead to a marked reduction of redness of the patient’s sore throat.



REACTION SCHEME

2. Anastrozole



PROCESS FLOW CHART

1st stage

,,,,-tetramethyl-5-(methyl)-1,3- benzenedi- acetonitrile

4 kg

Acetonitrile 15 kg

Water

5 kg

Output from 1st stage

4 kg

N- bromosuccianmide

3.3 kg

Distillation

GL Reactor

Ethyl acetate 15 kg

Centrifuge Centrifuge

Drying

Layer separation Process wastewater 6 kg

Hydrobromic acid - succinamide 2.3 kg scrubbung

Organic layer

Acetonitrile recovered 14 kg

loss 1 kg

Reaction mass Cyclohexane

2.5 kg

Distillation

Cyclohexane recovered 2.25 kg

loss 0.25 kg

Ethyl acetate recovered 14 kg

loss 1 kg



2nd stage

Process wastewater

6 kg

1,2,4-triazole

1.25 kg

GL Reactor

Sodium corbonate carbonate

2.5 kg


Output from 1st stage

4 kg

Output from 2nd stage

2.25 kg

Acetone

20 kg

Drying

Distillation

Ethyl acetate

5 kg

HCl

0.25 kg

Sodium chloride

1.25 kg water mix

GL Reactor

Filter

Acetone recovered 17 kg

loss 3 kg

Ethyl acetate recovered 4 kg

loss 1 kg

Water

2 kg



3rd stage

Sodium carbonate

1 kg

Anastrozole

1 kg

GL Reactor

Ethyl acetate 5 kg

Ethyl acetate layer

Layer separation

Distillation

Water

5 kg

Output from 2nd stage

2.25 kg

Cyclohexane

2.5 kg


Drying


Sodium chloride water mix

1.25 kg

Ethyl acetate recovered 4.5 kg

loss 0.5 kg

Reaction mass

Distillation

Cyclohexane recovered 2.25 kg

loss 0.25 kg



PROCEDURE

The process involves 3 steps.

1st stage

,,,, tetra methyl-5-(methyl)-1,3-benzene diacetontrile is charged in acetonitrile. N-bromosuccinimide is then added to the reaction mass & heated to 50 – 600 C for 4 hrs to complete the reaction. Then the product is extracted in ethyl acetate followed by washing with water. Ethyl acetate is distilled and product (1st stage) is crystallized in cyclohexane, centrifuged and dried to get the output from 1st stage. 2nd stage

The output from 1st stage is dissolved in acetone to which potassium carbonate and 1,2,4 triazole are added at 40 – 500 C for 2 hrs to complete the reaction. Potassium bromide salt formed is filtered; acetone is distilled to get the residue. Ethyl acetate is added to dissolve completely. Anastrozole hydrochloride is formed by adding hydrochloric acid which is cooled and filtered to get HCl salt of anastrozole. 3rd stage

Anastrozole hydrochloride is basified in water and sodium carbonate. It is then extracted in ethyl

acetate, & then washed with water. Ethyl acetate is separated and distilled and the product is

isolated by adding cyclohexane. The product is then centrifuged and dried to get pure

anastrozole.

Cycle time

Particulars Time (hrs)

1st stage 2nd stage 3rd stage

Reaction 8 - 10 6 – 8 6 – 8

Isolation & centrifugation 8 - 12 6 – 8 8 - 12

Solvent recovery 1 - 2 2 - 3 1 - 2

Total process time 17 - 24 14 - 19 15 - 22



Materail Balance

Stage – I



a,a,a,a,-tetramethyl-5-(methyl)-1,3- benzenedi- acetonitrile

4 GL Reactor Output from 1st stage 4

Hydrobromic acid – succinamide scrubing

2.3

Solvent

1) Ethyl acetate


loss 1

2) Cyclohexane

Acetonitrile 15 recovered from reaction 2.25

N- bromosuccianmide

3.3 loss 0.25

3) Acetonitrile

Ethyl acetate 15 recovered from reaction 14

Water 5 loss 1

Cyclohexane 2.5 GL Reactor Process wastewater 6

Total input 44.8 Total output 44.8

Stage – II



Output from 1st stage 4 GL Reactor

Output from 2nd stage 2.25

ØSodium chloride 1.25

1,2,4-triazole 1.25 Solvent

Sodiumcorbonate carbonate

2.5 1) Acetone

Acetone 20 Ø recovered from reaction 17

Water 2 Ø loss 3

Ethyl acetate 5 2) Ethyl acetate

Hydrochloric acid 0.25 Ø recovered from reaction 4

Ø loss 1



GL Reactor

Process wastewater 6

Total 35 Total output 35

Stage –III



Output from 2nd stage 2.25 GL Reactor

Anastrozole 1

2 no.s sodium chloride water mix 1.25

Water 5 Solvent

Sodium carbonate 1 1) Ethyl acetate

Ethyl acetate 5 recovered from reaction 4.5

Cyclohexane 2.5 loss 0.5

2) Cyclohexane

recovered from reaction 2.25

loss 0.25

Process wastewater 6

Total input 15.75 Total output 15.75

Applications

Anastrozole (Arimidex®) is a prescription medication used to treat breast cancer in

postmenopausal women. Specific anastrozole uses include treating postmenopausal women

with:

Early breast cancer that is hormone receptor-positive. It is used after breast cancer surgery with or without radiation. This is known as adjuvant therapy, or treatment that is used to help prevent the cancer from returning (see Adjuvant Therapy for Breast Cancer).

Advanced or metastatic breast cancer that is either hormone receptor-positive or the hormone receptor status is not known.

Advanced breast cancer that has not responded to tamoxifen (Nolvadex®, Soltamox®).

Note:-Detailed manufacturing process details with gravemetric balance chart & process flow chart of all products is submitted in pre feasibility report during TOR time. Now only two products typical process details is shown above.



2.7.3 RESOURCE OPTIMIZATION/RECYCLING AND RE-USE ENVISAGED IN THE INDUSTRY

2.7.3.1 SOLVENT RECOVERY & RE-USE

Various solvents are proposed to be used during the process of manufacture of APIs &

Intermediates. The solvents proposed to be recovered and recycled during the process of

manufacture of each product are detailed in table 2.7.

Table 2.7: Solvent recovery

S. No

Name of the Product

Stage Name of the solvent

Solvent Kg (Per Batch)

Used Recovered Loss

1 Ambroxol HCl I Methanol 2565 2536 29

II Acetone 2376 2347 29

2 Anastrozole

I

Acetonitrile 15 14 1

Ethyl acetate 15 14 1

Cyclohexane 2.5 2.25 0.25

II Acetone 20 17 3

Ethyl acetate 5 4 1

III Ethyl acetate 5 4.5 0.5

Cyclohexane 2.5 2.25 0.25

3 Gemcitabine HCl

I Methanol 117 111 6

II Methanol 90 84 6

III Acetic acid 240 237 3

4 Paclitaxel

I

Methanol 15.6 15 0.6

Ethyl acetate 22.5 22 0.5

II

MDC 17.45 54 0

Acetone 5.27

Petroleum ether 32.7

III Methanol 9.36 8 1.36

IV

MDC 4.85 4.5 0.35

Acetone 1.38 8.9 0.18

Petroleum ether 7.7

5 Temozolomide I -- -- -- --

II Acetone 16 15.4 0.6

6 Bicalutamide I Acetonitrile 100 97 3

IPA 10 8 2



7 Docetaxel trihydrate

I Acetonitrile 20 14 6


II

MDC 24 20 4

Acetone 24 22 2

Petroleum ether 60 54 6

III Methanol 24 20 4

8 3a,7B-Dihydroxy

Cholanic Acid

I Methanol 952.4 948.6 3.8

II Ethyl acetate 1071.4 1065.5 5.95

III -- -- -- --

IV 2M enol 3809.5 3807.61 1.9

V MDC 512 504.6 7.4

VI Butanol 4523.8 4516.2 7.6

9 Bendamustine HCl I -- -- -- --

10 Bortezomib

I MDC 0.2 0.15 0.05

II Methanol , EA 0.45 2.3 2.7

n-Heptane 2 1.5 0.5

III Methanol 0.039 0.039 0

11 Capecitabine

I

Toluene 30 29 1

MDC 50 49 1

Isopropyl alcohol 50 50 0

II MDC 25 25 0

Heptane 50 50 0

III

Toluene 90 89 1

MDC 25 24 1

Methanol 35 34 1

12 Imatinib mesylate I MDC 100 100 0

Methanol 50 50 0

13 Lenalidomide I Dimethyl sulphoxide

5 4.9 0.1

14 Letrozole

I Aceto niotrile 15 14.5 0.5

Hexane 3 2.5 0.3

II Ethyl acetate 10 9.5 0.5

DMF 3 2.7 0.3

15 Pemetrexed disodium I

MDC 38.5 36.8 1.7

DMF 10.2 9.5 0.7

II -- -- -- --

III Acetone 30.8 30 0.8

16 Dicitabine I Methanol 60.8 60 0.8

II MDC 121.6 100 21.6



III MDC 203 160 43

HMDS 23 18.5 4.5

IV -- -- -- --

V Methanol 76 44 32

17 Cytrabine I

DMF 20 20 0

Methanol 25 25 0

II

t-butylamine 0.18 0 0.18

Methanol 2.15 0 2.15

18 Cabazitaxel

I

DMF 2.19 0 2.19

Methanol 18.43 0 18.43

Diisopropyl ether 21.02 21.02 0

Tetrahydrofuran 8.86 8.86 0

Acetone 1.57 1.57 0

II

Ethyl acetate 21.45 21.45 0

Ethanol 9.16 9.16 0

Hexanes 5.58 5.58 0

III

Diisopropyl ether 30.97 30.97 0

Methanol 4.63 4.63 0

IV Methanol 16.28 16.28 0

19 Acebrophylline

I Methanol 910 895 15

II DMF 1065 0 15

Hexanes 5350 5330 10

20 Clofarabine

I Ethyl Acetate 30.98 0 30.98

Hexane 15.61 0 15.61

II Methanol 34.8 0 34.8

III Hexane 38.6 32 6.6

Ethyl Acetate 24.11 20 4.11

IV Methanol 46.28 0 46.28

21 Melphlan HCl

I Acetic Acid 164.6 152 12.6

II MDC 50 40 10

Ethyl Acetate 63.6 50 13.6

III Methanol 100 80 20

MDC 48 30 18

IV

Toluene 23 18 5

MDC 1024 1020 4

Methanol 2.6 1.5 1.1

1-Heptane 396.2 390 6.2

22 Cyclophosphamide I

Toluene 6.85 5 1.85

Acetone 5.43 5.2 0.23



II

Toluene 13.08 12.8 2.08

n-Heptane 10.34 8.2 2.14

III

MDC 37.23 36.8 0.43

Ethyl Acetate 36.8 35.8 1

n-hexane 13.14 12.2 0.94

23 Tenofovir

I

DMF 3850 3700 150

MDC 21900 21890 10

1,2-Propylene carbonate 520 520 10

II


MDC 1050 940 10

24 Pemetrexed dipotassium

I

MDC 1506.6 1506.6 0

DMF 39.9 32 7.9

II Ethanol 18.94 10 8.94

Ethanol 37.9 28.5 9.4

25

Erlotinib

I Ethyl Acetate 690 630 60

Hexane 200 190 10

II

Toluene 350 345 5

Ethyl Acetate 175 190 5

Toluene 2560 2580 10

IV IPA 32.5 32.5 0

26 Emtricitabine

I

DMF 400 380 20

Dichloromethane 7792.5 7713 79

Hexane 2262.5 2150 113

Tri ethyl amine 437.5 415 21


Toluene 1382.5 1313 69.5


II

Ethanol 3655 3550 105


1-Propanol 2600 2525 75

27 Dimethyl Fumarate

I Methanol 2222.182 2199.8 22.2

II Methanol 5333.33 5300 33.33

28 Elvitegravir

I

Toluene 773.178 695 78

Iso Propyl Alcohol 1030.904 928 104

n-Heptane 1546.356 1392 154

MDC 1030.904 927.8 102

II

THF 1288.63 1160 129

MDC 1700.991 1530 170

IPA 850.4957 766 85



n-Heptane 1133.994 1020 113

III

THF 3827.231 3444.508 383

n-Heptane 2577.26 2319.534 257.31

Ethyl acetate 1288.63 1159.767 129

IV Toluene 1340.175 1206 134

n-Heptane 1608.21 1447 161

V Toluene 2063.87 1857 207

IPA 247.4169 222 25

VI IPA 96.48 2238 249

29 Busulfan I Acetone 26.3 21.3 5

II Acetone 99.2 86.7 12.5

30 Cobocistat

I

Toluene 11.01 9 2.01

Ethyl Acetate 63.25 59.5 3.75

Heptane 10.75 6.8 3.95

THF 7.31 7.31 0

Acetic Acid 12.65 12 0.65

II Toluene 61.63 54.03 7.6

MDC 47.11 35.11 12

III MDC 142.58 120.58 22

THF 108.64 81.64 27

IV IPA 20.76 20.76 0

V MDC 70.04 55 15.04

VI

MDC 43.35 31.35 12

Acetone 24.4 18.4 6

Ethanol 4.29 0 4.29

VII MDC 89.18 89.18 0

HEptane 73.82 73.82 0

31 Zolodranic Acid

I

Isopropyl alcohol (IPA)

17.2 14 3.2

MDC 24.6 18 6.6

Triethylamine (TEA) 10.34 9.1 1.24

II Methanol 10.2 7.5 2.7

Acetone 11.8 9.2 2.6

III Chlorobenzene 7.3 6 1.3

Acetone 78 72 6

32 Tranexamic acid V Acetone 1401 1401 0

33 Sunitinib Malate I

Toluene 6.58 5.92 0.66

DCM 45.47 45.47 0

1 Mixed solvent(toline,hexane

34.73 25.5 9.23

II Methanol 16.79 13.43 3.36



III MEK 13.23 10.58 2.65

34 Sorafenib Tosylate I DCM 4 1.5 2.5


Toluene 25.2 24.5 0.7

Hexane 9.53 7.5 2.5

II Methil ethyl ketone 33.7 24 9.7

III Methil ethyl ketone 16.4 14 2.4

I Ethanol 789 789 0

II

MDC 1584 1492 92

Methanol 158.4 0 158.4

IPA 550.2 550.2 0

III IPA 360.1 360.1 0

IV MDC 792 396 396

N.Hexane 52.4 31.44 20.96

IVPurification

Acetone 795.2 707.6 66.8

MDC 633.6 316.8 316.8

N-Hexane 104.8 31.44 74.98

Ethanol 410.5 410 0

124222.9566 119512.988 5974.51

Note: * The solvent lost during the process of solvent distillation is mainly due to organic thermal disintegration and in form of residue left behind from the bottom un-distilled product.

2.7.3.2. STORAGE OF SOLVENTS

Solvents like Toluene and Methanol will be received in tankers. The same will be stored in above

ground storage tanks. The solvent storage tanks shall be provided with Dykes. The storage tanks

will be provided with condensers to prevent fugitive emissions, and flame arrestors. The solvents

will be transferred to production blocks by pipelines. Highly volatile solvents like Ethylene

dichloride will be received in drums (MS\HDPE). The same will be stored on a platform provided

with Concrete floor and collection pits. The solvents will be transported to production block by

means of drum trolley.



I. DETAILS OF BULK STORAGE OF SOLVENTS, SAFETY MEASURES, EVAPORATION LOSS

PREVENTION AND CONTROL.

SN SOLVENT MODE OF STORAGE

SAFETY SYSTEMS

MEASURES TO AVOID LOSS AND CONTROL OF EVAPORATION

1. METHYLENE CHLORIDE

DRUMS No dispensing in storage area. Secondary containment Spill and leak control kit Organic vapour detectors Stored at 200C

No dispensing of solvent is carried out in storage area. Required quantities are issued in sealed drums.

2. 2-ETHOXY BENZOYL CHLORIDE

DRUMS No dispensing in storage area. Secondary containment Spill and leak control kit Organic vapour detectors


3. n-METHYL PIPERAZINE



4. 2-METHOXY ETHANOL



5. METHANOL ABOVE GROUND

Breather valve followed by flame arrester.

Enclosed dispensing system. Pumps with double mechanical seal.



Non contact level indicator.

6. TOLUENE ABOVE GROUND

Breather valve followed by flame arrester. Non contact level indicator.


7. HEXANE. ABOVE GROUND



8. ACETIC ACID ABOVE GROUND



9. ACETIC AN HYDRIDE.

ABOVE GROUND



2.7.3.3 SOLVENT RECOVERY SYSTEM

After the reaction is complete the solvents are recovered in a distillation unit. The distillation unit has two condensers in series (shell and tube type). The first condenser is passed with chilled cooling tower water at 7-12 oC, while the second

condenser will be passed with chilled brine solution at -10 - 200 C as coolants. After the vapors are condensed, the condensate along with un-condensed vapors is

passed through a trap which is cooled externally with chilled water. The vents of condenser and receiver are connected to scrubber system. All the reaction vessels and centrifuges are connected to a common line. These fumes and

exhausts are sucked by ID fan and scrubbed by alkali solution. The air after scrubbing is let out into the atmosphere and the scrubbed water is sent to

ETP for further treatment. This wet scrubber absorbs acidic vapors, traces of solvents etc. and purified gas stream is

let out into the atmosphere.



Fig 2.2 Typical solvent recovery system

The details of different by-products generated during the process of manufacture of APIs & intermediates are given in the following table

Table: - 2.8 Quantity of by-products generated in kg

S. No

Name of the Product

Stage

By Product Quantity No. of

Batches/ month

By Product

generated Qty per

Month

By Product

generated Qty per

Year

Method of disposal

1 3a,7B-

Dihydroxy Cholanic Acid

II potasium acetate

595 20 11900 142800 Proposed to sale

IV Caustic potash lye solution

711.35 20 14227 170724 Proposed to sale

2 Capacitabine I Tin salt 20 50 1000 12000 Proposed to sale

II Pyridine Hcl

6.4 50 320 3840 Proposed to sale

3 Decitabine II Pyridine HCl 40.4 1.7 68.68 824.16 Proposed to sale

Condenser 2

Condenser 1

Chilled water

Cooling tower water

Distillation

column

Receiver

To scrubber

Recovered solvent

Residue to storage



2.7.4 RAW MATERIALS REQUIRED

2.7.4.1 QUANTITY REQUIREMENT

The raw materials required for the manufacture of Aromatic Chemicals are appended in the table

2.9 below. Raw materials as listed will be procured as per the production requirement.

Table 2.9: Raw materials requirement

Sl. No.

Product Raw materials Quantity required Solvents required

after recycling

kg/annum

Kg/Batch Kg/Month Kg/Annum

Active Parmaceauticals Ingradiants (API’S)

1

AMBROXYL HCL


342 581.4 6976.8


214 363.8 4365.6

Sodium borohydride 64 108.8 1305.6

Methanol 2565 4360.5 52326 69

Acetone 2376 4039.2 48470.4 69

Hydrochloric acid 128 217.6 2611.2

Activated Carbon 43 73.1 877.2


342 581.4 6976.8


214 363.8 4365.6

Sodium borohydride 64 108.8 1305.6

Methanol 2565 4360.5 52326

Acetone 2376 4039.2 48470.4

2 ANASTROZOLE

a,a,a,a,-tetramethyl-5-(methyl)-1,3- benzenedi- acetonitrile

10 80 960

Acetonitrile 15 120 1440 1

N- bromosuccianmide 8.25 66 792

Ethyl acetate 25 200 2400 2.5

Cyclohexane 5 40 480 0.25

1,2,4-triazole 3.125 25 300



Potassium carbonate 6.25 50 600

3 GEMCITABINE HCl

Methanol 117 351 4212 6

Ammonia 25% 67.8 203.4 2440.8

Methanol 90 270 3240 6

Carbon 1.2 3.6 43.2

HCl 4.8 14.4 172.8

Output from 2nd stage 4.5 13.5 162

Acetic acid 240 720 8640 3

HCl 4.8 14.4 172.8

4

PACLITAXEL

TxL RM 2 16.6 199.2

Zinc 3.75 31.125 373.5

Methanol 15.6 129.48 1553.76 0.6

Acetic acid 20 166 1992

Ethyl acetate 22.5 186.75 2241 0.5

MDC 17.45 144.835 1738.02 0

Acetone 5.27 43.741 524.892 0

Petroleum ether 32.7 271.41 3256.92 0

Methanol 9.36 77.688 932.256 1.36

MDC 4.85 40.255 483.06 0.35

Acetone 1.38 11.454 137.448 0.18

Petroleum ether 7.7 63.91 766.92

TxL RM 2 16.6 199.2

5 TEMOZOLOMIDE

5-amino-1-(n-methyl carbomyl) imidazole-4-carboxamide

4 32 384

Water 24 192 2304

Sodium nitrite 1.6 12.8 153.6

Tartaric acid 3.2 25.6 307.2

Acetone 16 128 1536 0.6

Carbon 0.2 1.6 19.2

6 BICALUTAMIDE

N-[4-cyano-3-trifluoromethyl phenyl]-3-[4-fluorophenyl thio]-2-hydroxy-2-methyl propanamide

12 60 720




Potassium permanganate

5 25 300

Isopropyl alcohol 10 50 600 2

7 DOCETAXEL TRIHYDRATE

CN1 2 16 192


6N HCl 0.84 6.72 80.64

Saturated sodium bicarbonate solution in water 10 kg in 12 L water

44 352 4224

Ethyl acetate 30 240 2880 4

Sodium chloride 0.6 4.8 57.6

Sodium sulfate 2 16 192

Methylene di chloride (MDC)

24 192 2304 4

Acetone 24 192 2304 2

Petroleum ether 60 480 5760 6

Methanol 24 192 2304 4

8

3A,7B-DIHYDROXY CHOLANIC

ACID

Methanol 952.4 19048 228576 23.8

Methylcholonate 595 11900 142800

Ethyl acetate 1071.4 21428 257136 5.95

Sodium carbonate 238 4760 57120

Acetic anhydride 357 7140 85680

Sodium hypochloride 952.4 19048 228576

Acetic acid 76 1520 18240

2M enol 3809.5 76190 914280 11.9

HzHz 500 10000 120000

KOH 357 7140 85680

Sodium bromate 95 1900 22800

MDC 512 10240 122880 17.4

Sodium metal 333.3 6666 79992

Hydrochloric acid 130.95 2619 31428

Butanol 4523.8 90476 1085712 47.6

9 BENDAMUSTINE HCL

Ethyl-4-(5-(bis(2-hydroxy ethyl) amino)-1-methyl-1H-benzoid) imidazol-2-yl)butanoate

5 70 840

Thionyl chloride 20 280 3360



10

BORTEZOMIB

R-borolex-(+)-pinanediol trifluoro acetic acid

0.045 1.8765 22.518

n-hydroxy succinamide

0.02 0.834 10.008

MDC 0.2 8.34 100.08 0.05

Disopropyl amine 0.04 1.668 20.016

1N HCl 0.5 20.85 250.2

Saturated sodium bicarbonate

0.5 20.85 250.2

Methanol 0.6 25.02 300.24

Methanol 0.1 4.17 50.04

0.5 MDC 0.2 8.34 100.08

Ethyl acetate 0.5 20.85 250.2

n-Heptane 2 83.4 1000.8

Isobutyl boronic acid 0.015 0.6255 7.506

1N HCl 0.5 20.85 250.2

Sat. sodium bicarbonate

0.5 20.85 250.2

Methanol 0.039 1.6263 19.5156 0

11 Capacitabine 5-methyl tetrahydrofuran-2,3,4-triyl triacetate

15 750 9000

Toluene 30 1500 18000 1

Hexa methyl disaline (HMDS)

15 750 9000

5-fluorocytosine 10 500 6000

Tetra methyl silyl chloride (TMSC)

0.5 25 300

Methylene di-chloride (MDC)

50 2500 30000 3

Sodium bicarbonate 15 750 9000

Water 30 1500 18000

Stannic chloride 16 800 9600

Isopropyl alcohol 50 2500 30000 2



Methylene di chloride (MDC)

25 1250 15000 5

N-pentyl chloroformate

11 550 6600

Pyridine 6 300 3600

Heptane 50 2500 30000 3

Methanol 35 1750 21000 2

MDC 25 1250 15000 3

Toluene 90 4500 54000 3

Hydrochloric acid 5 250 3000

Sodium hydroxide 2 100 1200

12

IMATINIB MESYLATE

4-methyl-N3-(5-pyridin-3yl pyrimidine-2-yl) benzene-1,3-diamine

10 417 5004

4-(4-methyl-piperazin-1-yl-ethyl)benzoic acid dihydrochloride

10 417 5004

Methylene dichloride (MDC)

100 4170 50040 5

Triethyl amine 20 834 10008

Hydroxy benzotriazole 6 250.2 3002.4

Methanol 50 2085 25020 3

Methane sulphonic acid

2 83.4 1000.8

Carbon 1 41.7 500.4

13 LENALIDOMIDE

Methanol 4 166.8 2001.6 1

4-nitropthalide 1 41.7 500.4

Raney nickel catalyst 0.1 4.17 50.04

Dimethyl sulphoxide 5 208.5 2502 0.1

L-glutamine 1 41.7 500.4

N,N, carbomyl diimidazole

3 125.1 1501.2

Carbon 0.1 4.17 50.04

14 LETROZOLE p-tolunitrile 3 12.6 151.2

n-bromosuccinamide 2.5 10.5 126

Aceto nitrile 15 63 756 0.5

Hexane 3 12.6 151.2 0.3

1,2,4-triazole 1 4.2 50.4



Dimethyl formamide 3 12.6 151.2 0.3

Potassium carbonate 3 12.6 151.2

Ethyl acetate 10 42 504 0.5

15 PEMETREXED DISODIUM

4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzolic acid

1.56 32.448 389.376

N-methyl morphalane 1.16 24.128 289.536

DMF 10.2 212.16 2545.92 0.7

MDC 38.5 800.8 9609.6 7.7

2-chloro-4,6-dimethoxy-1,3,5-triazine

1 20.8 249.6


Sodium hydroxide 1 20.8 249.6

Water 25 520 6240

Acetone 30.78 640.224 7682.688 0.8


Sodium hydroxide 1 20.8 249.6

16

Decitabine

2-Deoxy ribose 7.6 12.92 155.04

Methanol 60.8 103.36 1240.32 10.8

Acetyl chloride 0.38 0.646 7.752

Sodium bicarbonate 4 6.8 81.6

MDC 121.6 206.72 2480.64 21.6

Acetyl Chloride 19.1 32.47 389.64

Pyridine 19.3 32.81 393.72

Conc. HCl 3.8 6.46 77.52

Sodium Bicarbonate 3.8 6.46 77.52

Sodium Sulphate 5 8.5 102

5- Azacytocine 4.6 7.82 93.84

Ammonium Sulphate 0.28 0.476 5.712

HMDS 23 39.1 469.2 4.5

TMS triflate 14.6 24.82 297.84

MDC 203 345.1 4141.2 43

Sodium Sulphate 10 17 204

Isopropanol 41.6 70.72 848.64

Sodium Carbonate 3.3 5.61 67.32

Sodium bicarbonate 19.5 33.15 397.8



Metahnolic Ammonia 80 136 1632

Dimethyl Sulfoxide 5.5 9.35 112.2

Methanol 76 129.2 1550.4

Activated Char Coal 0.5 0.85 10.2

17 Cytrabine Cytidine 1 13 156

Di Methyl Formide 20 260 3120 20

Methanol 25 325 3900 25

Phosphoryl Chloride 5.67 73.71 884.52

t-butylamine 0.18 2.34 28.08 0.18

Methanol 2.15 27.95 335.4 2.15

18

Cabazitaxel

10-DAB-III 1 2.1 25.2

Dimethylsulphate 6.96 14.616 175.392

Sodium hydride (60% w/w)

0.22 0.462 5.544

Calcium hydirde 0.02 0.042 0.504

Tetrahydrofuran 8.86 18.606 223.272 8.86

30% Ammonium chloride solution

10 21 252

Diisopropyl ether 21.02 44.142 529.704 21.02

Acetone 1.57 3.297 39.564 1.57

DMF 2.19 4.599 55.188 2.19

Methanol 18.43 38.703 464.436 18.43

Oxazolidinesidechain 0.7 1.47 17.64

N,N'-Dicyclohexylcarbodiimide

0.73 1.533 18.396

4-Dimethylaminopyridine

0.05 0.105 1.26

Ethyl acetate 21.45 45.045 540.54 21.45

Ethanol 9.16 19.236 230.832 9.16

Hexanes 5.58 11.718 140.616 5.58

NaCl solution 30 63 756

p-Toluenesulfonic acid Monohydrate

0.07 0.147 1.764

Diisopropyl ether 30.97 65.037 780.444 30.97

Methanol 4.63 9.723 116.676 4.63

Methanol 16.19 33.999 407.988 0



19 Acebrophylline

2 – amino 3,5-dibromo benzaldehyde

150 495 5940

Trans-4-amino cyclohexanol

62.5 206.25 2475

Sodium borohydride 22.5 74.25 891

Methanol 910 3003 36036 15

Dimethyl formamide (DMF)

1065 3514.5 42174 15

Ethyl acetate 5350 17655 211860 40

Thiophylline-7-acetic acid

128 422.4 5068.8

20

Cloferabine

2-deoxy-2-â-fluoro-1,3,5-tri-O-benzoyl-1-R-D-ribofuranose

2.33 4.66 55.92

HBr in AcOH (30 wt %) 4.06 8.12 97.44

Dichloromethane 30.98 61.96 743.52 30.98

Sodiumbicarbonate 104.87 209.74 2516.88

Sodium sulphate 0.23 0.46 5.52

Hexane 15.61 31.22 374.64 15.61

2-Chloro adenine 1 2 24

Butyric anhydride 5.6 11.2 134.4

N-methyl imidazole 2.57 5.14 61.68

Methanol 34.8 69.6 835.2

Bromosugar (Stage-IA)

1.87 3.74 44.88

Potassium tert-butoxide

0.45 0.9 10.8

Calcium hydride 0.17 0.34 4.08

t-amyl alcohol 9.4 18.8 225.6

Anisole 2.87 5.74 68.88

Ethyl acetate 24.11 48.22 578.64 4.11

Saturated NaClsoln 9.6 19.2 230.4

Hexanes 38.6 77.2 926.4 6.6

Acetone 9.36 18.72 224.64

Celite 1.44 2.88 34.56

Sodium methoxide (30% w/w in methanol)

1.87 3.74 44.88

Methanol 46.28 92.56 1110.72 46.28



Acetic acid 0.17 0.34 4.08

Charcoal 0.14 0.28 3.36

Celite 2.14 4.28 51.36

21

MELPHALAN HCL

N-phthaloyl-p-nitro-L-phenylalanine

12.2 46.36 556.32

Acetic acid 164.6 625.48 7505.76 32.6

5 % Pd/C 1.22 4.636 55.632

Hydrogen gas cylinders

0 0 0

Methylene dichloride 50 190 2280 10

Celite 0.5 1.9 22.8

N-phthaloyl-p-nitro-L-phenylalanine

0 0 0

Thionyl chloride 4.3 16.34 196.08

Ethyl Acetate 63.6 241.68 2900.16 13.6

Methanol 100 380 4560 20

Methyl-N-phthaloyl-p-amino-L-phenylalanine

4.3 16.34 196.08

2-Chloroethanol 6 22.8 273.6

Di-isopropyl ethylamine

21 79.8 957.6

Dichloromethane 48 182.4 2188.8

Sodium sulphate 2 7.6 91.2

Methyl-N-phthaloyl-p-bis-(2-hydroxyethyl)-amino-L-phenylalanine

5.46 20.748 248.976

Phosphorous oxychloride

4.6 17.48 209.76

Toluene 23 87.4 1048.8 5

Dichloromethane 1024 3891.2 46694.4 374

Methanol 2.6 9.88 118.56 1.1

n-Heptane 396.2 1505.56 18066.72 36.2

Silica gel 47.4 180.12 2161.44

22 Tenfovir

3-(6-amino-9H-purin-9-yl)-1,1,1-trifluoropropan-2-ol

2100 132510 1590120

Sodium hydroxide 7.5 473.25 5679

1,2-Propylene carbonate

520 32812 393744 70



DMF 3850 242935 2915220 150

Lithium-t-butoxide 2890 182359 2188308

Diethyl p-toluenesulfonyl-oxymethylphosphonate

2100 132510 1590120

Acetic acid 440 27764 333168

MDC 21900 1381890 16582680 200


MDC 1050 66255 795060 150

Bromotrimethylsilane 980 61838 742056

Acetone 20 1262 15144

Acetonitrile 750 47325 567900 100

23 Cyclophosphamide

Diethanol amine 1 16.7 200.4

Thionyl chloride 3.38 56.446 677.352

Toluene 6.85 114.395 1372.74 1.85

Acetone 5.43 90.681 1088.172 0.23

Phosphorus Oxychloride

3.92 65.464 785.568

Toluene 13.08 218.436 2621.232 2.08

10% KH2PO4 Sol 22.83 381.261 4575.132


n-Heptane 10.34 172.678 2072.136 2.14

3-Aminopropanol 0.54 9.018 108.216

Triethylamine 1.47 24.549 294.588

Dichloromethane 37.23 621.741 7460.892

Ethylacetate 36.8 614.56 7374.72 8

n-Hexane 13.14 219.438 2633.256 4.94


24

PMK(PEMETREXED

DIPOTASSIUM )

4-(2-(2-amino-4,7-dihydro-4oxo-3H-pyrrolo[2,3-d]pyrimidine-5-yl)ethyl)benzoic acid

6 62.4 748.8

Dimethyl formamide 39.9 414.96 4979.52 7.9

N-methyl Morpholine 6.1 63.44 761.28



2-chloro-4,6 dimethoxy-1,3,5-triazine

3.9 40.56 486.72

L-Glutamic acid dimethyl ester hydrochloride

6.18 64.272 771.264

Methylene dichloride 156 1622.4 19468.8 26.6

Potassium bicarbonate

2.4 24.96 299.52

Potassium hydroxide 3.95 41.08 492.96

Conc. HCl 4.8 49.92 599.04

Activated Carbon 0.6 6.24 74.88

Celite 0.5 5.2 62.4

Potassium Acetate 21 218.4 2620.8

Ethanol 9.47 98.488 1181.856

Hydrochloric acid 1.09 11.336 136.032

Photassium hydroxide 0.21 2.184 26.208

Water 124.9 1298.96 15587.52

Potassium Acetate 42 436.8 5241.6

Ethanol 18.94 196.976 2363.712 8.94

Ethanol 37.9 394.16 4729.92 9.4

Hydrochloric acid 0.36 3.744 44.928

Photassium hydroxide 0.07 0.728 8.736

25 Erlotonib 4,5-bis(2-methoxyethoxy)-2-nitrobenzonitrile

42 281.4 3376.8

Sodium hydrosulfite 85%

84 562.8 6753.6

Con. HCl 160 1072 12864

50% Sodium hydroxide in water

80 536 6432

Sodium sulfate 10 67 804

Ethyl acetate 690 4623 55476 60

Hexane 200 1340 16080 40

Celite 1 6.7 80.4

Carbon 4.2 28.14 337.68

N,N-Dimethylformamide dimethyl acetal

35 234.5 2814

Toluene 350 2345 28140 35



Acetic acid 0.5 3.35 40.2

ET-RM-03 (17.5 Kg) 17.5 117.25 1407

Acetic acid (247 lit) 247 1654.9 19858.8 47

Ethyl acetate (175 lit) 175 1172.5 14070 45

25% Ammonia solution (230 lit)

