Environmental Impact Assessment Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO
Industrial Area, Village Keshwana Rajpoot, Kotputli
(Rajasthan)
By
M/s Otsuka Chemical India Pvt. Ltd.
SP-3, 10 & 11, RIICO
Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
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
EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Table of Contents
Chapter 1. Introduction ...... 12 1.1. Background ...... 12 1.2. Brief about Project Proponent- OCIPL and The Project ...... 12 1.3. Importance and Benefit of the Project ...... 13 1.4. Project Location and connectivity ...... 13 1.5. Regulatory Framework ...... 13 1.6. Objectives of the EIA Study ...... 17 1.7. Scope & Methodology of the EIA Study ...... 17 1.8. Approved TOR and Its Compliance status ...... 20 Chapter 2. Project Description ...... 29 2.1. Need and Justification of Project Location ...... 29 2.2. The Site ...... 30 2.3. Land allocation within plant ...... 30 2.4. Process Description ...... 31 2.5. Products ...... 31 Manufacturing process (Existing Products) ...... 34 2.5.1. GCLE Manufacturing ...... 34 Manufacturing Process (Expansion project) ...... 34 2.5.2. Cefixime Manufacturing Process ...... 34 2.5.3. Cefditoren Pivoxil Manufacturing Process ...... 37 2.5.4. Manufacturing Process of Cefprozil ...... 43 2.5.5. ACLE manufacturing Process Description: ...... 46 2.5.6. Ceftaroline Fosamil Acetate Manufacturing Process Description:...... 48 2.5.7. Manufacturing Process Ceftibuten ...... 52 2.5.8. Manufacturing Process of Tazocbactam Sodium ...... 59 2.5.9. Sulbactum Sodium Manufacturing Process ...... 62 2.5.10. Manufacturing Process Cefpodoxime proxetil ...... 66 2.5.11. Cefcapene Pivoxil MH HCl Manufacturing Process: ...... 69 2.5.12. Cefdinir Manufacturing Process ...... 73 2.5.13. Cefuroxime Axetil Amorphous Manufacturing Process ...... 77 2.6. R & D Products ...... 82 2.7. Solvents Management System ...... 83
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 2.8. Solvent Recovery System ...... 83 2.9. Raw Material for APIs Manufacturing ...... 84 2.10. Utilities ...... 92 2.10.1. Water Requirement ...... 92 2.10.2. Fuel ...... 93 2.10.3. Power ...... 93 2.10.4. Employment ...... 93 2.11. Generation of Pollutants ...... 93 2.11.1. Sewage Treatment ...... 93 2.11.2. Effluent Treatment Plant ...... 93 2.11.3. Multiple Effect Evaporator ...... 95 2.11.4. Hazardous Wastes and Management ...... 96 2.11.5. Solid waste management ...... 98 2.12. Air Emissions ...... 99 2.13. OHS System...... 100 2.14. Project Cost and Cost towards Environmental Protection ...... 102 2.15. Existing CSR ...... 102 2.16. Proposed CSR Plan ...... 102 Chapter 3. : Description of the Environment ...... 103 3.1. Background and Salient Environmental Features of the Study Area ...... 103 3.1.1. Environmental Setting and Salient Environmental Features of the Project Area .... 103 3.1.2. Primary Data Collection: Monitoring Plan and Quality Assurance Procedures ...... 106 3.2. Physical Enviroment ...... 107 3.2.1. Topography ...... 107 3.2.2. Drainage ...... 107 3.2.3. Geology & Hydrogeology ...... 107 3.2.4. Depth to Ground Water Table ...... 107 3.2.5. Ground water resources ...... 108 3.2.6. Seismicity of the Study Area ...... 109 3.3. Land use ...... 109 3.4. Ambient Air Quality ...... 113 3.4.2. Observations on Ambient Air Quality: ...... 115 3.5. Noise Environment ...... 115 3.5.2. Observation on Ambient Noise Quality: ...... 117
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 3.6. Water Quality ...... 117 3.6.1. Ground Water Quality ...... 117 3.6.2. Surface Water Quality ...... 123 3.7. Soil Quality ...... 123 3.7.1. General Characteristics of the Soil in the District ...... 124 3.7.2. Cropping Pattern ...... 124 3.7.3. Methodology ...... 126 3.7.4. Soil Sampling Locations ...... 126 3.7.5. Analysis of Soil Samples ...... 127 3.7.6. Observation on Soil Quality ...... 130 3.8. Biological Environment (Project Site And Zone Of 10 Km Radius) ...... 132 3.8.1. Flora ...... 132 3.9. Socio-Economic Environment ...... 137 3.9.2. Economic Structure ...... 142 3.9.3. Workers Scenario ...... 143 3.9.4. Basic Infrastructure Facilities Availability (as per the Census records of 2011) ...... 146 3.9.5. Education Facilities...... 146 3.9.6. Medical Facilities ...... 147 3.9.7. Potable Water Facilities ...... 147 3.9.8. Communication, Road, Transport Facilities ...... 148 3.9.9. Banking Facility ...... 148 3.9.10. Power Supply ...... 148 Chapter 4. : Anticipated Environmental Impacts And Mitigation Measures ...... 152 4.1. General ...... 152 4.2. Construction Phase ...... 152 4.2.1. Air Environment ...... 152 4.2.2. Operation Phase ...... 153 4.2.3. Model Details ...... 153 4.2.4. Predicted GLC due to Proposed Project ...... 154 4.2.5. Meteorological Data ...... 156 4.2.6. Receptor Locations...... 156 4.2.7. Summary of Predicted GLC’s ...... 156 4.3. Noise Environment ...... 158 4.3.1. Construction Phase ...... 158
