Sabic Research & Technology Pvt. Limited...

ENVIRONMENT IMPACT

ASSESSMENT REPORT FOR

FOR PROPOSED NEW MANUFACTURING UNIT OF

INTERMEDIATES API AND BULK DRUG

AT Plot 14,15,16 & 55-56-57, Sector-5, II E Pant Nagar

Rudrapur - 263153, Dist: Uddam Singh Nagar

Uttarakhand, India.

Prepared By:

EQMS INDIA PVT. LTD. 304-305, Rishabh Corporate Tower, Plot No. 16, Community Center

Karkardooma, Delhi – 110092, Phone: 011-30003200

E-mail : [email protected]; Website : www.eqmsindia.com

DECEMBER -2018

NAARI PHARMA PVT. LTD.

mailto:[email protected]

http://www.eqmsindia.com/

Draft Environmental Impact Assessment

Report for proposed New Manufacturing Unit

of Intermediates API and Bulk Drug

Doc No.: IA/UK/IND/69456/2017

Rev No. 0

Issue Date: 06.01.2018

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EQMS India Pvt. Ltd. Page 1

Table of Contents

Executive Summary .................................................................................................................... 7 Chapter 1. INTRODUCTION ................................................................................................. 16

1.1. Purpose of Report ....................................................................................................... 16 1.2. Proposal ...................................................................................................................... 16 1.3. Purpose of Report ....................................................................................................... 16 1.4. Objective of Report ...................................................................................................... 17 1.5. Breif about the Project & project proponent ................................................................ 17 1.6. Importance and Benefit of the Project ......................................................................... 20 1.7. Regulatory Framework ................................................................................................ 20 1.8. Demand-Supply Scenario ........................................................................................... 25 1.9. Site Selection Criteria .................................................................................................. 25 1.10. Scope and Methodology of the Study ......................................................................... 25 1.11. TOR Compliance ......................................................................................................... 26 1.12. Structure of the EIA Report ......................................................................................... 26

Chapter 2. Project Description ........................................................................................... 29 2.1. Type of the Project ...................................................................................................... 29 2.2. Justification of the Project ........................................................................................... 29 2.3. Project Commissioning Schedule and Project Cost .................................................... 30 2.4. Size and Magnitude of Proposed Project .................................................................... 30 2.5. Project Requirements .................................................................................................. 32 2.6. Process Description and Technology .......................................................................... 45 2.7. Manufacturing Process of Product .............................................................................. 48 2.8. Solvent Requirements & Recovery System ................................................................ 93 2.9. Pollution Potential and Management ......................................................................... 102

Chapter 3. DESCRIPTION OF THE ENVIRONMENT ........................................................ 117 3.1 Background and Salient Environmental Features of the Study Area ........................ 117 3.1.1 Environmental Setting and Salient Environmental Features of the Project Area ...... 117 3.1.2 Brief description of IEE SIDCUL Pant Nagar Industrial Area .................................... 119 3.1.3 Primary Data Collection: Monitoring Plan and Quality Assurance Procedures ......... 123 3.2 Physical Environment ................................................................................................ 126 3.2.1 Topography ............................................................................................................... 126 3.2.2 Drainage .................................................................................................................... 126 3.2.3 Geology & Hydrogeology .......................................................................................... 126 3.2.4 Ground Water Availability .......................................................................................... 126 3.2.5 Ground water Level ................................................................................................... 127 3.2.6 Seismicity of the Study Area ..................................................................................... 127 3.3 Land use.................................................................................................................... 129 3.4 Meteorology............................................................................................................... 132 3.4.1 Met Data Generated at Site ....................................................................................... 134 3.5 Ambient Air Quality .................................................................................................... 136 3.5.1 Observations on Ambient Air Quality: ....................................................................... 138 3.6 Noise Environment .................................................................................................... 139 3.6.1 Observation on Ambient Noise Quality: .................................................................... 140 3.7 Water Quality............................................................................................................. 140 3.7.1 Ground Water Quality ................................................................................................ 140 3.7.2 Surface Water Quality ............................................................................................... 146 3.8 Soil Quality ................................................................................................................ 148 3.8.1 Soil Classification of the Region ................................................................................ 148





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3.2. Agricultural Status of the District ............................................................................... 149 3.8.2 Cropping Pattern ....................................................................................................... 149 3.8.3 Methodology of Sampling .......................................................................................... 151 3.8.4 Selection of Sampling Locations ............................................................................... 151 3.8.5 Soil Sampling Locations ............................................................................................ 151 3.8.6 Analysis of Soil Samples ........................................................................................... 152 3.8.7 Interpretation of Analytical Results ............................................................................ 153 3.9 Ecological Environment ............................................................................................. 154 3.9.1 Forest and Forest Types ........................................................................................... 154 3.9.2 Vegetation profile of the proposed project site .......................................................... 155 3.9.3 Vegetation profile of the study area (within 10 km area) ........................................... 155 3.9.4 Medicinal Plants ........................................................................................................ 158 3.9.5 Threatened Plant Species ......................................................................................... 158 3.9.6 Faunal Resources ..................................................................................................... 158 3.9.7 National Parks, Sanctuaries, Biosphere Reserves etc in the Study Area ................. 159 3.9.8 Barriers and Corridors ............................................................................................... 159 3.9.9 Methodology .............................................................................................................. 159 3.10 Socio-Economic Environment ................................................................................... 163 3.10.1 Demography .............................................................................................................. 163 3.10.2 Description of Social Environment ............................................................................ 164 3.10.3 Sex Ratio ................................................................................................................... 168 3.10.4 Scheduled Caste & Scheduled Tribe Population ...................................................... 169 3.10.5 Literacy Rate ............................................................................................................. 170 3.10.6 Economic Structure ................................................................................................... 173 3.10.7 Workers Scenario (Occupation Pattern) .................................................................... 174 3.10.8 Composition of Marginal Workers ............................................................................. 177 3.10.9 Availability of Basic Infrastructure Facilities & Amenities in the Study Area .............. 178 3.10.10 Major Social and Cultural Activities in the District: .................................................... 184

Chapter 4. ANTICIPATED ENVIRONMENTAL IMPACTS AND MITIGATION MEASURES 185

4.1. .GENERAL ................................................................................................................ 185 Impact Assessment ............................................................................................................... 185 Construction Stage Impact .................................................................................................... 186 4.2. AIR ENVIRONMENT ................................................................................................. 186 4.3. NOISE ENVIRONMENT ............................................................................................ 199

4.3.1 Construction Phase ................................................................................... 199 4.3.2 Operation Phase ....................................................................................... 199 4.4 WATER ENVIRONMENT .......................................................................... 200 4.4.1 Construction Phase ................................................................................... 200 4.4.2 Operation Phase ....................................................................................... 200

4.4. LAND ENVIRONMENT ............................................................................................. 201 4.4.1 Construction Stage Impact ........................................................................................ 201 4.4.2 Impacts during Operational Phase ............................................................................ 201 4.5. BIOLOGICAL ENVIRONMENT ................................................................................. 202 4.6. Land/Soil Environment .............................................................................................. 205 4.7. Traffic Impact............................................................................................................. 206 4.8. SOCIO – ECONOMIC ENVIRONMENT ................................................................... 206

Chapter 5. ENVIRONMENT MONITORING PLAN ............................................................. 208 5.1. Environmental Monitoring Plan ................................................................................. 208





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5.2. EHS Cell .................................................................................................................... 208 5.3. Environment Monitoring ............................................................................................ 210

Chapter 6. Hazards Analysis & Risk Assessment .......................................................... 213 6.1. Introduction................................................................................................................ 213 6.2. Risk Assessment ....................................................................................................... 213 6.3. Risk Screening Approach .......................................................................................... 216

Chapter 7. ENVIRONMENT MANAGEMENT PLAN .......................................................... 239 7.1. Environment Management Plan (Operation Phase) .................................................. 239 7.2. Environment Health Safety Management Cell (EHSC) ............................................. 241 7.3. Institutional Arrangement .......................................................................................... 243 7.4. Greenbelt Development ............................................................................................ 246 7.5. CSR Plan................................................................................................................... 247 7.6. Rehabilitation and Resettlement Plan ....................................................................... 248 7.7. Emergency Preparedness Plan ................................................................................. 249 7.8. Rain Water Harvesting Plan ...................................................................................... 271 7.9. EMP Budget .............................................................................................................. 272

Chapter 8. SUMMARY & CONCLUSION ........................................................................... 274 Chapter 9. DISCLOSURE OF CONSULTANT ................................................................... 277





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List of Tables Table 1 Phase wise details ........................................................................................................... 7 Table 2 Environmental Setting within the Study Area ................................................................... 8 Table 3 : Phase wise details ......................................................................................................... 9 Table 4: Salient Environmental Features of Proposed Site ........................................................ 10 Table 1.1 Environmental Setting within the Study Area .............................................................. 18 Table 1.2 : Details of Permits and Clearance Applicable ............................................................ 20 Table 2.1 Phase wise details ...................................................................................................... 29 Table 2.2 List of Products and It‘s Intermediate with Quantity .................................................... 30 Table 2.3 Land Area Breakup ..................................................................................................... 33 Table 2.4 Fuel/ Power Requirement ........................................................................................... 33 Table 2.5 Water Balance for Phase-I .......................................................................................... 34 Table 2.6 Water Balance for Phase-II ......................................................................................... 35 Table 2.7 : Employment Generation ........................................................................................... 37 Table 2.8 : Raw List of Material Required (Phase-I) .................................................................. 38 Table 2.9 : Raw List of Material Required (Phase-II) ................................................................. 40 Table 2.10 Mass Balance of Dienogest ...................................................................................... 48 Table 2.11 Mass Balance Estroil ................................................................................................ 52 Table 2.12 Mass Balance of Ethinyl Estradiol ............................................................................. 59 Table 2.13 Mass balance of DP-15 Ketal to Dienogest: ............................................................. 64 Table 2.14 Mass Balance of Levonorgestrel ............................................................................... 68 Table 2.15 Material Balance –AD to MPA .................................................................................. 72 Table 2.16 Mass Balance ........................................................................................................... 77 Table 2.17 Mass Balance of Estradiol Hemihydrate to Estradiol Cypionate: .............................. 83 Table 2.18 Mass Balance of Norethisterone Acetate .................................................................. 88 Table 2.19 Material Balance ....................................................................................................... 90 Table 2.20 Details of Solvent used, and Recovery (Phase-I) .................................................... 94 Table 2.21 Details of Solvent used, their CAS Number and Recovery (Phase-II) ...................... 96 Table 2.22 Details of Air Emissions with emission levels ......................................................... 105 Table 2.23 Stacks in the API Plant ........................................................................................... 106 Table 2.24 :Type of Waste Generation ..................................................................................... 107 Table 2.25 Hazards Analysis –Raw materials (stored in Bulk) ................................................. 108 Table 3.2 : Salient Environmental Features of Proposed Site .................................................. 118 Table 3.3 : Summary of Methodology for Primary/Secondary Baseline Data Collection .......... 123 Table 3.4 Geological Details of the Area .................................................................................. 126 Table 3.5 Groundwater Resources Potential ............................................................................ 127 Table 3.6 : Land use of the Study Area .................................................................................... 129 Table 3.7 Long Term Meteorological Data of Bareilly (30 years average) ................................ 132 Table 3.8 No. of days with zero oktas of cloud cover (Bareilly) ................................................ 133 Table 3.9 Monthly Percentages of Calm Periods (IMD Bareilly) ............................................... 133 Table 3.10 Site Specific Meteorological Data ........................................................................... 134 Table 3.11 Ambient Air Quality Monitoring Locations ............................................................... 137 Table 3.12 Ambient Air Quality Monitoring Results (24-hour average) ..................................... 137 Table 3.13 Ambient Noise Quality Monitoring Locations .......................................................... 139 Table 3.14 Ambient Noise Quality in the Study Area ................................................................ 140 Table 3.15 Ground Water Sampling Locations ......................................................................... 141 Table 3.16 Ground Water Quality in the Study Area ................................................................. 142 Table 3.17 Ground Water Quality in the Study Area ................................................................. 143 Table 3.18 Surface Water Sampling Locations ......................................................................... 146





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Table 3.19 Surface Water Quality in the Study Area ................................................................ 147 Table 3.20 Cropping Pattern in the District as per Latest Figures, 2008-09 ............................. 149 Table 3.21 Table-2.0: Production and Productivity of Major Crops in the District, 2008-12...... 150 Table 3.22 Soil Sampling Locations .......................................................................................... 152 Table 3.23 Physicochemical Characteristics of Soil ................................................................. 152 Table 3.24 Details of the forest area present in Udham singh Nagar district ............................ 154 Table 3.25 :List of Common plant species observed in the study area .................................... 156 Table 3.26 : List of the Mammals Recorded in Study Area ....................................................... 160 Table 3.27 : List of Amphibians and Reptiles Recorded in Study Area .................................... 160 Table 3.28 List of Avifauna ....................................................................................................... 161 Table 3.29 : Caste-wise Population Distribution of 2.0-km Radial Zone ................................... 164 Table 3.30 : List of Revenue Villages in the 10km Radius Study Area ..................................... 165 Table 3.31 : Caste-wise Population Distribution of 10-km radial Study Area ............................ 166 Table 3.32 : Male-female wise Literates & Illiterates ................................................................ 171 Table 3.33 : Distribution of Work Participation Rate ................................................................. 174 Table 3.34 : Village wise Occupational Pattern in the Study Area ............................................ 175 Table 3.35 : Composition of Non-Workers ................................................................................ 178 Table 3.36 : Village wise Basic Amenities Availability .............................................................. 182 Table 4.2 Summary of Maximum Cumulative 24-hour GLC ..................................................... 191 Table 5.1 Manpower for EHS Cell ............................................................................................ 209 Table 5.2 Name of Instruments Required for Environmental Monitoring .................................. 209 Table 7.1 Environment Management Plan ................................................................................ 239 Table 2.26 CSR/CER Budget (in Rs) ........................................................................................ 248 Table 7.2 : Emergency Squad Members .................................................................................. 254 Table 7.3 : Estimation on Availability of Yearly Runoff ............................................................. 272 Table 7.4 Investment on Environmental Protection Measures (Rs. in Lacks)........................... 272 Appendix –I: TOR Letter and Point wise Compliance Status of Terms of Reference ............... 280 Point wise Compliance Status of Terms of Reference .............................................................. 288

List of Figures Figure 1.1 Close View Map Showing Coordinates of Site .......................................................... 19 Figure 1.2 Site Photographs ....................................................................................................... 22 Figure 1.3 Location Map of the Study Area ................................................................................ 23 Figure 1.4 Google Image Map of the Study Area ....................................................................... 24 Figure 2.1 ‗: Water Balance for Proposed Project (Phase-I) ...................................................... 36 Figure 2.2 :water balance for Project (Phase-II) ......................................................................... 36 Figure 2.3 Water Balance for Proposed Project (Combined) ...................................................... 37 Most of the raw material (liquid and solid) will be stored in drums, fibber drums, glass bottle and

bags (refer Table 2.9 & 2.10) ............................................................................................... 43 Figure 2.4 : General Layout Plan ................................................................................................ 44 Figure 2.5 Generalized Flow Chart for Bulk Drug Manufacturing ............................................... 45 Figure 2.6 Schematic Representation of Process ....................................................................... 47 Figure 2.7 Figure Solvent Requirements & Recovery System .................................................. 102 Figure 2.8 Overall Effluent Treatment Scheme (Capacity-100 KLD) ........................................ 104 Figure 3.1 Road Connectivity Map of Study Area ..................................................................... 118 Figure 3.2 Location Map of Study Area .................................................................................... 121 Figure 3.3 Google Map of 10 km Study Area ............................................................................ 122 Figure 3.4 Close View Map of Project Area .............................................................................. 124 Figure 3.5 Environment Sampling Location Map ...................................................................... 125





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Figure 3.6 Seismic Zones Map ................................................................................................. 127 Figure 3.7 Ground Water Dvelopment and categorization in Udham Singh Nagar District ...... 128 Figure 3.8 Figure Graphical Distribution of Land use ............................................................... 129 Figure 3.9 FCC Image of the study Area .................................................................................. 130 Figure 3.10 Land Use Map of the Study Area (10 km Radial Zone) ......................................... 131 Figure 3.11 Wind rose Diagram ................................................................................................ 135 Figure 3.12 Wind Frequency distribution .................................................................................. 136 Figure 3.13 Soil Map of Udham Singh Nagar District ............................................................... 151 Figure 3.14 : Male-Female wise Population Distribution in the Study Area .............................. 169 Figure 3.15 : Scheduled Caste Population in the Study Area ................................................... 170 Figure 3.16 : Scheduled Tribes Population in the Study Area .................................................. 170 Figure 3.17 : Male-Female wise Distribution of Literates & Illiterates ....................................... 171 Figure 3.18 : Workers Scenario of the Study Area ................................................................... 175 Figure 3.19 : Composition of Main Workers Population ........................................................... 177 Figure 3.20 : Composition of Marginal Workers ....................................................................... 178 Figure 3.21 : Composition of Non-Workers ............................................................................... 178 Figure 7.1 Structure of Environmental Management Department ............................................ 242 Figure 7.2 Photographs of Greenbelt Developed by NAARI ..................................................... 246

APPENDIX / ANNEXURE APPENDIX-I TOR Letter Annexure-I Land Allotment Letter Annexure-II Process Flow and material Balance for Phase-II Annexure-III CETP Agreement Annexure-IV NABET Certificate Annexure-V Lab Report Annexure-VI Authorization/Membership for Disposal of Hazardous waste for existing unit





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EXECUTIVE SUMMARY

1.0 Introduction

M/s. NAARI PHARMA PVT. LTD., proposes to establish Bulk drugs and intermediates

manufacturing plant at Plot 14-15-16 & 55-56-57, Sector-5, II E Pant Nagar, Rudrapur -

263153, Dist: Uddam Singh Nagar, (Uttarakhand), India. The proposed new establishment

is to manufacture Bulk Drugs and intermediates, which are active ingredients with medicinal

properties. NAARI‘s proposed unit will manufacture Bulk Drugs and intermediates with total

production capacity of 16.46 MT/Month. The project will be implemented in Phases. Detail

given in Table 1.0.

Table 1 Phase wise details

S. No. Phase Capacity (MT/Month)

Total Products

1 Phase –I 0.33 Total products are 37 out of the 37, 11 products will be manufactured in Phase-I.

2 Phase-II 16.13

3 Total 16.46

Source: NAARI As per Environmental Impact Assessment (EIA) Notification, dated 14.09.2006 and subsequent amendment dated 01.12.2009 of Ministry of Environment and Forests and Climate Change (MOEF&CC), the proposed project falls under Category B of schedule 5(f) and requires prior environmental clearance from SEAC. However, the Uttranchal SEAC/SEIAA has been dissolve, Hence the proposal will be appraised in MOEF as ―A‖ category project. As the site is located in Notified Industrial area hence the projects does not attract the provisions of Public Hearing. The EIA Report has been prepared in the line with Terms of Reference (TOR) prescribed by MOEF&CC.

2.0 Project Location

The proposed site is located at Latitude: 29°00'21"N and Longitude: 79°24'32"E. The site well connected to road and railway line. The site is located at Plot 14-15-16 & 55-56-57, Sector-5, IIE Pant Nagar, Rudrapur Industrial area, Dist: Udham Singh Nagar, (Uttarakhand), India. Proposed site is located in an industrial land allotted by State Industrial Development corporation of Uttarakhand (SIDCUL) in Udham Singh Nagar District. About 5.93 Acres (24000m2) land is available with NAARI at Plot 14-15-16 & 55-56-57, Sector-5, IIE Pant Nagar, Rudrapur Industrial area. Out of the total land the proposed unit (construction of manufacturing facility, utility, office and roads) will be established in 3.93 Acres (15904.5m2) land and remaining 2.0 Acres (8094 m2) will be reserved for greenbelt development. No archaeological, historical site is located within the study area. Therefore, the project site does not offer any negative impact on the local area as because it is a new establishment in existing vacant land in notified industrial area, but rather has a positive impact on socio economic conditions of the area. The plant is well connected both to NH-87 and Delhi-Kathgodam Railway line. Nearest Railway station is Rudrapur city located about 5.5 km from Project site. The nearest airport is at Pant Nagar located at an aerial distance of 6.5 km





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approx. Chaferi River is located about 6.2 km east and Baror Nadi located at 5.5 km E of the proposed site. Tanda Forest range is located about 4.62 km north of the site. There are no defence installations, National Park, Wild Life Sanctuary, Elephant/Tiger Reserve, elephant

corridor etc. within 10 km radius. The brief information about project site is given in Table 2.

Table 2 Environmental Setting within the Study Area

S. No.

Particulars Details

1 Project Location Plot 14-15-16 & 55-56-57, Sector-5, IIE Pant Nagar, Rudrapur Industrial area, Dist: Udham Singh Nagar, (Uttarakhand), India

2 Main Plant Site Latitude/Longitude

Corner Latitude Longitude

A 29° 0'26.63"N 79°24'29.64"E

B 29° 0'26.67"N 79°24'37.11"E

C 29° 0'21.81"N 79°24'30.33"E

D 29° 0'21.63"N 79°24'37.09"E

3 Present land use at the site Industrial Plot

4 Villages within 1 km (approx) radius area

None It is an industrial area nearest habitation is Kalyanpur 1.2 km SW

5 Nearest highway NH-87 (about 1 Km, west)

6 Nearest railway station Nearest railway station is Rudrapur 5 km SW

7 Nearest airport Pant Nagar about 6.5 km NE (Arial distance)

8 Nearest town/City / District Headquarters Rudrapur Town, 1.94 km, S

9 Hills/valleys None within 10 km area

10 State Boundary Uttar Pradesh State boundary : 5.77 km, SW

11 Topography Plain

12 Archaeologically important places None within 10 km area

13 Protected areas as per Wildlife Protection act, 1972 (Biospheres, Tiger reserves, Elephant reserves, National Parks / Wildlife Sanctuaries, Conservation reserves and

None within 10 km radius.





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S. No.

Particulars Details

Community reserves)

14 Reserved Forest (RF) and Protected Forests (PF). Distance (approx.)

There is forest block called Tanda forest Range at a distance of 4.62km (N)

15 Seismicity The project is located in High damage Risk Zone (Zone IV) as per IS: 1893 (Part-1) 2002

16 Surface water bodies Chaferi River, 6.19 km, E Baror Nadi 5.5 km E

17 Defense Installations None within 10 km radius

18 Water Source for project Ground water

3.0 Process Description

It is a Bulk Drugs and intermediates manufacturing unit having production capacity of 16.46 MT/Month. The unit proposes to manufacture all the API & Drugs products, which involves various chemical reactions like, chlorination, Ethynylation, Birch reduction, Grignard reaction and physical operations like Layer separation, Crystallization, Filtration, drying, packing etc. The project will be implemented in two phasesThe estimated cost of the project is Rs. 17500 Lacks (Rs. 3500 Lacks for Phase-I and 14000 Lakhs for Phase –II). The proposed unit will be installed in 5.93 Acres (24000m2) land which is already in possession of NAARI. About 200 people will be required to construct the project. About 150 people will be required to operate the project. The associated activities proposed are auxiliary plants like water de-mineralization plant, steam boiler, cooling water system, diesel generators, wastewater treatment plant, scrubbing systems, RO plant, etc. to support the process operations. The proposed unit will be installed in 5.93 Acres (24000m2) land which is already with NAARI. Out of the total land plant including construction of manufacturing facility, utility, office and roads will be established in 3.93 Acres (15904.5m2) of the land and rest of the area i.e 2.0 Acres (8094 m2) has been kept for as a greenbelt. Total water requirement will be 150 KLD. The project will be implemented in two phases hence the water required for phase–1 is 23 KLD and water requirement for phase-II will be 127 KLD. Permission for drawl of 150 KLD ground water shall be obtained from concerned authority. Application has been submitted to concerned authority. The project will be implemented in phases and detail given in Table 3.

Table 3: Phase wise details

Sl. No. Phase Capacity (MT/Month)

Total Products

1 Phase –I 0.33 Total products are 37. 11 products will manufactured in Phase-I. (refer Table 2.2)

2 Phase-II 16.13

3 Total 16.46

Source: NAARI





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4.0 Description of Environment

The baseline environmental data generation has been done for the period of 1st October 2017 to 31st December 2017. The 10 km radius area around the Unit was considered as study area. The data was generated by following the standard procedures of the Ministry of Environment & Forests and the Central Pollution Control Board. The salient environment features of the project is given in Table 4.

Table 4: Salient Environmental Features of Proposed Site

S. No.

Environmental Features

Within 500 m area around project site

Within 2 km area around project site


1 Ecological Environment

A Presence of Wildlife Sanctuary/ National Park/Biosphere Reserves

None None None

B Reserved /Protected Forests

None None Tanda forest Range at a distance of 4.62km, N & NE

C Wetland of state and national interest

None None None

D Migratory route for wild animals

None None None

E Presence of schedule-I Fauna

None None None

F Critically polluted Area None within 10 km study area

2. Physical Environment

H Road connectivity UPSIDC Industrial area road

NH-87, 1 km West

NH-87, 1 km West NH-74, 4.2 km, South

I Rail connectivity None None Rudrapur RS~5km SW

J Defence Installation None None None

K Densely Populated Area

None Rudrapur town Rudrapur town Pant Nagar

L Other village close to plant site

It is an industrial area nearest habitation is Kalyanpur which is located about 1.2 km SW of the site.

M Topography Plain, elevation of site ranges between 216 to 218 amsl

Plain, elevation ranges between 208 to 225 amsl

undulating, elevation ranges between 208 to 315 amsl

M Seismicity Seismic zone-IV ( High damage Risk Zone)

N Surface Water Resources (Rivers)

None None Chaferi River, 6.2 km, E Baror Nadi 5.5 km E

O Groundwater Semi-critical, Overall Groundwater quality is good for domestic and irrigation purpose.





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P Soil and Land-use Sandy loam, land use is Industrial

Sandy loam land use agriculture, industrial and settlement

Sandy loam land use agriculture, vegetation, industrial and settlement

3. Social Environment

S Physical Setting Industrial Rural and Industrial

Industrial, Rural & Urban

T Physical Sensitive Receptors

None School, Hospitals, Temple etc.

School, Hospitals, Temple etc.

U Archaeological Monuments

None None None

Meteorology: Meteorological station was setup near at project site. Wind speed, wind direction, temperature and humidity levels were recorded. Historical met data was collected from India Meteorological Department (IMD Bareilly). The predominant wind direction is from West and Northwest direction in most of the year. During monsoon season the wind flows from East and west direction. Average wind speed ranges between 4.4 to 9.3 km/hr. The annual rainfall is about 893 mm. Air Environment: PM2.5, PM10, SO2, NO, CO. HF, HBr and NH3 were monitored at eight locations in the study area. The locations were selected as per CPCB guidelines. Monitoring was done at upwind direction and various downwind directions of the project. The PM10 level in all the monitoring location of the study area was recorded are within the NAAQS level (100µg/m³). The PM2.5 level in all the monitoring location of the study area was recorded are within the NAAQS level (60µg/m³). SO2 and NOx levels in all monitoring locations were found within the NAAQS (80 µg/m³). NH3 were found in the rage of 15.3 to 17.7 µg/m3 which is found within the standard i.e. NAAQMS level 400µg/m3. CO mean Value are 0.25 to 0.57 mg/m3 and VOC, HBr, HF were not detected in the study area. Over all the ambient air quality of the study area is meeting the prescribed National Ambient Air Quality Standard at all locations. No abnormal values have been found in the dust of ambient air. Noise Environment: Ambient noise levels were monitored at eight (8) locations in the study area.The ambient noise quality of the study area is within the prescribed National Ambient Noise Quality Standards prescribed for industrial (Standards - 75 dBA during day time and 70 dBA during night time) residential area (Standards - 55 dBA during day time and 45 dBA during night time) and commercial area (Standards - 65 dBA during day time and 55 dBA during night time). Water Quality: Two surface water samples and eight groundwater samples were collected from the study area for chemical and biological analysis. Groundwater samples were collected from hand pumps and tube wells of villages around the project site. The water samples examined for physico-chemical parameters and bacteriological parameters. The samples collected and analysed as per the procedures specified in Standard Methods. Samples for chemical analyses collected in polyethylene carboys. Samples for bacteriological analyses collected in sterilized bottles. No biological and metallic contamination reported in any of the ground water sample of the study area. Overall the





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parameters in ground water sample were well within the desired limit of Indian Standard IS: 10500-2012, except Haldi location, where the hardness values are slightly above the desired limit but well within the desirable limit.

Bacterial and metallic contamination was observed in the surface water sample. However

the surface water was found to meet the Best Designated Use – ‗D‘ Criteria of CPCB (i.e fit

for fish propagation).

Soil Quality: Six soil samples were collected from the agriculture fields around the project area and analyzed for relevant physico-chemical parameters. The texture of soil varies from sandy loam. The soil pH ranges from 6.5 to 7.8 thereby indicating the soils are slightly acidic to neutral in nature. The organic matter, nitrogen, potassium and phosphorus content of the soil are found to be in low to moderate amount. Overall the soil is found moderately fertile. Sensitive Ecosystem: No ecologically sensitive area like national park, wildlife sanctuary, and biosphere reserve are present in the 10-km radius of project site. No species of plants and animals in the study area were found to be threatened, rare or endangered. Biological Environment: Proposed plant site is located in Notified industrial area. Most of the land around the proposed site is built-up industrial area. The common plant species observed in the study area are Acacia Catechu (Khair/ Kattha), Aegle Marmelos (Bel), Albizia Lebeck (Siris), Azadirachta indica (Neem), Mangifera indica (Aam), Bombax ceiba (Semal / Semar), Dalbergia sissoo (Shisham), Derris pinnata (Karang, Diospyros melanoxylon (Tendu), Ficus benghalensis (Bar/ Bargad), Ficus racemosa (Gular), Aegle marmelos Ficus religiosa (Pipal), Madhuca longifolia (Mahua), Phyllanthus emblica (Awla), Prosopis juliflora, Butea monosperma, Syzygium cuminii (Jamun), Terminalia tomentosa, Terminalia arjuna Tamarindus indica (Imli), Terminalia arjuna (Arjun/Kahua) Mallotus philippensis, and Lagerstroemia parviflora. No significant carnivorous and herbivorous wild animals are found in the area. Langurs, Mongoose and Jungle Cat are the common mammals observed in the area. No National Park, Wildlife Sanctuary of other protected area is present within 10-km radius of the project area. No rare and endangered faunal species was observed in the study area. There are no barriers for migration of any wild animals either within the Project area as well as in study area. Land Use: Land use of project site is industrial land. Most of the land within the 10 km area of the project site is under agriculture. As per the land use based on satellite image, about 67% of the land is under cultivation. 8.75% land is under vegetation, 7.35% of the land is under settlement, about 15.48% land is under open shrubs/plantation and rest of the land is under other uses

5.0 Environmental Impact and Mitigation Measures

Air Quality: The operation of the plant will leads the air emissions from the boiler and

process stcks. Handling & transportation of raw material shall also leads air and fugitive





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emissions. Besides this being a pharma plant the fugitive emissions in the form of organic

chemicals and VOCs may come from leakage through valves, fittings, pumps, etc.

Mitigation Measures:

Multi cyclone separator with stack height as per the CPCB guideline shall be provided for dispersion of particulate matter from Boiler. All process vents will be routed through dedicated two stage ventury scrubbing system. Adequate stack height to be provided in process stacks. Handling & transportation of the raw material as per norms. Sprinkling of water to control fugitive dust emission. Speed of vehicles inside the factory premises will be controlled.Greenbelt will be maintained to attenuate the air pollution. All trucks will be transported after covering from the top. All the trucks being used for transportation of raw material and final product shall be checked for "Pollution under Control" certificate prior to their entry to the plant premises

Water Quality: Total water requirement of the project will be 150 KLD. The project will be implemented in two phases. In phase–I only 23 KLD water is required and water requirement for phase-II will be 127 KLD. Permission for drawl of 150 KLDground water shall be obtained from concerned authority. Application has been submitted to concerned authority. Water is required for utility, process, washing and domestic uses. Being a pharma industry waste water generation is the main concerned. The discharge of untreated waste may lead to water pollution in surrounding area.

Mitigation Measures: In phase-I process waste water will be sent to CETP. Separate storm water and industrial wastewater drains to will be provided to eliminate chances of mixing of rainwater with wastewater. Domestic sewage will be disposed in septic tank. In phase -II100 KLD ETP plant will be established with advance treatment technology. Wastewater will be segregated into two streams as High TDS / High COD (HTDS) and Low TDS / Low COD (LTDS). The HTDS Effluent stream after neutralization, and after suspended solid seperaion it will be sent to Multi Effect Evaporator (MEE). The distillate water will be treated in ETP along with LTDS effluent. The concentrate will be sent to ATFD for drying. The dried salt will be sent to approved TSDF for final disposal. The ETP treated effluent will be passed through RO for recovery of water for recycling. The RO reject will be send sent to MEE. The provision of stripper for recovery of solvent (VOC) from HTDS effluent before MEE and incinerator for combustion of hazardous organic residues from the process is also made. The inorganic hazardous residues will be sent to TSDF No process effluent will be discharged outside the plant premises. Separate storm water and industrial wastewater drains to will be provided to eliminate chances of mixing of rainwater with wastewater. Domestic sewage generated from the sanitary blocks will be treated in STP (20 KLD). Plant should ensure that the treated effluent quality shall comply with norms set by SPCB. Noise Quality: The main source of noise generation during operation stages are mainly Boiler, pumps, blowers, compressors, DG sets and vehicles used for transportation of raw materials, finished goods etc.





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Mitigation Measures: Equipment will be maintained so that noise level does not increase due to improper maintenance. DG sets will be provided with acoustics enclosures. Mufflers, silencers, acoustics treatment of room will be done wherever required. To avoid occupational health hazard, workers will be provided PPEs like ear plug/ ear muffs, wherever required. It is expected that noise level at the plant boundary will be within the prescribed norms of CPCB due to operation of the proposed project and no significant impact on noise environment is expected. Greenbelt developed within the plant premises will also act as a barrier to the propagation of noise from the factory premises. This shall further reduce the noise levels appreciably. Hence, no significant impact is envisaged. It is, therefore, expected that noise level at the plant boundary will be within the prescribed norms of CPCB due to operation of the proposed project and hence no significant adverse impact on noise environment is expected.

Solid Wastes Disposal:

Under ordinary and safe operating conditions, no adverse impact is anticipated on land during the operation phase. Commercial waste like empty cement bags, Iron scrap etc. will be sold to scrap buyers after the construction phase. Domestic waste like used paper, label, cartoons will be disposed to the scrap buyers. Organic waste from canteen will be disposed as per the local Panchayath / Municipal disposal mechanism. Hazardous waste from Process and Effluent TreatmentPlant will be disposed as per CPCB/ SPCB Norms and HW Rules. Thus, the land pollution during the operation phase is minimal and not likely to create any significant impact.

Mitigation measure: The site is already levelled and located in industrial area. There will be no change in Landuse. Being a ZLD system there will no any discharge of wastewater on the land. Separate storm water and industrial wastewater drains will be provided to eliminate any contamination of the land. Hazardous wastes will be stored, managed and handles as per hazardous wastes rules.All bulk chemicals and fuel storage areas will be provided with dyke wall / bunds to eliminate chances of any spillages/ leakages.

Impact on Biological Environment: The attributes that are identified to describe ecology are animals, birds, fish, field crops, threatened species, natural vegetation etc. The study area does not have any identified endangered species, Forest, National Park, Sanctuaries and hence there is no question of any adverse impact on the same. The impact on the surrounding ecology during the operation of the project will mainly occur from the deposition of air pollutants. Air pollution affects the biotic and abiotic components of the ecosystem individually and synergistically with other pollutants. Chronic and acute effects on plants and animals may be induced when the concentration of air pollutants exceeds threshold limits. Particulate emission and other gaseous emissions from the proposed plant are the major pollutant that may affect the ecology of the area.

Mitigation Measures

The incremental emission of air pollutants is not likely to induce any significant changes in the ecology because the national ambient air quality standards will remain within the limits. The incremental MGLC of PM, SO2, NOx and HCL generated from the proposed plant will be very less and overall incremental GLC will remains within the NAAQS. Proposed plant is zero liquid discharge based so no waste water will be discharged out site the plant permises.





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solid waste and hazardous waste shall be disposed as per norm. Therefore impact of emission on the surrounding vegetation will be insignificant. Greenbelt development along the plant boundary, further development of gardens and lawns near admin building will mitigate the residual impact on natural resources.

Impact on Public Health: The national ambient air quality standards prescribe level of air pollutants that will protect public health and vegetation. Air quality dispersion modeling study proved that the ambient air quality of the area will remain within the national air quality standards. No toxic chemicals or wastes will be handled in the plant. Hence there will be no risk to public health.

6.0 Environmental Monitoring Plan

Environmental Health & Safety cell (EHSC) will be created to undertake routine environmental monitoring to evaluate performance of pollution control measures and to ensure compliance with the prescribed standards. Qualified scientists and other qualified staff will be recruited to manage the EHSC. Responsibilities of EHS cell are as below:

Implement EHS directives and guide line as per NAARI Pharma requirement Operation of wastewater pre-treatment plant and Effluent Treatment Plant (ETP) and

STP Monitoring hazardous work through work permit system Pre, periodical and post medical check of employees Conducting audiometry test for employees working in high noise area. Regular training to employees on Health, Safety and Environment Topics. Regular monitoring of wastewater, stacks, ambient air, noise etc either internally or by

appointing external agency and data analysis. Corrective and preventive action, wherever required.

Hazardous wastes management and handling. Preparation of various reports like environment statement, carrying out environment

audit, preparation of water cess returns and various consent applications and renewal under Water (Prevention and Control of Pollution) Act, 1974 and Air (Prevention and Control of Pollution) Act, 1981 as well as application for authorization and its renewal under Hazardous Wastes (Management, Handling and Transboundary Movement) Rules, 2016, and amendment thereof under Environment Protection Act, 1986.

7.0 Risk Mitigation Measures

Firefighting system with fire extinguishers, hydrant system, sprinkler system, pumps and

pipeline network will be strengthened as per the recommendation.

8.0 Environmental Management Plan (EMP)

EMP for effective management of environmental impacts and ensuring overall protection of the

environment through appropriate management procedures has been recommended in the EIA

report. The capital cost for environmental management of the proposed project is estimated to

be Rs. 9.25 crores. Budget allocation of Rs. 115 Lacks is required every year to meet the

annual recurring expenditure for implementing the environmental control and improvement

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CHAPTER 1. INTRODUCTION

1.1. Purpose of Report

M/s. NAARI PHARMA PVT. LTD., is a vertically integrated women‘s health pharma business

focused on hormones. NAARI have development and manufacturing capabilities for

fermentation/enzymatic and other intermediates, active pharmaceutical ingredients and FDFs.

Apart from a vast portfolio of Generic APIs and FDFs, NAARI has a robust innovative pipeline

at various stages of development and clinical trials.

NAARI has one of the most comprehensive hormonal API portfolios offered by any

manufacturer. NAARI‘s portfolio is vertically integrated to the very basic starting materials

giving us control on quality and security of supply. One of key strengths of NAARI is its ability

to produce the very basic intermediates that are the building blocks for most of the hormonal

APIs.

Between currently available and under development products, NAARI has more than 40

hormonal generics, giving it one of the most comprehensive hormone portfolios in the world.

Apart from hormones NAARI is also developing a basket of products that address the needs

of women like vaginal infections, acne etc.

Now considering the world markets demands M/s. NAARI PHARMA PVT. LTD., proposes

to establish bulk drugs and intermediates manufacturing plant at Plot 14-15-16 & 55-

56-57, Sector-5, II E Pant Nagar, Rudrapur - 263153, Dist: Uddam Singh Nagar,

(Uttarakhand), India. The proposed new establishment is to manufacture Bulk Drugs and

intermediates, which are active ingredients with medicinal properties.

1.2. Proposal

In view of the world markets demand and future capacity addition plans M/s. NAARI

PHARMA PVT. LTD., proposes to establish Bulk drugs and intermediates

manufacturing plant at Plot 14-16 & 55-57, Sector-5, II E Pant Nagar, Rudrapur - 263153,

Dist: Uddam Singh Nagar, (Uttarakhand), India. The proposed new establishment is to

manufacture Bulk Drugs and intermediates, which are active ingredients with medicinal

properties.

1.3. Purpose of Report

As per Environmental Impact Assessment (EIA) Notification, dated 14.09.2006 and

subsequent amendment dated 01.12.2009 of Ministry of Environment and Forests and

Climate Change (MOEF&CC), the proposed project falls under Category B of schedule 5(f)

and requires prior environmental clearance from SEAC. But the Uttranchal SEAC/SEIAA has

been dissolve, Hence the proposal will be appraised in MOEF as ―A‖ category project. As the

site is located in Notified Industrial area hence the projects does not attract the provisions of

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An application for TOR was submitted to MOEF&CC on 28th September 2017. Standard

Terms of Reference (TOR) for proposed project was accorded by MoEF & CC on dated 6th

November 2017.. One season baseline data has been generated for the proposed project

during 1st Oct 2017 to 31th December 2017. The EIA report has been prepared as per the

standard TOR prescribed by the MOEF&CC.

1.4. Objective of Report

Environmental Impact Assessment (EIA) is a planning tool to give the environment its due place in the decision making process by clearly evaluating the environmental consequences of a proposed activity before action is taken. Thus, the main objective of EIA is to determine as precisely as possible, within the present limits of knowledge and expertise, the likely environmental impacts of a planned development activity and incorporate efficient environmental protection measures right at the planning stage of project in such a way that the residual adverse effects becomes acceptable or almost none. The objectives of the present environmental impact assessment study briefly described below:

To support the goals of environmental protection and sustainable development. To integrate environmental protection and economic decisions at the earliest

stages of planning an activity. To identify and assess environmental, social, economic, and cultural

consequences of a proposed activity and to delineate plans for the mitigation of adverse impacts resulting from the proposed activity.

Thus, by using EIA tool both environmental and economic benefits can be achieved, such as

reduced cost & time of project design & implementation, avoided treatment/clean-up costs,

impacts of laws and regulations, etc.

1.5. Breif about the Project & project proponent

The proposed site is located at Latitude: 29°00'21"N and Longitude: 79°24'32"E. The site well connected to road and railway line. The site is located at Plot 14-16 & 55-57, Sector-5, IIE Pant Nagar, Rudrapur Industrial area, Dist: Udham Singh Nagar, (Uttarakhand) India. Proposed site is located in an industrial land allotted by State Industrial Development corporation of Uttarakhand (SIDCUL) in Udham Singh Nagar District. About 5.93 Acres (24000m2) land is available with NAARI at Plot 14-16 & 55-57, Sector-5, IIE Pant Nagar, Rudrapur Industrial area. out of the total land the proposed unit (construction of manufacturing facility, utility, office and roads) will be established in 3.93 Acres (15904.5m2) land and remaining 2.0 Acres (8094 m2) will be reserved for greenbelt development.

No archaeological, historical site is located within the study area. Therefore, the project site does not offer any negative impact on the local area as because it is a new establishment in existing vacant land in notified industrial area, but rather has a positive impact on socio economic conditions of the area. The plant is well connected both to NH-87 and Delhi-Kathgodam Railway line. Nearest Railway station is Rudrapur city located about 5.5 km from Project site. The nearest airport is at Pant Nagar located at an aerial distance of 6.5 km approx. Chaferi river is located about 6.2 km east and Baror Nadi located at 5.5 km E of the proposed site. Tanda Forest range is located about 4.62 km north of the site. There are no





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defence installations, National Park, Wild Life Sanctuary, Elephant/Tiger Reserve, elephant corridor etc. within 10 km radius.

The brief information about project site is given in Table1.1. Close view map of site showing

coordinates of site is presented in Figure 1.1. Site photographs provided in Figure 1.2. The

location map of the proposed Project site is presented in Figure 1.3. Map showing site and

surrounding features within 10 km area of the site is presented in Figure 1.3.

Table 1.1 Environmental Setting within the Study Area

Sr. No.

Particulars Details

1 Project Location Plot 14-15-16 & 55-56-57, Sector-5, IIE Pant Nagar, Rudrapur Industrial area, Dist: Udham Singh Nagar, (Uttarakhand), India

2 Main Plant Site Latitude/Longitude

Corner Latitude Longitude

A 29° 0'26.63"N 79°24'29.64"E

B 29° 0'26.67"N 79°24'37.11"E

C 29° 0'21.81"N 79°24'30.33"E

D 29° 0'21.63"N 79°24'37.09"E

3 Present land use at the site Industrial Plot

4 Villages within 1 km (approx) radius area

None It is an industrial area nearest habitation is Kalyanpur 1.2 km SW

5 Nearest highway NH-87 (about 1 Km, west)

6 Nearest railway station Nearest railway station is Rudrapur 5 km SW

7 Nearest airport Pant Nagar about 6.5 km NE (Arial distance)

8 Nearest town/City / District Headquarters Rudrapur Town, 1.94 km, S

9 Hills/valleys None within 10 km area

10 State Boundary Uttar Pradesh State boundary : 5.77 km,SW

11 Topography Plain

12 Archaeologically important places None within 10 km area

13 Protected areas as per Wildlife Protection act, 1972 (Biospheres, Tiger reserves,

None within 10 km radius.





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Sr. No.

Particulars Details

Elephant reserves, National Parks / Wildlife Sanctuaries, Conservation reserves and Community reserves)

14 Reserved Forest (RF) and Protected Forests (PF). Distance (approx.)

There is forest block called Tanda forest Range at a distance of 4.62km(N)

15 Seismicity The project is located in High damage Risk zone(Zone IV) as per IS: 1893 (Part-1) 2002

16 Surface water bodies Chaferi River, 6.2 km, E Baror Nadi 5.5 km E

17 Defense Installations None within 10 km radius

18 Water Source for project Ground water

Figure 1.1 Close View Map Showing Coordinates of Site

Project Proponant: Shri. Prithipal S. Kochhar is the Director of the company. Naari has one

of the most comprehensive hormonal API portfolios offered by any manufacturer. NAARI

portfolio is vertically integrated to the very basic starting materials giving NAARI control on

quality and security of supply. Naari is currently present in 29 countries and has products under

approval in 21 countries.





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1.6. Importance and Benefit of the Project

India ranks third with respect to the production capacity of pharmaceuticals in the world,

whereas in terms of value, India is in 14th place. The total turnover of pharmaceutical

industry in 2010 was US $ 20 billion, which is 20 times when compared with the turnover

in 1990 (Indian Pharmaceutical Industry, 2010). All major therapeutic groups of drugs are

manufactured in India. In terms of generics production India ranks 4th, but in terms of

export value India ranks 17th. The need of APIs is increasing every year due to continual

growth of pharmaceutical industry. This project is expected to partially fulfill the demand

of APIs of pharmaceutical industries.

1.7. Regulatory Framework

Requirement of Environmental Clearance

Prior Environmental Clearance is required from concerned authorities for all projects and

activities mentioned in ―Schedule‖ as per Environmental Impact Assessment notification

dated September 14, 2006. The project comes under ―project and activity-5 (f) of

schedule‖ and category B. in absence of the committee in Uttrancha the case will be

appraised for Environmental Clearance (EC) from MoEF&CC, New Delhi.

NAARI has commenced the process of obtaining required statutory permission from

concerned authorities. Details of permits and clearance applicable to this project are as

under.

Table 1.2 : Details of Permits and Clearance Applicable

S. No.

Permit / Clearance/Standards

For Proposed Project

Current Status for Proposed Project

1 No Objection Certificate / Consent to Establish from Uttarakhand Pollution Control Board for the proposed project

Mandatory, prior to establishment of proposed project

Not yet applied

2 Factory License

Mandatory approvals required for drawings prior to commencement of construction

Not yet applied. Shall be applied before start of construction

3 Water Permission

To be applied To be applied after getting EC

4 Environmental Clearance from Expert Appraisal Committee, Impact assessment Authority (IAA)

Required Under Process

5 The Hazardous Waste (Management and other Handling and Trans-boundary Movement) Rules 2016 amended to date.

Required CTO Will be applied after getting EC/ CTE and before starting production 6 Water (Prevention and Control of

Pollution) Act,1974





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S. No.

Permit / Clearance/Standards

For Proposed Project

Current Status for Proposed Project

7 Air (Prevention and Control of Pollution) Act, 1981

In addition to environmental regulatory compliance, other applicable statutory rules and

regulations including (but not limited to) are the following:

Permission for storage of hazardous Chemicals form Chief Controller of Explosive (CCOE) Labour laws and Safety guide lines as per Labour Commissioner, Government of Uttrahand.

Boiler Regulations as per Chief Inspector of Boilers, Government of UK.

ESIC etc.





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Figure 1.2 Site Photographs

Draft Environmental Impact Assessment Report for proposed

New Manufacturing Unit of Intermediates API and Bulk Drug


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EQMS India Pvt. Ltd.

Figure 1.3 Location Map of the Study Area

Draft Environmental Impact Assessment Report for proposed

New Manufacturing Unit of Intermediates API and Bulk Drug


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Figure 1.4 Google Image Map of the Study Area





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1.8. Demand-Supply Scenario

Based on Demand Supply situation in the country there is peak shortage even without

significant peaking up of the manufacturing Sector. The manufacturing sector is likely to peak

up with the Make-in-India campaign, which is likely to considerably erode whatever margins

are available in Base energy availability.

There is a quite considerable gap between supply and demand for bulk drugs and

intermediates. Very few players are in the market who can offer continuous supply. The

company wants to bridge this gap between demand and supply by expanding the production

capacity and thereby, making good business. Company's marketing edge comes from its

direct and close contact with the customers. Their products are major strength of their

customers. Each stage of their product is been monitored /checked for their quality to ensure

quality product reaches their customer. They plan to launch new products every year to

satisfy the need of their customers as per the market demand.

Conclusion: Considering the above, NAARI has planned to be commissioned during 13th

Plan period, is justified from demand supply consideration.

1.9. Site Selection Criteria

M/s. NAARI PHARMA PVT. LTD. is already operating a plant which is located close to the

proposed site. About 5.93 Acres (24000m2) of industrial land is already in possession of

NAARI which is allotted by State Industrial Development corporation of Uttarakhand

(SIDCUL) in Udham Singh Nagar District. Further no R&R, eco-sensitive issues are related

with the project hence, an alternative site analysis was not conducted.

1.10. Scope and Methodology of the Study

This Environmental Impact Assessment (EIA) study for the proposed project considers a core

study area covering a radius of 10 km around the proposed site. The scope of the study is

based on the standard TOR prescribed by MOEF & CC. The study broadly includes:-

A. Collection of Relevant Information on the Project

This is based on the Project Feasibility Report and other information made available by the

proponent which includes technology to be used, alternative technologies considered, the

requirement of raw materials, environmental resources, manpower etc.

B. Study of Existing Environmental Baseline Status

The baseline status of the environment in the 10 km radius study area has been determined

by monitoring/ sampling of selected environmental attributes during the study period.

The monitoring locations have been selected after reconnaissance survey and due

consideration to other factors like,

Predominant wind directions in the study area as recorded by India Meteorological Department (IMD) station





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Existing topography, locations of surface water bodies like ponds, canals and rivers

Location of villages/ towns/ sensitive areas; and Accessibility, power availability and security of monitoring equipment;

pollution pockets in the area; and areas that best represent the baseline conditions.

C. Assessment of the impacts on the environmental attributes due to the proposed

project

The processes, activities and associated sub-activities during the construction and

operation of the proposed power project have been examined in detail to identify their

impact on the environmental attributes in the study area. An attempt has been made to

quantify these impacts on the associated attribute using mathematical models and other

recommended methods. This is complimented with an assessment of the overall impact on

the environment.

D. Environment protection and mitigation measures

The measures for prevention and mitigation of adverse impacts on the environmental

components, already proposed by the proponent have been reviewed for adequacy and

additional measures, if required, has been suggested. All the measures will form a part of

the strategic Environmental Management Plan containing detailed plan for implementation

of the measures, along with the infrastructural requirements for these.

E. Identification of critical environmental attributes required to be monitored after the

implementation of proposed project

To verify the efficacy of the environmental protection measures, the environmental attributes

identified are likely to be affected by the project will be continued to be monitored during the

construction and operation of the unit. This monitoring will be the responsibility of the

proponent and done on a regular basis. The results of the monitoring will be submitted to

the regulatory agencies from time to time as required.

1.11. TOR Compliance

The EIA study has been conducted in accordance with the Standard TOR. The point wise

compliance is mentioned in Appendix-I.

1.12. Structure of the EIA Report

This EIA report has been prepared based on available on-site primary data (survey/

monitoring) and secondary data/literature data. The EIA report contains project features,

baseline environmental conditions, assessment of environmental impacts, and formulation of

mitigation measures along with environmental management and monitoring plan.

The report includes the following eleven chapters:





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Chapter 1: Introduction: This chapter provides background information of the project

proponent, need for the EIA study as per prevailing legislation, location and brief description of

the project, scope &methodology adopted for EIA study and structure of the report.

Chapter 2: Project Description: This chapter deals with the details of the proposed project

such as location, connectivity, size and magnitude of the operation, details of processes along

with identification of the activities likely to affect the environment and proposed mitigation

measures, project requirements, Infrastructure development, environmental consideration,

project cost, implementation schedule, etc.

Chapter 3: Baseline Environmental Status: This Chapter describes methodology and the

baseline environmental conditions around the project site for various environmental attributes,

viz., physical, biological and socio-economic, within the 10 km radial zone, which is termed as

the study area. Topography, soil, water, meteorology, air, noise, hydrology, geology, and land

constitute the physical environment, whereas flora and fauna constitute the biological

environment. Demographic details and occupational pattern in the study area constitute socio-

economic environment. Baseline environmental conditions are based on the field studies carried

out during Oct to Dec, 2017, at and around the proposed site and through secondary data

collected from published sources.

Chapter 4: Anticipated Environmental Impacts & Mitigation Measures: This chapter details

the inferences drawn from the environmental impact assessment of the proposed project during

construction and regular operation stages. It also details the prediction of impacts on the

environmental attributes using recommended methods and tools. The significance of these

impacts is assessed based on the significance of the environmental attributes being affected. It

also describes proposed mitigation measures to minimize the environmental impacts.

Chapter 5: Environmental Monitoring program: This chapter provides the environmental

monitoring plan for the proposed project for both the construction and operation stages.

Chapter 6: Additional Studies: This Chapter provides the details about the Risk Assessment,

Disaster Management Plan (DMP) and on-site emergency plan proposed for the expansion

project.

Chapter 7: Environmental Management Plan: This Chapter provides mitigation and control

measures to attenuate and/or eliminate environmental impacts, which are likely to be caused by

the proposed project. An Environmental Management Plan (EMP) has been developed to

mitigate the potential adverse impacts and to strengthen the beneficial impacts during the

construction and operation phase. It also describes the institutional arrangements and

budgetary allocation for environmental protection and conservation.