230 1541 18492

Water (820 lit) 820 5494 65928

Toluene (2560 lit) 2560 17152 205824 90

IPA 675 4522.5 54270

Carbon 2.5 16.75 201

Celite 2.5 16.75 201

Methyl isobutyl ketone

675 4522.5 54270

IPA-HCl 32.5 217.75 2613

26 Emtricitabine (2R,5R)-5-Hydroxy-[1,3]-oxathiolane-2-carboxylic acid,2S-isopropyl-5R-methyl-1R-cyclohexyl ester

532.5 159.75 1917

Thionyl chloride 282.5 84.75 1017

DMF 400 120 1440 20

Dichloromethane 7792.5 2337.75 28053 779

5-fluorocytosine 237.5 71.25 855

HMDS 345 103.5 1242

Methane Sulfonic acid 5 1.5 18

Hexane 2262.5 678.75 8145 113

Tri ethyl amine 437.5 131.25 1575 21

Ethyl acetate 240 72 864 12

Toluene 1382.5 414.75 4977 69.5


Dibasic potassium phosphate 657.5

197.25 2367

Sodium borohydride 102.5 30.75 369

Ethanol 3655 1096.5 13158 905

Ethyl acetate 2900 870 10440 650

85% Phosporic acid 227.5 68.25 819

1-Propanol 2600 780 9360 375

Carbon 9.5 2.85 34.2

27 Elvitegravir 3-Chloro-2-Fluoro Benzoic Acid

257.726 1030.904 12370.848



Toluene 773.178 3092.712 37112.544 78

N,N-Dimethyl form amide

10.30904 41.23616 494.83392

Thionyl Chloride 307.209392

1228.837568

14746.05082

Alluminium Chloride Anhydrous

226.025702

904.102808

10849.2337

Methylene Dichloride 1030.904 4123.616 49483.392 102

1,3-Dimethoxy Benzene

224.22162

896.88648 10762.63776

Sodium Chloride 103.0904 412.3616 4948.3392

Saturated Sodium Bicarbonate Solution

1288.63 5154.52 61854.24

Concentrated Ammonium hydroxide

51.5452 206.1808 2474.1696

Iso Propyl Alcohol 1030.904 4123.616 49483.392 104

n-Heptane 1546.356 6185.424 74225.088 154

Tetra hydro Furan 1288.63 5154.52 61854.24 129

Sodium Borohydride Powder

50.25656 201.02624 2412.31488

BF3.THF 404.6298 1618.5192 19422.2304

Acetone 162.3624 649.4496 7793.3952

Sodium Hydroxide 74.74053 298.96212 3587.54544

Methylene Dichloride 1700.991 6803.964 81647.568 170

Sodium Chloride 85.04957 340.19828 4082.37936

Aluminium Chloride 141.7493 566.9972 6803.9664

Acetyl Chloride 85.04957 340.19828 4082.37936

Isopropyl Alcohol 850.4957 3401.9828 40823.7936 85

n-Heptane 1133.994 4535.976 54431.712 113

Output from Stage - II 255.1487 1020.5948 12247.1376

Tetra hydro Furan 3827.231 15308.924 183707.088 383

Potassium tertiary But oxide

354.3732 1417.4928 17009.9136

Diethyl Carbonate 466.484 1865.936 22391.232

Concentrated Hydrochloride

288.6531 1154.6124 13855.3488

Sodium Chloride 103.0904 412.3616 4948.3392

Ethyl Acetate 1288.63 5154.52 61854.24 129

n-Heptane 2577.26 10309.04 123708.48 257.31

Toluene 1340.175 5360.7 64328.4 134



Acetic acid 1.0825 4.33 51.96

N,N-Dimethyl Form amide Dimethyl Acetal

122.1621 488.6484 5863.7808

Sodium Chloride 80.4105 321.642 3859.704

Ethyl acetate 402.0525 1608.21 19298.52

n-Heptane 1608.21 6432.84 77194.08 161

Toluene 2063.87 8255.48 99065.76 207

(S)-2-Amino-3-methyl-1-butanol

75.51 302.04 3624.48

N,O-Bis (trimethylsillyl)acetamide

330.5851 1322.3404 15868.0848


Con.HCl (33.5%) 44.92 179.68 2156.16

45% KOH Solution 39.99 159.96 1919.52

Isopropyl alcohol 247.4169 989.6676 11876.0112 25

Hyflo 30.92712 123.70848 1484.50176

45%w/w KOH solution 115.719 462.876 5554.512

DM Water 1650.735 6602.94 79235.28

Isopropyl alcohol 2486.54 9946.16 119353.92

Acetic acid 79.5877 318.3508 3820.2096

High Flow 30.92711 123.70844 1484.50128


Isopropyl alcohol 2040.979 8163.916 97966.992 204

28 Dimethyl fumarate

Fumaric Acid 277.77 83.331 999.972

Acetyl Chloride 187.77 56.331 675.972

Methanol 2222.182 666.6546 7999.8552 222.2

Hyflow 27.77 8.331 99.972

Methanol 5333.33 1599.999 19199.988 533

29 Busulfan 1,4-butane diol 1.5 49.5 594

Methane sulfonyl chloride

3.2 105.6 1267.2

Triethyl amine 6.8 224.4 2692.8

Acetonitrile 11.3 372.9 4474.8

Acetone 26.3 867.9 10414.8 5

Acetone 99.2 3273.6 39283.2 12.5

Act Carbon 0.169 5.577 66.924

Celite 0.845 27.885 334.62



30 Cobicistat (S)-2-benzyl-N,N-dimethylazaridine-1-sulfonamide

6.33 26.586 319.032

2,2,6,6-trimethylpipyridine(TMP)

0.37 1.554 18.648

n-hexyl lithium in hexane

2.91 12.222 146.664

Acetic acid 12.65 53.13 637.56 12.65

Ethyl acetate 63.25 265.65 3187.8 13.75

Toluene 11.01 46.242 554.904 2.01

THF 7.31 30.702 368.424 7.31

Heptane 10.75 45.15 541.8 3.95

Diethylene triamine 4.34 18.228 218.736

10%Pd/C 0.15 0.63 7.56

Toluene 61.63 258.846 3106.152 7.6

Water 116.38 488.796 5865.552

Sodium hydroxide 0.84 3.528 42.336

DCM 47.11 197.862 2374.344 12

IPA.HC l 0.61 2.562 30.744

NaOH 0.75 3.15 37.8

DCM 142.58 598.836 7186.032 22

4-nitrophenyl(thiazol-5-yl)methyl carbonate

2.71 11.382 136.584

THF 108.64 456.288 5475.456 27

(L)-Methionine 4.4 18.48 221.76

Bromoaceticacid 4.39 18.438 221.256

IPA 20.76 87.192 1046.304 0

IPA.HCl 4.4 18.48 221.76

MTBE 2.97 12.474 149.688

Methyl amino thiazolDihydrochloride

3.7 15.54 186.48

Carbonyldiimidazole 3.51 14.742 176.904

N,N-Diisopropylethylamine

7.87 33.054 396.648

Citric acid 4.39 18.438 221.256

Dichloromethane 70.04 294.168 3530.016 15.04

TMSI 9.87 41.454 497.448



Ethanol 4.29 18.018 216.216 4.29

Morpholine 9.55 40.11 481.32

Dichloromethane 43.35 182.07 2184.84 12

Oxalic Acid Dihydrate 3.45 14.49 173.88

Acetone 24.4 102.48 1229.76 6

Dichloro methane 89.18 374.556 4494.672 19

Potassium bicarbonate

7.17 30.114 361.368

Potassium hydroxide 0.68 2.856 34.272

HOBT.Hydrate 0.77 3.234 38.808

EDC.HCl 2.61 10.962 131.544

Citric acid 8.25 34.65 415.8

Potassium carbonate 5.15 21.63 259.56

Hyflow 2 8.4 100.8

Carbon, Activated 0.83 3.486 41.832

Zeofree 4.79 20.118 241.416

N-Heptane 73.82 310.044 3720.528 12

31 Zoledranic Acid

1,4-butane diol 1.5 0.6 7.2

Chloroacetic acid 5.5 2.2 26.4

Isopropyl alcohol (IPA) 17.2 6.88 82.56 3.2

Potassium hydrogen sulfate

8 3.2 38.4

Triethylamine (TEA) 10.34 4.136 49.632 1.24

Imidazole 2.64 1.056 12.672

MDC 24.6 9.84 118.08 6.6

DM water 29 11.6 139.2

Methanol 10.2 4.08 48.96 2.7

HCl 2.58 1.032 12.384

Acetone 11.8 4.72 56.64 2.6

Chlorobenzene 7.3 2.92 35.04 1.3

Ortho phosphoric acid 3.29 1.316 15.792

Phosphorous trichloride

5.38 2.152 25.824

9N HCl 8 3.2 38.4

Acetone 78 31.2 374.4 6


Celite 0.37 0.148



32 Tranexamic Acid

1,4 Dimethyl Cyclohexane dicarboxylate

1500 24750 297000

(DMCD)

Tin oxide 80 1320 15840

Ammonia gas 330 5445 65340

1,4 Dimethyl Cyclohexane dicarboxylate

1300 21450 257400

NaoH solution 622 10263 123156

24%-NaOH solution 731 12061.5 144738

Activated Raney-Ni 69.7 1150.05 13800.6

25%Ammonia solution

337 5560.5 66726

Hydrogen gas 14569 240388.5 2884662

1N NaOH solution 3476 57354 688248

0.2N NaOH solution 3376 55704 668448

Cataion resin 5510 90915 1090980

1.5% Ammonia solution

13945 230092.5 2761110

2.6% Ammonia solution

8135 134227.5 1610730

Anion resin 874.5 14429.25 173151

Activated carbon 167.74 2767.71 33212.52

Acetone 1401 23116.5 277398 101

33 Sunitinib Malate

N,N-Diethyl ethylene diamine (d:0.82)

0.63 7.875 94.5

HOBt 0.92 11.5 138

EDCI.HCl 1.31 16.375 196.5

DMAP 0.06 0.75 9

DCM d:1.33 45.47 568.375 6820.5 22.73

Sodium carbonate 0.38 4.75 57

Toluened:0.866 6.58 82.25 987 0.66



Celite 0.04 0.5 6

5-fluoroindolin-2-one 0.57 7.125 85.5

Pyrrolidine 0.04 0.5 6

Water 75.91 948.875 11386.5



Methanol d:0.791 16.79 209.875 2518.5 3.36

L- Malic acid 0.36 4.5 54

Methyl Ethyl Ketone d:0.805

13.23 165.375 1984.5 2.65

34 Sorafenib Tosylate

4-Chloro-N-methyl-2-pyridine carboxamide

0.44 11 132

4-Aminophenol 0.48 12 144

4-Chloro-3-trifluoro methyl phenyl Isocyanate

0.7 17.5 210

Para Toluene sulphonic acid

0.41 10.25 123

Sodium Hydroxide 0.21 5.25 63

Sodium chloride 0.8 20 240

Activated charcoal 0.09 2.25 27

Hyflow 7.5 187.5 2250

Dimethyl sulphoxide 2 50 600

DCM 4 100 1200 2.5

Toluene 25.2 630 7560 8.7

Hexanes 9.5 237.5 2850 2.5

DM water 24 600 7200

Methyl ethyl ketone 50 1250 15000 12.1


Dehydroepiandrosterone (DHEA) 100

250 3000

Hydrazine Monohydrate (64-65%) 43.2

108 1296

Ethanol 789 1972.5 23670 789

DM Water (Lot-1) 8.8 22 264

DM Water (Lot-2) 4000 10000 120000

DM Water (Lot-3) 200 500 6000

N-Bromo succinimide (NBS) 148

370 4440

1,1,3,3-Tetramethylguanidine (TMG) 248

620 7440

MDC 1584 3960 47520 792

DM Water (Lot-1) 1200 3000 36000

DM Water (Lot-2) 1200 3000 36000

DM Water (Lot-3) 600 1500 18000



DM Water (Lot-4) 100 250 3000

Metanol (Lot-1) 79.2 198 2376 158.4

Metanol (Lot-2) 79.2 198 2376

1N HCl solution 1000 2500 30000 1000

IPA (Lot-1) 78.6 196.5 2358

550.2 IPA (Lot-2) 393 982.5 11790

IPA (Lot-3) 78.6 196.5 2358

NaCl Solution 400 1000 12000

Anhydrous Na2SO4 60 150 1800 60

3-(diethylboryl)pyridine 27.5

68.75 825

Tetrakis(triphenylphosphine)palladium 2.15

5.375 64.5

Sodium carbonate 59.32 148.3 1779.6

IPA (Lot-1) 361.1 902.75 10833 360.1

IPA (Lot-2) 52 130 1560

DM Water (Lot-1) 276 690 8280

DM Water (Lot-2) 524.8 1312 15744

DM Water (Lot-3) 65.6 164 1968

DM Water (Lot-4) 524.8 1312 15744

DM Water (Lot-5) 65.6 164 1968

Methanol (Lot-1) 416 1040 12480

Methanol (Lot-2) 52 130 1560

Conc., HCl 46 115 1380

n-Hexane (Lot-1) 215 537.5 6450

n-Hexane (Lot-2) 215 537.5 6450

10% NaOHSolu 223 557.5 6690

Acetic acid 23.32 58.3 699.6

Tri ethyl amine (TEA) 16.8 42 504

MDC 792 1980 23760 396

DM Water (Lot-1) 600 1500 18000

DM Water (Lot-2) 200 500 6000

DM Water (Lot-3) 600 1500 18000

10% NaOH solution 6 15 180

n- Hexane 52.4 131 1572

AB-IV (Crude) 42.8 107 1284

Acetone (Lot-I) 696 1740 20880 751.6

Acetone (Lot-II) 63.2 158 1896

ConcHCl (10-15%) 30 75 900 30



MDC (Lot-I) 633.6 1584 19008 316.8

Sat., NaHCO3Solu (Lot-I)

240 600 7200

480 Sat., NaHCO3Solu (Lot-2)

240 600 7200

DM Water (Lot-I) 240 600 7200

DM Water (Lot-2) 520 1300 15600

n-Hexane (Lot-I) 52.4 131 1572 74.98 Chilled n-Hexane (Lot-

2) 52.4

131 1572

Ethanol (Lot-I) 379 947.5 11370 410.5

Hot Ethanol (Lot-2) 31.5 78.75 945

Activated carbon 2 5 60

2.7.4.2 SOURCE OF SUPPLY OF RAW MATERIALS & MARKETING AREA OF FINAL PRODUCTS

The raw materials are either obtained from local suppliers (Kolkata, Maharashtra, Karnataka, and Andhra Pradesh,) or imported (China) & transportation mode is by air, road & sea details appended in the table 2.10.

2.7.4.2.1 RAW MATERIALS SUPPLIERS

The raw materials are either obtained from local suppliers (Gujarat, Maharashtra, Karnataka, and Andhra Pradesh) or imported (China) & transportation mode is by air, road & sea.

Table 2.10 : Raw materials suppliers

Sl. no.

Raw material Supplier

1 Diethyl(3-pyridyl)borane Brilliant Top Corporation Limited,Room 2105 Bj 1689 Trend Centre 29-31, Cheung Lee Street, Chaiwan, HK Tel: +86-311-85855976,FAX:+86-311-85855976

2 THEOPHYLLINE-7 ACETIC ACID (ACEPHYLLINE)

Bajaj Health Care Limited, Block No.588, Savli-KarachiaRoad,Ta.Savli,Dist.Vadodara,INDIA

3 2 AMINO 3,5 DI BROMO BENZALDEHYDE (2 ADB)

Kores (India) limited ,C-7/1-b, T.T.C. Industrial Area M.I.D.C. Pawane, Navi, Mumbai -400705

4 TRANS-4-AMINO CYCLOHEXANOL (Tobic Aldehyde)

Hangzhou Longshan Chemical Co., Ltd Puyan Town, Binjiang District, Hangzhou, 310053, China



5 1-H 1,2,4-Triazole Sodium Salt Riddhi Pharma,A-2/2511,G.I.D.C,Estate,Near Asian paints crossing,Ankaleshwar-393002,Gujarat

6 3,5Bis(2-Cyano isopropyl)toluene(APRM01)

Nikita Chemical Industries ,T – 59, 60&72, M. I. D. C. Tarapur, Boisar, Thane- 401506, Maharashtra , India

7 6-Iodo 1-H-indozole

Dongying Huakang Chemical Co,Ltd, DongYing Port Economic,Development Zone,DongYing, City,Shandong province,China

8 2-Mercapto-N -methyl benzamide

Shanghai Yudiao Chemistry Technology Co.,Ltd,Xiachenqingyang Co.,Ltd,Xiachenqingyang, Mountian,Fenghua City,Zhejiang,China

9 2- Vinyl pyridine

Vertellus Health and specialty Products (LLC),1500S,TibbsAvenue,Indianapolis,Indiana-46241,USA

10 N-[4-CYANO-3-(TRIFLUOROMETHYL) PHENYL]-2-METHYLOXIRANE-2-CARBOXAMIDE (BIC-2)

Avra Laboratories P.Ltd, A-21, IDA Nacharam, Road No: 18, Hyderabad. Gyro Shanghai Puyi Chem-Tech Co., Ltd, , China. Shanghai willpower industrial co., ltd, 1958 Zhong shan north road, Shanghai-200063, China

11 4-FLUROTHIOPHENOL (FT) Alfa Aesar India,Johnson Matthey Chemicals,India Pvt. Ltd. Alfa Aesar Division,Survey No 195, 196,Kandlakoya Village Medchal Mandal,R R District,Hyderabad - 501401

12 (R)- BOROLEUCINE-(1S,2S,3R,5S)- (+)- PINANE DIOL (or) ( R)-BOROLEU-(+)-PINANEDIOL-CF3COOH (BZ-Intermediate)

Zhejiang Medicines & Health Products Import & Export Co., Ltd, ZMC Building, 101-2, N, Zhongshan Road, Hangzhou, 310003 China

13 L-Phenylalanine Navpad Trade Impex. P1/103, Munidhra, Phase II, Munisuvrat Complex, Behind Holley Merry School, Anjur Phata, Rahenal, Bhiwandi, THANE- 421302

14 1,4BUTANEDIOL (BD) BASF The chemical company, SE, 67056 Ludwigshafen, Germany, Tel: +49 1802273112.

15 METHANE SULFONYL CHLORIDE (G-3)

Henan Kebang Chemical Co., Ltd ,Industry zone,eastern citty,sheqi country,henan china.

16 7β,10β-dimethoxy-10(dab III -10-DAB III)

SM Herbals Pvt, Ltd., A-1132, RIICO Industrial Area, Phase-III, Bhiwadi Dist, Alwar (Raj,) 301019, Tel: 08310850975

17 2R, 4S, 5R)-3-(tert-Butoxycarbonyl)-2-(4- methoxyphenyl)-4 -Phenyloxazolidine-5-

Easter Technology development Co., Limited, Room c, 15/F Hua chiao commercial centre, 678 Nathan roads, Mongkok.KL, HK Tel: 86-311-67260775, Fax: 86-311-67591193



carboxylic acid/Oxazolidine side chain acid

18 5-FLUOROCYTOSINE (CP 005)

Hangzhou Utanphrma Biology Co., Ltd. RM D -912, No:789, Moganshan Road, Hangzhou Zhejiang. China

19 5-DEOXY-TRIACETATE- D-RIBOFURNANOSE (PCRMO1)

Suzhou lixin pharmaceutical Co, Ltd, No:21, Tangxi Road, Suzhou new district, 25151, P.R China

20 n-PENTYL CHLOROFORMATE (CPM)

Nutron Pharmaceuticals PVT, Ltd, 401 Earth Sampann Bldg, 198/200 Khet wadi main Road, 4th floor Mumbai-400004, India

21 2-Deoxy-2-Fluoro-1,3,5-Tri-O-Benzoyl-D-Ribofuranose

Easter technology development Co.,Limited

22 2-Chloro-6-Aminopurine/2-Chloro adenine

Easter technology development Co.,Limited

23 2-DEOXY -D- RIBOSE (DBRM01)

Beiging Ribo Biotech Co, Ltd Beijing –China Address: Room 710, XinCaiLiao ChuangYe Building, No.7 FengHuiZhong Road. HaiDian District, Beijing 100094, China

24 5-AZACYTOSINE (ATZRM01) Easter technology development Co.Ltd

25 Fumaric acid Anshan pan-asia import&export co ltd(Doshi enter prizes)

26 10-DEACETYL BACEATIN III (10-DAB)

SM Herbals Pvt, Ltd., A-1132, RIICO Industrial Area, Phase-III, Bhiwadi Dist, Alwar (Raj,)

27 (2R,3S)-2-BENZYLOXY-3-TETRA-BUTOXY CARBONYL AMINO 3-PHENYL PROPIONIC ACID (DCSC)

Accrete Pharmacetuticals Private Limited, office: 5-70, 1st floor, Near Andhra Bank, Street No:08, Habsiguda, Hyderabad-500 007, AP, India

28 3-Ethynylaniline HCl Suzhou lixin pharmaceutical Co, Ltd, No:21, Tangxi Road, Suzhou new district, 25151, P.R China

29 (4,5-bis(2-methoxyethoxy)-2-nitrobenzonitrile

Easter technology development Co.Ltd. Room c, 15/F Hua Chiao commercial centre,678 Nathan Road,Mangkok,KL,HK

30 ( N,N-Dimethylformamide dimethyl acetal) DMF-DMA

Vihita Chem Pvt Ltd,Plot No-305,GIDC,Ankeshwar 393002,Gujarat,India

31 4-bromo-2-fluorobenzoic acid (BFBA) (KSM-I)

BRILLIANT TOP Corporation, Room 2015 Bj 1689 Trend centre 29-31,Cheung Lee Street, Chai Wan, HK.

32 2-Aminoisobutyric acid (KSM-II)

BRILLIANT TOP Corporation, Room 2015 Bj 1689 Trend centre 29-31,Cheung Lee Street, Chai Wan, HK.



33 4- Isothiocyanato-2-(trifluoromethyl) benzonitrile.(ICTB) (KSM-III)

Moltus Research Laboratories, N-59, MIDC, Tarapur, Boisar -401506.

34 2-DEOXY-2,2-DIFLUORO-D-RIBOFURANOSE-3.5-DIBENZOATE (G-9)

SMS Pharmaceuticals P Ltd Industrial Estate Khazipalli Village, Jinnarm, Medak – 502319

35 N-ACETYL CYSTOSINE (G-2)

Sinochem Shanghai Corporation, 17-19TH /FL, No:33, Henan Road, (S) Shanghai, China.

36 4 –(4-METHYL PIPERAZIN -1-YL METHYL BENZOIC DI HYDRO CHLORIDE) (I2)

Shanghai multimed union co Ltd,

37 CHOLIC ACID (CHA) ICE SRL,42122 Reggio Emilia – Italy, Via Sicilia 8/10, Tel: 0522 55.12.50, Fax: 0522 55.89.63

38 4-(BROMOMETHYL) BENZONITRILE

AnamiOrganics,SurNO.306/1/P,At sukhlav,Tal.Pardi,396125,Dist.Valsad. Gujarat.India

39 4-FLUORO BENZONITRILE AnamiOrganics,SurNO.306/1/P,At sukhlav,Tal.Pardi,396125,Dist.Valsad. Gujarat.India

40 1H,1,2,4-TRIAZOLE Riddhi Pharma Ankaleshwar,A-2, 2511, G. I. D. C, Industrial Estate, Ankleshwar, Gujarat 393002

41 2-Chloroethanol Viswaat Chemicals Limited, “Viswaat” 7Satsang complex,upper govind nagar, L.S Racheja ,Malad(E),Mumbai- 400097,India

42 10-Deacetyl Baccatin-III (10-DAB)

Deccan Nutraceuticals Pvt Ltd, Gat No.1065, Golegaon road, Markal, Off Alandi-Markal road, Tal.Khed, Pune-412105, Maharashtra, India

43 (4S, 5R)-3-(N-Benzoyl)-2-Paramethoxy phenyl-4-phenyl Oxazolidine-5-carboxylic acid/Oxazolidine side chain (BPPOC)

Shanghai Jinhe Bio-Technology Co., Ltd, No.135, alley 89, Zhengxia road, Liantang industrial park, Qingpu district Shanghai-201716, China

44 4-[2-(2-AMINO-4,7-DIHYDRO-4-OXO-1H-PYRROLO[2,3-D]PYRIMIDIN-5-YL)ETHYL]BENZOIC ACID (PMDBA)

Suzhou Everich Import and Export Co.Ltd. Everich Trade mansion, No: 265, Fenghuang street, suzhou, Jiangsu, China.

45 L-GLUTAMIC ACID DIMETHYL ESTER HYDROCHLORIDE (PMDGA)

YangZhou Baosheng Bio-Chemical Co., LTD,Jianshan town northern,Yangzhou,China

46 Para Amino Phenol/4-Aminophenol (Sorafenib)

Urmi Chemicals,Hafizain building, 5th floor, 129/131, kazi sayed street, Mumbai-3, India



47 4-Chloro-N-methyl-2-pyidine carboxamide

Brilliant top corporation Ltd, Room 2105 BJ 1689 Trend Centre 29-31, Cheunglee Street, Chaiwan, HK

48 4-chloro-3-trifluoro methylphenyl isocyanate

Brilliant top corporation Ltd, Room 2105 BJ 1689 Trend Centre 29-31, Cheunglee Street, Chaiwan, HK

49 5-Fluoro-1,3-Dihydro-indol-2-one

Nanjing Baijingyu Pharmaceutical, Co.,Ltd,Address:No-29,Fangshui East Road,Luhe Industry Park, Nanjing, P. R. C(China).

50 5-Formyl-2,4-dimethyl-1H-Pyrrole-3-carboxylic acid

Brilliant top corporation limited,Room No-2105,BJ 1689 Trend centre 29-39,Cheung lee street,Chai-Wan,H.K,China

51 Cyclamic Acid/N-Cyclohexyl Sulfamic acid

Egis Pharmaceuticals PLC. 1106Budapest, Kereszturi ut30-38-Hungary

52 Adenine Easter Technology Development Co., Ltd

53 R (+)-Propylene Carbonate Weifang Huitao Chemical Co., LTD, No. 18 HaiWang Road, BinHai Economic Development, Zone,WeiFang City, ShanDong Province, China.

54 Fumaric acid Anshan pan-asia import&export co ltd(Doshi enter prizes)

55 (R)-9-(2-Phosphonylmethoxy propyl) adenine (R-PMPA/TNF-II )

Shanghai Xinda Pharmaceutical Co.,Ltd, 999 Linxian Road,Jinshan Industry Zone,Jinshan,Shanghai 201505,China PR

56 IMIDAZOLE (IM) Asian Scientific Instruments, 4-1-10, Tilak Road, Opp. Posnett Bhavan, Hyderabad-500 001, India.

57 CHLOROACETIC ACID (CL-1) SD Fine chem Limited, Regd office: 315-317, T.V Industrial Estate, 248, Worli Road, Mumbai-400 030, India.



2.7.4.3 STORAGE FACILITY FOR RAW MATERIALS AND PRODUCTS

Adequate storage facilities are proposed to be provided for the raw materials, products etc., Separate storage is proposed for the solvents.Details of strorage facilities is appended in the below table 2.11.

Table 2.11:- Details of Storage Facilities

Sl. No.

Storage Facility for Facility

1

Raw Materials WAREHOUSE

CDMA,HBT, Etc CONTROLLED STORAGE AREA

TRIETHYLAMINE,Zink metal dust Etc LOW VOLUME ONCO RM'S STORAGE AREA

10-DAB-III, 2-DEOXY D RIBOSE Etc STORAGE 20-80C

STANNIC CHLORIDE, N-PROPANOL Etc DRUM STORAGE YARD-2

HYDRAZINE HYDRATE, PYRIDINE ETC DRUM STORAGE YARD-1

PHOSPHORIC ACID,HCl Etc ACID STORAGE AREA

SODIUM METAL, SODIUM HYDRIDE Etc HAZARDOUS STORAGE AREA

METHANOL, TOLUENE Etc BULK SOLVENT YARD

2 Products Bonded finished good store.

3 Industrial Effluent The effluent generated from industry will be treated in ETP followed by Stripper,MEE & RO.

4 Hazardous Waste Process residue is sent to cement industries for co-incineration (as an auxiliary fuel) during the manufacture of cement. The inorganic residue from the process will be stored scientifically and will be sent to TSDF for scientific treatment and disposal.



2.7.5 MACHINERY & EQUIPMENT DETAILS

The detailed list of machinery & equipments in the industry are appended in the tables below

Table 2.12: List of the machinery & equipments

1) C- Block Equipment

Sl.No. Name of the Equipment Equip.ID Capacity MOC

1. Stainless Steel Reactor C/RE-01 2.0 KL SS-316


3. Glass Lined Reactor C/RE-03 3.0 KL MSGL













16. Air Handling Unit C/AHU-01 7300 CFM -

17. Pass Box C/PB-01 - SS 304

18. Pass Box C/PB-02 - SS 304

19. Ventilation C/V-01 15600 CFM -

20. Ventilation Exhaust C/VE-01 15600 CFM -



23. Sparkler Filter C/SF-01 18" x 23 Plates SS-316

24. Sparkler Filter C/SF-02 18" x 23 Plates SS-316



25. Centrifuge C/CF-01 48” SS-316




29. Roto-cone Vacuum Drier C/RCVD-01 1500 L SS-316

30. Roto-cone Vacuum Drier C/RCVD-02 1500 L SS-316

31. Rotary Vacuum Paddle Drier C/RVPD-01 500 L SS-316

32. Vibro Sifter C/VSF-01 50 to 250

Kg/hr SS-316

33. Multimill C/MM-01 50 to 250

Kg/hr SS-316

34. Agitated Nutsche Filter C/ANFD-01 2 m2 SS-316

35. Agitated Nutsche Filter C/ANFD-02 2 m2 SS-316

36. Pressure Module C/PM-01 2100 CFM -












48. Air Shower C/AS-01 - GI Powder

Coated

49. Air Shower C/AS-02 - GI Powder

Coated

50. Blender C/BL-01 1500 L SS-316

51. Micronizer C/MICRO-

01 5-15 kg/hr SS 316

52. Vacuum Tray Drier C/VTD-01 96 Trays SS 316



53. Vacuum Tray Drier C/VTD-02 96 Trays SS 316

54. Dynamic Pass Box C/DPB-01 -- SS 304

2) D- Block Equipment

S.No Name of the Equipment EQ.ID Capacity MOC

1. Glass Lined Reactor D/RE-01 1.60 KL MSGL






7. Agitated Nutsche Filter and Drier

D/ANFD-02 2 m2 SS-316

8. Charging Isolator D/CIS-01 - SS-316

9. Pack Off Isolator D/PIS-01 - SS-316

10. Isolator D/IS-01 - SS-316

11. Isolator Multimill D/ISMM-01 5-25 / Hr SS-316

12. Isolator Vibrosifter D/ISVSF-01 - SS-316

13. Centrifuge Isolator D/ISCF-01 - SS-316

14. Vacuum Tray Dryer Isolator

D/ISVTD-01 - SS-316

15. Vacuum Tray Dryer D/VTD-02 12 Trays SS-316



18. Centrifuge D/CF-01 36” SS-316

19. Centrifuge D/CF-02 36” SS-316

20. Robo Filter D/RF-01 150 Ltrs SS316

21. Sparkler Filter D/SF-01 14” x 12 Plates

SS-316

22. Pressure Nutsche Filter D/PNF-01 0.50 KL SS-316

23. Air Handling Unit D/AHU-01 8600 CFM -

24. Air Handling Unit D/AHU-02 2500 CFM -

25. Ventillation-1 D/V-01 4000 CFM -

26. Ventilation Exhaust D/VE-01 4000 CFM -


28. Ventilation Exhaust D/VE-02 5700 CFM -

29. Pressure Module-1 D/PM-01 1759 CFM -












38. Dynamic Pass Box D/DPB-01 3’ X 3” X 3’ SS - 304

39. Dynamic Pass Box D/DPB-02 3’ X 3” X 3’ SS - 304

40. Static Pass Box D/SPB-01 3’ X 3” X 3’ SS - 304

41. Air Shower D/AS-01 2 persons GI powder coated

42. Air shower D/AS-02 2 persons GI powder coated



3) E- Block Equipment

Sl.No. Name of the Equipment EQ.ID Capacity MOC

1. SS Reactor E/RE-01 6.0 KL SS-316




5. GL Reactor E/RE-05 3.0 KL MSGL










15. Centrifuge E/CF-01 48” SS-316





20. Tray Dryer E/TD-01 96 Trays SS-316





23. Rotocone Vacuum drier E/RCVD-01 1500 Lt SS-316

24. Rotocone Vacuum drier E/RCVD-02 1500 Lt SS-316

25. Rotary Vacuum drier E/RVPD-01 1000 Lt SS-316

26. Sparkler Filter E/SF-01 23"X18 Plates

SS-316


SS-316


SS-316

29. Double cone Blender E/BL-01 1500 Lt SS-316

30. Multimill E/MM-01 50-250 Kg/hr

SS-316

31. Vibro Sifter E/VSF-01 50-200 Kg/hr

SS-316

32. Air Handling Unit E/AHU-01 7800 CFM -



35. Ventilation E/V-01 15000 CFM -

36. Ventilation Exhaust E/VE-01 15600 CFM -

37. Pressure Module E/PM-01 - -




41. Pressure Module E/PM-05 -








49. Air Shower E/AS-01 - GIPC

50. Air Shower E/AS-02 - GIPC

51. Dynamic Pass Box E/DPB-01 - SS-304

52. Dynamic Pass Box E/DPB-01 - SS-304



4) G- Block Equipment


1. SS Reactor G/RE-01 3.0 KL SS-316










11. Centrifuge G/CF-01 48" SS-316

12. Centrifuge G/CF-02 48" SS-316

5) H- Block Equipment


1. Stainless Steel Reactor H/RE-01 0.75 KL SS-316





6. Glass Lined Reactor H/RE-06 0.63 KL MSGL












16. Hydrogenator H/HY-01 0.25KL SS-316 L

17. De-Contamination Tank H/DCT-01 0.50 KL MSHL

18. Pressure Nutsche Filter H/PNF-01 0.50 KL SS-316

19. Pressure Nutsche Filter H/PNF-02 0.10 KL SS-316

20. Agitated Nutsche Filter and drier H/ANFD-01 0.30 m2 SS-316

21. Charging Isolator H/CIS-01 - SS-316

22. Isolator H/IS-01 - SS-316

23. Multi Mill H/ISMM-01 - SS-316

24. Vibro Sifter H/ISVSF-01 - SS-316

25. Pack-Off Isolator H/PIS-01 - SS-316

26. Cage Blender H/CBL-01 - SS-316

27. Vacuum Tray Drier H/VTD-01 24 Trays SS-316




31. SS Centrifuge H/CF-01 36” Dia SS-316

32. Robo Filter H/RF-01 600 X 600 mm SS-316




36. Sparkler Filter H/SF-01 14” x 12 Plates SS-316






40. Air Shower H/AS-01 - GIPC




44. Air Handling Unit H/AHU-01 9000 CFM -

45. Air Handling Unit H/AHU-02 1100 CFM -

46. Ventilation Unit H/V-01 4000 CFM -

47. Ventilation Unit H/V-02 6000 CFM -

48. Ventilation Exhaust Unit H/VE-01 4000 CFM -

49. Ventilation Exhaust Unit H/VE-02 6000 CFM -

50. Pressure Module H/PM-01 2065 CFM -










60. Static Pass Box H/SPB-01 - SS-304

61. Dynamic Pass Box H/DPB-02 - SS-304

62. Dynamic Pass Box H/DPB-03 - SS-304

63. Centrifuge H/CF-02 18” SS-316

6) I- Block Equipment


1. Glass lined reactor I/RE-01 0.10 KL MSGL













12. Stainless steel reactor I/RE-13 0.10 KL SS-316

13. Stainless steel reactor I/RE-14 0.10 KL SS-316

14. Agitated Nutsche Filter Drier I/ANFD-01 0.10 m2 SS-316

15. Charging Isolator I/CIS-01 - SS-316

16. Pack off Isolator I/PIS-01 - SS-316

17. Isolator I/IS-01 - SS-316

18. Isolator Nutsche Filter I/ISNF-01 50 L SS-316

19. Isolator Vacuum tray drier I/ISVTD-01 12 Tray SS-316

20. Isolator Multi mill I/ISMM-01 - SS-316

21. Isolator Vibro sifter I/ISVSF-01 - SS-316

22. Vacuum tray drier I/VTD-01 12 Trays SS-316



25. Robo-filter I/RF-01 450 x 450

mm SS-316


mm SS-316


mm SS-316


mm SS-316


mm SS-316

30. Sparkler Filter I/SF-01 14” x 12 Plates

SS-316

31. Sparkler Filter I/SF-02 8” x 10 Plates SS-316

32. Cage Blender I/CBL-01 50 L SS-316



33. Air Handling Unit I/AHU-01 9000 CFM -

34. Air Handling Unit I/AHU-02 2500 CFM -

35. Ventilation I/V-01 4000 CFM -

36. Ventilation I/V-02 6000 CFM -

37. Ventilation Exhaust I/VE-01 4000 CFM -

38. Ventilation Exhaust I/VE-02 6000 CFM -

39. Pressure Module I/PM-01 500 CFM -










49. Static Pass Box I/PB-01 - SS-304

50. Dynamic Pass Box I/PB-02 - SS-304

51. Dynamic Pass Box I/PB-03 - SS-304

52. Air Shower I/AS-01 - GIPC




56. De-Contamination Tank I/DCT-01 1.0KL MSHL

7) List Of Utilities

Sl.No. Name of the equipment EQ.ID Capacity

1. Boiler P/BO-01 10 Ton

2. Boiler P/BO-02 6 Ton

3. RO Plant P/RO-01 20 m3/hr

4. Air compressor J/AC-01 40 HP

5. Air compressor J/AC-02 60 HP



6. Air Compressor J/AC-03 100 HP

7. N2 Plant J/AC-04 120 Nm3/hr

8. VAM J/VAM-01 470 TR

9. AVAM J/AVAM-01 100 TR

10. NH3 Compression system J/CH-03 100

8) AO - block equipment

Sl. No.

Name of the Equipment EQ.ID Capacity MOC

1. Stainless Steel Reactor AO/RE-01 4 KL SS - 316

2. Hydrogenator AO/HY-01 4 KL SS - 316





7. Stainless Steel Reactor AO/RE-07 4 KL SS-316

8. Stainless Steel Reactor AO/RE-08 7.5 KL SS-316



11. Pressure Filter Nutsche type AO/PNF-01 2000 Ltr SS-316



14. Filter Leaf type AO/LF-01 5 sq-mtr SS-316

15. Agitated Nutsche Filter Drier AO/ANFD-01 2.5 KL SS316

16. Multimill AO/MM-01 500-1000 Kg/h SS316

17. Double Cone Blender AO/BL-01 2 KL SS316

18. VSF AO/VSF-01 150 to 600 kg/hr SS316

19. Ion Exchange System AO/IX-01 3600 liter per cycle -

20. Bipolar membrane Electrodilyzer System

AO/BPED-01 8059 L -



21. Sparkler Filter AO/SF-01 14” x 9 Plates SS316

22. Evaporator AO/EV-01 1800kgs/Hr SS316

23. Ultra Filtration System AO/UF-01 1000 Litrs/ Hr /Kpa -

24. Drum Dryer AO/DD-01 8Drum (200 ltr

each) SS316

9) AI – Block Equipment

Sl.No. Name of the Equipment EQ-ID Capacity Model

1. GL Reactor AI/RE-01 0.16 KL MSGL




5. SS Reactor AI/RE-05 0.10 KL SS 316

6. GL Reactor AI/RE-06 30 Lt All Glass






12. Nutsche Filter Isolator AI/ISNF-01 -- SS-316

13. Vacuum Tray Drier Isolator AI/ISVTD-01` -- SS-316

14. Isolator AI/IS-01 -- SS-316

15. Pack off Isolator AI/PIS-01 -- SS-316

16. Vacuum Tray Drier AI/VTD-01 12 Trays SS-316




20. Pressure Nutsche Filter AI/PNF-01 200 Lt SS-316



21. Pressure Nutsche Filter AI/PNF-02 60 Lt SS-316

22. Nutsche Filter AI/NF-01 50 Lt SS-316

23. Nutsche Filter AI/NF-02 50 Lt SS-316

24. Multi Mill AI/MM-01 5-25 Kg/hr SS-316

25. Vibro Shifter AI/VSF-01 12” SS-316

26. Double Cone Blender AI/DBL-01 15 Lt SS-316

27. Sparkler Filter AI/SF-03 8” x 9 Plates SS-316

28. Sparkler Filter AI/SF-04 8” x 4 Plates SS-316

29. Air Shower AI/AS-01 2 Persons G.I Powder

coated


coated


coated

32. Dynamic Pass Box AI/DPB-01 -- SS-316

33. Air Handling Unit AI/AHU-01 7000 CFM --




10) AJ – Block Equipment

Sl. No.