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 4.3.2. Operation Phase ...... 158 4.4. Water Environment ...... 159 4.4.1. Construction Phase ...... 159 4.4.2. Operation Phase ...... 159 4.5. Land Environment ...... 159 4.6. Biological Environment ...... 160 4.7. Socio – Economic Environment ...... 162 4.8. Infrastructure ...... 163 4.9. Proposed Project Impact Matrix ...... 163 Chapter 5. Environment Management Plan ...... 170 5.1. Introduction ...... 170 5.2. Objectives of EMP ...... 170 5.3. Components of EMP ...... 170 5.4. Air Environment ...... 170 5.4.1. Air Pollution Control Measures ...... 171 5.5. Noise Environment ...... 173 5.6. Water Environment ...... 174 5.6.1. Construction Phase: ...... 174 5.6.2. Strom water management ...... 175 5.7. Biological Environment ...... 176 5.8. Land Environment ...... 177
5.9. Resource Conservation/ Waste Minimization ...... 179 5.11. Otsuka HSE Policy ...... 181 5.12. Environment Management Cell ...... 181
5.12.1. Post – Operational Monitoring Program ...... 182 5.12.2. Budget for environmental management plan ...... 183 Chapter 6. Additional Study ...... 184 6.1. Introduction ...... 184 6.2. Scope of Work ...... 184 6.3. Objectives ...... 184 6.4. Methodology of HIRA ...... 185 6.4.1. Identification of Hazards ...... 185 6.5.1. Hazardous Analysis of Bulk Storage Materials ...... 186
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 6.6. Detailed QRA Approach: Rule Sets and Assumptions ...... 197 6.6.1. Thermal Hazards ...... 198 6.6.2. Toxic Release ...... 200 6.6.3. Data Limitations ...... 200 6.7.1. Likely Failure Scenarios ...... 200 6.7.2. Weather Effect ...... 201 6.9. Consequence Analysis ...... 207 6.9.1. Toxicity...... 207 6.9.2. Thermal Hazards ...... 207 6.10. Conclusions and Recommendations ...... 207 6.11. Occupational Health and Safety ...... 208 6.12. Personal Protective Equipment (PPE) ...... 209 6.13. Occupational Health – Proposal for Surveillance ...... 213 Chapter 7. Disaster management plan ...... 215 7.1. Disaster Management Plan: Structure ...... 215 7.2. Policy ...... 215 7.2.1. Identification and Prevention of Possible Emergency Situations ...... 215 7.2.2. Identification and Compliance with Legislative Requirements: ...... 217 7.2.3. Identification of and communication with relevant Stakeholders ...... 218 7.2.4. Formation of Emergency Plan Objectives ...... 219 7.3. Implementation ...... 219 7.3.1. Allocation of Resources ...... 219 7.3.2. Emergency Structure and Responsibility ...... 219 7.3.3. OCIPL Disaster Prevention Committee (DPC) ...... 219 7.3.4. Emergency Control Center (EHS OFFICE) ...... 220 7.3.5. (A) Emergency Control Action Plan ...... 221 7.3.6. Setting up of Emergency Infrastructure ...... 222 7.3.7. Awareness, Training, and Competence...... 224 7.3.8. Communication ...... 225 7.3.9. Emergency Documentation and Document Control ...... 227 7.3.10. Emergency Control ...... 227 7.4. Checking and Corrective Action...... 230 7.4.1. Monitoring and Measurement ...... 230 7.4.2. Records ...... 230
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 7.4.3. EP Audit, Non Conformance and Corrective Action and Preventive Action 230 7.5. Review of Emergency Performance ...... 230 7.6. The Contingency Plan ...... 230 7.6.1. Contents of the Contingency Plan ...... 231 7.7. Emergency Organization ...... 231 7.8. Incident Controllers...... 232 7.9. Site Layout Plan with Escape Routes and Assembly Points ...... 233 7.10. Escape, Evacuation and Rescue (EER) Plan ...... 233 7.10.1. Escape ...... 233 7.10.2. Evacuation ...... 233 7.10.3. Rescue...... 233 7.11. Credible Loss Scenarios ...... 233 7.11.1. Atmospheric Stability Class Prevalence (ASCLAP) for nearest Observatory 233 7.12. Mutual Aid Organizations...... 233 7.13. Mock Drill and Review Procedure ...... 234 7.14. Offsite Plan Components ...... 234 7.15. Recommendations...... 234 7.15.1. Storage of Hazardous Chemicals in Bulk ...... 234 7.15.2. Storage of Hazardous Chemicals in Drums and other Containers ...... 235 7.15.3. Unloading of Tank Trucks ...... 235 7.15.4. Hazardous Waste Transport ...... 236 7.16. General Safety Practices ...... 236 7.16.1. Work Permit System ...... 236 7.16.2. Contractor Safety ...... 237 7.16.3. Static Electricity ...... 238 7.16.4. Lightning Protection ...... 238 7.17. Personnel Safety ...... 239 7.17.1. Personnel Protective Equipment ...... 239 7.17.2. Training ...... 240 7.18. Safety of Plant Equipment ...... 241 7.18.1. Thermal Insulation ...... 241 7.18.2. Electrical Equipment ...... 241