Chapter 8: Project Benefits: This chapter describes various benefits of the project to the

community in vicinity as well as to the region on the whole. It also envisages the Corporate

Social Responsibility and Community Development activities to be proposed in future.

Chapter 9: Summary and Conclusions: This chapter concludes on the findings that emerged

from the environmental impact assessment study and summarizes the key points to be





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addressed to ensure the environmental sustainability of the project during the construction and

operation phases.

Chapter 11: Disclosure of Consultants: This chapter lists the Functional Area Experts (FAEs)

who have worked in the preparation of EIA/EMP Report, brief introduction of the consultancy

organization along with details of accreditation of consultant with QCI-NABET.





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CHAPTER 2. PROJECT DESCRIPTION

2.1. Type of the Project



263153, Dist: Uddam Singh Nagar, (Uttarakhand), India. The proposed new establishment is

to manufacture Bulk Drugs and intermediates, which are active ingredients with medicinal


production capacity of 16.46 MT/Month. The project will be implemented in Phases. Detail given

in Table 2.1.

Table 2.1 Phase wise details

S. No. Phase Capacity (MT/Month)

Total Products

1 Phase –I 0.33 Total products are 37. 11 products will manufactured in Phase-I. (refer Table 2.2)

2 Phase-II 16.13

Total 16.46

Source: NAARI

2.2. Justification of the Project

India's pharmaceutical industry is now the third largest in the world in terms of volume and 14th

in terms of value. Being a ‗Life Saving Drug‘, there is a huge demand and potential of

marketing in India and around the world. In fact, bulk drugs/ API‘s are normally not used in their

basic form, so the demand for basic drugs emanates from formulation industries manufacturing

medicines in various forms. As medicines are highly consumed in all seasons, there are

thousands of companies in India, which are manufacturing tablets, capsules & syrups of the

proposed products. In India, it is highly demanded in the states like Uttarakhand, Gujrat,

Punjab, Haryana, Uttar Pradesh, Andhra Pradesh, Tamilnadu, Maharashtra, West Bengal, etc.

These states are the hub of the Pharmaceuticals markets.

Looking the anticipated demand of healthcare sector in domestic as well as global market and

growing volume of pharmaceuticals industry, the proposed project to manufacture

Pharmaceutical Bulk Drugs and & Drugs Intermediates, have no doubt for the guarantee of the

product and its acceptability in the local and international market. There is huge demand for

Export in countries like Sri Lanka, Iran, Bangladesh, Pakistan, Bhutan, Vietnam, Africa,

This chapter deals with the salient features of the proposed project such as size and

magnitude of the operation, technological consideration, process description, raw material

requirement & handling, project requirements, environmental consideration, project cost,

implementation schedule, likely environmental effects due to the proposed project and

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Nigeria, Singapore, Malaysia, Jordan etc. NAARI is currently present in 29 countries and has

products under approval in 21 countries.

2.3. Project Commissioning Schedule and Project Cost

The project will be implemented in phases. In first phase only 11 products will be

manufactured and capacity will be 0.33 MT/month and in phase II 37 product will be

manufactured and capacity will be 16.13 MT/month. Final capacity of the unit will be 16.46

MT/month. Cost of Estimates of the Greenfield Project is 17500 lakhs (INR). Project work will

be start after getting the environmental clearance.

2.4. Size and Magnitude of Proposed Project

It is a Bulk Drugs and intermediates manufacturing unit having production capacity of 16.46

MT/Month. However the project will be implemented in phases. Phase wise details provided in

Table 2.1. The estimated cost of the project is Rs. 17500 Lacks (Rs. 3500 Lacks for Phase-I

and 14000 Lakhs for Phase–II). The proposed unit will be installed in 5.93 Acres (24000m2) land

which is already in possession of NAARI. The project will be completed in two phases. Phase –I

will take 8-12 month to construct and phase-II will take 24-36 months to construct. About 200

people will be required to construct the project. About 150 people will be required to operate the

project. The associated activities proposed are auxiliary plants like water de-mineralization plant,

steam boiler, cooling water system, diesel generators, wastewater treatment plant, scrubbing

systems, RO plant, etc. to support the process operations. NAARI will manufacture the following

type of products in two phases (Total Capacity is 16.46 MT/Month) details provided in Table

2.2.

Table 2.2 List of Products and It‟s Intermediate with Quantity

S.No.

Product Name CAS number

LD50 Production Capacity in kg/month

Phase-1 Phase-2 Total

API

1 19-Norandrostenedione pure

734-32-7 NA 0 1830 1830

2 Androstadienedione 897-06-3 NA 0 110 110

3 Allylestrenol 432-60-0 LD50:>640 mg/kg

- 110 110

4 Cyproterone Acetate 2098-66-0

>5mg/Kg - 30 30

5 Deflazacort 14484-47-0

5200mg/Kg - 250 250

6 Dienogest 65928-58-7

Oral LD 50(mouse):

4mg/Kg

17 43 60





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7 Dydrogesterone 152-62-5 Oral LD 50(mouse):300mg/Kg

0 40 40

8 Estradiol Benzoate 50-50-0 TDLO (rat): 10 ug/kg

0 100 100

9 Estradiol Cypionate 313-06-4 NA 0 20 20

10 Estradiol Valerate 979-32-8 NA 0 40 40

11 Estriol 50-27-1 Oral LD50 (rat):>2 mg/kg;

3 98 100

12 Estrone 53-16-7 >5000mg/kg

0 210 210

13 Ethinyl Estradiol 57-63-6

1737mg/kg 8 62 70

14 Hydroxy Progesterone Caproate

630-56-8 Not available

17 243 260

15 Levonorgestrel 797-63-7 >4000mg/kg

33 37 70

16 Lynestrenol 52-76-6 Oral LD 50(mouse):300mg/Kg

0 20 20

17 Medroxyprogesterone Acetate

71-58-9 Oral LD50 (rat): >6400; Oral LD50

(mouse): >16 gm/kg;

42 928 970

18 Mifepristone IH/US 84371-65-3

Oral mouse:27m

g/Kg

17 53 70

19 Mifepristone IP/EM 84371-65-3

Oral mouse:27m

g/Kg

125 45 170

20 Nandrolone Decanoate 360-70-3 LD50(Mouse):

>566mg/kg

0 310 310

21 Nandrolone Phenyl Propionate

62-90-8 Not available

0 30 30

22 Norethisterone 68-22-4 LD50(Mouse): 6000 mg/kg

42 778 820

23 Norethisterone Acetate 51-98-9 Not available

25 315 340

24 Norethisterone Enanthate

3836-23-5

Not available

0 80 80

25 Norgestimate 35189- Oral TDLO 6 4 10





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28-7 (rat): 1 mg/kg

26 Ospemifene 128607-22-7

0 30 30

27 Progesterone 57-83-0 Oral LD50 (rabbit):

6,300 mg/kg

0 4920 4920

28 Testosterone Cypionate

58-20-8 LD 50 > 1000 mg/kg

0 370 370

29 Testosterone Enanthate

315-37-7 Oral LD50 (rat): >1 gm/kg

0 170 170

30 Testosterone Propionate

57-85-2 LD 50 > 1000 mg/kg

0 20 20

31 Ulipristal Acetate 126784-99-4

Oral LD 50(mouse):300mg/Kg

0 30 30

Intermediate

32 3,3-dimethypropylenedioxy -4,5-seco-estr-9-ene-5,17-dione (G4)

- - 0 1260 1260

33 Estrenone (Oxide) 3646-28-4

- 0 110 110

34 3-Ethoxyestra-3, 5-(6)-diene-17-one (NET)

2863-88-9

- 0 1390 1390

35 Nandrolone (PET) 434-22-0 - 0 260 260

36 Norandrostenedione Crude

734-32-7 - 0 1260 1260

37 ADD NPG Ketal (Intermediate for Estrone)

13258-43-0

- 0 520 520

TOTAL - - 334 16126 16460

Source: NAARI

2.5. Project Requirements

2.5.1. Land

Present site is located in an industrial land allotted by State Industrial Development corporation

of Uttarakhand (SIDCUL) in Udham Singh Nagar District hence no alternate site considered.

The identified land was alloted by State Industrial Development corporation of Uttarakhand

(SIDCUL) to NAARI pharma. Total land area is 45172.54 m2. Out of the total land about

21172.54 m2 land is under the existing Formulation unit and proposed unit will be installed in

rest of the land area i.e. 5.93 Acres (24000m2) land which is already with NAARI. Out of the total

land plant including construction of manufacturing facility, utility, office and roads will be





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established in 3.93 Acres (15904.5m2) of the land and rest of the area i.e 2.0 Acres (8094 m2)

has been kept for as a greenbelt. Greenbelt Development has been already done by NAARI at

this site. Land allotment letter by State Industrial Development corporation of Uttarakhand

(SIDCUL) is attached as Annexure-I.

As the site is well connected to the NH-87, further the site is located in an industrial area the

entire road network is already well developed. Hence no additional land is required for

construction of approach road. The project will be implemented in Phases and phasewise

General Layout Plan of the unit is enclosed as Figure 2.4. Land area break up is given in Table

2.3

Table 2.3 Land Area Breakup

Sl. No. Description Area (in Acres) Area (in %)

1. Plant Built up area including utility,

office and Road network 3.93 (15904.5 m2) 66.3

2. Greenbelt Area 2.0 (8094 m2) 33.7

Total 5.93 (24000 m2) 100

Source: NAARI

2.5.2. Power/Fuel Requirement

Power: Power will be required to operate the plant. It estimated that about 3000 KVA power

shall be required for the project, which will be sourced from Uttarakhand Power Supply

Corporation.

Fuel: About 5KLD furnace oil shall be require to operate the boilers (1 TPH boile for Phase –I

and 5TPH Boiler for Phase-II).

Emergency Power:

Phase-I: D. G. Set: 500KVA.

Phase-II: 2000 KVA Details provided in Table 2.4

Table 2.4 Fuel/ Power Requirement

S. No.

Details Particulars Phase-I (Unit)

Phase-II (Unit) Remarks

1 D.G. Set

Capacity 500KVA 2000KVA Used as backup during power failure (One standby), Stack height meeting CPCB norms and acoustic enclosure will be provided.

No‘s One One

Diesel 150 LPH* 300 LPH*

Sulphur 0.5% 0.5%

2 Boiler

Capacity 1 TPH 5 TPH Used for Steam generation for Process (one standby), Stack height meeting CPCB norms and acoustic enclosure will be provided.

No‘s One One

Furnace oil 1 KLD 5 KLD

Sulphur 0.5% 0.5%

* as per DG running hours





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2.5.3. Water

2.5.3.1 Source, Requirement and Availability of Water

Total water requirement will be 150 KLD. The project will be implemented in two phases hence

the water required for phase–I is 23 KLD and water requirement for phase-II will be 127 KLD.

Permission for drawl of 150 KLDground water shall be obtained from concerned authority.

Application has been submitted to concerned authority. Water Balance for Phase-I and Phase-

II is provided separately in Table 2.5 & Table 2.6 and Figure 2.1 & Figure 2.2.

Table 2.5 Water Balance for Phase-I

Type /

Source

Total Water

consumption

Quantity

of Waste

Water

Generated

(KLD)

Treatment

Capacity

(KLD)

Treatment

Method

Mode of

Disposal

Quantity of

Treated

Water Used

in

Recycling /

Reuse

(KLD)

Quantity of

Discharged

Water

(KLD)

Utility 10 2

CETP

Combined

Effluent

treatment

Plant

Through

SIDCUL

Common

effluent

Drain

Nil Nil

Process 5 6 Nil Nil

Washing 5 5 Nil Nil

Domestic 3 2 Soak Pit - - Nil Nil

a. Total water Consumption =23 KLD

b. Total Waste Water Generation= 15 KLD

c. Total Discharged Water- Nil

d. Total Reused Water- Nil

Source: NAARI





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Table 2.6 Water Balance for Phase-II

Type / Source

Total Water consumption

Quantity of Waste Water Generated (KLD)

Treatment Capacity (KLD)

Treatment Method

Mode of Disposal

Quantity of Treated Water Used in Recycling / Reuse (KLD)

Quantity of Discharged Water (KLD)

Utility 50 13

ETP 100 KLD

High TDS effluent

proposed to treat in

MEE Low TDS effluent

proposed to treat in ETP & ETP RO.

Pipe /Drain 12 Nil

Process 25 30 Pipe /Drain 24 Nil

Washing

35

35 Pipe /Drain 34 Nil

Domestic

17

16 STP

- Pipe/Drain 15

Nil Proposed to

treat in sewage

treatment plant and reused in Gardening

a. Total water Consumption =127 KLD

b. Total Waste Water Generation= 94 KLD

c. Total Discharged Water- Nil

d. Total Reused Water- 85 KLD

ETP RO reject and MEE condensate quantity not considered in total effluent generation





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Figure 2.1 „: Water Balance for Proposed Project (Phase-I)

Figure 2.2 :water balance for Project (Phase-II)





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Figure 2.3 Water Balance for Proposed Project (Combined)

2.5.4. Man Power Requirement

The employment generation from the proposed unit during construction and operation phase is

described in Table 2.7

Table 2.7 : Employment Generation

Period Phase-I Phase-II Remarks

Constrution Period 80 120 The company will prefer employing local people, who are trained in the job Operation Period 40 110

Source: NAARI

Apart from this there will be significant non estimated employment generation at the supplier

firms and service industry providing services to the company. Company shall be giving

preference to people from economically weaker sections for employment in various semi-

skilled/unskilled jobs there by contributing to their uplift the quality of life.

2.5.5. Raw Material Requirement

Raw materials consist of various chemicals and solvents. All the raw materials required for

manufacturing of proposed products will be sourced from local market. The Phase wise required

raw materials and quantities are provided in Table 2.8 & Table 2.9.





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Table 2.8 : Raw List of Material Required (Phase-I)

S.No

Material Name State Type of

Handling

RM consumpt

ion per kg/month

1 Di Ethyl Ether (Solvent) Liquid Drums 352

2 Magnesium (Critical reactant) Solid Alumium drums 216

3 Ethylene Dibromide (Catalyst) Liquid Drums 22

4 CKT (Critical reactant) Liquid Drums 559

5 THF (Solvent) Liquid Drums 13603

6 SSM (KSM) Solid Bags 472

7 Ammonium Chloride (Reagent) Solid Bags 1731

8 Water (Solvent) Liquid 117939

9 Toluene (Solvent) Liquid Drums 19491

10 Pyridine (Reagent) Liquid Drums 849

11 Chlorine Gas (Critical reactant) Gas Cylinders 227

12 Potassium Hydroxide (Reagent) Solid Bags 717

13 Sodium Sulphite (Reagent) Solid Bags 514

14 Sodium Carbonate (Reagent) Solid Bags 587

15 Methanol (Solvent) Liquid Drums 7545

16 Acetone (Solvent) Liquid Drums 9263

17 Conc. Hydrochloric Acid (Acid) Liquid Jars 470

18 Sodium Hydroxide (Base) Solid Bags 141

19 Potassium Tertiary Butoxide (Critical reactant)

Solid Fibre drums 166

20 IPA (Solvent) Liquid Drums 586

21 Acetic Acid (Weak Acid) Liquid jars 985

22 Ethylene Glycol (Reactant) Liquid Drums 122

23 Triethyl Ortho Formate (Reactant) Liquid Drums 183

24 Cyclohexane (Solvent) Liquid Drums 8016

25 1,2 Diethoxy Ethane (Solvent) Liquid Drums 2668

26 1,4 Dioxane HCl (Solvent) Liquid Drums 63

27 N-Butyl Lithium (Critical reactant) Liquid Glass bottles/Cylinder 146

28 Acetonitrile (olvent/Reactant) Liquid Drums 18

29 Sodium Chloride (Reagent) Solid Bags 842

30 70% Per Chloric Acid (Acid) Liquid Drums 40

31 Activated Carbone (Decolorizing Agent) Solid Bags 99

32 Hyflo (Filtration Acid) Solid Bags 302

33 Propyene Gas (Critical reactant) Gas Cylinders 578

34 Iodine (Catalyst) Solid Glass bottles 1





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35 Ethyl Bromide (Critical reactant) Liquid Drums 238

36 Ethyl Acetate (Solvent) Liquid Drums 6619

37 Dichloro Methane (Solvent) Liquid Drums 21637

38 Hexachloroacetone (Solvent) Liquid Drums 215

39 Hydrogen Peroxide 50% (Oxidising Agent) Liquid Drums 390

40 Sodium Bicarbonate (Weak Base) Solid Bags 807

41 Sodium Thiosulfate (Reagent) Solid Bags 260

42 Di-Isopropyl Ether (Solvent) Liquid Drums 5447

43 N, N-Dimethyl Para Bromo Aniline (Critical reactant)

Solid Drums 438

44 Cuprous Chloride (Reactant) Solid Bags 9

45 Neutral Alumina (Reagent) Solid Fibre drums 693

46 Potassium Hydrogen Sulphate (Reactant) Solid Fibre drums 308

47 Ethanol - 90 % - Thinner E (Solvent) Liquid Drums 584

48 Palladium (Catalyst) Solid Plastic drum 14

49 Phosphoric Acid (Acid) Liquid Jars 37

50 Hexane - Thinner E (Solvent) Liquid Drums 969

51 Ethanol - Dry (Solvent) Liquid Drums 631

52 TriChloroEthylene - TCE (Solvent) Liquid Drums 29

53 ParaToluene Sulphonic Acid- PTSA (Weak Acid)

Solid Fibre drums 14

54 TriEthyl Amine- TEA (Weak Base) Liquid Drums 11

55 Acetylene Gas (Critical reactant) Gas Cylinders 92

56 Acetic Anhydride (Critical reactant) Liquid Drums 2062

57 Zinc Chloride Anhydrous (Reactant) Solid Plastic drum 22

58 Hydrochloric Acid Gas (Acid) Gas Cylinders 2

59 MTE (KSM) Solid Fibre drums 65

60 Lithium Metal (Critical reactant) Solid Alumium drums 3

61 Liquified Ammonia (Solvent) Liquid Cylinders 522

62 Aluminium Isopropoxide (Reactant) Solid Drums 65

63 Cyclohexanone (Solvent) Liquid Drums 131

64 Aluminium Oxide Neutral (Reagent) Soild Fibre drums 11

65 Levo (KSM) Solid Fibre drums 7

66 Tri Ethanolamine (Reagent) Liquid Drums 7

67 Magnesium Chloride Hexa Hydrate (Reagent)

Solid Drums 0

68 Co- Enzyme (Enzyme) Solid Fibre drums 1

69 Enzyme IEP DD3 (Enzyme) Solid Fibre drums 15

70 Glycerol (Reagent) Liquid Drums 44

71 Polypropylene Glycol P 2000 (Reagent) Liquid Drums 3

72 4-Androstenedione (AD ) - Pulverised. Solid Fibre drums 155





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(KSM)

73 n Heptane (Solvent) Liquid Drums 51

74 Neo Pentyl Glycol (Reactant) Solid Bags 27

75 DiPhenyl Methane (Reagent) Solid Drums 16

76 Phenanthrene (Reactant) Solid Drums 6

77 Sulphuric Acid (Acid) Liquid Jars 34

78 Meta Chloro Benzoic Acid (Reagent) Solid Drums 28

79 Sodium Boro Hydride (Reactant) Solid Fibre drums 6

80 Acetone Cyanohydrin (Reactant) Liquid Drums 117

81 Potassium Cyanide (Reagent) Solid Drums 1

82 Imidazole (Reactant) Solid Fibre drums 32

83 DMF (Solvent) Liquid Drums 865

84 Trimethyl Chlorosilane (Reagent) Liquid Drums 44

85 Grignard Reagent (Critical reactant) Liquid Drums 2771

86 N-Caproic Anhydride (Hexonoic Anhydride) (Critical reactant)

Liquid Drums 27

87 N-Methylaniline (Reactant) Liquid Drums 18

88 Formaldehyde 40% (Reagent) Liquid Drums 18

Source: NAARI

Table 2.9 : Raw List of Material Required (Phase-II)

S.No.


Handling

RM Consumpt

ion per kg/month

1 11 HMO (KSM) Solid Fibre Drums 313

2 1-2 Ethanedithiol Liquid Drums 122

3 4-Androstenedione (AD) - Pulverised. (KSM)

Solid Fibre Drums 138

4 Acetic Acid (Weak Acid) Liquid Jars 15298

5 Acetic Anhydride (Critical reactant) Liquid Drums 2799

6 Acetone (Solvent) Liquid Drums 50851

7 Acetonitrile (Solvent) Liquid Drums 1238

8 Acetylene Gas (Critical reactant) Gas Cylinder 394

9 Activated Carbone (Decolorizing Agent) Solid Fibre Drums 266

10 ADD (KSM) Solid Fibre Drums 902

11 ADD NPG Ketal (KSM/inhouse manufactured) Solid Fibre Drums 1046

12 Allyl Bromide Liquid Drums 191

13 Aluminium Oxide Neutral Solid Fibre Drums 599

14 Ammonium Chloride (Reagent) Solid Bags 5422

15 Ascorbic Acid(Vitamin C) Solid Fibre Drums 14





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16 Benzoyl Chloride Liquid Drums 40

17 Benzyl-(2bromoethyl)ether Liquid Drums 3022

18 Bis-Ketal(KSM) Solid Fibre Drums 38

19 Calcuim Chloride Solid Bags 203

20 Chlorine Gas (Critical reactant) Gas Cylinder 2104

21 CKT (Critical reactant) Liquid Drums 11561

22 Co- Enzyme (Enzyme) Solid Fibre Drums 3

23 Cuprous Chloride (Reactant) Solid Bags 8

24 Cyclohexane (Solvent) Liquid Drums 2655

25 Cyclohexanone (Solvent) Liquid Drums 145

26 Cyclopentane propionyl chloride Liquid Drums 234

27 Decanoyl Chloride Liquid Drums 220

28 Delmadinone Acetate (KSM) Solid Fibre Drums 38

29 Di Ethyl Ether (Solvent) Liquid Drums 9767

30 Di-Isopropyl Ether (Solvent) Liquid Drums 827

31 Di-Ketal (KSM) Solid Fibre Drums 80

32 Dimethyl Acetamide Liquid Drums 1785

33 Dimethyl Formamide (DMF) Liquid Drums 81152

34 DiPhenyl Methane (Reagent) Solid Fibre Drums 265

35 DMSO Liquid Drums 375

36 DP-15 Ketal Solid Fibre Drums 139

37 Enamine (KSM) Solid Fibre Drums 7569

38 Enzyme IEP DD3 (Enzyme) Solid Fibre Drums 63

39 Estrone(KSM) Solid Fibre Drums 382

40 Ethanol - 90 % - Thinner E (Solvent) Liquid Drums 67658

41 Ethanol - Dry (Solvent) Liquid Drums 21795

42 Ethyl Acetate (Solvent) Liquid Drums 6098

43 Ethyl Bromide (Critical reactant) Liquid Drums 89

44 Ethylene Dibromide (Catalyst) Liquid Drums 453

45 Glycerol (Reagent) Liquid Drums 182

46 HCl Gas Gas Cylinder 1

47 Heptanoic Anhydride Liquid Drums 344

48 Hexachloroacetone (Solvent) Liquid Drums 946

49 Hexane - Thinner ARS (Solvent) Liquid Drums 28435

50 HP (KSM) Solid Fibre Drums 1569

51 Hydrochloric Acid (Acid) Liquid Jars 3151

52 Hydrochloric Acid Gas (Acid) Gas Cylinder 1

53 Hydrogen Gas Gas Cylinder 59

54 Hydrogen Peroxide 50% (Oxidising Agent) Liquid Drums 296

55 Hyflo (Filtration Acid) Solid Bags 1541





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56 Iodine (Catalyst) Solid Glass Bottles 438

57 IPA (Solvent) Liquid Jars 7350

58 IPE Liquid Drums 375

59 Levo (KSM) Solid Fibre Drums 4

60 Liqufied Ammonia (Solvent) Liquid Cylinder 9490

61 Lithium Metal (Critical reactant) Solid Aluminium Drums 32

62 Magnesium (Critical reactant) Solid Aluminium Drums 4020

63 Meta Chloro Benzoic Acid (Reagent) Solid Drums 1089

64 Methanol (Solvent) Liquid Drums 91681

65 Methylene Chloride (Solvent) Liquid Drums 24918

66 MTE (KSM) Solid Fibre Drums 73

67 n Heptane (Solvent) Liquid Drums 4556

68 N, N-Dimethyl Para Bromo Aniline (Critical reactant)

Liquid Drums 164

69 N-Butyl Lithium (Critical reactant) Liquid Glass Bottles/Cylinder 376

70 N-Caproic Anhydride (Hexonoic Anhydride) (Critical reactant)

Liquid Drums 395

71 N-Methylaniline Liquid Drums 398

72 Neo Pentyl Glycol (Reactant) Solid Bags 902

73 NET (KSM/inhouse manufactured) Solid Fibre Drums 3156

74 N-Pentane Liquid Drums 763

75 Palladium (Catalyst) Solid Plastic Drums 92

76 ParaToluene Sulphonic Acid- PTSA (Weak Acid)


77 P-bromo-dimethyl Aniline Liquid Drums 75

78 Per Chloric Acid 70% (Acid) Liquid Drums 41

79 Phenanthrene (Reactant) Solid Drums 105

80 Phenol Derivative (KSM) 36

81 Phenyl Propionyl Chloride(Reactant) Liquid Drums 18

82 Phosphoric Acid (Acid) Liquid Jars 4266

83 Polypropylene Glycol P 2000 (Reagent) Liquid Drums 14

84 Potassium Acetate Solid Fibre Drums 750

85 Potassium Carbonate Solid Bags 133

86 Potassium Cyanide (Reagent) Solid Drums 0

87 Potassium Hydrogen Sulphate (Reactant) Solid Fibre Drums 156

88 Potassium Hydroxide (Reagent) Solid Bags 14834

89 Potassium Tertiary Butoxide (Critical reactant)


90 Propyene Gas (Critical reactant) Gas Cylinder 216





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91 Pyridine (Reagent/Solvent) Liquid Drums 18087

92 Sodium Bicarbonate (Weak Base) Solid Bags 677

93 Sodium Boro Hydride (Reactant) Solid Fibre Drums 348

94 Sodium Carbonate (Reagent) Solid Bags 9173

95 Sodium Chloride (Reagent) Solid Bags 420

96 Sodium Hydroxide (Base) Solid Bags 462

97 Sodium Metal Solid Metallic Drums 225

98 Sodium Sulphate Anhydrous (Drying Agent) Solid Bags 336

99 Sodium Sulphite (Reagent) Solid Bags 10699

100 Sodium Thiosulfate (Reagent) Solid Bags 97

101 SSM (KSM) Solid Fibre Drums 9311

102 Sulphuric Acid (Acid) Liquid Jars 1306

103 THF (Solvent) Liquid Drums 94948

104 Toluene (Solvent) Liquid Drums 71642

105 Tri Ethanolamine (Reagent) Liquid Drums 0

106 TriChloroEthylene - TCE (Solvent) Liquid Drums 2031

107 TriEthyl Amine- TEA (Weak Base) Liquid Drums 252

108 Triethyl Ortho Formate (Reactant) Liquid Drums 3813

109 Trimethyl Chlorosilane (Reagent) Liquid Drums 0

110 Trimethylsulfoxonium Iodine (TMSI) Solid Fibre Drums 180

111 Triphenyl phosphene Solid Fibre Drums 114

112 Valeric Anhydride Liquid Drums 141

113 XRNG III (KSM) Solid Fibre Drums 63

114 Zinc Chloride Anhydrous (Reactant) Solid Fibre Drums 69

2.5.5.1 Transportation of Raw material and finished product

All the raw materials required for manufacturing of above products will be sourced from local

market and transported through road. Finished product shall also be transported through roads.

2.5.5.2 Storage Facilities

Most of the raw material (liquid and solid) will be stored in drums, fibber drums, glass bottle and bags (refer Table 2.9 & 2.10)

2.5.5.3 Infrastructure facilities required for workers:

Basic facilities like toilets, bathrooms, drinking water taps, common canteen shall be provided to

the construction workers. Drivers will be provided with restroom facility. The facility will be

extended to all type of workers, including the casual workers. The domestic sewage generated

from the labour colony will be disposed in septic tank and soak pits.


Report for proposed New Manufacturing

Unit of Intermediates API and Bulk Drug


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Figure 2.4 : General Layout Plan





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2.6. Process Description and Technology

The manufacturing process of bulk drugs and intermediates consists of chemical synthesis extending to stages of processing involving different type of chemical reactions. The generalized Flow chart for bulk drug manufacturing is shown in Figure 2.3.

Figure 2.5 Generalized Flow Chart for Bulk Drug Manufacturing





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The unit proposes to manufacture all the products as mentioned in Table 2.1, which involves various chemical reaction like, chlorination, dechlorination & Reductive Amination and physical operations like Layer separation, Crystallization, Filtration, drying, packing etc. The manufacturing process is briefly described in this section along with brief process description, chemical reaction and mass balance.

Raw Material Charging: Raw materials are issued from warehouse as per Batch Manufacturing Record issued by Quality Assurance department. These raw materials are carried to the production area, where dedicated reactor is situated for the reaction. Solvents are charged into reactor from drums with vacuum applied in the reactor. Solid raw materials are charged through manhole in the reactor and closed the vessel for the reaction

Reaction: Chemical reaction takes place in the solvent with key raw materials. This reaction takes place in definite physical parameters like temperature, pressure and agitation of the vessel. Reaction is monitored by QC department and the reaction is terminated once the entire starting material is converted into product

Quenching of reaction: Quenching/termination of reaction is done by supply of chilled water or mixing water into the reaction mass. The reaction is also arrested by adding some other solvents in the reaction mass

Layer separation: After termination of the reaction stirring is stopped and settling is done. After settling, layer is separated and solvent with product is transferred to another reactor for workup and crystallization

Crystallization: Solvent with product is distillated under vacuum to reduce the volume around 1/10th of the initial volume. After distillation, chilling is applied in the jacket to reduce the temperature of the reaction mass, 0 ˚C or below to crystallize the product under slow stirring

Filtration: After crystallization, first crop product is filtered in closed Nutsche filter under vacuum. The mother liquor is recycled to second time crystallization to recover the second crop product

Drying: Filtered product is unloaded from the Nutsche filter and loaded in the vacuum tray dryer or rotary vacuum dryer. After drying 12-16 hours Loss of Drying (LOD) is tested in QC laboratory. If the LOD is high, the drying process is further continued till desired LOD limit is achieved.

Packing: When the finished good is released by QC, it is transferred to warehouse for further packing of the material. This packing is done in 3 containment system like primary, secondary and tertiary packing

Dispatch of finished goods: After receiving the sales order from the sales team, material is planned to be dispatched from the site.





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Figure 2.6 Schematic Representation of Process





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EQMS India Pvt. Ltd. 48

2.7. Manufacturing Process of Product

Manufacturing details for Phase-I is provided in following sections, while manufacturing

process with flow diagram and material balance for Phase-II is given in Annexure-II.

2.7.1. Manufacturing Process Dienogest

Synthetic Sequence: SSM G4 DP15 DP15KETAL Dienogest

Brief Process: SSM to G4: Chloro compound was reacted with magnesium metal with catalytic amount of ethylene dibromide in Diethyl ether and THF to afford Grignard reagent. The prepared Grignard reagent was transferred to the solution of SSM in THF at ultra-low temperature to get the intermediate which was oxidised with chlorine in presence of pyridine to get the di-keto compound which was put in aldol condition with KOH to produce wet G4.

Brief process: G4 to DP-15: G4 is deprotected in acidic medium which was further cyclized with non-nucleophilic base to produce DP-15.

Brief process: DP-15 to DP-15 ketal: DP-15 was protected with ethylene glycol in acidic medium in 1,2 diethoxy ethane to produce DP-15 ketal.

Brief Process: DP-15 ketal to Dienogest: DP-15 ketal is reacted with Lithium salt of acetonitrile in THF at ultra-low temperature to produce protected dienogest which was further deprotected with the help perchloric acid in acetic acid to produce Dienogest which

was further purified in solvent to produce pure Dienogest.

Chemical Reaction:

Table 2.10 Mass Balance of Dienogest

Material Balance - SSM to G4

S.No. Raw Material Input in kg Output in kg

1. Di Ethyl Ether 13.46

2. Magnesium 2.66

3. Ethylene Dibromide 0.83

4. CKT 21.37

5. THF(Fresh/Recovered) 142.76

6. SSM(Fresh/Recovered) 18.04





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7. Ammonium Chloride 6.85

8. Water 709.12

9. Toluene 273.17

10. Pyridine 31.92

11. Chlorine Gas 8.66

12. Potassium Hydroxide 27.42

13. Sodium Sulphite 19.66

14. Sodium Carbonate 16.60

15. Methanol 99.93

16. Water in THF Distillation 138.80

1. G4 Dry 26.10

2. Moisture 1.66

3. Ammonium Chloride Layer to ETP 249.84

4. Sodium Sulphite Layer to ETP 180.44

5. Spent (THF +Water) for recovery for disposal

152.68

6. (Methanol +Alkali Layer) Spent for disposal 138.80

7. (Methanol +Water Layer) Spent for disposal 62.46

8. Water Neutral Wash of Toluene to ETP 284.54

9. Toluene Recovered for reuse in process 268.99

10. G4 ML to ETP 162.11

11. Loss During Distillation (Toluene) 3.63

TOTAL 1531.25 1531.25 `

Material Balance - G4 to DP-15

Sr. No. Raw Material Input in kg Output in kg

1. G4 (Dry) 26.10

2. Acetone 87.02

3. Conc. Hydrochloric Acid 5.22

4. Sodium Hydroxide 1.74

5. Toluene (Fresh/Recovered) 523.02

6. Potassium Tertiary Butoxide 2.30

7. IPA 2.30

8. Acetic Acid 2.34

9. Purified Water 775.39

1. Recovered Acetoneas spent for disposal 85.28

2. Recovered Toluene for reuse in process 514.32

3. Loss of Acetone During Distillation

1.71

4. Loss OfToluene During Distillation 8.70

5. Aqueous ML 797.15

6. DP-15 Dry 16.97

7. Loss During DP15 Drying 1.30

Total 1425.43 1425.43

Material Balance – DP-15 to DP-15 KETAL

Sr.No. Raw Material Input in kg Output in kg

1. DP-15 16.97

2. Ethylene Glycol 0.07

3. Triethyl Ortho Formate 1.93





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4. PTSA 0.02

5. Cyclohexane 3.91 6. 1,2 Diethoxy Ethane 121.90

7. 1,4 Dioxane HCl 2.89 8. Sodium Carbonate 6.96

9. Water 523.30

10. Acetone 69.65

1. Recovered Cyclohexaneas spent for disposal 3.48

2. Loss During Distillation 0.43

3. Aqueous ML to ETP 658.89

4. Acetone ML for Distillation 67.04

5. Acetone Loss During Filtration 2.61

6. DP-15 Ketal Dry 14.28

7. Loss During DP15 Ketal Dry 0.87

TOTAL 747.60 747.60

Material Balance – Acetone ML


1. Acetone ML 67.04

2. Distilled Acetoneas spent for disposal 64.86

3. Loss During Acetone Distillation 1.30

4. Residue 0.88

TOTAL 67.04 67.04

Material balance: DP-15 ketal to Dienogest


1. DP-15 Ketal 14.28

2. N-Butyl Lithium 87.50

3. THF (Fresh/Recovered) 353.57

4. Acetonitrile (Soc) 11.07

5. Acetone 771.42

6. Sodium Chloride 28.57

7. Acetic Acid 85.71

8. 70% Per Chloric Acid 24.28

9. Activated Carbone 2.14

10. Hyflo 10.71

11. Water 2728.57

1. Hyflo Wet Cake + Carbon 16.78

2. Acetone ML for Distillation 768.97

3. Aqueous Layer to ETP 2966.00

4. Recovered THF for reuse in process 342.86

5. THF Loss During Distillation 10.71

6. Dry- Wt of Dienogest 10.00

7. Loss During Drying of Dienogest 2.50

Total 4117.82 4117.82






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1. Acetone ML 768.97

2. Distilled Acetone as spent for disposal 694.00

3. Loss During Acetone Distillation 26.00

4. Residue 48.97

TOTAL 768.97 768.97

Process flow diagram:





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2.7.2. Manufacturing Process Estroil

Synthetic sequence:

4-AD ADD ADD NPG Ketal Estrone Stage I

Stage II Stage III Estriol

Brief Process: AD to ADD: 4-AD is selectively reduced with Enzyme IEP DD3 and Co-Enzyme to

produce ADD in Aqueous medium. Which was purified in organic solvent to produce ADD pure.

Brief process: ADD to NPG ketal: ADD is reacted with neopentyl glycol in presence of PTSA and

pyridine in Hexane to produce ADD NPG ketal which was purified in methanol to Produce ADD NPG

ketal.

Brief process: ADD NPG ketal to Estrone: ADD NPG ketal was reacted with Lithium metal in

presence of diphenyl methane and Phenanthrene in THF in reflux condition to produce estrone.

Brief process: Estrone to Stage-I: Estrone is reacted with acetic anhydride in Dichloromethane to

produce Stage I intermediate of estriol which was further purified in acetone to produce Stage I

diacetate intermediate of Estriol.

Brief process: Stage-I to Stage-II: Diacetate intermediate is reacted with m-CPBA in presence of

hexachloroacetone in DCM to produce epoxide intermediate which was triturated with Cyclohexane to

produce Epoxide intermediate.

Brief process: Stage-II to Stage-III: Epoxide intermediate is deprotected with sulfuric acid in THF

and water to produce dihydroxy intermediate which was further purified in methanol to produce

dihydroxy intermediate.

Brief process: Stage-III to Estriol: Dihydroxy intermediate was subjected to reduction with sodium

borohydride in methanol to produce estriol which was further purified in methanol to produce estriol.

Chemical reaction:

Table 2.11 Mass Balance Estroil

MATERIAL BALANCE - 4-AD TO ADD CRUDE

Sr.No. Raw Material Input in kg Output in Kg

1. 4-Androstenedione (Pulverized) 36.13

2. Ethanol (Dry) 75.16

3. Hydrochloric Acid 3.61

4. Triethanolamine 7.94

5. Magnesium Chloride Hexahydrate 0.14





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6. Co-Enzyme 0.77

7. Enzyme IEP DD3 16.62

8. Glycerol 47.69

9. Polypropylene Glycol P 2000 3.61

10. Acetone 1013.98

11. HyfloSupercel 7.21


13. Mother Liquor of ADD Crude Water to ETP 1088.42


15. Waste Proteins as spent for disposal 21.68

16. ADD Crude 33.39

17. Loss During Drying of ADD Crude 4.33

TOTAL 2159.63 2159.63

MATERIAL BALANCE - ADD CRUDE TO ADD PURE

Sr.No Raw Material Input in kg Output in Kg

1. Androstadienedione (ADD) Crude 33.39

2. Ethyl Acetate (Fresh/Recovered) 348.36

3. N-Heptane 55.65

4. Aluminum Oxide Neutral 8.16

5. Activated Carbon 3.25


7. ADD Mother Liquor Heptane for Distillation

96.12

8. Ethyl Acetate Recovered for reuse in process

303.54


10. Spent Carbon-Hyflo 13.73

11. Add Pure Dry Product 28.91

12. Loss During Drying of Add Wet Product

2.89

TOTAL 450.97 450.97

DISTILLATION OF ADD MOTHER LIQUOR

Sr. No. Raw material Input in Kg Output in Kg

1. ADD Mother Liquor Heptane for Distillation

96.12

2. Distilled Heptaneas spent for disposal 86.73

3. Loss During Distillation of Heptane

2.89

4. Residue 6.50

TOTAL 96.12 96.12





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MATERIAL BALANCE - ADD TO ADD NPG KETAL

Sr.No. Raw Material Input in Kg Output in Kg

1. Androstadienedione (ADD) 28.91

2. Thinner (ARS-Hexane) (Fresh/Recovered) 144.57

3. Neo Pentyl Glycol 28.91

4. Pyridine 2.42

5. Para Toluene Sulphonic Acid 3.46

6. Triethyl Amine 2.76

7. Methanol 146.88

8. Water 346.97

9. Distilled Hexane from ADD Ketal for reuse in process 138.78

10. Centrifuge Crude ML (Water) to ETP 277.57

11. Loss of Hexane During Distillation 5.77

12. Centrifuge Purification ML (Methanol- Water) for Distillation

247.97

13. Add NPG Ketal Wet 34.79

TOTAL 704.88 704.88

DISTILLATION OF METHANOL WATER MIXTURE

Sr.No. Raw Material In Put in Kg Output in Kg

1. Centrifuge Purification ML (Methanol- Water)

247.97

1. Distilled Methanolas spent for disposal 138.78

2. Loss of Methanol During Distillation 4.64

3. Water ML to ETP 104.55

TOTAL 247.97 247.97

MATERIAL BALANCE: ADD NPG KETAL TO ESTRONE

Sr. No. Raw Material In Put in Kg Output in Kg

1. ADD NPG Ketal 34.79

2. Lithium 2.08

3. Diphenyl Methane 17.51

4. Phenanthrene 6.94

5. Sulphuric Acid 32.20



8. Toluene 120.75

9. Water 323.86

1. ML(Toluene) for Distillation 115.66

2. ML(THF) to ETP 27.76

3. ML(Water) to ETP 69.40


5. THF Recovered (Reuse) 80.96





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6. THF+ Water (Recovered, Reuse After Distillation from Vendor) 552.88

7. Estrone Dry Weight 13.88

8. Loss During Drying of Wet Estrone 0.80

TOTAL 950.63 950.63

DISTILLATION OF TOLUENE ML:

Sr. No. Raw Material Input in Kg Output in Kg

1. Toluene ML 115.66

2. Distilled Tolueneas spent for disposal 106.41

3. Loss During Distillation 2031

4. Residue 6.94

TOTAL 115.66 115.66

MASS BALANCE OF ESTRONE TO STAGE-I:

MATERIAL BALANCE – STAGE I FORM ESTRONE


1 Estrone 13.88

2 Acetic Acid 41.64

3 Acetic Anhydride 27.76

4 MDC (Fresh/Recovered) 277.66

5 Water 416.49

6 Acetone 138.83

7 Aqueous Layer 485.89

8 Recovered MDC for reuse in process 274.89

9 Loss of MDC during Distillation 2.77

10 Acetone Filtrate ML for Distillation 126.61

11 Loss of Acetone During Filtration 1.11

12 Diacetate Intermediate 24.99

TOTAL 916.26 916.26

DISTILLATION OF ACETONE FILTRATE ML:


1 Acetone Filtrate ML 126.61

1 Distilled Acetoneas spent for disposal 113.83

2 Loss During Distillation of Acetone 4.44

3 Residue 8.32

TOTAL 126.61 126.61

MASS BALANCE OF STAGE-I TO STAGE-II:

MATERIAL BALANCE – STAGE II FROM STAGE 1


1 Diacetate Intermediate 24.99





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2 Meta Chloro Per Benzoic Acid 111.08


4 Hexachloroacetone 83.31

5 Ammonium Chloride 83.31

6 Water 833.14

7 Cyclohexane 222.17

8 Aqueous Layer to ETP 1110.85


10 Loss of MDC During Distillation 2.77

11 Cyclohexane Filtrate ML for Distillation 230.50

13 Epoxide Intermediate 19.44

TOTAL 1913.42 1913.42

DISTILLATION OF CYCLOHEXANE FILTRATE ML:


1 Cyclohexane Filtrate ML 230.50

1 Distilled Cyclohexaneas spent for disposal

219.39

2 Loss during Distillation Cyclohexane 2.77

3 Residue 8.33

TOTAL 230.50 230.50

MASS BALANCE OF STAGE-II TO STAGE-III:

MATERIAL BALANCE – STAGE III FROM STAGE II


1 Epoxide Intermediate 19.44

2 Sulphuric Acid 16.66

3 THF (Fresh/Recovered) 194.43

4 Water 666.62

5 Methanol 138.87


7 Loss of THF During Filtration 5.55

8 Methanol Filtrate ML for Distillation 135.54

9 Loss of Methanol During Filtration 1.11

10 Di-Hydroxy Intermediate Wet 16.11

TOTAL 1036.02 1036.02

DISTILLATION OF METHANOL FILTRATE ML:


1 Methanol Filtrate ML 135.54

1 Distilled Methanolas spent for disposal 122.21

2 Loss During Distillation of Methanol 4.44





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3 Residue 8.88

TOTAL 135.54 135.54

MASS BALANCE OF STAGE-III TO ESTRIOL:

MATERIAL BALANCE – ESTRIOL FROM STAGE III


1 Mono-Hydroxy Intermediate Wet 16.11

2 Sodium Borohydride 25.00

3 Methanol 416.66

4 Water 555.55


6 Carbon 0.83

7 Hyflo 3.88

8 Aqueous Filtrate Layer to ETP 581.66


10 Loss of MDC During Distillation 6.11



13 Waste Hyflo And Carbon 4.72

14 Estriol Dry Product 10.00

TOTAL 1434.70 1434.70

DISTILLATION OF METHANOL FILTRATE ML:


1 Methanol Filtrate ML 416.66

1 Distilled Methanol as spent for disposal

396.11

2 Loss During Distillation of Methanol 3.88

3 Residue 16.66

TOTAL 416.66 416.66






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2.7.3. Manufacturing Process of Ethinyl Estradiol

Synthetic sequence:

4-AD ADD ADD NPG Ketal Estrone Ethinyl Estradiol

Brief Process: AD to ADD: 4-AD is selectively reduced with Enzyme IEP DD3 and Co-Enzyme to produce ADD in Aqueous medium. which was purified in organic solvent to produce ADD pure.

Brief process: ADD to NPG ketal: ADD is reacted with neopentyl glycol in presence of PTSA and pyridine in Hexane to produce ADD NPG ketal which was purified in methanol to Produce ADD NPG ketal.

Brief process: ADD NPG ketal to Estrone: ADD NPG ketal was reacted with Lithium metal in presence of diphenyl methane and Phenanthrene in THF in reflux condition to produce estrone.





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Brief process: Estrone to Ethinyl Estradiol: Estrone is reacted in with potassium salt of acetylene in THF at low temperature to produce ethinyl estradiol which was purified in Toluene and followed by IPA to produce ethinyl estradiol.

Chemical reaction:

Table 2.12 Mass Balance of Ethinyl Estradiol

MATERIAL BALANCE - 4-AD TO ADD CRUDE

Sr.No. Raw Material Input in kg Output in Kg

18. 4-Androstenedione (Pulverised) 28.90



21. Triethanolamine 6.35

22. Magnesium Chloride Hexahydrate 0.11

23. Co-Enzyme 0.57

24. Enzyme IEP DD3 13.29

25. Glycerol 38.15

26. Polypropylene Glycol P 2000 2.89

27. Acetone 811.12



30. Mother Liquor of Add Crude Water to ETP 870.67


32. Waste Proteinsas spent for disposal 17.34

33. ADD Crude 26.71

34. Loss During Drying of ADD Crude 3.46

TOTAL 1727.53 1727.53

MATERIAL BALANCE - ADD CRUDE TO ADD PURE

Sr.No Raw Material Input in kg Output in Kg

13. Androstadienedione (ADD) Crude 26.71

14. Ethyl Acetate (Fresh/Recovered) 278.71

15. N-Heptane 44.52





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16. Aluminium Oxide Neutral 6.53



19. Add Mother Liquor Heptane for Distillation 76.90

20. Ethyl Acetate Recovered for reuse in process 242.86


22. Spent Carbon-Hyflo 10.98

23. Add Pure Dry Product 23.13

24. Loss During Drying of Add Wet Product 2.31

TOTAL 360.8 360.8

DISTILLATION OF ADD MOTHER LIQUOR


5. ADD Mother Liquor Heptane 76.90

6. Distilled Heptane as spent for disposal

69.39

7. Loss During Distillation of Heptane

2.31

8. Residue 5.20

TOTAL 76.90 76.90

MATERIAL BALANCE - ADD TO ADD NPG KETAL


14. Androstadienedione (ADD) 23.13

15. Thinner (ARS-Hexane) (Fresh/Recovered) 115.69

16. Neo Pentyl Glycol 23.13

17. Pyridine 1.94



20. Methanol 117.54

21. Water 277.54

22. Distilled Hexane from Add Ketal for reuse in process 111.06

23. Centrifuge Crude ML (Water) to ETP 222.11

24. Loss of Hexane During Distillation 4.62

25. Centrifuge Purification ML (Methanol- Water) for Distillation

198.43

26. ADD NPG Ketal Wet 27.84

TOTAL 564.06 564.06

DISTILLATION OF METHANOL WATER MIXTURE

Sr.No. Raw Material In Put in Kg Output in Kg

2. Centrifuge Purification ML (Methanol- Water)

198.43

2 Distilled Methanol as spent for disposal 111.06





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3 Loss of Methanol During Distillation 3.70

4 Water ML To ETP 83.66

TOTAL 198.43 198.43

MATERIAL BALANCE: ADD NPG KETAL TO ESTRONE

Sr. No. Raw Material In Put in Kg Output in Kg

10. ADD NPG Ketal 27.84

11. Lithium 1.66

12. Diphenyl Methane 14.01

13. Phenanthrene 5.55

14. Sulphuric Acid 25.77


16. THF(Fresh/Recovered) 319.04

17. Toluene 96.65

18. Water 259.23

9. ML(Toluene) for Distillation 92.58

10. ML(THF) to ETP 22.22

11. ML(Water) to ETP 55.55


13. THF Recovered (Reuse) 64.80

14. THF+ Water (Recovered, Reuse After Distillation From Vendor) 442.54

15. Estrone Dry Wt. 11.11

16. Loss During Drying of Wet Estrone 0.64

TOTAL 760.89 760.89



5. Toluene ML 92.58

6. Distilled Toluene as spent for disposal 85.17


8. Residue 5.55

TOTAL 92.58 92.58

MATERIAL BALANCE – ESTRONE TO ETHINYL ESTRADIOL

S. No. Raw Material Input in kg Output in kg

1. Estrone 11.11

2. Tetrahydrofuran 166.66

3. Potassium-Tert-Butoxide 12.22

4. Acetylene Gas 11.11

5. Con. HCL 11.11







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8. IPA 188.88

9. Hyflo 1.66

10. Carbon 0.55

1. Recovered (THFand Water Mixture) as spent for disposal 155.50

2. Loss of THF During Distillation 1.66

3. Water Mother Liquor to ETP 240.00


5. Loss of Toluene During Distillation 6.66

6. Toluene Filtrate ML for Distillation 166.61

7. Recovered IPA as spent for disposal 151.11

8. Loss of IPA During Distillation 4.44

9. IPA Filtrate ML for Distillation 33.33

10. Loss of IPA During Filtration 11.11

11. Waste Hyflo And Carbon 2.22

12. Ethinyl Estradiol Dry Weight 10.00

13. Loss During Drying of Ethinyl Estradiol Wet Product 3.33

TOTAL 1117.13 1117.13



1. Toluene ML 166.66

2. Distilled Toluene as spent for disposal 150.00


4. Residue 11.11

TOTAL 166.66 166.66

DISTILLATION OF IPA FILTRATE ML:


1. IPA Filtrate ML 33.33

2. Distilled IPA as spent for disposal 30.00

3. Loss During IPA Distillation 1.33

4. Residue 2.00

TOTAL 33.33 33.33





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Process Flow Diagram:





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2.7.4. Manufacturing Process (AD to HPC )

Synthetic sequence:

AD Step1 Step2 Step3 HP HPC

Brief process: AD to Step-1: AD istreated with cyanohydrin in basic medium to produce

step 1 intermediate.

Brief process: Step-1 to step-2: Step-1 was reacted with orthoester with PTSA to produce

step-2 intermediate.

Brief process: Step-2 to step-3: The step 2 intermediate treated with TMSCl to give

protected TMS intermediate step 3.

Brief process: Step-2 to step-3: The TMS intermediate step-3 treated with Grignard

reagent (methyl magnesium bromide) and acetic anhydride toproduce HP.

Brief process: HP to HPC: HP is reacted with hexanoic anhydride Oxide is reacted with

potassium salt of acetylene in THF to produce Lynestrenol crude which is purified in acetone

and subsequently in methanol to produce Lynestrenol pure.

Chemical reaction:

Table 2.13 Mass balance of DP-15 Ketal to Dienogest:

Material Balance - AD to Step-1


1. AD 15.98

2. Acetone Cyanohydrin 15.38

3. Potassium Cyanide 0.19

4. Water 33.97

5. Methanol 63.95

1. Step -1 Dry Weight 13.99

2. Loss During Step-1 Drying 3.56

3. Mother Liquor to ETP 111.92

TOTAL 129.47 129.47

Material Balance –Step-1 to Step-2:





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1. Step-1 Dry Weight 13.99

2. PTSA 0.27

3. MDC (Fresh/Recovered) 167.88

4. Ethylene Glycol 13.99

5. Trimethyl Ortho Formate 6.99


7. Methanol 55.96

1. Step-2 Dry Product 13.99

2. Loss During Drying 2.03

3. Recovered MDC for reuse in process 161.88

4. Loss During MDC Distillation 2.03

5. Mother Liquor with Methanol for Distillation 79.94

TOTAL 259.87 259.87

Material Balance – ML from Step-2


1. Mother Liquor with Methanol 79.94


3. Loss During Methanol Distillation 1.99

4. Residue 25.99

TOTAL 79.94 79.94

Material Balance –Step-2 to Step-3:


1. Step-2 Dry Weight 13.99

2. Imidazole 4.19

3. DMF 19.79

4. Trimethyl Chlorosilane 5.71


6. Water 28.04

1. Step-3 (Product in Toluene, Liquid) 62

2. Water Layer to ETP 57.71

TOTAL 119.71 119.71

Material Balance –Step-3 to HP:


1. Step-3 (Product inToluene, Liquid) 62.00

2. Grignard Reagent (Methyl Magnesium Bromide in Ether)

364.00

3. Acetic Anhydride 256.00

4. Water 392.00

5. Methanol 56.00

1. HP Dry Product 10.00

2. Loss During HP Drying 2.00


4. Recovered Etheras spent for disposal 250.00

5. Aqueous ML To ETP 748.00

6. Methanol ML for Distillation 76.00





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TOTAL 1130.00 1130.00

Material Balance – ML from HP


1. Mother Liquor with Methanol 76.00


2. Loss During Methanol Distillation 1.99

3. Residue 24.12

TOTAL 76.00 76.00

Material Balance - HP TO HPC (17α-HYDROXY PROGESTERONE CAPROATE)


1. 17α-Hydroxy Progesterone(HP) 10.00


3. N-Caproic Anhydride (Hexonoic Anhydride) 16.24

4. Methylene Chloride (Fresh/Recovered) 237.60

5. Methanol (Fresh/Recovered) 110.60

6. Iso Propyl Alcohol 31.20

7. Thinner (Ars-Hexane) 72.60

8. Activated Carbon (Acidic) 4.00

9. Hyflo Supercel 0.50


11. Sodium Hydroxide Flakes 9.00

12. Water 245.00

1. HPC Mother Liquor(Hexane) for Distillation 46.10

2. Methanol Recovered from HPCfor reuse in process

108.90

3. Methanol Loss During Distillation 1.70

4. Methylene Chloride Recovered (From HPC) for reuse in process

234.00

5. Methylene Chloride Loss During Distillation 3.60

6. Hexanes Recovered From HPC 26.40

7. Hexane Loss During Distillation 1.10

8. HPC Product Dry 10

9. Loss During Drying of Wet HPC Product 1.50

10. Spent Carbon &Hyflo 4.60


12. HPC Mother Liquor In IPA+ Methanol for Distillation

37.20

TOTAL 7496 7496

Material Balance -HPC ML (Hexane)





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1. HPC Mother Liquor(Hexane) 46.10

1. Distilled Hexaneas spent for disposal 45.29

2. Hexane Loss During Distillation 0.59

3. Recovered HPC 0.21

TOTAL 46.10 46.10

Material Balance -HPC ML (IPA+ Methanol)


1. HPC Mother Liquor (IPA+ Methanol) 37.2

1. Distilled Solvent 31.19

2. Solvent Loss During Distillation 1.61

3. Residue 4.40

TOTAL 37.2 37.2






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2.7.5. Brief Process: Levonorgestrel

Synthetic Sequence:

MTE MDE18 - methyl Levonorgestrel

Brief Process: MTE to MDE:

MTE was reduced with the help of lithium metal and liquid ammonia to produce crude MDE

which was purified in IPA to produce MDE.