Name of the Equipment EQ-ID Capacity Model

1. Stainless Steel Reactor AJ/RE-01 6.0KL SS -316 L




5. Glass Lined Reactor AJ/RE-05 6.3KL MSGL

6. Glass Lined Reactor AJ/RE-06 6.3 KL MSGL

7. Centrifuge AJ/CF-01 Ø 48'' SS -316

8. Centrifuge AJ/CF-02 Ø48'' SS -316

9. Centrifuge AJ/CF-03 Ø 48'' SS -316, Halar Lined

10. Tray Drier AJ/TD-01 96 Trays SS-316






11) AM- Block Equipment

Sl. No.

Name of the Equipment EQ-ID Capacity Model

1 All Glass Reactor AM/RE-01 10 L All Glass





6 Stainless Steel Reactor AM/RE-06 100 L SS-316

7 Stainless Steel Reactor AM/RE-07 50 L SS-316


9 Centrifuge AM/CF-01 18” SS-316

10 Centrifuge AM/CF-02 12” SS-316

11 Vacuum Tray Drier AM/VTD-01 4 Tray SS-316

12 Vacuum Tray Drier AM/VTD-02 4 Tray SS-316

13 Dynamic Pass Box AM/DPB-01 - SS-316

14 Air Handling Unit AM/AHU-01 2500 CFM -

12) R1- block equipment

1 All Glass Reactor R1/RE-01 20 Liters GLASS






7 Stainless Steel Reactor R1/RE-07 100 L SS 316

8 Vacuum Try Dryer R1/VTD-01 3 TRAYS SS 316

9 Air Handling Unit R1AHU-01 15000 CFM -------

10 Vacuum Tray Drier R1/VTD-02 4 Trays SS 316



Proposed list:

1) AR-Block Equipment:

Sl.No. Name of the Equipment Equip.ID Capacity MOC

1. Stainless Steel Reactor AR/RE-01 2.0 KL SS-316


3. Glass Lined Reactor AR/RE-03 3.0 KL MSGL






9. Air Handling Unit AR/AHU-

01 7300 CFM -

10. Pass Box AR/PB-01 - SS 304

11. Ventilation AR/V-01 15600 CFM -

12. Ventilation Exhaust AR/VE-01 15600 CFM -

13. Sparkler Filter AR/SF-01 18" x 23 Plates SS-316

14. Centrifuge AR/CF-01 48” SS-316



17. Roto-cone Vacuum Drier AR/RCVD-

01 1500 L SS-316

18. Agitated Nutsche Filter AR/ANFD-

01 2 m2 SS-316

19. Agitated Nutsche Filter AR/ANFD-

02 2 m2 SS-316

20. Pressure Module AR/PM-01 2100 CFM -




24. Air Shower AR/AS-02 - GI Powder

Coated



25. Blender AR/BL-01 1500 L SS-316

26. Vacuum Tray Drier AR/VTD-01 96 Trays SS 316

27. Vacuum Tray Drier AR/VTD-02 96 Trays SS 316

28. Dynamic Pass Box AR/DPB-01 -- SS 304

2) Q-Block Equipments:


1. SS Reactor Q/RE-03 5.0 KL SS-316


3. GL Reactor Q/RE-05 3.0 KL MSGL










13. Centrifuge Q/CF-01 48” SS-316





18. Tray Dryer Q/TD-01 96 Trays SS-316



21. Rotocone Vacuum drier Q/RCVD-01 1500 Lt SS-316

22. Rotocone Vacuum drier Q/RCVD-02 1500 Lt SS-316

23. Rotary Vacuum drier Q/RVPD-01 1000 Lt SS-316

24. Sparkler Filter Q/SF-01 23"X18 Plates

SS-316


SS-316




SS-316

27. Double cone Blender Q/BL-01 1500 Lt SS-316

28. Multimill Q/MM-01 50-250 Kg/hr

SS-316

29. Vibro Sifter Q/VSF-01 50-200 Kg/hr

SS-316

30. Air Handling Unit Q/AHU-01 7800 CFM -



33. Ventilation Q/V-01 15000 CFM -

34. Ventilation Exhaust Q/VE-01 15600 CFM -

35. Pressure Module Q/PM-01 - -




39. Pressure Module Q/PM-05 -








47. Air Shower Q/AS-01 - GIPC

48. Air Shower Q/AS-02 - GIPC

49. Dynamic Pass Box Q/DPB-01 - SS-304

50. Dynamic Pass Box Q/DPB-01 - SS-304

3) AS-Block Equipments:


1. Glass Lined Reactor AS/RE-01 1.60 KL MSGL









7. Agitated Nutsche Filter and Drier AS/ANFD-02

2 m2 SS-316

8. Charging Isolator AS/CIS-01 - SS-316

9. Pack Off Isolator AS/PIS-01 - SS-316

10. Isolator AS/IS-01 - SS-316

11. Isolator Multimill AS/ISMM-01

5-25 / Hr SS-316

12. Isolator Vibrosifter AS/ISVSF-01

- SS-316

13. Centrifuge Isolator AS/ISCF-01 - SS-316

14. Vacuum Tray Dryer Isolator AS/ISVTD-01

- SS-316

15. Vacuum Tray Dryer AS/VTD-02 12 Trays SS-316



18. Centrifuge AS/CF-01 36” SS-316

19. Centrifuge AS/CF-02 36” SS-316

20. Robo Filter AS/RF-01 150 Ltrs SS316

21. Sparkler Filter AS/SF-01 14” x 12 Plates

SS-316

22. Pressure Nutsche Filter AS/PNF-01 0.50 KL SS-316

23. Air Handling Unit AS/AHU-01 8600 CFM -

24. Air Handling Unit AS/AHU-02 2500 CFM -

25. Ventillation-1 AS/V-01 4000 CFM -

26. Ventilation Exhaust AS/VE-01 4000 CFM -


28. Ventilation Exhaust AS/VE-02 5700 CFM -

29. Pressure Module-1 AS/PM-01 1759 CFM -









38. Dynamic Pass Box AS/DPB-01 3’ X 3” X 3’ SS - 304

39. Dynamic Pass Box AS/DPB-02 3’ X 3” X 3’ SS - 304

40. Static Pass Box AS/SPB-01 3’ X 3” X 3’ SS - 304




41. Air Shower AS/AS-01 2 persons GI

powder coated

42. Air shower AS/AS-02 2 persons GI

powder coated


powder coated


powder coated

No of Products and No. of Reactors:

S.N Proposed Product Name

Manufacturing Qty

in MT/Year

Batch size

Kg/batch

No of Batch’s

No’s per year

Reactors used No’s

Capacity of Reactors&

All glass Reactors

Occupancy time

1 Ambroxol HCl 10 500 20 3 SSR- 2no’s GLR-1 no’s

30 days per year

2 Anasrozole 0.1 10 100 6 GLR-6 no’s 100 days per year

3 Gemcitabine HCl 0.1 30 36 5 SSR- 2 no’s GLR-3 no’s

75days per Year

4 Paclitaxel 0.1 10 100

4 GLR-4 no’s (1.5KL-4

no’s)

120 days per year

5 Temozolabide 0.1 10 100 2 SSR- 2no’s

40 days per year

6 Bicalutamide 0.5 10 50 1 GLR-1 no’s 120 days per year



7 Docetaxel Trihydrate

0.1 10 100 3 GLR-3 no’s 120 days per year


60 250 240 13 SSR- 13 no’s

300 days per year

9 Bendamustine hcl

0.2 12 168 1 GLR-1 no’s (1.5 KL)

100 days per year

10 Bortzomib 0.005 0.1 50 5 All Glass Reactor 5

no’s (0.5 Lit)

60 days per year

11 Capacitabine 60 250 240 3 GLR-3 no’s (5 Kl-2 no’s &

3 Kl 1no’s)

300 days per year

12 Imatinib 5 100 50 3 GLR-3 no’s (5 Kl-1 no’s& 3 Kl -2 no’s)

30 days per year

13 Lenalidomide 0.5 100 50 3 GLR-2 no’s (2 Kl -1 no’s

& (3 Kl -1 no’s) SSR-1 no’s

(5 Kl -1 no’s)

30 days per year

14 Letrozole 0.05 1 50 2 GLR-2 no’s (0.5KL-2

no’s)

50 days per year

15 PMD 0.25 10 25 3 GLR-3 no’s (1.5 KL-3

no’s)

40 days per year

16 Decitabine 0.01 0.5 20

5 GLR-5 no’s (0.5 KL-5

no’s)

30 days per year

17 Cytrabine 0.05 0.96 52 2 GLR-2 no’s (0.5 KL-2

no’s)

60 days per year



18 Cabazitaxel 0.01 0.4 26 4 GLR-2 no’s (0.5 KL-2

no’s)

60 days per year

19 Acebrophylline 10 250 40 3 GLR-3 no’s (0.5 KL-3

no’s)

60 days per year

20 Cloferabine 0.01 0.43 24 2 All glass reactor-2

no’s (100lts-2 no’s)

50 days per year

21 Melphalan 0.025 0.55 45 5 GLR-1 no’s (1.0 KL-1

no’s)

60 days per year

22 Cyclophosphamide

1 4.5 228

3 All glass reactor-3

no’s (100lts-3

no’s)

300 days per year

23 Tenfovir 50 250 200 2 GLR-2 no’s 200 days per year

24 PMK 0.25 2 125 3 GLR-3 no’s (100 lit-3

no’s)

35 days per year

25 Erlotonib 2 25 80 7 GLR-1 no’s SSR-6 no’s

150 days per year

26 Emtricitabine 1 250 4 4 SSR-1 no’s GLR-3 no’s

25 days per year


12 250 48 2 SSR-2 no’s 75days per year

28 Elvitegravir 1 250 4 12 GLR-12 no’s SSR-4 no’s

40 days per year

29 Cobicistat 100 250 400 7 GLR-5 no’s SSR-2 no’s

320 days per year

30 Busulfan 0.05 1 50 2 AGR-2 no’s 80 days per year

31 Zoledranic Acid 0.005 1 50 4 AGR-4 no’s 25 days per year

32 Tranexamic Acid 100 500 200 5 SSR-2 no’s GLR-3 no’s

300 days per year



33 Sunitinib Malate 3 50 60 3 SSR-3 no’s 60 days per year


3 100 30 3 SSR-3 no’s 60 days per year


2 30 67 5 GLR 5 no’s 45 days per year

Availability of Reactors:

S. No. Capacity of the reactors

SS R (No’s)

GLR (No’s)

All Glass (No’s)

1 100 Lit & below 3 5 12

2 0.5 & KL below 8 19 0

3 1.5 KL 2 6 0

4 2.0 KL 5 1 0

5 3.0 KL 7 3 0

6 4.0 KL 13 8 0

7 5.0 KL 23 6 0

8 6.0 KL 5 5 0

9 7.5 KL 1 0 0

10 10.0 KL 2 0 0

64 53 12

The total No of Reactors available is 129

The total No Of reactors required is 140

As the products are taken on campaign basis, the ocuupation of the products is not through

out the year for all the products, all the products can be manufactured in the given equipment

2.8 PROJECT DESCRIPTION INCLUDING DRAWINGS SHOWING PROJECT LAYOUT,

COMPONENTS OF PROJECT, SCHEMATIC REPRESENTATIONS OF THE FEASIBILITY DRAWING

GIVING INFORMATION IMPORTANT FOR EIA PURPOSE

2.8.1 PROJECT DESCRIPTION INCLUDING DRAWINGS SHOWING PROJECT LAYOUT,

COMPONENTS OF PROJECT

Site plan drawing showing project site layout & various components is appended as Fig 2.1 in

this chapter.



2.8.2 SCHEMATIC REPRESENTATIONS OF THE FEASIBILITY DRAWING

A schematic representation of the overall feasibility and environmental assessment process is

shown in Figure 2.3.

Fig 2.3: Feasibility & environmental assessment process



2.9 MITIGATION MEASURES INCORPORATED INTO THE PROJECT TO MEET

ENVIRONMENTAL STANDARDS, ENVIRONMENTAL OPERATING CONDITIONS OR OTHER EIA

REQUIREMENTS (AS REQUIRED BY THE SCOPE)

2.9.1. WATER DEMAND AND WASTEWATER/EFFLUENT DISCHARGE

2.9.1.1. SOURCE OF WATER SUPPLY

The water demand is met from KIADB water supply. The requirement of water for the unit is

for domestic, industrial purposes.

2.9.1.2 WATER DEMAND AND WASTEWATER DISCHARGE DURING OPERATION PHASE

Source of water supply: KIADB Water Supply

Total number of employees: 600 people

Per capita water demand: 50 LPCD

The total quantity of water required for the industry is about 214.6 KLD. The break-up of the consumption of water is as presented in below table 2.13.



Table 2.13: Water consumption and discharge

Sl. No.

Purpose Total Quantity LPD( Intal Water)

Recirculation /Recycle LPD

Loss/Consumption/Evaporation /Daily Make Up Water Etc LPD

Wastewater Generation In LPD

I Domestic (Toilet, Canteen etc.)

30,000

30,000 25,000

II. Gardening/Landscape development

15,000

15,000 -

III Industrial purpose 5,32,500 1,69,600 1,76,000

1 DM water/ Softener/RO plant

30,000 - 30,000 30,000

A Process 1,13,000 - 1,13,000 1,08,000 (Remaining

9,000 is By product)

B Washing/ Cleaning

12,500 - 12,500 12,500

C Boiler feed Boiler water = 2,16,000 =(2,16,000-

1,29,600 =86,400)

2,09,450 = 1,29,600 Condensate recycle + 79,850 *

6,550 10,000 Boiler Blow down (Boiler Blow down will be

used for Spraying on the

Ash)

D Cooling tower – 1 no.

1,55,500 = (1,55,500 –

1,41,450 = 14,050)

1,53,450 = 1,41,450 from

Recycled condensate water

from ZLD plant +12,000 LPD LTDS

ZLD recycled water)

2050 20,000 (bleed off)

2 Scrubber 3000 - 3000 3,000

3 R&D 2,500 - 2500 2,500

Grand Total 5,77,500 3,62,900 2,14,600 2,01,000

Note: * Water recycled back to the system from ZLD plant. LPD = L/day; KLD = kilo liter/day 38.25 KLD RO Rejects from Low Strength waste water ETP will be treated in High

Strength waste water ETP followed by MEE.



ii) WASTEWATER TREATMENT AND DISPOSAL DETAILS

The treatment methods and the final disposal of each type of wastewater generated is appended in the table 2.14 below

Table 2.14 : Sewage/effluent treatment and discharge

Type of wastewater

Source Quantity, KLD Treatment Re-use of treated wastewater

Low strength Process Effluent, Washing effluent & Domestic waste water

130.5 Treated in Effluent treatment palnt followed by Reverse Osmosis. Domestic waste is treated in ETP at the stage of Biological treatment.


High strength Process Effluent, R&D Effluent,

Scrubber wastes, LSWW ETP

RO(38.25 KLD ) reject & Shipa

Medicare Unit –I effluent.

84.75 KLD = 58.75 KLD

from this unit + 26 KLD From Unit-

I

Treated in Effluent treatment palnt followed by MEE.

High strength DM plant/ Softner rejects & Cooling tower bleed off.

50 KLD Treated in High rate Solids contact clarifier tank (HRSCC).

Note: - Additional 26 KLD Effluent from Shilpa Medicare Unit – I will be added to this Unit for further treatment and disposal and we have the permission for the same.



Fig 2.4 WATER BALANCE CHART



2.9.2 PRODUCT-WISE WATER CONSUMPTION AND DISCHARGE

The Product-wise water consumption and effluent discharge is appended in below table 2.15.

Table 2.15: Product-wise water consumption and effluent discharge

S No Product

Batch-wise process water consumption & discharge (L/batch) No. of

batches/month

Monthly process water consumption & effluent discharge (L/month)

Stage Water

consumption Effluent

discharge Water

consumption Effluent discharge

1 Ambroxol HCl

I 400 562

1.7

680 955.4

II 20 106 34 180.2

Total 420 668 714 1135.6

2 Anastrozole

I 5 6

8

40 48

II 2 7.75 16 62

III 5 6 40 48

Total 12 19.75 96 158

3 Gemcitabine HCl

I 0 90

3

0 270

II 0 21.3 0 63.9

III 3.6 12.9 10.8 38.7

Total 3.6 124.2 10.8 372.6

4 Paclitaxel

I 0 0

8.3

0 0

II 0 0 0 0

III 12 12.1 99.6 100.43

IV 0 0 0 0

Total 12 12.1 99.6 100.43



5 Temozolomide

I 24 30.64

8

192 245.12

II 6 7 48 56

Total 30 37.64 240 301.12

6 Bicalutamide I 0 0

5 0 0

Total 0 0 0 0


I 0 24

8

0 192

II 0 0 0 0

III 24 24.2 192 193.6

Total 24 48.2 192 385.6

8

3a,7B-Dihydroxy Cholanic Acid

I 0 0

20

0 0

II 0 0 0 0

III 300 220 6000 4400

IV 250 0 5000 0

V 150 110 3000 2200

VI 150 596.3 3000 11926

Total 850 926.3 17000 18526

9 Bendamusti HCl i 40 63.7

14 560 891.8

Total 40 63.7 560 891.8

10 Bortezomib

I 0 0.825

41.7

0 34.4025

II 0 0.742 0 30.9414

III 0.039 0.042 1.6263 1.7514

Total 0.039 1.609 1.6263 67.0953

11 Capecitabine

I 30 189.6

50

1500 9480

II 30 37.5 1500 1875

III 30 37 1500 1850

Total 90 264.1 4500 13205

12 Imatinib mesylate 1 0 38

41.7 0 1584.6

Total 0 0 0 0



13 Lenalidomide

I 0 0

41.7

0 0

II 25 26.9 1042.5 1121.73

Total 25 26.9 1042.5 1121.73

14 Letrozole

I 0 2.5

4.2

0 10.5

II 10 15.9 42 66.78

Total 10 18.4 42 77.28

15 Pemetrexed disodium

1 38.5 41.49

20.8

800.8 862.992

2 25 153.47 520 3192.176

3 13.6 13.03 282.88 271.024

Total 77.1 207.99 1603.68 4326.192

16 Dicitabine

I 0 4.38

1.7

0 7.446

II 150 193 255 328.1

III 200 218 8 370.6

IV 0 0 0 0

V 0 0 0 0

Total 350 415.38 263 706.146

17 Cytrabine

I 20 56

13 260 728

II 4.3 3.91 55.9 50.83

Total 24.3 59.91 315.9 778.83

18 Cabazitaxel

I 57 30.86

2.1

119.7 64.806

II 0 32.35 0 67.935

III 0 0 0 0

IV 0 0 0 0

Total 57 63.21 119.7 132.741

19 Acebrophylline

I 700 650

3.3 2310 2145

II 0 0 0 0

Total 700 650 2310 2145



20 Clofarabine

I 0 0

2

0 0

IA 0 0 0 0

II 0 29.39 0 58.78

III 0 0 0 0

Total 0 29.39 0 58.78

21 Melphalan

I 0 0

3.8

0 0

II 0 6 0 22.8

III 86 93.64 326.8 355.832

IV 0 0 0 0

V 0 0 0 0

Total 86 99.64 326.8 378.632

22 Cyclophosphamide

I 0 2.86

63.1

0 180.466

II 7.6 9.37 479.56 591.247

III 59.77 60.43 3771.487 3813.133

Total 67.37 72.66 4251.047 4584.846

23 Tenofovir

I 300 500

16.7

5010 8350

II 400 321.5 6680 5369.05

Total 700 821.5 11690 13719.05

24

Pemetrexed dipotassium

I 480 514.54

10.4

4992 5351.216

II 124.9 169.7 1298.96 1764.88

III 13.6 13 141.44 135.2

Total 618.5 697.24 6432.4 7251.296

25 Erlotonib HCl

I 500 600

6.7

3350 4020

II 0 0 0 0

III 600 400 4020 2680

IV 0 0 0 0

Total 1100 1000 7370 6700

26 Emtricitabine I 1000 1241 0.3 300 372.3



II 250 1084 75 325.2

Total 1250 2325 375 697.5


I 0 0

4

0 0

II 0 0 0 0

Total 0 0 0 0

28 Elvitegravir

I 55.09 39.99

0.3

16.527 11.997

II 100 150 30 45

III 120 407 36 122.1

IV 70 60 21 18

V 150 130 45 39

VI 200 180 60 54

VIA 100 115.179 30 34.5537

Total 795.09 1082.169 238.527 324.6507

29 Cobicistat

I 17.712 19.352

33

584.496 638.616

II 46.552 55.772 1536.216 1840.476

III 9.16 11.26 302.28 371.58

IV 3.52 25.65 116.16 846.45

V 12.284 31.174 405.372 1028.742

VI 32.592 59.002 1075.536 1947.066

VII 66.352 89.922 2189.616 2967.426

Total 188.172 292.132 6209.676 9640.356

30 Busulfan

I 24 43.41

4.2

100.8 182.322

II 0 0 0 0

Total 24 43.41 100.8 182.322

31 Zolodranic Acid

I 29 46.56

0.4

11.6 18.624

II 0 0 0 0

III 0 0 0 0

IV 34.21 34.42 13.684 13.768



Total 63.21 80.98 25.284 32.392

32 Tranexamic acid

I 0 20

18.5

0 370

II 4429 5435 81936.5 100547.5

III 0 7429 0 137436.5

IV 128817.5 133959.5 2383123.75 2478250.75

V 0 2116.5 0 39155.25

VI 14951 14369 276593.5 265826.5

VII 5630 4080 104155 75480

Total 153827.5 167409 2845808.75 3097066.5

33 Sunitinib Malate

I 987.6 1060

12.5

12345 13250

II 530.6 540 6632.5 6750

III 0 0 0 0

Total 1518.2 1600 18977.5 20000


I 480 520

25

12000 13000

II 0 0 0 0

III 0 0 0 0

Total 480 520 12000 13000

35

Abiraterone acetate

I 4208.8 4252.22

2.5

10522 10630.55

II 3100 3930.4 7750 9826

III 1456.8 1838.22 218520 4595.55

IV 1400 1426.52 210000 3566.3

IV(purification) 620 1262 1550 3155

Total 10785.6 12709.36 448342 31773.4

Qty/month 3391258.59 3249840.889

Qty/day 113041.95 108328.0296



Note: Considering no. of working days/month = 30

1. Daily process water consumption = 3391258.59/30 = 1,13,041.95 LPD 2. Daily process effluent discharge =3249840.889/30 = 1,08,328.0296 LPD 3. Scrubber effluent: 3000 LPD, if all products runs continuously. 4. R&D effluent: 2500 LPD.

2.9.2. (A) Raw material to product and product to waste generation ratio for each product

Table :- 2.15.A Raw materials to waste & Product to waste generation Ratio & Percentage

Raw materials to waste & Product to waste generation Ratio & Percentage

Products Product qty.

KG/Annum

Raw meterial Consumption

KG/Annum

Weste genartion Quatity Kg/Annum Toal waste genaration KG/annum

raw material to Waste

genaration Ratio

raw material to Waste

genaration %

product to waste

generation ratio

product to waste

generation %

Waste water Residue By products spent corbon

Solvent loss

Ambroxol HCl 10000 35360 11740 0 1620 80 2760 13440 0.3801 38.01 0.17 17.0

Anasrozole 100 37550 18000 0 5300 0 7000 23300 0.6205 62.05 53.00 5300.0

Gemcitabine HCl 100 15612.48 7452 0 1296 1086.5 1620 9834.48 0.6299 62.99 23.82 2382.5

Paclitaxel 100 25340 12100 900 4050 0 2990 17050 0.6728 67.28 49.50 4950.0

Temozolabide 100 41600 31840 160 5800 200 600 38000 0.9135 91.35 61.60 6160.0

Bicalutamide 500 1100 0 0 350 0 250 350 0.3182 31.82 0.70 70.0

Docetaxel Trihydrate

100 98400 48200 150 24100 0 22150 72450 0.7363 73.63 242.50 24250.0



Ursodeoxycholic Acid

60000 1624114 79512 19.2 841920 0 25596 921451.2 0.5674 56.74 14.03 1403.2

Bendamustine hcl 200 109200 10716 168 0 0 0 10884 0.0997 9.97 0.84 84.0

Bortzomib 5 169 139.35 6 7.5 0 7.5 152.85 0.9044 90.44 2.70 270.0

Capacitabine 60000 1064400 171360 58080 305736 0 324000 535176 0.5028 50.28 6.06 606.4

Imatinib 5000 28500 0 0 19000 500 4000 19500 0.6842 68.42 3.90 390.0

Lenalidomide 500 170500 134500 10500 0 500 5500 145500 0.8534 85.34 22.00 2200.0

Letrozole 50 1215 600 15 320 0 80 935 0.7695 76.95 6.70 670.0

PMD 250 27452.5 23900 100 0 0 2295 24000 0.8742 87.42 0.40 40.0

Decitabine 10 14571.2 7420 24 4633.2 10 2000 12087.2 0.8295 82.95 466.72 46672.0

Cytrabine 50 12277.2 9345.96 0 2811.12 0 7.8 12157.08 0.9902 99.02 56.22 5622.2

Cabazitaxel 10 6461.78 3547 0 0 0 2859.3 3547 0.5489 54.89 0.00 0.0

Acebrophylline 10000 53320 26000 0 6520 0 2800 32520 0.6099 60.99 0.65 65.2

Cloferabine 10 7199.8 709.36 214.32 2643.04 0 3521.52 3566.72 0.4954 49.54 285.74 28573.6

Melphalan 25 34577.15 4993.75 2796.25 1891.4 45 24384.1 9726.4 0.2813 28.13 189.31 18930.6

Cyclophosphamide 1000 36986.16 21119.64 6267.72 0 0 6643.2 27387.36 0.7405 74.05 6.27 626.8

Tenfovir 50000 2064000 180000 622530 1032470 0 134000 1835000 0.8891 88.91 33.10 3310.0

PMK 250 98501.75 79717.5 250 10653.6 87.5 6650.5 90708.6 0.9209 92.09 43.96 4396.4

Erlotonib 2000 184192.8 80000 880 59064 88.8 34160 140032.8 0.7603 76.03 30.02 3001.6

Emtricitabine 1000 110318 4400 140 4900 12 10720 9452 0.0857 8.57 5.05 505.2

Dimethyl fumarate 12000 71953.056 168 0 8869.056 0 36249.6 9037.056 0.1256 12.56 0.74 73.9

Elvitegravir 1000 141340.7332 3140.676 17.8997 22334.95292 12.8 10777.24 25506.32864 0.1805 18.05 22.37 2236.6

Cobicistat 100000 3616855.2 108824 3000 1598423.2 1508 1569200 1711755.2 0.4733 47.33 16.03 1602.9

Busulfan 50 8835.2 1839.65 0 0 101.05 875 1940.7 0.2197 21.97 2.02 202.1

Zoledranic Acid 5 13300.5 3749 75 1148 8 1047 4980 0.3744 37.44 246.20 24620.0



Tranexamic Acid 100000 24808800 13385800 9800 4042600 33548 42600 17471748 0.7043 70.43 40.86 4085.9

Sunitinib Malate 3000 188596 88870 9350 0 0 24280 98220 0.5208 52.08 3.12 311.7

Sorafenib Tosylate 3000 60030 17340 810 9462 0 23643 27612 0.4600 46.00 3.42 342.4

Abiraterone acetate

2000 1315573 799870.12 0 0 134 495668.7 800004.12 0.6081 60.81 0.07 6.7



2.9.2.1 PROCESS EFFLUENT CHARACTERISTICS

The characteristics of the effluent(HTDS &LTDS) generated during the process of manufacture of APIs & Intermediates for the emerging scenario are described in the following table’s.

Table 2.16 Effluent characteristics for the emerging scenario

Wastewater characteristics LTDS Before treatment

After Biological & RO treatment

Biochemical Oxygen Demand (BOD), ppm 1500- 3,000 <30

Chemical Oxygen Demand (COD), ppm 5,000- 10,000 <250

Total Dissolved Solids (TDS), ppm 5000 -10,000 <500

Suspended solids, ppm 1,000 - 2,500 <100

pH 6 - 12 5.5 to 9

Wastewater characteristics HTDS Before treatment

After Stripper, MEE and Biological treatment

Biochemical Oxygen Demand (BOD), ppm 12,000- 15,000 <30

Chemical Oxygen Demand (COD), ppm 20,000- 36,000 <250

Total Dissolved Solids (TDS), ppm 20,000 -30,000 <500

Suspended solids, ppm 1,500 - 2,500 <100

pH 6 - 12 5.5 to 9

2.9.2.2 STORAGE FACILITIES PROVIDED FOR INDUSTRIAL EFFLUENTS

The industry proposes to provide adequate storage facilities for the industrial effluents. The details of which are appended below.

Storage facilities at the project site The industrial effluent is transferred to collection tanks through HDPE pipe lining from production blocks.



2.9.2.3 TREATMENT SCHEME FOR WASTEWATER

Brief Treatment Process Description

The wastewater from the industry will be first passed through screen chamber for retaining the solid matter in the effluent followed by treatment in oil chamber where oil skimmer is provided to remove the oil content in the effluent. The wastewater is then made to flow to the equalization tank where floating aerator is provided for mixing of effluents. The effluent is then pumped to primary settling tank where hydrogen peroxide or bleach solution is dosed for removal of color and suspended solids in the effluent. The clear overflow from the primary settling tank is collected in a tank where pH correction is carried out. The treated effluent sends to Solvent Stripper in the stripper stripped the solvents in the effluent. The stripped effluent passed to the MEE (Multiple Effect Evaporation) concentrating the effluent. The condensate water collected in tank and it is used for cooling tower make ups and boiler ash moistening. The concentrate passed through to ATFD (Agitated Thin Film Drier), in drier concentrated effluent convert into dried salts. The dried salts bagged in Polyethylene bags and stored in dedicated Secured Hazardous waste storage room and send to the K.S.P.C.B approved land fill site.



Fig 2.5 ETP FLOW CHART FOR HTDS FLOW DIAGRAM



Fig 2.6 Proposed LTDS Effluent Diagram Effluent treatment process Schematic flow diagram of LTDS Effluent and Domestic in

SML, Unit-2



2.9.2.4 ETP Details:

1. E.T.P. PRE TREATMENT(HTDS)

SNO EQUIPMENT NAME QTY SIZE/CAPACITY

1 Hrscc 01 DIA3X3MT H

2 Tube settler 01 2.5X2.5X2.5MT

3 Multigrade Filter 01 15M3/HR

4 Activated carbon filter 01 15 M³/HR

5 HCl dosing Tank 01 400 LITERS

6 Hypo Dosing Tank 01 400LITERS

7 Castic dosing Tank 01 400 LITERS

8 Poly dosing Tank With Agitater 01 400 LITERS

9 Fluculent Dosing Tank with Agitator 01 400 LITERS

10 Fluculent Dosing Tank with Agitator for Press

filter

01 400 LITERS

11 Bio sludge filter tank 01 20 KL

12 Chemical sludge Feeding tank 01 20 KL

13 Chemical sludge Press filter 01 31PLATES

14 Bio Sludge Press Filter 01 21PLATES

15 Flashmixer 01 1000KG/HR

16 Chemical sludge hopper 01 2560 MM LENGTH ×

1500 MM HEIGHT

17 Bio Sludge Hopper 01 1930 MM LENGTH ×

1500 MM HEIGHT

18 Mgf Feeding Tank 01 10KL

19 Stripper Feeding Tank 01 30KL

20 Acid Dosing Tank 01 Capacity 500 lit

21 Acid Dosing tank 01 Capacity 1000lit

22 Uria dosing tank 01 Capacity 0-40 LPh

23 Polu Floc-1203 dosingtank – 01 Capacity: 100 Liter s

24 Polu Floc 4120dosing tank 01 Capacity: 100 Liter s

25 Clarified water Tank 01 10M3

26 Filtered water tank 01 30M3



2. ETP Treatement (LTDS)

Sr.No Description Qty Specification

1 Heat exchanger By Client

01 Capacity: 8 m3/hr

2 Collection Tank/ Equalization tank By Client

01 Capacity: 67 m3

3 Acid dosing tank (New) 01 Capacity: 500 liters

4 Alkali dosing tank (New) 01 Capacity: 1000 liters

5 Phosphoric acid dosing tank (New) 01 Capacity: 1000 liters

6 Urea dosing tank (New) 01 Capacity: 1000 liters

7 AHR Media (New) 01 Capacity: 8 m3/hr

8 AHR Grid (New) 01 Capacity: 8 m3/hr

9 AHR tank cover (NEW) 01 Capacity: 8 m3/hr

10 AHR tank (Existing - By Client) 01 Capacity: Dia. 10.5m x 7.2m H

+ 0.5m (FB)

11 AHR Sludge transfer pump (New) 01 Capacity : 10 m3/Hr

Head:30M

12 AHR Gas blower (New) 2

(1W+1S)

suitable

13 Aeration Tank-I (Existing Adequate) 01 Capacity: 380 m3

14 MBBR Media for Aeration (NEW) 01 Suitable

15 Air Blower (equalization tank & Aeration tank (1.2 &3) - NEW

3 (2W+

1S)

Capacity: 700Nm3/HR @4500mmWC

16 Secondary clarifier - 1 (Existing-Adequate) 01 Capacity: 8.6 m3/Hr

17 Sludge transfer pump – (NEW) 01 Capacity : 7 m3/Hr

Head:30M

18 Aeration Tank-II(Existing-Adequate) 01 Capacity: 220 m3

19 Secondary Clarifier- 2 Existing – By Client 01 Capacity: 4m

20 Clarified water Tank New - By client

01 Capacity: 5m3

21 Flash mixer (New) 01 Capacity: 1m3

22 Polu Floc-1203 dosing tank – (NEW) 01

Capacity: 100 Liters



23 Polu Floc 4120dosing tank – (NEW) 01

Capacity: 100 Liters

24 HRSCC Mechanism – (NEW) 01 3 m Dia.

25 HRSCC shell –New by client (drawing by MOWS)

01 3 m Dia.

26 Clarified Water Tank – Exisitng by client 01

Capacity : 10 m3

27 Hypo dosing tank – (NEW) 01 Capacity: 100 Liters

28 Pressure sand filter – Existing - By Client 01 Dia. 1.0 m X 1.5 m height

29 Activated Carbon filter – Existing -By Client 01

Dia. 1.0 m X 1.8 m height

30 Filtered water tank - New By client 01 30 L

Multiple Effect Evaporation system:

Evaporation flow rate : 100 m3/day

System : Triple effect Falling film cum Forced

Circulation (2FF+1FC) Evaporator with Thermal vapour re-Compressor (TVR)

Feed Rate : 4797(kg/h)

Initial Solids : 3.16(%)

Max. Suspended Solids : < 1000(ppm)

Solids IN Concentrate : 40(%)

Concentrate Output : 379(kg/h)

Water Evaporation : 4418(kg/h)

Thermal needs : Dry saturated Steam 1061 kg/hr

Steam temperature inlet : 180 0C

Compressed Air requirement : 4 Nm3/hr Cooling Water recirculation rate : 65 m3/hr

Electrical power consumption : 19 kW/hr

Supply voltage : 400 V

Verticle Thin Film Drier:

Feed Rate : 379 kg/h Initial TS : 40% Final Moisture : 6 – 8% Water Evaporation : 216 kg/h Dried (BAGGABLE) Solids Output : 163 kg/h Drying rate : 216 kg/hr Water Evaporation



Power consumption : 16 kw/hr

Compressed Air requirement : 4 Nm3/hr Cooling Water recirculation rate : 16 m3/hr

Reverse Osmosis Plant:

Feed rate : 80 m3/day Initial TDS : 10000 mg/lt Initial TSS : 200 mg/lt Initial COD : 600 mg/lt Final TDS : 500-750 mg/lt Final COD : 250 mg/lt

2.9.3 AIR POLLUTION SOURCES

2.9.3.1 POWER

The total power requirement of the industry is 1800 kVA. Further one diesel generator of 625 KVA -3 No.s & 750 KVA – 1 No. capacity is proposed to be installed to serve as an alternative source of power supply to this unit.

2.9.3.2 AIR POLLUTION SOURCES

The major air pollution sources from the industry are DG set, boiler and process sections. These sources are provided with stacks of adequate height so as to disperse the emanating flue gases containing SPM, oxides of sulfur and nitrogen without affecting the ground level concentrations and packed column scrubbers are proposed to the process sections with adequate stack height as per the regulatory requirements.

The sources of air pollution, type of fuel used, fuel consumption and chimney heights for each of the air pollution sources of the proposed project are indicated in the following table 2.17.



Table: 2.17 Air pollution sources, fuel consumption and chimney height details

SI. no.

Stack attached to Fuel used

Fuel consumption

Number of

stacks

Stack height

Air pollution control unit

Predicted emissions

Existing

1 Process section(scrubbers) (Production block & Finishing block 5 nos each)

- - 15 3 m ARL for each

Packed column scrubbers – 15 no.s

Acid mist/ VOCs

2 Steam boilers – 6 TPH 1 no. + 10 TPH – 1 no.

Coal/ Furnace oil / Husk

1303.06 kgs/Hr

1 32 m AGL (common stack for the 2 boilers)

Mechanical dust collectors/ multicyclone - 2 no.s

SO2, NOx, SPM

3 D.G. sets - 625 kVA – 3 no.s

HSD 125 L/hr 3 6 m ARL for each DG set

Stack SO2, NOx, SPM

Proposed

1 D.G. set new install -750 KVA-1 no.s

HSD 150 L/hr 1 6 m ARL For each DG set

stack SO2, NOx, SPM

2 Process section (Newly insttalled thermic flueid)

6 lakh kilo kalaries-1 no’s

FO/LDO 71 kgs/Hr 1 14 m AGL (combined stack)

Stack SO2, NOx, SPM

* Stack height calculation for Boilers Formula adopted for stack height calculation

H = 14(Q)0.3

Where, H is stack height Above Ground Level Q is sulfur emissions in kg/hr



6&10 TPH BOILER / 400kg/ hr Type of fuel used – Husk Sulfur content in Husk = 0.06% Moisture content=8.21% Nitrogen content=0.35% Ash content=17.62% Carbon content=36.07% However a stack of height 32 m AGL is installed Note : combined stack for 6 TPH, 10 TPH boiler & 6 LK/cl thermic fluid heater is installed The exhaust temperature will be nearly ambient and adequate port holes with access platform will be provided as per KSPCB guidelines as under 1. Location of port holes and approach platform The sampling porthole will be provided at a distance equal to at least eight times the stack diameters downstream and two diameters upstream from source of low disturbance such as bend, expansion, and construction valve fitting or visible flame for rectangular stacks. The equivalent diameter is calculated from the following equation Equivalent diameter = 2 (Length x Width) (Length x Width) 2. The diameter of the sampling port will be minimum 3”. Arrangement will be made to close the port hole firmly during the period when it is not used for sampling. 3. An easily accessible platform will be provided to accommodate 3 to 4 persons to conveniently sample stack emissions from the portholes. Ambient air quality and stack emission monitoring Ambient air quality monitoring will be conducted once in a month as per the guidelines of KSPCB for SPM, RSPM, SOx, NOx, HC and CO and the record of monitoring reports will be maintained and made available to authorities. Similarly stack monitoring will also be conducted for SOx.