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 7.18.3. Reactors ...... 242 7.18.4. Equipment Safety ...... 242 7.19. Tank Farm Safety ...... 247 7.19.1. Inspection of Flammable Solvent Storage Tanks ...... 247 7.19.2. Emergency Response ...... 247 7.19.3. Inspection of Fire Fighting Equipment and Systems ...... 248 7.19.4. Recommendations on Individual Accident Risks ...... 249 Chapter 8. Summary and conclusion ...... 251 Chapter 9. Disclosure of Consultants ...... 257
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) List of Tables Table 1.1 : Details of permits and clearance applicable ...... 14 Table 1.2 : Compliance Status of Terms of Reference ...... 20 Table 2.1 : Connectivity and Surrounding Area Profile ...... 30 Table 2.2 : Land Distribution of at Site ...... 30 Table 2.3 : List of Products manufactured in Existing unit ...... 31 Table 2.4 : List of Proposed product for expansion ...... 32 Table 2.5 List of Solvents used in Manufacturing Process ...... 83 Table 2.6 List of solvent recovered...... 83 Table 2.7 Details of distillation system...... 84 Table 2.8 Raw Material Requirement ...... 85 Table 2.9 Raw Material Requirement ...... 87 Table 2.10 Raw Material and Finished Good Storage Area and its Specifications...... 91 Table 2.11 :Water Consumption for Various Activities during Operation Phase...... 92 Table 2.12 : Fuel quantity and source ...... 93 Table 2.13 : Quantity of Hazardous Waste to be generated...... 97 Table 2.14 Waste Characteristics ...... 98 Table 2.15 Operating Conditions ...... 98 Table 2.16 : Incinerators ...... 98 Table 2.17 : Scrubbing System ...... 98 Table 2.18 : Type and Quantity of Solid Waste to be Generated in the Construction and Operation Phases ...... 99 Table 2.19 : Details of Air Emissions ...... 99 Table 2.20 : Stacks in the API Plant ...... 100 Table 2.21 : Pollutant Concentration ...... 100 Table 3.1 : Salient Environmental Features of Proposed Site ...... 104 Table 3.2 : Summary of Methodology for Primary/Secondary Baseline Data Collection .... 106 Table 3.3 : Land use of the Study Area ...... 109 Table 3.4 Ambient Air Quality Monitoring Locations ...... 113 Table 3.5 Ambient Air Quality Monitoring Results (24-hour average) ...... 113 Table 3.6 Ambient Air Quality Monitoring Results (24-hour average) ...... 114 Table 3.7 Ambient Noise Quality Monitoring Locations ...... 115 Table 3.8 Ambient Noise Quality in the Study Area ...... 116 Table 3.9 Ground Water Sampling Locations ...... 117 Table 3.10 Ground Water Quality in the Study Area ...... 119 Table 3.11 Ground Water Quality in the Study Area ...... 121 Table 3.12 Area under Major Field Crops & Horticulture, 2007-08 (as per latest figures) .. 124
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Table 3.13 Production and Productivity of major crops (Average of last 5 years: 2004-08) 125 Table 3.14 Soil Sampling Locations ...... 126 Table 3.15 Physicochemical Characteristics of Soil ...... 128 Table 3.16 List of Common Plant Species Present in Study Area ...... 133 Table 3.17 Mammalian Fauna reported in study area ...... 135 Table 3.18 : Reptiles and Amphibian observed in Study Area ...... 136 Table 3.19 : Avifauna Sighted during the primary survey ...... 136 Table 3.20 Caste-wise Population Distribution of Study Area Villages ...... 138 Table 3.21 Male-female wise Literates & Illiterates ...... 141 Table 3.22 Village wise Occupational Pattern in the Study Area ...... 144 Table 3.23 Distribution of Work Participation Rate ...... 145 Table 3.24 Composition of Non-Workers...... 146 Table 3.25 Village wise Basic Amenities Availability in the Study Area ...... 149 Table 4.1 : Stack Parameters and Emission Details of Proposed Project ...... 155 Table 4.2 : Summary of Maximum 24-hour Incremental GLC due to the Proposed Project Stacks ...... 156 Table 4.3 Ambient Air Quality Monitoring Results (24-hour average) ...... 156 Table 4.4 Ambient Air Quality Monitoring Results (24-hour average) ...... 157 Table 4.5 Ambient Air Quality Monitoring Results ...... 157 Table 4.6: (A) Evaluation of Environmental Impacts during Construction Phase Without EMP ...... 164 (B) Evaluation of Environmental Impacts During Construction Phase with EMP...... 165 (C): Evaluation of Environmental Impact during operation phase without EMP ...... 166 (D): Evaluation of Environmental Impacts during operational phase with EMP ...... 168 Table 5.1 : Design Features for Minimization of Fugitive Emissions ...... 172