Brief Process: MDE to 18- Methyl:

MDE was oxidized with aluminium isopropoxide in cyclohexane with cyclohexanone to

produce crude 18-methyl which was purified in protic solvent to produce pure 18-methyl.

Brief Process: 18- Methyl to Levonorgestrel

18-Methyl is reacted with potassium salt of acetylene in THF to produce protected

Levonorgestrel which was deprotected with the help of HCl to produce crude Levonorgestrel,

which was purified in acetone and subsequent purification with methanol produced pure

Levonorgestrel

Chemical Reaction:

Table 2.14 Mass Balance of Levonorgestrel

MASS BALANCE OF MTE TO MDE:

Sr. No.

Raw Material Input in Kg Output in Kg

1 MTE 19.59

2 THF 293.85

3 Lithium Metal 0.24

4 Liqufied Ammonia 156.72

5 Water 587.70

6 IPA 97.95


8 Recovered THF + IPA as spent for disposal

383.96

9 Loss of Solvent During Distillation 7.83

10 Liquid Ammonia as Spent For Disposal

656.00





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11 Aqueous Filtrate ML 117.81

12 Loss During Filtration 10.77

13 MDE Wet 19.59

14 TOTAL 1195.96 1195.96

MASS BALANCE OF MDE TO 18-METHYL:


1 MDE Wet 19.59


3 Aluminium Isopropoxide 19.59

4 Water 587.99

5 Cyclohexanone 39.19

6 Sodium Hydroxide 19.59

7 Methanol 195.99

8 Recovered Cyclohexane as spent for disposal

372.39

9 Loss During Distillation 19.57

10 Aqueous Filtrate ML to ETP 672.28



13 18-Methyl Dry 13.72

14 Loss During Drying Of 18-Methyl 5.87

15 TOTAL 1273.93 1273.93

MATERIAL BALANCE -METHANOL FILTRATE ML


1. Methanol Filtrate ML 186.19



4. Residue 12.73

TOTAL 186.19 186.19

MATERIAL BALANCE - 18-METHYL TO LEVONORGESTERL


1. Methoxydienone (18-Methyl) 13.72


3. Acetone 659.80

4. Methanol 725.49


6. Potassium Tert Butoxide 16.47



9. Aluminium Oxide Neutral 0.98





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12. Water 2260.78

1. Mother Liquor of Levonorgestrel(MeOH) for Distillation

68.62

2. Mother Liquor of Levonorgestrel(Acetone) for Distillation

88.23

3. Mother Liquor of Levonorgestrel(THF-Water) for THF recovery

406.84

4. Aqueous Layer for ETP (Layer Water Wash) 1705.85

5. Mother Liquor Water (Wet Cake Neutral Wash) to ETP

588.23

6. Recovered Acetoneas spent for disposal 558.82

7. Acetone Loss During Distillation 9.80

8. Spent Hyflow, Alumina & Carbon 4.90

9. Recovered Methanolas spent for disposal 647.05



12. MDC Loss During Distillation 5.88

13. Levonorgestrel Dry 10

14. Loss During Drying of Levonorgestrel Wet 1.76

TOTAL 4463.49 4463.49

MATERIAL BALANCE - LEVO ML


1. Levo Mother Liquor (MeOH and Acetone Layer) 156.85

2. Distilled Solvent for Washing 151.95

3. Solvent Loss During Distillation 2.94

4. Recovered Levo 1.96

TOTAL 156.85 156.85





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2.7.6. Brief process: MPA from AD

Synthetic Sequence:

AD Step1 Step2 Step3 HP

HPA MPA I MPA

Brief Process: AD to Step-1

AD istreated with cyanohydrin in basic medium to produce step 1 intermediate

Brief Process: Step-1 to Step-2





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Step-1 was reacted with orthoester with PTSA to produce step-2 intermediate.

Brief Process: Step-2 to Step-3

The step 2 intermediate treated with TMSClto give protected TMS intermediate step 3.

Brief Process: Step-3 to Step-3 HP

The TMS intermediate step-3 treated with Grignard reagent (methyl magnesium bromide)

and acetic anhydride toproduce HP.

Brief Process: HP to HPA

17 α hydroxyprogesterone is reacted with acetic anhydride in presence of acetic acid to

produce HPA.

Brief Process: HPA to MPA I

HPA is reacted with Triethyl orthoformate in presence of PTSA in ethanol to produce

protected intermediate which was further reacted with N- methyl aniline with formaldehyde to

produce MPA-I.

Brief Process: MPA I to MPA

MPA was reduced in presence of palladium carbon in cyclohexene and finally deprotected to

produce MPA which was further purified in protic solvent to produce pure Medroxy

progesterone acetate.

Chemical Reaction:

Table 2.15 Material Balance –AD to MPA

Material Balance - AD to Step-1


1 AD 22.82

2 Acetone Cyanohydrin 21.96

3 Potassium cyanide 0.28

4 Water 48.49

5 Methanol 91.29

6 Step -1 dry weight 19.97

7 Loss during Step-1 drying 5.11





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8 Mother Liquor to ETP 159.76

TOTAL 184.84 184.84

Material Balance – Step-1 to Step-2:


1 Step-1 dry weight 19.97

2 PTSA 0.39


4 Ethylene Glycol 19.97

5 Trimethyl ortho formate 9.98

6 Triethyl amine 1.14

7 Methanol 79.88

8 Step-2 dry product 19.97

9 Loss during drying 2.90


11 Loss during MDC distillation 2.90

12 Mother liquor with methanol for Distillation 114.11

TOTAL 370.97 370.97

Material Balance – ML from Step-2


1 Mother liquor with methanol 114.11


3 Loss during Methanol distillation 2.86

4 Residue 37.08

TOTAL 114.11 114.11

Material Balance – Step-2 to Step-3:


1 Step-2 dry weight 19.97

2 Imidazole 5.99

3 DMF 28.25

4 Trimethyl chlorosilane 8.16

5 Toluene (Fresh/Recovered) 68.49

6 Water 39.95

7 Step-3 (Product in Toluene, Liquid) 88.47

8 Water layer to ETP 82.34

TOTAL 170.81 170.81

Material Balance – Step-3 toHP:


1 Step-3 (Product in Toluene, Liquid) 88.47

2 Grignard reagent (Methyl magnesium bromide in Ether)

519.42

3 Acetic anhydride 365.31

4 Water 559.38

5 Methanol 79.91

6 HP dry product 14.27

7 Loss during HP drying 2.85





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8 Recovered Toluene for reuse in process 62.78

9 Recovered Etheras spent for disposal 356.75

10 Aqueous ML to ETP 1067.39

11 Methanol ML for Distillation 108.45

TOTAL 1612.49 1612.49

Material Balance – ML from HP


1 Mother liquor with methanol 108.45


3 Loss during Methanol distillation 2.85

4 Residue 34.26

TOTAL 108.45 108.45

Material Balance of HP to HPA:

Sr.No. Raw material Input in Kg Output in Kg

1 17 Α Hydroxyprogesterone 14.27

2 Acetic Anhydride 21.42

3 Acetic Acid 142.79

4 HCL 4.99

5 Zinc Chloride Anhydrous 3.56

6 DCM (Fresh/Recovered) 285.59

7 Acetone 114.23

8 Water 356.99


10 Loss During Filtration 2.80

11 Recovered MDC for Reuse in Process

282.74



14 Output Wet 21.42

TOTAL 943.84 943.84

Distillation of acetone filtrate ML



2 Distilled Acetone as spent for disposal

108.52


4 Residue 1.72

TOTAL 111.38 111.38

Material balance of HPA to MPA I:


1 HPA 21.42

2 THF 99.95

3 Triethyl Orthoformate 9.71

4 Ethanol (Fresh/Recovered) 99.95

5 P-TSA 0.28

6 N-Methylaniline 4.28

7 Formaldehyde 40% 4.28





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8 HCL 28.55

9 Water 285.59

12 Ethanol Filtrate ML for Distillation 115.66

13 Loss of Ethanol Filtrate ML 1.39

14 THF and Water Filtrate ML to ETP 415.54

15 MPA I 21.42

TOTAL 554.01 554.01

Distillation of Ethanol filtrate ML


1 Ethanol Filtrate ML 115.66

2 Distilled Ethanol for reuse in process

94.24


4 Residue 19.99

TOTAL 115.66 115.66

Mass balance of MPA I to MPA:

Material balance of MPA I to MPA:


1 MPA I 21.42

2 DMF 171.42

3 Cyclohexene 2.14

4 Pd/C 2.85

5 HCL 2.14

6 Sodium Bicarbonate 2.14

7 Water 535.71

8 Aqueous ML To ETP 722

9 MPA Dry Product 10

10 Loss During Drying 2.82

11 Spent PdCarbon 3

TOTAL 737.82 737.82






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2.7.7. Brief process: Mifepristone IH

Synthetic sequence:

SSM G4 D15 DP-15KETAL XRNG 1

XRNG II XRNG III Mifepristone IH

Brief Process: SSM to G4

Chloro compound was reacted with magnesium metal with catalytic amount of ethylene

dibromide in Diethyl ether and THF to afford Grignard reagent.

The prepared Grignard reagent was transferred to the solution of SSM in THF at ultra-low

temperature to get the intermediate which was oxidised with chlorine in presence of pyridine

to get the di-keto compound which was put in aldol condition with KOH to produce wet G4.

Brief process: G4 to DP-15

G4 is deprotected in acidic medium which was further cyclized with non-nucleophilic base to

produce DP-15.

Brief process: DP-15 to DP-15 ketal

DP-15 was protected with ethylene glycol in acidic medium in 1,2 diethoxy ethane to

produce DP-15 ketal.

Brief Process: DP-15 ketal to XRNG I

DP-15 ketal is reacted with propyne magnesium chloride in THF to produce XRNG I which

was triturated with cyclohexane to produce XRNG I.

Brief process: XRNG I to XRNG II

XRNGI is reacted with epoxidation reagent to produce XRNG II which was triturated with Di

Isopropyl ether to produce XRNG II.

Brief process: XRNG II to XRNG III

The Grignard reagent of N, N dimethyl para bromo aniline was reacted with XRNG II in

presence of cuprous chloride to give crude XRNG III which was further purified in ethyl

acetate to produce XRNG III.

Brief process: XRNG III to Mifepristone IH

The XRNG III intermediate was deprotected in acidic medium to produce Mifepristone crude

which was purified in aprotic solvent to produce Mifepristone IH.





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Chemical Reaction:

Table 2.16 Mass Balance

Material Balance - SSM to G4



2. Magnesium 3.80


4. CKT 30.53

5. THF (Fresh/ Recovered) 203.91

6. SSM 25.77


8. Water 1012.85

9. Toluene(Fresh/ Recovered) 390.17

10. Pyridine 45.59





15. Methanol 142.74


1. G4 WET 37.27

2. Moisture 2.38



5. Spent THF +Water for recovery 218.07

6. (Methanol +Alkali Layer) Spent for disposal

198.25

7. (Methanol +Water Layer) Spent for disposal

89.21


9. Toluene Recovered 384.20

10. G4 ML to ETP 231.55






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TOTAL 2187.16 2187.16

Material Balance - G4 to DP-15


1 G4 (Dry) 37.27

2 Acetone 124.25

3 Conc. Hydrochloric Acid 7.45

4 Sodium Hydroxide 2.48

5 Toluene (Fresh/ Recovered) 746.78

6 Potassium Tertiary Butoxide 3.29

7 IPA 3.29

8 Acetic Acid 3.35

9 Purified Water 1107.12

10 Recovered Acetone as spent for disposal 121.77

11 Recovered Toluene for reuse in process 734.35

12 Loss of Acetone During Distillation 2.48

13 Loss of Toluene During Distillation 12.42


15 DP-15 Dry 24.23

16 Loss During DP15 Drying 1.85

Total 2035.28 2035.28

Material Balance – DP-15 to DP-15 KETAL


1 DP-15 24.23

2 Ethylene Glycol 1.03

3 Triethyl Orthoformate 2.76

4 PTSA 0.03

5 Cyclohexane 5.59

6 1,2 Diethoxy Ethane 173.97

7 1,4 Dioxane HCl 4.13

8 Sodium Carbonate 9.94

9 Water 746.85

10 Acetone 99.41

11 Recovered Cyclohexane as spent for disposal 4.97



14 Acetone ML for Distillation 95.68

15 Acetone Loss During Filtration 3.72

16 DP-15 Ketal Dry 20.38

17 Loss During DP15 Ketal Dry 1.24

TOTAL 1067.94 1067.94



1 Acetone ML 95.68

2 Distilled Acetone as spent for disposal 92.57

3 Loss during acetone distillation 1.87

4 Residue 1.24





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5 TOTAL 95.68 95.68

Material Balance – DP-15 ketal to XRNG I


1 DP-15 Ketal 20.38

2 Magnesium 5.55

3 Propyne Gas 40.77

4 Iodine 0.05

5 Ethyl Bromide 16.82

6 THF 203.88


8 Purified Water 367

9 Ethyl Acetate 152.91

10 Sodium Chloride 20.38


12 XRNG I 18.35

13 Ammonium Chloride Layer to ETP 356.80

14 Sodium Chloride Layer to ETP 122.33

15 Recovered (Ethyl Acetate + THF) as spent for disposal

351.70


17 Cyclohexane ML for Distillation 97.86

TOTAL 951.09 951.09


Cyclohexane ML 97.86

1 Distilled Cyclohexane as spent for disposal

91.74

2 Loss during Cyclohexane Distillation 3.06

3 Residue 3.06

TOTAL 97.86 97.86

Material Balance – XRNG I to XRNG II


1 XRNG I 18.35

2 Dichloromethane(Fresh/ Recovered) 356.86

3 Pyridine 0.40

4 Hexachloroacetone 13.71

5 Hydrogen Peroxide (50%) 27.52


7 Sodium Thiosulfate 18.35


9 Di-Isopropyl Ether 155.99

10 Sodium Bicarbonate Layer 815.68

11 Sodium Thiosulfate Layer 180.47

12 Recovered Dichloromethane 351.76


14 Di-Isopropyl Ether ML for Distillation 163.13

15 XRNG II Wet 18.20

Total 1534.31 1534.31





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Distillation of Di-isopropyl ether ML


1 Di-Isopropyl Ether ML 163.13

2 Distilled Di- isopropyl ether as spent for disposal

155.15

3 Loss during Di-Isopropyl Distillation

3.99

4 Residue 3.99

TOTAL 163.13 163.13

Material Balance – XRNG II to XRNG III


1 XRNG II 18.20

2 Magnesium Turning 4.80

3 N, N-Dimethyl Para Bromo Aniline 30.90

4 Cuprous Chloride 0.653

5 THF 254.99

6 Iodine 0.0005



9 Di Isopropyl Ether 228.48


11 Neutral Alumina 48.95

12 Activated Carbon 4.07

13 Dichloromethane(Fresh/ Recovered) 326.39


15 Hyflo 12.23

16 XRNG III 14.28

17 Ammonium Chloride Layer with THF to ETP

520.19

18 Sodium Chloride Aqueous Layer to ETP

189.71

19 Recovered Dichloromethane for reuse in process

319.25


21 Di-Isopropyl Ether ML for Distillation 230.51

22 Ethyl Acetate ML + Washing for Distillation

165.23

23 Waste Hyflo And Carbon 65.58

Total 1511.86 1511.86

Distillation of Di-isopropyl ether ML


1 Di-Isopropyl Ether ML 230.51

2 Distilled Di- isopropyl ether as spent for disposal

218.27





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3 Loss during Di-Isopropyl Distillation 4.07

4 Residue 8.17

TOTAL 230.51 230.51

Distillation of Ethyl Acettae ML


1 Ethyl acetate ML 165.23

2 Distilled Ethyl Acetate as spent for disposal

157.07

3 Loss during Ethyl acetate Distillation 4.08

4 Residue 4.08

TOTAL 165.23 165.23

Material Balance – XRNG III to Mifepristone IH


1 XRNG III 14.28

2 Potassium Hydrogen Sulphate 21.75


4 Dichloromethane (Fresh/Recovered) 501.02



7 Activated Carbon 1.42



10 Hyflo 6.12

11 Mifepristone Dry Product 10

12 Loss During Drying of Mifepristone Wet Product

2.04

13 Aqueous Layer 462.24

14 Recovered Dichloromethane for reuse in process

495.91

15 Sodium Bicarbonate Layer to ETP 147.95


17 Sodium Chloride Layer to ETP 81.63

18 Hyflo+ Activated Carbon 7.44

19 Ethyl Acetate + Cyclohexane ML for Distillation

505.10

Total 1717.42 1717.42

Distillation of Ethyl Acetate + Cyclohexane ML


1 Ethyl acetate + Cyclohexane ML 505.10

2 Distilled Ethyl Acetate+ Cyclohexaneas spent for disposal

479.58

3 Loss during Ethyl Acetate + Cyclohexane Distillation

5.10

4 Residue 20.42

TOTAL 505.10 505.10





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2.7.8. Brief Process: NETP

Synthetic Sequence:

SSM G4 NAD (Crude) NAD(IH) NE NETP

Brief Process: SSM to G4





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Chloro compound was reacted with magnesium metal with catalytic amount of ethylene

dibromide in Diethyl ether and THF to afford Grignard reagent.

The prepared Grignard reagent was transferred to the solution of SSM in THF at ultra-low

temperature to get the intermediate which was oxidised with chlorine in presence of pyridine

to get the di-keto compound which was put in aldol condition with KOH to produce G4.

Brief process: G4 to NAD (Crude)

Wet G4 is hydrogenated in presence of pyridine with 5% palladium carbon to afford

hydrogenated intermediate which was subsequently cyclized in presence of phosphoric acid

to afford crude 19- Norandrostenedione.

Brief process: NAD (Crude) to NAD (IH)

NAD (crude) is purified in methanol hexane to produce NAD(IH)

Brief Process: NAD (IH) to NET

NAD(IH) is reacted with PTSA in presence of ethanol and triethyl orthoformate at lower

temperature to produce NET after adjusting the pH to neutral.

Brief process: NET to NETP

NET is reacted with potassium salt of acetylene in THF at low temperature to produce

protected Norethisterone which is deprotected with HCl to produce Norethisterone, which is

purified in acetone to produce Norethisterone

Chemical reaction:

Table 2.17 Mass Balance of Estradiol Hemihydrate to Estradiol Cypionate:

MATERIAL BALANCE - SSM TO G4



2. Magnesium 2.72





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4. CKT 21.82


6. SSM 18.42


8. Water 723.94

9. Toluene(Fresh/Recovered) 278.87

10. Pyridine 32.59





15. Methanol 102.02


1. G4 WET 28.34



4. Spent THF +Water for recovery 155.77

5. (Methanol +Alkali Layer) Spent for disposal 141.7

6. (Methanol +Water Layer) Spent for disposal 63.76


8. Toluene Recovered 274.61

9. G4 ML 165.50


Total 1563.25 1563.25 MATERIAL BALANCE - G4 TO NAD CRUDE


1. G4 (WET) 28.34

2. Thinner E(Fresh/Recovered) 140.24

3. Pyridine 1.40

4. PDC Wet(Fresh/Recovered) 0.48

5. Phosphoric Acid 8.84

6. Water in Process 252.53

7. Water for Wet Cake Neutral Wash 283.42

8. Water Slurry for Wet Cake 226.74

1. Wet NAD Crude 19.84

2. ML+ Washing to ETP

766.67

3. Distilled Thinner E for reuse in-process 152.90


5. PD/C Wet for Recovery

0.46

Total 941.99 941.99

MATERIAL BALANCE - NAD CRUDE TO NAD (IH)


1. NAD Crude Wet 19.84

2. Hexane(Fresh/Recovered) 58.81

3. Methanol 15.02





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1. NAD (IH) Dry 14.74

2. Loss During Drying of NAD Wet Product 1.41

3. ML for Distillation 77.52

Total 93.67 93.67

MATERIAL BALANCE – ML FOR DISTILLATION


1. ML for Distillation 77.52

2. Distilled Solvent for disposal 70.43


4. Residue 5.52

Total 77.52 77.52

MATERIAL BALANCE – NAD(IH) TO NET


1. 19-Norandrostenedione 14.74


3. Triethyl Orthoformate 11.23

4. Trichloro Ethylene 6.91



7. NET Mother Liquor for Distillation 55.14

8. NET Dry Product 12.05

9. Loss During Drying of NET Wet Product 1.39

TOTAL 68.58 68.58

MATERIAL BALANCE –ML FOR DISTILLATION


1 NET Mother Liquor 55.14

2 Distilled Solvent 48.76


4 NAD 2nd Crop Dry Product 3.27

5 Loss During Drying 0.99

TOTAL 55.14 55.14

MATERIAL BALANCE - NET TO NETP (NORETHISTERONE)


1. NET 12.05


3. Acetone(Fresh/Recovered) 190.54

4. Potassium Tart Butoxide 12.05






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7. Sodium Hydroxide Flakes 2.41


9. Hyflo Supercell 0.74

10. Water 865.49

11. Mother Liquor (Acetone for Distillation) 21.96

12. Acetone Recovered from Norethisterone (for reuse in process)

176.82

13. Acetone Loss in The Distillation 3.70

14. Waste Carbon/ Hyflo 1.48

15. Mother Liquor THF-Water Waste (Crude) for THF recovery to outside Vendor

390.53

16. Mother Liquor Water To ETP 639.05

17. NETP Dry Product 10.00

18. Loss During Drying of NETP Product 0.94

TOTAL 1244.3 1244.3

MATERIAL BALANCE –ML FOR DISTILLATION


1. Mother Liquor (Acetone for Distillation) 21.96

2. Distilled Acetone spent for disposal 5.96

3. Loss during distillation 3.00

4. Residue 13.00

TOTAL 21.96 21.96





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2.7.9. Brief process: Norethisterone Acetate

Synthetic sequence:

Norethisterone (NETP) Norethisterone Acetate (NETPAC)

Brief Process: Norethisterone to Norethisterone Acetate

Norethisterone is reacted with acetic anhydride in presence of Zinc chloride and acetic acid in dichloromethane to produce Norethisterone acetate.





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Chemical Reaction:

Table 2.18 Mass Balance of Norethisterone Acetate

Material Balance - NETP TO NETPAC (NORETHISTERONE ACETATE)

Sr.No Raw Material Input in kg Output in kg

1. Norethisterone 10.56



4. Zinc Chloride Anhydrous 2.15


6. Thinner (Ars-Hexane) 188.26




10. Sodium Bicarbonate 10.58

11. Acetone 45.88

12. Hydrochloric Acid Gas 0.12

13. Water 593.72

1. Mother Liquor Hexane MDC Traces for Distillation 200.78

2. Recovered Methylene Chloride from NETPAC 130.98

3. Methylene Chloride Loss During Distillation 2.11

4. Aqueous Layer Drain to ETP Acidic 190.18

5. Aqueous Layer Drain to ETP Basic 218.03

6. Waste Hyflo-Carbon 2.35

7. Mother Liquor Water (Acetone Traces) 285.29

8. Norethisterone Acetate 10.00

9. Loss During Drying of Wet Norethisterone Acetate 0.98





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Total 1040.70 1040.70

DISTILLATION OF MOTHERLIQUOR HEXNAE MDC TRACES


1 Mother Liquor Hexane MDC Traces 200.78

2 Distilled Hexane as spent for disposal

184..31


4 Residue 13.52

Total 200.78 200.78

Process Flow diagram:

2.7.10. Brief Process: Norgestimate

Synthetic Sequence:

Levonorgestrel Norgestimate

Brief Process: Levonorgestrel to Norgestimate

Levonorgestrel is acetylated with acetic acid in presence of Zinc chloride to produce

acetylated intermediate which was subjected to oxime formation with the help of hydroxyl

amine hydrochloride in pyridine to produce Norgestimate.





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Chemical Reaction:

Table 2.19 Material Balance

Material Balance – Levonorgestrel to Norgestimate


1. Levonorgestrel 11.11



4. Zinc Chloride 3.33

5. HCL Gas 3.33

6. MDC (Fresh/Recovered) 222.22

7. Water 222.22

8. Cyclohexane 111.11



3. Loss of MDC During Distillation 11.11

4. Cyclohexane Filtrate ML for Distillation 107.77

5. Loss of Cyclohexane During Filtration 1.11

6. Norgestimate Dry Product 10.00

7. Loss During Drying of Norgestimate Wet Product 3.33

TOTAL 701.09 701.09

DISTILLATION OF MOTHERLIQUOR CYCLOHEXANE


1 Cyclohexane Filtrate ML 107.77

2 Distilled Cyclohexane as spent for disposal

94.44


4 Residue 11.11

TOTAL 107.77 107.77





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2.7.11. Manufacturing process with chemical reaction and process flow diagram with mass balance of Mifepristone IP

Synthetic sequence:

XRNG III Mifepristone IP

(KSM)

.Brief process: Mifepristone IP

XRNG III is reacted with potassium hydrogen sulphate in aqueous medium to

produce crude Mifepristone which was treated with ethyl acetate and sub-zero

temperature to produce Mifepristone IP.

Chemical reaction:

Mass balance of Mifepristone IP:

Material Balance - XRNG III TO MIFEPRISTONE IP





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1 XRNG-III 100

2 POTASSIUM HYDROGEN SULPHATE 65

3 METHYLENE CHLORIDE 2416

4 ACTIVATED CARBON 5

5 ALUMINIUM OXIDE NEUTRAL 50

6 ETHYL ACETATE 598.5

7 WATER 2300

8 HYFLO SUPERCEL 5

9 RECOVERED MDC FROM MIFEPRISTONE 2375

10 LOSS IN MDC DISTILLATION 40

11 MIFEPRISTONE MOTHER LIQUOR 60

12 AQ. LAYER ACIDIC 1320

13 AQ. LAYER NEUTRAL 1050

14 SPENT HYFLO,NEUTRAL ALUMINA, CARBON 61

15 RECOVERD ETHYL ACETATE (STRIPING) 540

16 LOSS IN ETHYL ACETATE DISTILLATION 15

17 MIFEPRISTONE DRY PRODUCT 72

18 LOSS DURING DRYING OF MIFEPRISTONE WET 06

TOTAL 5539 5539

Material Balance - MIFEPRISTONE ML


1 MIFEPRISTONE MOTHER LIQUOR 60

2 DISTILLED ETHYL ACETATE 55

3 RECOVERED MIFE 5

TOTAL 60 60






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XRNG-III 100 6 LOSS DURING DRYING OF MIFEPRISTONE WET

POTASSIUM HYDROGEN SULPHATE 65 2375 RECOVERED MDC FROM MIFEPRISTONE

MDC 2416 40 LOSS IN MDC DISTILLATION

ACTIVATED CARBON 5 60 MIFEPRISTONE MOTHER LIQUOR

ALUMINIUM OXIDE NEUTRAL 50 1320 AQ. LAYER ACIDIC

ETHYL ACETATE 598.5 1050 AQ. LAYER NEUTRAL

WATER 2300 61 SPENT HYFLO, NEUTRAL ALUMINA, CARBON

HYFLO SUPERCEL 5 540 RECOVERD ETHYL ACETATE (STRIPING)

15 LOSS IN ETHYL ACETATE DISTILLATION

72 MIFEPRISTONE DRY PRODUCT

MIFEPRISTONE MOTHER LIQUOR 60

55 DISTILLED ETHYL ACETATE

5 RECOVERED MIFE

Reactor / Workup

Distillation

2.8. Solvent Requirements & Recovery System

The industry proposes to manufacture synthetic organic chemicals (Bulk Drugs &

Intermediates), which require solvents during various unit processes. The unit intends to use

various solvents viz. Mono Chloro Benzene, Acetone, Methanol and Xylene. The spent

solvent generated during the manufacturing process will be recovered by way of distillation

and reused in the process. The process of the solvent recovery system is described

hereunder;

After the completion of the reaction, the spent solvent/mother liquor will be separated by centrifuge and pumped to distillation reactor. It will be subjected to distillation to separate and recover solvent.

Firstly, the mass will be distilled at required temperature where pure solvents will be distilled out depending on their boiler points and it will be collected in the recovered solvent storage tank and reused in the process and then residue will be sent to TSDF site for the disposal by incineration.

Vaccum will also be applied during distillation.

Details of Phase wise solvent used, their CAS number and their recovery is given in Table

2.21 & Table 2.22.





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Table 2.20 Details of Solvent used and Recovery (Phase-I)

S.No

Product Name

Output of each batch in

kg

Solvents

Solvent Name

Input Qty per batch

in kg

Nett Qty of Solvent in the output after recovery, Kg

% Recovery

Use of Recovered Solvent / Spent Solvent

1 Dienogest 2.8 THF 99 76 76.50%

Spent (THF with water) is sent to outside vendor for recovery and reused in the process

Acetone 216 190 87.96% In process Recovery is done and resused in the process

2 Estriol 18

MDC 2250 2223 98.80% In process Recovery is done and resused in the process


Cyclohexane

400 395 98.75% In process Recovery is done and resused in the process

MEOH 1000 933 93.30% In process Recovery is done and resused in the process

3 Ethinyl Estradiol 9

THF 150 113 75.37% Spent (THF with water) is sent to outside vendor for recovery

and reused in the process Toluene 452.5 433 95.69% In process Recovery is done and resused in the process

IPA 170 136 80.00% In process Recovery is done and resused in the process

4 Hydroxy

Progesterone Caproate

100



IPA 312 312 100.00%

IPA along with small qty of Methanol for reactor and tray cleaning

Hexane 726 717 98.76% In process Recovery is done and resused in the process

5 Levonorgestrel 10.2

THF 676 604 89.32% Spent (THF with water) is sent to outside vendor for recovery

and reused in the process Cyclohex

ane 400 380 95.00% In process Recovery is done and resused in the process








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6 Medroxyprogeste

rone Acetate 35



THF 350

Spent (THF with water) disposed to autorised vendor

Ethanol 350 330 94.29% In process Recovery is done and resused in the process

Cyclohex

ane 85 80 94.12% In process Recovery is done and resused in the process

7 Mifepristone IH 9.8

Ethyl Acetate

436

Spent (Ethyl acettae +Cyclohexane+THF) disposed to authorised vendor

Cyclohexane

364

THF 450


Di isopropyl

Ether 377 370 98.14% In process Recovery is done and resused in the process

8 Mifepristone IP 72


Ethyl Acetate

598.5 540 90.23% In process Recovery is done and resused in the process

9 Norethisterone 53.9 THF 752

To ETP along with about 4528 L of water


10 Norethisterone

Acetate

51 THF 752





11 Norgestimate 9


Cyclohexane






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Table 2.21 Details of Solvent used and Recovery (Phase-II)

S.No

Product Name Output of

each batch in kg

Solvents

Solvent Name Input Qty per batch

in kg

Nett Qty of Solvent in the output after recovery, Kg

% Recovery

Use of Recovered Solvent / Spent Solvent

1 19-

Norandrostenedione

96

THF 1029 654.5 63.61% Spent (THF with water) is sent to outside vendor for

recovery and reused in the process

MEOH 720

Spent (MEOH with water) disposed to autorised vendor

Toluene 1968 1938 98.48% In process Recovery is done and resused in the process

Thinner E 989.6 917.15 92.68% In process Recovery is done and resused in the process



2 Androstadienedio

ne 40

Ethanol 104

0.00% Goes in ML


Ethyl Acetate 482 420 87.14% In process Recovery is done and resused in the process

3 Allylestrenol 19.8

Ether 497 480 96.58% In process Recovery is done and resused in the process

Acetonitrile 124 121 97.58% In process Recovery is done and resused in the process

4

Cyproterone Acetate

20 IPE 243 231 95.06% In process Recovery is done and resused in the process

5 Deflazacort 8

MEOH 210 263 99.25% Spent (MEOH with MDC) disposed to autorised vendor

MDC 55


6 Dienogest 2.8 THF 99 76 76.50%



7 Dydrogesterone 10

Ethanol 175 75 42.86% 100 kg along with 1000 L water goes in ETP


8 Estradiol 12 MDC 140 130 92.86% In process Recovery is done and resused in the process





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Benzoate Acetone 200 180 90.00% In process Recovery is done and resused in the process

9

Estradiol Cypionate

12 MEOH 200 170 85.00% In process Recovery is done and resused in the process

10 Estradiol Valerate 8.5



11 Estriol 18



Cyclohexane 400 395 98.75% In process Recovery is done and resused in the process


12 Estrone 60


Methanol 635 600 94.49% In process Recovery is done and resused in the process


THF 1723 1577 91.51%


13 Ethinyl Estradiol 9

THF 150 113 75.37% Spent (THF with water) is sent to outside vendor for


Toluene 452.5 433 95.69% In process Recovery is done and resused in the process

IPA 170 136 80.00% In process Recovery is done and resused in the process

14 Hydroxy

Progesterone Caproate

100



IPA 312 312 100.00%

IPA along with small qty of Methanol for reactor and tray cleaning


15 Levonorgestrel 10.2

THF 676 604 89.32% Spent (THF with water) is sent to outside vendor for









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16 Lynestrenol 17

THF 89



17 Medroxyprogeste

rone Acetate 35



THF 350




18 Mifepristone IH 9.8

Ethyl Acetate 436

Spent (Ethyl acettae +Cyclohexane+THF) disposed to authorised vendor

Cyclohexane 364

THF 450


Di isopropyl Ether


19 Mifepristone IP 72


Ethyl Acetate 598.5 540 90.23% In process Recovery is done and resused in the process

20 Nandrolone Decanoate

59.3

MDC 994 975 98.09%

Ethyl Acetate 172.8 117 67.71%

IPA 337

IPA distilled with water

Hexane 564 486 86.17%

21 Nandrolone

Phenyl Propionate

28

MDC 497


IPA 168

IPA distilled with water is disposed to authorised vendor

Di Ethyl Ether 487 449 92.20% In process Recovery is done and resused in the process





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22 Norethisterone 53.9 THF 752



23 Norethisterone

Acetate

51 THF 752





24 Norethisterone

Enanthate 64.6

THF 752



heptane 1691 1525 90.18%

1525 L heptane recovered. 277 L heptane recovered with Methanol MEOH 154

25 Norgestimate 9



26 Ospemifene 32



Ethyl Acetate 608 Distilled (Ethyl Acetate + Carbon tetrachloride) disposed to

authorised vendor Carbon tetrachloride

243.2


27 Progesterone 65


MEOH 17.5 12 68.57% In process Recovery is done and resused in the process

28

Testosterone Cypionate

21 Ethanol 68 50 73.53% In process Recovery is done and resused in the process

29 Testosterone

Enanthate 20




30

Testosterone Propionate

9 Ethanol 37 34 91.89% In process Recovery is done and resused in the process






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31 Ulipristal Acetate 8


Ethyl Acetate 88 600 L distilled (Ethyl Acetate + Heptane ) mixture disposed

to authorised vendor Heptane 600

32 G4 188



MEOH 720

Spent (MEOH with water) disposed to authorised vendor


33

Estrenone (Oxide)

27

Methanol 510.9

Spent (MEOH with other) disposed to authorised vendor

IPA 398

Spent (IPA+Water) disposed to authorised vendor


34 3-Ethoxyestra-3, 5-(6)-diene-17-

one (NET) 85



MEOH 720



Thinner E 989.6 890.64 90.00%

(Thinner E with water) In process Recovery is done and resused in the process



Ethanol 247

Spent (MEOH with water) disposed to authorised vendor

35 PET 43

IPA 337

Spent (IPA+Water) disposed to authorised vendor


Ethyl Acetate 172.8 117 67.71% In process Recovery is done and resused in the process

36 NAD Crude 120



MEOH 720







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Thinner E 989.6 917.15 92.68% In process Recovery is done and resused in the process

37 ADD NPG Ketal 140 Hexane 625 600 96.00% In process Recovery is done and resused in the process

Methanol 635 600 94.49% Spent (MEOH with other) disposed to authorised vendor





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2.8.1. Measures for achieving maximum solvent recovery

The entire manufacturing activities & distillation process will be carried out in the totally closed

system. Maintenance of the pipeline and valves & fittings will be carried out regularly to avoid

any leakages. Reactor will be connected with two numbers of condensers where cooling water

and chilled water will be used as media and also equipped with vacuum system as per

requirement. The condenser will be provided with the sufficient HTA and residence time to

achieve more than 90% recovery. The fresh solvent requirement will be depended on

generation of distillation loss.

For storage of solvents tankers or drums will be used Approximately 2 to 6 % of fresh solvents are required for replacement and rest is

recovered and reused. Some are carryover from raw materials. Some are by products from reaction Some are solvents are proceeded to next products as starting materials. Approximately 95 % of solvent recovery is around 95-98%. Solvent loss in waste water is recovered in Stripper. Solvent loss in solid waste is sent TSDF. Solvent consumed in products are recovery in next products.

Figure 2.7 Figure Solvent Requirements & Recovery System

2.9. Pollution Potential and Management

The proposed project will have potential of pollution mainly due to the wastewater generation &

disposal, gaseous emission from process, flue gas emission from utilities and hazardous waste





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generation & disposal. These potentials of pollution are described below under respective

heading with necessary details.

2.9.1. Water Pollution

The total water requirement is about 142 KLD. In Phase-I 23 KLD water will be required and in

Phase-II 127 KlD water will be required. In Phase-I the total waste generated will be approx 15

KLD. Out of the total waste generated the process effluent will be around 13 KLD and domestic

waste will be about 2 KLD. Domestic effluent wich will be disposed in Soak pit and rest 10 13

KLD waste water will be sent to Common effluent treatment plant of SIDCUL Industrial area

operated by M/s Pant Nagar CETP Pvt. Ltd. Service agreement between NAARI pharma Pvt.

Ltd. and Nagar CETP Pvt. Ltd. Dated 8th April 2018 is attached as Annexure II.

In Phase-II total waste generated will be 94 KLD out of the total waste generated about 85 KLD

will be reused in the process. Domestic effluent will be treated in 20 KLD STP. Industral

effluent shall be treated in ETP and reused in process. After using 85 KLD treated water the

Industrial fresh water requirement of the unit will be around 65 KLD (23 KLD for phase-I and

43 42 KLD for Phase-II), which comprises the need for process, boiler and cooling activity.

About 85 KLD water will be recycled water and used in the process.

Total effluent generated from the proposed unit will be treated in 100 KLD ETP (which includes

MEE condensate and ETP RO reject). The Effluent Treatment Plant (ETP) comprises of

primary, secondary & tertiary treatment system which will be adequate to achieve the zero

liquid discharge system. All the recycled/treated effluent is proposed to use for utility

operations, floor washing and toilet flushing‘s.

Effluent Treatment Plant

An ETP of 100 KLD capacity will be constructed to treat the effluents from the manufacturing of

APIs.

In aspect of the waste water management NAARI proposing well developed waste water

management system to meet the desire limits and norm for pollution control board. Details

given below:

Separation & segregation of effluent, generating from the process

HTDS Effluent

LTDS Effluent

Organic Solvent residue & MEE first fraction

HTDS Effluent will be treating through MEE, after the treatment MEE condensate goes

to ETP for further treatment and MEE concentrate to ATFD.

LTDS Effluent will be treating by ETP through the Primary, secondary and tertiary

treatment. RO plant rejects will goes to MEE& ATFD.





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Figure 2.8 Overall Effluent Treatment Scheme (Capacity-100 KLD)

Sewage Treatment Plant

Total sewage waste water generated is 20 KLD proposed to treat in-house sewage treatment

plant (STP). Treated sewage effluent proposed to use for gardening purpose within the

premises.

Multiple Effect Evaporator

The MEE will be three-effect configuration with Thermal Vapour Compressor. A Mechanical

compressor can be offered as well, but due to low steam cost and consumption, a TVR-based

system is considered as optimum. All three calandria to be configured as forced circulation

systems to minimize scaling. The final effect will have a salt settler, and the slurry from bottom

of the settler shall be dewatered in a Basket Centrifuge to provide wet salt with just 10-15%

moisture, which will be packed in HDPE bags/drums and disposed to approve landfill.

2.9.2. Air Pollution

The main source of air pollution will be flue gas emission and process gas emission from the

proposed project. There will be also chances of fugitive emission due to manufacturing

activities and storage, handing & transportation of raw materials & products. Various potential

of air pollution are described hereunder;

A. Flue Gas Emission





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Unit will install two nos. of steam boiler of 1 TPH and 5 TPH respectively wherein Furnace Oil

is used as fuel. The fuel requirement for the boilers wills be 1KLD and 5 KLD furnace oil

respectively. Unit will use furnace oil as a fuel. Stack with adequate height as per the CPCB

norms will be provided for proper dispersion of pollutant from the steam boiler.

A. Process Gas Emission Emission control will be through multi cyclone Separator with stack and scrubbers (water, acid

or caustic) shall be installed for process emission from the plant. The emission levels taken for

the stacks are mentioned below considered after using the controlled systems. The details of

air emissions are provided in Table 2.22.

Table 2.22 Details of Air Emissions with emission levels

S. No. Source of air emissions Type of Pollutant

Considered

Emission levels of Pollutant

1. Boiler (1 TPH) PM2.5, PM10,

NOx,SOx

PM (PM10,PM2.5): 800 mg/Nm3

NOx: 300 mg/Nm3

SO2: 600 mg/Nm3

2. Boiler (5 TPH) PM2.5, PM10, NOx,

SOx

PM (PM10,PM2.5): 800 mg/Nm3

NOx: 300 mg/Nm3

SO2: 600 mg/Nm3

3. Process scrubbers. PM2.5, PM10, NH3 PM10: 100 mg/Nm3

PM2.5: 60 mg/Nm3

NH3: 30 mg/Nm3

All process emission from the reaction streams will be routed through dedicated two stage

scrubbing system to scrub out various pollutants from the system. The stacks specifications

and emission details are as given in Table 2.23.





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Table 2.23 Stacks in the API Plant

Plant

Stack

Stack Specification Emission Load

Stack

Height

Stack

Diamet

er m

Exit

Velocity

m/sec

Temp

K

Normal

Flow rate

Nm3/hr

Conc of

PM10

(gm/sec)

Conc of

PM2.5

(gm/sec)

Conc of

Nox gm/sec

Conc of

Sox gm/sec

Conc of NH3

gm/sec

Boiler

Phase I

30 0.5 7.7 411.15 3944.37 0.53 0.35 0.33 0.66 NA

Boiler

Phase II

30 0.6 11.07 413 8126.22 1.08 0.72 0.68 1.35 NA

Process

Scrubber

Phase I

7.25 0.1 0.294 323.15 7.67 0.000213 0.000128 NA NA 6.38781E-05

Process

Scrubber

(Phase –

II)

7.25 0.1 0.294 323.15 7.67 0.000213 0.000128 NA NA 6.38781E-05

Process

Scrubber

(Phase –

II)

7.25 0.1 0.294 323.15 7.67 0.000213 0.000128 NA NA 6.38781E-05





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2.9.3. Noise Pollution Control

The main source of noise generation during operation stages are mainly from pumps, blowers,

compressors, DG sets, vehicle movement for transportation of raw materials, finished goods

etc. DG sets will be provided with acoustics enclosures. Mufflers, silencers, acoustics treatment

of room will be done wherever required. Equipment will be maintained so that noise level does

not increase due to improper maintenance. Besides, to avoid occupational health hazard,

workers will be provided PPEs like ear plug/ ear muffs, wherever required. It is expected that

noise level at the plant boundary will be within the prescribed norms of CPCB due to operation

of the proposed project and no significant impact on noise environment is expected. Greenbelt

developed within the plant premises will also act as a barrier to the propagation of noise from

the factory premises. This shall further reduce the noise levels appreciably. Hence, no

significant impact is envisaged.

2.9.4. Hazardous Waste Generation & Management

The type and quantity of hazardous wastes, which are anticipated to be generated from the

proposed project during construction and operation phase, are tabulated in Table 2.8.

Table 2.24 :Type of Waste Generation

S. No.

Waste Description

Category No.

Mode of Disposal/Treatment

Qty. Phase 1

Qty. Phase 2

Total

1. Used Oil/Waste Oil 5.1 TSDF site 2.75 TPA 0.25 TPA 3.0 TPA

2. Process Residue and wastes 28.1 TSDF site 18 TPA 84 TPA 102 TPA

3. Spent catalyst 28.2 Recycler for

Regeneration 1.2 TPA 4.8 TPA 6.0 TPA

4. Spent carbon 28.3 TSDF site 3.6 TPA 32.4 TPA 36 TPM

5. Off specification products 28.4 TSDF site 1.0 TPA 3.0 TPA 4.0TPA

6. Date expired products 28.5 TSDF site 0.5 TPA 2.0 TPA 2.5 TPA

7. Spent Solvents 28.6 Approved recycler /reuse/TSDF site 2920 TPA 7300 TPA

10220 TPA

8. Empty barrels/containers/lines contaminated with hazardous chemicals/wastes 33.1

Reuse/ Approved Recycler

12000 Nos. per

Annum

60000 Nos. per

Annum

72000 Nos. per

Annum

9.

Contaminated cotton rags or other cleaning materials

33.2 TSDF site 1.2 TPA 3.6 TPA 4.8 TPA

10. Exhaust air or gas cleaning residue 35.1 TSDF site

1.2 TPA 3.6 TPA 4.8 TPA

11. Spent ion exchange resin containing toxic metals 35.2 TSDF site 0.5 TPA 1.0 TPA 1.5 TPA

12. Chemical sludge from waste water treatment 35.3 TSDF site 2.4 TPA 108 TPA

110.4 TPA

13. Oil and Grease Skimming 35.4 TSDF site 3.6 TPA 6.0 TPA 9.6 TPA

14. Any process or distillation residue 36.1 TSDF site 9.6 TPA 60.0 TPA 69.6 TPA

15. Spent carbon or filter medium 36.2 TSDF site 6.0 TPA 42 TPA 48.0 TPA

16. Ash from incinerator and flue gas cleaning residue 37.2 TSDF site 3.6 TPA 9.6 TPA 13.2 TPA

17. Concentration or evaporation residues. 37.3 TSDF site 6.0 TPA

1095.0 TPA

1277.5 TPA

Source: NAARI

*Other wastes such as E-waste (0.75TPA), Bio-Medical Waste (2.4 TPA), Plastic waste (5.0TPA), Metalic Waste

(20TPA), Fly Ash / Bottom Ash (3.0TPA), Construction/Demolition waste(10TPA)/Paper/Card Bord

waste(15TPA),Insulation/Puff Waste (3.0TPA) will be generated and will be disposed as per Pollution Control Boards

Norms/Regulation.





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2.9.4.1 List of hazardous and Toxic Chemicals

Many of the Naari chemicals are hazardous in nature. However hazards potential (for damage)

of products and other materials to plant personnel, environment and off-site area is different for

different materials. Naari will be using a number ofliquid raw materials but

onlyThirteen(including liquid ammonia) are stored in bulk and all these are listed under ―List of

hazardous and Toxic Chemicals‖ category under MSIHC Rules, 1989.In addition five toxic

gases are also stored and have been listed below. The raw materials coming under hazardous

category as specified by MSIHC Rules, 1989 (including subsequent amendments) is given in

Table 2.25 below:

Table 2.25 Hazards Analysis –Raw materials (stored in Bulk)

S No

Material S. No & Threshold Quantity (TQ in Kg) as per MSHIC

Rules

Chemicals Hazards Potential

Remarks

Schedule-1,

Part-II

Schedule-2,

Part-I

Schedule-3,

Part-I

Hazards Toxic DT->---mg/Kg; OT----mg/Kg; IT----mg/l;

(Rats)

1.

Acetone CAS No:67-64-1 Colourless liquid with Fruity mint odour BP: 56.2 0C. Flash Point : -20 0C.

2 ----- ----- Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (permeator). Highly flammable in presence of open flames and sparks, of heat.

DT->---mg/Kg; OT—5800 mg/Kg (rat); IT—50100 mg/m3 8 hrs (rat)

2. Chlorine CAS No:7782-50-5 UN No:1017 A greenish yellow gas with a pungent suffocating odor. Toxic by inhalation.

119 5 TQ-1: 10MT TQ-2: 25 MT

108 TQ-1: 10MT TQ-2: 25 MT

Non Combustible;May ignite other combustible materials (wood, paper, oil, etc.). Mixture with fuels may cause

ERPG-1: 1.0 ppm ERPG-2: 3.0 ppm ERPG-3: 20 ppm IDLH: 10 ppm

Hazards: Poisonous; may be fatal if inhaled. Contact may cause burns to skin and eyes. Bronchiti





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explosion. Container may explode in heat of fire. Chlorine reacts explosively with or supports the burning of numerous common

s or chronic lung conditions Poisonous; may be fatal if inhaled. Contact may cause burns to skin and eyes. Bronchitis or chroniclung conditions

3. Cyclohexane C6-H12 CAS No:110-82-7 Liquid with Chloroform-like odor; solvent odor; mild sweet odor FP-18 0C ; BP-80.70C LEL-1.7 %; UEL-8.4%

161 --- --- Slightly hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion, of inhalation. Highly flammable in presence of open flames and sparks, of heat

DT->--18000 mg/Kg (Rabbit); OT----12705mg/Kg; Rat IT----mg/l; (Rats)

4. Dimethyl Formamide (DMF) CAS No:68-12-2 Colourless to light yellow Flammable liquid with mint like odour BP: 153 0C. Flash Point : 57.7 0C.

----- ----- ----- Hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion, of inhalation.

DT->--4720 mg/Kg (Rabbit); OT----2800 mg/Kg; Rat IT----mg/l; (Rats)

5. Ethanol CAS No; 64-17-5

248 ----- ----- Colourless liquid Flammable:





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A clear colorless liquid with pleasant odor

FP- 16.6 0C; Causes respiratory tract irritation. May cause liver, kidney and heart damage. Causes moderate skin / eye irritation. On ingestion may cause gastrointestinal tract irritation, vomiting and diarrhoea.

6. Ethyl Acetate (C4 H8 O2) CAS No: 141-78-6 Flammable Colourless liquid; Pleasant Etheral odour BP-77 0C FP—4.4 0C

247 --- --- Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, permeator), of eye contact (irritant). FLAMMABLE: FP (Closed Cup)- -4.4 0C Flammable Limits_ Lower 2.2%;Upper-9%

(LD50): Acute: 5620 mg/kg [Rat]. 4100 mg/kg [Mouse]. VAPOR (LC50): 16000 ppm 6 hours [Rat].

7. n-Hexane CAS No:110-54-3 UN No:1208 Clear colourless liquids with a petroleum-like odour. Flash points -9°F

306 ----- ----- Highly flammable; Vapours may explode; Health Hazards: Inhalation causes irritation of respiratory tract, cough, mild depression, cardiac arrhythmias.

TEEL-1: 400 ppm TEEL-2: 3300 ppm TEEL-3: 8600 ppm IDLH 1100 ppm





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Aspiration causes severe lung irritation, coughing, pulmonary edema; excitement followed by depression. Ingestion causes nausea, vomiting, swelling of abdomen, headache, and depression.

8. Hydrochloric acid (Gas) CAS No: 7647-01-0 UN No: 1789

313 ----- ----- Not Flammable; Inhalation of fumes results in coughing and choking sensation, and irritation of nose and lungs. Liquid causes burns

ERPG-1: 3.0 ppm ERPG-2: 20 ppm ERPG-3: 150 ppm IDLH: ---- ppm

Plant uses liquid and emits HCl gas

9. Hydrogen CAS No:1333-

74-0

Hydrogen is a colorless, odorless,

flammable gas BP:--252.8 0C

247 --- TQ-1: 2MT

TQ-2:50 MT

The main health hazard associated with releases of this gas is asphyxiation, by displacement of oxygen. The liquefied gas can cause frostbite to any contaminated tissue. Hydrogen poses a serious fire hazard when it is accidentally released.

------ Highly Flammab

le/ Explosiv

e





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10. Ammonia CAS No:7664-41-7 UN No:1005 Colourless gas / liquid with ammonical irritating odour

31 2 TQ-1: 60 MT TQ-2:

600 MT

105 TQ-1: 50 MT TQ-2:

500 MT

Fire Hazards: (Gas); Mixing of ammonia with several chemicals can cause fire hazards, / or explosions; vapours are toxic- irritation to eyes and respiratory tract.

ERPG-1: 25 ppm ERPG-2: 150 ppm IDLH: 300 ppm

Contact with liquid may cause froast bite.

11. Methanol CAS No:67-56-1 UN No:1230 FP—54.5 0F ; BP-64.5 0C A colorless fairly volatile liquid with a faintly sweet pungent odor like that of ethyl alcohol. Highly Flammable;

377 ---- ---- human poison by ingestion. Poison experimentally by skin contact. Moderately toxic experimentally by intravenous and intraperitoneal routes. Mildly toxic by inhalation.

ERPG-1: 200 ppm ERPG-2: 1000 ppm ERPG-3: 5000 ppm IDLH: 6000 ppm

Health Hazards: Exposure to excessive vapor causes eye irritation, headache, fatigue and drowsiness. 50,000 ppm will probably cause death in 1 to 2 hrs. Swallowing may cause death or eye damage.

12. Methylene Dichloride

CAS No: 75-09-2

Liquid BP-39.75 0C

May be combustible at

high temperature

400 --- --- Very hazardous in case of eye contact (irritant), of ingestion, of inhalation. Hazardous in case of skin contact (irritant,

DT->---mg/Kg; OT---1600 mg/Kg (Rat); IT----mg/I; (Rats)





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permeator). Inflammation of the eye is characterized by redness, watering, and itching.