SCRUBBER DETAILS

Scrubber systems are a diverse group of air pollution control devices that can be used to remove particulates and/or gases from industrial exhaust streams. Traditionally, the term "scrubber" has reference to pollution control devices that used liquid to "scrub" unwanted pollutants from a gas stream. Recently, the term is also used to describe systems that inject a dry reagent or slurry into a dirty exhaust stream to "scrub out" acid gases. Scrubbers are one of the primary devices that control gaseous emissions, especially acid gases. Wet scrubber is a form of pollution control technology in which the polluted gas stream is brought into contact with the scrubbing liquid by spraying it with the liquid, by forcing it through a pool of liquid, or by some other contact method, so as to remove the pollutants. The design of wet scrubbers or any air pollution control device depends on the industrial process conditions and the nature of the air pollutants involved. Inlet gas characteristics and dust properties (if particles are present) are of primary importance. Scrubbers can be designed to collect particulate matter and/or gaseous pollutants. Wet scrubbers remove dust particles by capturing them in liquid droplets; remove pollutant gases by dissolving or absorbing them into the liquid. Any droplets that are in the scrubber inlet gas must be separated from the outlet gas stream by means of another device referred to as a mist eliminator or entrainment separator (these terms are interchangeable). Also, the resultant scrubbing liquid must be treated prior to any ultimate discharge or before being reused in the plant. There are numerous configurations of scrubbers and scrubbing systems, all designed to provide good contact between the liquid and polluted gas stream. The process and solvent recovery sections are provided with scrubber to scrub the fumes and vapors generated in order to remove such emissions before it is let out into the atmosphere. Scrubber Details:

1) scrubbing system for C block intermediate reactors

Type : Single Stage

Counter Flow Packed Bed

Dia : 1250 mm

Height : 4000 mm

M O C : PP/FRP

PP : 5 mm

FRP : 7 mm with Isopthalic Resin

Packing : Polypropylene Pal Rings

Size : 40 mm dia x 40 mm height

Filter Plate : PP Perforated - 15 mm thick

Spray : Polypropylene Jet Spray System



b) Blower:

Type : Backward Curve SISW

Casing : PP/FRP with Isopthalic Resin

Impeller : MS/FRP with Bisphenol Resin

Capacity : 18000 CMH

Stat. Pressure : 150 mmwg

Motor : 20 HP FLP – 1440 RPM

Make : Kirloskar or CG

Drive : Belt

c) Ducting Details:

M O C : PP/FRP

Sizes : 250, 350, 450 & 700 mm dia

Ducting includes Straight lengths, Elbows, T-sections & Reducers

d) Liquid Circulation Tank:

Capacity : 3 K L

PP : 5 mm

FRP : 7 mm with Isopthalic Resin

Cylindrical, vertical, flat bottom & conical top

External MS/FRP Reinforcement

Necessary Nozzles & Manhole

e) Pump:

Make : Antico

Model : 130 CT

Drive Motor : 3 HP – 2900 RPM FLP

f) Liquid Circulation Lines:

MOC : HDPE

Sizes : Variable from 40 mm dia to 75 mm dia

g) MS Support Structure for Scrubber with Anti Corrosive Coating:

Vertical Design 6 L Kcal Capacity Oil fired Thermic Fluid Heater:

Equipments Connected to the System: AO/RE-01, AO/RE-02, AO/RE-03, AO/RE-04, AO/RE-05, AO/RE-06.



a) Technical specifications:

MODEL VRT-HT-06

HEAT OUTPUT [KCAL/H] 600000

THERMIC FLUID FLOW THROUGH THE UNIT [L/H] 79000

TEMPERATURE AT HEATER OUTLET 345 º C

THERMAL EFFICIENCY [%] 88

FUEL OIL CONSUMPTION AT MAX. OUTPUT [KG/H] FO/LDO

- FURNACE OIL 9650 KCAL/KG NCV 70.65

- LDO OF 10200 KCAL/KG NCV 66.85

ELECTRICAL CONNECTED LOADS [KW]

THERMIC FLUID PUMP MOTOR 22 KW

BLOWER MOTOR 3.7 KW

FUEL OIL PUMP 0.37 KW

ELECTRICAL OIL PRE HEATER (3.0+3.0+3) KW

ELECTRIC SUPPLY AC;3PHASE;415±5%V;50±3% HZ;4WIRE SYSTEM

APPROX. OVERALL SIZE [MM]

LENGTH 2650

WIDTH 1650

HEIGHT 2520

APPROX. DRY WEIGHT [KG] 3100

b) Technical Comparison for Thermic Fluid Heater

Sr. No Item Description

1 Make Maxima

2 Model VRT-HT-06

3 Type Fully automatic, coil type, pressurized,

Thermic fluid tube. Vertical Unit

4 Heat output 600000 kcal/Hr

5 Thermic fluid inlet temperature 0C 325 Deg C

6 Thermic fluid outlet temperature 0C 340 Deg C

7 Furnace oil consumption (kg/hr) 71 Kgs/Hr

8 Thermal Efficiency 88%

9 Overall dimensions including space for cleaning and maintenance (L X B X H),

mm

L-2100 x W-2100 x H-2950 add another 3.0 mtr for coil removal

10 Empty weight of the unit 3100 Kgs

11 Operating weight of the unit 3397 Kgs

12 Dimensions of coil (Dia X Length X no

of turns)

a Quantity of Thermic fluid required Coil Hold-up 297 Litrs

b Pressure Drop across Hot Oil Unit 20 MLC



13 Expansion tank 3 KL

a Dimensions (L x B x H ), mm 1900 x 1300 x 1300 mm

b MOC IS 2062

c Empty weight (kg) 1296 Kgs

d Operating weight (kg) 4406 Kgs

14 Thermic fluid storage tank or Dump

Tank 5 KL


b MOC IS 2062



15 Furnace oil day tank 0.99 KL


b MOC IS 2062



16 Thermic fluid circulation pumps

a Capacity 79 M3/Hr

b Head 60 MLC

c Speed 2900 rpm

d BKW / Recommended motor BKW - 18 / KW- 22KW

e MOC of casing CI

f MOC of impeller CI

g Shaft seal details Mechnaical Seal

h Flushing plan details Drain Point

17 Thermic fluid filling pump

a Capacity 1000 LPH

b Head 50 MLC

c Speed 1440 rpm

d BKW / Recommended motor BKW - 0.5 / KW- 0.75 KW

e MOC of casing CI/CS

f MOC of impeller EN (Gear + Shaft)



18 Blower

a Capacity 1800 M3/Hr

b Head 400 mm Wc

c BKW / Rec. motor (KW) BKW - 3 / KW- 3.7 KW

19 Thermic fluid Drain pump Not

Required



a Capacity 1000 LPH

b Head 50 MLC

c Speed 1440 rpm


e MOC of casing CI/CS

f MOC of impeller EN (Gear + Shaft)



20 Stack Details Customer Scope

a Diameter 350 mm

b Height 30.5 Mtr

c M.O.C. IS 2062

d Type Self Supported, as per IS 6533

e Connected Electric load 22.22 KW

21 OIL PUMP Make Prakash /Eqvt

a Type Gear

b Capacity 300 LPH

c Head 300 mWC


22 BURNER Make Maxima

a Type Pr. Jet Spill return

b Capacity 0.8 MW

c Modulation Two stage

Fig 2.7: Column scrubber



Mechanical dust collector:

Capacity of boiler : 10 Ton Output gas flow : 24000 CMH Type of fuel : Coal/husk Temp of flue gases : 180°C-220°C Air quantity to be handled : 24000 CMH Pressure drop across the system : 70-75 MMWG Total no of cyclones : 16 No.’s Size of output pipe : Ф 150 mm Thickness of cones : 10 mm Material of construction of cones : IS 210 Thickness of outer casing & hopper : 3.15 mm

2.9.3.3 NOISE GENERATION AND ITS MANAGEMENT

The major source of noise pollution in the industry is the DG set for which acoustic enclosure is proposed. Also ambient noise levels will be ensured within the ambient standards by inbuilt design of mechanical equipment and building apart from vegetation (tree plantations) along the periphery and at various locations within the industry premises.

2.9.3.4 SOLID WASTE GENERATION AND MANAGEMENT

The quantity of solid waste generated from the industry is calculated as below in the table 2.18



TABLE 2.18 SOLID WASTE GENERATION

Total no. of employees 600

Assuming per capita solid waste generation rate as 0.2 kg/capita/day

Quantity of solid waste generated 120 kg/day

Organic solid waste : 60 % of the total waste 72 kg/day

Inorganic solid waste : 40 % of the total waste 48 kg/day

Disposal of domestic solid waste The domestic wastes are segregated at source, collected in bins and composted.

2.9.3.5 Hazardous raw materials used in the manufacturing process and hazardous waste

generation and management

2.9.3.5.1 HAZARDOUS RAW MATERIALS

The following raw materials used during the process of manufacture of APIs and

Intermediates are hazardous in nature according to Manufacture, Storage and Import of

Hazardous Chemical (Amendment) Rules, 1989 (as amended on 24-9-2008), Schedule-1.

TABLE 2.19: Hazardous raw materials

Hazardous raw material Sl. No. as per Hazardous Wastes (Management & Handling) Rules, 1989 (as amended on 24-9-2008), Schedule-1.

Acetic acid 2

Acetic anhydride 3

Acetone 4

Acetonitrile 7

Aluminum chloride 22

Ammonia 31

Benzene sulfonyl chloride 57

Bromine 84

Chlorobenzene 128

Chloroform 130

Chlorosulphonic acid 136

Cyclohexane 161

Dimethyl amine 215

Dioxane 224

Ethyl acetate 247

Ethyl alcohol 248



Formaldehyde 285

Hexane 306

Hydrogen 314

Isopropyl alcohol 334

Methyl alcohol 377

Methylene chloride 400

Nickel powder 420

Phosphoric acid 497

Phosphorous trichloride 506

Phthalic anhydride 508

Piperidine catalyst 514

Potassium hydroxide 522

Pyridine 547

Sodium hydroxide 571

Sulfuric acid 591

Thionyl chloride 620

Toluene 628

Triethyl amine 652

2.9.3.5.2 HAZARDOUS WASTE GENERATION AND MANAGEMENT

The hazardous wastes generated during the process of manufacture of different APIs & Intermediates are stored at hazardous waste storage area and sent to TSDF. The quantities of hazardous waste generated from various processes are shown in the following tables.



1. PROCESS RESIDUE

Table : -2.20 Quantity of organic process residue generation from manufacturing process.

Stages Residue generation

Name of the Product Stage Residue generated

Qty per Batch

No. of Batches/

month

Residue generated

Qty /month

Residue generated Qty /year

Ambroxol Hcl I 0 1.7 0 0

II 0 1.7 0 0

Anastrozole I 0 8 0 0

II 0 8 0 0

III 0 8 0 0

Gemcitabine Hcl I 0 3 0 0

II 0 3 0 0

III 0 3 0 0

Paclitaxel I 0.1 8.3 0.83 9.96

II 0.2 8.3 1.66 19.92

III 0 8.3 0 0

IV 0 8.3 0 0

Temozolomide I 0.16 8 1.28 15.36

II 0 8 0 0

Bicalutamide I 2 5 10 120

Docetaxel trihydrate I 2.15 8 17.2 206.4

II 0.4 8 3.2 38.4

III 0 8 0 0


I 0 20 0 0

II 0 20 0 0

III 0.08 20 1.6 19.2

IV 0 20 0 0

V 0 20 0 0

VI 0 20 0 0

Bendamustine Hcl I 0.1 14 1.4 16.8

Bortezomib I 0.1 41.7 4.17 50.04

II 0.02 41.7 0.834 10.008

III 0 41.7 0 0



Capecitabine I 0.4 50 20 240

II 0.1 50 5 60

III 0.2 50 10 120

Imatinib mesylate I 0 41.7 0 0

Lenalidomide I 0.1 41.7 4.17 50.04

II 2 41.7 83.4 1000.8

Letrozole I 0.2 4.2 0.84 10.08

II 0.7 4.2 2.94 35.28

Pemetrexed disodium I 0 20.8 0 0

II 0 20.8 0 0

III 0.4 20.8 8.32 99.84

Decitabine I 0 1.7 0 0

II 0 1.7 0 0

III 1.2 1.7 2.04 24.48

IV 0 1.7 0 0

V 0 1.7 0 0

Cytrabine I 0 13 0 0

II 0.05 13 0.65 7.8

Cabazitaxel I 0 2.1 0 0

II 0 2.1 0 0

III 0 2.1 0 0

Acebrophylline I 0 3.3 0 0

II 0 3.3 0 0

Clofarabine I 0 2 0 0

II 0 2 0 0

III 2.9 2 5.8 69.6

IV 0 2 0 0

Melphalan Hcl I 0 3.8 0 0

II 0 3.8 0 0

III 0 3.8 0 0

IV 0 3.8 0 0

V 0 3.8 0 0

Cyclophosphamide I 0 63.1 0 0

II 0 63.1 0 0

III 0 63.1 0 0

Tenofovir I 0.15 16.7 2.505 30.06

II 0 16.7 0 0

Pemetrexed dipotassium I 0 10.4 0 0



II 0 10.4 0 0

III 2 10.4 20.8 249.6

Erlotinib I 0 6.7 0 0

II 6 6.7 40.2 482.4

III 0 6.7 0 0

IV 5 6.7 33.5 402

Emtricitabine I 0 0.3 0 0

II 0 0.3 0 0

Dimethyl Fumarate I 3 4 12 144

II 0.5 4 2 24

Elvitegravir I 0.25 0.3 0.075 0.9

II 0.05 0.3 0.015 0.18

III 0 0.3 0 0

IV 0 0.3 0 0

V 0 0.3 0 0

VI 0 0.3 0 0

Cobicistat I 0 33 0 0

II 0 33 0 0

III 1.31 33 43.23 518.76

IV 3.8 33 125.4 1504.8

V 0 33 0 0

VI 0 33 0 0

VII 0 33 0 0

Busulfan I 0 4.2 0 0

II 1.376 4.2 5.7792 69.3504

Zoledronic Acid I 1.5 0.4 0.6 7.2

II 3.04 0.4 1.216 14.592

III 2.2 0.4 0.88 10.56

IV 0 0.4 0 0

Tranexamic acid I 0 18.5 0 0

II 0 18.5 0 0

III 0 18.5 0 0

IV 0 18.5 0 0

V 0 18.5 0 0

VI 0 18.5 0 0

VII 0 18.5 0 0

Sunitinib Malate I 3 12.5 37.5 450

II 0 12.5 0 0



III 0 12.5 0 0

Sorafenib Tosylate I 6 25 150 1800

II 2.5 25 62.5 750

III 0 25 0 0

Abiraterone acetate IV 0 2.5 0 0

Total qty/year Total qty/month 723.5342 8682.4104

Total qty/month Total qty/year 8682.4104

SPENT CARBON

Table : -2.21 Details of Spent carbon

Spent Carbon generation in kg

Sl.No

Name of the Product

Manufacturing qty/year

(MT)

Stage Spent Carbon

generated Qty per Batch

No. of Batches/

month

Spent Carbon generated

Qty /month

Spent Carbon

generated Qty /year

1 Ambroxol Hcl 10 I 0 1.7 0 0

II 4 1.7 6.8 81.6

2 Anastrozole 0.1 I 0 8 0 0

II 0 8 0 0

III 0 8 0 0

3 Gemcitabine Hcl

0.1 I 0 3 0 0

II 0.18 3 0.54 6.48

III 0 3 0 0

4 Paclitaxel 0.1 I 0 8.3 0 0

II 0 8.3 0 0

III 0 8.3 0 0

IV 0 8.3 0 0

5 Temozolomide 0.1 I 0 8 0 0

II 0.2 8 1.6 19.2

6 Bicalutamide 0.5 I 0 5 0 0


0.1 I 0 8 0 0

II 0 8 0 0

III 0 8 0 0


60 I 0 20 0 0

II 0 20 0 0

III 0 20 0 0

IV 0 20 0 0

V 0 20 0 0

VI 0 20 0 0



9 Bendamustine Hcl

0.2 I 0 14 0 0

10 Bortezomib 0.005 I 0 41.7 0 0

II 0 41.7 0 0

III 0 41.7 0 0

11 Capecitabine 60 I 0 50 0 0

II 0 50 0 0

III 0 50 0 0

12 Imatinib mesylate

5 I 1 41.7 41.7 500.4

13 Lenalidomide 0.5 I 0 41.7 0 0

II 0.1 41.7 4.17 50.04

14 Letrozole 0.05 I 0 4.2 0 0

II 0 4.2 0 0

15 Pemetrexed disodium

0.25 I 0 20.8 0 0

II 0 20.8 0 0

III 0 20.8 0 0

16 Decitabine 0.01 I 0 1.7 0 0

II 0 1.7 0 0

III 0 1.7 0 0

IV 0 1.7 0 0

V 0.5 1.7 0.85 10.2

17 Cytrabine 0.5 I 0 13 0 0

II 0 13 0 0

18 Cabazitaxel 0.001 I 0 2.1 0 0

II 0 2.1 0 0

III 0 2.1 0 0

19 Acebrophylline 10 I 0 3.3 0 0

II 0 3.3 0 0

20 Clofarabine 0.001 I 0 2 0 0

II 0 2 0 0

III 0 2 0 0

IV 0 2 0 0

21 Melphalan Hcl 0.025 I 1 3.8 3.8 45.6

II 0 3.8 0 0

III 0 3.8 0 0

IV 0 3.8 0 0

V 0 3.8 0 0

22 Cyclophosphamide

1.00 I 0 63.1 0 0

II 0 63.1 0 0



III 0 63.1 0 0

23 Tenofovir 50 I 0 16.7 0 0

II 0 16.7 0 0

24 Pemetrexed dipotassium

0.25 I 0.7 10.4 7.28 87.36

II 0 10.4 0 0

III 0 10.4 0 0

25 Erlotinib 2 I 0.705 6.7 4.7235 56.682

II 0 6.7 0 0

III 0 6.7 0 0

IV 0.405 6.7 2.7135 32.562

26 Emtricitabine 1 I 0 0.3 0 0

II 3 0.3 0.9 10.8

27 Dimethyl Fumarate

12 I 0 4 0 0

II 0 4 0 0

28 Elvitegravir 1 I 0 0.3 0 0

II 0 0.3 0 0

III 0 0.3 0 0

IV 1.2 0.3 0.36 4.32

V 2 0.3 0.6 7.2

VI 0 0.3 0 0

29 Cobicistat 100 I 0 33 0 0

II 0 33 0 0

III 0 33 0 0

IV 0 33 0 0

V 0 33 0 0

VI 0 33 0 0

VII 3.77 33 124.41 1492.92

30 Busulfan 0.05 I 0 4.2 0 0

II 1 4.2 4.2 50.4

31 Zoledronic Acid 0.005 I 0 0.4 0 0

II 0 0.4 0 0

III 0 0.4 0 0

IV 0.16 0.4 0.064 0.768

32 Tranexamic acid 100 I 0 18.5 0 0

II 0 18.5 0 0

III 0 18.5 0 0

IV 0.1 18.5 1.65 22.2

V 0 18.5 0 0

VI 0 18.5 0 0

I 0 18.5 0 0



33 Sunitinib Malate

3 I 0 12.5 0 0

II 0 12.5 0 0

III 0 12.5 0 0


3 I 0 25 0 0

II 0 25 0 0

III 0 25 0 0


2 I 0 2.5 0 0

II 0 2.5 0 0

III 0 2.5 0 0

IV 2 2.5 5 60

Total qty in kg/month 211.561 2538.37 or say 2539

Note: Spent carbon will be sent to authorize re-processors for recovery & re-use. INORGANIC SALT GENERATION FROM THE PROCESS

Table : -2.22 Inorganic Salt Generation From The Process

Stages Inorganic salt generation

Name of the Product Stage

Inorganic Salt

generated Qty per batch

No. of Batches/

month

Inorganic Salt

generated Qty per month

Inorganic Salt

generated Qty per

year

Ambroxol Hcl I 0 1.7 0 0

II 0 1.7 0 0

Anastrozole

I 0 8 0 0

II 0 8 0 0

III 1.25 8 10 120

Gemcitabine Hcl

I 0 3 0 0

II 0 3 0 0

III 0 3 0 0

Paclitaxel

I 3.75 8.3 31.125 373.5

II 0 8.3 0 0

III 0 8.3 0 0

IV 0 8.3 0 0

Temozolomide I 0 8 0 0

II 0 8 0 0

Bicalutamide I 5 5 25 300

Docetaxel trihydrate I 21.6 8 172.8 2073.6



II 0 8 0 0

III 0 8 0 0


I 0 20 0 0

II 0 20 0 0

III 0 20 0 0

IV 0 20 0 0

V 0 20 0 0

VI 0 20 0 0

Bendamustine Hcl I 0 14 0 0

Bortezomib

I 0.8 41.7 33.36 400.32

II 0.8 41.7 33.36 400.32

III 0 41.7 0 0

Capecitabine

I 1.5 50 75 900

II 0 50 0 0

III 7.5 50 375 4500

Imatinib mesylate I 0 41.7 0 0

Lenalidomide I 0 41.7 0 0

II 0 41.7 0 0

Letrozole I 0 4.2 0 0

II 0 4.2 0 0

Pemetrexed disodium

I 0 20.8 0 0

II 0 20.8 0 0

III 0 20.8 0 0

Decitabine

I 4.38 1.7 7.446 89.352

II 8 1.7 13.6 163.2

III 79.88 1.7 135.796 1629.552

IV 0 1.7 0 0

V 0 1.7 0 0

Cytrabine I 0 13 0 0

II 0 13 0 0

Cabazitaxel

I 0 2.1 0 0

II 0 2.1 0 0

III 0 2.1 0 0

Acebrophylline I 85 3.3 280.5 3366

II 0 3.3 0 0

Clofarabine

I 110.21 2 220.42 2645.04

II 0 2 0 0

III 0 2 0 0

IV 2.45 2 4.9 58.8



Melphalan Hcl

I 1.29 3.8 4.902 58.824

II 0 3.8 0 0

III 2.5 3.8 9.5 114

IV 57.46 3.8 218.348 2620.176

V 0 3.8 0 0

Cyclophosphamide

I 0 63.1 0 0

II 23.25 63.1 1467.075 17604.9

III 0.22 63.1 13.882 166.584

Tenofovir I 0 16.7 0 0

II 0 16.7 0 0

Pemetrexed dipotassium

I 0.7 10.4 7.28 87.36

II 0 10.4 0 0

III 0 10.4 0 0

Erlotinib

I 241 6.7 1614.7 19376.4

II 11.5 6.7 77.05 924.6

III 445.5 6.7 2984.85 35818.2

IV 2.7 6.7 18.09 217.08

Emtricitabine I 0 0.3 0 0

II 35 0.3 10.5 126

Dimethyl Fumarate I 55.55 4 222.2 2666.4

II 0.1 4 0.4 4.8

Elvitegravir

I 16 0.3 4.8 57.6

II 0 0.3 0 0

III 4.17 0.3 1.251 15.012

IV 0 0.3 0 0

V 0 0.3 0 0

VI 0 0.3 0 0

Cobicistat

I 0 33 0 0

II 0 33 0 0

III 0 33 0 0

IV 0 33 0 0

V 0 33 0 0

VI 0 33 0 0

VII 0 33 0 0

Busulfan I 0 4.2 0 0

II 0 4.2 0 0

Zoledronic Acid

I 0 0.4 0 0

II 0 0.4 0 0

III 0 0.4 0 0



IV 0.4 0.4 0.16 1.92

Tranexamic acid

I 0 18.5 0 0

II 0 18.5 0 0

III 0 18.5 0 0

IV 0 18.5 0 0

V 0 18.5 0 0

VI 0 18.5 0 0

VII 0 18.5 0 0

Sunitinib Malate

I 0 12.5 0 0

II 0 12.5 0 0

III 0 12.5 0 0

Sorafenib Tosylate

I 0 25 0 0

II 0 25 0 0

III 0 25 0 0

Abiraterone acetate IV 0 2.5 0 0

Total qty/year Total qty/month 8073.295 96879.54

Total qty/month Total qty/year 96879.54

SPENT CATALYS

Table : -2.23 Quantity of spent catalyst generation from manufacturing process Sl. No. APIs &

intermediates Stage Type of

catalyst Quantity of spent catalyst generated

kg/batch kg/month kg/annum

1 Bicalutamide

1st Potassium permanganate

5 5 60

2 Ursodeoxycholic Acid 1st

3 Ambroxol HCl - - - - -

4 Anasrozole - - - - -

5 Temozolabide -

6 Docetaxel Trihydrate - - - - -

7 Paclitaxel - Zinc dust 3.75 30 360

8 Acebrophylline - - - - -

9 Imatinib - - - - -

10 Capacitabine - Pyridine 6 120 1440

11 Bendamustine

12 PMD - - - - -

13 Bortzomib 2nd

14 Busulfan 1st

15 Letrozole 2nd

16 Lenalidomide - Raney nickel 0.6 0.6 7.2

17 Tenfovir -

18 Erlotonib -



19 PMK -

20 Decitabine - Pyridine 19.3 19.3 231.6

21 Zoledranic Acid - - - - -

22 Melphalan - - - - -

23 Cytrabine - - - - -

24 Cyclophosphamide - - - -

25 Cabazitaxel - - - - -

26 Cloferabine - - - - -

27 Emtricitabine - - - - -

28 Dimethyl fumarate - - - - -

29 Elvitegravir - - - - -

30 Cobicistat - - - - -

31 Gemcitabine HCl

- - - - -

32 Tranexamic acid 2nd Raney-Ni 49 808.5 9702

33 Sunitinib Malate - - - - -

34 Sorafenib Tosylate - - - - -

35 Abiraterone acetate - - - - -

Total qty in kg 83.65 875.4 11,800.8

Note: Spent catalysts will be sent to authorized re-processors for recovery & re-use.



OTHER HAZARDOUS WASTES Table : -2.24 Summary of the total quantity of hazardous wastes:

Sl. No.

Source

Quantity of hazardous waste generated

Category according to Schedule I of hazardous waste categories

Treatment/ Disposal kg/month kg/annum

1 Process residue 723.5 8682.4 28.1 Send to Co processing industries in cement industries.


8073.295 kg 96879.54 kg 34.3 Send to TSDF (Treatment Storage & Disposal Facility), Bangalore

3 Spent Carbon 211.36 2536.3 28.2 Send to Co processing industries in cement industries

4 Spent catalyst

875.4 11,800.8 28.2

Sent to manufacturer/ reprocessor for recycle and reuse.


150 L/Month 1800 L/annum


6 Spent Solvent 51940 L/month 623288 L/annum

20.2

Solvent distillation inhouse/Send to authorized spent solvent re-processors for recover & re-use.

7 Distillation residue

1.5 MT/month 20.3 MT/annum

20.3 Send to Co processing industries in cement industries

8

Salt from Multiple effect Evaporation System

32739 kg/monh (26739 kg from unit-2 + 6000 from unit-1)

393 Tons/annum

34.3

Send to TSDF (Treatment Storage & Disposal Facility), Bangalore/ Co processing industries.

9 ETP Sludge 3000 kg 36000 kg 34.4




10 Discarded Containers/ liners /barrels

500 No’s/month 6000 no’s/annum


11 Used Batteries -- 05 Hand over to authorized re – cyclers

12 E-Waste 5 kg 60 kg Handed over to KSPCB authorized recyclers/re-processors

Table 2.25: Characteristics of hazardous waste

Sl. No

Parameter Unit Method CPCB Std. and WLT/TCLP Limit for Direct Landfill

1 Physical state - Visual observation -

2 Color - Visual observation -

3 Texture - Visual observation -

4 Bulk density gm/cc ASTM Std: D 5057 -1990 (Reapproved 2001)

-

5 Paint Filter Liquid Test

- SW-846:9095 A Pass

6 pH (at 29.60 C) - SW-846:9040B, 9045 C 4.0 - 12.0

7 Calorific Value kcal/kg IS:1350 (Part II)-1970 (Reaffirmed 1983)

<2500.0

8 Flash Point 0C SW-846:1020A >60.0

9 Loss on drying at 103-1050 C

% (w/w) Std.Methods:2540 B -

10 Loss on ignition at 5500 C (dry basis)

% (w/w) Std. Methods:2540 E < 20.0 (non-biodegradable) <5.0 (biodegradable)

11 Reactive cyanide mg/kg SW-846: Ch.7 (7.3.3), 9014 -

12 Reactive sulfide mg/kg SW-846: Ch.7 (7.3.4), 9034 -

13 Water soluble compounds except salts – in WLT extract

% (w/w) DIN:38414 Part 4 (S4) Std. Methods:2540 B,E

<10.0

14 Oil and grease (As n-hexane extractable)

% (w/w) SW-846:3540C, 9071A <4.0

15 Cyanide-total mg/kg SW-846:9010B, 9014 -



15 a

Cyanide-WLT mg/L DIN:38414 Part 4 (S4) Std. Methods:4500-CN-C SW-846:9014

<2.0

16 Fluoride-Total mg/kg Std.Methods:4500-F-B,D -

16 a

Fluoride-WLT mg/L DIN:38414 Part 4 (S4) Std.Methods:4500F-B,D

<50.0

17 Nitrate-WLT mg/L DIN:38414 Part4 (S4) Std.Methods:4500-NO3

- E <30.0

18 Ammonia -WLT mg/L DIN:38414 Part4 (S4) Std.Methods:4500-NH3 B,C

<1000.0

19 Arsenic-Total mg/kg SW-846:3050B Std.Methods:3500-As B

-

19 a

Arsenic- WLT mg/L DIN:38414 Part 4(S4) SW-846:3010A Std.Methods:3500-As B

<1.0

20 Cadmium –Total mg/kg SW-846:3050B,7130 -

20 a

Cadmium - WLT mg/L DIN:38414 Part4(S4) SW-846:3010A,7130

<0.20

21 Chromium – Total mg/kg SW-846 :3050 B, 7190 -

21 a

Chromium (VI)-WLT

mg/L DIN:38414 Part4(S4) Std.Methods:3500-Cr B

<0.50

21 b

Chromium-TCLP mg/L SW-846:1311 SW-846:3010A, 7190

<5.0

22 Copper-Total mg/kg SW-846:3050B, 7210 -

22 a

Copper-WLT mg/L DIN:38414 Part4(S4) SW-846:3010A, 7210

<10.0

23 Lead-Total mg/kg SW-846:3050B, 7420 -

23 a

Lead-WLT mg/L DIN:38414 Part4(S4) SW-846:3010A, 7420

<2.0

25 Nickel-Total mg/kg SW-846:3050B, 7520 -

25 a

Nickel-WLT mg/L DIN:38414 Part4(S4) SW-846:3010A, 7520

<3.0

27 Zinc-Total mg/kg SW-846:3050B, 7950 -

27 a

Zinc-WLT mg/L DIN:38414 Part4(S4) SW-846:3010A, 7950

<10.0

28 Phenol-Total mg/kg SW-846:9065 -

28 a

Phenol-WLT mg/L DIN:38414 Part4(S4) SW-846:9065

<100.0



2.9.3.5.3 STORAGE FACILITIES FOR HAZARDOUS WASTE

The industry proposes to provide adequate storage facilities for the hazardous wastes. The details are appended below.

Table :- 2.26 Storage Facilities For Hazardous Waste

Storage facilities at the project site

A designated impervious structure (sealed drums under cover roof) is proposed at the project site for collection and storage of hazardous waste.

Hazardous waste disposal Hazardous waste generated from the proposed Industry will be handed over to M/s. Karnataka Waste Management Project (a division of RAMKY Enviro Engineers Ltd) and Mother Earth Environ tech private limited. situated at Sy. No. 7-85, KIADB Industrial area, Thimmanayakahalli, Dabaspet, Nelamangala Taluk, Bangalore.

Distance from the project site About 450 km

Mode of transport Provided by M/s. Karnataka Waste Management Project,

M./sMothwer earth Environ Tech private limited Table: -2.27 Disposal Facilities For Hazardous Waste

Sl. No.

Source Treatment/ Disposal

1 Process residue Send to authorized spent re-processors /Co processing industries.


Send to TSDF (Treatment Storage & Disposal Facility), Bangalore

3 Spent Carbon Send to authorized spent catalyst re-processors for regeneration & re-use.


Handed over to KSPCB authorized recyclers/re-processors

5 Spent Solvent Send to authorized spent re-processors for recover & re-use.

6 Salt from Multiple effect Evaporation System


7 ETP Sludge Send to TSDF (Treatment Storage & Disposal Facility), Bangalore/ Co processing industries.

8 Discarded Containers Handed over to KSPCB authorized recyclers/re-processors

9 Used Batteries Hand over to authorized re – cyclers

10 E-Waste Handed over to KSPCB authorized recyclers/re-processors



Hazop analysis of the products is enclosed as annexure- 1

2.9.4 RAINWATER HARVESTING & GROUNDWATER RECHARGING The total amount/quantity of water i.e., received in the form of rainfall over an area is called

the rain water endowment of that area, out of which the amount of water that can be

effectively harvested is called the rain water harvesting potential.

Rain water harvesting potential = Intensity of rainfall (m) x Roof area x

Impermeability factor

The collection efficiency accounts for the fact that all the rain water falling over an area cannot be effectively harvested due to losses on account of evaporation, spillage or runoff etc. According to the meteorological data for Raichur, the average rainfall = 2.67 mm/hr Assuming that about 90% rainfall can be effectively harvested No. of hours it rains/day = 2 hrs Therefore intensity of rainfall = 4.8 mm/day or 0.005 m/day

Quantity of roof top rain water harvested from the project: The Ground Coverage area of the proposed project is about 19459 sq m. For rain water harvesting consider 75% of this total area = 14594.25 sq m. Quantity of Rain Water that can be harvested from the proposed project is calculated as below. Water Harvested per Year = Mean Annual Rainfall x Area x Collection Efficiency = 0.005 x 14594.25 x 0.9 = 65.67 or say 66 m3/day However, it proposed to initially utilize the entire quantity of the rainfall potential by providing adequate storage facilities of 200 KL capcity of open pond. The amount of storm water that the landscaped/open area will produce can be determined by considering the impermeability factor to be 0.3. Q = 0.005 x 56066.06x 0.3 = 84.09 m3/day or say 85 m3/day

The amount of storm water that the paved area will produce can be determined by

considering the impermeability factor to be 0.3.

Q = 0.005 x 9458.94x 0.9

= 42.56 m3/day or say 43 m3/day



The total amount of storm water = landscaped area + paved area

= 43 + 85 m3/day

= 128 m3/day

The project Proponents will also provide recharging pits along the inner periphery of the

boundary wall. Each recharging pit will be of size 1.2 m dia x 2.5 m deep spaced at 20 m center

to center. These recharging pits are filled with graded media comprising of boulder at bottom

and with coarse aggregates to facilitate percolation of harvested rainwater to recharge

ground water table. The recharge pits are interconnected in such a way that the rain led to

the first recharge pit is also led to the next pit.

2.10 ASSESSMENT OF NEW & UNTESTED TECHNOLOGY FOR THE RISK OF TECHNOLOGICAL

FAILURE

The proposed project involves expansion and modification of Active Pharmaceutical Ingredients (APIs) & Intermediats manufacturing industry with R & D activity in an existing industry. The manufacturing process for these products is a tried & tested method & therefore there is no risk of technological failure. In addition to this the facility is being backed up by the R & D centre there would be continuous efforts for optimization of the process to care of the any technological failures.



CHAPTER 3

DESCRIPTION OF THE

ENVIRONMENT

3.1 STUDY AREA, PERIOD, COMPONENTS & METHODOLOGY

STUDY AREA: An area, covering 10 km radial distance around the project site is considered as

the study area for conducting baseline studies.

PERIOD: Baseline study in this Rapid Environmental Impact Assessment report was conducted

for a period of three months during December 2016 to Febraury 2017.

COMPONENTS: Air, noise, water & soil analysis studies were carried out. Survey of the flora &

fauna in the surroundings & demographic pattern of the survey area were also studied.

METHODOLOGY: Baseline environmental studies were conducted to know the status of various

environmental attributes, viz. climatic and atmospheric conditions, air, water, noise, soil, land

use pattern, ecological, socioeconomical environment. The studies involved conducting field

studies and analyzing various parameters that might be affected due to the expansion and

conducting socio-economic survey among the people. Secondary data was collected from

State/Central Government organizations, semi-Government and public sector organizations.



Fig 3.0: Topo map of the study area

Source: Survey of India; Scale: 1:50000

Note: Topo map of 10 km radius is appended as Annexure B



3.2 ESTABLISHMENT OF BASELINE 3.2.1 Meteorological data Assessment of the micro and macro meteorology is important from the standpoint of

understanding the nature and extent of air pollution in the study area. Climate has an important

role in the build-up of pollution levels. The climatic condition of the area may be classified as

moderately or seasonally dry, tropical or temperate savanna climate with four seasons in a

year. Winter is critical for air pollution build-up because of frequent calm conditions with

temperature inversions resulting in poor atmospheric mixing, natural ventilation and high

emission loads.

The classification of months according to the seasons is given in the following table.