Table 5.2 :Ambient air environment impact and management plan ...... 172
Table 5.3 : Ambient noise environment impact and management plan ...... 174 Table 5.4 : Water environment impact and management plan ...... 175 Table 5.5 : Ecological criteria & Observations ...... 176 Table 5.6 : Species suggested for plantation under Greenbelt Development Progaramme 177 Table 5.7 : Impact and management plan ...... 179 Table 5.8 : Budget for environmental management plan ...... 183 Table 7.1 : Applicable EHS regulatory requirements – Otsuka ...... 217 Table 7.2 : Emergency Organization ...... 232 Table: Summary of Maximum 24-hour Incremental GLC due to the Proposed Expansion Project Stacks ...... 252
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
List of Annexure Annexure I : Nabet Certificate
Annexure II : TOR Letter Prescribed by MOEF&CC
Annexure III : Water Approval letter
Annexure IV : MoEF&CC Certified Compliance report
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) CHAPTER 1. INTRODUCTION
This chapter provides background information of the project, need of the project, need of the EIA study, scope and EIA methodology adopted and structure of the report.
1.1. Background M/s Otsuka Chemical India Pvt Ltd (OCIPL), proposed to expand its production facility at its existing API plant by setting up additional API unit (say unit II) next to existing unit ( say unit I). Though both the units will be set up at the same facility but due to nature of products and drug policy, both the unit have to function independently. Existing unit was set up for the production of GCLE with valid Environmental Clearance from Ministry of Environment, Forests & Climate Change (MOEF&CC) Government of India, vide EC letter no J11011/241/2012. Unit has obtained certified compliance from Regional office of MOEF&CC on 23.08.2018, File No: IV/ENV/R/IND-160/929/2017/232. Copy enclose as Annexure IV. MOEF&CCC as per its policy of sustainable development, has notified “Environmental Impact Assessment Notification“ in September, 2006 for grant of environmental clearance (EC) for establishing new or expansion or modification of an industry or other listed projects as per schedule attached to above EIA notification. The proposed industrial expansion project falls under “project classification no 5 (f) of schedule to EIA notification of 2006” and category B appraised as categpry A due to presence of interstate boundry of Rajasthan & Haryana located at a distance of 2.38 KM from the project location ( refer Figure 1.2 for Interstate boundry distance from the plant ) . As per the EC procedure an Environmental Impact assessment ( EIA) Report is to be prepared in accordance to the TOR (Terms of Reference) approved by MOEF&CC. Since, this proposed project is located in a notified Keshwana industrial estate, develop by RIICO, the public hearing is exempt as per existing regulations. EIA report is prepared based on one season monitoring data collected in and around project site as per approved TOR on 30th May 2018 by MOEF&CC. 1.2. Brief about Project Proponent- OCIPL and The Project OCIPL was incorporated in January 2006 to set up an API manufacturing plant for the production of Advance Cephalosporin Drug Intermediate namely “GCLE” which is a major raw material for production of vital Cephalosporin antibiotics namely Cefixime, Cefdinir, Cefprozil and Cefpodoxime. OCIPL is a subsidiary of Otsuka Chemical Company Ltd., Japan which is leading multinational pharmecutical company having its presence in 180 countries at present supported by its strong R&D facilities at Japan and India. OCIPL has setup its pant ( Unit I ) at RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli, Jaipur (Rajasthan) on plot no SP 3,10,11 on 88000 sqm area with a investment of about Rs 400 crore and commence its commercial production in March’2008. It was first Japanese investment in Rajasthan which acted as catalyst for attracting major Japanees investment in the area and setting up Neemrana Japanese zone. OCIPL now plans to invest about Rs 150 crore and increase current employement level from 450 to 600 in next 3-4 years.