13. Toluene C6-H5-CH3 CAS No: 108-88-3 UN No: 1294 A clear colorless Flammable liquid with a characteristic aromatic odor. Flash point 40°F

628 ---- ---- Flammability: Ignites at normal temperatures; Vapor is heavier than air and may travel a considerable distance to a source of ignition and flash back; Health Hazard Vapors irritate eyes and upper respiratory tract; cause dizziness, headache, anesthesia, respiratory arrest. Liquid irritates eyes and causes drying of skin. If aspirated, causes coughing, gagging, distress, and rapidly developing pulmonary edema. If ingested causes vomiting, griping, diarrhea, depressed respiration.

DT->--14100 mg/Kg (Rabbit); OT----636 mg/Kg; IT----49000 ppm; 4 hrs (Rat)

14. Acetylene Gas CAS No: 74-86-

8 ---- TQ-1: 5 MT

Acetylene is

------





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2 UN No: 1001 Colourless gas with unknown odour

TQ-2: --- MT

extremely flammable and slightly lighter than air. Acetylene ignites easily and burn with an extremely hot bright flame giving off black smoke.

15. Benzyl-(2bromoethyl)ether CAS No: 1462-37-9 BP:254 0C

---- ----- ---- Harmful if swallowed; causes skin/eye irritation

----

16. CKT [(2-(3-CHLOROPROPYL)-2,5,5-TRIMETHYL-[1,3]-DIOXANE); C10H19ClO2 ] CAS No: 88128-57-8 BP: 247.7±15.0℃

---- ----- ---- ---- --- No data

17. Di Ethyl Ether C4H100 CAS No: 60-29-7 Colourless Liquid with sweet ether like odour BP: 34.6 0C

---- ----- ---- Extremely flammable liquid and vapour. May form explosive peroxides Harmful if swallowed

DT->--14.2 g/Kg (Rabbit); OT-1215 mg/Kg (rat); IT----32000 ppm; 4 hrs (Rats)

18. Heptane CAS No:142-82-5; UN No 1206 Flammable colourless liquid and vapor. Will be easily ignited by heat, spark or flames. with gasoline like odor;

--- --- --- Harmful or fatal if swallowed. Causes skin and eye irritation. Causes respiratory tract irritation.

High vapor concentrations may cause

DT->---mg/Kg (Rabbit); OT--------mg/Kg; IT----103 mg/l; 4 hrs (Rats)





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FP- -4 0C ; BP-98.5 0C

drowsiness and irritation of the eyes or respiratory tract.

19. Propylene CAS No: 115-07-1 Colorless Gas (Liquid under pressure) Odor: Mild Olefin Vapor Density: 1.4 (air=1)

--- ---- ----- F P: -108°C LEL: 2.0% UEL: 11.1% Flammable Gas Unusual Fire and Explosion Hazards: Vapors are heavier than air and may travel along the ground or may be moved by ventilation and ignited by flame, sparks, heaters or other ignition sources at distant locations. Vapors may explode if ignited in a closed area. Containers may explode in a fire.

NFPA 704 (1997) Health: 1 Flammability: 4 Reactivity: 1

20. Pyridine 4-(p-nitrobenzyl)- C12-H10-N2-O2 CAS No:1083-48-3 Powder Solid

547 ---- ----- Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation (lung irritant).

-----

21. THF Tetrahydrofuran C4H8O CAS No:109-99-9 Flammable clourless liquid with Ethereal

---- ---- ---- Hazardous in case of skin contact (irritant), of eye contact (irritant). Slightly hazardous in

DT->--1650 mg/Kg (Rabbit); OT--------mg/Kg; IT----24000 mg/m3; 2 hrs





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odour BP:65 0C

case of skin contact (permeator), of ingestion, of inhalation

(mouse)

22. Phosphoric Acid (85%) H3PO4 CAS No 7664-38-2 Syrupy viscous odourless liquid

497 ---- ---- Very hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, . Hazardous in case of skin contact (corrosive, permeator), of eye contact (corrosive). Slightly hazardous in case of inhalation (lung sensitizer).

DT->--2740 mg/Kg (Rabbit); OT--1530mg/Kg; IT----850 mg/m3; 1 hrs (rat)

note: TQ-I: Threshold quantity (for application of rules 4,5,7 to 9 and 13 to 15) TQ-II: Threshold quantity (for application of rules 10 to 12)

As detailed in the above table out of 22 (17- liquid/ 5-gaseous) materials stored in bulk only 14

are coming within Schedule I part II (List of Hazardous and Toxic Chemicals) of MSIHC

Rules.Only fourmaterial (Chlorine, Hydrogen, Ammonia and Acetylene) of them comes under

Schedule 3 (list of hazardous chemicals for application of rules 5 and 7 to 15).

All solvent materials are inflammable and some may be explosive also. Some of these

hazardous liquid materials are toxic also such as Methanol, Ethyl Acetate, Methylene Chloride,

Pyridine, Toluene and Phosphoric Acid.





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CHAPTER 3. DESCRIPTION OF THE ENVIRONMENT

3.1 Background and Salient Environmental Features of the Study Area

Generation of environmental baseline of a project area is an important phase of any

Environmental Assessment process. Baseline data provide vital information on the existing

environmental quality in which a development is planned. It is also useful for delineating

environmental sensitive areas and for preparing an Environmental Sensitivity Map for

contingency planning. In this study, the environmental characteristics of the project area (10 km

study area) were established through extensive literature search, field

sampling/measurements, laboratory analysis, consultation and data interpretation.

Secondary data from literature search were also obtained from the Govt. sources i.e.

Meteorological Department, CPCB publication; Forest Department and other Govt. Sources.

The baseline environmental data generation has been done for the period of 1st October 2017

to 31st December 2017. M/s JP Test & research centre, Sahibabad, Uttar Pradesh along with

EQMS Team, carried out sampling and testing. The study area within a 10 km radius around

the proposed plant site has been considered as impact zone for EIA study. Primary and

secondary data has been collected for 10 Km radius of the project site.

3.1.1 Environmental Setting and Salient Environmental Features of the Project Area

The proposed site is located at Latitude: 29°00'21"N and Longitude: 79°24'32"E. The site well

connected to road and railway line. The site is located at Plot 14-16 & 55-57, Sector-5, IIE Pant

Nagar, Rudrapur Industrial area, Dist: Udham Singh Nagar, (Uttarakhand) India. Proposed site

is located in an industrial land allotted by State Industrial Development Corporation of

Uttarakhand (SIDCUL) in Udham Singh Nagar District. About 5.93 Acres (24000m2) land is

available with NAARI at Plot 14-15-16 & 55-56-57, Sector-5, IIE Pant Nagar, Rudrapur

Industrial area. Out of the total land, the proposed unit (construction of manufacturing facility,

utility, office and roads) will be established in 3.93 Acres (15904.5m2) land and remaining 2.0

Acres, (8094 m2) will be reserved for greenbelt development.

No archaeological, historical site is located within the study area. Therefore, the project site

does not offer any negative impact on the local area as because it is a new establishment in

existing vacant land in notified industrial area, but rather has a positive impact on socio

economic conditions of the area. The plant is well connected both to NH-87 and Delhi-

Kathgodam Railway line. Nearest Railway, station is Rudrapur city located about 5.5 km from

Project site. Road connectivity map is provided in Figure 3.1. Pant Nagar Agriculture University

This Chapter describes the baseline environmental conditions around the NAARI Pharma

Pvt Ltd, project site for various environmental attributes, i.e. physical, biological and socio-

economic conditions, within the 10 km radial zone of the proposed project site, which is

termed as the study area. Topography, drainage, meteorology, air, noise, water, soil and

land constitute the physical environment, where as flora and fauna constitute the biological

environment. Demographic details and occupational pattern in the study area constitute

socio-economic environment.





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is located about 6.0 km northeast of the proposed site. The nearest airport is at Pant Nagar

located at an aerial distance of 6.5 km approx. Chaferi River is located about 6.2 km east of the

proposed site. Tanda Forest range is located about 4.62 km north of the site.

Figure 3.1 Road Connectivity Map of Study Area

There are no defence installations, National Park, Wild Life Sanctuary, Elephant/Tiger Reserve,

elephant corridor etc. within 10 km radius. Location map provided in Figure 3.2. Study area

map showing site and surrounding environment features within the 10 km area is provided in

Figure 3.3 and Google Map of 10 km study area is presented in Figure 3.4. The Salient

Environmental Features of plant site within 500m, 2 Km and 10 Km radius is summarised at

Table 3.1.

Table 3.2 : Salient Environmental Features of Proposed Site

S. No.

Environmental Features

Within 500 m area around project site



1 Ecological Environment

A Presence of Wildlife Sanctuary/ National Park/Biosphere Reserves

None None None

B Reserved /Protected Forests

None None Tanda forest Range at a distance of 4.62km, N & NE

C Wetland of state and national interest

None None None

D Migratory route for wild animals

None None None

E Presence of schedule-I Fauna

None None None

G Critically polluted Area None within 10 km study area





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2. Physical Environment

H Road connectivity UPSIDC Industrial area road

NH-87, 1 km West

NH-87, 1 km West NH-74, 4.2 km, south

I Rail connectivity None None Rudrapur RS~5km SW

J Defence Installation None None None

K Densely Populated Area

None Rudrapur town Rudrapur town Pant Nagar

L Other village close to plant site

It is an industrial area nearest habitation is Kalyanpur which is located about 1.2 km SW of the site.

M Topography Plain, elevation of site ranges between 216 to 218 amsl

Plain, elevation ranges between 208 to 225 amsl

undulating, elevation ranges between 208 to 315 amsl

M Seismicity Seismic zone-IV ( High damage Risk Zone)

N Surface Water Resources (Rivers)

None None Chaferi River, 6.2 km, E Baror Nadi 5.5 km E

O Groundwater Semi-critical, Overall Groundwater quality is good for domestic and irrigation purpose.

P Soil and Land-use Sandy loam, land use is Industrial

Sandy loam land use agriculture, industrial and settlement

Sandy loam land use agriculture, vegetation, industrial and settlement

3. Social Environment

S Physical Setting Industrial Rural and Industrial

Industrial, Rural & Urban

T Physical Sensitive Receptors

None School, Hospitals, Temple etc.

School, Hospitals, Temple etc.

U Archaeological Monuments

None None None

IIE SIDCUL

3.1.2 Brief description of IEE SIDCUL Pant Nagar Industrial Area

The State Industrial Development Corporation of Uttarakhand Limited (SIDCUL) is a

government of Uttarakhand enterprise which promotes industries and develops industrial

infrastructure in the State. This industrial area is located at National Highway no. NH-87.

Industrial area is located 235 Km from National Capital Delhi and 300 Km from State Capital

Dehradun. Total Area of the IEE SIDCUL Pant Nagar Industrial Area is 3339 Acres. Total no of

industrial plots are 1840 acre. At present 465 industries is operation in the industrial area.

Details of IEE SIDCUL Pant Nagar Industrial Area are tabulated below:

https://en.wikipedia.org/wiki/Uttarakhand





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S. No. Name of Ind. Area

Land developed

(In ha)

No of Plots No of allotted

Plots

No of Vacant Plots

No. of Units in Production

1 IIE SIDCUL Pant Nagar

3339 1840 acre

1840 acre

16.79 acre

465





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Figure 3.2 Location Map of Study Area





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Figure 3.3 Google Map of 10 km Study Area





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3.1.3 Primary Data Collection: Monitoring Plan and Quality Assurance Procedures

Primary baseline data has been collected as per the TOR prescribed by MOEF 1st October 2017

to 31st December 2017 for one complete season. The study period and methodology for primary

data collection is summarized in Table 3.3.

Table 3.3 : Summary of Methodology for Primary/Secondary Baseline Data Collection

Parameters No. of

Sampling Locations

Frequency/ Season

Remark

Ambient Air Quality

PM (10), PM(2.5), SO2 , Nox CO, NH3, HBr, VOC, HF

8 locations (Refer Fig.

No.3.6 )

Twice a Week

For post monsoon season

AAQ monitoring was carried out at 8 locations (representing upwind, downwind and sensitive locations). 24 hours sampling at each location was carried out as per CPCB guide lines (CPCB Gazette notification dated 18.11.2009 on AAQ).

Meteorology

Temperature, Humidity, Wind speed, Direction, Rainfall etc.

One location

Hourly for post monsoon

season

Met station was established close to the site to record the site specific

hourly met data.

Ground Water Quality

Physical, chemical and biological parameters as per IS 10,500

8 locations in

study area (Fig 3.6)

Once in post

monsoon season

Ground water: Sampling was conducted at 8 locations. Samples were preserved, transported and analysed for different parameters based on APHA methods. Temp, conductivity and pH which were measured instantly at site itself.

Surface Water Quality

Physical, chemical and biological

parameters as per IS: 10,500

Two locations in study area (Fig 3.6)

Once in post monsoon season

Surface Water: Sampling was conducted at two locations.

Samples were preserved and transported for analysis for different

parameters based on APHA methods. Temp, conductivity, DO

and pH which were measured instantly at site itself.

Soil

Texture, bulk density, pH, conductivity, cation exchange capacity, organic matter, Total N,P,K, and Heavy metals etc

6 locations in study area (Fig 3.6)


Soil samples were collected at six locations within the study area and

analysed as per IARI method

Noise





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Parameters No. of

Sampling Locations

Frequency/ Season

Remark

Noise profiling for 24 hrs 8 locations in

study area (Fig 3.6)


Noise monitoring was conducted within the 10 km area of project site for noise profiling for 24 hrs using integrated sound level meter, as

per CPCB guidelines.

Ecology (Flora & Fauna)

Flora & Fauna


Primary survey and Secondary sources

Demography & Socio-economics

Demography & Socioeconomic - Once in post

monsoon season

Primary survey/ Secondary sources

Standard methods and procedures have been strictly adhered to in the course of this study.

QA/QC procedures were strictly followed which covers all aspects of the study, and includes

sample collection, handling, laboratory analyses, data coding, statistical analyses, presentation

and communication of results. All analysis was carried out in NABL/MoEF&CC

accredited/recognized laboratory. Environment sampling Map is provided in Figure 3.7.

Close view Map of Project site: Close view map of project site showing coordinates of four

corners of the site is presented in Figure 3.6

Figure 3.4 Close View Map of Project Area





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Figure 3.5 Environment Sampling Location Map





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3.2 Physical Environment

3.2.1 Topography

The topography of proposed site is almost plain. The site elevation ranges between 216 to 218

amsl. Topography around 10 km area of the proposed site is flat to undulating near foothill

region. The average elevation in 10 km area around the site ranges between 208-315 metres

above mean sea level. The overall slope of the study area is from north to south.

3.2.2 Drainage

The rivers of the district belong to the Ganges drainage system. The unique feature of the area

is debouching of major rivers into the plains from Lower Himalayas in north. The overall flow

direction of rivers in generally is north–south trend. There is no major river present within the

study area. Chaferi River, Baror River and other seasonal nallas are the main surface water

sources in the study area and the drainage of the study area is mainly controlled by these

streams.

3.2.3 Geology & Hydrogeology

Piedmont alluvial deposits represent the geology of the study area. Broadly, it can be divided

into two formations viz. Bhabar and Tarai. These are characterized by distinct lithology, grain

size distribution, variation of degree of sorting etc. a generalized geological succession, of the

area, is as follows:

Table 3.4 Geological Details of the Area

Age Morphotectonic Unit

Divisions/ Formation

Lithology

Recent to Quaternary Piedmont Bhabar Boulder sand and clay

Alluvial plain Alluvial Plain Tarai Sand, clay and slit

Bhabar Formation: The northern hilly region of the study area comprises of Bhabar formation. Bhabar formation is

constituted of alluvial deposits lying on the sloping plains in the Himalayan foothills. It is

primarily constituted of unconsolidated sediments like sand, gravel, boulder and clays. The

grain size varies from material of sand grade (2 mm) through granules, pebbles, cobbles to

boulders size i.e. >256 mm, sometimes the boulders have dimensions in feet. The clays are

generally brown in color and clay bed sequences tend to pinch and for the same reason have

short lateral continuity.

Tarai Formation: The immediate plain area along the hills is comprises of the Tarai formation. Tarai formation

consists of clays, sandy clays, fine to medium sand and occasional gravels. In this formation

there is a dominance of clayey successions over sandy horizons. The granular zones mostly

occur as lenses and have inter–tonguing relationships with clastic and non-clastic units. The

Tarai sediments representing the finer portion of the channel bed load and the load in

suspension and solution, which are brought by the streams and evenly sorted out by the river

action. Tarai formation is better sorted as compared to the Bhabar.

3.2.4 Ground Water Availability





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The study area falls in Rudrapur block of Udham Singh Nagar District. A total ground water

resource in Rudrapur block is based on water level fluctuation method is estimated to be

7880.80 ham. Draft for all use is 6838.26 ham and over all stage of development is 86.77%.

overall the Rudrapur block is categorized as semi-critical category. The ground water potential

of the study area is presented in Table 3.5.

Table 3.5 Groundwater Resources Potential

S. No Block/District GW Availability

GW Draft Level of Developme

nt (%)

Categorization

1 Rudrapur 7880.80 6838.26 86.77 Semi–Critical

2 Udham Singh Nagar

62005.8 49207.27 79.67 Semi–Critical & Safe

Source: CGWB Voucher 2006

3.2.5 Ground water Level

The 10 km study area falls in Udham Singh Nagar block of Rudrapur District. The depth to

water level in the study area during pre monsoon season was >5 m bgl and in post monsoon

season depth to water table ranges 2 m to 5 m.

3.2.6 Seismicity of the Study Area

Based on tectonic features and records of past earthquakes, a seismic zoning map of India has

been prepared by a committee of experts under the auspices of Bureau of Indian Standard

(BIS Code: IS: 1893: Part I 2002. According to the seismic-zoning map of India, the project

area falls in Zone IV (High Risk Zone) of seismicity. Thus lies among the moderate-risk

earthquake areas. The seismicity map of study area shown in Figure 3.9.

Figure 3.6 Seismic Zones Map





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Figure 3.7 Ground Water Dvelopment and categorization in Udham Singh Nagar District





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3.3 Land use

Land use analysis was carried out using remote Sensing Data. Interpretation approach based

on systematic digital imaging was used for delineating the land use classes. The demarcation

of boundaries falling under different land use/land cover units is done using different colours

assigned to different land use/land cover units of satellite imagery1.

Land use of project site is industrial land. Most of the land within the 10 km area of the project

site is under agriculture. As per the land use based on satellite image, about 67% of the land is

under cultivation. 8.75% land is under vegetation, 7.35% of the land is under settlement, about

15.48% land is under open shrubs/plantation and rest of the land is under other uses (Refer

Figure 3.9 and Table 3.6).

Table 3.6 : Land use of the Study Area

Sl. No. Class Area(Sq km) Percentage

1 Agricultural Land 216.14 67.06

2 Vegetation 28.19 8.75

3 Settlement 23.69 7.35

4 Waterbody 4.38 1.36

5 Open Shrub Land/Plantation

49.9 15.48

Total 322.3 100.00

Source: Satellite Image analysis

Figure 3.8 Figure Graphical Distribution of Land use

1 LANDSAT 8 imagery were used for the complete coverage of the study area





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Figure 3.9 FCC Image of the study Area





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Source: Interpretation of Satellite image

Figure 3.10 Land Use Map of the Study Area (10 km Radial Zone)





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3.4 Meteorology

Historical meteorological data was obtained from nearest IMD station located at district

headquarter Bareilly. The predominant wind direction is from west and northwest direction in all

season. Details provided in Table 3.5.

Table 3.7 Long Term Meteorological Data of Bareilly (30 years average)

Month

Temperature (oC) daily

Relative Humidity (%) Rainfall

(mm)

Predominant Wind Direction

(From)

Cloud Amounts Oktas

Wind Speed Km/hr Max Min Max Min 08:30 17:30

January 21.6 8.2 82 58 19.6 W, NW 2.0 2.1 3.6

February 24.6 10.6 75 48 20.8 W, NW 1.8 2.1 4.7

March 30.8 15.1 63 37 14.0 W, NW 1.5 2.0 5.8

April 37.2 21.0 46 27 9.0 W, NW 1.3 1.8 5.9

May 39.7 24.5 46 30 22.5 E, W 1.2 1.4 6.0

June 38.7 26.6 63 45 118.6 E, W 3.3 29 6.0

July 34.2 25.8 82 71 297.2 E, W 5.4 5.3 5.3

August 33.1 25.7 85 76 316.9 E, W 5.3 5.4 4.5

September 33.2 24.1 82 70 190.8 E, W 3.4 3.5 4.1

October 32.5 19.4 77 58 37.4 E, W 1.0 1.0 2.6

November 28.3 13.4 76 57 1.1 W, NW 0.7 0.9 2.2

December 23.2 9.0 81 60 11.8 W, NW 1.8 1.8 2.8

Annual Total / Mean

31.4 18.6 72 53 1059.7 W, E 2.4 2.5 4.5

Source: IMD

Temperature– December, January and February constitutes winter months with daily mean

minimum temperature around 8.20C and daily mean maximum temperature around 24.6 0C.

May is the hottest month with daily mean maximum temperature at 39.7 0C and daily mean

minimum temperature at 24.5 0C.

Relative Humidity– The air is generally dry in the region except during monsoon. April and May

are driest with relative humidity ranges between 27-46%. The maximum humidity during rainy

season is 85%.

Rainfall– The annual total rainfall is 1059.7 mm. Over 87% of the total annual rainfall is

received during the monsoon period between June to September.





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Cloud Cover – In the study area, clear weather prevails in most of the time during post

monsoon, winter and summer seasons. Only during monsoon months of July, August and

September, moderate to heavy clouds are observed. Relevant details about the number of days

with zero oktas of cloud cover (all clouds) for all months are presented in Table 3.6.

Table 3.8 No. of days with zero oktas of cloud cover (Bareilly)

Cloud Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

Time 08:30 19 17 19 19 22 12 4 4 10 23 24 19

17:30 18 15 16 17 20 13 4 3 9 22 23 17

Wind Speed– The mean wind speed ranges from 2.2 to 2.8 kmph during post-monsoon, 4.1 to

6.0 kmph during monsoon and 5.8 to 6.0 kmph in pre-monsoon season.

Wind Direction– The predominant wind direction at Bareilly is from West and North-West in

summer and winter months. The second most predominant wind direction is from East and

West monsoon months.

Calm Periods – The calm period constitute an important factor in the dispersion of air pollution.

The calm period is more during daytime compared to night-time. The maximum calm period

occur during October to February months. Monthly calm period values obtained from nearest

IMD is shown in Table 3.8.

Table 3.9 Monthly Percentages of Calm Periods (IMD Bareilly)

Calm (%) Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec

Time 08:30 34 23 17 16 16 16 21 21 27 44 49 45

17:30 47 24 14 16 18 20 23 29 36 64 68 58

Special Weather Phenomena- The occurrence of thunderstorm is 31.9 days per year, mostly

spread across the months of May to September. Annual Dust Storm is 3.1 days during summer.

Annually 7.3 days have visibility less than 1 km, 71.3 days has visibility in the range of 1 - 4 km,

260.2 days have visibility in the range of 4 -10 km, 24.8 days between 10 - 20 km and 1.4 days

have visibility above 20 km. No dust storm or thunderstorm occurred during the study period.





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3.4.1 Met Data Generated at Site

Met data for 1st October 2017 to 31st December 2017 month was generated at site. An

automatic weather monitoring station was installed at Project site, keeping the sensors free

exposed to the atmosphere and with minimum interference with the nearby structures. The

micro-meteorological data like wind speed, wind direction, temperature, relative humidity and

atmospheric pressure were collected using the weather stationed cloud cover was recorded

manually for the study period.

The wind directions, wind speed, temperature, rainfall and humidity recorded at site during study

period are presented in Table 3.8. Site specific wind rose diagram for study period (1st October

2017 to 31st December 2017) is presented in Figure 3.11. Graphical representation of wind

frequency distribution patter is provided in Figure 3.12.

Table 3.10 Site Specific Meteorological Data

Month Temperature

(deg C)

Relative

Humidity, %

Wind speed

(m/s)

Predominant

wind Direction

Calm

Period

Min Max Min Max Average (from ) %

Oct.- 2017 18 28 49 79

0.84 West 48.23 Nov.- 2017 12 20 55 77

Dec.- 2017 06 17 59 88

(Source: Field Survey)

Temperature – During the study period daily mean minimum temperature was 6 0C and daily

mean maximum temperature was 28 0C.

Relative Humidity –The maximum humidity during study period was 88 % and minimum was

49 %. High humidity is found during daytime and low humidity values during night time.

Wind Speed– The wind speed ranges between 0.5 to 3.0 m/s during study period except calm

conditions. Most of the time wind speed ranges between 1.0 to 2.5 m/s. Wind frequency

distribution during the study period is presented in Figure 3.11.





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Wind Direction – The predominant wind direction at site is from West and West- North West

direction. Windrose diagram is presented in Figure 3.12.

Calm Periods – Calm period is more during night time than day time. Percentage calm periods

during study period was 48.23%.

Figure 3.11 Wind rose Diagram





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Figure 3.12 Wind Frequency distribution

3.5 Ambient Air Quality

CPCB guidelines were applied for selecting the appropriateness of monitoring locations. The

location and height of the stations were so selected (>5 m from base) to avoid the capture of re-

suspended road dust and fugitive domestic emissions due to burning. All the ambient air

analysis with respect to each parameter were analysed as per CPCB guidelines. AAQ

monitoring was done at eight locations within the study area considering dominant wind

direction, populated area and sensitive receptors. Details of monitoring locations are shown in

Table 3.9. Monitoring Location map is shown in Figure 3.4. The summary of Ambient Air quality

results is presented in Table 3.8 and Table 3.9.





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Table 3.11 Ambient Air Quality Monitoring Locations

S. No. Location Direction wrt Plant site with approx. distance

Terrain features Tentative Geo-coordinates

AAQ-1 Project Site 00 Industrial setting, Flat Terrain

29° 0'24.36"N 79°24'34.21"E

AAQ-2 Foji Matkota 3.25(W) Rural setting, Flat Terrain located in upwind direction

29° 0'28.39"N 79°22'35.14"E

AAQ-3 Chhatarpur 3.17(NW) Rural setting, Flat Terrain located in upwind direction

29° 1'43.49"N 79°23'19.46"E

AAQ-4 Pantnagar** 7.93km(E) Rural setting, Flat Terrain located in downwind direction

29° 1'19.47"N 79°29'22.42"E

AAQ-5 Rudrapur 3.18km(S) urban setting, Populated area Flat Terrain located in crosswind direction

28°58'48.45"N 79°23'59.82"E

AAQ-6 Kalyanpur 1.24km(SW) Rural setting, Flat Terrain located in downwind direction

29° 0'11.98"N 79°23'49.94"E

AAQ-7 Haldi 4.93km(NE) Rural setting, Flat Terrain located in Crosswind direction

29° 2'12.73"N 79°26'49.32"E

AAQ-8

SIDCUL Industrial

Area (Near Delta Power

Solu.)

0.200km(E Industrial setting, Flat Terrain located in downwind direction

29° 0'30.82"N 79°24'27.93"E

Note: **There is no habitation/ settlement in downwind direction up to Pant Nagar.

Table 3.12 Ambient Air Quality Monitoring Results (24-hour average)

Location Code

Location PM2.5 (g/m3) PM10 (g/m3)

Min Max Mean 98 Percentile


AAQ-1 Project Site 24 42 34 42 47 80 66 80

AAQ-2 Foji Matkota 25 43 33 42 44 75 59 73

AAQ-3 Chhatarpur 21 44 34 44 38 79 62 79

AAQ-4 Pantnagar 27 45 34 43 50 81 62 77

AAQ-5 Rudrapur 28 49 36 47 53 90 66 84

AAQ-6 Kalyanpur 22 39 31 39 44 74 58 73

AAQ-7 Haldi 26 41 32 41 53 78 63 77

AAQ-8 SIDCUL Industrial Area (Near Delta Power Solu.)

23 43 32 41 42 75 60 73





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Source: Primary Data Collection and analysis during study period by Laboratory

Table 3.10 continued……

Location Code

Location SO2 (g/m3) NOx (g/m3)



AAQ-1 Project Site 5.2 9.1 6.9 9.1 9.2 14.7 12.4 14.6

AAQ-2 Foji Matkota 5.5 9.1 7.2 8.8 9.7 14.8 12.2 14.5

AAQ-3 Chhatarpur 4.8 8.4 6.6 8.2 8.2 17.4 12.3 17.1

AAQ-4 Pantnagar 5.0 8.8 7.0 8.8 8.5 15.7 12.0 15.1

AAQ-5 Rudrapur 6.2 9.2 7.7 9.1 10.0 18.4 12.4 16.5

AAQ-6 Kalyanpur 5.3 7.6 6.5 7.6 10.2 14.9 12.2 14.9

AAQ-7 Haldi 5.4 9.1 7.4 9.1 10.2 17.3 12.4 16.4


6.1 8.9 7.7 8.9 9.6 15.0 12.0 14.6

Source: Primery Data Collection and analysis during study period by Laboratory

Table 3.10 continued……

Location Code

Location

NH3 (µg/m³)

CO, mg/m3 (8 hrs Conc.)

VOC (µg/m³)

HF (µg/m³)

HBr (µg/m³)

AAQ-1 Project Site 15.3 0.35 <0.1 <0.1 <0.1 AAQ-2 Foji Matkota 15.4 0.46 <0.1 <0.1 <0.1

AAQ-3 Chhatarpur 15.7 0.25 <0.1 <0.1 <0.1

AAQ-4 Pantnagar 16.6 0.29 <0.1 <0.1 <0.1

AAQ-5 Rudrapur 17.7 0.57 <0.1 <0.1 <0.1

AAQ-6 Kalyanpur 17.3 0.42 <0.1 <0.1 <0.1

AAQ-7 Haldi 16.1 0.34 <0.1 <0.1 <0.1


15.4 0.51 <0.1 <0.1 <0.1

3.5.1 Observations on Ambient Air Quality:

Particulate Matter (PM10): The highest PM10 level were found at Rudrapur town (90 µg/m3) and

lowest PM10 level (38 µg/m3) were observed at at Chhatpur, while the mean conc. of all location

ranges between 58-66 µg/m3. The PM10 level in all the monitoring locations is within the

standard i.e. NAAQMS level 100µg/m3





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Particulate Matter (PM2.5): The highest PM2.5 level were found at Rudrapur (49 µg/m3) and

lowest PM2.5 level were observed at Chhatarpur (21 µg/m3) while the mean conc. of all location

ranges between 31-36 µg/m3. The PM2.5 level in all the monitoring locations is within the


Sulphur Dioxide (SO2): The highest SO2 level were found at Rudraur (9.2 µg/m3) and lowest

SO2 level were observed also at Chhatrpur (4.8 µg/m3) while the mean conc. of all location

ranges between 6.5-7.7 µg/m3. The SO2 level in all the monitoring locations is found quite

below the standard i.e. NAAQMS level 80µg/m3

Oxides of Nitrogen (NOx): The highest NOx level were found at Rudrapur (18.4 µg/m3) and

lowest NOx level were observed at Chhatarpur (8.2 µg/m3) while the mean conc. of all location

ranges between 12.0-12.4 µg/m3. The NOx level in all monitoring location are quite below the


Other Parameters: NH3 were found in the rage of 15.3 to 17.7 µg/m3 which is found within the

standard i.e. NAAQMS level 400µg/m3. CO mean Value are 0.25 to 0.57 mg/m3 and VOC, HBr,

HF were not detected in the study area. Over all the ambient air quality of the study area is

meeting the prescribed National Ambient Air Quality Standard at all locations. No abnormal

values have been found in the dust of ambient air.

3.6 Noise Environment

Noise after a certain level can have a very disturbing effect on the people and animals exposed

to it. Hence, it is important to assess the present noise quality of the area in order to predict the

potential impact of future noise levels due to the proposed project. Ambient noise

measurements were taken at 8 locations, represented in Table 3.13. Location wise result for

day time and night time is presented in Table 3.14.

The monitored levels were compared against the Noise Pollution (Regulation and Control)

Rules 2000, as amended through the Noise Pollution (Regulation and Control) Amendment

Rules 2010 dated 11th January 2010. The project site falls in designated industrial area and the

noise levels at all the locations were found within the ambient noise standards.

Table 3.13 Ambient Noise Quality Monitoring Locations

S. No.

Location Direction wrt Plant site with approx. distance

Category Tentative Geo-coordinates

N-1 Project Site 00 Industrial 29° 0'24.36"N 79°24'34.21"E





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N-2 Foji Matkota 3.24(W)

Residential 29° 0'28.32"N 79°22'35.12"E

N-3 Chhatarpur 3.18(NW)

Residential 29° 1'43.39"N 79°23'19.36"E

N-4 Pantnagar 7.88km(E)

Commercial/ Mixed use area

29° 1'19.37"N 79°29'22.32"E

N-5 Rudrapur 3.12km(S)

Commercial/ Mixed use area

28°58'48.41"N 79°23'59.80"E

N-6 Bilaspur – Haldwani Road (Near Kalyanpur) , 1.0 Km., W

1.0 Km(W) Commercial/ Mixed use area

29° 0'24.48"N 79°23'53.00"E

N-7 Haldi 4.91km(NE)

Residential 29° 2'12.63"N 79°26'49.22"E

N-8 SIDCUL Industrial Area (Near Delta Power Solu.)

0.200km(N) Industrial 29° 0'30.82"N

79°24'27.93"E

Table 3.14 Ambient Noise Quality in the Study Area

S. No. Locations

dB(A) Leq Day time

Standard dB(A) Leq

dB(A) Leq Night time

Standard dB(A) Leq

N-1 Project Site 58.4 75 47.0 70

N-2 Foji Matkota 51.0 55 42.2 45

N-3 Chhatarpur 50.4 55 41.5 45

N-4 Pantnagar 59.6 65 45.8 55

N-5 Rudrapur 61.2 65 51.5 55

N-6 Bilaspur – Haldwani Road (Near Kalyanpur) , 1.0 Km., W

61.4 65 49.5 55

N-7 Haldi 51.2 55 40.4 45

N-8 SIDCUL Industrial Area (Near Delta Power Solu.)

57.7 75 47.3 70

Source: Analysis during study period, EQMS

3.6.1 Observation on Ambient Noise Quality:

The ambient noise quality of the study area is within the prescribed National Ambient Noise

Quality Standards prescribed for industrial (Standards - 75 dBA during day time and 70 dBA

during night time) residential area (Standards - 55 dBA during day time and 45 dBA during night

time) and commercial area (Standards - 65 dBA during day time and 55 dBA during night time).

3.7 Water Quality

3.7.1 Ground Water Quality





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Eight ground water samples and two surface water sample were collected from different

locations around the site during study period. The water samples were examined for physico-

chemical parameters and bacteriological parameters. The samples were collected and analysed

as per the procedures specified in Standard Methods. Samples for chemical analyses were

collected in polyethylene carboys. Samples for bacteriological analyses were collected in

sterilized bottles. Temperature, pH, conductivity and dissolved oxygen were measured at site

itself. Surface water sample were analyzed for various parameters and assessed using the

CPCB‘s BDU Criteria.

The name of ground water sampling locations is presented in Table 3.15. The analysis results

of groundwater are presented in Table 3.15 and Table 3.16.

Table 3.15 Ground Water Sampling Locations

S. No. Location Source Distance & Direction from site

Coordinates

GW1 Project Site Borewell Site

29° 0'24.36"N 79°24'34.21"E

GW2 Rudrapur Hand pump 3.12 km, S

28°58'38.41"N 79°23'59.70"E

GW3 Pantnagar Hand pump 7.8 km, E 29° 1'19.32"N 79°29'22.22"E

GW4 FaujiMatkota Hand pump 3.1 km, W

29° 0'28.27"N 79°22'35.16"E

GW5 SIDCUL Industrial Area Near Delta Power

Borewell 0.2, km, N

29° 0'30.82"N 79°24'27.93"E

GW6 Haldi Hand pump 4.8 km, NE

29° 2'12.53"N 79°26'49.12"E

GW7 Kalyanpur Hand pump 1.14 km, SW

29° 0'11.88"N 79°23'49.84"E

GW8 Chhatarpur Hand pump 3.15 km, NW

29° 1'43.29"N 79°23'19.26"E





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Table 3.16 Ground Water Quality in the Study Area

S.N. Parameters GW1 GW2 GW3 GW4

Limits as per IS: 10500-2012

Medhods

Desirable Permissible

1 pH Value 7.18 7.25 7.20 7.05 6.5-8.5 No Relaxation

IS :3025(Pt-11)1983RA2017

2 Temperature 0C 25.2 25.0 25.6 25.4 - - IS: 3025(Pt-9)

3 Conductivity,

mhos/cm

368 392 448 435 - - IS: 3025(Pt-14)

4 Turbidity (NTU) <1 <1 <1 <1 1 5

IS: 3025(Pt-10)1984RA2017

5 Total Dissolved solids mg/l

230 246 281 272 500 2000

IS : 3025(Pt-16)1984 RA 2017

6 Total Suspended solids mg/l

<2 <2 <2 <2 - -

IS-3025 (p-17) :1984 RA 2006

7 Total Hardness as CaCO3 mg/l

168 180 192 186 200 600 IS : 3025(Pt-21)2009R2014 8 Chloride as Cl mg/l 18 21 27 24

250 1000 IS : 3025(Pt-32)

1988R2014

9 Total Alkalinity mg/l 132 138 160 156 200 600

IS : 3025(Pt-23) 1986R2014

10 Sulphates as SO4

mg/l 12.8 14.2 18 16.6

200 400 IS : 3025(Pt-24)

1986R2014

11 Nitrates as NO3 mg/l 1.9 2.1 2.5 2.3 45 No Relaxation

IS : 3025(Pt-34) 1988R2014

12 Fluoride as F mg/l 0.32 0.38 0.46 0.42 1 1.5

APHA 23rd Ed, 4500 F (D)

13 Iron as Fe mg/l 0.22 0.25 0.28 0.26 0.3 No Relaxation

APHA 23rd Ed, 3111

14 Zinc as Zn mg/l <0.01 <0.01 <0.01 <0.01 5 15 APHA 23rd Ed, 3111 15 Calcium as Ca mg/l 44 47.2 50.2 48.8

75 200 IS : 3025(Pt-40)

1991R2014

16 Magnesium as Mg mg/l

14.4 15.1 16.0 15.6 30 100

APHA 23rd Ed, 3500 Mg B

17 Sodium as Na mg/l 16.0 18.0 21.0 28 - - APHA 23rd Ed,





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3500 Na (B)

18 Potassium as K mg/l

6.2 6.9 5.6 11 - -

APHA 23rd Ed, 3500 K (B)

19 Cadmium as Cd mg/l

<0.01 <0.01 <0.01 <0.01 0.003 No Relaxation

APHA 23rd Ed, 3111

20 Copper as Cu mg/l <0.01 <0.01 0.03 <0.01 0.05 1.5

APHA 23rd Ed, 3111

21 Nickel as Ni mg/l <0.01 <0.01 <0.01 <0.01 0.02 No Relaxation

APHA 23rd Ed, 3111

22 Lead as Pb mg/l <0.01 <0.01 0.022 <0.01 0.01 No Relaxation

APHA 23rd Ed, 3111

23 Mercury as Hg mg/l <0.001 <0.001 <0.001 <0.001 0.001 No Relaxation

APHA 23rd Ed, 3112

24 Chromium (Total as Cr) mg/l

<0.05 <0.05 <0.05 <0.05 0.05 No Relaxation

APHA 23rd Ed, 3111

25 Arsenic as As mg/l <0.01 <0.01 <0.01 <0.01 0.01 0.05

APHA 23rd Ed, 3114

26 Phenolic compound mg/l

<0.001 <0.001 <0.001 <0.001 0.001 0.002

IS : 3025(Pt-43) 1992R2014

27 Total coliform MPN/100ml

ND <2 ND <2 ND <2 ND <2 Shall not be detectable IS : 1622-2003 RA – 2009

Source: Water Analysis during study period

Table 3.17 Ground Water Quality in the Study Area

S.N. Parameters GW5

GW6

GW7 GW8

Max Requirement as per (IS-10500-2012) Limit Medhods

Desirable Permissible

1 pH Value 7.30 6.59 7.23 6.87 6.5-8.5

No Relaxation

IS :3025(Pt-11)1983RA2017

2 Temperature 0C 26.0 25.7 25.9 26.0 - - IS: 3025(Pt-9)

3 Conductivity,

mhos/cm

358 572 410 422 - - IS: 3025(Pt-14)

4 Turbidity (NTU) <1 <1 <1 <1 1 5

IS: 3025(Pt-10)1984RA2017





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5 Total Dissolved solids mg/l

224 360 256 264 500 2000

IS : 3025(Pt-16)1984 RA 2017

6 Total Suspended solids mg/l

<2 <2 <2 <2 - -

IS-3025 (p-17) :1984 RA 2006

7 Total Hardness as CaCO3 mg/l

148 240 182 186 200 600 IS : 3025(Pt-21)2009R2014 8 Chloride as Cl

mg/l 17 22 20 24

250 1000 IS : 3025(Pt-32)

1988R2014

9 Total Alkalinity mg/l

122 198 142 156 200 600

IS : 3025(Pt-23) 1986R2014

10 Sulphates as SO4 mg/l

11.2 18 16.8 18 200 400

IS : 3025(Pt-24) 1986R2014

11 Nitrates as NO3

mg/l 1.4 1.8 1.5 1.6

45 No

Relaxation IS : 3025(Pt-34)

1988R2014

12 Fluoride as F mg/l

0.22 0.28 0.52 0.56 1 1.5

APHA 23rd Ed, 4500 F (D)

13 Iron as Fe mg/l 0.18 0.22 0.18 0.20 0.3

No Relaxation

APHA 23rd Ed, 3111

14 Zinc as Zn mg/l <0.01 <0.01 <0.01 <0.01 5 15 APHA 23rd Ed, 3111 15 Calcium as Ca

mg/l 44.8 52 46 50.4

75 200 IS : 3025(Pt-40)

1991R2014

16 Magnesium as Mg mg/l

11.2 26.7 12.6 16.6 30 100

APHA 23rd Ed, 3500 Mg B

17 Sodium as Na mg/l

17.0 30.0 23 19 - -

APHA 23rd Ed, 3500 Na (B)

18 Potassium as K mg/l

6.1 13.0 9.4 7.4 - -

APHA 23rd Ed, 3500 K (B)

19 Cadmium as Cd mg/l

<0.01 <0.01 <0.01 <0.01 0.003

No Relaxation

APHA 23rd Ed, 3111

20 Copper as Cu mg/l

<0.01 <0.01 <0.01 <0.01 0.05 1.5

APHA 23rd Ed, 3111

21 Nickel as Ni mg/l

<0.01 <0.01 <0.01 <0.01 0.02

No Relaxation

APHA 23rd Ed, 3111

22 Lead as Pb <0.01 <0.01 <0.01 <0.01 0.01 No APHA 23rd Ed,





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mg/l Relaxation 3111

23 Mercury as Hg mg/l

<0.001 <0.001 <0.001 <0.001 0.001

No Relaxation

APHA 23rd Ed, 3112

24 Chromium (Total as Cr) mg/l

<0.05 <0.05 <0.05 <0.05 0.05

No Relaxation

APHA 23rd Ed, 3111

25 Arsenic as As mg/l

<0.01 <0.01 <0.01 <0.01 0.01 0.05

APHA 23rd Ed, 3114

26 Phenolic compound mg/l

<0.001 <0.001 <0.001 <0.001 0.001 0.002

IS : 3025(Pt-43) 1992R2014

27 Total coliform MPN/100ml

ND <2 ND <2 ND <2 ND <2 Shall not be detectable IS : 1622-2003 RA - 2009






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Observation on Ground water Quality

The pH value of drinking water is an important index of acidity or alkalinity. pH value of

the sample vary from 6.76 to 7.30 in all locations, which is well within the specified

standard of 6.5 to 8.5. The pH of the ground water in the study area is neutral to slightly

alkaline in nature.

Electric Conductivity levels vary from 358 to 572 µmho/cm. Total dissolved solids

ranges from 224 to 360 µg/l which is found within the desired limit.

The total hardness is an important parameter of water quality. The hardness values in

ground water of the study area ranges between 148 to 240 mg/l which is well within the

permissible limit except Rudrapur location, where the hardness values are slightly above

the permissible limit but well within the desirable limit. The calcium values in ground

water of the study area are well within the specified desirable limit. Magnesium values in

ground water of the study area are well within the specified permissible limit of Indian

drinking water standard.

The chloride values in ground water of the study area ranges between 17.0 to 28.0 mg/l

which is well within the permissible limit

No biological and metallic contamination has been found in any of the ground water

sample of the study area.

Overall the parameters in ground water sample were well within the desired limit of Indian

Standard IS: 10500-2012, except Haldi location, where the hardness values are slightly above

the desired limit but well within the desirable limit. No metallic and bacterial contamination was

found in the ground water samples.

3.7.2 Surface Water Quality

Two surface water samples were collected from the study area. One sample Baror stream, and

one from Chakpheri Nadi collected as per standard method. The samples were collected and

analysed as per the procedures specified in Standard Methods. Samples for chemical analyses

were collected in polyethylene carboys. Samples for bacteriological analyses were collected in

sterilized bottles. Temperature, pH, conductivity and dissolved oxygen were measured at site

itself. Surface water sample were analyzed for various parameters and assessed using the

CPCB‘s BDU Criteria. Surface water sampling location is presented in Table 3.18 and analysis

results are presented in Table 3.19.

Table 3.18 Surface Water Sampling Locations

S. No. Location Source Distance from Plant site

Coordinates

SW1 Baror Nadi Stream 5.25km(E) 28 59 42.44 N 79 29 31.36 E

SW2 Chakpheri Stream 6.5 km(E) 28 59 51.30 N





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79 27 40.25 E


Table 3.19 Surface Water Quality in the Study Area

S.N. Parameters SW1 SW2 Method

1 pH Value 7.10 7.36 IS : 3025(Pt-11) 1983R2012

2 Temperature 0C 24.8 24.6 IS: 3025(Pt-9)

3 Conductivity, mhos/cm 668 630 IS: 3025(Pt-14)

4 Turbidity (NTU) <1 <1 IS: 3025(Pt-10)1984 R 2012

5 Total Dissolved solids mg/l 419 398 IS : 3025(Pt-16)1984 R 2012

6 Total Suspended solids mg/l 7 5 IS-3025 (p-17) 1984 RA 2006

7 Total Hardness as CaCO3 mg/l 280 264 IS : 3025(Pt-21)2009R2014

8 Chloride as Cl mg/l 38 36 IS : 3025(Pt-32) 1988R2014

9 Total Alkalinity mg/l 230 216 IS : 3025(Pt-23) 1986R2014

10 Sulphates as SO4 mg/l 20.8 19.6 IS : 3025(Pt-24) 1986R2014

11 Fluoride as F mg/l 0.56 0.48 APHA 23rd Ed, 4500 F (D)

12 Iron as Fe mg/l 0.38 0.34 APHA 23rd Ed, 3111

13 Zinc as Zn mg/l 0.78 0.72 APHA 23rd Ed, 3111

14 Calcium as Ca mg/l 66.0 62.4 IS : 3025(Pt-40) 1991R2014

15 Magnesium as Mg mg/l 27.7 26.2 APHA 23rd Ed, 3500 Mg B

16 Cadmium as Cd mg/l <0.01 <0.01 APHA 23rd Ed, 3111

17 Copper as Cu mg/l <0.01 <0.01 APHA 23rd Ed, 3111

18 Nickel as Ni mg/l <0.01 <0.01 APHA 23rd Ed, 3111

19 Lead as Pb mg/l <0.05 <0.03 APHA 23rd Ed, 3111

20 Mercury as Hg mg/l <0.001 <0.001 APHA 23rd Ed, 3112

21 Total Chromium (Total as Cr)

mg/l

<0.05 <0.05 APHA 23rd Ed, 3111

22 Arsenic as As mg/l <0.025 <0.025 APHA 23rd Ed, 3114

23 Oil & Grease mg/l <2 <2 IS : 3025(Pt-39)1991R2014

24 Chemical Oxygen Demand (as

COD mg/l)

36 34 IS : 3025(Pt-58) 2006R2012

25 Bio- Chemical Oxygen Demand

as BOD (for 3 Days 27 ˚C) mg/l

9.4 8.8 IS : 3025(Pt-44) 1993R2014

26 Dissolved Oxygen mg/l 6.2 6.6 IS : 3025(Pt-38) 1989R2003

27 Total Coliform MPN/100ml 1080 1020 IS : 1622-2003 RA - 2009


Observation on Surface water Quality:





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Bacterial and metallic contamination was observed in the surface water sample. However the

surface water was found to meet the Best Designated Use – ‗D‘ Criteria of CPCB (i.e fit for fish

propagation).

3.8 Soil Quality

Soil is our most important natural resource and a natural resource is anything that comes from

the earth and is used by us. We depend on the soil for food, clothing, shelter, minerals, clay &

water. Soil is the seat of many macro and micro flora like algae, fungi, earthworms, bacteria etc.

These are very beneficial in promoting soil reactions and decomposing the organic matter by

which essential nutrients for plants are liberated. Most of the soil is made-up of two main parts:

Tiny bits of mineral particles which come from larger rocks, and humus, which is dark brown in color and consists of decaying remains of plants and animals.

Soil also contains water, air and living organisms, such as fungi, bacteria, earthworms, roundworms, insects, etc. Actually more living organisms live in the soil than above it.

For general characterization of soil a few random samples from the study area to the depth of

about 15-cm may sufficient. Deeper soil samples may be needed only for the study of soil

profile.

3.8.1 Soil Classification of the Region2

The soil types are controlled by the topography and rock types. Based on the National Bureau

of Soil Survey and Land Use (NBSS & LU) Planning (ICAR) Nagpur, the soils of the district

Udham Singh Nagar can be classified into Udifluventic Ustochrepts, Typic Ustipsamments, Udic

Ustochrepts, Udic Haplusstolls, Typic Ustochrepts as determined by their diagnostic properties.

The Bhabar soils lay at the northern extremity of Khatima and Bazpur blocks, part of the alluvial

fan deposits. Soils are shallow with sandy to loamy texture, poorly sorted, comprising mainly of

gravel, sand, silt, clay with pebbles etc.

The Tarai soils run all along the northern extremity of the district, form continuous fringe with the

Bhabar Zone. Bhabar formation is found in extreme northern parts of the Khatima and Bazpur

blocks, boundary demarcated by the contact of Tarai and Bhabar. The Tarai belt is 8–25-km in

width, and the general slope is <1% towards south. Soil is calcareous, moderately productive

and suitable for extensive cultivation of high yielding variety of crops like rice and sugarcane.

2 (Source-http://www.cgwb.gov.in/District_Profile/Uttarakhand/UdhamSinghNagar.pdf)

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3.2. Agricultural Status of the District

Udham Singh Nagar District is the food bowl of Uttarakhand State. Prior to its formation, it was

part of District Nainital. It was separated out on the basis of physiographical conditions i.e.

Tarai. Udham Singh Nagar district is famous for its agriculture and irrigation on synchronized

patterns from the past as garner of popularity for its productivity in paddy crops in the whole

Uttarakhand state, and it is rightly called ―Chawal-ki-Nagari‖, thus making it importance in

bringing out the district groundwater brochure. Udham Singh Nagar district falls in the Tarai

region of Kumaon Divison.

3.8.2 Cropping Pattern

Agriculture is the primary occupation of the people in the District as it justifies the title of

―Chawal-ki-Nagari‖. About 64% of the total work force is engaged in farming the very fertile land

(Tarai formation). Kharif and Rabi are two major cropping seasons. The main Kharif crops are

rice, Soybean, Urd, Moong and till, and the Rabi crops are wheat, barley, Gram, Masoor,

Mustard, Sunflower. It is observed in the study area that the rice crop is grown three times in a

year. The total reported area of district is 279455.0-ha, out of which 84717.0-ha is occupied by

the forests. Net sown area in the district is 149523.0-ha and gross sown area is 246481.0-ha.

Area has been sown more than once in the district is 96561.0-ha Area under Rabi and Kharif

crops are 97973.0-ha and 139928.0-ha respectively. 8580.0-ha is reported under the Zaid crop.

The sugarcane crop is also grown in very intensively as it is a major cash crop.

Cropping Pattern, Production and Productivity of major cultivated crops is shown in Table: 3.20

& 3.21 respectively. Soil map of the district is also presented by Figure: 3.13.

Table 3.20 Cropping Pattern in the District as per Latest Figures, 2008-09

Major Field Crops Area (000-ha) Irrigated Rain fed

Sugarcane 38.1 nil nil

Paddy 108.0 ― ―

Wheat 83.0 ― ―

Maize 0.7 ― ―

Pulses 3.7 ― ―

Horticultural Crops-Fruits

Mango 234 ― ―

Litchi 640 ― ―

Guava 432 ― ―

Vegetable Crops

Okra 393 ― ―

Vegetable Pea 1346 ― ―

Potato 1832 ― ―

Cauliflower 219 ― ―





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Onion 288 ― ―

Cabbage 270 ― ―

Source-http://usnagar.nic.in/pages/display/170-statistical-handbook-2009

Table 3.21 Table-2.0: Production and Productivity of Major Crops in the District, 2008-12

Major Crops

Kharif Rabi Summer Total

Prodn. („000t)

Prod.ty (kg/ha)

Prodn. („000t)

Prod.ty (kg/ha)

Prodn. („000t)

Prod.ty (kg/ha)

Prodn. („000t)

Prod.ty (kg/ha)

Paddy 263.9 2851 nil nil 29.293 3386 263.9 3118.5

Wheat nil nil 89.3 3815 ― ― 89.3 3815

Peas ― ― 6.1 1100 ― ― 6.1 1100

Mustard

― ― 4.8 841 ― ― 4.8 841

Sugarcane

1736.3 62220 nil nil ― ―

1736.3 62220

Major Horticultural Crops, Productivity (t/ha)

Mango nil nil ― ― ― ― 21.07 9.0

Litchi ― ― ― ― ― ― 1.03 1.6

Guava ― ― ― ― ― ― 3.07 7.1

Peach ― ― ― ― ― ― 10.1 7.5

Potato ― ― ― ― ― ― 39.5 21.6

onion ― ― ― ― ― ― 10.1 7.5 (Source-http://agricoop.nic.in/Agriculture%20Contingency%20Plan/Uttarakhand/udham%20singh%20nagar.pdf)

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SOILS OF UDHAM SINGH NAGAR

DISTRICT OF UTTARAKHAND

Piedmont Plain : (1-3% Slope)

1. Deep, Stratified Loamy Sandy Soils

2. Deep, Loamy Soils

3. Deep, Loamy Silt Soils

Alluvial Plain : (0-1% Slope)



Active Flood Plain : (0-3% Slope)

6. Deep, Sandy Soils

(Source-http://agricoop.nic.in/Agriculture%20Contingency%20Plan/Uttarakhand/udham%20singh%20nagar.pdf)

Figure 3.13 Soil Map of Udham Singh Nagar District

3.8.3 Methodology of Sampling

The soil samples were collected from Six (06) selected locations during summer season. The

samples collected were homogeneous representatives of each location. At random five sub-

locations were identified at each location and soil samples were collected from 5 to 15-cm below

the surface. It was uniformly mixed before homogenizing the soil samples. The samples about

500-gms were packed in polythene bags labelled in the field with location & number and sent to

the laboratory for the analysis of physicochemical parameters.