Season Period Summer March to May

Monsoon June to September

Post monsoon October to November

Winter December to February

The metrological data reflecting minimum, maximum temperature in 0C, relative humidity in

%, rainfall in mm/hr, wind speed in m/s, mixing height in m, cloud cover in tenths and

atmospheric pressure in mb for the year 2016 obtained from modeling studies carried out

using U.S. EPA AERMOD dispersion model, 1996 – 2016 Lakes Environmental Software,

Version 7.1.0 has been appended as table 3.1.



TABLE 3.1: METEOROLOGICAL DATA OF BANGALORE FOR THE YEAR 2016

Month Temperature 0C

Relative humidity

%

Precipitation rate

(mm/hr)

Atmospheric Pr. (mb)

Wind speed (m/s)

Predominant wind

direction (blowing

from)

Inversion / mixing height

(m)

Cloud cover

(tenths)

Min Max Min Max Min Day Night Min Max Max Day Night Min Max

Jan 14.9 29.7 41 85 0 0.25 966 978 0 6.2 SE & E 2011 826 2 10

Feb 17.9 32.3 36 78 0 0.51 965 973 0 5.7 SE 2751 1206 2 10

Mar 20.0 33 34 70 0 2.79 963 973 0 6.7 SE & NW 2853 2143 2 6

Apr 22.4 36 24 55 0 0.76 961 970 0 6.7 NW 3626 2479 2 4

May 20.7 36.1 24 50 0 4.06 958 969 0 6.7 NW 3823 2555 2 5

June 22 35.1 29 60 0 3.30 959 968 0 8.2 W & SW 3298 3289 2 5

July 21.1 32.4 50 90 0 4.06 958 968 1 9.3 SW 2366 2506 3 10

Aug 21.1 32.8 36 74 0 5.33 959 969 0 8.2 W 2741 2294 2 10

Sept 21 33.8 33 70 0 5.08 959 969 0 7.2 W 3073 2776 2 10

Oct 21.1 32.1 32 70 0 4.06 957 973 0 6.7 NE 2935 1760 2 10

Nov 16.3 29.3 37 78 0 2.54 960 974 0 8.7 NE 2114 1267 2 10

Dec 16.3 27.5 40 82 0 1.52 966 976 0 5.1 E 1901 787 2 10



3.2.2 TEMPERATURE

The mean maximum temperature is observed at (36.1°C) in the month of May and the mean minimum temperature at (14.9°C) is observed in the month of January.

In the summer season the mean minimum temperature is observed during the month of

March (20°C). During the monsoon the mean maximum temperature is observed to be

35.1°C for June with the mean minimum temperature at 21°C during September. By the

end of September with the onset of post monsoon season (October - November), day

temperatures drop slightly with the mean maximum temperature at 32.1°C in October

and mean minimum temperature is observed at 16.3°C in the month of November. The

values are presented in table 3.1.

3.2.3 RELATIVE HUMIDITY

Minimum and maximum values of relative humidity have been recorded. During summer

season the minimum & maximum humidity value observed are 24% in April & May & 70%

in March. The mean minimum value of humidity during monsoon season is 29% in the

month of June & the maximum is 90% in the month of July. During the post-monsoon &

winter season the maximum value of humidity is 78% & 85% in November & January

respectively. The minimum values during these seasons are 32% in October & 36% in

February respectively.The values are presented in table 3.1.

3.2.4 RAINFALL

The monsoon in this region usually occurs twice in a year i.e. from June to September and

from October to November. The maximum annual rate of precipitation over this region

ranges between 0.25 to 4.06 mm/hr.

3.2.5 ATMOSPHERIC PRESSURE

The maximum and the minimum atmospheric pressures are recorded during all seasons.

In the summer season, the mean maximum and minimum pressure values are observed

to be 973 mb in the month of March and 958 mb in the month of May respectively. During

monsoon season, the maximum pressure is 969 mb and minimum 958 mb. The maximum

pressure during the post-monsoon season is observed to be 974 mb in November and

minimum pressure is 957 mb in the month of October. During the winter season the

minimum atmospheric pressure is 965 mb in February and the maximum is 978 mb in the

month of January.The values are presented in table 3.1.



3.2.6 WIND The data on wind patterns are pictorially represented by means of wind rose diagrams for the entire year as figure 3.1(for different seasons). Predominant wind directions

Season Period Wind direction Summer March to May South East

Monsoon June to September North East

Post monsoon October to November South West

Winter December to February South West



Fig 3.1: Wind rose diagrams

1) March to May (summer season)

WRPLOT View - Lakes Environmental Software

WIND ROSE PLOT:

Summer season - March to May

COMMENTS:

MODELER:

Aqua Tech Enviro Engineers

DATE:

9/15/2012

PROJECT NO.:

NORTH

SOUTH

WEST EAST

4%

8%

12%

16%

20%

WIND SPEED

(m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 14.09%

TOTAL COUNT:

2208 hrs.

CALM WINDS:

14.09%

DATA PERIOD:

2009 Mar 1 - May 3100:00 - 23:00

AVG. WIND SPEED:

2.46 m/s

DISPLAY:

Wind SpeedDirection (blowing from)

2016



2) June to September (monsoon season)


WIND ROSE PLOT:

Monsoon season - June to September

COMMENTS:

MODELER:


DATE:

9/15/2012

PROJECT NO.:

NORTH

SOUTH

WEST EAST

6%

12%

18%

24%

30%

WIND SPEED

(m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 2.22%

TOTAL COUNT:

2928 hrs.

CALM WINDS:

2.22%

DATA PERIOD:

2009 Jun 1 - Sep 3000:00 - 23:00

AVG. WIND SPEED:

3.75 m/s

DISPLAY:


2016



3) October to November (post monsoon season)


WIND ROSE PLOT:

Post monsoon season - October to November

COMMENTS:

MODELER:


DATE:

9/15/2012

PROJECT NO.:

NORTH

SOUTH

WEST EAST

5%

10%

15%

20%

25%

WIND SPEED

(m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 11.34%

TOTAL COUNT:

1464 hrs.

CALM WINDS:

11.34%

DATA PERIOD:

2009 Oct 1 - Nov 3000:00 - 23:00

AVG. WIND SPEED:

2.49 m/s

DISPLAY:


2016



4) December to February (winter season)


WIND ROSE PLOT:

Winter season - December to February

COMMENTS:

MODELER:


DATE:

9/15/2012

PROJECT NO.:

NORTH

SOUTH

WEST EAST

5%

10%

15%

20%

25%

WIND SPEED

(m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 21.57%

TOTAL COUNT:

2160 hrs.

CALM WINDS:

21.57%

DATA PERIOD:

2009 Check Date Range Report00:00 - 23:00

AVG. WIND SPEED:

2.04 m/s

DISPLAY:


2016



3.2.7 INVERSION HEIGHT The maximum inversion heights at the project site during the day time & night time for all the months of the year is as given in the table 3.1. The maximum mixing height of 3823 m is observed during the month of May during the day time and 3289 m during the month of June during the night time. The minimum inversion heights are 1901 m during the day & 787 m during the night both in the month of December. 3.2.8 CLOUD COVER

The minimum cover measured in the unit of tenths is 2 and the maximum observed cloud cover is 10.

3.3 BASELINE MONITORING

3.3.1 SAMPLING AND ANALYTICAL TECHNIQUES

AIR QUALITY

PM10 and PM2.5 have been estimated by gravimetric method. Modified West and Gaeke

Method (IS: 5182 Part – II, 1969) has been adopted for estimation of SO2. Jacobs –

Hochheiser Method (IS: 5182 Part-VI, 1975) has been adopted for the estimation of NOx.

NDIRS (Non-Dispersive Infra Red Spectroscopic) Method (IS: 5182 Part-X, 1999) has been

adopted for the estimation of CO and Electrochem sensor method has been adopted for

the estimation of Ozone. Spectrophotometric method for ammonia, AAS (Atomic

Absorption Spectrophotometry) method for lead. Summary of the analytical techniques

and their references are appended in the following table 3.2 & Protocol for surface water

quality & ground water quality monitoring is detailed in table 3.3 & 3.4 and Equipments

used for noise & soil monitoring is stated in table 3.5.



Table: 3.2: Techniques adopted/Protocols for ambient air quality monitoring

SL.

No

Parameters Techniques Technical

Protocol

Minimum

detectable limits

as provided by lab

1 Sulphur Dioxide (SO2) West & Gaeke IS:5182 (P2) 4 mcg

2 Nitrogen Dioxide (NO2) Jacob & Hochheiser IS:5182 (P6) 1 mcg

3 Particulate Matter PM10 Gravimetric IS:5182 (P15) 5 mcg

4 Particulate Matter

PM2.5

Gravimetric - 5 mcg

5 Ozone (O3) Electrochem sensor - NIL

6 Ammonia as NH3 Spectrophotometric Handbook of air

pollution

analysis

NIL

7 Carbon monoxide as CO NDIR IS: 5182 (P-10) 10 mcg

8 Lead as Pb AAS IS:5182 (P22) 0.01 mcg

WATER QUALITY

Table: 3.3: Protocol for surface water quality monitoring

Sl.

No.

Parameter/Test Protocol

Physical parameters

1 pH IS: 3025 (P 11)

2 Suspended solids IS: 3025 (P 17)

3 Color & odor IS: 3025 (P 4&5)

4 Oil & grease IS: 3025 (P 39)

Chemicals parameters

5 Total dissolved solids IS: 3025 (P 16)

6 Ammoniacal nitrogen, as N IS: 3025 (P 34)

7 Total kjeldahl nitrogen, as N IS: 3025 (P 34)

8 Biochemical Oxygen Demand at

270 C for 3 days

IS: 3025 (P 44)

9 Chemical Oxygen Demand APHA

10 Chlorides, as Cl IS: 3025 (P 32)

11 Sulfates, as SO4 IS: 3025 (P 24)

12 Nitrates, as NO3 IS: 3025 (P 34)



13 Phosphates, as PO4 IS: 3025 (P 31)

14 Phenolic compounds, as C6H5OH IS: 3025 (P 43)

15 Total hardness, as CaCO3 IS: 3025 (P 21)

16 Calcium, as Ca IS: 3025 (P 40)

17 Magnesium, as Mg IS: 3025 (P 46)

18 Nitrates, as NO2 IS: 3025 (P 34)

19 Alkalinity, as CaCO3 IS: 3025 (P 23)

20 Fluoride, as F IS: 3025 (P 60)

21 Electrical conductivity APHA

22 Dissolved oxygen, mg/L -

Table: 3.4: Protocol for ground water quality monitoring

Sl.

No.

Parameter/Test Unit Protocol

1 Color True color units IS: 3025 (P 4)

2 Odor - IS: 3025 (P 5)

3 Taste - IS: 3025 (P 8)

4 Turbidity NTU IS: 3025 (P 10)

5 pH - IS: 3025 (P 11)

6 Chlorides as Cl mg/L AN-S-003

7 Total hardness as CaCO3 mg/L IS: 3025 (P 21)

8 Calcium as Ca mg/L IS: 3025 (P 40)

9 Magnesium as Mg mg/L IS: 3025 (P 46)

10 Total dissolved solids mg/L IS: 3025 (P 16)

11 Sulfates as SO4 mg/L AN-S-003

12 Copper as Cu mg/L IS: 3025 (P 42)

13 Iron as Fe mg/L IS: 3025 (P 53)

14 Manganese as Mn mg/L IS: 3025 (P 59)

15 Nitrate as NO3 mg/L AN-S-003

16 Fluoride as F mg/L AN-S-003

17 Phenolic compounds as C6H5OH mg/L IS: 3025 (P 43)

18 Mercury as Hg mg/L IS: 3025 (P 48)

19 Cadmium as Cd mg/L IS: 3025 (P 41)

20 Selenium as Se mg/L IS: 3025 (P 56)

21 Arsenic as As mg/L IS: 3025 (P 37)

22 Cyanide as CN mg/L APHA



23 Lead as Pb mg/L IS: 3025 (P 47)

24 Zinc as Zn mg/L IS: 3025 (P 49)

25 Anionic detergents as MBAS mg/L Annex K of

IS:13428

26 Chromium as Cr+6 mg/L IS: 3025 (P 52)

27 Residual free chlorine mg/L IS: 3025 (P 26)

28 Alkalinity as CaCO3 mg/L IS: 3025 (P 23)

29 Aluminum as Al mg/L IS: 3025 (P 55)

30 Boron as B mg/L APHA

NOISE & SOIL MONITORING

Table: 3.5: Equipments used for noise & soil monitoring

Noise levels were measured using integrated sound level meter & soil quality using pH

meter, Conductivity meter, Turbidity Meter, Flame Photometer, Spectro photometer,

Mercury Analyzer, Oven, Electronic Balance

3.3.2 AIR QUALITY

The baseline air quality was established by monitoring major air pollutants like suspended

particulate matter, oxides of sulfur & nitrogen at various locations near the project site.

High volume samplers were used for ambient air sampling. Suspended Particulate Matter

(SPM) i.e. PM2.5 & PM10, sulfur dioxide (SO2), oxides of nitrogen (NOx), NH3, Pb, O3,

Benzo(a) pyrene in particulate phase, As, Ni, CO etc. were determined. Samples were

collected continuously from all the stations for 24 hours. Samples thus collected were

analyzed for various pollutants as above.

Baseline data for ambient air quality was collected during the months of of December, 2016 & January & February 2017. The sampling stations along with their distance and direction from the project site, ambient air quality monitoring stations, wind rose diagram showing the direction of the blowing wind during the analysis period, ambient air quality analysis data & National Ambient Air Quality Standards specified by MoEF are detailed subsequently. To study the existing ambient air quality, monitoring was done by Bengalore Test House,

Bengalore.



The observations made during the study period are presented under the forthcoming sub-

sections.

Methodology adopted for the study

The baseline status of the ambient air has been established through a scientifically

designed ambient air quality monitoring network. The following criteria were taken into

account during selection of the sampling stations:

Topography of the area

Human settlements within the study area

Safety, accessibility and non-interference with general routine of the people

residing near the station

Prediction of maximum concentration of the air pollutants through dispersion

modeling for the proposed source details using prevailing meteorological

conditions in the region

The Ambient air sampling stations details is shown in the below table 3.6.

Table 3.6: Ambient air sampling stations

Sl. No.

Code no. Name of the station Direction from the site

Distance from site (km)

1 A 1 Project site - -

2 A 2 Chiksugur (downwind direction)

West 1

3 A 3 Hanumandoddi North East 5

4 A 4 Yermaras South 5

5 A 5 Hospet South West 6

6 A 6 Shaktinagar North 5



Fig 3.2: Wind rose diagram – December to February (sampling period)


WIND ROSE PLOT:

Winter season - December to February

COMMENTS:

MODELER:


DATE:

9/15/2012

PROJECT NO.:

NORTH

SOUTH

WEST EAST

5%

10%

15%

20%

25%

WIND SPEED

(m/s)

>= 11.1

8.8 - 11.1

5.7 - 8.8

3.6 - 5.7

2.1 - 3.6

0.5 - 2.1

Calms: 21.57%

TOTAL COUNT:

2160 hrs.

CALM WINDS:

21.57%

DATA PERIOD:

2009 Check Date Range Report00:00 - 23:00

AVG. WIND SPEED:

2.04 m/s

DISPLAY:


2017



3.3.2.1 AIR QUALITY AT ALL LOCATION:

Ambient air quality analysis was conducted at the project site for 3 months from

December 2016 to Febraury 2017. The Air quality data analysis at the project site are

appended in the table 3.7, Air quality data analysis at other locations in the table 3.8

& Ambient air quality standards – MoEF as per the notification dated 16th November 2009

for industrial, residential & rural areas is shown table 3.7 below.

Table 3.7: Air quality data analysis results

Sl. No.

Parameter Description 24 Hrs concentration (µg/m3) Monitoring station

A1 A 2 A 3

A 4 A 5 A 6 1. Particulate matter

(size less than 2.5

µm), (PM2.5) ,µg/m3

December 24 12 14 17 15 15

Janaury 27 15 15 14 12 17

Febraury 29 19 17 18 17 20

Average 26.6 15.33 15.33 16.33 14.66 17.33

2. Particulate matter

(size less than 10

µm), (PM10), µg/m3

December 50 33 34 33 33 31

Janaury 53 35 35 36 36 33

Febraury 60 39 37 39 37 35

Average 54.33 35.66 35.33 36 35.33 33

3. Sulfur dioxide (SO2),

µg/m3

December 11.6 6.9 5.4 8.6 7.6 7.5

Janaury 13.7 7.3 6.5 7.9 7.8 8.1

Febraury 15.2 8.0 7.7 9.2 8.6 8.5

Average 13.5 7.4 6.5 8.5 8 8.0

4. Nitrogen oxides

(NOx), µg/m3

December 9.20 7.1 7.6 6.5 7.2 6.5

Janaury 11.5 8.6 9.1 9.5 9.6 8.5

Febraury 12.4 9.4 9.4 7.9 8.4 9.9

Average 11.03 8.36 8.8 7.9 8.4 8.3

5. NH3, µg/m3 -

ND 6. Pb, µg/m3 -

7. O3, µg/m3 - 10 - 14

8. C6H6, µg/m3 -

ND 9. Benzo(a) pyrene in particulate phase, ng/m3

-



10. As, ng/m3 -

<0.01 11. Ni, ng/m3 -

12. CO, mg/m3 - 0.1 – 0.5

13. HC, ppm -

ND 14. Volatile Organic Compounds. (VOCs), ppm

-

Table 3.8: Ambient air quality standards – MoEF as per the notification dated 16th

November 2009 for industrial, residential & rural areas

Air quality parameter Concentration

24 hrs Annual

1 Particulate matter (size less than 2.5 µm), (PM2.5) ,µg/m3 60 40

2 Particulate matter (size less than 10 µm), (PM10), µg/m3 100 60

3 Sulfur-di-oxide (SO2), µg/m3 80 50

4 Nitrogen dioxide (NOx), µg/m3 80 40

5 Ammonia (NH3), µg/m3 400 100

6 Lead (Pb), µg/m3 1 0.5

7 Ozone (O3), µg/m3 180 – 1

hr

100 – 8

hrs

8 Benzene (C6H6), µg/m3 - 5

9 Carbon monoxide (CO), mg/m3 4 – 1 hr 2 – 8 hrs

10 Arsenic (As), ng/m3 - 6

11 Nickel (Ni), ng/m3 - 20

12 Benzo(a) pyrene in particulate phase, ng/m3 - 1

13 Volatile organic compounds (VOCs), µg/m3 - NS

Note:

24 hourly or 08 hourly or 01 hourly monitored values, as applicable, shall be complied

with 98% of the time in a year. 2% of the time, they may exceed the limits but not on

two consecutive days of monitoring.

Whenever and wherever monitoring results on two constitutive days of monitoring

exceed the limits specified above for the respective category, it shall be considered



adequate reason to institute regular or continuous monitoring and further

investigation.

3.3.2.2 OBSERVATIONS

The monitored values observed at the all location are in the range of

Sl. No.

Parameter 24 Hrs concentration (µg/m3) Monitoring station

At all locations

15 PM2.5, µg/m3 14.66-26.6 16 PM10, µg/m3 33-54.33 17 SO2, µg/m3 6.5-13.5

18 NOx, µg/m3 7.9-11.03 19 NH3, µg/m3 ND 20 Pb, µg/m3 ND 21 O3, µg/m3 10-14 22 C6H6, µg/m3

ND 23 Benzo(a) pyrene in particulate phase, ng/m3

24 As, ng/m3 <0.01

25 Ni, ng/m3

26 CO, mg/m3 0.1-0.5

27 HC, ppm ND 28 Volatile Organic Compounds

(VOCs), ppm

The monitored values are within the limits specified by MoEF (as per the notification dated 16th November 2009 for industrial, residential & rural areas). At all the other locations it has been observed that the maximum concentration of all the parameters monitored at all the locations are within the limits specified by MoEF.

3.3.3 NOISE ENVIRONMENT

The proposed project M/s. Shilpa Medicare Limited., will result in moderate increase in

traffic during the construction phase due to movement of construction materials, tools

and tackles, laborers required for construction. Since it is an expansion project

construction activities will be minimum as optimum utilization of the existing

infrastructural facilities will be made.



The proposed project is an Herbal Extract and Active Pharmaceutical Ingredients (APIs) &

Intermediates manufacturing industry with R&D activity and hence requires movement

of raw materials, chemicals, fuels, tools & tackles required for its manufacturing process

and also transportation of finished products to its destination. The movement of

personnel from their residence to industry would also result in a moderate increase in the

traffic, which would not result in any drastic change in either the existing traffic pattern

or noise levels of the area.

Background noise levels were measured in 6 locations. A sound level meter was used for

measuring the noise level at one-hour interval continuously for 24 hrs at 1.5 m above

ground level, about 3 m from walls, buildings or other sound reflecting sources.

The measurements were carried out in such a way that the monitoring locations were 1

m away from the sources and 1 m away from the edge of the roads. The lowest & highest

noise levels and the limits as per Environmental Protection Rules, 1986 for both industrial

and commercial areas are presented in the following table 3.11 and summary of noise

levels is shown in table 3. 10. And the Photographs Showing the Noise Monitoring during

Baseline Data Collection is shown in fig 3.9

Table 3.9: Noise level monitoring stations

Sl. No.

Code no. Name of the station Direction from the site

Distance from site (km)

1 N 1 Project site - -


West 1

3 N 3 Hanumandoddi North East 5

4 N 4 Yermaras South 5

5 N 5 Hospet South West 6

6 N 6 Shaktinagar North 5

Table 3.10: Summary of noise levels

Sl. No. Code No. Name of the Station Lowest

dB (A)

Highest dB

(A)

1 N 1 Project site 40.7 49.0


31.5 43.8

3 N 3 Hanumandoddi 37.8 46.4

4 N 4 Yermaras 37.3 47.5

5 N 5 Hospet 38.3 48.6

6 N 6 Shaktinagar 41.8 45.8



Table 3.11: Limits as per Environmental Protection Rules, 1986

Limits as per Env. Protection Rules, 1986 in dB(A)Leq

Industrial area Commercial area Residential area Silent zone

Day Night Day Night Day Night Day Night

75 70 65 55 55 45 50 40


The baseline noise levels have been monitored at different locations as indicated in the table above. The noise levels in the study area varies between 31.5 – 49. It has been observed that the maximum noise levels at all the locations are within the limits specified for industrial areas. Marginally high values at Shaktinagar is due to the operation of power plant.

3.3.4 WATER ENVIRONMENT

3.3.4.1 RECONNAISSANCE SURVEY

The impact has been assessed on randomly selected surface and ground water sources

falling within the impact zone.

In order to assess the existing water quality, the water samples were collected three

different locations within the study area and analyzed as per the procedure specified in

standard methods for examination of water and wastewater published by American

Public Health Association and Bureau of Indian Standards (APHA/BIS). Name of the

locations, orientation with respect to the project site along with the type of source, the

analytical data for surface water quality and ground water quality at all locations has been

depicted in the following table 3.12 .



Table 3.12: Water sampling stations

Sl.

No.

Code

No.

Name of the Station Direction

from site

Distance

from

site (km)

Source/ Type

10 GW 1 Project site - - Borewell

11 GW 2 Chiksugur (downwind direction)

West 1 Borewell

12 GW 3 Hanumandoddi North East 5 Borewell

13 GW 4 Yermaras South 5 Borewell

14 GW 5 Hospet South West 6 Borewell

15 GW 6 Shaktinagar North 5 Borewell

16 SW 1 Krishna river upstream North West 14.6 River

17 SW2 Krishna river downstream

North 7.4 River

18 SW3 Konad Halla North West 2.3 Canal

3.3.4.2 SURFACE WATER

The water requirement of about 12 KLD for the proposed Project will be met by Borewell

water supply source.

The results of the analysis of surface water sample collected from the Kabini River is

appended in the following table 3.13



Table 3.13: Surface water quality

Sl No

Tests Results Maximum Acceptable

Limits As per IS:10500-1991

Maximum Permissible Limits in the Absence of Alternate Source As Per IS:10500-

1991

W1 (Krishna river

upstream)

W2 (Krishna river downstream)

1 Color (Hazen Units) 6 6 5 25

2 Odour Un-objectionable

Un-objectionable

Un-objectionable

-

3 Taste Agreeable Agreeable Agreeable -

4 pH 7.63 7.60 6.50-8.50 No relaxation

5 Turbidity, NTU 8 9 5 10

6 Total Hardness as CaCO3, mg/L

135 125 300 600

7 Iron, as Fe, mg/L 0.30 0.30 0.30 1.0

8 Chlorides, as Cl, mg/L

45 47 250 1000

9 Residual free chlorine, mg/L

Nil Nil 0.2 – desirable limit

-

10 Total dissolved solids, mg/L

320 336 500 2000

11 Calcium, as Ca, mg/L

32 30 75 200

12 Manganeese, as Mg, mg/L

13 12 30 100

13 Nitrates, as NO3 , mg/L

1.0 1.0 45 No relaxation

14 Sulphates, as SO4, mg/L

58 51 200 400

15 Fluorides, as F, mg/L

0.60 0.60 1.0 1.5

16 Alkalinity, as CaCO3, mg/L

120 120 200 600

17 Copper as Cu, mg/L

<0.01 <0.01 0.05 1.5

18 Magnesium as Mn, mg/L

<0.01 <0.01 30 100

19 Phenolic Compounds as C6H5OH, mg/L

<0.001 <0.001 0.001 0.002

20 Mercury as Hg, mg/L

<0.001 <0.001 0.001 No relaxation

21 Cadmium ad Cd, mg/L

<0.01 <0.01 0.01 No relaxation

22 Selenium as Se, mg/L


23 Arsenic as As, mg/L <0.01 <0.01 0.01 No relaxation

24 Cyanide as CN, mg/L


25 Lead as Pb, mg/L <0.01 <0.01 0.05 No relaxation

26 Zinc as Zn, mg/L <0.01 <0.01 5 15

27 Anionic detergents (as MBAS)

Absent Absent 0.20 1.0

28 Chromium as Cr6+,mg/L


29 Poly nuclear aromatic Hydrocarbons (as PAH)

Absent Absent - -



30 Mineral Oil, mg/L Absent Absent 0.01 0.03

31 Pesticides mg/L Absent Absent Absent -

32 Radioactive materials a. Alpha emitters, µCi/mL, max b. Beta emitters, µCi/mL, max

Absent Absent a. 10-8 b. 10-7

-

33 Aluminium as Al, mg/L

<0.01 <0.01 0.03 0.2

34 Boron as B, mg/L 0.04 0.05 1.00 5.0

Surface water quality – canal

Sl No


Limits As per IS:10500-1991

Maximum Permissible Limits in the Absence of Alternate Source As

Per IS:10500-

1991

W 3 (Konad Halla)

1 Color (Hazen Units) 4 5 25

2 Odour Un-objectionable

Un-objectionable

-

3 Taste Agreeable Agreeable -

4 pH 8.17 6.50-8.50 No relaxation

5 Turbidity, NTU 22 5 10

6 Total Hardness as CaCO3, mg/L

125 300 600

7 Iron, as Fe, mg/L 0.40 0.30 1.0

8 Chlorides, as Cl, mg/L 37 250 1000

9 Residual free chlorine, mg/L Nil 0.2 – desirable limit

-

10 Total dissolved solids, mg/L 274 500 2000

11 Calcium, as Ca, mg/L 30 75 200

12 Magnesium, as Mg, mg/L 12 30 100

13 Nitrates, as NO3 , mg/L 3.0 45 No relaxation 14 Sulphates, as SO4, mg/L 35 200 400

15 Fluorides, as F, mg/L 0.60 1.0 1.5

16 Alkalinity, as CaCO3, mg/L 110 200 600

17 Copper as Cu, mg/L <0.01 0.05 1.5

18 Manganeese as Mn, mg/L <0.01 30 100


<0.001 0.001 0.002

20 Mercury as Hg, mg/L <0.001 0.001 No relaxation 21 Cadmium ad Cd, mg/L <0.01 0.01 No relaxation



22 Selenium as Se, mg/L <0.01 0.01 No relaxation 23 Arsenic as As, mg/L <0.01 0.01 No relaxation 24 Cyanide as CN, mg/L <0.01 0.05 No relaxation 25 Lead as Pb, mg/L <0.01 0.05 No relaxation 26 Zinc as Zn, mg/L <0.01 5 15

27 Anionic detergents (as MBAS) Absent 0.20 1.0

28 Chromium as Cr6+,mg/L <0.01 0.05 No relaxation 29 Poly nuclear aromatic

Hydrocarbons (as PAH) Absent - -

30 Mineral Oil, mg/L Absent 0.01 0.03

31 Pesticides mg/L Absent Absent -

32 Radioactive materials a. Alpha emitters, µCi/mL, max b. Beta emitters, µCi/mL, max

Absent a. 10-8 b. 10-7

-

33 Aluminum as Al, mg/L <0.01 0.03 0.2

34 Boron as B, mg/L 0.08 1.00 5.0



3.3.4.3 GROUND WATER

Ground water is the major source of water in the district, occurring under water table conditions in the weathered mantle of granite

gneisses and in the joints, cracks and crevices of the basement rock. The depth of water is also dependent on topography and varies

depending on the depth of weathering.

The results of the analysis of Ground water samples collected from the project site and others locations is appended in the following table 3.14.

Table 3.14: Ground water quality

Sl. No


Limits As per IS:10500-

1991

Maximum Permissible Limits in the Absence of

Alternate Source As Per IS:10500-

1991

GW1

GW1

GW 3

GW 4

GW 5

GW6

1 Color (Hazen Units)

Clear <5 <5 Clear <5 <5 5 25

2 Odour UO UO UO UO UO UO UO -

3 Taste A A A A A A A -

4 pH 7.9 7.89 7.48 7.61 7.61 8.12 6.50-8.50 No relaxation

5 Turbidity, NTU 2.9 3.0 2.0 4.2 1.0 2.0 5 10

6 Total hardness as CaCO3, mg/L

310 250 175 205 700 150 300 600

7 Iron, as Fe, mg/L 0.19 0.14 0.15 0.30 0.10 0.15 0.30 1.0



8 Chlorides, as Cl ,mg/L

205 159 162 102 230 85 250 1000

9 Total Dissolved Solids, mg/L

448 425 430 366 380 410 500 2000

10 Residual free chlorine, mg/L

Nil Nil Nil Nil Nil Nil 0.2 – desirable

limit

-

11 Calcium, as Ca, mg/L

62 35 44 39 40 42 75 200

12 Magnesium, as Mg, mg/L

22.5 18 16 19.5 22 11 30 100

13 Nitrates, as NO3 , mg/L

11 19 21 15 16 26 45 No relaxation

14 Sulphates, as SO4, mg/L

105 98 77 68 126 37 200 400

15 Fluorides, as F, mg/L

0.53 0.60 0.90 0.66 1.35 1.20 1.0 1.5

16 Alkalinity, as CaCO3, mg/L

151 145 160 148 160 115 200 600

17 Copper as Cu, mg/L

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.05 1.5

18 Manganeese as Mn, mg/L

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 30 100


<0.01 <0.01 <0.001 Absent <0.001 <0.001 0.001 0.002

20 Mercury as Hg, mg/L

<0.001

<0.001 <0.001 <0.001 <0.001 <0.001 0.001 No relaxation



21 Cadmium ad Cd, mg/L

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.01 No relaxation

22 Selenium as Se, mg/L

<0.01 <0.01 <0.01 <0.01 <0.01 0.01 No relaxation

23 Arsenic as As, mg/L

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.01 No relaxation

24 Cyanide as CN, mg/L

Nil Nil Nil Nil Nil Nil 0.05 No relaxation

25 Lead as Pb, mg/L <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.05 No relaxation

26 Zinc as Zn, mg/L <0.01 <0.01 <0.01 <0.05 <0.01 <0.01 5 15

27 Anionic detergents (as MBAS)

Absent

Absent Absent Absent Absent 0.20 1.0

28 Chromium as Cr6+,mg/L

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.05 No relaxation

29 Poly nuclear aromatic Hydrocarbons (as PAH)

Absent

Absent Absent Absent Absent Absent - -

30 Mineral Oil, mg/L Absent

Absent Absent Absent Absent Absent 0.01 0.03

31 Pesticides mg/L Absent

Absent Absent Absent <0.001 Absent Absent -

32 Radioactive materials a. Alpha emitters, µCi/mL, max

Absent

Absent Absent Absent Absent Absent a. 10-8 b. 10-7

-



b. Beta emitters, µCi/mL, max

33 Aluminum as Al, mg/L

<0.01 <0.01 <0.01 <0.01 <0.01 <0.01 0.03 0.2

34 Boron as B, mg/L 0.05 0.05 0.06 0.05 0.04 0.06 1.00 5.0

35 Colifrom MPN/100 mL

Nil Nil Nil Nil Nil Nil 1 coliform/100 mL




The analysis of samples collected from the lakes for various parameters reveals that the

quality of water is within the maximum acceptable limits as per IS:10500-1991.the water is

treated before discharging to users.

The physicochemical quality of the ground water sources at and around the plant site has

been analyzed, which indicates that almost all the parameters analyzed are within “Maximum

Acceptable Limits As per IS:10500-2012” & few parameters like alkalinity are within the

“Maximum Permissible Limits in the Absence of Alternate Source As Per IS:10500-2012”.

The observations made are tabulated below table 3.15

Table: - 3.15 Observations

Sl. no.

Parameter Surface water Ground water

5 pH 7.6 - 8.17 7.48 - 8.12

6 Total dissolved solids, mg/L 274 - 336 366 - 448

7 Total hardness, mg/L 125 - 135 150 – 700

8 Fluoride, mg/L 0.60 0.53 – 1.35

3.3.5 SOIL AND GEOLOGY

Soil characteristics, erosion aspects, soil fertility etc., have direct bearing on the environment. Knowledge of soil parameters is essential for the planning and implementation of green belt. Hence it becomes important to study the soil characteristics. Baseline data for land environment was collected at Six locations in order to assess the soil quality of the study area. Soil samples at a depth of one and half feet were collected using sampling augers, spades and field capacity apparatus. The list of locations and the orientation with reference to the project site are listed in table 3.16. Soil samples were analyzed for physical and chemical parameters the results of which are given in table 3.17 and sampling locations marked in the Google map is shown in fig 3.3.



Table 3.16: Soil sampling stations

Sl.

No.

Name of the Station Direction from

site

Distance

from site

(km)

1 Project site - -

2 Chikkanagamangala North 1.58

3 Huskur North east 2.50

4 Shantipura (Vaddarapally) South East 1.75

5 Hebbagodi South 2.65

6 Doddathoguru West 3.91

Table 3.17: Physico-chemical characteristics of soil

Sl.

no.

Parameters Unit Results

Sampling station S 1 S 2 S 3 S 4 S5 S6

1 pH value (20 % solution) - 9.35 8.32 8.45 8.04 7.69 7.96

2 Organic colids % 6.2 5.6 6.35 7.89 8.20 9.15

3 Chlorides, as Cl % 0.015 0.013 0.014 0.012 0.011 0.019

4 Phosphorous, as P % 0.009 0.015 0.018 0.016 0.012 0.007

5 Nitrogen, as N % 0.078 0.046 0.059 0.07 0.05 0.051

6 Potassium, as K % 0.13 0.15 0.17 0.13 0.08 0.01

7 Iron, as Fe % 5.9 3.2 6.35 4.9 5.8 6.2

8 Sulphates, as SO4 % 0.011 0.012 0.013 0.014 0.016 0.012

9 Calcium, as Ca, % % 0.05 0.043 0.12 0.11 0.32 0.20

10 Magnesium, as Mg, % % 0.032 0.046 0.11 0.04 0.043 0.17

11 Conductivity micromhos/cm

(20% Suspension)@ 25 deg C

µs/cm 123.0 132.0 148.0 189.0 115.0 79.0

12 Moisture % 1.9 0.72 2.3 3.6 1.32 5.9

13 Inorganic solids % 98.2 95.0 93.6 95.6 92.7 87.2



Fig 3.3: Location of sampling stations

Source: Google Earth



Table 3.18: LOCATION OF SAMPLING STATIONS

Sl.no. Code.No Description Direction Distance Sampling Stations No.

1 A1 Project site - - A1, N1, W1,S1

2 A2 Chiksugur (downwind direction) West 1 A2, N2, W2,S2

3 A3 Hanumandoddi North East 5 A3, N3, W3,S3

4 A4 Yermaras South 5 A4, N4, W4,S4

6 A5 Hospet South West 6 A5, N5, W5,S5

7 A6 Shaktinagar North 5 A6, N6, W6,S6

8 SW1 Krishna river upstream North West 14.6 SW1

9 SW2 Krishna river downstream North 7.4 SW2

10 SW3 Konad Halla North West 2.3 SW3

3.4 ECOLOGY

Natural flora and fauna are important features of the environment. They are organized into

natural communities with mutual dependencies among their members and show various

responses and sensitivities to physical innocence. The integrated ecological thinking and planning

process is an urgent need in the context of natural environment's deterioration which has a direct

bearing on socio-economic development.

Ecological survey of the study area was carried out by actual field visits of the lease area to

observe the various species of flora and fauna. Personal enquiries/discussion with local people

and forest department officials was also conducted to get a fair idea of the existing ecological

status.

The area does not have any hiding place for wild life and hence they are not spotted in the area.

The flora and fauna existing in the study area is presented below.

3.4.1 ANTICIPATED IMPACTS

The impact can be considered insignificant as the region consists of only skeletal Vegetation like

grasses & thorny shrubs with no rare & endangered species. As the Project activity will be limited

only to the core zone and mitigative measures will be implemented to contain air and noise

pollution, there shall be no damage to the flora of the buffer zone.

The area is not a significant faunal habitat. No deforestation will take place in the Buffer zone.

Thus, the impact on fauna of the buffer zone will be minimal.



3.4.2 FLORA

Land use pattern within the study zone is industrial oriented with rural village settings. Floral

composition in the study area is presented in the table 3.19 below.

Table 3.19: Flora in the study area

Sl. No.