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) OCIPL caters to nearly 50% of GCLE requirement of the world demand and supplies majorly to Indian, Chinese & Japanese companies. OCIL propose to expand its products and production capacity ( propose to set up Unit II) on the land area of 26800 sqm ( the area earmarked for expansion out of existing land area of 88000 sqm) for production of new API products with total production capacity of 25 TPD. The API products proposed for production at unit II are derivatives of Tazobactum. Since nature of API at unit I and II are very different. Hence these two units I & II will be maintained as independent production units with no interface even for utilities management, production area, waste management and administration. 1.3. 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. 1.4. Project Location and connectivity As indicated above, the proposed expansion unit wl be set up at existing plant located at SP-3, 10 & 11, RIICO Industrial area, Village Keshwana Rajdoot (Kotputli) Rajasthan. The proposed site is located at a distance of about 0.600 km from Village Paniyala. The project is connected with National Highway NH-8 at a distance of 1.80 km East in Direction through industrial extate internal roads. It is connected with rail at Alwar ( the nearest Railway station) located at distance of about 47 km from the project site and by air with Jaipur located at about 128 km away from project site (aerial distance). The project location map on google platform and Top sheet with distance of interstate boundary is shown at Figure 1.1, Figure 1.2 Since the site is located in notified industrioal area, many industries situated close to the project site. The list of select industries are as below: • Shree Krishna Paper Mill • Alstine Industries • Dhanuka Laboratories Limited • NIMT • Emerging glasses etc. The are map with project laction and location of neighbourin industries is given at Figure 1.3. 1.5. Regulatory Framework Requirement of Environmental Clearance
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • 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 state boundary Rajasthan and Haryana at a distance of 2.38 KM. Considering the products portfolio, the proposed projects falls in “Category A” of Schedule of the EIA notification which requires Environmental Clearance (EC) from MoEF&CC, New Delhi. • Otsuka 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 1.1 : Details of permits and clearance applicable S. Permit / For Proposed Project Current Status for No. Clearance/Standards • • Proposed expansionProject 1 No Objection Certificate / Mandatory, prior to • Not yet applied Consent to Establish from establishment of Rajasthan Pollution Control proposed project Board (RPCB) for the proposed project• 2 Factory License Mandatory approvals Not yet applied. Shall • required for drawings prior be applied before start to commencement of of construction construction 3 Water Permission Not required as already• • have Ground water approval. 4 Environmental Clearance • Required • Under Process from Expert Appraisal Committee, Impact assessment Authority (IAA) 5 The Hazardous Waste (Management, Required CTO Will be applied Handling and Trans boundary after getting EC/ CTE Movement) Rules 2008 amended to and before starting date. • production 6 Water (Prevention and Control of Pollution) Act,1974 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 Rajasthan. • Boiler Regulations as per Chief Inspector of Boilers, Government of Rajasthan. • ESIC etc.