3.8.4 Selection of Sampling Locations

Six (06) soil sampling locations were selected based on the land use conditions and the

agricultural practices.

3.8.5 Soil Sampling Locations

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Soil sampling was conducted once during the study period of summer season. Six (06) soil

samples were collected from selected locations in the vicinity of the proposed project. For

studying soil quality environment in the study area, sampling locations were selected to assess

the existing soil conditions in and around the existing plant area representing various land use

conditions. The homogenized samples were analyzed for physicochemical characteristics. Soil

sampling locations with their distance & directions with respect to the project site, are presented

in Table: 3.22.

Table 3.22 Soil Sampling Locations

Sample Code

Sampling Locations

Distance from Project Site (Km)

Direction from Project Site

Coordinates

S-1 Project site - - 29° 0'24.36"N 79°24'34.21"E

S-2 FojiMatkota 3.10 W 29° 0'28.17"N 79°22'35.10"E

S-3 Chhatarpur 3.12 NW 29° 1'43.19"N 79°23'19.16"E

S-4 Fulsunga 3.80 SE 28°59'12.81"N 79°26'27.10"E

S-5 Haldi 4.82km NE 29° 2'12.43"N 79°26'49.13"E

S-6 Rampura 5.60 S 28°57'22.98"N 79°24'16.09"E

3.8.6 Analysis of Soil Samples

The soil samples were examined for various physicochemical parameters, to determine the

existing soil characteristics of the study area. Soil samples were collected from the vicinity of

proposed mine site. Physicochemical characteristics of soil are presented in Table: 3.23.

Table 3.23 Physicochemical Characteristics of Soil

S. No.

Parameters

Unit

Project Site (S-1)

Foji Matkota (S-2)

Chhatarpur (S-3)

Fulsunga (S-4)

Haldi (S-5)

Rampura (S-6)

Physical Characteristics

1. Color - Brown Brown Brown Brown Brown Brown

2. Texture

USDA Sandy Loam

Sandy Loam

Sandy Loam

Sandy Loam

Sandy Loam

Sandy Loam

3. Particle Size Distribution

i) Sand % 54 53 55 56 58 57

ii) Silt % 28 30 34 26 30 28

iii) Clay % 18 17 11 18 12 15

4. Porosity % 48.7 46.4 47.9 45.3 47.2 44.2

5. Bulk Density (BD)

gm/cc 1.36 1.42 1.38 1.48 1.40 1.45





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3.8.7 Interpretation of Analytical Results

Physical Properties

Brown colour soils are commonly observed in the study zone. Texturally the soils of study area

are observed as Sandy Loam soils. The Bulk Density of the soils was found in the range of 1.36

to 1.48-gm/cc. Porosity was observed in the range of 44.2 to 48.7% in the soils of the study

area. Water holding capacity of study area soils was observed as 28.2 to 30.5%. The test result

shows the Permeability values were found to vary from 0.94 to 2.32-cm/hr under Sandy Loam

textured Soils in the study area.

Chemical Properties

The soil pH ranges from 6.5 to 7.8 thereby indicating the soils are slightly acidic to neutral in

nature. The organic carbon content of soil varied from 0.65 to 0.94% (1.12 to 1.62% as organic

matter) thereby implying that soils are high in organic content. Available nitrogen content in the

surface soils ranges between 275.4 & 302.5-kg/ha, thereby indicating that soils are medium in

available nitrogen content. Available phosphorus content ranges between 26.9 & 31.2kg/ha,

thereby indicating that soils are high in available phosphorus. Available potassium content in

these soils ranges between 96.4 & 124.5kg/ha, thereby is indicating that the soils are medium in

potassium content. Above description of study area soils reveals that the soils in the study area

are having moderate fertility index.

6. Water Holding Capacity (WHC)

% 28.2

28.8

29.4

30.2

30.5

29.7

7. Permeability cm/hr 0.96 1.09 2.32 0.94 2.02 1.37

Chemical Characteristics

8. pH (20% Slurry)

- 7.2 7.8 7.5 6.5 7.4 7.0

9. EC (20% Slurry)

µmhos/cm 246.8 317.9 296.4 286.6 324.7 296.5

10. CEC meq/100gm 9.5 8.8 10.2 9.2 11.8 10.5

11. Organic Matter % 1.62 1.46 1.34 1.12 1.22 1.41

12. Organic Carbon % 0.94 0.85 0.78 0.65 0.71 0.82

13. Zinc as Zn mg/kg 1.58 1.45 2.12 1.69 1.66 2.05

14. Iron as Fe mg/kg 14.5 12.8 16.2 11.8 13.5 15.2

15. Copper as Cu mg/kg 0.59 0.56 0.62 0.54 0.48 0.51

16. Manganese as Mn

mg/kg 8.5 7.8 9.2 8.1 9.6 8.4

17. Available Nutrients

i) Nitrogen as N kg/ha 285.6 298.2 288.5 275.4 292.8 302.5

ii) Phosphorus as P

kg/ha 28.5 31.2 30.8 26.9 29.6 28.5

iii) Potassium as K kg/ha 98.5 106.8 118.2 124.5 96.4 112.8

18. SAR - 1.66 1.75 2.24 1.45 1.56 1.71





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3.9 Ecological Environment

Project Area

Proposed plant site is located in Notified industrial area. most of the land around the proposed

site is built-up industrial area. the topography of the site is almost flat. The plantation is

observed all along the industrial area roads. NAARI has already developed a 15 m wide and 3

tier green belt all around the proposed site. the common trees planted under greenbelt are

Manga, Guava, citrus, Pongamia, Siris, Jamun, bottle brush and ashok.

3.9.1 Forest and Forest Types

The total Forest area under various classes of the Uttrakhand State is 37999.53 Km², which is

71% of the geographic area. Forest area under forest department is 24418.67 Km². In state

according to FSI-2011 the Very dense forest is 4,002 Km², moderately dense forest, 14,396

Km², and open forest, 6,044 Km². Scrub is 320 Km². About 19% area of the State is under

permanent snow cover, glaciers and steep slopes where it is not possible to grow trees due to

physical limitation.

Forest in Udham Singh Nagar District

Udham Singh Nagar district falls in sub Himalaya zone which includes Shiwalik range in foothills

and the Tarai range. The Sub–Himalayas forms the southernmost and the lowest zone,

bordering the Great Plains. It comprises of Shiwalik range and the Tarai forests. There is only

22.7 % of the area is under forest in Udham singh nagar district The details of the forest area

present in Udhamsingh Nagar district and state is presented in Table 3.24.

Table 3.24 Details of the forest area present in Udham singh Nagar district

Sl. No. District /State Geographical Area (km2)

Forest Cover (km2)

Forest Cover (%)

1. Udham singh Nagar 2542 577 22.70

2. Uttrakhand 53,483 24905 46.57

Forest in Study Area

The study area (10 km area) comprises of Tarai Forest. The northern part of the study area

along the foothills i.e. Tanda reserve forest comes under the study area. other wise the rest of

the area is under agriculture and settlement.





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Forest Type in tanda Forest range: The Tarai is a complex ecosystem including Sal forests,

tall grassland and swamps maintained by periodic flooding, being one of the most diverse

ecosystems of Tanda Forest Range. As per Champion HG, Seth SK. 1968 the forest type in

Tanda forest range is mainly alluvial savannah woodland type 3/I51, with some pockets of the

moist Tarai Sal forest type 3C/C2c (Champion HG, Seth SK. 1968.).

The fertile soil is fine-textured, alluvial, loamy and free from boulders. Because the Tarai is

recharged by water seepage from higher elevations it has a high water table and thus a high

moisture and nutrient content (Neelu Lodhiyal et al 2002). The forest type is mostly consisting of

mixed broad leaved species. The indigenous vegetation in this zone is very sparse and almost

nonexistent in the area and largely being replaced by agricultural areas and miscellaneous tree

growth. The vegetation consists of tall grasses and mixed tree species such as: Dalbergia

sissoo, Terminalia tomentosa, and Acacia catechu with other associated tree species like Butea

monosperma, Bombex ceiba, L., Sterculia urens Roxb., Aegle marmelos Corr., Terminalia alata

Linn, Terminalia arjuna (Roxb.) Wright &Arn., Adina cordifolia Hook.f.ex Brandis , Syzygium

cumini, Azadirachta indica, Mallotus philippensis, and Lagerstroemia parviflora. Grasses like

Themeda, Saccharum, Phragmites, Vetiveria and several others also characterize the Tanda

Forest range. Among shrubs Murraya koenigii is the most ubiquitous species in the lands cape.

3.9.2 Vegetation profile of the proposed project site

Proposed plant site is located in Notified industrial area. Most of the land around the proposed

site is built-up industrial area. The topography of the site is almost flat. The plantation is

observed all along the industrial area roads. NAARI has already developed a 15 m wide and 3

tier green belt all around the proposed site. the common trees planted under greenbelt are

Manga, Guava, citrus, Pongamia, Siris, Jamun, bottle brush and ashok.

3.9.3 Vegetation profile of the study area (within 10 km area)

During floral investigation the common plant species observed in the study area are Acacia

Catechu (Khair/ Kattha), Aegle Marmelos (Bel), Albizia Lebeck (Siris), Azadirachta indica

(Neem), Mangifera indica (Aam), Bombax ceiba (Semal / Semar), Dalbergia sissoo (Shisham),

Derris pinnata (Karang, Diospyros melanoxylon (Tendu), Ficus benghalensis (Bar/ Bargad),

Ficus racemosa (Gular), Aegle marmelos Ficus religiosa (Pipal), Madhuca longifolia (Mahua),

Phyllanthus emblica (Awla), Prosopis juliflora, Butea monosperma, Syzygium cuminii (Jamun),





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Terminalia tomentosa, Terminalia arjuna Tamarindus indica (Imli), Terminalia arjuna

(Arjun/Kahua) Mallotus philippensis, and Lagerstroemia parviflora.

Dominant herb and shrubs observed during survey are Murraya koenigii Calotropis procera,

Adhatoda vasica, Argimone Mexicana, Carissa spinarium, Lantana camara, Zizyphus

nummularia, Salvadora persica, Grewia hirsute, Cassia tora, Indigofera hirsute, Cannabis

sativa, Vitex negundo, Agave Americana, Solnum xanthocarpum etc. List of floral species

observed in the study area is given in Table 3.25.

Table 3.25 :List of Common plant species observed in the study area

Sl. No. Local/ Hindi Name Botanical Name

1. Aam Mangifera indica

2 Amaltas Cassia fistula

3 Amaltas Cassia fistula

4 Anwala Emblica officinalis

5 Arjun Terminalia arjuna

6 Asan Terminalia tomentosa

7 Ashok Polyathia longifolia

8 Babool Acacia arabica

9 Baheda Terminalia balerica

10 Bans Dendrocalamus strictus

11 Bar Ficus bengalensis

12 Bel Aegle marmelos

13 Chamror Ehretia laevis

14 Chhal Anogeissus latifolia

15 Baikan Melia azadiarchta

16 Dhak Butea monosperma

17 Dhamman Grewia oppositifolia

18 Dhauri Lagerstromia parviflora

19 Fagura Ficus recemosa

20 Guava Psidium guajava

21 Gullar Ficus glomerata

22 Gulmohar Delonix regia

23 Harar Terminalia chebula

24 Jamun Syzygium cumini

25 Jhingan Lannea coromendelica

26 Kachnaar Bauhinia variegate

27 Kadamb Anthocepnalus indicus

28 Kaimb Mitragyna parviflora

29 Kala siris Albizzia odoratissima

30 Kamela Malotus philippinensis

31 Kangu Flacurtia indica

32 Kankachampa Pterospermum acerifolium

33 Karanj Pongamia pinnata

34 Kath ber Zizyphus mauritiana





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35 Khair Acacia catechu

36 Khajur Phoenix humilis

37 Kharik Celtis ostralis

38 Kusum Schelicher oleosa

39 Mahaneem Ailanthus excelsa

40 Mahua Madhuca indica

41 Mahuli Bauhinia racemosa

42 Major phalli Holarrhena antidysentreica

43 Neem Azadirachta indica

44 Phaldu Mitragyna parviflora

45 Pipal Ficus relegiosa

46 Popular Populus ciliate

47 Pula Kydia calycina

48 Ritha Sapindus mukurossi

49 Safed siris Albizzia lebbek

50 Safeda Eucalyptus sps.

51 Sagaun Tectona grandis

52 Sain Terminalia tomentosa

53 Sainja Lagerstroemia parviflora

54 Sandan Ougenia oojenensis

55 Sanjana Moringa oleifera

56 Semal Bombax ceiba

57 Shahtoot Morus alba

58 Sheesham Dalbergia sissoo

59 Shisam Dalbergia sissoo

60 Tamarind Tamarindus indica

61 Tittri Rhus punjabensis

62 Toon Cedrela toona

Shrubs & Herbs

Sl. No. Local/ Hindi Name Botanical Name

1 Aak Calotropis procera

2 Poppy Argimone Mexicana

3 Alai Caesalpinia decapetala

4 Ban gulab Rosa moschata

5 Ban chemeli Jaminum humile

6 Ban tambaku Solanum indicum

7 Besaram Vitex negundo

8 Bans Bambusa arundinacea

9 Banwan Myrsine africana

10 Basuti, Arusa Adhotoda vasica

11 Bekhal Prinsepia utilis

12 Bhang Cannabis sativa

13 Binda Colebrookia oppositifolia

14 Charmer Artemisia vulgaris

15 Chilla Casearia tomentosa

16 Dhatura Dhatura suaveolens

17 Dhau Woodfordia fruticosa

18 Gendhela Murraya koenigii





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19 Harshingar Nyctanthes arbortristis

20 Kali kathi Indigifera hirsuta

21 Kari Patta Murraya koenigii 22 Karaunda Carissa spinarum

23 Kashmal Berberis lyceum

24 Keor Holarrhena antidysenterica

25 Kingora Barberis asiatica

26 Lantana Lantana camara

27 Mithiari Hedera helix

28 Panibel Vitis parviflora

29 Panwal Cassia tora

30 Safed kathi Desmodium tiliaefolium

31 Saun Crotolatia albida

32 Taur Bauhinia vahlii

33 White jasmine Jasminum officinale

34 Ramban Agave americana

Grasses

3.9.4 Medicinal Plants

The study area shows presence of medicinal plants. Ground flora in the study area is covered

by herbaceous vegetation, which has many Ayurvedic medicinal plants. The area abounds in

production of many kinds of fruits, flowers, seeds and leaves which have medicinal properties.

The medicinal plants mostly found in this area includes Azadirachta indica (Neem), Acacia

Catechu (Khair/ Kattha), Aegle Marmelos (Bel), Diospyros melanoxylon (Tendu), Ficus

benghalensis (Bar/ Bargad), Ficus racemosa (Gular), Ficus religiosa (Pipal), Madhuca longifolia

(Mahua), Phyllanthus emblica (Awla / Aura), Syzygium cuminii (Jamun), Tamarindus indica

(Imli), Terminalia arjuna (Arjun/Kahua) etc.

3.9.5 Threatened Plant Species

During the course of survey, no plant species were recorded as threatened in the study area.

3.9.6 Faunal Resources

The animal life of an area is dependant upon the vegetation and there are countless

relationships between the species composing an animal community. Faunal assessment

provides a basis for determining relative abundance and rarity of each species which is

Sl. No. Local Name Botanical Name

1 Bhabhar Eulaliopsis binata

2 Dhaulu Chrysopogon fulvus

3 Dub Cynodon dactylon

4 Kans Saccharum spontaneum

5 Lamb Heteropogon contortus

6 Makora Cymbopogon martini

7 Munj Saccharum munja





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important for assessing the diversity of fauna of a particular area. Since animals are capable of

movements from one place to another, this makes their study entirely different. Therefore,

specific methods were adopted for counting them in the field.

3.9.7 National Parks, Sanctuaries, Biosphere Reserves etc in the Study Area

There are no National Parks, Wildlife Sanctuaries or Biosphere Reserves or Important Bird

Areas (IBA) or other protected or ecologically sensitive areas such as migratory routes or

corridors of tigers or elephants within the study area.

3.9.8 Barriers and Corridors

There are no barriers for migration of any wild animals either within the Project area as well as

in study area.

3.9.9 Methodology

The on-site information collected during survey was further enriched by the information collected

from different sources. Assessment of wildlife fauna has been done on the basis of secondary

data collected from different government offices (including Forest and Wildlife Departments) and

by the visual observations during the survey. The study of fauna takes substantial amount of

time to understand the specific faunal characteristics of the area. Faunal studies are generally

conducted based on the available secondary data. In the present study, secondary data sources

i.e. Public consultations have been used to a large extent. In addition the following sources were

also used.

Sighting during ecological studies

Animal call

Foot mark and excreta

Most of the part of the study area is covered with agricultural fields, settlements and maximum

part of the study area is under this category. The northern part i.e. Tanda Forest range (about 5

km away from site) is the only forest present within the study area.

Mammals: No significant carnivorous and herbivorous wild animals are found in the area.

Langurs (Semnopithecus entellus), Mongoose (Herpestes edwards) and Jungle Cat (Felis

chaus) are often seen in the study area. Indian wild boar (Sus scrofa) has been reported in the

study area.





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Amphibian & Reptiles: Frog, Indian bull frog, snake like Indian cobra (Naja naja); Krait

(Bungarus coeruleus), and lizard are encountered at various places in study area. List of faunal

species observed in the study area is given in Error! Reference source not found.6.

Table 3.26 : List of the Mammals Recorded in Study Area

S.N Local Name Common Name Scientific Name Feeding

Status

Schedule

1. Lomdi Fox Vulpes bengalensis C II

2. Gilahri Striped s squirrel Funambulus pennanti H IV

3. Chuha Field rat Bandicota bangalonsis H V

4. Sehi Porcupine Hystrix Indica C IV

5. Khargosh Hare Lepus nigricollis H IV

6. Van Vilao Jungle cat Felis chaus C II

7. Nevala Mongoose Herpestes edwardsi C IV

8. Monkey Bandaer Presbytis phyarei H II

9. Langoor Langur Macaca mulata H II

10. Suwar Indian wild boar Susscrofa cristatus H III

11. Chamgadad fruit bat Cynopterus sphinx C V

12 Nilgai Nilgai Boselaphusragocamelus H III

13 Chamgadad Bat Cyanopterus gigenticus C -

H – Herbivorous, C – Carnivorous, O – Omnivorous

Table 3.27 : List of Amphibians and Reptiles Recorded in Study Area

S.N Common

Name Scientific Name

Vernacular

Name Family

Feeding

Status

Schedule

Amphibians

1 Frog Rana tigrina - - C IV

2 Indian bull

frog

Hoplobatrachus

tigerinus

- - C IV





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S.N Common

Name Scientific Name

Vernacular

Name Family

Feeding

Status

Schedule

Amphibians

Reptiles

3 Binocellate

cobra

Naja naja Nag Elapidae C II

4 Indian Krait Bungarus coeruleus - Elapidae C IV

5 Russell’s

Viper

Vipera russellis - Crotalidae C II

6 Rat snake Ptyas mucosus Dhaman Colubridae C II

7 Garden

Lizard

Calotes versicolor - Agamidae C II

8 Brooks

geeko

Hemidactylis brooki - Gekkonidae C II

C – Carnivorous

Avifaunal Investigation

Avifauna is an important part of the ecosystem playing the various roles as scavengers,

pollinators, predators of insect, pest, etc. They are also one of the bio indicators of different

status of environment and affected by urbanization, industrialization and human interference.

They can be used as sensitive indicators of pollution and malfunction of ecosystem.

There is a wide range of avifauna observed in the study area. The list of avifauna observed in

the study area is given in Table 1.28.

Table 3.28 List of Avifauna

Zoological name Local / English Name Distribution

1 Ploceus philippines Baya /Weaver bird Common

2 Pyonotus cafer Bulbul Common

3 Corvus splendens Kaua / House crow Common

4 Corvus corvus Jangli kau / Jungle crow Common





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5 Acridotheres tristicus Myna Common

6 Uroloncha striata Spotted munia Common

7 Passer domestica House sparrow Common

8 Coculus micropterus Koyal / kooku Common

9 Megalaima merulinus Indian kooku Common

10 Pisttachula krammeri Rose ringed parakeet Common

11 Merops orinetalis Bee eater Common

12 Microfus affnis House swift Common

13 Caprimulgus asiaticus Indian jar Common

14 Haliasturindus Brahmni kite Common

15 Milvus migrans Pariah kite Common

16 Columba livia Blue rock pigeon Common

17 Streptopelia spp. Dove (ghughuti) Common

18 Francolinus francolinus Black Partridge (kala teetar) Common

19 Perdicula asiatica Jungle bush quail (Bater) Common

20 Gallinula chloropus Indian moorhen (Jal murgi) Common

21 Amaurornis phoenicurus White breasted water hen Common

22 Anus acuta Common teal Common

23 Bulbucus ibis Little egret Common

24 Egretta garzetta Cattle egret Common

25 Milyus migrans Kite Common

26 Targos calvus King vulture Common

27 Bubo bubo Indian owl Common

28 Colombus livibus Rock pigeon Common

29 Pavo cristayus Common peafowl Common





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30 Accipiter badius Shikra Common

31 Upupa epops Hoopoe Common

32 Pycronotus cafer Bulbul Common

Endangered animals: No National Park, Wildlife Sanctuary of other protected area is present

within 10-km radius of the project area. No rare and endangered faunal species was observed in

the study area. (Source: Red Data Book of Indian Animal).

3.10 Socio-Economic Environment

3.10.1 Demography

Demography is one of the important indicators of environmental health of an area. It includes

population, number of households, literacy, population density, etc. In order to assess the

demographic features of the area, census data of Udham Singh Nagar District of Uttrakhand

State for the year 2011, was compiled and placed in the form of tabulation and graphical

presentation. Study area falls mainly under Udham Singh Nagar District of Uttrakhand State.

Demography of the District

As per the census records 2011, the total population of the Udham Singh Nagar district is

1,648,902 of which 1062142 persons live in rural and rest 586760 in urban parts. The district

has a population density of 648 inhabitants per square kilometre. Its population growth rate was

observed as 33.4% over the decade 2001-11. Udham Singh Nagar district has a sex ratio of

919 females for every 1000 males. The sex-ratio of population in the age group of 0-6 years is

899 in the district which is higher than the state being only at 890. As against the 0-6 age group

sex-ratio of 902 in the rural area of the district it is only 894 in urban areas. Literacy rate in the

district was observed as about 73.1%. The literacy rate was also observed as 75.9 & 71.5% in

the urban and rural areas respectively of the district. The male-female wise literacy rates also

recorded as higher as 81.1% males against about 64.5% female in the district.

Methodology

In order to assess the Demography & Socio-economic features of the 10-km radius study area

based on field surveys and public consultations undertaken during the baseline field study

period and Census records 2011, for the concerned district namely Udham Singh Nagar of

Uttrakhand State was compiled and placed in the form of tabulation and graphical

representation. Entire study area is observed predominantly rural.

https://en.wikipedia.org/wiki/2011_census_of_India

https://en.wikipedia.org/wiki/Family_planning_in_India

https://en.wikipedia.org/wiki/Sex_ratio

https://en.wikipedia.org/wiki/Women_in_India





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Purpose of the Study

Socio-economic study was conducted to establish the baseline demographic features and

impacts due to upcoming proposed new production unit of APIs and bulk drug, as construction

of any major industrial project invariably leads to Socio-economic changes. The construction of

the project could lead to unplanned and haphazard development of slums of various size and

description with little or rudimentary.

3.10.2 Description of Social Environment

Population Distribution within 2.0-km radial Zone of the Study Area

As per the census records 2011, the total population of the 2.0-km radial zone of study area was

recorded as 2883 persons of Kalyanpur revenue village of Kichha tahsil in Udham Singh Nagar

District of Uttrakhand. Total number of ‗Households‘ was observed as 593 in the 2.0-km radius

study zone. Male-female wise total population was recorded as 1566 males and 1317 females

respectively. Caste-wise population distribution of the 2.0-km radial study zone is shown in

Table 3.29.

Table 3.29 : Caste-wise Population Distribution of 2.0-km Radial Zone

Name of

Village

No of

Households

Total Population

Scheduled

Castes

Scheduled

Tribes

Tahsil/

District

Persons Male Female Male Female Male Female

Kalyanpur 593 2883 1566 1317 469 384 28 27 U. S. Nagar

/ Kichha Total 593 2883 1566 1317 469 384 28 27

Source-Census Records 2011

Population Distribution within 10.0-km radial Zone of the Study Area

As per the census records 2011, the total population of the 10-km radius study area was

recorded as 279273 persons of forty nine (49) revenue villages/towns of Udham Singh Nagar

district of Uttrakhand state. All study area villages are under five (05) tahsils namely Kichha (34

Villages), Gadarpur (11 Villages), Khatima (1 Village), Jaspur (1 Village) and Bajpur (2 Villages)

of Udham Singh Nagar district in Uttrakhand. There are mainly three (3) towns in the study area

named Rudrapur (NPP+OG), Dineshpur (NP) and Nagla (CT) respectively. Total number of

‗Households‘ was observed as 53659 in the study area. Male-female wise total population was





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recorded as 146962 males and 132311 females respectively. List of Revenue villages/towns in

the 10km radius study area is presented in the Table 3.30.

Table 3.30 : List of Revenue Villages in the 10km Radius Study Area

S. No. Name of Village Distance, km S. No. Name of the Village Distance, km

1 Kalyanpur 1.18 26 Vijay Nagar 7.40

2 Simla Bahadur 2.13 27 Jafarpur 7.43

3 Rudrapur (Rural) 2.65 28 Kanakpur 7.58

4 Rudrapur (NPP + OG) 2.65 29 Shoka Nagla 7.69

5 Mat Kota 3.30 30 Shimala Pistore 7.81

6 Fulsunga 3.41 31 Indarpur 7.88

7 Chhatarpur 3.55 32 Buksaura 7.89

8 Fulsungi 4.03 33 Bagwala 8.08

9 Phoolbag 4.29 34 Malsi 8.08

10 Loharri 4.79 35 Srirampur 8.10

11 Bigbara 4.98 36 Rameswarpur 8.42

12 Rampura 5.12 37 Tanda Range 8.48

13 Haldi 5.14 38 Lalpur 8.95

14 Gangapur Patia 5.17 39 Amarpur 9.02

15 Fajalpur Mahraula 5.51 40 Bhjuwa Nagla 9.10

16 Raipur 5.65 41 Anandpur 9.14

17 Kolara 5.73 42 Maharajpur 9.40

18 Jainagar 5.76 43 Malsagirdharpur 9.43

19 Loharra 5.81 44 Anandkhera 9.44

20 Danpur 6.00 45 Turka Gori 9.69

21 Bharatpur 6.06 46 Sripur 9.75

22 Pratappur 6.29 47 Khatola 9.82





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23 Bhamraula 6.51 48 Dineshpur (NP) 9.88

24 Kotha 6.80 49 Nagla (CT) 9.91

25 Narayanpur 6.93

Caste wise male-female population breakup of the entire study area is shown in Table 3.31.

Table 3.31 : Caste-wise Population Distribution of 10-km radial Study Area

Name of

Village

No of

Households

Total Population

Scheduled

Castes

Scheduled

Tribes

Tahsil

Persons Male Female Male Female Male Female

Kalyanpur 593 2883 1566 1317 469 384 28 27 Kichha

Simla Bahadur 247 1233 666 567 115 103 0 0

Rudrapur 479 2225 1180 1045 50 36 6 6

Rudrapur

(NPP + OG)

29662

154554

81340

73214

13135

12063

633

585

Mat Kota 392 1875 1024 851 176 140 0 0

Fulsunga 318 1714 911 803 77 83 2 2

Chhatarpur 300 1498 828 670 216 199 0 0

Fulsungi 199 893 477 416 96 90 0 0

Phoolbag 2228 11251 5879 5372 1585 1464 21 21

Loharri 137 748 401 347 88 93 0 0

Bigbara 341 1729 884 845 389 383 1 3

Rampura 276 1226 666 560 13 14 0 0

Haldi 191 948 507 441 150 129 1 0 Khatima

Gangapur Patia 174 979 516 463 253 229 0 0 Kichha

Fajalpur

Mahraula

954 4672 2483 2189 352 327 2 2

Raipur 313 1636 822 814 25 24 0 0 Gadarpur





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Kolara 218 1212 638 574 232 200 0 0 Kichha

Jainagar 462 2257 1202 1055 350 304 1 0 Gadarpur

Loharra 90 532 277 255 136 143 0 0 Kichha

Danpur 243 1158 608 550 145 128 3 2

Bharatpur 524 2538 1336 1202 1115 990 1 0 Jaspur

Pratappur 74 472 238 234 48 42 0 0 Kichha

Bhamraula 268 1555 816 739 151 172 0 0

Kotha 145 741 382 359 258 256 1 2

Narayanpur 184 935 477 458 15 15 0 0 Gadarpur

Vijay Nagar 1708 8818 4536 4282 236 232 0 0

Jafarpur 450 2258 1186 1072 386 308 2 1

Kanakpur 194 1052 537 515 145 132 1 2 Kichha

Shoka Nagla 136 735 388 347 213 202 0 0 Bajpur

Shimala Pistore 341 1679 891 788 111 94 0 0 Kichha

Indarpur 159 990 530 460 104 86 0 0

Buksaura 525 2690 1370 1320 15 18 158 160 Gadarpur

Bagwala 202 1082 565 517 269 235 6 3 Kichha

Malsi 337 1885 982 903 405 416 0 0

Srirampur 523 2638 1324 1314 17 25 0 0 Gadarpur

Rameswarpur 394 1774 906 868 158 161 0 0 Kichha

Tanda Range 22 125 66 59 16 11 0 0

Lalpur 797 3975 2075 1900 240 201 11 6

Amarpur 244 1242 627 615 0 0 0 0 Gadarpur

Bhjuwa Nagla 99 557 292 265 117 126 13 16 Bajpur

Anandpur 144 917 481 436 175 163 0 0 Kichha

Maharajpur 404 2083 1099 984 255 238 0 0

Malsagirdharpur 211 1158 609 549 15 12 0 0





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Anandkhera 619 3332 1752 1580 9 2 0 0 Gadarpur

Turka Gori 314 1503 798 705 140 144 0 0 Kichha

Sripur 6 33 17 16 8 11 0 0

Khatola 697 3682 1930 1752 7 5 96 103 Gadarpur

Dineshpur (NP) 2323 11343 5888 5455 276 234 0 0

Nagla (CT) 3798 22258 11989 10269 2474 2277 37 49 Kichha

TOTAL 53659 279273 146962 132311 25430 23344 1024 990


3.10.3 Sex Ratio

The ‘Sex Ratio’ is a numeric relationship between females and males of an area and bears

paramount importance in the present day scenario where the un-ethnic pre-determination of sex

and killing of female foetus during pregnancy is practiced by unscrupulous medical practitioners

against the rule of the law of the country. It is evident that by contrast the practice of female

foeticide is not prevalent in the study area.

As per the census records 2011, the entire study area is falling mainly in Udham Singh Nagar

district of Uttrakhand state. The ‗Sex Ratio‘ was observed as 919 females per 1000 males in the

Udham Singh Nagar District. The same was recorded as 900 females for every 1000 males in

the study area. The child sex ratio for the age group of 0-6 years in the study area was

observed as 915 female children per 1000 male children. The same was recorded in the district

as 889 female children per 1000 male children reveal the better position in the study area.

The village wise male-female population distribution for the study area is depicted and shown by

graphical representation in Figure 3.13

https://en.wikipedia.org/wiki/Women_in_India





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Figure 3.14 : Male-Female wise Population Distribution in the Study Area

3.10.4 Scheduled Caste & Scheduled Tribe Population

On the basis of the village/town wise Scheduled Caste & Scheduled Tribe population

distribution of the study area during 2011, the ‗Scheduled Castes‘ population was observed as

48774 persons consisting of 25430 males and 23344 females respectively in the study area

which accounts as 17.5% to the total population (279273 persons) of the study area. ‗Scheduled

Tribes‘ population was observed too meagre as 2014 persons, accounting as 0.7% to the total

population of the study area consisting of 1024 males and 990 females. It implies that the rest

81.8% of the total population belongs to the General category. Male-female wise distribution of

Scheduled Caste & Scheduled Tribe population in the study area is graphically shown in Figure

3.14 &3.15.





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Figure 3.15 : Scheduled Caste Population in the Study Area

Figure 3.16 : Scheduled Tribes Population in the Study Area

3.10.5 Literacy Rate

Literacy level is quantifiable indicator to assess the development status of an area or region.

Male-Female wise literates and illiterates population is represented in Table 3.32. Total literates

population was recorded as 180623 persons (64.7%) in the study area. Table 3.32 reveals that

Male-Female wise literates are observed as 104494 & 76129 persons respectively, implies that

the ‗Literacy Rate‘ is recorded as 64.7% with male-female wise percentages being 37.4% &





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27.3% respectively. The total illiterate‘s population was recorded as 98650 persons (35.3%) in

the study area. Male-Female wise illiterates were 42468 (15.2%) and 56182 (20.1%)

respectively. The Male-Female wise graphical representation of literates & illiterates population

in study area villages/town is shown in Figure 3.16.

Figure 3.17 : Male-Female wise Distribution of Literates & Illiterates

Table 3.32 : Male-female wise Literates & Illiterates

Name of Village

Total

Populatio

n

Literates Illiterates

Person

s Males

Female

s

Person

s Males

Female

s

Kalyanpur 2883 1963 1179 784 920 387 533

Simla Bahadur 1233 885 506 379 348 160 188

Rudrapur 2225 1626 933 693 599 247 352

Rudrapur

(NPP + OG)

154554

96993

55939

41054

57561

25401

32160

Mat Kota 1875 1417 835 582 458 189 269

Fulsunga 1714 1144 662 482 570 249 321





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Chhatarpur 1498 1018 607 411 480 221 259

Fulsungi 893 547 317 230 346 160 186

Phoolbag 11251 7515 4423 3092 3736 1456 2280

Loharri 748 489 277 212 259 124 135

Bigbara 1729 1044 603 441 685 281 404

Rampura 1226 965 528 437 261 138 123

Haldi 948 646 391 255 302 116 186

Gangapur Patia 979 708 399 309 271 117 154

Fajalpur

Mahraula 4672 3201 1833 1368 1471 650 821

Raipur 1636 981 587 394 655 235 420

Kolara 1212 870 508 362 342 130 212

Jainagar 2257 1422 850 572 835 352 483

Loharra 532 328 183 145 204 94 110

Danpur 1158 850 471 379 308 137 171

Bharatpur 2538 1575 950 625 963 386 577

Pratappur 472 362 186 176 110 52 58

Bhamraula 1555 1131 637 494 424 179 245

Kotha 741 462 287 175 279 95 184

Narayanpur 935 559 335 224 376 142 234

Vijay Nagar 8818 5324 3114 2210 3494 1422 2072

Jafarpur 2258 1263 722 541 995 464 531

Kanakpur 1052 621 346 275 431 191 240

Shoka Nagla 735 514 311 203 221 77 144

Shimala Pistore 1679 1028 601 427 651 290 361

Indarpur 990 655 377 278 335 153 182





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Buksaura 2690 1558 904 654 1132 466 666

Bagwala 1082 645 390 255 437 175 262

Malsi 1885 1074 614 460 811 368 443

Srirampur 2638 1567 888 679 1071 436 635

Rameswarpur 1774 1172 656 516 602 250 352

Tanda Range 125 69 43 26 56 23 33

Lalpur 3975 2464 1426 1038 1511 649 862

Amarpur 1242 839 485 354 403 142 261

Bhjuwa Nagla 557 339 192 147 218 100 118

Anandpur 917 642 366 276 275 115 160

Maharajpur 2083 1282 743 539 801 356 445

Malsagirdharpur 1158 780 456 324 378 153 225

Anandkhera 3332 2208 1310 898 1124 442 682

Turka Gori 1503 977 586 391 526 212 314

Sripur 33 12 8 4 21 9 12

Khatola 3682 2638 1519 1119 1044 411 633

Dineshpur (NP) 11343 7616 4354 3262 3727 1534 2193

Nagla (CT) 22258 16635 9657 6978 5623 2332 3291

TOTAL 279273 180623 104494 76129 98650 42468 56182


3.10.6 Economic Structure

The majority of people in rural sector are cultivators & agricultural labors which indicates

dominant agricultural economy. A small section of people are engaged as workers in household

industries. But in urban sector the existing scenario is completely reversed as most of the

people there are engaged in non-agricultural activity especially in local hotels/restaurants and

as drivers some people also operates their vans/jeeps/cars as tourist vehicle.





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Annual income helps in identifying families below poverty line. During the field survey, income of

a household through all possible sources was recorded. Agriculture and allied activities was

reported to be the major source of income followed by non-farm wage labor, business,

Government and Private Service etc. The other important sources of income include

government pension and income from selling of fodder.

Economy of the District

Agriculture is the major livelihood activity in the district. The farmers extensively use improved

seeds, fertilizers, irrigation and technology. The net sown land area is about 53%. Allied

activities related to agriculture, such as animal rearing, milk production and horticulture find top

priority in the district. Pantnagar University leads all the programmes in the fields related to

human resource development, agriculture research, fisheries and animal husbandry.

Udham Singh Nagar is also basically an industrial district. The availability of fertile land is

responsible for development of agro-based industries. The industrial development is

contributing significantly to economic development of the district. Pantnagar University is a

leading ‘Temple of Education’ (learning) in the fields of agriculture and technology.

3.10.7 Workers Scenario (Occupation Pattern)

Occupational pattern was studied to assess the skills of people in the study area. Occupational

pattern helps in identifying major economic activities of the area. The main and marginal

workers population with further classification as casual, agricultural, households and other

workers is shown in Table 3.33. In the study area the Main and Marginal Workers population

was observed as 80031 (28.6%) and 15252 (5.5%) respectively of the total population (279273)

while the remaining 183990 (65.9%) persons were recorded as non-workers. Thus it implies that

the semi-skilled and non-skilled work-force required in study area for the project is available in

aplenty.

Occupation Pattern wise distribution of Population and Graphical representation of ‗Workers

Scenario‘ of the study area are shown as Table 3.33 and Figure 3.17.

Table 3.33 : Distribution of Work Participation Rate

Occupation Class 2011

Main Workers 80031 (28.6 %)

Male 66583 (83.2 %)

Female 13448 (16.8 %)

Marginal Workers 15252 (5.5 %)

Male 8942 (58.6 %)

Female 6310 (41.4 %)





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Non-Workers 183990 (65.9 %)

Male 71437 (38.8 %)

Female 112553 (61.2 %)

Total Population 279273 (100%)

Source: Census of India Records, 2011

Figure 3.18 : Workers Scenario of the Study Area

Table 3.34 : Village wise Occupational Pattern in the Study Area

Name of Village

MAIN WORK_

P

MAIN_CL_

P MAIN_AL_P

MAIN_HH_P

MAIN_OT_

P

MARG WORK –

P

MARG_CL

_P

MARG_AL

_P MARG_HH_P

MARG_OT

_P

Kalyanpur 853 10 20 8 815 138 3 60 5 70

Simla Bahadur 334 17 26 9 282 53 5 19 4 25

Rudrapur 705 60 31 69 545 22 4 7 2 9

Rudrapur (NPP + OG) 42895 490 3208 2026

37171 8838 163 737 502 7436

Mat Kota 660 174 30 21 435 118 4 50 16 48

Fulsunga 360 88 107 4 161 39 4 5 0 30

Chhatarpur 540 142 109 30 259 40 8 22 2 8

Fulsungi 177 27 43 17 90 32 0 13 8 11

Phoolbag 3271 41 36 33 3161 184 9 13 17 145

Loharri 214 58 65 0 91 50 1 36 1 12

Bigbara 550 155 191 17 187 72 1 26 6 39

Rampura 408 19 0 11 378 38 2 1 1 34

Haldi 408 186 117 12 93 7 1 1 0 5





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Gangapur Patia 316 100 163 1 52 5 1 4 0 0

Fajalpur Mahraula 1293 70 227 94 902 274 15 167 16 76

Raipur 424 143 178 1 102 91 18 62 1 10

Kolara 379 129 52 37 161 122 57 13 16 36

Jainagar 698 259 245 7 187 242 36 182 4 20

Loharra 136 38 64 1 33 2 0 2 0 0

Danpur 291 64 95 7 125 69 16 14 3 36

Bharatpur 1040 194 750 34 62 63 6 29 6 22

Pratappur 168 49 71 0 48 12 0 5 4 3

Bhamraula 349 76 41 6 226 174 9 113 10 42

Kotha 34 5 6 1 22 171 1 155 1 14

Narayanpur 107 47 7 1 52 176 2 170 0 4

Vijay Nagar 2984 587 1782 62 553 605 25 440 21 119

Jafarpur 845 100 452 19 274 20 0 9 0 11

Kanakpur 225 67 79 1 78 236 0 231 0 5

Shoka Nagla 235 101 59 0 75 7 0 0 1 6

Shimala Pistore 396 60 78 2 256 278 1 243 3 31

Indarpur 235 124 71 1 39 25 1 16 0 8

Buksaura 929 229 571 28 101 220 20 170 6 24

Bagwala 342 58 212 11 61 23 5 10 6 2

Malsi 498 94 157 7 240 65 4 29 3 29

Srirampur 880 236 499 9 136 161 20 134 1 6

Rameswarpur 507 79 108 13 307 148 2 123 2 21

Tanda Range 54 0 40 0 14 2 1 0 0 1

Lalpur 1023 97 125 28 773 230 12 73 3 142

Amarpur 274 68 187 6 13 181 2 164 6 9

Bhjuwa Nagla 201 52 122 5 22 14 5 8 0 1

Anandpur 257 95 130 7 25 67 9 42 1 15

Maharajpur 773 69 346 28 330 60 2 20 8 30

Malsagirdharpur 375 91 136 5 143 31 0 2 0 29

Anandkhera 1226 248 678 15 285 134 9 107 8 10

Turka Gori 537 3 100 6 428 32 0 18 5 9

Sripur 10 0 9 0 1 2 0 0 0 2

Khatola 1040 307 564 12 157 562 142 405 3 12

Dineshpur (NP) 3761 292 1547 147 1775 404 5 261 9 129

Nagla (CT) 5814 14 21 181 5598 713 4 20 50 639

TOTAL 80031 5712 13955 3040 5732

4 15252 635 4431 761 9425

Abbreviations: MAIN WORKERS POPULATION: MAIN WORK_P : Main workers total population, MAIN_CL_P : Main cultivated labour population, MAIN_AL_P : Main agricultural labour population, MAIN_HH_P : Main





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workers population involved in household industries, MAIN_OT_P : Main other workers population MARGINAL WORKERS POPULATION: MARG WORK_P : Marginal workers total population, MARG_CL_P : Marginal cultivated labors total population, MARG_AL_P : Marginal agricultural labors population, MARG_HH_P : Marginal workers involved in household industries, MARG_OT_P : Marginal other workers Population

Source: Census of India Records, 2011

Composition of Main Workers

The ‗Main Workers‘ were observed as 80031 persons (28.6%) to the total population of the

study area and its composition is made-up of Casual laborers as 5712 (7.1%), Agricultural

laborers as 13955 (17.5%), Household workers 3040 (3.8%) and other workers as 57324

(71.6%) respectively. Composition of Main workers is shown below in Figure 3.18.

Figure 3.19 : Composition of Main Workers Population

3.10.8 Composition of Marginal Workers

The total marginal workers are observed as 15252 which constitute 5.5% of the total

population (279273) comprise of Marginal Casual Laborers as 635 (4.2%), Marginal

Agricultural Laborers as 4431 (29.0%), Marginal Household laborers as 761 (5.0%) and

marginal other workers were also observed as 9425 (61.8%) of the total marginal

workers respectively. Details about marginal workers in the study area are tabulated in

Table 3.34 and Figure 3.19.





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Figure 3.20 : Composition of Marginal Workers

Composition of Non-workers

The total Non-workers population was observed as 183990 which constitute 65.9% to the total

population (279273) of the study area. Male-female wise Non-workers population was recorded

as 71437 Males (38.8%) and 112553 Females (61.2%) respectively. Details about total Non-

workers of the study area with Graphical representation are compiled in Table 3.35 and Figure

3.20.

Table 3.35 : Composition of Non-Workers

Non-Workers Population

Persons Males Females

183990 71437 (38.8%) 112553 (61.2%)

Figure 3.21 : Composition of Non-Workers

3.10.9 Availability of Basic Infrastructure Facilities & Amenities in the Study Area





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A review of basic infrastructure facility and amenities available in the study area villages has

been done on the basis of the field survey and Census Records of 2011. There are a total forty

nine (49) revenue villages/towns in the 10km radius study area and falling under Udham Singh

Nagar district of Uttrakhand state. All the revenue villages of the study area are mainly under

five (05) tahsils namely Kichha (34 Villages), Gadarpur (11 Villages), Khatima (1 Village),

Jaspur (1 Village) and Bajpur (2 Villages) of Udham Singh Nagar district in Uttrakhand. The

study area has good level of basic infrastructure facilities like educational, medical, potable

water, power supply, and transport & communication network. Entire study area is

predominantly rural except 3 towns namely Rudrapur (NPP+OG), Dineshpur (NP) and Nagla

(CT) respectively.

Education Facilities

There are a total forty nine (49) revenue villages/towns in the 10km radius study area and falling

under Udham Singh Nagar district of Uttrakhand state. There are about fifty four (54) Primary

Schools existing in the revenue villages as rural part of the study area. Middle schools are

eighteen (18 no‘s) in the rural part of the study area. Only seven (7 no‘s) Higher Secondary

Schools are available in the rural part of the study area. Senior Secondary School facility is

available in five (5) revenue villages of the study area as rural part. The educational facilities

have been further strengthening now and a number of private public schools and colleges are

also functioning in the surroundings of the study area. Besides, there are Engineering and

Medical colleges available in Towns and District headquarters only. Higher education facilities

are available in Towns of the area. There is considerable improvement in educational facility.

The villages/towns of the study area have no such facilities can reach within 5.0 to 10.0-km

range. Majority of the villages are little far from their nearest town.

Out of total forty nine (49) revenue villages/towns of the study area four (4) villages namely

Narayanpur, Tanda Range (forest village), Bhjuwa Nagla and do not have primary school facility

and children of these villages have to travel less than 5.0-km for their primary schooling.

Medical Facilities

The medical facilities are provided by different agencies like Govt. & Private individuals and

voluntary organizations in the study area. As per the information compiled from district census

handbook information of 2011, no community health centre (CHC) was observed in the study

area. Primary health center (PHC) also exists in three villages of the study area; most of the

villages depend upon these three villages and towns / district HQ of the study area having such

facility. Primary health sub-centers (PHSC) exists in eleven villages of the rural part in the study





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area. Mother & child welfare centre (MCWC) are available in eight (8) revenue villages of the

study area. No family welfare centre (FWC) was observed in the study area. Hospital facility is

available only in towns and districts headquarter of the study area and rests of the villages are

depending upon towns and district headquarters for such type of medical facility. Medical

dispensary facility was not observed in the study area. Overall study area villages are served by

average medical facilities. Specialized medical facilities are available in towns and district

headquarters (HQ) only.

Potable Water Facilities

Potable water facility is available in most of the villages/towns of the study area. The entire

study area has plenty of good potable water facilities. Most of the villages (about 90.4%) having

hand pumps (HP) facility as potable water facility. Tap water facility is also commonly observed

in the study area villages. Out of total forty nine (49) revenue villages/towns about thirty (30)

villages are served with river/canal water as drinking water in the study area. As per the census

records of 2011, about eleven (11) villages (22.6%) are being served with Tank/Pond/Lake in

the study area. Good potable water facilities are available in the study area. There is Chaferi

River and Baror River passing at a distance of 6.2 km and 5.5 km E in the east of the project

site.

Communication, Road, Transport and Banking Facilities

Apart from Post &Telegraph (P & T) services, transport is the main communication linkage in

the study area. Out of forty nine (49) villages/towns of the study area, only one (1) village

named Phoolbag is served with Post Office facilities in the study area, remaining villages are

depending upon this villages and towns of the study area. Telephone facility is observed at

highest in 100% villages of all the C.D. blocks of the district.

As per the district census handbook 2011, Post office facility is available least 5.6% in forest

block and highest 23.3% in Rudrapur C.D. block of Udham Singh Nagar.

The study area has good road network, passes from the area. National Highways No-87 passes

at a distance of 0.91 km in the west direction of the project site.

Transport and communication are basic infrastructure which play important role in the social,

economic and industrial development of any area. District Udham Singh Nagar is well

connected by railways. As per the district census handbook of 2011, Transport and

communications services are less developed in forest villages of Udham Singh Nagar district

where only 11.1% villages are covered by this facility.





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Only one (1) village named Phoolbag is served with railway station facility in the study area and

rest of the villages are depending upon this village and towns with this facility. Nearest railway

station is Phoolbag and Rudrapur at about 4.29 & 5.5-km away in the ESE & SSW direction

respectively to the project site. Nearest town/city is Rudrapur (NPP) at about 5.5-km away from

the project site in the SSW direction of the project site. Pantnagar airport is the nearest airport

which is located around 7.0-kms from the proposed project site.

Mainly eight (8) towns named Rudrapur, Kichha, Khatima, Dineshpur, Kashipur, Kela Khera,

Gadarpur and Bajpur are available within the distance range of about 0-23kms away from the

villages of the study area. About 37 villages (75.5%) are served with Pucca road facility in the

study area. Pucca road facility is observed as highest in Bajpur block as 97.4% whereas it

lowest in forest villages 16.7% in the district. There is a state boundary of at a distance of

5.8km, in the SW direction of the proposed project site.

The study area has almost all the schedule commercial banks with ATM facility in urban areas

and the district HQ.

Power Supply

As per the district census handbook of 2011, almost all villages of the study area as well as

district are electrified. Major consumer of the electricity is industrial sector which consumes

77.2% of the total electricity closely followed by agriculture as 4.1%. Domestic light sector

consumes 9.7% electricity. Other sectors such as commercial as 8.1%, public lighting 0.4% and

public utility as 0.6% consume rest of electricity. To facilitate the uninterrupted power supply

there are 18 stations of 33 & 11 KVA in the district. The ratio of per person electric consumption

was recorded as 443.40 KWH during the year 2009-10.

It is revealed from the compiled information on amenities availability as per the census record of

2011; forty three (43) villages (about 87.7%) are electrified for Agriculture and all purpose in the

study area. About forty four (44) villages/towns of the study area are observed as electrified for

domestic purpose. About forty one (41) villages are observed as electrified for Commercial

purposes in the study area. Only two villages named Narayanpur and Tanda Range (forest

village) are observed as un-electrified villages in the study zone of 10km radius. Village/town

wise ‗Basic Infrastructure and Amenities’ availability data for the entire study area is compiled

and presented in Table 3.26.





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Table 3.36 : Village wise Basic Amenities Availability

Village Name Educational Medical Drinking Water Communication & Transport

Approach to the

Villages

Power Supply Nearest Town & Distance, km

P M SS

SSS

CHC

PHC

PHSC

MCWC

H D FWC

T W HP

TW

R TK

PO

P & T

Tel.

Mob.

BS

RS

PR KR

FP

ED

E Ag.