Botanical name Common name

1 Alangium lamarckii Ankola

2 Acacia nilotica Karijali

3 Aegle marmelos Bilpathre

4 Azadirachta indica Bevu

5 Albizzia amara Tugli

6 Aloe vera Lolesara

7 Albezzia lebbeck Bage

8 Acacia senegal Mugli

9 Acacia chundra Kagglia

10 Acacia leucophloea Kikar

11 Abrus precatorius Gulaganji

12 Annona squamosa Sitaphal

13 Acacia catechu Kaggali

14 Bauhinia racemosa Ari Basavanapada

15 Boswellia serrata Dhupa

16 Buchanania lanzan Chironji

17 Bassia latifolia Mokhab

18 Butea monosperma Muthuga

19 Butea superba Palash lata

20 Cassia fistula Kokke

21 Careya arborea Kaval

22 Chloroxylon Hugagalu

23 Cassia auriculata Tangadi

24 Carissa carandas Kawli hannu

25 Cochlospermum White silk cotton

26 Diospyros Tupra

27 Dodonaea viscosa Junglianar

28 Emblica officinalis Nelli

29 Eugenia jambolana Neral

30 Ficus infectoria Jir

31 Ficus bengalensis Ala

32 Ficus religiosa Arli

33 Mangifera India Mavu

34 Moringa tinctoria Moogilli



35 Nyctanthes Kumbala

36 Pongamia pinnata Honge

37 Prosopis juliflora Bellary jail

38 Syzygium cumini Nerale

39 Aptuda mutica Karru guddi

40 Cymbopogon Coloratus Bodha

3.4.3 FAUNA

The area under consideration is not suitable for any rare or endangered or endemic or threatened

wildlife as there are no forests or other protected areas. Fauna observed in the region include

domestic animals, retiles and birds. The composition of fauna in the study area is presented in

the table 3.20 below.

Table 3.20: Fauna in the study area

MAMMALS

Sl.

No.

Scientific name Common name

1 Bandicota bengalensis Lesser Bandicoot

2 Bandicota indica Greater bandicoot

3 Lupus nibricollis Indian hare

4 Macaca mulatto Rhesus macaque

5 Mus booduga Indian field rat

6 Oryctolagus cuniculus Rabbit

7 Varanus indicus Common mongoose

8 Funambulus palmarum Three striped palm squrrel

REPTILES

9 Bungarus caeruleus Common Indian krait

10 Calotes versicolor Garden lizard

11 Chameleon zeylanicus Chameleon

12 Dryphis sp. Tree snake

13 Hemidactylus flaviviridis Indian wall lizard

14 Hemidactylus triedrus Termite hill gecko

15 Naja naja Cobra

16 Ptyas mucosus Rat snake

17 Ramphotyphliops braminus Brahminy blind snake

18 Typhlops porrectus Slender blind snake

19 Vipera russeli Russell’s viper



AMPHIBIANS

20 Rana hexadactyla Ordinary frog

21 Bufo melonosticatus South Indian Toad

22 Hyla arboria Tree frog

23 Cacopus bystema Burrowing frog

24 Rana tigrina Tiger frog

BIRDS

25 Acridothers trists Myna

26 Athene brama Owl, spotted

27 Bubulcus ibis Cattle egret

28 Centrpus sinesis Crow pheasant

29 Columbia livaia Pigeon, blue rock

30 Corvus macrohyuchos Jungle crow

31 Corvus splendens Crow

32 Cuculus varus Cuckoo

33 Egretta garetta Egret, little

34 Eudynamis scolopaceus Koel

35 Francolinus pondicerianus Partridge, grey

36 Hirando rustica Swallow, common

37 Lonchura striata Munia, spotted

38 Pavo cristatus Common peafowl

39 Ploceus philippinus Weaver bird, common

40 Psittacula eupatria Parakeet Large Indian

41 Psittacula krameri Parakeet, rose-ringed

42 Saxicoloides fulicata Indian robin

3.5 SOCIO-ECONOMIC ENVIRONMENT

The baseline data referring to the socio-economic environment is collected by way of secondary

sources such as census records, statistical hand book and relevant official records with the

government agencies and primary sources such as the socio-economic surveys conducted by

different Govt. & Non Govt. Agencies.

The growth of industrial sectors and infrastructure development in and around the agricultural

area i.e. villages and semi-urban settings and towns is bound to create certain socio-economic

impacts on the local populace. The impacts may be either positive or negative depending on the



nature of development. To assess such impact it is necessary to know the existing socio-economic

order of the study area, which will be helpful in improving the overall quality of life.

3.6 DEMOGRAPHIC STRUCTURE

The information collected from the secondary sources are from the district census statistical hand books and the records of the National Informatics Center, New Delhi in respect of the population, infrastructure facilities available and the occupational structures of the study area. The socio-ecological aspect of the study include the agro based economy, industry based economy and occupational structure of the workers. The study has been divided in to three zones which include the core and buffer zones which are presented as table 3.21 below.

Table 3.21: Break-up of the study area

Study area Zones considered for the study

0 - 5 km Zone - I (Chiksugur)

5 - 10 km Zone - II (Shaktinagar)

10 – 15 Zone – III (Raichur)

The distributions of population in the study area as per the census record of the 2011 are presented as table 3.22 below.

Table 3.22: Distribution of population

Particulars 0-5 km

radius

5-10 km

radius

10-15 km

radius

2011 2011 2011

Total residential houses 584 3802 52001

Total population 2815 17088 264564

Population male 1440 8632 131899

Population female 1375 8456 132665

Schedule caste male 315 2061 29361

Schedule caste female 288 1969 29229

Schedule tribe male 6 407 26458

Schedule tribe female 5 395 26980

Literates male 997 6542 73276

Literates female 648 4855 46794

Main workers male 515 4255 62853

Main workers female 185 1376 41989

Marginal workers male 241 437 11285

Marginal workers female 175 296 18304

Non workers male 684 3940 57761

Non workers female 1015 6784 72372



Source: District census handbook

Male population – 51.6 % Female population – 48.4 % Sex ratio – 937 females per 1000 males Literacy levels The literacy level in the study area is appended as table 3.23 below

Table 3.23: Distribution of literates and literacy levels in the study area

Particulars 0-5 km radius

5-10 km radius

10-15 km radius

2011 2011 2011

Total population 2815 17088 264564

Total literate 1645

11397

120070

Literate male 997 6542 73276

% of Male literate 60.60 54.80 61.02

Literate female 648 4855 46794

% of Female literate

39.39 42.59 38.97

Source: District census hand book

3.6.1 SOCIAL INFRASTRUCTURE AVAILABLE

Infrastructure is the basic physical and organizational structures needed for the operation of a

society or enterprise or the services and facilities necessary for an economy to function.

The term typically refers to the technical structures that support a society, such as roads, water

supply, sewers, electrical grids, telecommunications and so forth and can be defined as "the

physical components of interrelated systems providing commodities and services essential to

enable, sustain or enhance societal living conditions.

Viewed functionally, infrastructure facilitates the production of goods and services, and also the

distribution of finished products to markets, as well as basic social services such as schools and

hospitals; for example, roads enable the transport of raw materials to a factory.

The list of hospitals & other infrastructural facilities available in the vicinity of the proposed

industry is tabulated in below table 3.24.



Table 3.24: List of infrastructural facilities in the surroundings

Sl. No.

Hospital Distance from the industry (km)

Direction w.r.t. the industry

1 Primary Health Center, Ramadurga

30 West

2 Rajiv Gandhi Memorial Hospital

9 South

3 Government Hospital, Raichur 10.1 South

4 Chaitanya Hospital 11.8 South West

5 Raichur railway station 11.6 South

6 Hyderabad airport 152 North East

Note: All distances mentioned are aerial.

3.7 CONNECTIVITY

Connectivity to the project site is detailed in the following table 3.25. Google map showing the

same is appended subsequently in fig 3.4.

Table 3.25: Connectivity from the project site

Sl. No.

Road Distance from the project site (km)

Direction w.r.t. project site

1 NH-167 & SH 51 1.0 West

2 Yedlapur Railway Station 8.69 North – West

3 Hyderabad airport 152 North East

4 Raichur railway station 11.6 South

5 Karnataka Andhra Pradesh border 8 North

Note: All distances mentioned are aerial



Fig 3.4: Google map showing connectivity

The details of 1 km, 5 km & 10 km distance google map is showing in below fig 3.5,3.6 & 3.7.



Fig 3.5: GOOGLE MAP COVERING 1 KM AERIAL DISTANCE FROM THE PROJECT SITE



3.8 BASE MAPS OF ALL ENVIRONMENTAL COMPONENTS

The major environmental components in the surroundings along with the distance & direction

from the project site are tabulated in below table 3.26. Google maps showing the locations of

the environmental parameters are appended as figure 3.8 below & the topo map of 10 km radius

is appended as Annexure - B.

Table 3.26: Existing land-use pattern

Sl. No.

Particulars Details Distance from the

project site (km)

Direction w.r.t. project

site

1 Agriculture Minor activities - scattered Beyond industrial

area

-

2 National park, forest Banerghatta national park 16 South West

3 Water bodies Raysandra lake 3 North west

Chikka tagur lake 3 East

Veersandra lake 2 South west

Hebbagodi lake 2.5 South

Kamasandra Lake 2.5 South East

Heelalige railway station 4.5 South east

Note:

a) All distances mentioned are aerial. b) The project is a notified by KIADB, Karnataka Govt. industrial area.



Fig 3.8: Google map showing land-use pattern



CHAPTER 4

ANTICIPATED ENVIRONMENTAL IMPACTS & MITIGATION MEASURES

4.1 DETAILS OF INVESTIGATED ENVIRONMENTAL IMPACTS DUE TO PROJECT LOCATION,

POSSIBLE ACCIDENTS, PROJECT DESIGN, PROJECT CONSTRUCTION, REGULAR OPERATIONS,

FINAL DECOMMISSIONING OR REHABILITATION OF COMPLETED PROJECT

4.1.1 ENVIRONMENTAL IMPACTS DUE TO PROJECT LOCATION, POSSIBLE ACCIDENTS, PROJECT

DESIGN

PROJECT LOCATION

Major environmental impacts due to project location is not anticipated because

The Environmental Clearance has been obtained from MOEF for the Active

Pharmaceutical Ingredients (APIs) & Intermediates manufacturing industry with R & D

activity vide EC letter no F.No. J-11011/71/2007-IA II (I) Dated March 12th 2008, and also

Consent for Establishment has obtained from KSPCB and since then the industry is in

operation with valid Consent for Operation from KSPCB.

Now the proponents intend to expansion and modification of an Active Pharmaceutical

Ingredients (APIs) & Intermediats manufacturing industry with R & D activity in an existing

industry.

The industry is located in KIADB Industrial area, Raichur.

No national park is located in the vicinity (10 km radius - aerial).

POSSIBLE ACCIDENTS

CONSTRUCTION PHASE

The proposed project is expansion and modification of an Active Pharmaceutical Ingredients

(APIs) & Intermediats manufacturing industry with R & D activity in an existing industry with on-

going production activities. No major construction activities are proposed in the project as

optimum utilization of the existing infrastructural facilities will be made. Therefore

environmental impacts due to possible accidents are not anticipated.



OPEARTION PHASE

PERSONAL SAFETY (PPE)

The following Personal Protection Equipments (PPE) are proposed to be provided

1. Helmet

2. Goggles

3. Nose masks

4. Uniform

5. Aprons

6. Hand gloves

7. Safety shoes

8. Face shield

PLANT SAFETY

The following measures and initiatives are proposed to ensure plant safety

1) Safety manual

2) MSDS

3) Onsite emergency plan

Fire extinguishers

Flame-proof fittings

Emergency no.s

4) Insurance coverage in case of fire (PLI)

5) Electric safety, audit

ENVIRONMENT SAFETY

The following measures are taken for environmental safety in case of accidents

1) Important telephone no.s

2) MSDS

3) Environment policy

4) Evacuation procedure

SAFETY AUDIT

1) Internal audit

2) SOP for safety audit

3) Safety training

4) First-aid training

5) Mock drill in case of emergency with respect to fire accident and handling of

extinguishers.



HEALTH SAFETY

1) Annual medical check –up

2) Medi-claim scheme for all employees.

PROJECT DESIGN

The industry is designed with utmost consideration to the environment. A total area of 58,755.16 sq m i.e. 65.9 % of the total plot area is reserved exclusively for green-belt/landscape development.

4.1.2 ENVIRONMENTAL IMPACTS DUE TO PROJECT CONSTRUCTION, REGULAR OPERATIONS

The Environmental Impact Statement enumerates the likely impacts due to the implementation

of the proposed project on the six basic environmental parameters, which are listed below.

1. Air environment

2. Noise environment

3. Water environment

4. Land environment

5. Biological environment

6. Socio-economic environment

The impacts on the above parameters have been identified, analyzed and classified as adverse,

beneficial impacts and the impact matrix is presented later in the report.

4.2 ACTIONS LIKELY TO AFFECT THE ENVIRONMENT

Table 4.3 enumerates the various activities of M/s. Shilpa Medicare Limited., which are likely to

have impact on the various environmental parameters. The impact matrix appended later (as

table 4.4) identifies all such impacts.



4.2.1 AIR ENVIRONMENT

4.2.1.2 AIR ENVIRONMENT

4.2.1.2.1. CONSTRUCTION PHASE

The effect of the proposed project on the air environment is basically due to the construction

activities and establishment of pollution abatement systems that are undertaken for the project

which results in a marginal impact on the air environment deteriorating the air quality. Fugitive

dust emissions due to the movement of the construction materials, actual construction activity

and its related works are expected.

4.2.1.2.2 OPERATION PHASE

Pollutants in the form of oxides of nitrogen, sulfur & SPM from generators, boilers and thermic

fluid heater & acid mist/VOCs from the process section, contribute and cause certain impacts on

the air quality.

4.2.2 NOISE ENVIRONMENT

4.2.2.1 CONSTRUCTION PHASE

Construction activities and establishment of pollution abatement systems that are the major

sources of noise pollution during construction phase.

4.2.2.2 OPERATION PHASE

DG sets are the major noise generating sources during the operation phase. Also handling and

conveying of raw materials and semi-finished components to different operations can be

a source of noise pollution.

4.2.3 WATER ENVIRONMENT


Surface water quality can deteriorate due to run-off of loose exposed soil and sanitary wastes

from labor force during construction phase.




Type of wastewater

Source Treatment Re-use of treated wastewater

Low strength Process Effluent, Washing effluent & Domestic waste water

Treated in Effluent treatment palnt followed by Reverse Osmosis. Domestic waste is treated in ETP at the stage of Biological treatment.


High strength Process Effluent, R&D Effluent, Scrubber wastes, LSWW ETP RO(38.25 KLD ) reject & Shipa

Medicare Unit –I effluent.

Treated in Effluent treatment plant followed by MEE.

High strength DM plant/ Softner rejects & Cooling tower bleed off.

Treated in High rate Solids contact clarifier tank (HRSCC).

4.2.4 LAND AND BIOLOGICAL ENVIRONMENT


The proposed project is being setup in KIADB industrial area and therefore major/significant

changes in land use pattern is not anticipated. Also it is existing manufacturing industry & involves

only minor construction activities.


IMPACTS



MITIGATION MEASURES

The treated wastewater will be re-used for landscape development, cooling tower make-up water etc.




4.2.5 SOCIO-ECONOMIC ENVIRONMENT


The proposed project will increase the employment potential by creating direct and in-direct

employment opportunities. Preference will be given to the local skilled, semi-skilled and unskilled

workers.

A detailed proposal for the mitigation of all the above stated impacts is detailed in the EMP

(Environmental Management Plan).

4.3 MEASURES FOR MINIMIZING & / OR OFFSETTING ADVERSE IMPACTS IDENTIFIED &

MITIGATION MEASURES – ENVIRONMENTAL MANAGEMENT PLAN (EMP)

4.3.1 INTRODUCTION

The Environmental Management Plan (EMP) is aimed at mitigating the possible adverse impacts

of a project and ensuring the existing environmental quality. The EMP converses all aspects of

planning, construction and operation of the project relevant to environment. It is essential to

implement the EMP right from the planning stage continuing throughout the construction and

operation stage. Therefore the main purpose of the Environmental Management Plan (EMP) is

to identify the project specific activities that would have to be considered for significant adverse

impacts and the mitigation measures required.

The construction phase impacts are mostly short term, restricted to the plot area and not

envisaged on a larger scale. In the operational phase the environmental impacts are due to

continuous operation of the project, hence, the emphasis in the Environment Management Plan

(EMP) is to minimize such impacts.

Environmental Management Plan has been discussed in the following sections separately for

construction phase and operational phase.

4.3.2 SCOPE OF EMP

Collection of data on the baseline environmental quality around the proposed industry

including air, water, noise and land environments.

Identification and assessment of potential adverse and beneficial environmental impacts due

to the proposed project.



Preparation of an EMP to minimize the adverse impacts.

Preparation of post-project monitoring plan to ensure that the EMP achieves its desired

objectives.

4.3.3 EMP DURING CONSTRUCTION PHASE

The proposed project is an expansion proposal and therefore does not involve extensive construction activities. The activities which need to be monitored and managed from the point of view of pollution are detailed in the subsequent sections.

4.3.3.1 AIR ENVIRONMENT

The fugitive dust emissions generated during construction in the beginning followed by

fabrication, erection of plant and machinery during later part of the project are controlled

by carrying out the construction activities in closed manner and by intermittent spraying

of water.

4.3.3.2 NOISE ENVIRONMENT

Construction activity during the phase of setting up of the proposed facility generates

noise which will be due to movement of vehicles carrying construction materials and

operation of machinery.

These activities are limited to construction period and are only temporary phenomena

which shall be managed by properly planning the movement of vehicular traffic, proper

and periodic upkeep of construction equipments, providing noise reduction gadgets,

providing PPE to construction workers to prevent its effect on them.

4.3.3.3 WATER ENVIRONMENT

Water required for construction activity and workers involved in the construction and

fabrication activities are met by KIADB water supply.

The wastewater generated from the construction workers will be treated in the existing

Effluent treatment plant (along with low strength wastewater stream).



4.3.3.4 LAND ENVIRONMENT

The proposed project is being setup in KIADB industrial area and therefore major/significant

changes in land use pattern is not anticipated. Also it is an existing manufacturing industry &

involves only minor construction activities.

4.3.3.5 MANAGEMENT MEASURES FOR FLORA AND FAUNA

FLORA: The proposed project is an expansion proposal of an existing industry and therefore

major impacts on flora are not anticipated. Also the unit is located in a designated industrial area.

Green-belt development is proposed within the project site.

FAUNA: The industry is located in an industrial area and therefore Environmental Management

Plan for fauna is not envisaged.

4.3.3.6 SOCIO-ECONOMIC ENVIRONMENT

The expansion of Existing Active Pharmaceutical Ingredients (APIs) & Intermediats manufacturing industry with R & D activity industry will benefit the local population as it

creates employment opportunities. The management of the industry proposes to give preference to local people with both direct and indirect employment. 4.3.4 EMP DURING OPERATION PHASE 4.3.4.1 AIR ENVIRONMENT

The process of manufacture of Active Pharmaceutical Ingredients (APIs) & Intermediats

manufacturing industry with R & D activity involves closed operations in various controlled

reactors the handling and operation of such activity invariably generates small quantity of

acid mist and VOCs from the process and other physical operations which would cause

hazardous impact on the environment.

Reactor emissions stem from the following causes:

a) displacement of air containing VOC during reactor charging,

b) solvent evaporation during the reaction cycle (often VOC.s are emitted along with

reaction by-product gases which act as carriers),

c) overhead condenser venting uncondensed VOC during refluxing,

d) purging vaporized VOC remaining from a solvent wash and

e) Opening reactors during a reaction cycle to take samples, determine reaction end-points

etc.,



The process area shall be provided with abundant natural light and ventilation to disperse

the fumes/gases to the outside atmosphere; the roof heights for the process area will be

more so that the fumes emanating from the process do not increase the ground level

concentrations (GLC’S) as it gets dispersed.

Pollutants like SPM, SO2, NOx and CO are envisaged from the proposed project mainly due to

burning of fuel in DGs, boilers. Exhausts from these sources will be emitted from stacks of

adequate height for dispersion of gaseous pollutants.

There is a possibility of plant personnel coming in contact with gaseous fumes and

prolonged exposure to such an environment can adversely affect their health. Therefore,

the management of the industry shall provide the personnel engaged in production

operations with Personal Protective Equipments (PPE) to protect themselves from

possible occupational hazards.

The following table 4.0 presents the EMP for air quality management during operation phase.

Table 4.0 :- Air quality management during operation phase

Environmental impacts Mitigation proposed

Process of manufacture of APIs, intermediates

Particulate and

gaseous emissions

from DG set and

Boiler


The process area shall be provided with abundant natural light and ventilation and high roofs to disperse the fumes/gases to the outside atmosphere; preventing the increase of ground level concentrations (GLC’S) as it gets dispersed.



The emissions from DG & boiler will be let out through stacks of heights 7 m AGL and 30 m AGL respectively.

Ambient air quality Ambient air quality monitoring as per the prescribed

norms at regular intervals is proposed.



4.3.4.2 NOISE ENVIRONMENT

The main sources of noise pollution in the industry are from the operation of machineries

during the manufacturing process, handling and conveying of raw materials and semi-

finished components to different operations.

The conveying system shall be maintained by following routine and periodic maintenance

to reduce noise generation in material handling.

High noise generating units such as DG sets will be provided with acoustic enclosures/silencer.

Green belt at the project boundary will further act as noise barrier and help in attenuation of

noise. The following table 4.1 presents the EMP for noise level.

Table 4.1 :- Noise management during operation phase

Environmental impacts Mitigation proposed


Handling and conveying of raw materials and semi-finished components to different operations.



DG set will be provided with acoustic enclosure. They will be installed in dedicated utility area, where the access will be restricted. Also the use of PPE (ear plugs) will be mandatory in this area.


4.3.4.3 TRAFFIC DENSITY AND ITS IMPACT Raw materials will be procured from various locations and transported to the factory through lorries. The vehicles will move mainly through State and National highways which are tarred roads. Presently, the traffic on these roads is meager. The additional traffic due to the proposed activity is not likely to affect the environment. 4.3.4.4 WATER CONSUMPTION AND WASTEWATER TREATMENT AND DISPOSAL DETAILS

There are no water bodies nearby hence there is no scope of effluent discharge directly

to water bodies.

The total water demand of 214.6 KLD will be met through KIADB water& Borewell Water

supply.



The wastewater generated from the project is about 201.0 KLD is treated in Zero liquid

discharge (ZLD) effluent treatment plant with MEE and RO system.

The Domestic sewage is being mixed with low strength effluent and treated.

The following table 4.2 presents the EMP for water quality.

Table 4.2 :- Water quality management during operation phase

Environmental impacts

Mitigation proposed

(a) Domestic Domestic sewage is being mixed with low strength effluent and treated.

(b) Industrial The industrial effluent is treated in Zero liquid discharge (ZLD) effluent treatment plant with MEE and RO system.

4.3.4.5 LAND ENVIRONMENT

Table 4.3:- land quality management during operation phase

Environmental impacts

Mitigation proposed

(a) Discharge of wastewater.

Domestic sewage is being mixed with low strength effluent and treated.

(b) Storage and disposal of solid wastes.

The total quantity of domestic solid wastes generated which will be segregated at source, collected in bins and composted. The composted waste will be used as manure for landscape development.

The domestic solid waste generated in the premises is estimated to be about 120 kg/day out of

which 72 kg/day (60%) is biodegradable & 48 kg/day (40%) is non-biodegradable/recyclable

wastes. The domestic wastes are segregated at source, collected in bins and composted. The

in-organic solid waste will be sent for recycling.

The various mitigation measures to be adopted during collection and disposal of domestic solid

wastes are as follows:

It is preferable that the container and bins used for collection of waste should be of closed

type so that the waste is not exposed and thus the pos sibility of spreading of disease

through flies and mosquitoes is minimized.

Collection system should be properly supervised so that quick and regular removal of

waste from the dustbin is practiced.

The domestic wastes are segregated at source, collected in bins and composted. The in-

organic solid waste will be sent for recycling.



The details of the hazardous waste generated from the various processes are described in detail

earlier in this report. These wastes are stored in hazardous waste storage area and disposed

through TSDF or authorized agencies.

4.3.5 EMP IMPLEMENTATION SCHEDULE

Phased according to the priority, the implementation schedule is presented in the following table

4.4.

Table 4.4 :- Implementation schedule for EMP

Sl. No. Recommendations Requirement

1 Air pollution control measures Existing

2 Water pollution control

measures

Existing

3 Noise control measures Existing

4 Solid waste management Existing

5 Landscape development Existing

The responsibility of EMP implementation lies with M/s. Shilpa Medicare Limited., and the

financial allocation/budgetary provisions for environmental management is detailed in table 4.5.

Table 4.5: Financial allocation/budgetary provisions for environmental management Aspects

Sl. No. Description Financial provision in Lakhs/annum

Capital cost Recurring cost

1 Effluent, hazardous waste storage facilities. 30 4

3 ETP & MEE upgradation 200 10

4 Implementation of Air Pollution Control Systems viz. required stack heights for DG set, boiler, and process section, scrubber systems.

30 4

5 Personal protection safety gadgets and health care

07 0.25

6 Tree plantation & landscaping measures 1.0 1.0

7 Environmental Monitoring Plan (air, noise, water and solid waste)

6.0 1.0

TOTAL 274 20.25



4.4 IRREVERSIBLE & IRRETRIEVABLE COMMITMENTS OF ENVIRONMENTAL COMPONENTS

There are no irreversible or irretrievable commitments of the environmental components as

adequate care will be taken to prevent any major impact on the environmental parameters.

4.5 ASSESSMENT OF SIGNIFICANCE OF IMPACTS (CRITERIA FOR DETERMINING SIGNIFICANCE, ASSIGNING SIGNIFICANCE)

The significance of the impacts identified in the previous sections for various environmental

parameters is detailed in this section.

4.5.1 IMPACT MATRIX

Table 4.8 presents the impact matrix for the actions identified and table 4.6 various

environmental parameters. A rating scale has been devised to give severity of impacts in the

following manner.

A : Strongly beneficial (positive) impact

B : Low beneficial impact

C : Strong adverse (negative) impact

D : Low adverse impact (localized in nature)

- : No conceivable impacts on environment

Table 4.6: Actions likely to affect environment

Sl. no. Actions Envisaged for the following

Construction phase

1 Civil works Existing

2 Fabrication and erection

3 Commissioning

Operational phase

1 Manufacture of Herbal Extract

and Active Pharmaceutical

Ingredients (APIs) &

Intermediates manufacturing

industry with R&D activity

Sources of air pollution Process sections, Boiler, DG sets

Air pollution control units provided

* Packed column scrubbers for process sections with Chimney height of 3 m above RL. * DG set stackt height as per the stack height calculation for 625



&750 KVA is 6 m above RL. * Steam boilers – 6 TPH- 1 No and 10 TPH– 1 no.s - Mechanical dust collectors & Bag Filter with chimney height 32 mt.



4.5.2 ENVIRONMENTAL IMPACT ASSESSMENT The environmental impact assessment is detailed in table 4.7

Table 4.7: Environmental impact assessment during Construction phase

Activity & sub

activities

Environmental

impacts on

Mitigation measures Final

Impacts

A. CONSTRUCTION PHASE

Minor

construction,

erection

activities

of the plant,

manpower

requirement.

Air, noise, water,

land, socio

economic &

safety.

Barricading of the site will be done.

Water sprinkling to avoid dust getting air borne.

Asphalted road will be made for the vehicle

movement.

It will be ensured to use well maintained vehicles to

reduce the vehicular air pollution.

Local labor will be employed.

Proper sanitation facility will be provided.

Construction material will be handled with due care to

avoid any spillage.

Fuel to be used will be stored on impervious surface to

prevent the soil contamination in case of spillage &

leakage.

Any hazardous waste generation will be handled as per

the Environmental Management Plan.

Low impacts due to

temporary activities.

Beneficial impacts due

to employment generation.



Table 4.7.1: Environmental impact assessment during operation phase

Sl. no.


Predicted impacts















-

















-




-



Table 4.8:- Impact matrix Sl. no Environmental parameter Proposed actions

Excavation Civil works Fabrication /Erection Operation phase

1.0 Air environment

Ambient air quality

Suspended particulates C C - D

Sulfur dioxide - - - D

Nitrogen oxides - - - D

Carbon monoxides - - - D

2.0 Water environment

Ground water quality/availability - - - -

Surface water availability - - - -

Receiving water body quality - - - -

Drainage system - - - -

3.0 Solid & hazardous waste

Land disposal - C - C

4.0 Noise

Ambient noise levels C C C C

5.0 Ecological parameters

Flora - - - -

Fauna - - - -

Aquatic ecology - - - -

6.0 Human settlement

Economic output - B B A

Employment opportunity - A A A

Occupational health - D D C

Infrastructure - C C B

7.0 Aesthetics

Topography / skyline - - - C

Visual air quality C C - C

Visual water quality - - - -

A:Strongly beneficial (positive) impact, B: Low beneficial impact, C:Low adverse impact (localized in nature), D:Strong adverse (negative) impact -:No conceivable impacts on environment



CHAPTER 5

ANALYSIS OF ALTERNATIVES (TECHNOLOGY & SITE)

5.1 ALTERNATIVES FOR TECHNOLOGY

5.1.1 EMISSION CONTROL TECHNIQUES

No single emission control technique can be used for all equipment leaks. The techniques

used to control emissions from equipment leaks can be separated into two categories:

equipment practices and work practices.

1) EQUIPMENT PRACTICES

Equipment practices involve the use of equipment to reduce or eliminate emissions. A

common example is an add-on control device, such as an adsorption, that is used to

reduce organic emissions from a process vent.

Other equipment controls include 1) leakless technology for valves and pumps; 2) plugs,

caps, and blinds for open-ended lines; 3) rupture discs and soft seats (Orings) for pressure

relief valves (PRVs); 4) dual mechanical seals with non-VOC barrier fluid/degassing vent

systems for rotary equipment; 5) closed-loop sampling systems; and 6) enclosure of seal

area/vent to a combustion control device for dynamic seals.

These equipment controls generally can attain up to 100 percent reduction of VOC

emissions. Mechanical seals and techniques that rely upon combustion control have been

assigned an overall control efficiency of 95 percent, which is consistent with the

efficiencies assigned to other frequently applied recovery techniques.

2) WORK PRACTICES

Work practices refer to the plans and procedures undertaken to reduce or estimate

emissions. Work practices with Standard operating procedures (SOPs) are the most

commonly used control techniques for equipment leaks. The primary work practice



applied to pressure relief valves, other valves, pumps and other sources is leak detection

and repair (LDAR) of sources

The emissions reduction potential for LDAR is highly variable and depends upon several

factors, including the frequency of monitoring (surveying) sources for leaks and the

threshold definition of a leak. A quarterly monitoring plan is generally more effective than

a half yearly monitoring plan in reducing emissions, since leaks are found and corrected

more quickly. Similarly, a maintenance system that corrects smaller leaks usually is more

effective than a system that responds only to larger leaks.

Characteristics of individual sources can affect the emissions reduction achieved by LDAR.

Important characteristics include leak occurrence rate, leak recurrence rate, accessibility

of leaking equipment and repair effectiveness.

5.1.2 OXIDES OF NITROGEN EMISSIONS FROM BOILER

LOW NITROGEN FUEL OIL

When firing fuel oils, NOx formed by fuel bound nitrogen can account for 20-50% of the

total NOx level. Utilizing fuel oils with lower nitrogen contents results in lower NOx levels.

One method to reduce NOx levels from boilers firing distillate oils is through the use of

low nitrogen fuel oil. Low nitrogen oils can contain up to 15-20 times less fuel-bound

nitrogen than standard No. 2 oil (less than 0.001% fuel-bound nitrogen). When low NOx

oil is fired in fire-tube boilers utilizing flue gas recirculation, NOx reductions of 60%-70%

over NOx emissions from standard No. 2 oils have been achieved.

BURNER MODIFICATIONS

Burner modifications for NOx control involve changing the design of a standard burner in

order to create a larger flame. Enlarging the flame results in lower flame temperatures

and lower thermal NOx formation which, in turn, results in lower overall NOx emissions.

The technology can be applied to most boiler types and sizes. It is most effective when

firing natural gas and distillate fuel oil and has little affect on boilers firing heavy oil. To

comply with the more stringent regulations, burner modifications must be used in

conjunction with other NOx reduction methods, such as flue gas recirculation. If burner

modifications are utilized exclusively to achieve low NOx levels (30 ppm), adverse affects

on boiler operating parameters such as turndown, capacity, CO levels and efficiency may

result. It is important to address all aspects of NOx control when selecting NOx control

technologies.



FLUE GAS RECIRCULATION

Flue gas recirculation, or FGR, is the most effective method of reducing NOx emission from

industrial boilers with inputs below 100 MMBtu/hr. FGR entails re-circulating a portion of

relatively cool exhaust gases back into the combustion zone in order to lower the flame

temperature and reduce NOx formation. It is currently the most effective and popular low

NOx technology for firetube and watertube boilers. And, in many applications, it does not

require any additional reduction equipment to comply with the most stringent

regulations. Flue gas recirculation technology can be classified into two types; external or

induced.

External flue gas recirculation utilizes an external fan to re-circulate the flue gases back

into the combustion zone. External piping routes the exhaust gases from the stack to the

burner. A valve controls the recirculation rate, based on boiler input.

Induced flue gas recirculation utilizes the combustion air fan to re-circulate the flue gases

back into the combustion zone. A portion of the flue gases are routed by duct work or

internally to the combustion air fan, where they are premixed with the combustion air

and introduced into the flame through the burner.

New designs of induced FGR that utilize an integral FGR design are becoming popular

among boiler owners and operators because of their uncomplicated design and reliability.

Theoretically, there is no limit to the amount of NOx reduction with FGR; practically, there

is a physical, feasible limit. The limit of NOx reduction varies for different fuels - 80% for

natural gas and 20-25% for standard fuel oils.

The current trends with low NOx technologies are to design the boiler and low NOx

equipment as a package. Designing as a true package allows the NOx control technology

to be specifically tailored to match the boiler’s furnace design features, such as shape,

volume, and heat release. By designing the low NOx technology as a package with the

boiler, the effects of the low NOx technology on boiler operating parameters (turndown,

capacity, efficiency, and CO levels) can be addressed and minimized.

CHOOSING THE BEST NOX TECHNOLOGY FOR THE JOB

Certain NOx controls can worsen boiler performance while other controls can appreciably

improve performance. Aspects of the boiler performance that could be affected include

turndown, capacity, efficiency, excess air, and CO emissions. Failure to take into account



all of the boiler operating parameters can lead to increased operating and maintenance

costs, loss of efficiency, elevated CO levels, and shortening of the boiler’s life.

5.2 ALTERNATIVES FOR SITE

The proposed project is an Active Pharmaceutical Ingredients (APIs) & Intermediats

manufacturing industry with R & D activity in an existing industry. Hence no alternative

sites are considered.



CHAPTER 6

ENVIRONMENTAL MONITORING PROGRAM

6.1 TECHNICAL ASPECTS OF MONITORING THE EFFECTIVENESS OF MITIGATION

MEASURES (INCLUDING MEASUREMENT METHODOLOGIES, FREQUENCY, LOCATION,

DATA ANALYSIS, REPORTING SCHEDULES, EMERGENCY PROCEDURES, DETAILED

BUDGET & PROCUREMENT SCHEDULES)

6.1.1 MEASUREMENT METHODOLOGY

Ambient air & noise monitoring, water, wastewater & soil quality: outsourced to NABEL

accredited laboratory.

6.1.2 FREQUENCY, LOCATION, DATA ANALYSIS, REPORTING SCHEDULES

A comprehensive monitoring program is suggested in below table 6.1.

Table 6.1: Monitoring schedule for environmental parameters

Sl. No

Particulars

Monitoring frequency

Duration of monitoring

Important parameters for monitoring

I Air quality

a Ambient air monitoring

1. Project premises Once in a month 24 hourly sample RSPM, SPM, SO2, NOx

2. Stack monitoring Once in a month Grab SPM, SO2, NOx, HC, CO

II Water and wastewater quality

b Water quality

i. Groundwater at two locations (up-gradient and down-gradient)


c Wastewater quality

i. Low strength & high strength wastewater streams (raw & treated)


III Soil quality

1. Within project premises at 1 location

Once in a year Composite sample

As per KSPCB requirements

2. Ecological preservation and up-gradation

Seasonal Visual observations

Survival rate

IV Noise monitoring

1. Project premises Once in a year Day and night As per KSPCB requirements

V Hazardous waste monitoring

1. Hazardous waste characterization

Annually Day and night As per KSPCB requirements



6.1.3 EMERGENCY PROCEDURES

STRUCTURE OF ONSITE EMERGENCY PREPAREDNESS AND RESPONSE

Plant Level Worker noticing an emergency situation

Shift In-charge

1. If necessary, shutdown the plant. 2. Contact the emergency declarer

If emergency is off site contact concerned authority and handover the charge of emergency control operations.

Govt. Authorities

Police

Fire

Accounting of personnel

All clear signal (when emergency is over)

Incident/Emergency controller

Fire/Security Team

Rescue/First Aid Team

Declarer of emergency

Raise alarm

Inform over phone



EMERGENCY ORGANIZATION STRUCTURE

SITE CONTROLLER & CHIEF EMERGENCY DECLARER

(GENERAL MANAGER/PRODUCTION MANAGER)

INCIDENT CONTROLLER/ALTERNATIVE EMERGENCY DECLARER

(ADMINISTRATOR)

MAINTENANCE SUPERVISORS / INCIDENT EMERGENCY

DECLARER/CONTROLLER

MAINTENANCE SUPERVISORS /

ALTERNATIVE EMERGENCY DECLARER



EMERGENCY COORDINATES

6.1.4 DETAILED BUDGET & PROCUREMENT SCHEDULES

Detailed budgetary provisions for monitoring program is detailed in the following table

6.2.

Table 6.2: Financial allocation/budgetary provisions for monitoring program

Sl. No. Description Financial provision in Lakhs/annum

Capital cost Recurring cost

1 Effluent, hazardous waste storage facilities. 30 4

3 ETP & MEE upgradation 200 10

4 Implementation of Air Pollution Control Systems viz. required stack heights for DG set, boiler, and process

section, scrubber systems.

30 4

5 Personal protection safety gadgets and health care 07 0.25

6 Tree plantation & landscaping measures 1.0 1.0

7 Environmental Monitoring Plan (air, noise, water and solid waste)

6.0 1.0

TOTAL 274 20.25

CONCERNED DEPARTMENTS

SECURITY

PERSONNEL

ESSENTIAL & SUPPORT SERVICES

FIRE FIGHTING RESCUE REHABILITATION & TRANSPORT



CHAPTER 7

ADDITIONAL STUDIES

7.1 INTRODUCTION

The Active Pharmaceutical Ingredients (APIs) & Intermediats manufacturing industry with

R & D activity industries are generally associated with use of raw materials and chemicals

which are hazardous in nature. The process activities of these industries are also

associated with certain risks. Therefore Hazop analysis and risk assessment are addressed

in detail as additional studies.