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EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
1.6. Objectives of the EIA Study The objectives of the present EIA are to: • To comply with the approved TOR • Esstablis baselin conditions base on primary and seconadary data collection • Assess the proposed project process,input material supply, tranpotation, storage, utilities management nd waste management • Assess interface of the proposed project with environment using established qualitative an quntitave mpact assessment tools and techniques. • Assess and anlyse the impacts of the project on valued environmental components ( viz, air quality, Noise levels, water environment, land environment, socio-economic conditions, and biological environment ) • Deveop mitigation, management and monitoring plans to eliminate or minise the identified impacts • Undertake risk assessment and propose sutiable mitigation and emergency preparedness measures. • Allocate required budget and develop environment social responsibility requirements an dbudget. • Present this report for grant of environmental clearance for the proposed expansion. 1.7. Scope & Methodology of the EIA Study This study is aimed at providing a deeper insight into the proposed project and its various environmental components. The present study area for the environmental assessment is within 10 km radius of the location of the project. The methodology used for the study is given below: i. Monitoring and collection of baseline data for various environmental components as per the MoEFCC guidelines. ii. Identification and quantification of significant environmental impactsdue to the project and associated activities. iii. Evaluation of impacts due to proposed activities and preparation of an environmental impact statement. iv. Preparation of appropriate Environmental Management Plan (EMP) encompassing strategies for minimizing identified adverse impacts along with budgetary provisions to be made by the project authorities for implementation of mitigation measures. v. Delineation of post Environmental Quality Monitoring Programme (EQMP) along with organizational setup required for monitoring the effectiveness of mitigation measures
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
1.8. Approved TOR and Its Compliance status Terms of Reference (TOR) was issued by MoEF&CC vide their letter No: J- 11011/190/2017-IA II (I) dated 30th May 2017 for preparation of EIA/EMP in 23rd EAC meeting of Industry II as new project. However, in 33rd EAC meeting for EC presentation, committee suggested to trat project as expansion since propose unit was being set up withn land area of the existing plant. EAc desired to update the EIA and also submit certified compliance from concerned regional office of MOEF&CC. The compliance status of earlier approved TOR is given at Table 1.2 below:
Table 1.2 : Compliance Status of Terms of Reference S.No. TOR Points Compliance 1. Executive Summary Attached with EIA report 2. Introduction i. Details of the EIA Consultant including NABET NABET accreditation accreditation certificated attached as Annexure I ii. Information about the project proponent Details of project proponent given in Section 1.2 iii. Importance and benefits of the project Benefits of the project given in Chapter 1 Section 1.3 3. Project Description i. Cost of project and time of completion. Total cost of the project is Rs 150 cr. Project implantation shall be started after EC issued by MOEF&CC ii. Products with capacities for the proposed Products with capacities project. given in Section 2.5 i. If expansion project, details of existing products The detailof existing product with capacities and whether adequate land is is given in chapter 2 available for expansion, reference of earlier EC if
any. ii. List of raw materials required and their source Raw materials source along along with mode of transportation. with mode of transportation given in Section 2.9. iii. Other chemicals and materials required with Not required, Raw materials quantities and storage capacities source along with mode of transportation given in Section 2.9. iv. Details of Emission, effluents, hazardous waste Details of Emission, generation and their management. effluents, hazardous waste generation and their management given in Section 2.11 v. Requirement of water, power, with source of Project Utilities given in supply, status of approval, water balance diagram, Section 2.10 man-power requirement (regular and contract) vi. Process description along with major Products with capacities equipment’s and machineries, process flow sheet given in Section 2.5
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) (quantitative)from raw material to products to be provided Hazard identification and details of proposed safety Details of Emission, systems. effluents, hazardous waste generation and their management given in Section 2.11 4. Expansion/modernization proposals: a. Copy of all the Environmental Clearance(s) The certified compliance including Amendments thereto obtained for the report is enclosed as project from MOEF/SEIAA shall be attached as an Annexure. Annexure. A certified copy of the latest Monitoring Report of the Regional Office of the Ministry of Environment and Forests as per circular dated 30th May, 2012 on the status of compliance of conditions stipulated in all the existing environmental clearances including Amendments shall be provided. In addition, status of compliance of Consent to Operate for the ongoing / existing operation of the project from SPCB shall be attached with the EIA- EMP report. b. In case the existing project has not 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 5. Site Details i. Location of the project site covering village, Justification of the project Taluka/Tehsil, District and State, Justification for and Location of the project selecting the site, whether other sites were given in Section 2.1 and considered. Figure 2.1 ii. A toposheet of the study area of radius of 10km Toposheet map of the study and site location on 1:50,000/1:25,000 scale on an area given in Figure 1.2 A3/A2 sheet. (including all eco-sensitive areas and environmentally sensitive places) iii. Details w.r.t. option analysis for selection of site Proposed project is located in notified industril area and API production unit is setting at the adjacent of running unit. iv. Co-ordinates (lat-long) of all four corners of the Close view Map showing site. coordinates of Project site is given in Figure 3.5 v. Google map-Earth downloaded of the project Google map of the study site. area given as Figure 1.1