EC

EA

Kalyanpur 2 1 0 0 0 0 0 0 0 0 0 1 2 1 1 2 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Rudrapur, 3.0km

Simla Bahadur 1 1 0 0 0 0 0 0 0 0 0 1 2 1 1 1 2 2 2 2 1 2 2 1 1 1 1 1 1 1 Rudrapur, 5.0km

Rudrapur 1 0 0 0 0 0 1 0 0 0 0 1 2 1 1 1 1 2 2 2 1 2 2 1 1 1 1 1 1 1 Rudrapur, 6.0km

Rudrapur (NPP + OG)

Urban Part

Mat Kota 1 1 1 1 0 0 0 1 0 0 0 1 2 1 1 1 2 2 2 2 1 2 2 1 1 1 1 1 1 1 Rudrapur, 5.0km

Fulsunga 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Kichha, 17.0km

Chhatarpur 1 1 0 0 0 0 0 0 0 0 0 1 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Kichha, 10.0km

Fulsungi 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Kichha, 5.0km

Phoolbag 3 2 2 2 0 1 1 1 0 0 0 1 2 1 1 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 Rudrapur, 15.0km

Loharri 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 2 2 2 2 2 1 2 2 1 1 1 1 1 1 1 Rudrapur, 5.0km

Bigbara 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 1 1 2 2 1 1 2 2 1 1 1 1 1 1 1 Rudrapur, 3.0km

Rampura 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 2 2 2 2 2 1 2 2 1 1 1 1 1 1 1 Rudrapur, 1.0km

Haldi 1 0 0 0 0 0 1 0 1 0 0 2 2 1 1 2 2 2 2 1 1 1 2 1 1 1 1 1 2 1 Khatima, 13.0km

Gangapur Patia 2 0 0 0 0 0 0 0 0 0 0 1 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Rudrapur, 23.0km

Fajalpur Mahraula 1 1 1 1 0 0 0 0 0 0 0 1 2 1 1 2 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Rudrapur, 4.0km

Raipur 1 0 0 0 0 1 1 0 1 0 0 2 2 1 1 1 1 2 2 1 1 2 2 2 1 1 1 1 1 1 Dineshpur, 10.0km

Kolara 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 2 2 2 2 2 1 2 2 1 1 1 1 1 1 1 Rudrapur, 5.0km

Jainagar 1 1 1 1 0 0 0 0 0 0 0 2 2 1 1 1 1 2 2 1 1 2 2 2 1 1 1 1 1 1 Dineshpur, 6.0km

Loharra 1 0 0 0 0 0 0 0 0 0 0 2 2 1 1 2 2 2 2 2 1 2 2 1 2 1 1 1 1 1 Rudrapur, 6.0km

Danpur 1 1 0 0 0 0 1 1 0 0 0 1 2 1 1 2 2 2 2 2 1 2 2 1 1 1 1 1 1 1 Rudrapur, 4.0km

Bharatpur 1 1 0 0 0 0 0 0 0 0 0 1 2 1 1 1 1 2 2 1 1 1 2 1 1 1 1 1 2 1 Kashipur, 12.0km

Pratappur 1 0 0 0 0 0 1 0 0 0 0 1 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Rudrapur, 12.0km

Bhamraula 2 1 0 0 0 0 0 0 0 0 0 2 2 1 2 2 2 2 2 2 1 1 2 1 2 1 1 1 1 1 Rudrapur, 4.0km

Kotha 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 1 2 2 2 2 1 2 2 1 1 1 1 1 1 1 Rudrapur, 11.0km

Narayanpur 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Rudrapur, 14.0km





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Vijay Nagar 2 1 1 0 0 0 1 1 0 0 0 2 2 1 1 1 1 2 2 1 1 2 2 2 1 1 1 1 1 1 Dineshpur, 4.0km

Jafarpur 2 0 0 0 0 0 0 0 0 0 0 1 2 1 1 1 2 2 2 1 1 1 2 1 1 1 1 1 1 1 Dineshpur, 8.0km

Kanakpur 1 0 1 0 0 0 1 0 0 0 0 1 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Rudrapur, 12.0km

Shoka Nagla 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 1 2 2 2 2 1 2 2 1 1 1 1 1 1 1 Kela Khera, 5.0km

Shimala Pistore 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 2 2 2 2 2 1 2 2 1 2 1 1 1 1 1 Rudrapur, 6.0km

Indarpur 1 0 0 0 0 0 0 0 0 0 0 2 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Kichha, 11.0km

Buksaura 2 0 0 0 0 0 0 0 0 0 0 2 2 1 1 1 1 2 2 1 1 2 2 2 1 1 1 1 1 1 Dineshpur, 3.0km

Bagwala 1 0 0 0 0 0 0 1 0 0 0 1 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Kichha, 21.0km

Malsi 2 0 0 0 0 0 0 0 0 0 0 2 2 1 1 2 2 2 2 2 1 2 2 1 2 1 1 1 1 1 Rudrapur, 7.0km

Srirampur 3 1 0 0 0 0 0 0 0 0 0 2 2 1 1 1 1 2 2 1 1 2 2 2 1 1 1 1 1 1 Dineshpur, 5.0km

Rameswarpur 1 1 0 0 0 0 1 0 0 0 0 2 2 1 1 2 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Kichha, 7.0km

Tanda Range 0 0 0 0 0 0 0 0 0 0 0 2 2 1 2 2 2 2 2 2 1 2 2 2 2 1 2 2 2 2 Rudrapur, 10.0km

Lalpur 1 0 0 0 0 1 1 0 0 0 0 1 2 1 1 1 1 2 2 1 1 2 2 1 1 1 1 1 1 1 Rudrapur, 8.0km

Amarpur 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Gadarpur, 10.0km

Bhjuwa Nagla 0 0 0 0 0 0 0 0 0 0 0 1 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Bajpur, 10.0km

Anandpur 1 0 0 0 0 0 0 0 0 0 0 2 2 2 1 1 2 2 2 2 1 2 2 1 1 1 1 1 1 1 Kichha, 12.0km

Maharajpur 1 1 0 0 0 0 0 1 0 0 0 2 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Kichha, 6.0km

Malsagirdharpur 1 0 0 0 0 0 0 0 0 0 0 2 2 1 2 2 2 2 2 1 1 2 2 1 2 1 1 1 1 1 Rudrapur, 8.0km

Anandkhera 1 1 0 0 0 0 0 1 0 0 0 2 2 1 1 1 1 2 2 1 1 2 2 2 1 1 1 1 1 1 Dineshpur, 5.0km

Turka Gori 1 1 0 0 0 0 1 1 0 0 0 1 2 1 1 1 2 2 2 1 1 2 2 1 1 1 1 1 1 1 Kichha, 8.0

Sripur 0 0 0 0 0 0 0 0 0 0 0 2 2 1 1 1 2 2 2 2 1 2 2 1 1 1 1 2 2 2 Kichha, 6.0km

Khatola 2 1 0 0 0 0 0 0 0 0 0 2 2 1 1 2 1 2 2 1 1 2 2 2 1 1 1 1 1 1 Dineshpur, 2.0km

Dineshpur (NP) Urban Part

Nagla (CT) Urban Part

TOTAL

54

18 7 5 0 3

11 8 2 0 0 Status for Availability and Non-Availability is shown as A (1) & NA (2) respectively

Abbreviations: Educational Facilities: P-Primary School, M-Middle School, SS-Higher Secondary Schools, SSS- Senior Secondary School Medical Facilities: CHC- Community Health Centre, PHC-Primary Health Centre, PHSC-Primary Health Sub-Centre, MCWC-Maternity and Child Welfare Centre, H-Hospital, D- Dispensary, FWC-Family Welfare Centre Drinking Water Facilities: T-Tap Water, W-Well Water, HP-Hand Pump, TW-Tube Well Water, R-River Water, Tk-Tank Water, O-Other Drinking Water Facility Communication and Transport Facilities: PO-Post Office, SPO-Sub-Post Office, PTO- Post & Telegraph Office, Tel. - Telephone Connection, Mob.- Mobile Phone Coverage, BS-Bus Services, RS-Railways Services Approach to Village: PR- Paved Roads, KR-Kuchha Road, FP-Foot Path Power Supply: ED-Power Supply for Domestic use, E Ag.- Power Supply for Agricultural use, EC- Power supply for Commercial use, EA-Electricity for All Purposes

Source-http://www.censusindia.gov.in/2011census/dchb/DCHB.html

http://www.censusindia.gov.in/2011census/dchb/DCHB.html





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3.10.10 Major Social and Cultural Activities in the District:

Socially the district Udham Singh Nagar represents whole country, as people from all corners of

India co-habit in this district. Hard working people from Punjab and other region virtually

changed this place from malarial hell to agricultural heaven. Settlers struggled against

inhospitable conditions and made this district food bowl of this region. Under the Government of

India‘s colonization plan of displaced persons after the partition of the country, first batch of

refugees came here in 1948. Forest lands were cleared and reclaimed for agricultural purposes.

Prevalence of malaria was controlled through malaria eradication scheme undertaken by the

health department. Taking advantage of the fertile land, the settlers putting on their hard labour

made this region prosperous and in the process they themselves became rich and prosperous.

Most of the people involved themselves in agriculture, but a large number of people branched

out to trade and industry. As a result the district has not only become rich in agriculture sector

but developed in the industrial sector as well. The pace of growth has become rapid after it

gained the status of a separate district.

Culturally this district now represents the picture of diversity of India. People from all parts of the

country live here happily as a close knit family. Although all ethnic groups maintain their own

culture but there is no cultural barriers among them. They celebrate all Indian festivals together

in the broad perspective of Indian culture. No untoward event has been reported from this part

of the country until now. Some resenting voices were heard at the time of the merger of this

district with the newly created state of Uttaranchal. But now they have accepted the new

administrative change.

No mentionable social, cultural or natural development has taken place during the last decade.

However a major administrative change has taken place during the last decade. The most

significant jurisdictional change that took place during the last decade was the creation of this

district itself by carving out Tarai tract from erstwhile district of Nainital. By honouring the

sentiments of the dominant ethnic group of Sikhs, this district was named after the great martyr

Udham Singh. Another jurisdictional change was the creation of Uttaranchal state with District

Udham Singh Nagar being part of the new state. Being part of the plain region of the Himalayan

state of Uttaranchal, this district is at an advantageous position and is bound to progress and

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CHAPTER 4. ANTICIPATED ENVIRONMENTAL IMPACTS AND MITIGATION MEASURES

4.1. .GENERAL

EIA provides a mechanism to simultaneously consider base line data & probable future adverse

effects on the environment as a consequence of the action to create any processing unit,

expressway, irrigation, canal, barrage, mining activity etc. before the commissioning of the

desired project work. A significant component of EIA studies exists to predict, assess the

potential of impacts of the project on the surrounding environment. Environmental impact in the

study area reflects in any changes of environmental conditions, adverse or beneficial effects

caused or induced by the impact of project if implemented. Superimposition of predicted impact

over pre-project base line data shows final picture of environmental conditions. Step of

quantitative impact prediction leads to decide suitable environment management plan needed to

implement before initiation of project & commissioning stage to mitigate adverse effects on

environmental quality. The construction and operation phase of the proposed project comprises

various activities each of which have been considered to assess the impact on one or another

environmental components. Impact predictions are based on conceptual notions on how the

universe acts that is intuitive and/ or explicit assumptions concerning the nature of

environmental processes. In most cases the predictions consists of indicating merely whether

there will be degradation, no change, or enhancement of environmental quality. In other cases,

quantitative ranking scales are used. Significant environmental impacts have been categorized

as long term or short term and reversible or irreversible impacts. Impact prediction in various

areas of air, water, soil, noise, socio-economic for the proposed project are given in the

following sections

Impact Assessment

Proposed expansion involves activities to set up a plant, machinery, create infrastructure to

transport raw materials, finished products, process manufacturing, use of boiler and DG during

emergency as main activities leading to generation of pollution. These activities would have

adverse impact on the environment health if not controlled adequately. The impact assessment

is focused on the significant areas of environment during two different following phases of the

proposed plant:

Construction phase

Operation phase





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Construction Stage Impact

The construction of the project will completed in two phase. Phase-I will be completed in 8-12

months and phase-II will be completed in 24-36 months. During this period the plant civil works

is done and the major activities will involve development of site, transport of construction

materials, erection of Structure, demolition of old structures etc. Because it located in an

industrial area having site boundary wall, leveling of site and other associated infrastructure

work like construction of road etc is not required.

Operation Stage Impacts

The operation of the project will involve discharge of pollutants in different compartments of the

environment. There will be air emissions, fugitive dust emission, generation of solid/hazardous

waste, dust, waste water and mechanical noise. An assessment of the quantitative changes in

the various environmental components is therefore essential for predicting the impacts. The

construction and operational stage impacts are described in following sections:

4.2. AIR ENVIRONMENT

4.2.1 Construction stage Impacts


months and phase-II will be completed in 24-36 months. During this period the plant civil works

is done and the major activities will involve development of site, transport of construction

materials, erection of Structure, demolition of old structures etc. Because it located in an

industrial area having site boundary wall, leveling of site and other associated infrastructure

work like construction of road etc is not required. However following impact on air quality is

anticipated during construction period.

Excavation activities leads to dust and debris generation in the study area Air emission and Fugitive dust emission due to operation of construction machinaries like

trucks/dumpers, excavator etc. Generation of domestic waste Air emission due to use of DG sets.

Mitigation Measures

Excavators shall be used for construction. The excavated material (debris) shall be stacked at safe places for backfill at a later stage of construction.

To control the fugitive emission during construction phase adequate water sprinking system will be developed in dust generating area.

All trucks/machenaries used for construction should have PUC.

All the loose construction material will be transported in covered trucks/dumpers.

Regular maintenance of al the construction equipment including dumpers/trucks to prevent leakage and other emissions.

DG set will be used only during the power failure and will be connected with a separate stack as per CPCB guideline.

Further dense greenbelt, 10-15 m wide has been already deeopled by NAARI which shall be strengthened will also act as barrier for air and noise pollution.





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4.2.2 Operation Phase (Fugitive Dust):

The operation of the plant will leads the air emissions from the boiler and process stcks.

Handling & transportation of raw material shall also leads air and fugitive emissions. Beside this

being a pharma plant the fugitive emissions in the form of organic chemicals and VOCs may

come from leakage through valves, fittings, pumps, etc in to the air.

Mitigation Measures

Multi cyclone separator with stack height as per the CPCB guideline shall be provided for dispersion of particulate matter from Boiler.

All process vents will be routed through dedicated two stage ventury scrubbing system. Adequate stack height to be provided in process stacks.

Handling & transportation of the raw material as per norms.

Sprinkling of water to control fugive dust emission.

Speed of vehicles inside the factory premises will be controlled.

Greenbelt will be maintained to attenuate the air pollution.

Closed loop system will be adopted to reduce the workers exposure to hazardous chemicals during manufacturing process.

Proper personal protective equipment will be provided to the workers.

All trucks will be transported after covering from the top.

Raw material unloading will be done by mechanized truck unloading system.

Dust collectors will be in line with unloading hoppers.

Material handling in the plant will be done in closed conveyors. All the trucks being used for transportation of raw material and final product shall be checked for

"Pollution under Control" certificate prior to their entry to the plant premises.

4.2.3 Action Plan to control Odour emission

Being a pharma plant the fugitive emissions in the form of organic chemicals and VOCs may come from leakage through valves, fittings, pumps, etc in to the air.

Mitigation Measures

All vents of centrifuges / filters will be connected to scrubbers. The drying of the product is done in a closed type continuous Fluidized Bed dryer/ Nudge filter to avoid the exposure of any chemicals to human being.

Volatile organic solvents are carefully handled in a closed system, thereby preventing any discharge of these chemicals into the air

4.2.4 Modelling prediction

Prediction of ground level concentration (GLCs) due to proposed expansion has been made by

using air dispersion model as per CPCB Guideline.

1. The pre-project (baseline) ambient air quality status in the study area indicates that

all the criteria pollutants except PM (due to local phenomenon) are well within the

prescribed National Ambient Air Quality Standards (NAAQS) for industrial,





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residential, rural and other areas.

2. The ambient air quality with respect to air pollutants will change during the operation

phase of the proposed project. However, adequate stack height will be provided for

better dispersion of flue gas as per the guidelines of CPCB. In addition to that,

adequate greenbelt will be developed for further control of air pollution.

To assess the impact of air emissions from various continuous point sources, air

dispersion modelling study has been conducted with the help of AERMOD version

6.2 of Lakes. Detailed description has been given in the following sub-sections:

4.3.1.1 Model Details

Air dispersion modeling can be used to predict atmospheric concentrations of pollutants at specific locations (receptors) over specific averaging times (i.e. annual, daily, and hourly). An atmospheric dispersion model accounts for the emissions from a source; estimates how high into the atmosphere they will go, how widely they will spread and how far they will travel based on temporal meteorological data; and outputs the pattern of concentrations that will occur for various exposure periods, thereby providing the exposure risks for different receptors.

In the proposed project, prediction of impacts on air environment has been carried out employing mathematical model based on a Steady State Gaussian Plume Dispersion Model designed for multiple point sources for short term. In the present case, AERMOD dispersion model based on steady state Gaussian Plume Dispersion, designed for multiple point sources for short term and developed by United States Environmental Protection Agency (US EPA) has been used for simulations from point sources.

The major air pollutants expected to be emitted from NAARI proposed project are Nitrogen

oxides (NOx), sulphur oxides (SO2), particulate matter less than 10 microns (PM10), particulate

matter less than 2.5 microns (PM2.5), and ammonia (NH3). The major sources of continuous

emissions are from the proposed project are Stacks attached to Boiler and process scrubbers.

The options used for short-term computations are:

Effective stack height is used by default

Stack tip down-wash is not considered

Buoyancy induced dispersion is used to describe the increase in plume dispersion during

the ascension phase

Calms processing routine is used by default

Wind profile exponents is used by default

Flat terrain is used for computation

Pollutants do not undergo any physico-chemical transformation

No pollutant removal by dry deposition

Universal Transverse Meter (UTM) coordinates have been used for computation





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A uniform polar grid was used for the computation and extended to 10 km from the centre

of the proposed project. In addition to that, receptors were also placed at the sampling

locations.

4.3.1.2 Emissions

The main sources of air pollution due to the operation of the plant are the Boiler and Process

stack. The contribution to GLCs for the pollutants i.e. particulate matter, SOx, NOx, NH3 etc.

were predicted over the study area proposed project after using controlled systems. The

emission load from proposed project is given in Table 4.1. The prediction (maximum) is based

on the expected total emission rate from each stack and are given in isopleths Figure 4.1 (A, B,

C and D) for proposed project.





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Table 4.1: Stack Parameters and Emission Details of Proposed Project

Plant

Stack

Stack Specification Emission Load

Stack

Heigh

t

Stack

Diamet

er m

Exit

Velocity

m/sec

Temp

K

Normal

Flow

rate

Nm3/hr

Conc of

PM10

(gm/sec)

Conc of

PM2.5

(gm/sec)

Conc of

NOx

gm/sec

Conc of

SOx

gm/sec

Conc of NH3

gm/sec

Boiler

Phase I

30 0.5 7.7 411.1

5

3944.37 0.53 0.35 0.33 0.66 NA

Boiler

Phase II

30 0.6 11.07 413 8126.22 1.08 0.72 0.68 1.35 NA

Process

Scrubber

Phase I

7.25 0.1 0.294 323.1

5

7.67 0.000213 0.000128 NA NA 6.38781E-05

Process

Scrubber

(Phase –II)

7.25 0.1 0.294 323.1

5

7.67 0.000213 0.000128 NA NA 6.38781E-05

Process

Scrubber

(Phase –II)

7.25 0.1 0.294 323.1

5

7.67 0.000213 0.000128 NA NA 6.38781E-05





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4.3.1.3 Methodology and Output of Modeling:

In order to estimate the project scenario, the ground level concentration was computed

considering the plant emissions. 24-hourly average ground level concentrations (GLCs) were

computed for 24-hour mean meteorological data (October 1 through December 31, 2017).

4.3.1.3.1 Meteorological Data

The meteorological data consists of wind speed, direction, temperature, humidity, solar radiation, cloud cover and rainfall recorded during the months of October 1 through December 31, 2017, on an hourly basis. Wind speed, wind direction and temperature have been processed to extract the 24–hour mean meteorological data for application in AERMOD.

4.3.1.3.2 Receptor Locations

A total of about 16 receptors – 20 receptors which were generated with a polar grid from the center of the proposed project and extended to 10 km.

4.3.1.3.3 Summary of Predicted GLC’s

The summary of maximum cumulative ground level concentrations (GLCs) for the proposed project and its impact on the study area under the worst meteorological scenario is listed in Table 4.2.

Table 4.2 Summary of Maximum Cumulative 24-hour GLC

Description Concentration (µg/m3)

PM10 PM2.5 SO2 NOx NH3

Maximum Rise in GLC 7.49 4.99 9.35 4.67 0.021

Distance of occurrence

(km)* 0.45 0.45 0.45 0.45 0.0

Direction of Occurrence E E E E E

Prescribed Standards 100 60 80 80 400

* The distance is measured from center of Plant Boundary to the receptor of

maximum GLC

Results & Discussion: The model was set up for calculation of 24-hour average values. The ground level concentration (glc) is plotted as isopleths and presented in Figures 4.1 to 4.4. The worst incremental glc value of PM10 PM2.5, SO2, NOx and NH3 from the project shall occur in the downwind east direction, between 200m to 1.0 km distance from proposed plant stack. The MGLC is superimposed over the baseline ambient values of PM10 PM2.5, SO2, NOx and NH3 in downwind direction and other monitored locations and the resultant scenario is shown in Table 4.3.





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The location near SIDCUL Industrial Area is located about 200 m East of the project site, the

impact from the project due to increase in MGLC is found to be 82.49 µg/m3 for PM10, 47.99

µg/m3 for PM2.5, 19.67 µg/m3 for NOx, 19.69 µg/m3 for SO2 and 15.42 µg/m3 for NH3 which is

meeting the prescribed NAAQ standards. Contours of the incremental GLCs depict that the

travel of emissions from the proposed project would be mainly in E, quadrant.

Additionally, the cumulative impact of the proposed project at the monitoring locations within 10

km radius is provided in Table 4.3.

Table 4.3: Cumulative Impact of the proposed project at the monitoring locations

Location Rise in GLC

(µg/m3)

Max.

Background

Concentration

(µg/m3)

Impact from

Project

(µg/m3)

NAAQS

(µg/m3)

Project Site

PM10 0.368 80 80.368 100

PM2.5 0.22 42 42.22 60

NOx 0.04 14.7 14.74 80

SO2 0.09 9.1 9.19 80

NH3 0.12 15.3 15.42 400

Foji Matkota

PM10 1.48 75 76.48 100

PM2.5 0.99 43 43.99 60

NOx 0.92 14.8 15.72 80

SO2 1.84 9.1 10.94 80

NH3 0.00 15.4 15.4 400

Chhatarpur

PM10 0.61 79 79.61 100

PM2.5 0.41 44 44.41 60

NOx 0.38 17.4 17.78 80

SO2 0.76 8.4 9.16 80

NH3 0.00 15.7 15.7 400

Pantnagar

PM10 0.19 81 81.19 100

PM2.5 0.13 45 45.13 60

NOx 0.12 15.7 15.82 80

SO2 0.24 8.8 9.04 80

NH3 0.00 16.6 16.6 400

Rudrapur

PM10 0.39 90 90.39 100

PM2.5 0.26 49 49.26 60

NOx 0.24 18.4 18.64 80

SO2 0.49 9.2 9.69 80

NH3 0.00 17.7 17.7 400





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Location Rise in GLC

(µg/m3)

Max.

Background

Concentration

(µg/m3)

Impact from

Project

(µg/m3)

NAAQS

(µg/m3)

Kalyanpur

PM10 0.76 74 74.76 100

PM2.5 0.26 39 39.26 60

NOx 0.48 14.9 15.38 80

SO2 0.49 7.6 8.09 80

NH3 0.00 17.3 17.3 400

Haldi

PM10 0.43 78 78.43 100

PM2.5 0.29 41 41.29 60

NOx 0.27 17.3 17.57 80

SO2 0.54 9.1 9.64 80

NH3 0.00 16.1 16.1 400

SIDCUL

Industrial

Area (Near

Delta Power

Solu.)

PM10 7.49 75 82.49 100

PM2.5 4.99 43 47.99 60

NOx 4.67 15 19.69 80

SO2 9.35 8.9 19.67 80

NH3 0.021 15.4 15.42 400





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Figure 4.1: Isopleth for PM10 GLC





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Figure 4.2: Isopleth for PM2.5 GLC





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Figure 4.3: Isopleth for SO2 GLC





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Figure 4.4: Isopleth for NOx GLC





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Figure 4.5: Isopleth for NH3 GLC





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4.3. NOISE ENVIRONMENT

4.3.1 Construction Phase


months and phase-II will be completed in 24-36 months. During construction phase, there will

be noise generation due to use of construction machenary like bulldozers, JCB, trucks/dumpers,

vibrators, heavy fabrication work for erecting major plant equipment including crane, hydra etc.

D.G. sets will be the other source of noise during construction period. The noise produced

during construction may have significant impact on the existing ambient noise levels.

Mitigation Measures

Foundations and structures will be designed to minimize vibrations and noise. Regular equipment maintenance and better work habits will be adopted. D.G. set is proposed to be housed in an inbuilt acoustic enclosure. Necessary safety and personal protective equipment such as ear plugs, ear muffs,

helmet etc will be provided to the workers. Noise levels generated will be maintained to comply with the Factories Act & Rules and

will not exceed 75 dB (A) at 1 m distance. Green belt within the premises of plant will absorb the noise. Thus will help to control the

noise pollution. Proper maintenance, oiling and greasing of machines at regular intervals reduced

generation of vibration due to machines. The noise will be localized and will be intermittent during construction stage and hence

no significant impact is envisaged.

4.3.2 Operation Phase

The main source of noise generation during operation stages are mainly Boiler, pumps, blowers,

compressors, DG sets and vehicles used for transportation of raw materials, finished goods etc.

Mitigation measures:

Equipment will be maintained so that noise level does not increase due to improper maintenance.

DG sets will be provided with acoustics enclosures. Mufflers, silencers, acoustics treatment of room will be done wherever required. To avoid occupational health hazard, workers will be provided PPEs like ear plug/ ear

muffs, wherever required. It is expected that noise level at the plant boundary will be within the prescribed norms of

CPCB due to operation of the proposed project and no significant impact on noise environment is expected.

Greenbelt developed within the plant premises will also act as a barrier to the propagation of noise from the factory premises. This shall further reduce the noise levels appreciably. Hence, no significant impact is envisaged.

It is, therefore, expected that noise level at the plant boundary will be within the prescribed

norms of CPCB due to operation of the proposed project and hence no significant adverse





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impact on noise environment is expected.

4.4 WATER ENVIRONMENT

4.4.1 Construction Phase

During construction, water will be needed mainly for construction and domestic purpose i.e. for drinking and sanitation. Drinking and sanitation facilities shall be provided to workers and staff during construction. Water will also be needed for sprinkling to reduce dust emission, if any.

Mitigation Measures:

The water required in the above activities will be only a fraction of total water required. Moreover, this requirement will be irregular and limited to construction phase only and

hence no impact is envisaged during construction phase. The domestic wastewater generated from the sanitation facility will be disposed in septic

tank. Separate storm water drain to be provided.

4.4.2 Operation Phase

Total water requirement of the project will be 150 KLD. The project will be implemented in two phases. In phase–I only 23 KLD water is required and water requirement for phase-II will be 127 KLD. Permission for drawl of 150 KLDground water shall be obtained from concerned authority. Application has been submitted to concerned authority. Water is required for utility, process, washing and domestic uses. Being a pharma industry waste water generation is the main concerned. The discharge of untreated waste may lead to water pollution in surrounding area. Mitigation Measures

In phase-I process waste water will be sent to CETP. Separate storm water and industrial wastewater drains to will be provided to eliminate

chances of mixing of rainwater with wastewater. Domestic sewage will be disposed in septic tank. In phase -II100 KLD ETP plant will be established with advance treatment technology. Wastewater will be segregated into two streams as High TDS / High COD (HTDS) and

Low TDS / Low COD (LTDS). The HTDS Effluent stream after neutralization, filtration will be sent to Multi Effect Evaporator (MEE). The distillate water will be treated in ETP along with LTDS effluent. The concentrate will be sent to ATFD for drying. The dried salt will be sent to approved TSDF for final disposal.

The ETP treated effluent will be passed through RO for recovery of water for recycling. The RO reject will be send to MEE.

The provision of stripper for recovery of solvent (VOC) from HTDS effluent before MEE and incinerator for combustion of hazardous organic residues from the process is also made. The inorganic hazardous residues will be sent to TSDF.

No process effluent will be discharged outside the plant premises. Separate storm water and industrial wastewater drains to will be provided to eliminate

chances of mixing of rainwater with wastewater. Provision of slit traps in storm water drains. Good housekeeping to avoid contamination of storm water. Domestic sewage generated from the sanitary blocks will be treated in STP (20 KLD). Plant should ensure that the treated effluent quality shall comply with norms set by

SPCB.





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Rainwater harvesting will be done and the water will be discharge in ground water

By implementing the above mitigation measures, no significant adverse impact on the surface and ground water or soil quality is envisaged in viewof the proposed mitigative measures.

4.4. LAND ENVIRONMENT

4.4.1 Construction Stage Impact

The site is located in SIDCUL industrial area and the plot is in possession of NAARI Pharma. The landuse of the site is already industrial hence no change in Land use is anticipated. At Present land use of the project open land with greenbelt all along the site boundary. Being an industrial plot the site is already leveled and no filling is required. There is no vegetation at proposed site. The site is also well connected from NH-87 through internal industrial area roads. Hence no external road or transport infrastructure development is required. So there will no change in landuse due to proposed plant.

There will be temporary change in top layer of soil will be occurred but the construction activity will help in fixation of soil, thereby reducing the soil erosion. However construction waste and domestic waste shall be generated during the construction period. All the construction debris will be segregated reusable debris shall be reused and rest of the material shall be recycled or

disposed to authorized land filling site. Domestic waste shall be disposed in Soak pit and septic

tank. Hazardous wastes will be stored at earmarked area with impervious flooring, shed and spillage/ leakage collection system to eliminate rainwater contamination, chances of overflow / spillages going on to the land and thus land/ soil contamination. Hazardous wastes will be disposed as per the Hazardous Waste Rules.

Mitigation Measures

Construction dust shall be controlled using water sprinkling at regular interval.

Top soil to be generated during construction activity will be preserved and used for the green belt development.

Other excavated earth from the construction activity will be used for the greenbelt development and leveling the site.

Greenbelt development will have significant impact in reduction of the soil erosion.

4.4.2 Impacts during Operational Phase

Under ordinary and safe operating conditions, no adverse impact is anticipated on land during the operation phase. Commercial waste like empty cement bags, Iron scrap etc. will be sold to scrap buyers after the construction phase. Domestic waste like used paper, label, cartoons will be disposed to the scrap buyers. Organic waste from canteen will be disposed as per the local Panchayath / Municipal disposal mechanism. Hazardous waste from Process and Effluent TreatmentPlant will be disposed as per CPCB/ SPCB Norms and HW Rules. Thus, the land pollution during the operation phase is minimal and not likely to create any significant impact.

Mitigation Measures

The site is already levelled and located in industrial area. There will be no change in Landuse

Being a ZLD system there will no any discharge of wastewater on the land.

Separate storm water and industrial wastewater drains will be provided to eliminate any





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contamination of the land.

Hazardous wastes will be collected, stored, transported and disposed off as per hazardous wastes rules 2016.

All bulk chemicals and fuel storage areas will be provided with dyke wall / bunds to eliminate chances of any spillages/ leakages.

4.5. BIOLOGICAL ENVIRONMENT

Though the concentrations of the emitted pollutants will be kept within permissible levels

through the various engineering controls, it is essential to have eco-management in the Likely

Impact Zone for safeguard and enhanced of ecological environment of the project area. The

likely impacts and mitigation measures associated with different phases due to various project

activities area describes in following Table.

Project Aspect

Description

Likely Impacts

on Ecology

and

Biodiversity

(EB)

Impact

Consequence

-

Probability

Description /

Justification

Mitigation

measures

Type

Pre Construction Stage Impacts

Removal of site

vegetation like

herbs, shrubs

and grasses

site specific loss of common floral diversity

As the site is an industrial plot already developed.

No vegetation is present except grasses.

No threat of loss of faunal diversity as no faunal species reported at site.

NAARI has

already

developed a 3

tier dense

greenbelt / all

around the

project

premises,

which will help

to control the

dust and noise

generation

during

construction

period.

Short term

Construction Stage Impacts

Dust and Noise

Generation due

to movement

construction

activites and

Dust settlement

on vegetation

Disturbance to

faunal species

is surroundings

Being an

industrial area

there is no

natural

vegetation in

Subject to

periodic

monitoring and

surveillance.

Water

Short term





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construction

machinery like

JCBs,

excavator,

dumpers, trucks

and other

machinery

immediate

surrounding of

the proposed

site. No

endangered

fauna reported

form the site as

well as in study

area.

The species

reported from

project site and

buffer zone are

common /

generalist

species and not

very sensitive

to the routine

activities, so

there will be no

threat of facing

disturbance.

sprinkling for

Dust

suppression.

Construction

activities shall

be restricted in

night time.

Operation Stage Impact

Emission of

PM, SO2, NOx

and HCL due

to operation

(Indirect impact

on crops, trees

and shrubs of

vicinity

due to

contamination

of ambient air,

dust

emission,

vehicular

exhaust)

Impact on

surrounding

vegetation, land

and

Associated

biodiversity.

Though the

emission levels

of all pollutants

will be kept

within

permissible

limits. APCD

shall be used to

control dust

emissions from

various

sections of

plant.

Modeling

studies proves

that the

incremental air

pollution will not

violate the air

quality

Operation

subject to

management

by operational

controls.

Emission levels

of all pollutants

will be kept

within

permissible

levels through

various

engineering

control

measures.

Long term

(insignificant)





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standards.

Noise

Generation

(Disturbance to

sensitive

terrestrial fauna

due to

noise pollution)

Impact on

surrounding

wild life

No major

wildlife is

present in the

study area.

Noise level at

the plant

boundary will

be kept within

the norms.

Greenbelt has

been already

developed

which, will also

act as a noise

barrier.

Operation

subject to

management

by operational

controls. Noise

levels of all

pollutants will

be kept within

permissible

levels through

various

engineering

control

measures.

Long term

(insignificant

Land

contamination

due to waste

water discharge

and bulk

chemicals and

fuel storage

and leackage

Proposed plant

is zero liquid

discharge

based hence no

land

contamination

is anticipated.

all the

chemicals shall

be stored in

drums,

container on

puccka floor.

hence no

impact

anticipated.

By

implementaing

the EMP

Long term

(insignificant

Construction Stage Impacts

No vegetation is present on the site, however plantation undergreenbelt is done all along the premises of the plot. No tree cutting is required. Excavation and filling up operation may results in fugitive dust emission. The dust deposition on pubescent leaves of the surrounding vegetation may leads to temporary reduction of photosynthesis. Noise will generated during construction period which will have impact on surrounding wildlife.

Mitigation Measures





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Such impacts would however be confined mostly to the initial period of the construction phase and would minimized through paving of roads, surface treatment, regular water sprinkling in dust generating areas.

No wild life is present in imeadate vicinity of proposed site. No endangered fauna reported form the site as well as in study area.

The impact on the ecology of the surrounding area during the construction stage will be insignificant in nature.

Greenbelt development along the plant boundary, further development of gardens and lawns near admin building will mitigate the residual impact on natural resources.

4.1.1. Operation stage Impacts

The attributes that are identified to describe ecology are animals, birds, fish, field crops, threatened species, natural vegetation etc. The study area does not have any identified endangered species, Forest, National Park, Sanctuaries and hence there is no question of any adverse impact on the same.

The impact on the surrounding ecology during the operation of the project will mainly occur from the deposition of air pollutants. Air pollution affects the biotic and abiotic components of the ecosystem individually and synergistically with other pollutants. Chronic and acute effects on plants and animals may be induced when the concentration of air pollutants exceeds threshold limits. Particulate emission and other gaseous emissions from the proposed plant are the major pollutant that may affect the ecology of the area.

Mitigation Measures

The incremental emission of air pollutants is not likely to induce any significant changes in the ecology because the national ambient air quality standards will remain within the limits. The incremental MGLC of PM, SO2, NOx and HCL generated from the proposed plant will be very less and overall incremental GLC will remains within the NAAQS.

Proposed plant is zero liquid discharge based so no waste water will be discharged.

All solid waste and hazardous waste shall be disposed as per norm. Therefore impact of emission on the surrounding vegetation will be insignificant.

Greenbelt development along the plant boundary, further development of gardens and lawns near admin building will mitigate the residual impact on natural resources.

4.6. Land/Soil Environment

The main source of impact on land and soil environment will be due to construction activities and hazardous waste disposal. Construction Phase

Since, the proposed project will be established in SIDCUL industrial area; there will be construction activities to be carried out. There will also be installation of new machineries and equipments. But all this would not make a huge damage to the present condition of land. Further, the area of the plant is flat. Leveling would not be required. Thus, topography will also remain unchanged after execution of the proposal. Thus, the impact on the land/soil during the construction is for short terms and insignificant. Operation Phase





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Entire quantity of the hazardous waste will be stored in the isolated hazardous waste storage

area within premises having leachate collection system and roof cover. Entire quantity of ETP sludge generated from the Effluent Treatment Facilities will be sent to TSDF site. Whereas, discarded barrels/bags/drums/liners will be decontaminated and reuse/sold to authorized end users after decontamination and waste/spent oil will be For Selling to CPCB/MoEF registered refiners or re-processors. 4.7. Traffic Impact

As a matter of fact of capacity of the proposed Pharma Plant i.e. 16.46 T/month, it does not invite heavy vehicular traffic at the site. Vehicles used for transportation of raw material as well as finished product would be truck/tanker and buses, cars and cycles by the staff for movement. The raw material required for the projet will be 23.6 T/month and 73.1 T/month respectively for phase-I and Phase-II. Most of the raw materials and finished product shall be transported through road. The plant is well connected both to NH-87 and Delhi-Kathgodam Railway line. The site is located in SIDCUL industrial area having a well developed road network. The transportation route will be the National highway-87 (Delhi-Rudrapur) and the road network of SIDCUL industrial area. All trucks proposed to be used for transportation will be covered with tarpaulin, maintained, optimally loaded and have PUC certificates. The maximum trucks required for transportation for raw material and finished product will be around 7 trucks/Trailer for raw material and only two trucks for finished product. It can be says that only 9-10 trucks/month is reuired for transportation.

The site is already very closed to the highway. It is four lane highway, having the design service value of 30000 PCU/day. The highway is well capable to bear additional increase in the traffic. Form highway there is a separate road (SIDCUL industrial area road network) connecting the plant site. This road is not used by the villagers. Hence there will be no traffic jams situation. NAARI shall put a strategy to check regularly the PUC of all auto vehicles, servicing & maintenance, in order to have minimum environmental impact due to the vehicle exhaust emission / noise. Garden & tree plantation plans will ensure the target of minimum fugitive emissions.

4.8. SOCIO – ECONOMIC ENVIRONMENT

The proposed project is located in a well-established and industrial notified estate i.e State Infrastructure and Industrial Development Corporation of Uttarakhand Ltd.” (SIDCUL), Pantnagar Rudrapur. Thus no land acquisition is envoleved with the project. Subsequently, the said project will not have any significant impact on Socio-economic pattern of the surrounding region. However during construction and operation phase of the project air and noise pollution generated from the plant may impact the surrounding environment but in the same time the project shall generate indirect employment opportunities, which will contribute to social upliftment of the people in surrounding area. the other impacts associated with project are:

Increase in population density in core zone study area due to workforce involvement during construction phase of the proposed project activity.

Dust and other emissions are expected during construction phase and local people may be affected.

Ground water contamination is also expected due to the proposed project activities which would affect the local people.





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Improper management of waste material from the proposed activities may affect the local peoples.

Due to Noise generation during the operation phase of the proposed project, local people may be adversely affected.

Mitigation Measures

Increase in population density in core zone study area due to workforce involvement

during construction phase is only for short term impact.

Suitable dust suppression techniques will be adopted, such as water sprinkling will be

taken.

All the emission and noise will be kept within the standards.

Proposed plant is zero liquid discharge based so no waste water will be discharged. All solid waste and hazardous waste shall be disposed as per norm. Therefore impact

of emission on the surrounding vegetation will be insignificant.

Overall the construction and operation of the proposed plant may require the workforce of about 250 personnel during construction period and about 150 people during operation phase. Thus, increasing industrial activity will boost up the commercial and economical status of the locality to some extent. Thus, overall impacts on socio-economic environment due to the existence of plant will be long term and positive in nature.Further NAARI group has allotted. No land acquisition is envoleved with the project. Company shall be giving preference to people from economically weaker sections for employment in various semi- skilled/unskilled jobs there by contributing to their uplift the quality of life.





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Chapter 5. ENVIRONMENT MONITORING PLAN

5.1. Environmental Monitoring Plan

Regular monitoring in a systematic manner provides information on operational performance of

installed pollution control facilities, checks the extent of environmental degradation taking place

and adequacy of mitigation measures applied. The monitoring plan also ensures compliance

with the environmental legislation. The objectives of the monitoring plan are as follows:

To verify the results of the EIA Report. To study the trend of various pollution parameters, which are identified as critical. To check the efficacy of pollution control equipment.

To ensure that any additional parameters, other than those identified in the EIA, do not become critical after the commissioning of plant.

The effectiveness of monitoring program depends mainly how best the objective of the

monitoring is addressed through its core elements, for example.

Monitoring network Manpower and Instruments Parameters to be monitored Frequency of monitoring Method and duration of sampling Method of analysis

Regular monitoring of important and crucial environmental parameters is of immense

importance to assess the status of environment during the plant operation. The knowledge of

baseline status and monitored data is an indicator to ascertain for any deterioration in

environmental condition due to operation of the plant based on these data, suitable mitigation

steps could be taken in time to safeguard the environment. Monitoring is as important as that of

pollution control since the efficiency of control measures can only be determined by monitoring.

5.2. EHS Cell

For regular environment health safety monitoring purpose an Environment health and safety

Management Cell (EHS Cell) shall be created. Working environmental laboratory shall be

established. The function of EHS department includes the following:

Implement EHS directives and guide line as per NAARI Pharma requirement

Operation of wastewater pre-treatment plant and Effluent Treatment Plant (ETP)

Monitoring hazardous work through work permit system

Pre, periodical and post medical check of employees

Conducting audiometry test for employees working in high noise area.





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Regular training to employees on Health, Safety and Environment Topics.

Regular monitoring of wastewater, stacks, ambient air, noise etc either internally or by

appointing external agency and data analysis. Corrective and preventive action,

wherever required.

Hazardous wastes management and handling.

Preparation of various reports like environment statement, carrying out environment

audit, preparation of water cess returns and various consent applications and renewal

under Water (Prevention and Control of Pollution) Act, 1974 and Air (Prevention and

Control of Pollution) Act, 1981 as well as application for authorization and its renewal

under Hazardous Wastes (Management, Handling and Transboundary Movement)

Rules,2016, and amendment thereof under Environment Protection Act, 1986.

List of manpower and instrument required for environmental laboratory is provided in Table 5.1

and 5.2.

Table 5.1 Manpower for EHS Cell

S.No. Designation Qualification No. of Staff

Experience

1. Environmental Health and safety Manager (Head)

M.Sc – Science (Diploma EHS)

1 2 years in environmental management of pharma industry or in recognized environmental laboratory

2. Assistant Manager / Chemist/Lab Assistant

B.Sc – Science

1 2 years experience in laboratory, greenery development, sampling, pollution monitoring, etc.

Table 5.2 Name of Instruments Required for Environmental Monitoring

S.No. Name of Instruments Number Purpose

1. Refrigerator 1 Preserving collected samples

2. pH meter 1 PH measurement

3. Conductivity meter 1 Conductivity measurement

4. DO Meter 1 DO measurement

5. Electronic Balance 1 Weighing

6. Oven 1 Drying

7. Desiccators 1 Desiccation

8. BOD incubator 1 BOD

9. COD digester 1 COD





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5.3. Environment Monitoring

5.3.1. Stack Emission Monitoring

Air emissions from the stacks and vents shall be monitored using Stack Monitoring Kit as per

Method prescribed by CPCB. Online stack emission monitor shall be installed as per the

guideline. The details of grab sampling are given below:

Component Location Parameter Monitoring & Analysis Method

Monitoring Frequency

Stack Emissions Monitoring

All major stacks Port holes should be made on the stack (6 cm diameter, 2 Nos. at 90o to each other), provided with flange. Location of the port hole should be at 6 times the stack diameter. Platforms with railings should be provided.

PM, SO2and NOx (for Boiler and scrubber stacks) PM, SO2, NOx, CO, CO2, HC (for DG)

PM & SO2 – CPCB Method NOx: EPA Method Duration of sampling–so as to collect 500 l of flue gas Isokinetic sampling method using stack monitoring kit to be used

Quarterly

5.3.2. Ambient Air Monitoring (Fugitive Dust and Ambient Air Quality)

Ambient air of the premises (upwind and downwind of fugitive dust generating points) shall be

monitored using Hhigh volume Sampler as per Method prescribed by CPCB.

Ambient Air Quality Monitoring of the surrounding villages shall be done at three nearest

villages by establishing permanent monitoring stations (120 degree to each other; one station at

MGLC location). The monitoring height should not be less than 3 m from ground. The station

should not have any obstacles around 500 m area. Station should be 500 m away from road.

Monitoring should be done during the construction stage as well as during the operation stage.

The sampling details are given below.



Ambient Air Quality

At 3 locations within 2-3 km of plant (120 degree to each other; at human settlements)

PM2.5 PM10 SO2

NO2

PM10, PM2.5, SO2 , NO2 CPCB Method

Duration of sampling–24 h Sample volume – Not less than 1100 lit/minute

Six monthly





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5.3.3. Action plan to control Ambient Air Quality as per NAAQS Standard

The particulate matter from the project will be < 50 µg/Nm2 Fly ash will be stored in silos All the internal roads will be asphalted in the plant. Water sprinklers will be installed at the loading and unloading of raw material. Stack emissions will be monitored regularly.

5.3.4. Equipment and Ambient Noise

Noise monitoring shall be done at all work areas inside the work place, plant boundary and

surrounding villages. The details of noise monitoring are given below:



Plant Noise Levels

Plant Boundary (4 sides), Equipment and Work Place (all units)

Average Leq values and Maximum value of Sound Pressure Level in dB(A)

CPCB method using equipment as per IS-9989 & IS:9779

Quarterly

Ambient Noise Levels

Two nearest villages outside the plant

Leq values in dB(A) CPCB method using equipment as per IS-9989 & IS :9779

Monthly (day & night time)

5.3.5. Water Quality Monitoring

All the effluent emanating from the plant will be monitored for their physico-chemical

characteristics and heavy metals. In addition ground water samples surrounding the storage

area will be monitored in pre monsoon and post monsoon season at regular interval.



Groundwater Quality

Observation wells inside plant Groundwater of two villages around the plant

Ground water Level pH TDS TSS Total hardness Fluoride O&G Heavy metals

Standard Methods of APHA

Once during pre-monsoon and once during post monsoon

Industrial Waste Water

ETP inlet and out let

Flow, pH, O&G TDS TSS Total hardness, Fluoride Heavy metals BOD COD, Sulphates Coliform Count

Standard Methods of APHA

Monthly





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5.3.6. Solid Waste Monitoring

Ash, Empty drums, soiled cotton materials; garbage from plant comprises solid wastes. The

monitoring plan is given below:

Component Parameter Frequency

Waste Management

Maintaining Records of generation, receipt & disposal in Form-3

Daily

Filling of annual returns of in Form-4 for Haz. Waste handling

Every year 30th June

Maintain records of transportation in Form-13

While sending for disposal

Obtaining consent to operate (and renewal) under Air & Water Acts and authorization Under HW rules

90 days before expiry of validity

NAARI pharma shall create an Environmental Health Safety Committee under the control of

Plant Head. Annual monitoring shall be done by appointing an Independent Firm. The data shall

be submitted to UPPCB, CPCB and MOEF on six-monthly basis. The committee shall comprise

the following members:

a) Plant Head/ EMC Head Chairman

b) Manager-Project, NAARI Pharma Member Secretary





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CHAPTER 6. HAZARDS ANALYSIS & RISK ASSESSMENT

6.1. Introduction

Industrial plants deal with materials, which are generally hazardous in nature by virtue of their

intrinsic chemical properties or their operating temperatures or pressures or a combination of

these. Fire, explosion, toxic release or combinations of these are the hazards associated with

industrial plants using hazardous chemicals. More comprehensive, systematic and sophisticated

methods of Safety Engineering, such as, Hazard Analysis and QuantitativeRisk

Assessment have now been developed to improve upon the integrity, reliability and safety of

industrial plants.

The primary emphasis in safety engineering is to reduce risk to human life, property and

environment. Some of the more important methods used to achieve this are:

Quantitative Risk Analysis: Provides a relative measure of the likelihood and

severity of various possible hazardous events by critically examining the plant

process and design.

Work Safety Analysis: The technique discerns whether the plant layout and

operating procedures in practice have any inherent infirmities.

Safety Audit: Takes a careful look at plant operating conditions, work practices and

work environments to detect unsafe conditions.

Together, these three broad tools attempt to minimize the chances of accidents occurring. Yet,

there always exists, no matter how remote, probability of occurrence of a major accident. If the

accident involves highly hazardous chemicals in sufficiently large quantities, the consequences

may be serious to the plant, to surrounding areas and the populations residing therein.

6.2. Risk Assessment

A three ‗levels‘ risk assessment approach has been adopted for the M/s. NAARI PHARMA

PVT. LTD (henceforth Naari) proposed pharmaceutical (bulk drug and intermediates) projectat

Plot 14-15-16 & 55-56-57, Sector-5, II E Pant Nagar, Rudrapur - 263153, Dist: Udham Singh

Nagar, Uttarakhand. The risk assessment levels are generally consistent with the practices

encountered through various assignments for medium and large chemical complexes. The brief

outline of the three-tier approach is given below:

Level 1 – Risk Screening

This is top-down review of worst- case potential hazards/risks, aimed primarily at identifying

plant sites or areas within plant, which pose the highest risk. Various screening factors

considered include:

Inventory of hazardous materials;

Hazardous Materials properties;





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Storage conditions (e.g. temperature and pressure);

Location sensitivity (distance to residential areas / populace).

The data / information are obtained from plant. The results provide a relative indication of the

extent of hazards and potential for risk exposure.

Level 2 – Major Risk Survey (Semi - Quantitative)

The survey approach combines the site inspection with established risk assessment techniques

applied both qualitative as well quantitative mode. The primary objective is to identify and select

major risks at a specific location in the plant considering possible soft spots / weak links during

operation / maintenance. Aspects covered in the risk usually include:

Process Hazards;

Process Safety Management Systems;

Fire Protection and Emergency response equipment and programs.

Security Vulnerability;

Impact of hazards consequences (equipment damage, business interruption, injury,

fatalities);

Qualitative risk identification of scenarios involving hazardous materials;

Risk reduction measures.

Selection of critical scenarios and their potential of damage provide means of prioritising

mitigative measures and allocate the resources to the areas with highest risks.

Level 3 – Quantitative Risk Assessment (Deterministic)

This is the stage of assessment of risks associated with all credible hazards (scenarios) with

potential to cause an undesirable outcome such as human injury, fatality or destruction of

property. The four basic elements include:

Hazards identification utilising formal approach (Level 2, HAZOP etc.);

Frequency Analysis. Based on past safety data (incidents / accidents); Identifying

likely pathway of failures and quantifying the toxic / inflammable material release;

Hazards analysis to quantify the consequences of various hazards scenarios (fire,

explosion, BLEVE, toxic vapour release etc.).Establish minimum value for damage

(e.g. IDLH, over pressure, radiation flux) to assess the impact on environment.

Risk Quantification: Quantitative techniques are used considering effect / impact due

to weather data, population data, and frequency of occurrences and likely hood of

ignition / toxic release. Data are analysed considering likely damage (in terms of

injury / fatality, property damage) each scenarios is likely to cause.





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QRA provides a means to determine the relative significance of a number of undesired events,

allowing analyst and the team to focus their risk reduction efforts where they will be beneficial

most.

Naariproposed API project is hazardous in nature. The RA for this plant is based on Level 1 and

Level 2.

Table in Chapter 2 gives the list of products (and their monthly production capacity) and raw

materials to be manufactured and used in the proposed NAARI project. Table 6.1below gives

the bulk storages of liquid andgaseous raw materials and their monthly consumption.

Table 6.1. List of Solvents / Chemicals to be stored in Bulk in Naari Project

Sr.No


Handling

Tank / Cylinder Size (KL)

Remarks

1. Acetone (Solvent) Liquid Tank 2 X25 2 X25 KL

2. Cyclohexane (Solvent) Liquid Tank 9 Over Ground

3. Dimethyl Formamide (DMF) Liquid Tank 2 X 30 Over Ground

4. Ethanol - 90 % - Thinner E (Solvent) Liquid Tank 2 X 30 Over Ground

5. Ethanol - Dry (Solvent) Liquid Tank 25 Over Ground

6. Ethyl Acetate (Solvent) Liquid Tank 10 Over Ground

7. Hexane - Thinner ARS (Solvent) Liquid Drums 30

8. Liquefied Ammonia (Solvent) Liquid Cylinder

60 Kg Line Pr.: 1 to 1.5 Kg/Cm2 g

9. Methanol (Solvent) Liquid Tank 2 X 30 Over Ground

10. Methylene Chloride (Solvent) Liquid Tank 25 Over Ground

11. Phosphoric Acid (Acid) Liquid Jars 5 Over Ground

12. Toluene (Solvent) Liquid Tank 2 X 30 Kl Over Ground

13. Dichloro Methane (Solvent) Liquid Tank 25 Over Ground

14. Diesel Liquid Tank 25 Over Ground

Table 6.2. Gaseous Storages

Sr.No


Handling

Cylinder Size ~`

Remarks

1. Acetylene Gas (Critical reactant) Gas Cylinder

3 Kg; Line Pr.: 0.5 to 1 Kg/Cm2 g

2. Chlorine Gas (Critical reactant) Gas Cylinder

100 Kg

Line Pr.: 1 to 1.5 Kg/Cm2 g

3. Hydrochloric Acid Gas (Acid) Gas Cylinder

32 Kg Line Pr.: 1 to 1.5 Kg/Cm2 g

4. Hydrogen Gas Gas Cylinder 5 NM3 Line Pr.: 1 to 1.5





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Kg/Cm2 g

5. Propylene Gas (Critical reactant) Gas Cylinder

~50 Kg Line Pr.: 1 to 1.5 Kg/Cm2 g

the gases will be stored separately in a ventilated shed.

6.3. Risk Screening Approach

Proposed Plant: Risk screening of Naariplant was undertaken through process study and study

of data / information provided by Naari. Data of major / bulk storages of raw materials,

intermediates and other chemicals were collected. MSDS of hazardous chemicals were studied

vis a vis their inventories and mode of storage. Naari plant will be using number of hazardous

chemicals and also producing organic chemicals – hazardous in nature. The chemicals stored in

bulk (liquid or gaseous) and defined under MSHIC Rule will be considered for detailed analysis.

Naari will be producing bulk drugs and intermediates. Most of the products are new molecules

and very little information and data are available for these products. The products are being

produced in small quantities. The limited hazard analysis of the products are as given below in

the Table 6.3:

Table 6.3. Products Hazards Analysis

No

Material CAS No

S. No & Threshold Quantity (TQ in Kg) as per MSHIC Rules

Remarks

Schedule-1, Part-

II

Schedule-2, Part-

I

Schedule-3, Part-

I

1. 19-Norandrostenedione pure C18H24o2 White Crystalline odourless powder

734-32-7

---- ---- ----- NA

2. Androstadienedione C19H24O2 Crystal or Powder

897-06-3

---- ---- ----- NA

3. Allylestrenol C21H32O

432-60-0

---- ---- ----- LD50:>640 mg/kg

4. Cyproterone Acetate Crystalline Solid

2098-66-0

---- ---- ----- >5mg/Kg

5. Deflazacort Crystalline Solid

14484-47-0

---- ---- ----- 5200mg/Kg

6. Dienogest C20H25NO2 White to yellow crystalline Powder

65928-58-7

---- ---- ----- Oral LD 50(mouse):4mg/Kg





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7. Dydrogesterone No Data

152-62-5

---- ---- ----- Oral LD 50(mouse):300mg/

Kg

8. Estradiol Benzoate Crystalline Solid

50-50-0

---- ---- ----- TDLO (rat): 10 ug/kg

9. EstradiolCypionate C26h36O3 Solid

313-06-4

---- ---- ----- NA

10. EstradiolValerate C23H32O3 Solid. (Hygroscopic crystals.)

979-32-8

---- ---- ----- NA

11. Estriol Highly Flammable Liquid

50-27-1

---- ---- ----- Oral LD50 (rat):>2 mg/kg;

12. Estrone C18 H22 O22 White to Off White Crystalline Powder

53-16-7

---- ---- ----- >5000mg/kg

13. EthinylEstradiol C20H24O2 Odourless Crystalline Solid

57-63-6

---- ---- ----- 1737mg/kg

14. Hydroxy Progesterone Caproate C27H40O4 White or creamy white, crystalline powder; odorless

630-56-8

---- ---- ----- Not available

15. Levonorgestrel C21H28O2 White Powder

797-63-7

---- ---- ----- >4000mg/kg

16. Lynestrenol C20 H28 O White or almost-white crystalline powder

52-76-6

---- ---- ----- Oral LD 50(mouse):300mg/

Kg

17. Medroxyprogesterone Acetate Solid

71-58-9

---- ---- ----- Oral LD50 (rat): >6400; Oral LD50

(mouse): >16 gm/kg;

18. Mifepristone IH/US C29H35NO2 Light yellow to yellow crystalline powder.

84371-65-3

---- ---- ----- Oral mouse:27mg/Kg





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19. Mifepristone IP/EM C29H35NO2 Light yellow to yellow crystalline powder.