Apart from the above studies air pollution dispersion modeling using US EPA approved

AERMOD software has been used to predict the profile of dispersion and associated

impacts within the project study area.

7.2 HAZOP ANALYSIS

Detailed step-wise hazop analysis studies describing process, operation, possible hazard

failure and remedial actions for each of the product manufactured is given in

annexure- 1



7.3 SAFETY PRECAUTIONS FOR THE HANDLING OF HYDROGEN GAS AND PD/CARBON

The following are the safety precautions adopted while handling hydrogen gas &

palladium carbon.

1. It is ensured that all the equipments have earthing and bondings.

2. It is ensured that the mechanical seal pressure is +2.0 kg/cm2 with operating pressure.

3. Care is taken to see that there are no leackages in the mechanical seal.

4. Cleanliness of autoclave reactor and it is surroundings is maintained.

5. Before charging pressure test of autoclave is taken; only if it is ok proceed further

otherwise leak should be rectified.

6. Hydrogen lines and availability of required cylinders near header is ensured.

7. All the cylinders are tied with chain and it is ensured that there are no leackages in

the manifold.

8. All the gauges are calibrated.

9. Presence of water in autoclave vent receiver is ensured.

10. Availability of suitable rupture disc & its connection to the dump vessel is ensured.

11. Use the necessary PPE’s before batch charging i.e., 3M cartridge mask, safety goggles,

safety helmets, safety shoes & safety gloves.

12. Availability of fire fighting equipments nearby is ensured.

13. ERT (Emergency Response Team) is available in case of emergency.

14. Hydrogen Gas detector is on.

15. 50% Pd/C making slurry with suitable solvent under nitrogen blanketing with proper

earthing by holding the vacuum into the receiver.

16. Vacuum is released with nitrogen pressure only through vent line.

17. Hydrogen gas 0.2 kg/cm2 is slowly applied and flushed out. The process is repeated

once again.

18. Hydrogen gas 4.0-4.5 kg/cm2 is slowly applied and pressure is maintained as per BPR.

19. All necessary PPE’s i.e., 3M cartridge mask, safety goggles, safety helmets, safety

shoes & safety gloves are used during filtration.

20. Nitrogen blanketing in the nutch filter is added and slowly filtration into the nutch

filter is started.

21. Main filtration is completed and the spent Pd/C cake is washed with suitable solvent

under nitrogen blanketing until absence of the product.

22. Water and HCl are charged into the reactor for decomposing of left over traces of

spent Pd/C; the mass is unloaded and transferred to EHS department for further

disposal.

23. Wet spent Pd/C is unloaded from Nutsche filter and packed under nitrogen blanketing

& transferred to WH for recovery.



7.4 RISK ASSESSMENT

7.4.1 BACKGROUND

The manufacture of an Active Pharmaceutical Ingredients (APIs) and Intermediates with

R&D Activity by “ M/s. Shilpa Medicare Limited.,” involves use and storage of certain

solvents which may cause hazards/risks in case of accidental spill/leakage. Also the

operation of DGs, boilers requires the use and storage of diesel and fuel oil which can be

a source of hazard in case of accidental spill/leakage. Therefore a methodology has to be

developed for identifying and evaluating the potential risks and preparation of

intervention plans to reduce and prevent the associated risks.

The above factors have necessitated preparation of risk assessment report for

“M/s. Shilpa Medicare Limited.,”

7.4.2 INTRODUCTION

Environmental risk analysis deals with the identification and quantification of risks the

equipment and personnel are exposed to, from the hazards present in the area.

Risk analysis follows hazard analysis (Risk = Hazard x Probability of occurrence). It involves

identification and assessment of risks to the plant personnel and neighboring populations.

This requires a thorough knowledge of failure probability, credible accident scenario,

vulnerability of population etc. Much of this information is difficult to procure.

Consequently, the risk analysis is confined to maximum credible accident studies. The

subsequent sections shall address the identification of various hazards and risks in the

operations, which will give a broad identification of risks involved.

7.4.3 OBJECTIVE & SCOPE

The objective of the study is to carry out risk analysis and prepare disaster management

plan/emergency preparedness plans.

The risk analysis/assessment study covers the following:

(a) Identification of potential hazards associated with the solvent storage and their

usage.

(b) Identification of potential hazard due fuel storage.



(c) Assess the overall damage potential of the identified hazardous events and impact

zones from the accident scenarios.

(d) Suggestions and recommendations on the minimization of the accident

possibilities.

7.4.4 HAZARD IDENTIFICATION

The technique used for the hazard identification is Maximum Credible Accident (MCA)

analysis, which allows identification of an accident with probable maximum damage

distance.

Apart from the solvents, diesel fuel and fuel oil will also be stored in plant premises. The

solvent storage tanks are designed as per the safety norms of Hazardous Storage

Guidelines of Institute of Fire and Safety Engineering, Nagpur. Apart from the tanks small

quantities of solvents are stored in flame proof barrels in the designated storage area.

Storage tank sizes and quantity of solvent is planned as per the storage capacity of

respective solvents. The solvent and fuel requirement for the industry/plant on monthly

basis is detailed table 7.1 & Probable hazards in the plant is shown in table 7.2.

Table 7.1: Product wise solvents recovered in Kg

Sl. No

Product Raw materials Quantity (kg/annum)

Recovered and recycled

Lost

A Herbal Extract

1 Coleus Forskholli extract

Toluene 3,49,200 10800

Hexane 34,200 1800

2 Curcumin Ethyl Acetate 19,350 900

3 TetrahydroCurcuminoids

Acetone 47400 2400

IPA 14250 750

4 Piperine Methanol 5616 624

5 Tetrahydropiperine Acetone 13446 698

IPA 4084 199

B Cosmetics ingredients, neutraceutical ingredients, pharama intermediates and API

1 Benzal Koniumchloride

---

2 4-nhexylresercinol Methanol 28500 1500

Hexane 28500 1500



3 4-n Butylresercinol Methanol 21243 1002

Hexane 21042 1203

4 2- Methylresercinol Mesitylene 13496 698

5 1,4 cyclohexanedione

Methanol 41040 2160

Ethyl acetate 95400 4800

6 Tasmsulosin HCL and its itermediates

Isopropyl alchol 4770 241

Ethyl acetate 6693 321

Methanol 5299 279

7 1-chloromethyl Naphthalene

----

8 Piroctone Olamine Methanol 85560 4440

Ethyl Acetate 146400 7200

EDC 85800 4200

9 Ethylhexyl Trizone Acetonitrile 34800 1200

Methanol 40500 2100

Hexane 32400 1800

Perchloroethylene 53400 3300

Xylene 22800 1200

10 Benzethonium Chloride

Ethyl Acetate 26653 1403

Toulene 52405 1102

11 Iscotrizinol Acetonitrile 4910 201

Hexane 10321 501

Methanol 8016 401

Toulene 23347 902

12 Tinosorb- S Hexane 1046 50

Ethylene Dichloride 6872 359

Isopropyl alcohol 9711 548

Methanol 797 50

Toulene 16932 897

13 Tinosorb -M Methanol 5677 299

Isopropyl alcohol 947 50

Methanol 15139 797

Toulene 7121 349

Xylene 4831 249

Table 7.2: Probable hazards in the plant

Hazard type Description

Solvent use Spillage of chemicals while handling.

Spillage of chemicals or baths into trench.

Fuel storage Diesel and furnace oil spill and fire.

Tank failure and fire.



The drawing indicating the areas earmarked for storage of solvents and fuel is shown in

the appended plant layout of the industry.

7.4.4.1 EXPOSURE TO SOLVENTS

As per the Manufacture, Storage and Import of APIs are hazardous in nature according to

Manufacture, Storage and Import of Hazardous Chemical (Amendment) 1989 (as

amended on 24-9-2008), Schedule-1, these solvents possess risk to the health and safety

and the user must be aware of the safe handling procedures, health risk involved and

safety arrangements.

Severity mapping for the various solvents used is detailed in the tables 7.3 below.


- 254 -

Table 7.3: Severity mapping FIRE

Sl.

No.

Solvent Severity Precautionary measures proposed Mitigation measures

proposed Less severe Moderate Severe

FIRE

1 Cyclohexane - Flammable - Storage: Non-corrosive in the presence of

glass & metals.

Stored in segregated and approved area. Kept

in cool, well-ventilated areas in tightly closed

and sealed containers. All possible sources of

ignition should be avoided.

Stability and reactivity: Reactive with

oxidizing agents.

Fire fighting measures:

Small fire: dry chemical

powder to be used.

Large fire: Water spray or fog

to be used.

2 Methyl alcohol

- - Highly

flammable

Storage: Stored in tightly closed containers in

a cool, dry, well-ventilated areas away from

direct sunlight and any area where the fire

hazard may be acute.

Separate from oxidizing materials.

Storage and use should be no smoking areas.

Stability and reactivity: Stable under ordinary

conditions of use and storage. Heat

contributes to instability.

May produce acrid smoke and irritating fumes

when heated to decomposition.

Incompatible with strong oxidizers.

Fire fighting measures:

Methanol burns with a clean

clear flame that is almost

invisible in daylight. Fine

water spray or fog to be used

to control fire spread and cool

adjacent structures and

containers.

Fire fighters must wear full

face positive pressure, self-

contained breathing

apparatus or airline

appropriate protective

clothing.



3 Toluene - Flammable - Storage: Stored in a segregated and approved

area in a cool well-ventilated area in tightly

closed and sealed containers away from all

possible sources of ignition.

Stability and reactivity: Stable under normal

conditions. Can become instable when

exposed to conditions of heat and ignition

sources.

Incompatible with strong oxidizers, silver

perchlorate, sodium difluoride,

tetranitromethane, uranium hexafluoride.

Frozen bromine trifluoride reacts violently

with toluene at – 800C

Reactive with oxidizing agents.

Reacts chemically with nitrogen oxides or

halogens to form nitrotoulene, nitrobenzene

and nitrophenol and halogenated products

respectively.

Toluene forms explosive reaction with 1,3-

dichloro-5,5-dimethyl-2,4-imidazolididione,

dinitrogen tetrachloride.

Non-corrosive in the presence of glass.

Fire fighting measures: Dry

chemical powder, water spray

or fog can be used as fire

extinguishing media.

4 Diesel - - Highly

flammable

Storage: Should be kept away from flame,

sparks, excessive temperatures and open

flame.

Incompatibility: High temperatures, open

flames, sparks, welding, smoking and other

Fire fighting measures: Water

spray, fog or fire fighting

foam. Water may be

ineffective for fighting the

fire, but may be used to cool

fire-exposed containers.



ignition sources. Should be kept away from

strong oxidizers.

Carbon monoxide, carbon dioxide and non-

combusted hydrocarbons (smoke) are the

hazardous decomposition products that may

be formed.

SPILLAGES

Sl.

No.

Raw material Severity Precautionary measures

proposed

Mitigation measures proposed

Less

severe

Moderate Severe

SPILLAGES

1 Cyclohexane - Moderately

toxic

- EXPOSURE CONTROLS AND

PERSONNEL PROTECTION:

Engineering controls: Exhaust

ventilation or other engineering

controls to be provided to keep

the air-borne concentrations

below the threshold limit.

Eyewash stations & safety

showers should be proximal to

the work-station location.

Personal protection: Splash

goggles, lab coat, vapor

respirator, gloves, safety goggles

or glasses, boots etc. to be

provided.

FIRST AID MEASURES:

After inhalation: Removed to fresh air. If not breathing,

artificial respiration to be given. If breathing is difficult,

oxygen to be given. Medical attention to be sought

immediately.

After skin contact: Remove contaminated clothing and wash

affected areas with plenty of water. Cover irritated skin with

emollient. Seek medical attention.

After eye contact: Remove contact lenses if any. Flush eyes

immediately with water for at least 15 minutes keeping

eyelids open. Get medical attention immediately.

After ingestion: DO NOT INDUCE VOMITING unless directed

to do so by medical personnel. Never give anything by mouth



to an unconscious person. Aspiration hazard if swallowed –

can enter lungs & cause damage. Loosen tight clothing such

as collar, tie, belt or waist-band. Get medical attention if

symptoms appear.

Methyl alcohol

Less

toxic

- - EXPOSURE CONTROLS AND


Engineering controls: In confined

areas, local and general

ventilation should be provided,

ventilation systems designed

according to approved

engineering standards.

Respiratory protection: NIOSH

approved supplied air respirator

when air-borne concentrations

exceed exposure limits.

Eye and face protection: Face

shield and chemical splash

goggles when transferring is

taking place.

FIRST AID MEASURES:

After inhalation: Remove to fresh air. Restore or assist

breathing if necessary. Obtain medical attention.

After skin contact: Remove contaminated clothing. Wash skin

with soap and water for at least 15 min. Seek medical

attention if irritation develops or persists. Wash clothing

before re-use.

After eye contact: Remove contact lenses if worn. Flush eyes

immediately with plenty of running water for at least 15

minutes lifting lower and upper eyelids occasionally. Get

medical attention.

After ingestion: Swallowing methanol is potentially life

threatening. On-set of symptoms may be delayed for 18-24

hours after digestion. If conscious and medical aid is not

immediately available do not induce vomiting. Transport to

medical facility immediately.

2 Toluene - Moderately

toxic

- EXPOSURE CONTROLS AND


Engineering controls: Exhaust

ventilation should be provided.

FIRST AID MEASURES:

After inhalation: Remove to fresh air. If breathing stops

provide artificial respiration. If breathing is difficult oxygen

should be administered. Get medical attention.



Personnel protection: Splash

goggles, lab coat, vapor

respirator, gloves.

Personnel protection in case of

large spill: Splash goggles, full

suit, vapor respirator, boots,

gloves, self-contained breathing

apparatus.

After skin contact: Wash with a disinfectant soap and cover

contaminated skin with an anti-bacterial cream. Seek

immediate medical attention

After eye contact: Remove contact lenses. Immediately flush

eyes with plenty of water for at least 15 minutes. Obtain

medical attention.

After ingestion: DO NOT INDUCE VOMITING unless directed

to do so by medical personnel. Never give anything by mouth

to an unconscious person. Loosen tight clothing such as

collar, tie, belt or waist-band.

3 Diesel - Moderately

toxic

- To be handled carefully with the

usual precautionary measures.

The product should not be

allowed to reach the

groundwater, water bodies or

sewerage system in large

quantities.

Runoff to sewer may cause fire or

explosion hazard.

FIRST AID MEASURES:

Eye & Skin: In case of contact, eyes are immediately flushed

with clean, low-pressure water for at least 15 min. Eyelids are

held open to ensure adequate flushing. Medical attention is

obtained if irritation or redness develops in skin.

Ingestion: VOMITING SHOULD NOT BE INDUCED. Liquids

should not be given.

Inhalation: The person should be removed to fresh air. If

person is not breathing artificial respiration to be provided. If

necessary, additional oxygen to be provided once breathing

is restored if trained to do so. Medical attention to be sought

immediately.



7.4.4.5.1 Fire & Explosing Index

Fire and Explosion Index FIRE AND EXPLOSION INDEX 40.46

User entries should only be made in the yellow cells. Notes are attached to most entry cells. If you need further details. - read the manual

Instructions for user - read comments attached to this cell

Level 2 Risk Analysis is not triggered

Pertinent Process Unit HYDROGENATION

Material in Process Unit HYDROGENATION

Material Factor (see Material Data tab) 21 21.00

NFPA Health rating (Nh) - see Material Data 0

NFPA Flammability rating (Nf) - see Material Data 4

NFPA Instability rating (Ni) - see Material Data 0

1 General Process Hazards

Calculated Penalties

Base 1.00 REMARKS

1A Exothermic Reaction (input range 0.0 - 1.25) 0.3 0.30

1B Endothermic Reaction (input range 0.0 - 0.4) 0 0.00



1C Material Handling and Transfer (input range 0.0 - 0.8) 0 0.00

1D

Enclosed or Indoor Process or storage Units handling Flammable materials (input range 0.0 - 0.9) 0 0.00

1E Ease of Access for Emergency Responders (input range 0.0 - 0.35) 0.2 0.20

1F Drainage and Spill Control (input range 0.0 - 0.5) 0.1 0.10

General Process Hazards Factor F1 1.60

2 Special Process Hazards

Base 1.00

2a Toxicity of the material handled (Entry is automatic). 0 0.00

2B Process or Storage operates at vacuum (<500mmHg) -(input 0.5 0 0.00

2C Operation in or near the flammable range (input range 0.0 - 0.8) 0 0.00

2D Dust Explosion (input range 0.0 - 2.0) 0 0.00



2E Pressure Penalty

Operating Pressure (fig 2) Kpa g 60

Relief Pressure Setting Kpa g 90

Penalty

Viscous non volatile materials multiplier input 0.7 0

Flammable Liquids at Press > 1 barg multiplier input 1.2 0

LPG or Flammable Gas multiplier input 1.3 0

None of the above - multiplier 1.0 0

Final Penalty 0 0.00

2F Low Temperature Operation 0 0.00

2G Combustible and Flammable materials in Process

2G1 Liquids or Gases in Process

Q Process Kg

Hc Kcal/Kg (see Material data)

Penalty 0.00

2G2 Liquids or gases in Storage

Liquefied Flammable Gases



Q Storage kg 0

Hc Kcal/Kg (see Material data) 0

Class 1 Flammable Liquids (FP<37.8 C) in

Q Storage Kg 0


Class 2 Flammable Liquids (37.8<FP<60 C)

Q Storage Kg 0


Penalty 0.00

2G3 Solids in Storage or Process

Quantity in Kg - Combustible Solids in Storage , Dust in Process Bulk Density <160Kg/m3 0

Quantity in kg - Combustible Solids in Storage , Dust in Process Bulk Density >160Kg/m3 0

Penalty 0.00



2H Corrosion and Erosion (input range 0.0 -0.75) 0.1 0.10

2I Leakage, Joints, packing, flexible joints 0.1 0.10

2J Use of Fired Equipment (fig 6)

Distance of ignition source from potential leak

If there is a strong source of ignition (open flame) within 100 metres enter in one of the columns below

Distance in metres (for Material >F.P.) 500

Distance in metres (for Material >B.P.) 500

Penalty 0.00

2K Hot Oil Heat Exchange Equipment (table 5)

Quantity in pumps and pipes > F.P is between 100 and 20000 litres input 0.15 0





Quantity in pumps and pipes > F.P is >100000 litres input 0.75 0

Quantity in pumps and pipes > B.P is between 100 and 20000 litres input 0.25 0



Quantity in pumps and pipes > B.P is >100000 litres input 1.15 0

Penalty 0.00

2L Rotating Equipment

Unit includes Compressor in excess of 500KW or pump in excess of 80KW or Safety Critical Agitator, input 0.5 0

Penalty 0.00

Special Process Hazards Factor f2 1.20

F1 X F2 1.93



Fire and Explosion Index 40.46

Print section follows:

HYDROGENATION


Material Factor (see Material Data tab) 21.00

NFPA Health rating (Nh) 0

NFPA Flammability rating (Nf) 4

NFPA Instability rating (Ni) 0

General Process Hazards

Base 1

1A Exothermic Reaction (range of input 0.3 - 1.25) 0.30

1B Endothermic Reaction (input range 0.2 - 0.4) 0.00

1C Material Handling and Transfer (input range 0.25 - 0.8) 0.00

1D Enclosed or Indoor Process or storage Units handling Flammable materials 0.00

1E Ease of Access for Emergency Responders 0.20

1F Drainage and Spill Control 0.10 General Process Hazards Factor 1.60

Base 1 2A Toxicity of the material handled. 0.00



2B Process or Storage operates at vacuum (<500mmHg) -penalty 0.5 0.00

2C Operation in or near the flammable range (input range 0.0 - 0.8) 0.00

2D Dust Explosion (input range 0.0 - 2.0) 0.00 2E Pressure Penalty 0.00 2F Low Temperature Operation 0.00

2G1 Combustible and Flammable materials in Process 0.00

2G2 Liquids or gases in Storage 0.00 2G3 Solids in Storage or Process 0.00

2H Corrosion and Erosion (input range 0.0 -0.75) 0.10

2I Leakage, Joints, packing, flexible joints 0.10 2J Use of Fired Equipment (fig 6) 0.00

2K Hot Oil Heat Exchange Equipment (table 5) 0.00

2L Rotating Equipment 0.00

Special Process Hazards Factor 1.20


Level 2 Risk Analysis is not triggered



7.4.5 FIRE HAZARDS

7.4.5.1 INTRODUCTION TO THE FIRE & EXPLOSION INDEX (F & EI)

The Fire and Explosion Risk Analysis System is a step-by-step objective evaluation of the

realistic fire, explosion and reactivity potential of process equipment and its contents. The

quantitative measurements used in the analysis are based on historic loss data, the energy

potential of the material under study, and the extent to which loss prevention practices are

currently applied.

The purpose of the F&EI system is to:

1. QUANTIFY the expected damage of potential fire, explosion and reactivity

incidents in realistic terms.

2. IDENTIFY equipment that would be likely to contribute to the creation or

escalation of an incident.

3. COMMUNICATE the F&EI risk potential to management.

The most important goal of the F&EI System is to make the engineer aware of the loss

potential of each process area and to help the engineer identify ways to lessen the severity

and resultant rupee loss of potential incidents in an efficient and cost effective manner.

The F&EI is used in the Dow Risk Review Process. Determination of the F&EI is done in

conducting a Process Hazard Analysis or Level I Risk Review.

The Dow F&EI system attempts to determine the realistic maximum loss that can occur to a

process plant (or process unit) or related facility - a loss that could actually be experienced

under the most adverse operating conditions. The calculation is based on quantifiable data.

Finite spill rates, process temperature in relation to material flash points and boiling points

and reactivity are just a few of the many contributors to a probable incident.

The system can be applied if handling a minimum of approximately 454 kg of a flammable or

reactive material.



7.4.5.2 PROCEDURE FOR RISK ANALYSIS CALCULATIONS

7.4.5.3 IMPORTANT CONSIDERATIONS

A. The Fire and Explosion Index system assumes that a process unit handles a minimum of

2268 kg, or about 2.27 m3 of a flammable, combustible or reactive material. If less material

is involved, generally the risk will be overstated. However, F&EI calculations can provide

meaningful results for pilot plants if they handle at least 454 kg or about 0.454 m3 of

combustible or reactive material.

B. Careful consideration is needed when equipment is arranged in series and the items are

not effectively isolated from each other.

Selection of pertinent process unit

Determination of Material Factor

Calculation of General Process Hazards

Factor (F1)

Calculation of Special Process Hazards

Factor (F2)

Determination of Process Unit Hazards Factor

F3 = F1 x F2

Determination of F&EI F&EI = F3 x Material Factor



7.4.5.4 CALCULATION OF F & EI FOR THE STORAGE AREA OF M/S. SHILPA MEDICARE

LIMITED.,

The warehouse/storage area is considered for the calculation of the fire & explosion index.

The solvents & fuels are stored in large quantities in the factory premises. The calculation of

F & EI is shown in the following stages.

Step 1: Determination of material factors (MF)

Step 2: Determination of general process hazards factor (F1)

Step 3: Determination of special process hazards factor (F2)

Step 4: Determination of process unit hazard factor (F3)

F3 = F1 x F2

Step 5: Determination of Fire & Explosion Index (F & EI)

F & EI = F3 x material factor (MF)

Step 6: Determination of degree of hazard potential

The degree of hazard potential is identified based on the numerical value of F&EI as per the

criteria given in the following table 7.4.

Table 7.4: Degree of hazard

F&EI range Degree of hazard

1 - 60 Light

61 - 96 Moderate

97 - 127 Intermediate

128 - 158 Heavy

159 - up Severe

Following table 7.5 provides the details of the identified potential hazards and the systems

suggested to minimize the hazards in the industry.



Table 7.5: Preventive systems provided in the plant

Unit Hazard identified Provision

Solvent use and

mixing

Spill of solvents

Fire

Health hazard

Eye wash / Shower rooms.

Adequate firefighting equipment is

provided at all storage areas and in

various parts of the plant.

MSDS sheets are available.

Use of PPE while handing the solvents.

Diesel and furnace

oil

Fire CO2, extinguishing powder or water jet,

alcohol - resistant foam.

Factory fire bridge.

Unloading trucks Fire/Explosion

Factory fire bridge and fire fighting systems.

7.4.6 MAXIMUM CREDIBLE ACCIDENT (MCA) ANALYSIS

The MCA scenarios were short-listed based on the storage quantities and properties of the

chemicals, (hazard identification). MCA analysis studies were conducted for following

scenario "Pool fire due to rupture/leakage and accumulation of solvents and fuel".

7.4.6.1 FIRE DAMAGE

A flammable liquid in a pool will burn with a large turbulent diffusion flame. This release of

heat is based on the heat of combustion and the burning rate of the liquid. A part of the heat

is radiated while the rest is convected away by the rising hot air and combustion products.

The radiation may heat the contents of a nearby storage or process unit to above its ignition

temperature and thus result in the spread of fire. The radiation may also cause severe burns

or fatalities of workers or fire fighters located within a certain distance. Hence, it will be

important to know beforehand the damage potential of a flammable liquid pool likely to be

created due to leakage or catastrophic failure of a storage or process vessel. This will help to

decide the type of protective clothing for the workers/fire fighters, the time they can be in

vicinity of the fire (without any significant danger to life and health), the fire extinguishing

systems needed and the protection needs for the nearby storage/process vessels. The

following table 7.6 & 7.7 presents the damage effect on equipment at different thermal

radiation levels & Radiation exposure and lethality.



Table 7.6 :- Damage due to incident radiation intensities

Sl.

no.

Incident radiation

(kW/m2)

Type of damage intensity

Damage to equipment Damage to people

1 37.5 Damage to process

equipment

100% lethality in 1 min.

1% lethality in 10 s.

2 25.0 Minimum energy required to

ignite wood at indefinitely

long exposure without a

flame.

50% lethality in 1 min.

Significant injury in 10 s.

3 19.0 Maximum thermal radiation

intensity allowed on

thermally unprotected

adjoining equipment.

-

4 12.5 Minimum energy to ignite

with a flame; melts plastic

tubing

1 % lethality in 1 min.

5 4.5 - Causes pain if duration is

longer than 20 s; however

blistering is un-likely (first

degree burns)

6 1.6 - Causes no discomfort on long

exposures.

Table 7.7 :- Radiation exposure and lethality

Radiation intensity

(kW/m2)

Exposure time

(s)

Lethality

(%)

Degree of burns

1.6 - 0 No discomfort even

after long exposure.

4.5 20 0 1st

4.5 50 0 1st

8.0 20 0 1st

8.0 50 <1 3rd

8.0 60 <1 3rd

12.0 20 <1 2nd

12.0 50 8 3rd

12.5 60 1 3rd

25.0 60 50 3rd

37.5 60 100 3rd



For tank storage, it is assumed that the fuel leaks due to tank failure or rupture develops into a

pool and gets ignited (pool fire). Pool fire can also take place in case of pipeline rupture and

accumulation of solvents or fuels.

Following are the assumptions of the MCA analysis

no fire detection and mitigation measures are initiated;

secondary containment (dykes) that will confine flow of liquid and liquid absorption into

the ground is not considered;

secondary fire at public road and building is not likely to happen, since they are far away

from the storage area;

the effect of smoke on reduction of source radiation intensity has not been considered;

therefore hazard distances calculated tend to be conservative;

shielding effect of intervening trees or other structures has not been considered.

7.4.6.2 PROPERTIES OF SOLVENTS/FUELS

The chemical data for fuel and solvents is compiled from the MSDS, literature. The properties

of the same are presented in the following table 7.8.

Table 7.8: Properties of solvents and fuels

Sl. no.

Solvent/Fuel Molecular weight (g/mole)

Boiling point (oC)

Flash point (0F)

Specific gravity

1 Cyclohexane 98.15 g/mole 156 °C 109.4 °F 0.9478 @ 20 °C

2 Methanol 32.04 64.5 53.6 0.7915

3 Toluene 92.14 110.6 40 0.8636

4 Diesel oil (HSD) 500 - 1500 140 - 400 100-130 0.82 – 1.08

Note: NA – Not available

Adequate fire detection and protection systems needs to be installed to handle such

emergencies as suggested in the following table 7.9.



Table 7.9: - Fire protection system proposed for M/s.Shilpa Medicare Limited,

100% EOU

Suggested system

1. For unloading area (solvents and fuel), automatic detection system and manually

operated medium velocity water spray system along with foam system should be

provided.

2. An adequate number of portable chemical fire extinguishers will be installed at suitable

locations throughout the plant area. The extinguisher will be used during the early

stages of fire to prevent spreading while handling flammable solvents.

3. Hydrant system covering the entire plant including all important auxiliaries and

buildings will be installed. The system will be complete with piping, valves,

instrumentation, hoses, nozzles, hydrants valves etc.

4. All electrical fittings in hazardous area should be of flame-proof type.

7.4.7 SALIENT FEATURES OF RISK AUDITING AND ASSESSMENT

The risks associated with the Active Pharmaceutical Ingredients (APIs) & Intermediats

manufacturing industry with R & D activity are commensurate with their rapid growth and

development. Apart from their utility, chemicals and the raw materials used in their

production 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. Though many of chemical accidents have a limited effect,

occasionally there are disasters like the one in Bhopal, India, in 1984, where lakhs of people

were affected and LPG explosion in Vizag refinery where huge property damage in addition

to 60 deaths was experienced. Therefore chemicals have the potential to affect the nearby

environment also.

Design and pre-modification review: Improper layout like location of plant in downwind

side of tank farm, fire station near process area, process area very close to public road

and wrong material of selection had caused severe damages to the work and outside

environment.

Chemical risk assessment: Not assessed for new chemicals from the point of view of

compatibility, storage, fire protection, toxicity, hazard index rating, fire and explosion

hazards.

Process safety management: HAZOP, FTA, F&E Index calculation, reliability assessment

of process equipment, incorporating safety trips and interlocks, scrubbing system, etc.



not done before effecting major process changes, lack of Management of Change

procedure (MoC), etc.

Electrical safety: Hazardous area classification, protection against static electricity,

improper maintenance of specialized equipment like flameproof etc. were ignored.

Safety audits: Periodical assessment of safety procedures and practices, performance of

safety systems and gadgets along with follow up measures were not carried out.

Emergency planning: Lack of comprehensive risk analysis indicating the impact of

consequences and specific written down and practiced emergency procedures along

with suitable facilities had increased the severity of the emergency situations.

Training: Safety induction and periodical refresher training for the regular employees

and contract workmen were not carried out.

Risk management & insurance planning: Thorough identification and analysis of all risks

and insurance planning were not done so that interruption risks and public liability risks

could also be managed effectively.

A few reviews that are recommended for industries are:

7.4.7.1 FIRE PROTECTION

INDIAN STANDARDS

IS 2189 - Standard for automatic fire detection and alarm system.

IS 2190 - Code of practice for selection, installation and maintenance of first aid fire

extinguishers.

IS 3844 - Code of practice for installation and maintenance of internal fire hydrants and

hose reels.

IS 6382 - Carbon dioxide fire extinguishing system - fixed design and installation.

Oil Industry Safety Directorate

OISD 117 - Fire Protection Facilities for Petroleum Depots and Terminals.

OISD 142 - Inspection of firefighting equipment and systems.

OISD 158 - Recommended Practices on Storage and Handling of Bulk Liquefied

Petroleum Gas.



NFPA STANDARDS

NFPA 12 - Carbon Dioxide Fire Extinguishing Systems.

NFPA 1600 - Disaster Management.

NFPA 921 - Fire & Explosion Investigation.

NFPA 45 - Fire protection for Laboratories using Chemicals.

7.4.7.2 OHS (OCCUPATIONAL HEALTH AND SAFETY)

IS 14489 - Code of Practice for Occupational Safety & Health Audit.

NFPA 101 - Life Safety Code.

7.4.7.3 ER (ELECTRICAL RISK)

Hazardous Area Classification (base standard: IS 5572)

Selection of Electrical Equipment for Hazardous Areas (base standard: IS 5571)

Lightning Protection (base document: IS: 2309 /NFPA 780 /BS 6651)

NFPA 70 B - Recommended Practice for Electrical Equipment Maintenance

NFPA 70 E - Standard for Electrical Safety in Employee Work places

7.4.8 PROCESS SAFETY MANAGEMENT

Hazard & Operability (HAZOP) studies

Failure Tree Analysis (FTA)

Event Tree Analysis (ETA)

Primary Hazard Analysis (PHA) using Dow Index

Risk Assessment (with risk ranking technique)

7.4.9 ELECTRICAL RISK ASSESSMENT

Review of Hazardous Area Classification

Lightning Protection Risk Assessment

Identification & Control of Electro-Static Hazards

Review of electrical Preventive Maintenance System

Electrical Risk Assessment (fire, shock explosion) using Semi-Quantitative Risk Ranking

(SQRR) technique.



7.4.10 FIRE RISK ASSESSMENT

Identification & assessment of fire risks during operations in receipt, storage, transfer

and handling of chemicals (raw materials and finished products).

Identification & control of ignition sources in areas where flammable chemicals are

stored / handled / transferred.

o Review of chemical compatibility in storage areas and to suggest appropriate fire

loss control measures.

o Review of fire detection measures adopted in the plant & to suggest suitable

improvement measures.

o Review of the various active (fire hydrant, sprinkler, portable fire extinguishers)

and passive fire protection requirements for chemical storage and handling areas

and to suggest improvements as necessary.

o Review of contractor safety awareness (chemical spill, fire fighting, emergency

communication, knowledge of plant hazards & safety regulations) and to

recommend suitable improvement measures to enhance contractor safety.

o Review of safety awareness and safety training requirements (training

identification and efficacy) of plant employees with respect to hazards present in

the plant.

Fire risk assessment will be carried out based on techniques like Matrix method, Hani Raafat

Risk Calculator. The consequence, likelihood and exposure of each hazard are arrived using a

systematic approach and will help to determine the relative importance of hazard and focus

on significant risks.

7.4.11 RISK ANALYSIS & EMERGENCY PLAN

Identification of scenarios of potential disasters / emergencies leading to loss of life,

property damage etc. and qualitative assessment of their likelihood.

Quantitative risk assessment for selected scenarios of major credible events.

Recommendations for risk control measures wherever applicable.

Preparation of onsite emergency preparedness plan.

7.4.12 RISK MANAGEMENT & INSURANCE PLANNING

Identification of all major internal and external risks including the natural risks and analysis of the impact of above risks.

Review of existing risk control measures and offering comments. Scrutiny of all existing major insurance policies in respect of:

o Rationalization of basic rate of premium and widening of covers. o Applicability / eligibility of discounts in premium.



o Application of suitable clauses, warranties and conditions.

Identification of possible areas for refund of premium and suggestions regarding procedure for the same.

Selection of insurance coverage on the basis of risk analysis. Providing guidelines for fixation of sum insured and illustrating the same on selected

equipment. Evaluation of business interruption exposure due to identified risks. Providing guidelines on documentation requirements, procedures for claims under

various policies, evaluation of insurers.

7.4.13 RISK MANAGEMENT TRAINING

Specialized and focussed training, if imparted effectively, can contribute significantly to Risk

Management. Expert faculty, carefully selected training module, interactive and participate

approach, useful training material, case studies and syndicate exercises could help in having

effective risk management system in place.

The training topics for industry could be:

Chemical safety

Safety with compressed gases

Solvent safety

Hazard identification techniques

Industrial risk management

Fire prevention and protection

Electrical risk management

Emergency preparedness

Safety management system

Accident prevention

Personal Protective Equipment

7.4.14 GENERAL GUIDELINES TO BE ADOPTED BY THE UNIT FOR MINIMIZING ASSOCIATED

RISKS AT M/s. SHILPA MEDICARE LIMITED.,

The plant should draft an environmental health and safety policy and work adhering to it.

1. The study is based on assumptions that the storage are designed, constructed and

operated in accordance with the safe engineering practices and standards. It is

recommended that strict adherence to the standards, accepted practices and operating



maintenance & safety procedures are followed not only during the installation of the

plant but also throughout the life of the plant.

2. Wind direction plays a major role in case of chemical releases. Hence adequate wind

socks are to be provided at strategic locations for people to notice and take appropriate

actions in case of an emergency.

3. Non essential personnel should be located away from the main plant area. These include

office staff, administration, accounts etc. and they should be restricted to the

administrative building.

4. The main plant area within the plant premises should be marked as high safety zone and

only operation and maintenance personnel and authorized staff/visitor should be

allowed to enter in this area. Any person entering this area, be it visitor or plant

personnel must be equipped with safety gadgets and must be made aware of the

assembly points.

5. The safety instructions and safe operating conditions (for the plant and machinery)

recommended by the manufacturers / vendors should be strictly followed.

6. Maintenance plays a vital role in proper upkeep of the plant. An equally important

function is monitoring of health of equipment, pipelines and machinery. The following

systems will be adopted

thickness survey (including supports),

maintenance history cards,

preventive maintenance practices

These will not only improve plant performance but also safety. It should be pointed out that

the failure rates of equipment and pipes are influenced by the maintenance practice followed.

When the plant starts aging, it is suggested that due attention to be given to this aspect when

formulating a maintenance strategy.

7.4.15 ACCIDENT REPORTING

7.4.15.1 INTRODUCTION

An accident is an unplanned event that results in injury, damage to property or some other

loss. The law requires that certain work-related accidents are reported to the local authority

or the Health and Safety Executive.

All accidents to employees, however minor, should be recorded. This is a requirement under

social security legislation. As a result of a workplace injury an employee may need to claim



for benefits in the future, and the relevant checks will be made to confirm that the accident

occurred at work.

Reporting and recording procedures vary. Employers need to be sure that they satisfy all legal

reporting requirements for employees and non-employees, and take measures to monitor

accidents. As part of the reactive monitoring process, accident records are needed to assess

whether the existing controls are adequate or to identify if trends are developing and to

implement new procedures.