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) vi. Land allotment/ Land ownership letter should be Land allotment letter submitted. attached as Anneuxre vii. Layout maps indicating existing unit as well as Plant layout indicating proposed unit indicating storage area, plant area, storage area, plant area, greenbelt area, utilities etc. If located within an greenbelt area, utilities etc Industrial area/Estate/Complex, layout of Industrial given in Figure 2.2 Area indicating location of unit within the Industrial area/Estate. viii. Photographs of the proposed and existing (if Site photographs are given in applicable) plant site. If existing, show photographs chapter 5 of plantation/greenbelt, in particular. ix. Land use break-up of total land of the project Land use break-up of total site (identified and acquired), government/ private - land of the project agricultural, forest, wasteland, water bodies, siteindicating storage area, settlements, etc shall be included. (not required for plant area, greenbelt area, industrial area) utilities etc given in Figure 2.2 x. A list of major industries with name and type A list of major industries within study area (10km radius) shall be shown in Figure 1.3. incorporated. Land use details of the study area xi. Geological features and Geo-hydrological status Geological features of the of the study area shall be included. study area given in Section 3.2.3 xii. Details of Drainage of the project up to 5km Details of Drainage of the radius of study area. If the site is within 1 km radius project given in Section of any major river, peak and lean season river 3.2.2. 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) xiii. Status of acquisition of land. If acquisition is not Land already acquired complete, stage of the acquisition process and expected time of complete possession of the land. R&R details in respect of land in line with state No R & R applicable. Government policy. 6. Forest and wildlife related issues (if applicable): i. The PP shall obtain prior clearance from Not Applicable forestry and wild life angle including clearance from Standing Committee of the National Board Wild Life as applicable. It is further categorically stated that grant of EC does not necessary implies that forestry and wild life clearance shall be granted to the project and that their proposals for forestry and wild life clearance will be considered by the respective authorities on their merits and Decision taken. The investment made in the project, if any, based on environment clearance so granted, in anticipation of the clearance from forestry and wildlife angle shall be entirely at the cost and risk of the project
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) proponent and Ministry of Environment & Forests shall not be responsible in this regard in any manner. ii. Permission and approval for the use of forest Not Applicable land (forestry clearance), if any, and recommendations of the State Forest Department. (if applicable) iii. Land use map based on High resolution satellite Landuse of the study area imagery (GPS) of the proposed site delineating the given in Section 3.3 forestland (in case of projects involving forest land more than 40 ha) iv. Status of Application submitted for obtaining the No forest clearance required stage I forestry clearance along with latest status shall be submitted. v. The projects to be located within 10 km of the None within 10 km of the National Parks, Sanctuaries, Biosphere Reserves, National Parks, Sanctuaries, Migratory Corridors of Wild Animals, the project Biosphere Reserves, proponent shall submit the map duly authenticated Migratory Corridors of Wild by Chief Wildlife Warden showing these features vis- Animals, à-vis the project location and the recommendations or comments of the Chief Wildlife Warden-thereon. vi. Wildlife Conservation Plan duly authenticated by Not Applicable the Chief Wildlife Warden of the State Government for conservation of Schedule I fauna, if any exists in the study area. Copy of application submitted for clearance under Not Applicable the Wildlife (Protection) Act, 1972, to the Standing Committee of the National Board for Wildlife. 7. Environmental Status i. Determination of atmospheric inversion level at Micro-meteorological data the project site and site-specific micro- using temperature, relative meteorological data using temperature, relative humidity, hourly wind speed humidity, hourly wind speed and direction and and direction and rainfall rainfall. given in Section 3.4. ii. AAQ data (except monsoon) at 8 locations for AAQ data (except monsoon) PM10, PM2.5, SO2, NOX, CO and other parameters at 8 locations for PM10, relevant to the project shall be collected. The PM2.5, SO2, NOX, CO and monitoring stations shall be based CPCB guidelines other parameters given in and consider the pre-dominant wind direction, Section 3.5 population zone and sensitive receptors including reserved forests. iii. Raw data of all AAQ measurement for 12 weeks Raw data of all AAQ of all stations as per frequency given in the NAQQM measurement for 12 weeks Notification of Nov. 2009 along with - min., max., of all stations as per average and 98% values for each of the AAQ frequency attached as parameters from data of all AAQ stations should be Annexure III provided as an annexure to the EIA Report.