84371-65-3

---- ---- ----- Oral mouse:27mg/Kg

20. NandroloneDecanoate C28 H44 O3 .10H2O Solid

360-70-3

---- ---- ----- LD50(Mouse): >566mg/kg

21. Nandrolone Phenyl Propionate C27 H34 O3

62-90-8


22. Norethisterone Solid Powder with bitter taste

68-22-4

---- ---- ----- LD50(Mouse): 6000 mg/kg

23. Norethisterone Acetate C22H28O3 Solid Powder

51-98-9


24. NorethisteroneEnanthate C27 H38 O3 Solid

3836-23-5


25. Norgestimate Crystalline Solid

35189-28-7

---- ---- ----- Oral TDLO (rat): 1 mg/kg

26. Ospemifene C24 H23 Cl O2 Solid

128607-22-7

---- ---- -----

27. Progesterone Crystalline Solid

57-83-0

---- ---- ----- Oral LD50 (rabbit): 6,300 mg/kg

28. Testosterone Cypionate C27 H40 O3 Crystalline Solid with slight odour

58-20-8

---- ---- ----- LD 50 > 1000 mg/kg

29. Testosterone Enanthate Crystalline Solid

315-37-7

---- ---- ----- Oral LD50 (rat): >1 gm/kg

30. Testosterone Propionate C22 H32 O3 Solid

57-85-2

---- ---- ----- LD 50 > 1000 mg/kg

31. Ulipristal Acetate C30 H37 NO4 Powder

126784-99-4

---- ---- ----- Oral LD 50(mouse):300mg/

Kg





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Intermediate

32. 3,3-dimethypropylenedioxy -4,5-seco-estr-9-ene-5,17-dione (G4)

---- ---- ----- --------

33. Estrenone (Oxide) 3646-28-4

---- ---- ----- --------

34. 3-Ethoxyestra-3, 5-(6)-diene-17-one (NET)

2863-88-9

---- ---- ----- --------

35. Nandrolone (PET) C18 H26 O2 White Crystalline Solid

434-22-0

---- ---- ----- --------

36. Norandrostenedione Crude

734-32-7

---- ---- ----- --------

37. ADD NPG Ketal (Intermediate for Estrone)

13258-43-0

---- ---- ----- --------

Many of the Naari chemicals are hazardous in nature. However hazards potential (for damage)

of products and other materials to plant personnel, environment and off-site area is different for

different materials. Naari will be using a number ofliquid raw materials but

onlyThirteen(including liquid ammonia) are stored in bulkand all these are listed under ―List of

hazardous and Toxic Chemicals‖ category under MSIHC Rules, 1989.In addition five toxic

gases are also stored and have been listed below. The raw materials coming under hazardous

category as specified by MSIHC Rules, 1989 (including subsequent amendments) is given in

Table 6.4 below:

Table 6.4. Hazards Analysis –Raw materials (stored in Bulk)

S No

Material S. No & Threshold Quantity (TQ in Kg) as per MSHIC

Rules

Chemicals Hazards Potential

Remarks

Schedule-1,

Part-II

Schedule-2,

Part-I

Schedule-3,

Part-I

Hazards Toxic DT->---mg/Kg; OT----mg/Kg; IT----mg/l;

(Rats)

23. Acetone CAS No:67-64-1 Colourless liquid with Fruity

2 ----- ----- Hazardous in case of skin contact (irritant), of eye contact

DT->---mg/Kg; OT—5800 mg/Kg (rat);





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mint odour BP: 56.2 0C. Flash Point : -20 0C.

(irritant), of ingestion, of inhalation. Slightly hazardous in case of skin contact (permeator). Highly flammable in presence of open flames and sparks, of heat.

IT—50100 mg/m3 8 hrs (rat)

24. Chlorine CAS No:7782-50-5 UN No:1017 A greenish yellow gas with a pungent suffocating odor. Toxic by inhalation.

119 5 TQ-1: 10MT

TQ-2: 25 MT

108 TQ-1: 10MT TQ-2:

25 MT

Non Combustible;May ignite other combustible materials (wood, paper, oil, etc.). Mixture with fuels may cause explosion. Container may explode in heat of fire. Chlorine reacts explosively with or supports the burning of numerous common

ERPG-1: 1.0 ppm ERPG-2: 3.0 ppm ERPG-3: 20 ppm IDLH: 10 ppm

Hazards: Poisonous; may be fatal if inhaled. Contact may cause burns to skin and eyes. Bronchitis or chronic lung conditions Poisonous; may be fatal if inhaled. Contact may cause burns to skin and eyes. Bronchitis or chroniclung conditions

25. Cyclohexane C6-H12

161 --- --- Slightly hazardous in

DT->--18000





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CAS No:110-82-7 Liquid with Chloroform-like odor; solvent odor; mild sweet odor FP-18 0C ; BP-80.70C LEL-1.7 %; UEL-8.4%

case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion, of inhalation. Highly flammable in presence of open flames and sparks, of heat

mg/Kg (Rabbit); OT----12705mg/Kg; Rat IT----mg/l; (Rats)

26. Dimethyl Formamide (DMF) CAS No:68-12-2 Colourless to light yellow Flammable liquid with mint like odour BP: 153 0C. Flash Point : 57.7 0C.

----- ----- ----- Hazardous in case of skin contact (irritant, permeator), of eye contact (irritant), of ingestion, of inhalation.

DT->--4720 mg/Kg (Rabbit); OT----2800 mg/Kg; Rat IT----mg/l; (Rats)

27. Ethanol CAS No; 64-17-5 A clear colorless liquid with pleasant odor

248 ----- ----- Colourless liquid Flammable: FP- 16.6 0C; Causes respiratory tract irritation. May cause liver, kidney and heart damage. Causes moderate skin / eye irritation. On ingestion may cause gastrointestinal tract irritation, vomiting and diarrhoea.





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28. Ethyl Acetate (C4 H8 O2) CAS No: 141-78-6 Flammable Colourless liquid; Pleasant Etheral odour BP-77 0C FP—4.4 0C

247 --- --- Hazardous in case of ingestion, of inhalation. Slightly hazardous in case of skin contact (irritant, permeator), of eye contact (irritant). FLAMMABLE: FP (Closed Cup)- -4.4 0C Flammable Limits_ Lower 2.2%;Upper-9%

(LD50): Acute: 5620 mg/kg [Rat]. 4100 mg/kg [Mouse]. VAPOR (LC50): 16000 ppm 6 hours [Rat].

29. n-Hexane CAS No:110-54-3 UN No:1208 Clear colourless liquids with a petroleum-like odour. Flash points -9°F

306 ----- ----- Highly flammable; Vapours may explode; Health Hazards: Inhalation causes irritation of respiratory tract, cough, mild depression, cardiac arrhythmias. Aspiration causes severe lung irritation, coughing, pulmonary edema; excitement followed by depression. Ingestion causes nausea, vomiting, swelling of

TEEL-1: 400 ppm TEEL-2: 3300 ppm TEEL-3: 8600 ppm IDLH 1100 ppm





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abdomen, headache, and depression.

30. Hydrochloric acid (Gas) CAS No: 7647-01-0 UN No: 1789

313 ----- ----- Not Flammable; Inhalation of fumes results in coughing and choking sensation, and irritation of nose and lungs. Liquid causes burns

ERPG-1: 3.0 ppm ERPG-2: 20 ppm ERPG-3: 150 ppm IDLH: ---- ppm

Plant uses liquid and emits HCl gas

31. Hydrogen CAS No:1333-

74-0

Hydrogen is a colorless, odorless,

flammable gas BP:--252.8 0C

247 --- TQ-1: 2MT TQ-2:50 MT

The main health hazard associated with releases of this gas is asphyxiation, by displacement of oxygen. The liquefied gas can cause frostbite to any contaminated tissue. Hydrogen poses a serious fire hazard when it is accidentally released.

------ Highly Flammab

le/ Explosiv

e

32. Ammonia CAS No:7664-41-7 UN No:1005 Colourless gas / liquid with ammonical irritating odour

31 2 TQ-1: 60

MT TQ-2:

600 MT

105 TQ-1:

50 MT

TQ-2: 500 MT

Fire Hazards: (Gas); Mixing of ammonia with several chemicals can cause fire hazards, / or explosions; vapours are toxic- irritation to eyes and

ERPG-1: 25 ppm ERPG-2: 150 ppm IDLH: 300 ppm

Contact with liquid may cause froast bite.





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respiratory tract.

33. Methanol CAS No:67-56-1 UN No:1230 FP—54.5 0F ; BP-64.5 0C A colorless fairly volatile liquid with a faintly sweet pungent odor like that of ethyl alcohol. Highly Flammable;

377 ---- ---- human poison by ingestion. Poison experimentally by skin contact. Moderately toxic experimentally by intravenous and intraperitoneal routes. Mildly toxic by inhalation.

ERPG-1: 200 ppm ERPG-2: 1000 ppm ERPG-3: 5000 ppm IDLH: 6000 ppm

Health Hazards: Exposure to excessive vapor causes eye irritation, headache, fatigue and drowsiness. 50,000 ppm will probably cause death in 1 to 2 hrs. Swallowing may cause death or eye damage.

34. Methylene Dichloride

CAS No: 75-09-2

Liquid BP-39.75 0C

May be combustible at

high temperature

400 --- --- Very hazardous in case of eye contact (irritant), of ingestion, of inhalation. Hazardous in case of skin contact (irritant, permeator). Inflammation of the eye is characterized by redness, watering, and itching.

DT->---mg/Kg; OT---1600 mg/Kg (Rat); IT----mg/I; (Rats)





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35. Toluene C6-H5-CH3 CAS No: 108-88-3 UN No: 1294 A clear colorless Flammable liquid with a characteristic aromatic odor. Flash point 40°F

628 ---- ---- Flammability: Ignites at normal temperatures; Vapor is heavier than air and may travel a considerable distance to a source of ignition and flash back; Health Hazard Vapors irritate eyes and upper respiratory tract; cause dizziness, headache, anesthesia, respiratory arrest. Liquid irritates eyes and causes drying of skin. If aspirated, causes coughing, gagging, distress, and rapidly developing pulmonary edema. If ingested causes vomiting, griping, diarrhea, depressed respiration.

DT->--14100 mg/Kg (Rabbit); OT----636 mg/Kg; IT----49000 ppm; 4 hrs (Rat)

36. Acetylene Gas CAS No: 74-86-2 UN No: 1001 Colourless gas

8 ---- TQ-1: 5 MT TQ-2: --- MT

Acetylene is extremely flammable and slightly

------





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with unknown odour

lighter than air. Acetylene ignites easily and burn with an extremely hot bright flame giving off black smoke.

37. Benzyl-(2bromoethyl)ether CAS No: 1462-37-9 BP:254 0C

---- ----- ---- Harmful if swallowed; causes skin/eye irritation

----

38. CKT [(2-(3-CHLOROPROPYL)-2,5,5-TRIMETHYL-[1,3]-DIOXANE); C10H19ClO2 ] CAS No: 88128-57-8 BP: 247.7±15.0℃

---- ----- ---- ---- --- No data

39. Di Ethyl Ether C4H100 CAS No: 60-29-7 Colourless Liquid with sweet ether like odour BP: 34.6 0C

---- ----- ---- Extremely flammable liquid and vapour. May form explosive peroxides Harmful if swallowed

DT->--14.2 g/Kg (Rabbit); OT-1215 mg/Kg (rat); IT----32000 ppm; 4 hrs (Rats)

40. Heptane CAS No:142-82-5; UN No 1206 Flammable colourless liquid and vapor. Will be easily ignited by heat, spark or flames. with gasoline like

--- --- --- Harmful or fatal if swallowed. Causes skin and eye irritation. Causes respiratory tract irritation.

High vapor concentration

DT->---mg/Kg (Rabbit); OT--------mg/Kg; IT----103 mg/l; 4 hrs (Rats)





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odor; FP- -4 0C ; BP-98.5 0C

s may cause drowsiness and irritation of the eyes or respiratory tract.

41. Propylene CAS No: 115-07-1 Colorless Gas (Liquid under pressure) Odor: Mild Olefin Vapor Density: 1.4 (air=1)

--- ---- ----- F P: -108°C LEL: 2.0% UEL: 11.1% Flammable Gas Unusual Fire and Explosion Hazards: Vapors are heavier than air and may travel along the ground or may be moved by ventilation and ignited by flame, sparks, heaters or other ignition sources at distant locations. Vapors may explode if ignited in a closed area. Containers may explode in a fire.

NFPA 704 (1997) Health: 1 Flammability: 4 Reactivity: 1

42. Pyridine 4-(p-nitrobenzyl)- C12-H10-N2-O2 CAS No:1083-48-3 Powder Solid

547 ---- ----- Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation (lung irritant).

-----

43. THF Tetrahydrofuran C4H8O

---- ---- ---- Hazardous in case of skin contact

DT->--1650 mg/Kg (Rabbit);





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CAS No:109-99-9 Flammable clourless liquid with Ethereal odour BP:65 0C

(irritant), of eye contact (irritant). Slightly hazardous in case of skin contact (permeator), of ingestion, of inhalation

OT--------mg/Kg; IT----24000 mg/m3; 2 hrs (mouse)

44. Phosphoric Acid (85%) H3PO4 CAS No 7664-38-2 Syrupy viscous odourless liquid

497 ---- ---- Very hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, . Hazardous in case of skin contact (corrosive, permeator), of eye contact (corrosive). Slightly hazardous in case of inhalation (lung sensitizer).

DT->--2740 mg/Kg (Rabbit); OT--1530mg/Kg; IT----850 mg/m3; 1 hrs (rat)

note: TQ-I: Threshold quantity (for application of rules 4,5,7 to 9 and 13 to 15) TQ-II: Threshold quantity (for application of rules 10 to 12)

As detailed in the above table out of 22 (17- liquid/ 5-gaseous) materials stored in bulk only 14

are coming within Schedule I part II (List of Hazardous and Toxic Chemicals) of MSIHC

Rules.Only fourmaterial (Chlorine, Hydrogen, Ammonia and Acetylene) of them comes under

Schedule 3 (list of hazardous chemicals for application of rules 5 and 7 to 15).

All solvent materials are inflammable and some may be explosive also. Some of these

hazardous liquid materials are toxic also such as Methanol, Ethyl Acetate, Methylene Chloride,

Pyridine, Toluene and Phosphoric Acid.

Note:

1. Oral Toxicity (OT) in LD50 (mg/kg)





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2. Dermal Toxicity (DT) in LD50 (mg/kg)

3. Inhalation Toxicity in LC50 (mg/l) [4 hrs.]

Acute Exposure Guideline Levels (AEGLs)

AEGL-3 is "the airborne concentration of a substance above which it is predicted that the general population, including susceptible individuals, could experience life-threatening adverse health effects or death."

AEGL-2 is "the airborne concentration of a substance above which it is predicted that the general population, including susceptible individuals, could experience irreversible or other serious, long-lasting adverse health effects or an impaired ability to escape."

AEGL-1 is "the airborne concentration of a substance above which it is predicted that the general population, including susceptible individuals, could experience notable discomfort, irritation, or certain asymptomatic nonsensory effects.

Emergency Response Planning Guidelines (ERPGs)

The 3 ERPG tiers are defined as follows:

ERPG-3 is "the maximum airborne concentration below which it is believed that nearly all individuals could be exposed for up to 1 hour without experiencing or developing life-threatening health effects."

ERPG-2 is "the maximum airborne concentration below which it is believed that nearly all individuals could be exposed for up to 1 hour without experiencing or developing irreversible or other serious health effects or symptoms which could impair an individual's ability to take protective action."

ERPG-1 is "the maximum airborne concentration below which it is believed that nearly all individuals could be exposed for up to 1 hour without experiencing other than mild transient health effects or perceiving a clearly defined, objectionable odor."

1. Temporary Emergency Exposure Limits (TEELs)

TEELs are used in similar situations as the 60-minute AEGLs and ERPGs. However, in situations where the concentration varies over time, the TEEL developers recommend using a conservative 15-minute time-weighted average concentration. A chemical may have up to 4 TEEL values, each of which corresponds to a specific tier of health effects.

The 4 TEEL tiers are defined as follows:

TEEL-3 is "the maximum concentration in air below which it is believed nearly all individuals could be exposed without experiencing or developing life-threatening health effects."





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TEEL-2 is "the maximum concentration in air below which it is believed nearly all individuals could be exposed without experiencing or developing irreversible or other serious health effects or symptoms that could impair their abilities to take protective action."

TEEL-1 is "the maximum concentration in air below which it is believed nearly all individuals could be exposed without experiencing other than mild transient health effects or perceiving a clearly defined objectionable odor."

TEEL-0 is "the threshold concentration below which most people will experience no appreciable risk of health effects."

The National Institute of Occupational Safety and Health (NIOSH) defines an immediately dangerous to life or health condition as a situation "that poses a threat of exposure to airborne contaminants when that exposure is likely to cause death or immediate or delayed permanent adverse health effects or prevent escape from such an environment."

The IDLH limit represents the concentration of a chemical in the air to which healthy adult workers could be exposed (if their respirators fail) without suffering permanent or escape-impairing health effects.

6.4. Hazardous Materials Storage

The solid raw materials will be received in bags or drums and will be stored inchemicals

godowns. The products (liquid or solid) will be packed in drums and stored in product godowns

as per market demand. Many of the materials will be stored in tanks in bulk. Appropriate

arrangement will be done for absorption of gases/Cooling of storage tanks/Vent condenser (if

required)/ Sealing arrangement etc.

The bulk storages of liquid hazardous materials are given in the Table 6.1

The solid material powder or granules spillage can results in polluting small area only. The

damage to personnel can be through ingress- dermal (if individual come in contact), oral (if

individual food gets infected through fugitive dust) or inhalation (fugitive dust). The main route is

fugitive dust which incovered area will move to short distance only.

The risk is through liquid / gaseousmaterials which are volatile material. The toxic vapours due

to spillage of such material can travel to some distance (as they are stored in covered godowns)

and cause damage.

6.5. QRA Approach

Identification of hazards and likely scenarios (based on Level-1 and Level-2 activities) calls for

detailed analysis of each scenario for potential of damage, impact area (may vary with weather

conditions / wind direction) and safety system in place. Subsequently each incident is classified

according to relative risk classifications provided in Table below asTable 6.5:





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Table 6.5. Risk Classification

Stage Description

High (> 10-2/yr)

A failure which could reasonably be expected to occur within the expected life time of the plant. Examples of high failure likelihood are process leaks or single instrument or valve failures or a human error which could result in releases of hazardous materials.

Moderate (10-2 --10-

4/yr)

A failure or sequence of failures which has a low probability of occurrence within the expected lifetime of the plant. Examples of moderate likelihood are dual instrument or valve failures, combination of instrument failures and human errors, or single failures of small process lines or fittings.

Low (<10-4)

A failure or series of failures which have a very low probability of occurrence within the expected lifetime of plant. Examples of ‗low‘ likelihood are multiple instruments or valve failures or multiple human errors, or single spontaneous failures of tanks or process vessels.

Minor Incidents

Impact limited to the local area of the event with potent for ‗knock – on- events‘

Serious Incident

One that could cause: Any serious injury or fatality on/off site; Property damage of $ 1 million offsite or $ 5 million onsite.

Extensive Incident

One that is five or more times worse than a serious incident.

Assigning a relative risk to each scenario provides a means of prioritising associated risk

mitigation measures and planned actions.

6.6. Thermal Hazards

In order to understand the damages produced by various scenarios, it is appropriate to

understand the physiological/physical effects of thermal radiation intensities. The thermal

radiation due to tank fire usually results in burn on the human body. Furthermore, inanimate

objects like equipment, piping, cables, etc. may also be affected and also need to be evaluated

for damages.Table 6.5, Table 6.60andTable 6.7(below), respectively give tolerable intensities

of various objects and desirable escape time for thermal radiation.

Thermal hazards could be from fires or explosion. Fire releases energy slowly while explosion

release energy very rapidly (typically in micro seconds). Explosion is rapid expansion of gases

resulting in rapidly moving shock wave. Explosion can be confined (within a vessel or building)

or unconfined (due to release of flammable gases).

BLEVE (boiling liquid expanding vapour explosion) occurs if a vessel containing a liquid at a

temperature above its atmospheric boiling point ruptures. The subsequent BLEVE is the

explosive vaporisation of large fraction of its vapour contents; possibly followed by combustion

or explosion of the vaporised cloud if it is combustible.

Thermal hazards have been considered for various scenarios including:

Fire in inflammable chemicals storage tanks.





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Table 6.6. Effects due to Incident Radiation Intensity

Incident Radiation kW/m2

Damage Type

0.7 Equivalent to Solar Radiation

1.6 No discomfort on long duration

4.0 Sufficient to cause pain within 20 sec. Blistering of skin (first degree burn are likely).

9.5 Pain threshold reached after 8 sec. Second degree burn after 20 sec.

12.5 Minimum energy required for piloted ignition of wood, melting of plastic tubing etc.

25

Minimum Energy required for piloted ignition of wood, melting, plastic tubing etc.

37.5 Sufficient to cause damage to process equipment.

62.0 Spontaneous ignition of wood.

Table 6.7. Thermal Radiation Impact to Human

Exposure Duration

Radiation Energy {1% lethality; kW/m2}

Radiation Energy for 2nd degree burns;

kW/m2

Radiation Energy for 1st degree burns;

kW/m2

10 sec 21.2 16 12.5

30 9.3 7.0 4.0

Table 6.8. Tolerable Intensities for Various Objects

Sl. No Objects Tolerable Intensities (kw/m2)

1 Drenched Tank 38

2 Special Buildings (No window, fire proof doors) 25

3 Normal Buildings 14

4 Vegetation 10-12

5 Escape Route 6 (up to 30 secs.)

6 Personnel in Emergencies 3 (up to 30 secs.)

7 Plastic Cables 2

8 Stationary Personnel 1.5

6.7. Damage due to Explosion

The explosion of a dust or gas (either as a deflagration or detonation) results in a reaction front

moving outwards from the ignition source preceded by a shock wave or pressure front. After the

combustible material is consumed the reaction front terminates but the pressure wave continues

its outward movement. Blast damage is based on the determination of the peak overpressure

resulting from the pressure wave impacting on the object or structure. Damage estimates based

on overpressure are given in Table 6.8below:





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Table 6.9. Damage due to Overpressure

Sl. No Overpressure (psig / bar)

Damage

1. 0.04 Loud Noise / sonic boom glass failure

2. 0.15 Typical pressure for glass failure

3. 0.5 - 1 Large and small windows usually shattered

4. 0.7 Minor damage to house structure

5. 1 Partial demolition of houses, made uninhabitable.

6. 2.3 Lower limit of serious structure damage

7. 5 – 7 Nearly complete destruction of houses

8. 9 Loaded train box wagons completely demolished

9. 10 Probable total destruction of houses

10. 200 Limits of crater lip

6.8. Toxic Release

Damage criteria: For toxic release the damage criteria considered is IDLH concentration (if data

are available). In the absence of non-availability of IDLH, ‗Inhalation Toxicity (AEGL) data are

considered. ‗AEGL‘ norms are used for chemicals, as IDLH are not available for these

chemicals.

6.8.1. Acid / Alkali Hazards

Various hazards that can occur due to the acid and alkali incidents are

Skin irritation and corrosive effects after spillage

Spill pool evaporation of sulphuric/ hydrochloric acid or Caustic lye storage tanks catastrophic failure are limited only

Catastrophic failure giving rise to spill pool evaporation dispersion up to LC50, IDLH and TLV level

The more hazardous scenario likely are if spilled acid comes in contact with metal and hydrogen

is generated resulting in fire / explosion hazards.

Based on the outcome of the risk assessment, following recommendation has been made to

avoid any risk associated with the storage and use ofacid and other hazardous liquid chemicals

in the plant:

Double drain valve will be provided to storage tank.

Full body protection will be provided to operator.

Caution note and emergency first aid will be displayed

All employees will be trained for use of emergency first aid.

Safety shower and eye wash will be provided in storage tank area and plant area.

Total close process will be adopted for hazardous chemicals handling.

Dyke wall will be provided to storage tank

Tanker unloading procedure will be prepared.





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SOP will be prepared for sulphuric acid handling.

Training programme will be conducted for safe handling and emergency handling of hazardouschemicals.

In Storage Tank Area, reaction with water generating fumes should be displayed and avoided

Suitable extinguishing media-Extinguish with dry powder / sand. DO NOT USE WATER.

Fire and explosion hazards-Not flammable. May evolve toxic fumes in fire (sulphur oxides/

Carbon Monoxide or other toxic gases).

6.9. Likely Failure Scenarios

Few likely failure scenarios have been selected after critical appraisal of raw materials and

storage inventories. Failure scenarios selected are as given in Table 6.10 below:

Table 6.10. Different Failure Scenarios

S. No. Scenario Remark

RM-1 Chlorine line leakage Toxic

RM-2 DMF Tank Spillage Toxic

RM-3 Ammonia gas Leakage Toxic

RM-4 Methanol Tank Spillage Toxic

RM-5 Dichloro Methane Tank Leakage Toxic

RM-6 Cyclohexane Tank pillage & Fire Thermal

RM-7 Toluene Tank Spillage Toxic

RM-8 Propylene Line Leakage & Fire Thermal

RM-9 Diesel Spillage & Fire Thermal

6.9.1. Weather Effect

The effect of ambient conditions on the impact of fire / heat radiation and GLC of hazardous /

toxic material can be beneficial as well as harmful. A high wind (turbulence) can dilute the toxic

material while stable environment can extend the reach of IDLH or IT (inhalation LC50 rats for

products) or AEGL (in absence of IDLH data) concentration to long distance. Any inflammable

gas / vapour release in turbulent weather will soon dilute the hazardous gases below LEL and

thus save the disaster. For toxic materials Stability class ―F‖ (wind speed 1.5 m/sec and Temp.

15 0C) has been considered and for inflammable materials stability class ―E‖ (wind speed 4

m/sec and Temp. 35 0C) has been considered.

6.10. Incidents Impacts

The identified failure scenarios (Table 6.9) have been analysed(Using ALOHA Module) for the

impact zones considering damage due to thermal and toxic impacts. Each incident will have

Impact on the surrounding environment which in extreme case may cross plant boundary. The

impact zones for various scenarios are given in Table 6.11.





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Table 6.11. : HazardsScenario Impact

Scenario No.

Scenario Impact Zone (m)

Remarks

Scenario Raw Material

RM-1 Chlorine 133 306

IDLH ; Stability Class D; Template 1 IDLH ; Stability Class F; Template 2

RM-2 DMF Tank Spillage < 10 IDLH; Stability Class D

RM-3 Ammonia gas Leakage

22 IDLH; Stability Class D

RM-4 Methanol Tank Spillage

<10 IDLH; Stability Class D

RM-5 Dichloro Methane Tank Leakage

75 AEGL 1; Stability Class D; Template 3

RM-6 Cyclohexane Tank Spillage & Fire

13 1st degree burn; Template 4

RM-7 Toluene Tank Spillage

<10 IDLH; Stability Class D

RM-8 Propylene Line Leakage & Fire

<10 1st degree burn

RM-9 Diesel Spillage & Fire

28 1500

1st Degree Burn Vapour Cloud Explosion; Serious Injury Likely (from the center of fire ball)

Template 1. Chlorinepipe leakage: Toxic Impact Zone Stability Class “D”





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Template 2. Chlorine pipe leakage: Toxic Impact Zone Stability Class “F”

Template 3. Heavy Dichloromethane Spillage – Toxic Zone





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Template 4. Cyclohexane Spillage: Fire- Thermal Impact Zone

6.11. Consequential Impacts

The consequential impacts from each incident scenarios can be though thermal, over pressure

wave and toxic route. The damage can be on plant personnel (and neighbouring industry/

residents in case incident crosses boundary), property and also loss in production.

6.11.1. Thermal and Explosion Hazards

Incidents involving thermal hazards are mainly due to raw material and fuel (Furnace oil)

spillage and fire (in tank farms). The impact (1st degree burn) is limited to ~ 28 m (Diesel) and ~

13 m onlydue to Cyclohexane incident. The thermal impact will be limited within plant boundary

only. The impact can cross plant boundary due to vapour cloud explosion (rare case).

6.11.2. Toxic Hazards

Toxic hazards are mainly due toChlorine, Ammonia and Dichloromethane and other chemicals

leakageand their impact can cross the plant boundary (if not controlled in time). The impact due

to Chlorine and Ammonia release may go up to ~306 and 22mi.e. it may cross plant area

/storage area and may also have impact on outside plant area. Any suchrelease will have

adverse impact outside the plant battery limit and may involve district authorities to contain the

damage.





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6.11.3. Other Hazards

The other hazards in the plant include (but not limited to):

Other toxic hazards due to acids / other toxic spillages (mainly limited to spillage area only.).

Mechanical hazards due to machines / equipment.

Hazards due to individual soft spots like walking casually and noticing a pit and falling or colliding/ stumbling or slipping (not noticing a wet place etc.).

6.11.4. Other Toxic Hazards

Acid spillage-its impact will be limited to spillage area. The spillage if comes in contact with

metal parts will produce hydrogen which is highly flammable gas. Any person moving in area

and getting splash will get the injury. In addition the spillage will cause pollution problem. The

spillage is to be collected and neutralized for toxic contents before disposal.

6.12. Occupational Health

Naariwill have a well-equipped first aid post. It will also have staff personnel trained in first aid.

Injured personnel will be immediately rushed to hospital after giving first aid.All employees will

have regular medical checkup as per norms.

An emergency vehicle / ambulance will always (round the clock) available for meeting any

eventuality.

6.13. Emergency Management Plan

Naari already have Emergency Management Plan based on existing Formulation unit. The plan

is to be reviewed and revised based on additional hazards. Naari has to add additional facilities

to deal with preventive measures for thermal and toxic hazards. Some of the preventive

measures/ facilities are given below:

Fire Fighting Measures

a. Fire Water reservoir along with Fire water pump etc.

b. Fire hydrant around sensitive areas like Storage Tank area, Ware house,

process area etc.

c. Emergency Water Spray system on sensitive solvent tanks.

Toxic Hazards:Gas masks, Chlorine safety kit and other safety appliances.

Toxic Gas detectors at sensitive locations.

Additional training system considering process details.

Solvent/ fuel tanker unloading facility with all safety measures. Etc.

Mutual aid agreements to be made with neighboring industries. EMP is to be revised and submitted to authorities.





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CHAPTER 7. ENVIRONMENT MANAGEMENT PLAN

This chapter describes the administrative aspects for ensuring that mitigation measures are

implemented and their effectiveness monitored, after approval of the EIA. Environmental

Management Plan provides a logical framework within which identified environmental impacts

are managed. Technical methods to be used to mitigate (prevent, control and reduce) negative

impacts and working practices are described in Chapter 4.

7.1. Environment Management Plan (Operation Phase)

The management of NAARI Pharma is quite conscious of its responsibility for maintaining clean

and a healthy environment. The management is also keen to modify and make more efficient

measures towards suppression of pollution sources. Lot of adequate funds for pollution control

measures are provided as a part of overall project financing to ensure the availability of proper

treatment facilities before the commissioning of the proposed unit. The overall investment in the

project for plant is assumed to be Rs. 175 Crore. The unit has proposed Rs. 6.75 Crore as

capital investment towards Environmental Protection measures and Rs. 55 Lacs as recurring

cost. The proposed Environment Management Plan for the proposed plant is summarized in the

below Table 7.1.

Table 7.1 Environment Management Plan

S. No.

Particulars Mitigation measures

1. Air Environment Adequate Stack height for boiler and process scrubber will be provided for better dispersion of the air pollutants.

Ambient air quality and stack emission would be regularly monitored and effective control exercised, so that the stack emission load limits would be met at all the time.

Providing road surface with black toping to avoid dust emission due to transportation and all the roads will be asphalted

Ensuring greenbelt in 33% area of the total project area which will help in attenuating the pollutants emitted by the plant

Adequate measures for control of fugitive dust emissions will be taken

2. Water Environment

Fresh water requirement of the project will be met by ground water. Application has been made to CGWB.

100 KLD ETP plant will be established with advance treatment technology.

Zero waste discharge from the plant. The treated water will be reused in process. Provision of slit traps in storm water drains. Good housekeeping to avoid contamination of storm water. The sewage generated from the sanitary blocks will be treated

treated in STP (20 KLD). Plant should ensure that the treated effluent quality shall





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S. No.


comply with norms set by UPSPCB. Rainwater harvesting will be done and the water will be

discharge in ground water

3. Solid Waste Management

Construction waste / debris will be used for internal road laying purpose & landscaping.

Empty barrels (used for non-hazardous materials): Collected and sold to authorize recyclers after cleaning.

Scrap metals: Collected and sold to authorize recyclers. Used / Spent oil: will be given to authorised recycler. Other hazardouswaste will be sent to TSDF site

4. Noise environment

Foundations and structures will be designed to minimize vibrations and noise.

Regular equipment maintenance and better work habits will be adopted.

D.G. set is proposed to be housed in an inbuilt acoustic enclosure.

Necessary safety and personal protective equipment such as ear plugs, ear muffs, helmet etc will be provided to the workers.

Noise levels generated will be maintained to comply with the Factories Act & Rules and will not exceed 75 dB (A) at 1 m distance.

Implementation of green belt within the premises of plant will absorb the noise. Thus will help to control the noise pollution.

Proper lubrication and housekeeping is usually done to avoid excessive noise generation.

In addition to personnel working near high noise level generating sources is provided with ear muffs.

Equipment will be designed to conform to noise levels prescribed by regulatory agencies where necessary, high noise generating equipment should be acoustically treated or housed.

Proper maintenance, oiling and greasing of machines at regular intervals reduced generation of vibration due to machines.

5. Storage and handling of chemicals

Ensure the storage and handling of all the chemicals in a proper manner to avoid any spillages and also to prevent runoff contamination in monsoon.

Ensure collection & treatment of spillages, if any, ensure good House keeping to maintain clean and orderly working

environment. Provide training to the persons handling chemicals and

hazardous wastes. Ensure the provision of designated hazardous waste storage

area with proper roofing and leachate collection. Ensure the disposal of hazardous wastes at approved TSDF

with manifest only.





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S. No.


6. Transportation of hazardous chemicals and hazardous waste

Vehicles must be PUC certified. Ensure vehicular movement only during day time. Ensure the transportation only by covered vehicles. Ensure availability of manifest/TREM card with driver during

the transportation of Hazardous Waste /hazardous chemicals.

7. Biological environment

There is no endangered flora and fauna or rare species of plant and animals exist in the study area

Control and disperse emission through wet scrubber and appropriate stacks. As ambient air quality will be within limits, no active injury to the vegetation is expected.

Greenbelt shall be strengthened further.

8. Socio-economic Provisions infrastructure development under CSR activity. Employment generation to local people. Local employment will be ensured as per their skill.

9. Occupational Health

Provision of appropriate personal protective equipment as well as ensuring a safe and healthy environment for workers.

Persons will be subjected to both Initial and Periodical Medical Examination.

First aid kits will be given to the authorized persons and also kept in the office in case of emergencies.

10. Greenbelt Development

The proposed unit will be installed in 5.93 Acres (24000m2) land which is already with NAARI. Out of the total land plant including construction of manufacturing facility, utility, office and roads will be established in 3.93 Acres (15904.5m2) of the land and rest of the area i.e 2.0 Acres (8094 m2) has been kept for as a greenbelt.

Provision for community plantation under CSR activity in panchayat land after consultation with Gram Panchayat.

In order to effectively manage the environmental management (including social management) of

the project, following management plans are required.

Creation of Environmental Management Department Institutionalized Management Structure Greenery Development Plan CSR Plan Risk Management Rainwater harvesting plan Occupational Health Management Plan Budget for Environmental Management Plan

7.2. Environment Health Safety Management Cell (EHSC)

First of all EHS Cell shall be created in the proposed unit. The organizational structure of EHS

Cell responsible for routine environmental management and monitoring measures,





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implementing the EMP and complying with the conditions stipulated by SPCB and MOEF is

shown in Figure 7.1.

The Head of EHS Cell shall directly report to the GM of the Plant. The Head of Safety and

Health shall also directly report to the GM of the Plant. In case the HOD notes any non-

compliance or violation of environmental, safety or health law/ regulations, the same shall be

brought to the notice of the GM (during the weekly review meeting). In case the non-compliance

or violation is of manageable nature, GM will issue instruction and sanction budget and

resources to rectify the same. Otherwise GM will obtain financial approval from the Board of

Directors (Top Management) and then address the problem. In any case all matters of non-

compliance and violations shall be brought to the notice of the Top Management / Board of

Directors, action taken report shall be submitted on regular basis, till the problem is rectified.

Figure 7.1 Structure of Environmental Management Department

Functions of EHS Cell: Head of the EHS Cell shall form a Consultative Working Group by

involving responsible citizens from the surrounding community and develop action plans to

address any grievances of the public related to environmental performance of the project and

develop targets for addressing the grievances. The Cell shall thoroughly study each activities

and suggest additional mitigation measures (if required) for improvement of environmental

performance and discuss them in monthly meetings with the departmental HOD for

implementation. The EHS Cell shall co-ordinate all related activities such as safety, workers

health, and health of surrounding community and prepare statistical records. Responsibilities of

EHS cell are as below:

Implement EHS directives and guide line as per NAARI Pharma requirement

Operation of wastewater pre-treatment plant and Effluent Treatment Plant (ETP)

FACTORY MANAGER

MANAGER (EHS)

Executive (ETP)

Executive (Safety & Health)

Lab Assistants

(Environ. Sampling and

Monitoring work)





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Monitoring hazardous work through work permit system

Pre, periodical and post medical check of employees

Conducting audiometry test for employees working in high noise area.

Regular training to employees on Health, Safety and Environment Topics.

Regular monitoring of wastewater, stacks, ambient air, noise etc either internally or by

appointing external agency and data analysis. Corrective and preventive action,

wherever required.

Hazardous wastes management and handling.

Preparation of various reports like environment statement, carrying out environment

audit, preparation of water cess returns and various consent applications and renewal

under Water (Prevention and Control of Pollution) Act, 1974 and Air (Prevention and

Control of Pollution) Act, 1981 as well as application for authorization and its renewal

under Hazardous Wastes (Management, Handling and Transboundary Movement)

Rules, 2016, and amendment thereof under Environment Protection Act, 1986.

Pollution control equipment’s of each department is under respective department heads.

A team of well-trained and experienced staff should carry out the tests (as desired) in the

laboratory.

7.3. Institutional Arrangement

NAARI Pharma shall ensure following action items to be complied with throughout the life cycle

of the project:

Formulate Environmental Health & Safety Policy Document the organization structure, roles and responsibilities for implementation and

for functioning of Environmental Management System (EMS) and Safety Management System (SMS) Procedures.

Develop standard operating process and procedures to bring into focus any infringement / deviation / violation of the environment or forest norms/conditions.

Obtain ISO 9001, 14001 and 18001 Certification Carry out regular inspections, monitoring and auditing; Carry out periodical review and issuing amendments; Reporting and communication (including internal and external reporting);

Documentation and Record Keeping; An effective system of management is a key technique for ensuring that all pollution prevention

and control techniques, monitoring plan and risk mitigation measures are delivered reliably and

on an integrated basis. NAARI shall operate a formal Environmental Management System,

certified EMS/ ISO 14001/ OHSAS 18001 system for the proposed expansion project. NAARI

shall document the Standard Operating Procedures to bring in any deviation / violation of the

environmental norms as prescribed. The SOP shall address the system of reporting of non-





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compliances / violations of environmental norms to the Board of Directors of the Company

including all shareholders and stakeholders. The salient features of Environmental Management

System (EMS) are listed below:

Effective operational and maintenance systems shall be employed on all aspects of the process whose failure could impact on the environment:

Documented procedures to control operations that may have an adverse impact on the environment

Define procedure for identifying, reviewing and prioritizing items of plant for which a preventative maintenance regime is appropriate

Documented procedure for monitoring impacts Preventative maintenance programme, whose failure could lead to impact on the

environment The maintenance system includes auditing of performance against requirements arising

from the above and reporting the result of audits to top management. The skills and competencies necessary for key posts shall be documented and records

of training needs and training received for these post maintained. The potential environmental risks posed by the work of contractors shall be assessed

and instructions provided to contractors about protecting the environment while working on site.

Written procedures for handling, investigating, communicating and reporting actual or potential non-compliance with operating procedures.

Written procedures for handling, investigating, communicating and reporting environmental complaints and implementation of appropriate actions.

Written procedures for investigating incidents, (and near misses) including identifying suitable corrective action and following up

The company shall conduct audits, annually, to check that all activities are carried out in conformity with the above requirements.

The company shall report and publish annual report on environmental performance, objectives and targets, and future planned improvements.

The company shall have demonstrable procedures (eg. written instructions) which incorporate environmental considerations into the following areas:

1. The control of process and engineering change on the installation; 2. Design, construction and review of new facilities and other capital projects 3. Capital approval; and 4. Purchasing policy

The company shall have a clear and logical system for keeping records of policies, roles and

responsibilities, targets, procedures.

Training Requirement of Staff: Training systems, covering the following items, shall be in

place for all staff of EC and other staff of various departments, which cover the following:

Awareness of the regulatory implications of the Environmental Permits for the activity and their work activities;

Awareness of all potential environmental effects from operation under normal and abnormal circumstances.

Awareness of the need to report deviation from the Permit.





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Prevention of accidental emissions and action to be taken when accidental emissions occur.

The staff of the EMC will be trained every year by arranging in house training programs by

inviting experts or faculty members from reputed institutes.

Periodical Review: NAARI will annually review the EMP and identified management action

plans to address any changes in the organization, process or regulatory requirements.

Documentation and Record Keeping: The EMC will maintain following documents for

effective implementation of the EMP:

Master management system document; Legal Register; Operation control procedures; Work instructions; Incident reports; Emergency preparedness and response procedures; Training records; Monitoring reports; Auditing reports; and Complaints register and issues attended/closed.

Environment Policy An effective system of management is a key technique for ensuring that all pollution prevention

and control techniques, monitoring plan and risk mitigation measures are delivered reliably and

on an integrated basis. NAARI have a well laid down Environment Policy approved by its Board

of Directors.

Objectives of Environmental Policy ―To be a role model in protection of environment for sustainable development, NAARI is

committed to implement best global practices in its operations through prevention / mitigation of

pollution, proper disposal / reclamation of wastes and bringing awareness among all the

stakeholders for continuous improvement in environmental performance‖

To take account of environment concerns in planning and decision making.

Compliance of conditions imposed in Environmental Clearance and all other statutory clearances issued by the Regulatory Authorities.

To prevent pollution of surrounding habitation by monitoring & measurement of environmental parameters.

Identification of significant impacts and preparation of environment management system for implementation.

To reduce waste generation and promote recycling of materials, wherever possible.

Optimum utilization of resources i.e. Electricity, Oil and Water.

To take up development works in surrounding villages as a part of corporate social responsibility.





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To provide appropriate training and disseminate information to enable all employees to implement best practices and work in partnership to create a culture of continuous improvement.

The company shall document the Standard Operating Procedures to bring in any deviation / violation of the environment norms as prescribed.

7.4. Greenbelt Development

In order to mitigate and minimize the environmental impacts, arising due to project especially

from air pollution, noise pollution, soil erosion etc. the Greenbelt development work has been

already started by NAARI Pharma. The green canopy not only absorbs some of these pollutants

as carbon sink but also improves the aesthetic environment, besides attenuating the noise

levels.

NAARI Pharma has developed a three tier and 10-15 m wide greenbelt all around the proposed

plant premises. As per CPCB/MoEF guidelines 33% (8093 m2) of the total land area ((24000m2)

has been kept as greenbelt. Photographs of the greenbelt developed by NAARI Pharma is

provided in Figure 5.2.

Figure 7.2 Photographs of Greenbelt Developed by NAARI





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Species selected for plantation: The species selected for this plantation are moderately high,

good foliage bearing and are able to trap dust and noise. The following species have been

planted under green belt. (Table 1.1).

Table….Species suggested for plantation under Greenbelt Development Progaramme

Sr. no

Common name Botanical name Family

01 Lemon Citrus limon Rutaceae

02 Guava Psidium guajava Myrtaceae

03 Ashoka Saraca asoca Fabaceae

04 Mango Mangifera indica Anacardiaceae

05 Alistonia Alstonia scholaris Apocynaceae

06 Silver oak Grevillea robusta Proteaceae

07 Semal Bombax ceiba Malvaceae

08 Gular Ficus recemosa Moraceae

09 Neem Azadirachta indica Miliaceae

10 Kathal artocarpus heterophyllus Anacardiaceae

11 Jamun Syzygium cumini Myrtaceae

12 Sheesham Dalbergia sissoo Fabaceae

Source: NAARI

Budget for Greenbelt:

NAARI Pharma has already developed a dense greenbelt in about 8044 m2(33%) of the area

within the plant. More than 350 trees has been already planted along the plant permises.

Further 5 no. of lawn shall be developed in the proposed plant area.

Till date Rs. 25 lacks has been already spent by NAARI for greenbelt plantation and

maintenance. Further NAARI Pharma has earmarked a budget of Rs. 10 lacks/year for

development of lawns and other form of greenery and maintenance (including manure/ watering

and labour charges etc.) of the existing greenbelt.

7.5. CSR Plan

Social and community infrastructure and services would be provided in response to the need of

communities. This will help in enhancement of the overall quality of life in the area. The

company will also undertake community development in surrounding villages in the field of

sport, drinking water, road development and greenbelt development in Panchayat land with

consultation of the Pram Panchayat.

M/s NAARI Pharma Limited is fully conscious of its Corporate Social and Environment

Responsibility towards community as well as environment and as per the latest Office

memorandum of MOEF&CC dated 1st May 2018, NAARI has earmarked a budget i.e Rs. 264

Lacks(@ 1.5% of the project cost) for CER/CSR activities. The thrust area under CER/CSR will

be education, sanitation, health, Environment and Providing employment and making people





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able to earn their livelihood so that their living standard could be improved. NAARI has planned

to play a leading and meaningful role in bringing qualitative improvement in the life of

community and the surrounding environment.

NAARI shall create a CSR Cell under the direct control of Chief Executive of the project. The

CSR Cell shall implement the CSR Plan by making a Consultative Committee comprising the

Panchayat Members and village elders. The main objective of CSR wing will be to prepare a

proper plan for development / uplifting of the rural people (surrounding the site) and implement

the same (based on need based survey). CSR Budget is given in Table 7.4.

Table 2.26 CSR/CER Budget (in Rs)

Sl.No. CSR Activity Area Phase-I Phase-II Total

1 Education and Medical 15 65 80

2 Energy Conservation 15 40 55

3 Water Conservation & Improovement

14 65 79

4 Add for Plantation in consultation with Forest department

10 40 50

Source: NAARI

Identification of Employable Youth: NAARI will continuously have interactions with local ITI

trained youth. Training Division of NAARI will have campus interview in near by ITI located in

Rudraour and surrounding. After selecting the ITI trained youth they will be provided jobs in

following areas:

Fitters Welders Carpenters bar bending Mason Maintenance of Pumps and other mechanical equipments Electrical Maintenance Environment Monitoring Green belt Development ( Gardner Training) Laboratory Chemist ( Water Testing) Brick Manufacturing Vehicle Driver

7.6. Rehabilitation and Resettlement Plan

R & R study has not been found relevant for the proposed project since the project is located in

Industrial area. Hence, no R & R is relevant for the proposed project





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7.7. Emergency Preparedness Plan

An industry with its complex of activities involving various plant machineries, raw materials,

products operations, intermediates and environmental discharge has a number of associated

hazards. A minor failure can lead to major failure resulting into a disaster causing heavy losses

to life, property and environment. Emergency Preparedness Plan had been prepared by NAARI

to overcome the emergecy sitiations and Controlling the emergency, localize the emergency

and eliminating the hazard.

7.7.1. Objectives

The objectives of the plan are as follows;

1. Controlling the emergency, localize the emergency and eliminating the hazard.

2. Welfare of persons managing the disaster. 3. Head-Count and rescue operations. 4. Rescue of personnel. 5. Treatment of injured personnel. 6. Safeguarding others by steps including evacuation. 7. Minimizing damage to property and environment. 8. Informing and assisting relatives. 9. Informing and collaborating with statutory authorities. 10. Informing the News Media. 11. Preserving records and organizing investigation. 12. Ensuring safety of the workers before personnel re-enters and resumes work. 13. Investigating & taking steps to prevent recurrence. 14. Restoring normalcy.

7.7.2. Role and Responsibilities During Emergency

In order to achieve above objectives, the role of key personnel is clearly defined to avoid

confusion and to meet the emergency effectively. The Site Main Controller (SMC) and the Site

Incident Controller (SIC) are the personnel for effective control of an emergency. As per the

emergency preparedness chart the success of control of an emergency situation depends upon

their timely action. The action for these persons and Emergency Do‟s and Don‟ts are given in

this section.

Site Main Controller, Site Incident Controller, EHS Coordinator, Security personnel, Shift supervisor (Affected area), Shift supervisor (non-affected area), Rescue team/ Emergency squad members. Telephone operator,





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Outside drivers/ Owners of vehicle Any one noticing fire/ gas leak or other emergency.

The Rudrapur Plant Head is authorized to operate the assistance of any available Factory staff

to assist with the handling of any emergency. The Rudrapur Plant Emergency Coordinator is

also authorized, within the constraints determined by the management of Naari Pharma Pvt

Limited., to assign resources and to expend funds using procedures deemed appropriate under

the circumstances. A report of all such expenditure is to be made.

In the absence of the Plant Head from the plant the various responsibilities and authorities set

out in this document would pass to the QA Head and in absence of QA Head passed to the

Production Head. In this document, the term Head(s) of Department (HOD‘s) refers to

Production Head / QA Head / QC Head / Engineering Head / Warehouse Head / Security

Officer.

7.7.3. Site Main Controller

To supervision of site incident controller, EHS Coordinator, Security Personnel, Shift Supervisor,

(Affected Area), Shift Supervisor (non-affected area), Rescue Team/ Emergency Squad

Members, Telephone Operator, outside Drivers/ Owners of vehicle anyone is noticing fire in

case of emergency.





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7.7.4. Site Incident Controller

Production Head/ HR/Admin Head / Engineering Head/ QA Head/QC Head / Warehouse Head

(During silent hours concerned departmental person)

Arrive immediately at site and assess the situation Activate the On-Site Emergency based on assessment. Report head count to

SMC. Direct shutdown and evacuation of plant. Identify areas likely to affected by

emergency. Call outside emergency services-fire brigade, MARG (Mutual Aided Resource

Group) Provide information to emergency services about the chemicals/incident To inform SMC about emergency.

He Shall,

a) On arrival immediately assess the scale of emergency and decide if a major emergency exists or is likely.

Direct the security head to report the emergency to Site Main Controller. Direct the onsite action plan depending on the type of emergency.Call outside

emergency services like fire brigade, police, and members of mutual aid. Give advice, information as requested by the head of the Fire Brigade, Police and

Mutual Aid members. Make available the copies of ―EMERGENCY PREPAREDNESS PLAN‖. Assume the responsibility of the Site Main Controller till the arrival of the site main

controller. Direct the shutdown and evacuation of the plant. Identify the areas likely to be

affected by the to inform SMC about emergency. Preserve all evidence for a subsequent inquiry and he shall maintain a record of

events to facilitate further investigation. b) Direct to remove the combustible material from nearby area.

c) Direct the firefighting operations with the help of Emergency Squad looking to the

emergency he will inform to the site main controller for the requirement of external help

such as fire brigade, mutual aid.

d) Aid move the casualties from the site of emergency to occupational health center and/or

hospital as necessary.

e) Organizes a team to carry out decontamination of the affected area under his directions.

f) Assess damage to the equipment and if necessary organize shut down of part section of

the plant.

g) After the emergency is brought under control, he will ask to the SMC

h) After the ―all clear‖ he will bring the operation of the works back to normal.

i) After normal operations of the plant have been restored, then Incident Main Controller

will prepare and submit a report of the incident in the following format to the Plant Head

& copy to Engineering Head.

Date and time of the incident.

Nature & place of incident.





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Equipment/ machinery affected.

Action taken to bring the emergency back to normal

7.7.5. Ehs Co-ordinator

Execute instructions given by SMC - seek assistance of Local Industrial Area – Emergency

Response Station/ Fire Brigade, Mutual Aid Response Group (MARG), specialist of manufacturer if required.

Lead the firefighting& rescue operations. Liaison with Factory Inspectorate, UPCB (Uttaranchal Pollution Control Board). Supervise duties of Security personnel. Supervise rescue & medical operations.

EHS Co-Ordinator will immediately proceed to the scene of emergency as leader of Emergency

squad and will assist, guide and advice to Site Incident Controller. He shall ensure that correct

and safe actions are initiated and required personnel protective equipment‘s are used. He will

also assist Site main controller as important key person and coordinator. In addition to his

general duties of maintaining order of administration he shall discharge following duties;

He Shall,

a. Execute all directions and instruction of Site Main Controller regarding.

Calling mutual aid members.

Specialist from the supplying company. b. For efficient and successful operation of the plan statutory agencies listed below

should be actively involved for guidance and help: -

Fire Brigade

Police Authorities

Collect orate / revenue officials

Directorate of Industrial Safety and Health

Uttarakhand Pollution Control Board.

District Health Authorities

Non-Government Organization

Local News Media.

Local Leaders c. Supervise the duties of Security Personnel. If injuries and casualties do occur then he

shall obtain names and addresses of the injuredand dead.

Arrange for the medical aid. Talk to the hospital and doctors. Report about the type of injury/ burn injuries and or toxic effects.

Report to the hospital and make arrangement for likely more cases of injuries. d. In consultation with the site main controller he shall identify the antidote or any special

medical procedure and report the same to hospitals.





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7.7.6. Security Personnel

Start firefighting and rescue operations with assistance from essential workers, under the direct supervision of SIC (Site Incident Controller)

Ask for ambulance to proceed to scene of emergency Remove obstruction from road and keep clear always. Assist Fire brigade &

Ambulance services, as instructed by SMC (Site main Controller). Restrict entry of unauthorised & untrained persons or vehicles from scene of

emergency / premises. Control traffic movement for smooth & normal flow. Initiate rescue operations if required Call for fire brigade & ambulance during off hours. Inform police, if instructed by SMC (Site main Controller). Liaison with EHS Co-ordinator.

Upon receiving the information of emergency, the Security Officer/ Guard will take the following

action:

Ensure the number of total persons at site including employees, contractor employees, and visitors from their records.

Stop movement of men & Materials from the entrance gate. According to hazard and instruction from site main controllers operate the sirens for

one minute on wailing mode and declare an emergency. Handle the main gate and vehicles at main gate according to the requirements and

instructions from Site Main Controller. Check and record the head count. Follow the instruction according to the Site Main Controller. Operate the siren to declare an evacuation by operating siren for three minutes on

wailing mode. Record headcount, report and response received from various departments and

verify with headcount system. Keep internal roads clear for transportation movement. Indicate the way to emergency site for emergency services inside as well as for

outside like MARG (Mutual Aid Resource Group) if it is required. On holidays take regular rounds of the plant. Ask for ambulance to proceed to scene of emergency based on requirement. Remove obstruction from road and keep clear always. Assist fire brigade &

ambulance service, as instructed by SMC (Site main Controller). Restrict the entry of unauthorized & untrained persons or vehicles from scene of

emergency/ premises. Control traffic movement for smooth & normal flow. Initiate rescue operation if required and asked by SMC (Site main Controller). Call for fire brigade & ambulance during emergency. Inform police, if instructed by

SMC (Site main Controller). Liaison with EHS co- coordinator.