7.4.15.2 ACTION TO BE TAKEN IN THE EVENT OF AN ACCIDENT/INCIDENT

The following actions are to be taken in the event of an accident/incident

Area to be made safe if necessary or possible.

First-aider to be contacted if there is an injured person. Alternatively, Security can be

contacted for first-aid assistance.

Report accident/incident to the relevant manager and/or safety officer. The safety

officer must investigate the accident recording corrective actions, sign the form and

forward a copy to the safety office within 4 days.

7.4.15.3 REPORTS TO BE GENERATED IN THE EVENT OF ACCIDENTS

The following reports have to be generated

Accidents involving employees, including minor injuries.

Accidents involving non-employees e.g visitors.

Incidents where no one is injured but there is a potential for injury.

Physical assaults or verbal abuse of employees.

Dangerous occurrences such as fires, gas leaks or explosions, chemical spillages,

damage to materials, failure or collapse of equipment etc.

Work-related ill-health from use of chemicals, occupational asthma, musculo-skeletal

pain etc.

7.4.15.4 THE REPORTING OF INJURIES, DISEASES AND DANGEROUS OCCURRENCES

REGULATIONS

The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) 1995

requires the Industry to notify certain work related injuries, illness and “dangerous

occurrences” (summarized below) to the Health and Safety Executive (HSE) at the earliest



practicable time after the event. This reporting responsibility will be with the safety office

staff or the duty manager in the absence of safety personnel.

Any incident that results in a serious injury to an employee including

A break or fracture of any bone except those of the fingers or toes;

Any amputation;

Dislocation of the shoulder, hip, knee or spine;

Loss of sight (whether temporary or permanent);

Chemical or hot burn to the eye or any penetrating injury to the eye;

An injury resulting from electric shock or electrical burns;

An injury that leads to a loss of consciousness or requires resuscitation;

An injury resulting in an employee being unable to perform regular duties or being

away from work for 3 days or more;

An injury that requires the injured employee to be hospitalised for more than 24

hours.

Any accident or incident, connected with or arising out of the industrial work activity,

that results in a 'non-employee', i.e someone who is not a industry employee, being

taken from the scene of the accident to hospital for treatment. This is regardless

whether or not they are admitted into hospital.

Any dangerous occurrence such as fires.

Specified diseases associated with certain work activities, or exposure to certain

substances.

7.4.15.5 RESPONSIBILITIES

1. EMPLOYEES

It is the responsibility of individual employees to report accidents/incidents to their heads of

process as soon as possible. In most cases, individual employees will complete their own

accident report form but it is important that this form is forwarded to the safety officer.

2. SAFETY OFFICER

Safety officer must ensure that all accidents are investigated to identify underlying causes,

the accident/investigation report form is completed and the original is forwarded to the

safety office within 4 days of the accident. The safety officer should recommend appropriate

corrective actions and ensure that risk assessments are revised if necessary.



3. MANAGERS

Managers must ensure that corrective actions are implemented and communicated to all

relevant persons.

If an employee is absent as a result of an accident then the manager or safety officer must

complete the form on his/her behalf.

4. SAFETY OFFICE

Maintaining records: record of incidents and investigations reports will be maintained by the

Safety Office according to statutory requirements.

Investigating: The safety office will investigate all serious incidents/dangerous

occurrences/near misses/diseases.

Monitoring: The safety office will monitor the details and information provided on the

accident investigation report form, follow-up on corrective actions and report trends to the

safety officer.

The incident and accident investigation and reporting procedure will be audited as part of

each area’s Health and Safety Management audit.



7.4.15.6 INCIDENT/ACCIDENT REPORTING AND INVESTIGATION FLOW CHART FOR WORK-

RELATED ACCIDENTS/INCIDENT AND NEAR MISSES

7.4.16 CONCLUSIONS DRAWN FROM THE RISK ASSESSMENT STUDIES CARRIED OUT FOR

M/s. Shilpa Medicare Limited.,

The risk assessment studies carried out for the industry, M/s. Shilpa Medicare Limited., has

covered various aspects encompassing hazard identification, severity mapping for fire and

spillages, MCA analysis studies etc.

No

*Work-related accidents/incidents involving employees

Accidents/incidents involving non-

employees i.e visitors

Fatality or taken from

the scene of accident to hospital for treatment

Major injury ** or fatality

Over 3 day’s incapacity or

absence from work

Contact process head or manager on duty immediately

Investigate and send completed accident form to safety office

within 4 days

All other accidents including acts of violence against staff and near

misses

Yes

*Work-related accidents, near misses and illnesses are those that are attributed to work activity, equipment and substances, condition of the premises or the level of supervision.

**Major injuries include fractures (except fingers and toes), amputations, loss of sight, 24 hrs hospitalization etc.



Based on the above it can be concluded that there are sample risks associated with the

handling of various solvents and fuel as elucidated in the severity matrix studies.

Suitable fire protection system and general guidelines to be adopted by the industry and

preventive systems provided to prevent or reduce the hazards have been proposed.

The management of M/s. Shilpa Medicare Limited., is committed to the implementation of

the recommendations of the risk assessment report in true spirits.

7.5 AIR POLLUTION DISPERSION MODELING STUDIES

7.5.1 INTRODUCTION

Atmospheric dispersion modeling is the mathematical simulation of how air pollutants

disperse in the ambient atmosphere. It is performed with computer programs that solve the

mathematical equations and algorithms which simulate the pollutant dispersion. The

dispersion models are used to estimate or to predict the downwind concentration of air

pollutants emitted from sources such as industrial plants and vehicular traffic. Such models

are important to governmental agencies tasked with protecting and managing the ambient

air quality. The models are typically employed to determine whether existing or proposed

new industrial facilities are or will be in compliance with the National Ambient Air Quality

Standards (NAAQS) in the United States and other nations. The models also serve to assist in

the design of effective control strategies to reduce emissions of harmful air pollutants.

In the present study prediction of impacts on the air environment has been carried out

employing U.S. EPA AERMOD dispersion model, 1996 – 2016 Lakes Environmental Software,

Version 7.1.0 and designed for multiple sources for predicting the maximum ground level

concentration (GLC).

7.5.2 MODEL INPUT DATA

The major air emissions at the site of M/s Shilpa Medicare Limited., are SPM, SO2 and NOx

from boilers and DGs. The Proponents have proposed to provide adequate stacks to the

process section. Also the manufacturing process involves reactions in completely closed

reactors and therefore no emissions are anticipated. The site specific details considered as

input data for the software (AERMOD view by Lakes Environmental) to predict the impacts

on the air environment are given in the following table 7.10.



Table 7.10: Data considered for calculation of GLC

Particulars Details

DG set

(625 kVA

– 3no.s)

750 kVA – 1 no Boiler

(6 TPH – 1 no.)

10 TPH -1 no.

Stack height, m 5 mtr

(ARL)

10 Mtr (ARL) 30 Mtr (AGL) 30 Mtr (AGL)

Stack diameter, m 0.5 mtr 0.5 mtr 1.12 mtr 1.12 mtr

Flue gas temperature, 0C

120 to

130 0C

125 to 130 0C 130 to 140 0C 130 to 140 0C

Gas exit velocity, m/s 7 to 8

m/s

7 to 8 m/s 7 to 8 m/s 7 to 8 m/s

Emission rate, g/s

PM10 0.00186 0.016763 0.11616 0.1936

SO2 0.0341 0.041012 0.00366 0.0061

NOx 0.05588 0.11175 0.00126 0.0021

CO 0.48425 0.5811 0.24198 0.4033

7.5.3 METEOROLOGICAL DATA

Data recorded at the site for one year period (2016) for wind speed, direction and

temperature has been used for computations. In order to conduct a refined air dispersion

modeling short term air quality dispersion models, the site specific hourly meteorological

data measured at the site is pre-processed using U.S. EPA AERMET program.

7.5.4 PRESENTATION OF RESULTS

The simulations were made to evaluate incremental short-term concentrations due to

proposed project.

In the short-term simulations, the incremental concentrations were estimated to obtain an

optimum description of variations in concentrations within study area of 10 km radius. The

predicted results are tabulated in the following table.



Table 7.11 is presented the Predicted incremental short-term concentrations due to the proposed project – existing with proposed Fig 7.1 is presented Suspended Particulate Matter (PM10) isotherms for the proposed project (existing+proposed) for i) 24 hours – 1st highest value, ii) 24 hours – 98 percentile, iii) Annual Fig 7.2 is presented the Sulfur di-oxide (SO2) isotherms for proposed project (existing + proposed) for i) 24 hours – 1st highest value, ii) 24 hours – 98 percentile, iii) Annual Fig 7.3 is presented the Oxides of nitrogen (NOx) isotherms for proposed project (existing+proposed) for i) 24 hours – 1st highest value, ii) 24 hours – 98 percentile and iii) Annual. Fig 7.4 is presented the Carbon monoxide (CO) isotherms for proposed project (existing + proposed) for i) 1 hour – 1st highest value, ii) 1 hour – 98 percentile, iii) 8 hours – 1st highest value, iv) 8 hours – 98 percentile. Table 7.11 is presented the Resultant maximum 24 hourly concentrations

Table 7.11: Predicted incremental short-term concentrations due to the proposed project

Time Maximum predicted

concentrations, µg/m3

Direction and distance of occurrence

24 hour Annual 24 hour Annual

1ST

highest

values

98

percentile

1ST

highest

values

98 percentile

Suspended

Particulate

Matter

(PM10)

0.96121 0.73359 0.1826

9

0.338

km- NE

0.328 km -NE 0.13 km -

NE

Sulfur di-

oxide (SO2)

13.41829 8.58964 1.9416

8

0.29847

km – NW

0.684 km – S

0.862 KM –N

0.825 KM - E

1.355 KM - W

Within

site

boundary

Oxides of

nitrogen

(NOx)

29.8148 18.81924 4.2930

2

0.301 km

– NW

0.935 km – N

1.824K M – W

0.753 KM - S

1.776 KM -E

Within

site

boundary



Carbon

monoxide

(CO)

1 hr –

190.50

8 hr –

516.874

1 hr –

121.83

8 hr –

179.16

27.58 1 hr –

0.318

NW

8 hr –

0.57 NW

1 hr – 3.410 N

& 9.703 S

&

8 hr – 0.57 KM

NW

Within

the site

boundary



Fig 7.1: Suspended Particulate Matter (PM) isotherms for the proposed project

i) 24 hours – 1st highest value



ii) 24 hours – 98 percentile



iii) Annual



Fig 7.2: Sulfur di-oxide (SO2) isotherms for proposed project




iii) Annual



Fig 7.3: Oxides of nitrogen (NOx) isotherms for proposed project




iii) Annual

Fig 7.5: Carbon monoxide (CO) isotherms for proposed project (Existing + Proposed)

i) 1 hour – 1st highest value

ii) 1 hour – 98 percentile

iii) 8 hours – 98 percentile

iv) Annual



Fig 7.4: Oxides of Corbon Monoxide (CO) isotherms for proposed project




ii) 8 hours – 1st highest value



iii) 24hours-98th Percentile



iv) 8 hours-98th Percentile



v) Annual



7.5.5 COMMENTS

The maximum short-term incremental ground-level concentrations are superimposed on the

baseline data to get the likely resultant levels after the establishment of the proposed project

as tabulated in below table 7.12.

Table 7.12: Resultant maximum 24 hourly concentrations

Pollutant Incremental

concentrations,

µg/m3

Max. baseline

concentrations,

µg/m3

Resultant

concentrations,

µg/m3

Limits as

per MoEF,

µg/m3 for

industrial

areas (24

hrs)

Percentage

(%)Resultant

concentrations

Below the threshold

limits

PROJECT SITE (A1)

PM10 0.73359 54.33 55.06359 100 44.94

SO2 8.58964 13.5 22.08964 80 57.92

NOx 18.81924 11.03 29.84924 80 50.16

CO 1 hr – 121.83

8 hr – 179.16

0.5 1 hr –122.33

8 hr – 179.66

4,000 – 1 hr

2,000 – 8

hrs

96.94

91.01

Chiksugur (downwind direction) (A2)

PM10 0.73359 35.66 36.39359 100 63.61

SO2 8.58964 7.4 15.98964 80 64.02

NOx 18.81924 8.36 27.17924 80 52.81

CO 1 hr – 121.83

8 hr – 179.16

0.5 1 hr –122.33

8 hr – 179.66

4,000 – 1 hr

2,000 – 8

hrs

96.94

91.01

Hanumandoddi (A3)

PM10 0.73359 35.33 36.06359 100 63.94

SO2 8.58964 6.5 15.08964 80 64.92

NOx 18.81924 8.8 27.61924 80 52.39

CO 1 hr – 121.83

8 hr – 179.16

0.5 1 hr – 122.33

8 hr – 179.66

4,000 – 1 hr

2,000 – 8

hrs

96.94

91.01



Yermaras (A4)

PM10 0.73359 36 36.73359 100 63.27

SO2 8.58964 8.5 17.08964 80 62.92

NOx 18.81924 7.9 26.71924 80 53.29

CO 1 hr – 121.83

8 hr – 179.16

0.5 1 hr – 122.33

8 hr – 179.66

4,000 – 1 hr

2,000 – 8

hrs

96.94

91.01

Hospet (A5)

PM10 0.73359 35.33 36.06359 100 63.94

SO2 8.58964 8 16.58964 80 63.42

NOx 18.81924 8.4 27.21924 80 52.79

CO 1 hr – 121.83

8 hr – 179.16

0.5 1 hr – 122.33

8 hr – 179.66

4,000 – 1 hr

2,000 – 8

hrs

96.94

91.01

Shaktinagar (A6)

PM10 0.73359 33 33.73359 100 66.27

SO2 8.58964 8.0 16.58964 80 63.46

NOx 18.81924 8.3 27.11924 80 52.89

CO 1 hr – 121.83

8 hr – 179.16

0.5 1 hr –122.33

8 hr – 179.66

4,000 – 1 hr

2,000 – 8

hrs

96.94

91.01

According to MoEF air quality standards (as per the notification dated 16th November 2009

for industrial, residential & rural areas) 24 hourly or 8 hourly or 1 hourly monitored values, as

applicable, shall be complied with 98% of the time in a year; 2% of the time, they may exceed

the limits but not on two consecutive days of monitoring.

Therefore the 98% values are considered for estimation of the incremental concentration.

The above table indicates that the cumulative resultant ambient air quality after proposed

project operation will be within the ambient air quality limits specified by MoEF as per the

notification dated 16th November 2009 for industrial, residential & rural areas.

7.6 PUBLIC CONSULTATION

The industry is proposed to be established at a designated industrial area (KIADB). Therefore

the proposed project falls under CATEGORY 5(f) & no public consultation is required.



7.7 SOCIAL IMPACT ASSESSMENT, R&R ACTION PLANS

The proposed project is an Expansion and modification of an Active Pharmaceutical

Ingredients (APIs) & Intermediates manufacturing industry with R&D activity in an existing

insudtry. The existing land is sufficient for the proposal also & therefore no re-settlement &

re-habilitation is envisaged.



CHAPTER 8

PROJECT BENEFITS

8.1 IMPROVEMENTS IN THE PHYSICAL INFRASTRUCTURE, SOCIAL INFRASTRUCTURE

The proposed project is an Expansion and modification of an Active Pharmaceutical

Ingredients (APIs) & Intermediates manufacturing industry with R&D activity in an existing

insudtry.

8.2 TANGIBLE BENIFITS

The proposed project will generate direct and indirect employment opportunities for the

local people. The plant will create employment as under

The total employment potential of the industry is detailed below

Managerial – 10

Skilled – 350

Semi-skilled – 190

Un-skilled –50

TOTAL - 600

Additionally, certain works like security will be outsourced on contract. Secondary

employment in the form of providing services to the employed manpower will also be

developed in the neighboring villages.

The company will also take part in the development of the surroundings villages by following

ways:

There will not be any displacement of people from the project as the industry is

coming up in the designated industrial area in the existing allotted plot from KIADB

and land being allocated to the project. Also it is an existing & on-going industry.

Employment opportunities for the local people.

Conducting Medical Camps for medical examination of the villagers and distribution

of medicines.

Funding the local educational facilities.

The company will also provide funds for the various development activities of the

neighboring villages as and when required.



8.3 INTANGIBLE BENEFITS

Products manufactured will be at affordable prices when compared to international

manufacturers. This plant will employ skilled and semi-skilled people from the

surrounding areas.

With this project, business for ancillary units like equipment manufacturers, machining

works, motor rewinding for regular maintenance, shut down annual and mechanical

consumable vendors, periodical painting works etc. thereby giving the indirect

maintenance people like equipment suppliers and various consumable vendors

employment opportunities.

To us, a commitment to sustainability means a commitment to fulfilling our obligations

to all of our stakeholders -- our customers and partners, employees, shareholders and

society. Thus, while optimizing profitability may be one measurement of our

performance, we also judge our success by our performance with regard to the

communities in which we live and work, the environment and our employees. We

understand that it is only by increasing value to all of these stakeholders that we can build

an ever flourishing and lasting organization.



CHAPTER 9

ENVIRONMENTAL COST BENEFIT

ANALYSIS

9.1 INTRODUCTION

Cost–benefit analysis (CBA), sometimes called benefit–cost analysis (BCA), is a systematic

process for calculating and comparing benefits and costs of a project for two purposes

to determine if it is a sound investment (justification/feasibility)

to see how it compares with alternate projects (ranking/priority assignment)

It involves comparing the total expected cost of each option against the total expected

benefits, to see whether the benefits outweigh the costs, and by how much.

In CBA, benefits and costs are expressed in money terms, and are adjusted for the time value

of money, so that all flows of benefits and flows of project costs over time (which tend to

occur at different points in time) are expressed on a common basis in terms of their "present

value."

ENVIRONMENTAL COST-BENEFIT ANALYSIS, refers to the economic appraisal of policies and

projects that have the deliberate aim of improving the provision of environmental services or

actions that might affect (sometimes adversely) the environment as an indirect consequence.

9.2 USES OF CBA

► CBA has traditionally been applied to big public sector projects such as new motorways,

by-passes, dams, tunnels, bridges, flood relief schemes and new power stations.

► The basic principles of CBA can be applied to many other projects or programmes. For

example, -public health programmes (e.g. the mass immunization of children using new

drugs), an investment in a new rail safety systems, or opening a new railway line, or the

costs and benefits of the new deal programme designed to reduce long-term

unemployment. Cost benefit analysis was also used during the recent inquiry

into genetically modified foods. Increasingly the principles of cost benefit analysis are

http://en.wikipedia.org/wiki/Time_value_of_money

http://en.wikipedia.org/wiki/Time_value_of_money

http://news.bbc.co.uk/1/hi/sci/tech/5098468.stm



being used to evaluate the returns from investment in environmental projects such as

wind farms and the development of other sources of renewable energy.

► Because financial resources are scarce, CBA allows different projects to be ranked

according to those that provide the highest expected net gains in social welfare - this is

particularly important given the limitations of government spending.

9.3 MAIN STAGES

The main stages in the CBA approach are detailed below

Stage 1(a)

Calculation of social costs & social benefits. This would include calculation of

Tangible benefits and costs (i.e. direct costs and benefits)

Intangible benefits and costs (i.e. indirect costs and benefits – externalities)

This process is very important – it involves trying to identify all of the significant costs &

benefits.

Stage 1(b)

Sensitivity analysis of events occurring i.e. determination of how likely is it that a predicted

outcome will occur? If we are reasonably sure that a benefit or cost will ‘occur’ – what is the

scale of uncertainty about the actual values of the costs and benefits?

Stage 2

Discounting the future value of benefits - costs and benefits accrue over time. Individuals

normally prefer to enjoy the benefits now rather than later – so the value of future benefits

has to be discounted.

Stage 3

Comparing the costs and benefits to determine the net social rate of return.

Stage 4

Comparing net rate of return from different projects – the government may have limited

funds at its disposal and therefore faces a choice about which projects should be given the

go-ahead.



9.4 DISADVANTAGES

There are several objections to the use of CBA for environmental impact assessment:

1) Problems in attaching valuations to costs and benefits: Some costs are easy to value

such as the running costs (e.g. staff costs) + capital costs (new equipment). Other costs

are more difficult – not least when a project has a significant impact on the

environment. The value attached to the destruction of a habitat is to some “priceless”

and to others “worthless”. Costs are also subject to change over time – i.e. the

construction costs of a new bridge over a river or the introduction of electronic road

pricing.

2) The CBA may not cover everyone affected (i.e. all third parties): Inevitably with major

construction projects such as a new airport or a new road, there are a huge number

of potential “stakeholders” who stand to be affected (positively or negatively) by the

decision. CBA cannot hope to include all stakeholders – there is a risk that some

groups might be left out of the decision process, for example future generations &

“non-human” stakeholders

3) Distributional consequences: Costs and benefits mean different things to different

income groups - benefits to the poor are usually worth more (or are they?). Those

receiving benefits and those burdened with the costs of a project may not be the

same.

4) Social welfare is not the same as individual welfare: What we want individually may

not be what we want collectively. A different value is not attached to those who feel

“passionately” about something (for example the building of new housing on

greenfield sites) contrasted with those who are more ambivalent?

5) Valuing the environment: Valuation of the public goods such as the environment

where there is no market established for the valuation of “property rights” over

environmental resources is very difficult. Similarly things such as “nuisance” and

“aesthetic values” are very ambiguous & difficult to value.

6) Valuing human life: Some measurements of benefits require the valuation of human

life – many people are intrinsically opposed to any attempt to do this. This objection

can be partly overcome if we focus instead on the probability of a project “reducing

the risk of death” – and there are insurance markets in existence which tell something

about how much people value their health and life when they take out insurance

policies.



7) Attitudes to risk – e.g. a cost benefit analysis of the effects of genetically modified

foods

Precautionary principle: Assume toxicity until proven safe; if in doubt, then

regulate

Free market principle: Assume it is safe until a hazard is identified; if in doubt, do

not regulate.

Despite these problems, most economists argue that CBA is better than other ways of

including the environment in project appraisal.

Cost benefit analysis is basically an appraisal technique that tries to place monetary values

on all benefits arising from a project and then compares the total value with the project's

total cost. It has numerous potential applications although there are inherent difficulties with

the issue of valuation. Essentially the process of CBA is a comparative one, so that we can

perhaps make judgments about which projects from a limited choice should be given the go

ahead.

9.5 DISCOUNTING THE FUTURE

Discounting is a widely used technique as part of cost benefit analysis. The technique of

discounting reflects the following:

the value of a cost or benefit now

the value of a cost or benefit in future years

Discounting reflects this by reducing all future costs and benefits to express them as today’s

values. The key question being - how to choose an ‘interest rate’ for reducing future costs to

give them a present value today?

Setting a general discount rate for new projects has important implications for the

environment:

A low discount rate is often favored by economists since they argue that investing a

high proportion of current income is a good way of providing for the future.

A high discount rate may also be favored since it discourages investment (and by

implication environmental damage) in the present.

Most projects have lifetimes of 20-30 years – with many of the big costs arising early in a

project e.g. from construction whereas the stream of benefits from a project occur over a

much longer period of time. But for many huge construction projects, some of the costs only



become apparent in the long run. Consider the building of a new nuclear power station.

Environmentalists would argue that there is a long list of costs from waste management and

decommissioning which stretch over 100 years into the future whereas no social benefits

exist to offset these costs beyond year 30 or 40 (where the nuclear power station might

reasonably be expected to be ready for closure).

The value of decommissioning costs over 100 years away is almost negligible no matter what

discount rate we use. This makes discounting difficult to justify.

9.6 COST-BENEFIT ANALYSIS FOR M/S. SHILPA MEDICARE LIMITED.,

CBA for M/s. Shilpa Medicare Limited., Is tabulated in below table 9.1.

Table 9.1: CBA for M/s. Shilpa Medicare Limited.,

Costs Benefits

Charges paid to Pollution Control Board

for not meeting standards or threat of

closure.

Savings in costs for meeting standards.

DAMAGES CAUSED BY WATER

POLLUTION

a) Waterborne diseases

b) Losses to farmers

c) Degradation of soil fertility and

increase in toxicity

d) Degradation of water aquifer

BENEFITS INCURRED DUE TO WATER

POLLUTION PREVENTION/CONTROL

a) Savings due to water borne diseases

avoided through proper treatment of

both domestic & industrial wastewater.

b) Degradation of soil fertility & water

aquifer reversed.

DAMAGES CAUSED BY AIR POLLUTION

a) Airborne diseases.

b) Losses to farmers due to increase in

oxides of sulfur concentrations.

BENEFITS INCURRED DUE TO AIR


a) Savings due to air borne diseases

avoided through proper maintenance

& management of air pollution sources.

b) Losses to the farmers reversed.

DAMAGES CAUSED BY NOISE POLLUTION

Health & behavioral effects on humans

BENEFITS INCURRED DUE TO NOISE


Health & behavioral effects on humans

reversed.

DAMAGES CAUSED BY SOLD/HAZARDOUS

WASTE

a) Impact on aesthetics.

b) Degradation of groundwater aquifer.

BENEFITS INCURRED DUE TO SOLID WASTE

MANAGEMENT/CONTROL

a) Impacts on aesthetics reversed by

proper management.



b) Degradation of water aquifer reversed

by proper management.

- BENEFITS TO THE SOCIAL/ECONOMIC

ENVIRONMENT

a) Employment and income generation

from industries.

b) Infrastructural development benefits

due to proximity of industries.



CHAPTER 10

ENVIRONMENTAL MANAGEMENT PLAN (EMP)

10.1 INTRODUCTION

The Environment Management Plan (EMP) is required to ensure sustainable development

in the area of the proposed project. Hence it needs to be an all encompassive plan for which

the industry, Government, Regulating agencies like Pollution Control Board working in the

region and more importantly the population of the area need to extend their co-operation

and contribution.

It has been evaluated that the project area will not be affected significantly with proposed

project. Mitigation measures at the source level and an overall Management Plan at the

site level are elicited so as to improve the surrounding environment.

The following mitigation measures are recommended in order to synchronize the economic

development of the project area with the environmental protection of the region. The

construction phase impacts are mostly short term, restricted to the plot area and not

envisaged on the larger scale. Also since it is coming in an existing industry major impacts

are not anticipated. In the operational phase the environmental impacts are due to

continuous operation of the project, hence, the emphasis in the Environment Management

Plan (EMP) is to minimize such impacts.

The emphasis on the EMP development is on the following:

Mitigation measures for each of the activities causing the environmental impact;

Monitoring plans for checking activities and environmental parameters and

monitoring responsibilities;

Role responsibilities and resource allocation for monitoring.

Following sections describes in brief the environment management plan proposed for

construction and operation phases.



10.2 MITIGATION MEASURES

Each of the activities during production phase is critically reviewed for suggestion of

mitigation measures. Based on this, the table 10.1 gives the mitigation measures for the

activities considered to be causing significant environmental impacts during construction

phase & table 10.2 during operation phase. Table 10.3 gives the environmental management

plan during storage, handling & transportation of raw materials and products.

In general the best housekeeping practices are incorporated in the design as well as in

production phase to reduce the short term impacts due to the proposed activities.



10.3 ENVIRONMENTAL MANAGEMENT PLAN (EMP)

The environmental management plan during construction phase and occupancy phase is detailed in tables 10.1 & 10.2.

Environmnetal Management Paln during construction phase

Table 10.1:- Environmnetal Management Paln during construction phase

Sl. no.


Predicted impacts Probable source of impact

Mitigation measures Remarks


Negative impact inside the construction site premises. No negative impact outside.

Fugitive dust emissions generated during construction in the beginning followed by fabrication, erection of plant and machinery during later part of the project.

Carrying out the construction activities in closed manner.

Intermittent spraying of water.

Use of PPE.

Impacts are temporary (only during construction period) in nature. Also the proposed project does not involve extensive construction activities as it is an expansion proposal of an existing industry & optimum utilization of the existing infrastructure facilities will be made; construction is more of fabrication and erection type.

2 Noise Negative impact near noise generation sources inside the premises. No significant impact on the ambient noise levels in the surrounding area.

Noise generation from construction activities and operation of construction equipments and also from the movement of vehicles carrying construction materials to and from the project site.

Use of well maintained equipment.

Use of PPE – ear plugs and muffs by the construction workers.

Temporary impact only during construction phase.



3 Water quality No significant impact Discharge of sewage from laborers.

The sewage generated shall be mixed with the low strength wastewater from the existing industry & is treated in Existing ETP.

Impact will be temporary. Local laborers shall be

employed.

4 Land No negative impact Waste from laborers. Waste from laborers will be collected and composted on site. Non-compostable waste will be sent for recycling.

-



- -



Operation of the facilities/utilities

ENVIRONMENTAL MANAGEMENT PLAN DURING OPERATION PHASE

Table 10.2:- ENVIRONMENTAL MANAGEMENT PLAN DURING OPERATION PHASE

Sl. no.


Predicted impacts





















-










-







-



a. Storage, handling & transportation of raw materials and products

Environmental management plan during storage, handling & transportation of raw

materials and products is detailed in table 10.3.

Table 10.3: Environmental management plan during storage, handling &

transportation of raw materials and products

Activity Environmental

impacts

Mitigation Remarks

Storage of all

the raw

materials,

products.

• Air

• Water

• Land

Hydrogen, organic chemicals & solvents

to be stored in accordance with the rules

and regulations of the Safety

Department.

Separate storage area for solid/liquid

raw materials.

Gas detectors with alarm will be

installed for detection of fugitive

emissions.

Installation of proper facilities to

prevent rain/storm water

contamination during the storage of

solid raw materials.

Ensure disposal of used drums, bags as

per the rules/regulations.

Implementation

Responsibility:

M/s. Shilpa

Medicare Limited.,

Transportation

of all the raw

materials,

finished

products &

hazardous

wastes.

• Air

• Water

• Land

Trained/Approved Transports will be

engaged for the transportation of the

raw materials/products.

TREMCARD will be followed to ensure

availability of MSDS of all the raw

materials and finished products to the

off-site emergency team.

Implementation

responsibility:

M/s. Shilpa

Medicare Limited.,



10.4 ENVIRONMENTAL POLICY

M/s. Shilpa Medicare Limited., 100% Export Oriented Unit, Unit –II, Plot No. 33, 33A & 40

to 47, Raichur, Industrial Growth Centre, Wadloor Road, Chicksugur - 584134, Raichur

Dist, Karnataka intends to expand and modify the Active Pharmaceutical Ingredients

(APIs) & Intermediats manufacturing industry with R & D activity in an existing industry at

Unit –II, Plot No. 33, 33A & 40 to 47, Raichur, Industrial Growth Centre, Wadloor Road,

Chicksugur - 584134, Raichur Dist.

The Board of Directors of M/s. Shilpa Medicare Limited., recognize the important

responsibility it has towards the environment, and is committed to:

Complying with all applicable environmental legislation.

Planned evaluation of compliance by external auditors and the implementation of

improvement programmes.

Continuous improvement by following best practice guidance produced by

appropriate regulatory and advisory organisations and aim to get certified to

ISO-14001, the internationally recognised Environmental Management System

standard.

Ensuring that all employees are aware of their duty to fellow employees, suppliers,

customers and those who live in the surrounding community, to act in an

environmentally responsible and safe manner.

Collecting, analysing and publishing key environmental performance metrics to

enable the Group to continually review, assess and improve its environmental

performance.

Minimising, where practicable, the Group’s impact on the local and global

environment arising from its operations and products, by:

Integrating environmental considerations into the development of any new

products and processes;

Achieving a reduction in emissions of greenhouse gases by using energy, raw

materials and natural resources efficiently;

Reducing the emissions of harmful substances and where practicable using

alternative environmentally safer substances in its manufacturing processes;

Reducing waste generated by its operations through recycling programmes

and minimising the amount of waste sent to landfill.

Working with all the suppliers to minimise the impact of their products and

operations on the environment.



The Board delegates responsibility for oversight of environmental policy and performance

to all to the Director, Management and employees for local implementation of this policy.

This policy and its implementation will be reviewed on a regular basis by the Board to

ensure that it remains appropriate and relevant to the organization. The Group is

committed to providing the necessary support in order to ensure that all sites can fulfill

the requirements outlined in this policy.

This policy will be communicated to everyone working for or on behalf of the Group. The

non compliance will be communicated and will be brought to the notice of all the board

of directors during the board meeting.

The Health Safety & Environment Policy of the Company is appended as Annexure- 2

10.5 DESCRIPTION OF THE ADMINISTRATIVE ASPECTS OF ENSURING THAT MITIGATIVE

MEASURES ARE IMPLEMENTED & THEIR EFFECTIVENESS MONITORED, AFTER

APPROVAL, IMPLEMENTATION AND DURING OPERATION

In order to maintain the environmental quality within the standards, regular monitoring

network to maintain environmental quality will be implemented.

10.5.1 ENVIRONMENT MANAGEMENT CELL

A separate Environment Management Cell will be established to monitor and control the

environmental quality. Members of the Environmental Cell would be well qualified and

experienced in the concerned field. Some experienced people & few new people will be

appointed to take care of the requirement.

Services of reputed laboratories as well as that of a consultant of repute would be

engaged for various monitoring & other environmental management needs of the plant

from time to time.



FIG 10.1:- ORGANIZATIONAL STRUCTURE

Manager –Head

Technician - 1 Technician -2

Field Assistance - 1 Field Assistance - 2



CHAPTER 11

SUMMARY & CONCLUSION

11.1 OVERALL JUSTIFICATION FOR IMPLEMENTATION OF THE PROJECT

The Environmental Impact Assessment studies carried out for the proposed project of

M/s. Shilpa Medicare Limited., has been completed. The study conducted has covered

various facts of the proposed expansion project starting with the need for expansion, its

basic requirements like raw materials, water requirement, availability of land,

manufacturing process etc.

In addition to this the metrological data and baseline environmental features have been

evaluated to understand the environmental setting of the project site. Based on the

baseline environmental survey air pollution modeling studies were carried out to predict

the impact of the proposed project on the air environment. Also the ecological features

of the location including the flora & fauna, socio-economic environment, the

demographic structure have been evaluated.

Based on the above studies an Environmental Impact Statement has been prepared to

ascertain the possible impacts of the proposed project on the environmental parameters

like air, water, land, biological and socio-economic environment. An impact matrix has

also been prepared based on the observations of the impacts on the environment.

An Environmental Management Plan has been prepared covering the environmental

aspect and the management plan required to be adopted by the management not only

during the course of setting up of the proposed industry but also during its operational

phase. An environmental monitoring plan is envisaged deciding frequency, location, data

analysis, reporting schedules.

Detailed risk assessment study is carried out to evaluate the risks involved due to storage

of various solvents & precautionary measures to be taken for prevention/management of

such risks.



The conclusions drawn from the above study relates to the fact that the proposed project

is Establishment of an expansion and modificationof the Active Pharmaceutical

Ingredients (APIs) & Intermediats manufacturing industry with R & D activity undertaken

by the management of the industry has certain level or marginal impacts on the local

environmental setting, which will not affect the natural environmental setting of the

study zone either drastically or otherwise. However, certain beneficial impacts are

anticipated in terms of the employment opportunities created during the operation of

the industry. Also there will be economic growth at the regional level.

The industry proposes to create Environmental Management Cell in its organization to

monitor and implement programs to improve its environmental status from time to time

and will adopt all such technological advances to reduce the impact due to its operation

on the environment.

To put it in a nut shell the management of M/s. Shilpa Medicare Limited., strongly believes

in the concept of sustainable development and understands the impacts of the proposed

industry on the environment from the Environmental Impact Assessment studies

conducted. It is committed to develop its industry without giving room for any adverse

impacts on the environment and also lays emphasis on the implementation of the

recommendations of the Environmental Management Plan in true spirits.

11.2 EXPLANATION OF HOW ADVERSE EFFECTS HAVE BEEN MITIGATED

The measures adopted to mitigate the impacts due to the proposed expansion is

tabulated below table 11.0.

Table 11.0 :- Measures adopted to mitigate the impacts

Sl.

no.

Parameter Mitigation measures

1 Water pollution sources

Domestic sewage Domestic sewage generated from the project will be

treatred in existing ETP.

Industrial

wastewater

Effluent generated from the project will be treated in Zero liquid discharge (ZLD) effluent treatment plant with MEE and RO system

2 Air pollution sources

D.G. sets Stacks of adequate heights

Steam boilers Stacks of adequate heights.



3 Noise pollution

sources – DG sets

In-built acoustic enclosures.

4 Solid/Hazardous waste

Domestic garbage Organic portion is composted & in-organic portion is sent for

recycling.

Hazardous solid

waste

Disposed through

TSDF (Treatment Storage & Disposal Facility) or

Handed over to authorized agency or

Handed over to the manufacturers for recharge & re-

use.



CHAPTER 12

DISCLOSURE OF CONSULTANTS ENGAGED

12.1 THE NAMES OF THE CONSULTANTS ENGAGED WITH THEIR BRIEF RESUME &

NATURE OF CONSULTANCY RENDERED

Address: SAMRAKSHAN F- 4, I Floor, Swastik Manandi Arcade,

S C Road, Sheshadripuram,

Bangalore - 560 020.

Ph. : 080-41466009

E mail id – [email protected], [email protected]

INTRODUCTORY PROFILE

SAMRAKSHAN is a Bangalore, Karnataka based Environmental Engineering Consultancy

Company. SAMRAKSHAN is an off shoot of AQUATECH ENVIRO ENGINEERS, Bangalore.

We are leading solutions providers of B2B solutions in the field of Environment since two

decades. SAMRAKSHAN is a specialized solution providers, we serve varied industries like

Distillery, Sugar, Fertilizers, Pharmaceuticals, Power generation, Service industries,

Common waste disposal facilities etc.,

Professional Services Offered:

We under take works related to Pollution Control,

Environmental Impact Assessment studies, Preparation of Environmental Management plan, design and execution of Effluent / wastewater and water treatment plants, air pollution control and management, solid and hazardous waste management, Due-diligence studies. Assists clients for implementation of conditions stipulated in the Environmental

Clearances, Consent to Establish and consent to operate issued by the Regulatory agencies.

Assist clients in Environment related Project Management Consultancy. Imparting training to the industries for Environment regulatory compliances. Compliance report preparation. We also undertake assisting clients in techno-legal issues before the Hon’ble High Court,

NGT and Supreme Court etc.,



KEY PERSONNEL OF THE ORGANISATION:

ENVIRONMENTAL IMPACT ASSESSMENT (EIA) REPORT...

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