In – Charge Security:

a) On hearing the Fire Alarm or on being informed. He will rush to the site of Emergency, will assess the situation and will take over and direct the Fire Fighting Operations under the overall direction of the Site Incident Main Controller.





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b) If he feels that the Fire is going out of control. He will advise the Incident Main Controller accordingly and Incident Main Controller will then decide whether assistance

c) from the ―Fire Brigade‖ is to be called for. d) After fire is brought under control and is fully extinguished, he will inform the Incident

Main Controller. e) He will arrange for refilling of the spent Fire Fighting Extinguishers/ Appliances. f) He will help Incident Controller to mobilize resources with in the works. g) He will help to evacuate the affected area and assemble the people at the assembly

point. h) He will arrange search, rescue operations of those who are not identified at the time of

taking roll calls. Security Officer/In charge:

i) On hearing the Fire/ Emergency siren the Security Officer will make one security guard j) as In-charge of the main gate with the instructions to Hear the gate siren Inform the In-

charge Security and Emergency Control Officer.

k) He will then instruct the security guard on duty to clear all the vehicular traffic on the road leading to the location of the Emergency and will then rush to the location of the emergency along with the security guard and report to the Incident Controller and follow the instructions by Incident Main Controller

7.7.7. Emergency Response Team (Emergency Squad)

If you are a trained emergency squad member and your name is listed for the day, you would get relived of your responsibilities.

Shall report to the Site Incident Controller for further instructions. Carry out firefighting, first aid, search & rescue operations, and Spill control as

directed by SIC. Shift Electrician shall ensure power to fire pump and critical equipment's, lighting.

Switch off power, if instructed by SIC. Transport the injured, load to ambulance.

Table 7.2 : Emergency Squad Members

EMERGENY / FIRE FIGHTING TEAM

FIRST AIDER TEAM SUPPORT/

SUPPLY TEAM

General manage and 8 nos. of supporting staff

4 nos. of staff 4 nos. of staff

This team is trained in firefighting; spill management, emergency management, rescue

operation and response functions.

A list of Team is available with Security office/ emergency control center at the main gate. The members of the emergency squad will assist the Incident Controller during emergencies and will work under his instructions.





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For purpose of emergency management, their respective departments will release the nominated members of the squad at the time of emergency.

The members of the Emergency Squad will act as: Firefighters. Runners & Messengers if required in case of failure of the communication system. Handle casualties. Perform emergency duties such as providing lighting, isolating equipment,

firefighting, search and rescue, spill control, operations, rescue, first aider etc. according to requirement and as directed by the Site Incident Controller.

If you are trained Emergency Squad member and your name is listed for the day you would get

relived of your responsibility.

Shall report to the Site Incident Controller for further instructions. Carry out firefighting, spill control, first aid, search and rescue, as directed by SIC

(Site Incident Controller). Shift electrician shall ensure power to fire pump and critical equipment, lighting

switch off power, if instructed by SIC (Site Incident Controller). Transport the injured, load to ambulance. Reporting to site incidence controller and Site main controller about the work of

emergency controlled, head count.

Fire Fighting Team:

On hearing the siren, the members of the shift Fire Fighting Team intimate their respective area

In-charge and report to the Incident Main Controller and follow the Instructions given by

Incident Main Controller.

First Aid/ Rescue Team Members:

On hearing the Emergency siren, the security officer on duty will alert the Emergency vehicle

driver to be ready with the vehicle, receive and transport the casualties, if any-

Inform the company‘s Medical Officer about the Incident telephonically. Keeps ready the First Aid Kit. Rush Emergency location and remove the casualties

to the Admin Block to administer the First Aid Treatment. Works under the guidance of Incident Controller till the Medical Officer arrives at the

site and takes charge of the medical angle of the situation. The Incident Controller deputes a company representative to accompany the

casualties to be shifted to the hospitals. On hearing the siren members of the First Aid & Rescue Team intimate their respective area In-

charge and report to the Engineering Head and follow the instructions according to him.

Production/ Quality Assurance / Quality Control/ Stores Head-:





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a) If any of the above-mentioned Head‘s happening to be present him/ they will proceed to the site where Emergency has arisen, provide support and guidance to the Incident Controller

b) In the case of ―B‖, ―C‖ ―D‖ Class Emergencies the Plant Head will take charge of dealing with statutory authorities, Fire Brigade and Hospitals in a coordinated manner.

Human Resource Executive -:

c) During the working hours if the emergency takes place in general shift the Human Resource Executive carries out following duties.

d) Position himself at security main gate. e) Handle the outside communications to Police, Press, Government Authorities, Relatives,

etc. as per the direction of the Site Main Controller. f) Assume the charge of the security at the gate and impose control on all traffic to and

from plant. g) Decide to keep the approach road to the factory cleared. Post a guard at the Corner for

the incoming emergency vehicles. h) In case of emergency requiring evacuation, he makes the arrangement for transport. i) Assist in prompt medical attention to the affected persons and handle information to

relatives of the seriously injured. He provides the list of Blood Group of employees to dispensary.

j) Collect information on roll – calls from assembly points. k) Handle all the enquiries of the employees‘ relatives from outside.

EHS Coordinator:

a) He will visit the site of Emergency. Assess the situation and informs Plant Manager over the Telephone/ Mobile/ E-mail / Fax etc.

b) He will call Fire Brigade if situation is beyond control of Emergency Control Team. c) He will assist site controller in communicating Government agencies. d) He will help to Medical Officer in shifting casualties to the hospitals. e) He will help to evacuate the affected area and assemble the people at the assembly

point cited area. ENGINEERING HEAD

a) He will visit at the site of emergency, assess the situation and provides engineering supports to Control emergency.

b) In case of emergency he will provide outside services like SIDCUL and cranes. c) One portable pump to be maintained & made available in case of requirement during

Emergencies.

SHIFT SUPERVISOR (AFFECTED AREA)

Inform to HOD EHS, Security, Plant/ Dept. Head or his nominee, Plant Head, SMC on telephone immediately.

Take charge as SIC till his arrival & also of SMC during emergency hours till his arrival.





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Direct contractor employees, visitors to assembly point. Head count. Deploy trained Emergency Response Team & direct them. Act as per instruction of SIC/ SMC on their arrival. Provide information to external agency about the chemical involved to control

emergency/ treating injured employees. Personnel in Affected Area

The personnel in the affected area, under the guidance of the incident controller, shall tackle the

emergency as per laid down procedures for the area bearing in mind the requirements of the

situation called for by the progress of the emergency. Remove all unwanted personnel from the

area of emergency;and Stop all the activities that could initiate emergency such as maintenance

work, hot work.

Shift Supervisor (Non-Affected Area)

Ensure all contractor employees & visitors stop their activity and report at Assembly point.

Take Head Count & report to SMC at ECC (Security main gate). Switch off all critical operations. Be Alert for evacuation & evacuate on instructions from SMC. Keep ready - Emergency Response Team members. Provide necessary information and support to affected department/ plant to control

emergency. Hold personnel at Assembly Point till ‗All Clear‘ siren is raised.

Personnel in Non-Affected Area

Will report the head count immediately to Site Main Controller. He will Keep their plants

operating safely & follow the instruction of the Site Main controller. Will release members of their

staff for emergency? duties bearing in mind the condition of their plants at the time and ask

them to report to the Site Incident Controller. Keep close vigilance to ensure that the emergency

does not spread to other plants. In such an event, they should be prepared to shut the plant

safely and Keep the Incident Controller and Site main controller informed of all activities.

d) When emergency is declared all employees would initiate actions like shutting off non-critical

e) operations and isolation of hazardous material, actions to take safer mode of operation in process and operation e.g. shut of steam if standard process permits, use of cooling - chilling, closing of drums containing material, stoppage of non-critical operation and be ready for evacuation considering the possibility of evacuation order.

f) Proceed through safest route to the nearest assembly point at main Gate or in front of respective plant s assembly point which is nearer and safer. And wait for further instructions. The employees shall stay at the assembly points in a peaceful manner and to assist the Site Main Controller/ Site Incident controller in any manner he may require.

g) All such people assemble at such assembly points shall respond to the security guard on duty at all locations. The security guard based on the information relating to





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the number of people present on site conducts a head count. Any shortfall in the number of people will be reported immediately to the Site Main Controller.

SHIFT ENGINEERS (MAINTENANCE & UTILITY):

On hearing the siren, he rushes to the site of Emergency and reports to the Incident Controller.

He helps in providing necessary resources for controlling the Emergency.

Utility Operator/ Shift Electrician:

He reports to the Shift Engineer (Maintenance and Utility) and follows the instructions given by

him to control the Emergency

Maintenance Personnel (Excluding those involved in emergency duties)

All maintenance staff on the duty will support and assist to face an emergency. These could

require use of rigging and other resources. While rendering to such assistance they shall ensure

that the personnel are not exposed to undue risks posed by the incident or the emergency

action taken. Isolation of electrical equipment and provision of temporary lightning, power etc.

shall be organized by the electrical personnel under guidance.

All Other Employees

All employee‘s other than those mentioned above should immediately proceed to their

respective places of work and act as per the instructions of the shift in-charges. All activities,

which relate to the area under emergency, will come under the control of the Incident Controller

and personnel will act under his instructions. Stop all non-critical activities immediately and be

ready for shutdown procedure and to evacuate the plant considering the possibility of

Evacuation. Safe guard valuable materials & documents in the areas as required under

guidance of the shift in charge.

Contractor Employees

Contractor employees at the site shall stop work, keep all tools safely aside and report to the

assembly point. They should stand in a queue behind their supervisors.

Visitors: All visitors to the site shall proceed to the Assembly Points for Head Count.

Key Contact Numbers

A list of key telephone numbers for emergency contact is given as an annexure for ready

reference. A copy of same will be readily available with all shifts in charges as well as in

emergency control center. This list will be updated time to maintain the updated information all

the times.





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Outside Drivers/ Owner Of The Vehicles:

Outside Drivers/Owners of vehicles: Should not start their vehicle unless instructed by SIC /

SMC. On instructed should move out without obstructing the road.

Off Duty Employees: Employees who are on off duty & available should immediately report to

the EMERGENCY CONTROL ROOM & wait for the instructions.

Communications

Communications- Receptionist/ Administrative officer.

HR Head should assist the works controller in the following functions.

Determine the need to inform statutory authorities of the accident and prepare the necessary forms for submission.

Arrange for assistance or support required at site such as medical assistance, food, informing to the families of the affected / injured persons, hospital accommodation etc.

Arrange for legal and other to the site on dealing with accident issues. This shall be done with the help of the Site Main Controller.

Inform H.O. for arranging for insurance company surveyors in the event of loss of material or property and arrange for survey of the site as per the rules of the company and the insurance requirements.

Any One Noticing Fire/ Gas Leak/ Any Emergency

Action plan for anyone noticing fire / gas leak or any emergency:

The person who notices the Fire/ Spillage/ Toxic release shouts ―Fire! Fire!! Fire!!!‖ Fire at….(Location) or ―Danger! Danger!! Danger!!!‖ as applicable. He informs the concerned area In-charge, who sounds the siren.

It is however, not advisable to sound the siren in the case of a minor fire, minor spillage, leakage which can be controlled.

Major fire/ explosion/ gas leak/ chemical spillage:

Operate the manual call point or alert the personal by shouting fire-fire-fire/ help–help-help.

Inform the shift supervisor about. a) Place.

b) Extent/ severity.

c) Action taken if any.

d) Material /chemical involved.

e) No. of affected people, if any.

General Instructions





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Speed is essential. In all cases the first few minutes are critical and in the case of emergenciesthreatening life or property the initial reactions should be: ASSESS, NOTIFY, and EVACUATE.

Clarity of information and instructions to all concerned persons and authorities.

Telephone numbers are to be used only for essential communication to combat the emergency.

In case of communication failure, send messengers by bicycle or any other transport available.

Ensure only trained persons are deployed for combating the situation and safety procedures are followed.

Ensure that MOCK DRILLS are conducted regularly. -once in a quarter year (four per year).

Adequate quantity of material to neutralize the risk elements should be kept ready.

After All Clear Signal

Investigation to avoid recurrence, recommendations and records.

Salvage operations with all safety precautions.

Resetting the operations - Production Head.

Resetting the plant / department operations.

Permission from different Authorities and Final Clearance from SMC.

7.7.8. Emergency Do’s And Don’ts

DO‟S DON‟TS

ANY ONE NOTICING AN EMERGENCY: Actuate nearest MCP or inform shift supervisor. Get back to your normal workstation (if safe) or else report to the assembly point. In Safe Assembly Point wait for further instruction from management and follow the same.

Do Not panic and avoid running all over the place prevent others from doing so. Do NOT enter the site unless instructed if you are outside and emergency alarm is sounded

CONTRACTOR PERSONNEL: Stop work on hearing Emergency siren and assemble at the ―Assembly Point‖ and be ready to evacuate. In Safe Assembly Point wait for further instruction from management and follow the same.

DO NOT enter site until cleared for the normal work by Site Incident Controller (SIC).

SECURITY: Keep the gate unmanned. Keep the road clear for movement of fire tenders.

DO NOT allow unauthorized visitors free to enter.





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Control traffic at gates. Park fire tenders/ ambulance vans at gate –standby. Head Count.

VISITORS: Leave the place and assemble at assembly point. In Safe Assembly Point wait for further instruction from management and follow the same.

DO NOT enter the site if emergency siren is heard.

ALL OTHER EMPLOYEES ON SITE: On hearing Emergency Alarm, get back to workplace (if safe) and get instructions from supervisor.

DO NOT panic/ run. DO NOT go to the scene of emergency unless specifically instructed by Incident Controller.

7.7.9. OUTSIDE ORGANIZATION IF INVOLVED IN ASSISTING DURING ON – SITE EMERGENCY

TYPE OF ACCIDENT

a) Spills,

b) Fire,

c) Explosion,

d) Fall of structure/ building/ lifting device,

e) Accidents in nearby industry,

f) Heavy rainfall, &

g) Flooding.

7.7.10. Responsibilities Assigned

Firefighting system (fire tender, ambulance, gas masks with canisters and necessary antidote)

for most emergencies the civil authorities, such as police, fire brigade, ambulance and State

Emergency Services, will arrive within minutes to deal with the majority of, but not necessarily

all, aspects of an emergency.

7.7.11. Details of Liaison Arrangement Between The Organizations.

In case of any emergency these industries are having adequate resources such as follows to

overcome the emergency.

1. Ambulance Service. 2. Occupational Health Center. 3. Doctors and Para Medical Staff. 4. Technical Staff to assist in Emergency.





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5. First-Aid equipment, Safety equipment. 6. Fire water/ Antidotes.

7.7.12. Preliminary Hazard Analysis

Type of Accident

Fire, Gas leak -flammable or toxic, Explosion, Fall of structure/ building/ lifting device, Spillage.

CAUSES

The causes or events that can lead to a major accident

Natural. Storm, Wind, Cyclones, Tempest, Flood, Earthquake, Lightning strikes, & Epidemics.

Deliberate. Sabotage, Terrorism, Civil Commotion/Armed conflicts, & Plane crash/ Air raid.

Unsafe Acts and Situations.

Corrosion, Equipment failure, Design deficiency, Abnormalities in operation or maintenance, & Fire/ Emergency in neighborhood.

7.7.13. System Elements Or Events That Can Lead To A Major Hazard

At the Site Disaster could be of the following type,

Fire / Explosion Large Spillage of hazardous chemicals. Toxic gas release from neighboring factory. Overturning of road tanker containing flammable / toxic materials Failure of piping containing flammable materials Fall of structure or building. Release of high velocity fragments of ruptured equipment‘s due to

overpressure conditions.

7.7.14. Hazards





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Solvent Fire, Fire/ Explosion, Spill

NFPA HAZARD INDEX:

SR. NO.

NAME NFPA HAZARD INDEX

N h N f N r

31 HSD. 1 2 0

National Fire Protection Association (NFPA)

N h - Health N f – Highly flammable, N r - Reactivity

7.7.15. Safety Relevant Components

Fire hydrant, AFFF foam nozzles and solutions, Fire water tanks, Gas masks & safety PPEs, Portable fire extinguishers, sand buckets.

DETAILS OF SITE

LOCATION OF DANGEROUS SUBSTANCES

The site surrounded by engineering industrial units and is accessible by road. The

manufacturing activities consist of following stages.

Dispensing, Granulation, Compression, Coating, Packing.

Following hazardous materials are stored/ handled at site. The locations are shown on the site

plan on following page.

SR. NO. NAME OF DANGEROUS

SUBSTANCES

MODE OF STORAGE LOCATION

1. Diesel. Drum. DG Set.

7.7.16. Legend for Site Plan

Diesel tank 0.5 KL. Finished goods.

Linen room Primary pack material day store.

Scrap yard. Inactive dispensing room

AC store area Active dispensing room





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Non-AC store Clean room.

461. Dedusting granulation area

462. Blister packing cubicle -1 Wash area

463. Tablet coating room – 1, IPQC for capsule

464. Lab chemicals store Capsule filling

465. Tablet inspection -1 Transformer.

466. Tablet inspection -2 DG set.

467. IPQC area Compressed Air System

468. Die punch change part area. STP/ETP.

469. Compression cubicle -1 Water tanks.

470. Security. Office

471. Leak test room. Bore wells 2

472. Change room. Unclean vessel store

473. CHILLER Room Clean container store

Granule quarantine Tablet quarantine

474. Packing hall. QA/QC Block

VCB room Admin Block

LT Panel room

Contact Details of Key Personnel:

The contact details of key personnel are available at the Emergency Control Room.

Emergency Control Room : EMERGENCY CONTROL CENTER is functional at security near

main gate as marked on site plan will be focal point in case of an emergency, from where the

operations to handle the emergency are directed and co-ordinate by Site Main Controller.

EMERGENCY CONTROL CENTER, will be equipped with following items

1. Copy of Emergency Preparedness Plan and off-site emergency plan. 2. Telephone (Internal and External) Telephone with only incoming, intercom and

one telephone with local facility exclusively for call facility transmitting the message.

3. Note pads, pencil etc. to record messages received and any instructions to be passed on through runners/ messengers.





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4. Technical Manuals on Startup, Shutdown etc. operating, maintenance procedures.

PROTECTIVE WEARS: Following personal protective equipment are kept in emergency control

room for use in case of emergency.

SR. NO. PPE NAME INTENDED USE

1. Rubber Hand Gloves. For handling Acids & Alkalis.

2. PVC Hand Gloves. For Handling Solvent.

3. Heat Resistant Hand Gloves. For Handling, hot articles or working near hot objects.

4. Welders Hand Gloves. For welding jobs.

5. Ear plugs. To Protect from noise.

6. Ear muffs. To Protect from noise.

7. Aprons. To Protect from chemical splash.

8. Safety Goggle/ Face shield. To Protect eyes and face.

9. Dust masks. To protect inhalation

10. Safety Belt. To Protect from fallen from Height

11. 3M masks To protect inhalation

12 Helmet To protect head

7.7.17. Details of Safety Systems

Hazard Control Plan: In Line with Disaster Control and Hazard Control Planning, Ensuring the Necessary Technical And Organizational Precautions. Assembly Point: Assembly point as marked on SITE PLAN is located farthest from the location of likely hazardous event.

LOCATION OF ASSEMBLY POINT FOR PERSON

One Nos. (as marked on the site plan)

Persons from works.





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Evacuation: If the incident is likely to affect people in the other plant area or environment outside the site. The Site Main Controller will intimate evacuation. Evacuation of the personnel to assembly area or away from site ensuring proper head count. Accounting for site Personnel Visitors and Contractors, particularly those know to have been in the affected area. The evacuation is along the escape route leading to assembly point. People must be evacuated at right angle to wind or opposite the wind direction. Display located at main gate indicates the actual number of persons present at site at any given time. It should be noted that maximum number of persons present at site is likely at changeover time between first and second shift and evacuation arrangement for same may be required in worst possible scenario. Evacuation Procedure & Rescue Incident Main Controller (IMC) assesses the situation and decides to evacuate affected area of the plant or total plant and informs Site Controller. Incident Main Controller (IMC) gets the announcement from ECC on PA system/ telephone/ personal messenger for evacuation of the affected plant or total plant. Shift Officer on the job safely stops the operation of the plant. He guides the employees in the dept. for safe evacuation to assembly point and gathering at assembly point. Shift officer arranges to take roll call at assembly point In case any employee has not arrived at assembly point, he informs Incident Controller who organizes search for the missing person. Emergency Preparedness The term emergency is defined as an abnormal and dangerous situation, Threatening Life, Environment or property or, requiring immediate action. Under this definition this Plan is applicable to the following emergencies: CLASSIFICATION OF EMERGENCIES The Emergencies that may possibly arise are listed and classified as under. This list is only indicative and not exhaustive.

NATURE OF EMERGENCY CLASSIFICATION

Smoldering and/or localized fire which can be handled by works superintendent by mobilizing the internal resources of the works and/ or injuries to personnel, which can be treated in the factory.

―A‖

Fire in a large area/toxic release/heavy spillage/injuries to personnel requiring hospitalization.

―B‖

Major fire which has the potential to Spread/ Explosion/ Bulk leakage/ Serious injuries to personnel, which may require evacuation of the works Partly or wholly.

―C‖

Natural calamities like Earthquakes, Flood, and Cyclone and tempest resulting in damage to life and property.

―D‖





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Environmental Emergency. ―E‖

‗A‘ type of emergency is handled by Incident controller and B, C, D, E types of emergencies handled by Site Controller, when site is affected. Incase such emergencies affect area outside the site the Off-Site Emergency Control Plan is initiated by Site Controller by Communicating at District Emergency Control Center.

RESPONSE LEVELS FOR EMERGENCIES

SR. NO.

RESPONSE LEVEL

DESCRIPTION CONTACT

1. Potential Emergency Condition.

An Incident or threat of a release which can be controlled by the first response agencies i. e. by Incident Controller and does not require evacuation of other than the involved structure or the area. The incident is confined to a small area and does not pose an immediate threat to life or property.

Emergency Control Centre, Plant Control Centre, OHC, Safety Dept. HOD‘s.

2. Limited Emergency Condition.

An Incident involving greater hazard or larger area which poses a potential threat to life or property and which may require a limited evacuation of the surrounding area.

All agencies of Level I, Site Controller, MARG, Fire Brigade.

3. Full Emergency Condition.

An Incident involving a severe hazard or a large area which poses an extreme threat to life and property and will probably require a large-scale evacuation.

All agencies of Level I & II, Police, Emergency Control Manager, District Collector Civil Hospital, DISH, MPCB.

ESSENTIAL EMPLOYEES In each shift, there will be available some trained workers in firefighting, use of gas masks, first aid. It will be a task force to assist and execute the instructions of ―The Site Incident Controller‖ and ―The Site Main Controller‖.Emergency Squad: Number of persons trained for firefighting/ first aid/ rescue operations/ spillage control. Rehearsal/ Mock Drill In disaster, management time is very important, the initial few minutes are critical and timely action may control the emergency. For persons to perform quickly their assigned roles, it is essential that each individual should be made aware of emergency rehearsals, which will impart procedures and their individual roles through proper training. It is necessary to test through necessary expertise to individuals to act quickly in case of a real emergency. This will help in identifying the deficiencies in the procedures and the likely difficulties, that may be encountered during implementation hence rehearsal of the plan will be undertaken at an interval of three





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months of work or when any new substance is introduced in the process or in the event of a serious accident taking place it will be reviewed and modified to the extent necessary. MOCK DRILL: Table top exercise. Partial mock drill - within one department/ plant. Full scale Mock Drill once every quarter year. REVISION ―The Plan‖, will be reviewed once in every calendar year, and modified if necessary in case of any changes in the process of operations or methods. SAFETY POLICY As a commitment towards safe working environment, the Management has formulated a safety policy and the same is displayed at prominent places at site. Emergency Response Procedure.

SR.no.

Major accident SCENARIO

Cause Action requirement

1. Fire/ Explosion in nearby company.

Improper method of material handling, shortcuts, over speed of work, faulty equipment.

Same should notify the co-workers and take appropriate precautions from nearer company to mitigate the hazards due to an emergency. Whenever possible, and without putting yourself at risk, shut down industrial equipment before leaving. Emergency squad teams take the necessary action. Evacuation and assembling at assembly point. Head count by respective department in charge/ Personnel dept. Management should take necessary action as per situation.

2. Heavy rainfall/ flooding.

Natural calamity. Same should notify the co-workers and take appropriate precautions from nearer company to mitigate the hazards due to an emergency. Emergency personnel in Departments should be on the alert and be geared up. Life jackets should be made available for use in emergency. Whenever possible, and without putting yourself at risk, shut down industrial equipment before leaving. Head count by respective department in charge/ Personnel dept. Management should take necessary





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action as per situation.

3. Gas leak from nearby company.

Failure of process control, leak from tanks, cylinder.

Same should notify the co-workers and take appropriate precautions from nearer company to mitigate the hazards due to an emergency. If you suspect a gas leak, open windows and shut off the main valve. Leave the building and report the gas leaks. Do not light a fire. Emergency personnel in Departments should be on the alert and be geared up. Do not allow any naked flame, spark, smoking, digging and alteration or construction work. Respiratory system should be made available for use in emergency. Whenever possible, and without putting yourself at risk, shut down industrial equipment before leaving. Verification of gas characteristics and wind direction, be ready for evacuation by nearest and safest route with possible PPE even with wet handkerchief to scrub the gas if you don‘t get the gas mask at the time Head count by respective department in charge/ Personnel dept. Management should take necessary action as per situation.

4 Earth quake/ Fall of Building/ Structure.

Natural calamity. Safe shutting down of plant operations/ other departments by concerned departments. Evacuation and assembling at assembly point. If the earthquake catches you indoors, stay indoors. Stay away from glass, or loose hanging objects. If you are outside, move away from buildings, steep slopes and utility wires. Head count by respective department in charge/ Personnel dept. Evacuation of factory premises. In case of any damage to property or life Incident controller will initiate necessary action. He will consult





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Plant Manager/ Engineering Manager/ EHS Officer.

5. High wind/ Cyclone/ Fall of roof/ Structure.

Natural calamity. Safe shutting down of plant operations/ other departments by concerned departments. Avoid contact with wet electric lines and switches. Do not move outside unless and until required. If required evacuate and gathered at safe assembly point. Head count by respective department in charge/ Personnel dept. Evacuation of factory premises. In case of any damage to property or life Incident controller will initiate necessary action. He will consult Plant Manager/Engineering Manager/ EHS - Officer.

Emergency Services

Police

Sr. No. NAME Code TELEPHONE

1.

Police Station – 05944 242378

2.

SP – 05944 243867

FIRE BRIGADE

Sr. No. NAME Code TELEPHONE

1.

Fire officer SIDCUL Station - 7830500707

ADMINISTRATION/ REGULATORY AGENCIES

S. No. Authority Code TELEPHONE

1. Collector –

05944 242304

2. Pollution Control Environmental Engineer -- 9412084871

3. SIDCUL

05944 250355

Fire Fighting Resources Fire Extinguisher: Fire extinguishers for emergency, located at strategic positions at each process plant, storage areas, security office etc. The same are be easily accessible, marked properly, and maintained regularly. Following Fire Extinguishers are provided:





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S. No. Type Capacity Numbers

1. ABC 5 Kg. 44

2 ABC 6 kg 11

3 CO2. 4.5 Kg. 21

4 Mechanical/Foam 9 Liters 5

Total 81

Fire Water Storage: Total Water Storagecapacity : 115 KL (Underground tank). Source of Water supply : Underground water Borewell : 2 Nos. Fire Tender: Fire tender available at fire station. Medical Facilities (First Aid ) Fully equipped first aid boxes are provided at strategic locations.

7.8. Rain Water Harvesting Plan

Rainwater harvesting is a mechanism involved in collecting, storing and using rainwater when it

is most needed. A rainwater harvesting system comprises of various stages – transporting

rainwater through pipes or drains, filtration, and storage in tanks for reuse or recharge. There

are five components in a rainwater harvesting system namely catchment, conveyance, filtration,

storage and recharge.

Advantages of Rain Water Harvesting: There are various advantages of Rain Water

recharging from which some of those are listed below:

Solution to water scarcity problems

Effective rise in ground water levels

Inexpensive and simple technology

It‘s economical and energy saving as it prevents extraction of water from depleting

ground water table

Provides high quality water, having low mineral content

Easy operation and maintenance

Artificial recharge to ground water is the process of augmenting the ground water resources at a

rate exceeding that under natural conditions of replenishment. Rain water harvesting is the

technique of collection of rain water and recharging of ground water artificially by means of

recharge structure. Recharge structure includes recharge pits, check dams, recharge well, nala

bunding and recharge tank construction. It may be possible to collect rainwater through

necessary infrastructure construction for diverting; collecting and storing it into groundwater





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reservoir as recharge into aquifer on subjected it through filtration media. If planned properly

and designed scientifically, it may aid in improving recharge availability and opportunity. Rainfall

is one of the important parameters that contribute water for the purpose of recharge into ground

water reservoir and therefore to estimate its likely quantum long term rainfall data is essential.

The average annual rainfall in the district is 1059 mm.

Unit has total plot area of 18380 m2 for rain water harvesting and based on the average rainfall

in the study area and effective area available for rain water harvesting, quantity of yearly runoff

has been derived as 5659 m3. Estimation of availability of yearly runoff is given in Table 5.3.

The total water requirement for project will be 42,600 m3/year (for 300 working days per year),

and hence ground water recharge would be only about 16% of total water requirement.

Table 7.3 : Estimation on Availability of Yearly Runoff

Sr.

Area available

Runoff

Long Term Estimate

Particulars

for rain water

Average

d yearly

No.

coefficient

harvesting, m2 Rainfall, mm runoff, m3

1 Roof top area 3876 0.85 1059 3488

2 Greenbelt & other area 8093 0.20 1059 1714

3 Lawn area 6411 0.20 1059 1357

Total yearly runoff 6559

Based on the estimation of yearly runoff and survey of the study area, it is observed that:

From the ground water development point of view this area falls in safe category. Effective runoff water available for ground water recharge is only about 16% of total water

requirement.

7.9. EMP Budget

The capital cost for environmental management of the proposed project is estimated to be Rs.

9.25 crores. Budget allocation of Rs. 115 Lacks is required every year to meet the recurring

expenditure for implementing the environmental control and improvement measures. The break-

up of the investment is shown in Table 7.7.

Table 7.4 Investment on Environmental Protection Measures (Rs. in Lacks)

S. No.

Particulars Capital Cost

(Rs. in Lakhs)

Annual Recurring Cost (Rs. in Lakhs)





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1. Air Pollution Control Systems (wet scrubber, periodic monitoring the emissions and ambient air quality monitoring, dust polltion)

100 10

2.

Water Pollution Control Systems (ETP, septic tank, soak pit, Plant Drainage system with sedimentation pits, oil water separator, and routine environmental montoring etc)

450 80

3. Noise Pollution Control (acoustic treatment of compressors, mills, etc), routine nosie monitoring

50 5

4.

Waste Management (disposal of spent oil, e-wastes, etc), Capital cost would include cost of providing storage space for hazardous waste. Recurring cost would include cost of transportation & disposal

150 2

5. Environment Monitoring and Management (development of environment cell, etc)

25 3

6. Greenbelt development and Maintenance 100 10.0

7. Add for Plantation in consultation with Forest department

50 5

Total (Rs.lakhs)

Rs. 925 Lakhs

Rs. 115 Lakhs





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CHAPTER 8. SUMMARY & CONCLUSION



263153, Dist: Uddam Singh Nagar, (Uttarakhand), India. The proposed new establishment is

to manufacture Bulk Drugs and intermediates, which are active ingredients with medicinal


production capacity of 16.46 MT/Month. The project will be implemented in Phases. Detail given

Below:

Sl. No. Phase Capacity (MT/Month)

Total Products

1 Phase –I 0.33 Total products are 37 out of the total 11 products will manufactured in Phase-I. (refer Table 2.2)

2 Phase-II 16.13

3 Total 16.46

Source: NAARI As the site is located in Notified Industrial area hence the projects does not attract the provisions of Public Hearing. The EIA Report has been prepared in the line with Terms of Reference (TOR) prescribed by MOEF&CC. The proposed site is located at Latitude: 29°00'21"N and Longitude:79°24'32"E. The site well connected to road and railway line. The site is located at Plot 14-16 & 55-57, Sector-5, IIE Pant Nagar, Rudrapur Industrial area, Dist: Udham Singh Nagar, (Uttarakhand), India. Proposed site is located in an industrial land allotted by State Industrial Development corporation of Uttarakhand (SIDCUL) in Udham Singh Nagar District. About 5.93 Acres (24000m2) land is available with NAARI at Plot 14-16 & 55-57, Sector-5, IIE Pant Nagar, Rudrapur Industrial area. out of the total land the proposed unit (construction of manufacturing facility, utility, office and roads) will be established in 3.93 Acres (15904.5m2) land and remaining 2.0 Acres (8094 m2) will be reserved for greenbelt development. It is a Bulk Drugs and intermediates manufacturing unit having production capacity of 16.46 MT/Month. The unit proposes to manufacture all the API & Drugs products, which involves various chemical reaction like, chlorination, dechlorination & Reductive Amination and physical operations like Layer separation, Crystallization, Filtration, drying, packing etc. The project will be implemented in two phases. phases. The estimated cost of the project is Rs. 17500 Lacks (Rs. 3500 Lacks for Phase-I and 14000 Lakhs for Phase –II). The proposed unit will be installed in 5.93 Acres (24000m2) land which is already in possession of NAARI. About 200 people will be required to construct the project. About 150 people will be required to operate the project. The project will be implemented in two phases hence the water required for phase –I is 23 KLD and water requirement for phase-II will be 127 KLD. Permission for drawl of 150 KLDground water shall be obtained from concerned authority. Application has been submitted to concerned authority





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The baseline environmental data generation has been done for the period of 1st October 2017 to 31st December 2017. The predominant wind direction is from West and Northwest direction in most of the year. During monsoon season the wind flows from East and west direction. Average wind speed ranges between 4.4 to 9.3 km/hr. The annual rainfall is about 893 mm. The ambient air quality of the study area is meeting the prescribed National Ambient Air Quality Standard at all locations. The ambient noise quality of the study area is within the prescribed National Ambient Noise Quality Standards. Parameters in ground water sample were well within the desired limit of Indian Standard IS: 10500-2012, except Haldi location, where the hardness values are slightly above the desired limit but well within the desirable limit. Bacterial and metallic contamination was observed in the surface water sample. However the surface water was found to meet the Best Designated Use – ‗D‘ Criteria of CPCB (i.e fit for fish propagation). The texture of soil varies from sandy loam. The soil pH ranges from 6.5 to 7.8 thereby indicating the soils are slightly acidic to neutral in nature. The organic matter, nitrogen, potassium and phosphorus content of the soil are found to be in low to moderate amount. Overall the soil is found moderately fertile. No ecologically sensitive area like national park, wildlife sanctuary, and biosphere reserve are present in the 10-km radius of project site. No species of plants and animals in the study area were found to be threatened, rare or endangered. No rare and endangered floral and faunal species was observed in the study area. The operation of the plant will leads the air emissions from the boiler and process stcks.

Handling & transportation of raw material shall also leads air and fugitive emissions. Multi

cyclone separator with stack height as per the CPCB guideline shall be provided for dispersion

of particulate matter from Boiler. All process vents will be routed through dedicated two stage

ventury scrubbing system. Water is required for utility, process, washing and domestic uses.

Being a pharma industry waste water generation is the main concerned. The discharge of

untreated waste may lead to water pollution in surrounding area. In phase-I process waste

water will be sent to CETP. In phase -II100 KLD ETP plant will be established with advance

treatment technology. Domestic sewage generated from the sanitary blocks will be treated in

STP (20 KLD).

The main source of noise generation during operation stages are mainly Boiler, pumps, blowers, compressors, Equipment will be maintained so that noise level does not increase due to improper maintenance. It is expected that noise level at the plant boundary will be within the prescribed norms of CPCB due to operation of the proposed project and no significant impact on noise environment is expected. Greenbelt developed within the plant premises will also act as a barrier to the propagation of noise from the factory premises. This shall further reduce the noise levels appreciably. Hence, no significant impact is envisaged.





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Under ordinary and safe operating conditions, no adverse impact is anticipated on land during the operation phase. Commercial waste like empty cement bags, Iron scrap etc. will be sold to scrap buyers after the construction phase. Domestic waste like used paper, label, cartoons will be disposed to the scrap buyers. Organic waste from canteen will be disposed as per the local Panchayath / Municipal disposal mechanism. Hazardous waste from Process and Effluent TreatmentPlant will be disposed as per CPCB/ SPCB Norms and HW Rules.

The incremental emission of air pollutants is not likely to induce any significant changes in the

ecology because the national ambient air quality standards will remain within the limits. The

incremental MGLC of PM, SO2, NOx and HCL generated from the proposed plant will be very

less and overall incremental GLC will remains within the NAAQS. Proposed plant is zero liquid

discharge based so no waste water will be discharged out site the plant permises. solid waste

and hazardous waste shall be disposed as per norm. Therefore impact of emission on the

surrounding vegetation will be insignificant. Greenbelt development along the plant boundary,

further development of gardens and lawns near admin building will mitigate the residual impact

on natural resources.

Firefighting system with fire extinguishers, hydrant system, sprinkler system, pumps and

pipeline network will be strengthened as per the recommendation.

EMP for effective management of environmental impacts and ensuring overall protection of the

environment through appropriate management procedures has been recommended in the EIA

report. The capital cost for environmental management of the proposed project is estimated to

be Rs. 9.25 crores. Budget allocation of Rs. 115 Lacks is required every year to meet the

annual recurring expenditure for implementing the environmental control and improvement

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CHAPTER 9. DISCLOSURE OF CONSULTANT

PRELUDE

Declaration by Experts Contributing To the EIA/EMP REPORT for setting up of new

Manufacturing unit of of Intermediate and Bulk Drug at Plot 14-16 & 55-57, Sector-5, IIE Pant Nagar, Rudrapur - 263153, Dist: Uddam Singh Nagar, (Uttarakhand) ,India by M/s NAARI Pharma Pvt. Ltd. I, hereby, certify that I was a part of the EIA team in the following capacity that developed the above EIA.

EIA Coordinator:

Name: Y Bordia

Signature & Date:

Period of involvement March 2017 to finalization of report

Contact Information: 011-30003200

Functional Area Experts

Functional Areas

Name of the Expert

Involvement (Period and Task**) December 2016 to finalization of report

Signature

Air Pollution Monitoring & Control (AP)

S K JAIN

Air pollution monitoring.

Meteorological parameter measurement.

Identification & assessment of quantum of emission and its Mitigation measures.

Air Quality Modeling and Prediction (AQ)

Mr. Sanjeev Sharma

Ambient Air Quality monitoring network designing.

Processing of micrometeorological data for using in model.

Air quality modelling through ISC- Aermod for proposed prediction of impact

Noise Mr. Sanjeev Sharma

Monitoring of noise levels of the project site and surrounding area.

Assessment of noise level and vibration potential due to





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Functional Areas

Name of the Expert


Signature

proposed project and its mitigation measures.

Water Pollution (WP)

Y Bordia

Water Quality monitoring network designing.

Sampling of water samples (surface and ground water).

Monitoring of water quality.

Water Balance

Identification & assessment of quantum of water pollution and its Mitigation measures.

ETP Suggestion.

Ecology and Bio-diversity Conservation (EB)

Ratnesh Kotiyal

Conducted Ecological survey & preparation of status report.

Application of taxonomy in resource inventory (Flora & Fauna)

List of species animals and plants report.

Identification & assessment of ecological impact due to proposed project and its Mitigation measures.

Solid and Hazardous Waste Management (SHW)

Y Bordia

Identification of hazardous and non hazardous wastes.

Reuse and recycling of solid wastes.

Handling and disposal of Non- Hazardous solid waste & Hazardous waste.

Socio-

Economics

(SE)

Anil Kumar

Site visit, contribution to Baseline environment and contribution to EIA documentation

Landuse

(LU) Anil Kumar

Development of landuse maps of study area using GIS / related tools, site visit for ground truth survey, finalization of landuse maps

Risk and Hazards (RH)

P K Srivastava

Identification of hazards due to proposed project.

Identification of hazardous substances in the proposed





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Functional Areas

Name of the Expert


Signature

project.

Preparation of risk assessment report and onsite emergency plan.

Photograph 9.1 *Following category ‘B’ FAEs have worked as support FAE to category ‘A’ FAEs. Mr.Om Prakash for Air and Water Environment and Ms.Shweta Gupta for Noise and

Vibration. ** Om Prakash and Sweta Gupta worked as team member in Air Quality Modeling and

Prediction (AQ) Declaration by the Head of the Accredited Consultant Organization/authorized person

I, S.K.Jain, hereby confirm that the above-mentioned experts the EIA/EMP REPORT for setting

up of new Manufacturing unit of of Intermediate and Bulk Drug at Plot 14-16 & 55-57, Sector-5, IIE Pant Nagar, Rudrapur - 263153, Dist: Uddam Singh Nagar, (Uttarakhand), India by M/s NAARI Pharma Pvt. Ltd. I also confirm that the consultant organization shall be fully accountable for any mis-leading information mentioned in this statement.

Signature:

Name: S.K.Jain

Designation: Director, Technical

Name of the EIA Consultant organization EQMS India Pvt. Ltd.

NABET Certificate No. and date NABET/EIA/1619/SA 070, 17th July, 2018





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APPENDIX –I: TOR LETTER AND POINT WISE COMPLIANCE STATUS OF TERMS OF REFERENCE





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Point wise Compliance Status of Terms of Reference

S.No. 2. TOR Points 3. Compliance

1. 4. Executive Summary Provided before Chapter 1

2. 5. Introduction 6.

7. i. Details of the EIA Consultant including NABET accreditation

NABET accreditation certificated attached as Annexure 4

8. ii. Information about the project proponent Details of project proponent given in Section 1.5, Chapter 1

9. iii. Importance and benefits of the project Benefits of the project given in Chapter 1 Section 1.6, Chapter 1

3. 10. Project Description 11.

12. i. Cost of project and time of completion. Total cost of the project is Rs 175 cr. Project implantation shall be started after EC issued by MOEF&CC and it will be completed in two phases.

13. ii. Products with capacities for the proposed project.

List of Products with capacities given in Table 2.2, Chapter 2.

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

It‘s a new project hence not applicable

15. iv. List of raw materials required and their source along with mode of transportation.

Raw materials source along with mode of transportation given in Section 2.5.5, Chapter of EIA report.

16. v. Other chemicals and materials required with quantities and storage capacities

Not required, Raw materials source along with mode of transportation given in Section 2.5.5, Chapter of EIA report

17. vi. Details of Emission, effluents, hazardous waste generation and their management.

Details of Emission, effluents, hazardous waste generation and their management given in Section 2.9, Chapter 2 of EIA report.

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

Project Utilities given in Section 2.5, Chapter 2 of Report.

19. viii. Process description along with major Manufacturing process with





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equipment’s and machineries, process flow sheet (quantitative)from raw material to products to be provided

material balance and flow sheet for phase-I is given in Section 2.7, Chapter 2 and for Phase –II it is attached as Annexure-2.

20. ix. Hazard identification and details of proposed safety systems.

Provided in Chapter 6

21. 22. x. Expansion/modernization proposals:

23. xi. Copy of all the Environmental Clearance(s) including Amendments thereto obtained for the project from MOEF/SEIAA shall be attached as an Annexure. A certified copy of the latest Monitoring Report of the Regional Office of the Ministry of Environment and Forests as per circular dated 30th May, 2012 on the status of compliance of conditions stipulated in all the existing environmental clearances including Amendments shall be provided. In addition, status of compliance of Consent to Operate for the ongoing / existing operation of the project from SPCB shall be attached with the EIA-EMP report.

Being a new project it is Not applicable to this project.

24. xii. In case the existing project has not obtained environmental clearance, reasons for not taking EC under the provisions of the EIA Notification 1994 and/or EIA Notification 2006 shall be provided. Copies of Consent to Establish/No Objection Certificate and Consent to Operate (in case of units operating prior to EIA Notification 2006, CTE and CTO of FY 2005-2006) obtained from the SPCB shall be submitted. Further, compliance report to the conditions of consents from the SPCB shall be submitted

Site Details

25. i. Location of the project site covering village, Taluka/Tehsil, District and State, Justification for selecting the site, whether other sites were considered.

The site is located at Plot 14-16 & 55-57, Sector-5, IIE Pant Nagar, Rudrapur Industrial area, Dist: Udham Singh Nagar, (Uttarakhand) details provided in section 1.5, Chapter 1.

26. ii. A toposheet of the study area of radius of 10km and site location on 1:50,000/1:25,000 scale on an A3/A2 sheet. ( including all eco-sensitive areas and environmentally sensitive places)

Toposheet map of the study area given in Figure 1.2

27. iii. Details w.r.t. option analysis for selection of site It‘s a new project Located in SIDCUL industrial Area.

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

Provided in Figure 1.1, Chapter 1, EIA report.

29. v. Google map-Earth downloaded of the project Google map of the study





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site. area given as Figure 2.3, Chapter 2, of EIA report.

30. 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.

Plant layout indicating storage area, plant area, greenbelt area, utilities etc given in Figure 2.3, chapter 2 of Report.

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

Being a new project it is Not applicable

32. vii. Land use 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)

The proposed unit will be installed in 5.93 Acres (24000m2) land which is already with NAARI. Out of the total land plant including construction of manufacturing facility, utility, office and roads will be established in 3.93 Acres (15904.5m2) of the land and rest of the area i.e 2.0 Acres (8094 m2) has been kept for as a greenbelt. Lay out map given in Figure 2.3

33. 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

Site is located in SIDCUL industrial area. At present 465 industries is operation in the industrial area. detils of the industrial is provided in section 3.1.2, chapter 3

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

Geological features of the study area given in Section 3.2.3, Chapter 3 of EIA report.

35. xi. Details of Drainage of the project up to 5 km 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)

Details of Drainage of the project given in Section 3.2.2, Chapter 3 of EIA report.

36. 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.

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allotment letter is attached as Annexure-1.

37. xiii.R&R details in respect of land in line with state Government policy.

No R & R applicable.

4. 38. Forest and wildlife related issues (if applicable):

39. i. Permission and approval for the use of forest land (forestry clearance), if any, and recommendations of the State Forest Department. (if applicable)

Not Applicable

40. ii. Land use 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)

Land use of the study area given in Section 3.3 land use map provided in Figure 3.9.

41. iii. Status of Application submitted for obtaining the stage I forestry clearance along with latest status shall be submitted.

Not Applicable

42. 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.

No National Parks, wildlife Sanctuary, Biosphere Reserves, Migratory Corridors of Wild Animals is present withon 10 km radius of the project site hence not applicable.

43. v. Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the State Government for conservation of Schedule I fauna, if any exists in the study area.

Not Applicable

44. vi. Copy of application submitted for clearance under the Wildlife (Protection) Act, 1972, to the Standing Committee of the National Board for Wildlife.

Not Applicable

5. 45. Environmental Status

46. i. Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall.

Micro-meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall given in Section 3.4, chapter 3 of EIA

47. 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 consider the pre-dominant wind direction, population zone and sensitive receptors including reserved forests.

AAQ data (except monsoon) at 8 locations for PM10, PM2.5, SO2, NOX, CO and other parameters given in Section 3.5, chapter 3 of EIA.

48. iii. Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in the NAQQM Notification of Nov. 2009 along with - min., max., average and 98% values for each of the AAQ parameters from data of all AAQ stations should be

Date wise AAQ test Report attached as Annexure-5





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provided as an annexure to the EIA Report.

49. iv. Surface water quality of nearby River (100 m upstream and downstream of discharge point) and other surface drains at eight locations as per CPCB/MoEF & CC guidelines.

Surface water quality of the study area given in Section 3.7.2, chapter 3 of EIA.

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

Not Applicable

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

Ground water monitoring at 8 locations given in Section 3.7.1, chapter 3 of EIA.

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

Noise levels monitoring at 8 locations given in Section 3.6, chapter 3 of EIA.

53. viii. Soil Characteristic as per CPCB guidelines. Soil Characteristic given in Section 3.8, chapter 3 of EIA.

54. 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.

As site located near National highway, due to this proposed no project no traffic will increase

55. x. Detailed description of flora and fauna (terrestrial and aquatic) existing in the study area shall be given with special reference to rare, endemic and endangered species. If Schedule-I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared and furnished.

Detailed description of flora and fauna given in Section 3.9, chapter 3 of EIA.

56. xi. Socio-economic status of the study area. Demography of the study area given in Section 3.10, , chapter 3 of EIA.

6. 57. Impact and Environment Management Plan

58.

59. i. Assessment of ground level concentration of pollutants from the stack emission based on site-specific meteorological features. In case the project is located on a hilly terrain, the AQIP Modelling shall be done using inputs of the specific terrain characteristics for determining the potential impacts of the project on the AAQ. Cumulative impact of all sources of emissions (including transportation) on the AAQ of the area shall be assessed. Details of the model used and the input data used for modelling shall also be provided. The air quality contours shall be plotted on a location map showing the location of project site, habitation nearby, sensitive receptors, if any.

Provided in section 4.2, chapter 4 of EIA report.

60. ii. Water Quality modelling - in case of discharge in water body

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Applicable.

61. iii. Impact of the transport of the raw materials and end products on the surrounding environment hall be assessed and provided. In this regard, options for transport of raw materials and finished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined.

Transportation impact provided in section 4.7, Chapter 4 of EIA report.

62. 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.

Unit based on Zero discharge concepts. Treatment scheme of wastewater from different plant operations, extent recycled and reused is given in Section 2.9.1, Chapter 2 of EIA report.

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

Details of stack emission and action plan for control of emissions to meet standards given in Chapter 4.

64. vi. Measures for fugitive emission control

65. 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.

Details of Emission, effluents, hazardous waste generation and their management given in Section 2.9.4, Chapter 2 of EIA report.

66. 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 generation. Hence not applicable.

67. 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.

Action plan for green belt development is given in section 7.4, Chapter 7 of EIA report.

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

Provided in section 7.8, Chapter 7 of EIA report.

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

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the recurring expenditure. Details provided in Table 7.4, Chapter 7 of EIA report.

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

Post-project environmental monitoring given in Chapter 5 of EIA report.

71. 72. xiii. Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency Management Plan including Risk Assessment and damage control. Disaster management plan shoud be linked with District Disaster Management Plan.

Provided in Chapter 6 and section 8.7 of EIA report.

7. 73. Occupational health 74.

i. Plan and fund allocation to ensure the occupational health & safety of all contract and casual workers

Occupational health & safety of all contract and casual workers shall be applicable as per factory acts.

ii. Details of exposure specific health status evaluation of worker. If the workers' health is being evaluated by pre-designed format, chest x rays, Audiometry, Spirometry, Vision testing (Far & Near vision, colour vision and any other ocular defect) ECG, during pre-placement and periodical examinations give the details of the same. Details regarding last month analysed data of above mentioned parameters as per age, sex, duration of exposure and department wise.

During joining of any new employe, and there will be pre-placement and periodical examinations taken.

iii. Details of existing Occupational & Safety Hazards. What are the exposure levels of hazards and whether they are within Permissible Exposure level (PEL). If these are not within PEL, what measures the company has adopted to keep them within PEL so that health of the workers can be preserved,

It‘s a new project, appropriate safety measures shall be taken.

75. iv. Annual report of health status of workers with special reference to Occupational Health and Safety.

During joining of any new employe, and there will be pre-placement and periodical examinations taken.

8. 76. Corporate Environment Policy

77. 78. 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.

Organization have well develop environmental management Policy described in Section 7.2, Chapter 7

79. ii. Does the Environment Policy prescribe for standard operating process / procedures to bring into focus any infringement / deviation / violation of the environmental or forest norms / conditions? If so, it may be detailed in the EIA.

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environmental clearance conditions? Details of this system may be given.

81. iv. Does the company have system of reporting of non-compliances / violations of environmental norms to the Board of Directors of the company and / or shareholders or stakeholders at large? This reporting mechanism shall be detailed in the EIA report

9. 82. 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.

Provided in section 2.5.3.3, Chapter 2 of EIA report.

10. 83. Enterprise Social Commitment (ESC)

84. i. Adequate funds (at least 2.5 % of the project cost) shall be earmarked for Socio-economic development activities need to be elaborated upon.

As per the latest Office memorandum of MOEF&CC dated 1st May 2018, NAARI has earmarked a budget i.e Rs. 264 Lacks(@ 1.5% of the project cost) for CER/CSR activities. Detail provided in section 7.5.

11. 85. Any litigation pending against the project and/or any direction/order passed by any Court of Law against the project, if so, details thereof shall also be included. Has the unit received any notice under the Section 5 of Environment (Protection) Act, 1986 or relevant Sections of Air and Water Acts? If so, details thereof and compliance/ATR to the notice(s) and present status of the case

As per the statement of NAARI Pharma Pvt. Ltd. no Litigation is pending against the project.

12. A tabular chart with index for print wise compliance of above TOR.

Provided

86. SPECIFIC TERMS OF REFERENCE

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

Solvent recovery system given in Section 2.8, Chapter 2 of EIA report.

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

Process emissions from the proposed unit and its arrangement to control given in Section 2.9.2.

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

90. Ambient air monitoring details given in Section 3.5

4 91. Work zone monitoring arrangements for hazardous chemicals.

92. Provided in chapter 5

5 93. Detailed effluent treatment scheme including segregation of effluent streams for units adopting

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'Zero' liquid discharge. detail provided in section 2.9.1, chapter 2 of EIA report.

6 94. Action plan for odour control to be submitted. All vents of centrifuges / filters will be connected to scrubbers. The drying of the product is done in a closed type continuous Fluidized Bed dryer/ Nudge filter to avoid the exposure of any chemicals to human being. Volatile organic solvents are carefully handled in a closed system, thereby preventing any discharge of these chemicals into the air given in Section 4.2.2.

7 95. A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearly that they co-process organic solid/hazardous waste generated, in case waste is proposed to be used for this purpose.

The hazardous waste will be sent to authorized TSDF site.

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

9 97. Action plan for utilization of MEE/dryers salts. Details of MEE given in Section 2.9.1.

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

Material Safety Data Sheet for all the Chemicals Attached as Annexure 2.2

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

Attached as Annexure 6.

12 100. Details of incinerator/s (if any) if to be installed. No incinerator proposed

13 101. Risk assessment for storage and handling of hazardous chemicals/solvents(HAZOP Study). Action plan for handling & safety system to be incorporated.

Details risk assessment study carried out given in Chapter 6

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

Appropriate safety measures shall be taken.

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