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) iv. Surface water quality of nearby River (100m Surface water quality of the upstream and downstream of discharge point) and study area given in Section other surface drains at eight locations as per 3.7.2. CPCB/MoEF&CC guidelines. vi. Whether the site falls near to polluted stretch of No such pollution stretch of river identified by the CPCB/MoEF&CC, if yes give river falls within 10 Km rdius details. of plnt. vii. Ground water monitoring at minimum at 8 Ground water monitoring at 8 locations shall be included. locations given in Section 3.7.1 viii. Noise levels monitoring at 8 locations within the Noise levels monitoring at 8 study area. locations given in Section 3.6. ix. Soil Characteristic as per CPCB guidelines. Soil Characteristic given in Section 3.8. x. Traffic study of the area, type of vehicles, As site located near National frequency of vehicles for transportation of materials, highway, due to this additional traffic due to proposed project, parking proposed no project no traffic arrangement etc. will increase x. Detailed description of flora and fauna Detailed description of flora (terrestrial and aquatic) existing in the study area and fauna given in Section shall be given with special reference to rare, 3.9. endemic and endangered species. If Schedule-I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared and furnished. Socio-economic status of the study area. Demography of the study area given in Section 3.10. 8. Impact and Environment Management Plan i. Assessment of ground level concentration of Assessment of ground level pollutants from the stack emission based on site- concentration of pollutants specific meteorological features. In case the project from the stack emission with is located on a hilly terrain, the AQIP Modelling shall Aermod modeling is given in be done using inputs of the specific terrain Chapter 4 characteristics for determining the potential impacts of the project on the AAQ. Cumulative impact of all sources of emissions (including transportation) on the AAQ of the area shall be assessed. Details of the model used and the input data used for modelling shall also be provided. The air quality contours shall be plotted on a location map showing the location of project site, habitation nearby, sensitive receptors, if any. ii. Water Quality modelling - in case of discharge Plant based on ZLD in water body concepts. iii. Impact of the transport of the raw materials Infrastructure details given in and end products on the surrounding environment Section 4.7. 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
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) shall be examined. iv. A note on treatment of wastewater from Unit based on Zero different plant operations, extent recycled and discharge concepts. reused for different purposes shall be included. Treatment scheme of Complete scheme of effluent treatment. wastewater from different Characteristics of untreated and treated effluent to plant operations, extent meet the prescribed standards of discharge under recycled and reused is given E(P) Rules. in Section 2.11 v. Details of stack emission and action plan for Details of stack emission and control of emissions to meet standards. action plan for control of vi. Measures for fugitive emission control emissions to meet standards given in Chapter 5. vii. Details of hazardous waste generation and Details of Emission, their storage, utilization and management. Copies of effluents, hazardous waste MOU regarding utilization of solid and hazardous generation and their waste in cement plant shall also be included. EMP management given in shall include the concept of waste-minimization, Section 2.11 recycle/reuse/recover techniques, Energy conservation, and natural resource conservation. viii. Proper utilization of fly ash shall be ensured as No Fly ash generation. per Fly Ash Notification, 2009. A detailed plan of action shall be provided. ix. Action plan for the green belt development plan in Action plan for green belt 33 % area i.e. land with not less than 1,500 trees per given in Chapter 5 ha. Giving details of species, width of plantation, planning schedule etc. shall be included. The green belt shall be around the project boundary and a scheme for greening of the roads used for the project shall also be incorporated. x. Action plan for rainwater harvesting measures at It’s a chemical unit, Hence plant site shall be submitted to harvest rainwater rain water harvesting is not from the roof tops and storm water drains to taken with in premises, RWH recharge the ground water and to use for the various shall be taken as suggested activities at the project site to conserve fresh water by authorities. and reduce the water requirement from other sources. xi. Total capital cost and recurring cost/annum for Total cost of the project is Rs environmental pollution control measures shall be 150 crores, Environmental included. Pollution control measures budget is Rs 2 crores. xii. Action plan for post-project environmental post-project environmental monitoring shall be submitted. monitoring given in Chapter 5 9. Occupational health i. Plan and fund allocation to ensure the Occupationalhealth & safety occupational health & safety of all contract and of all contract and casual casual workers workers shall be applicable as per factory acts. ii. Details of exposure specific health status During joining of any new evaluation of worker. If the workers' health is being employe, and there will be
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) evaluated by pre-designed format, chest x rays, pre-placement and periodical Audiometry, Spirometry, Vision testing (Far & Near examinations taken. 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. iii. Details of existing Occupational & Safety Wel delvelop OHS system Hazards. What are the exposure levels of hazards present and appropriate and whether they are within Permissible Exposure safety measures shall be level (PEL). If these are not within PEL, what taken for he proposed unit. measures the company has adopted to keep them within PEL so that health of the workers can be preserved, iv. Annual report of health status of workers with During joining of any new special reference to Occupational Health and Safety. employe, and there will be pre-placement and periodical examinations taken. 10. Corporate Environment Policy 11. i. Does the company have a well laid down Organization have well Environment Policy approved by its Board of develop environmental Directors? If so, it may be detailed in the EIA report. management cell detail given ii. Does the Environment Policy prescribe for in Chapter 5 , Table 5.1. standard operating process / procedures to bring
into focus any infringement / deviation / violation of the environmental or forest norms / conditions? If so, it may be detailed in the EIA. iii. What is the hierarchical system or Administrative order of the company to deal with the environmental issues and for ensuring compliance with the environmental clearance conditions? Details of this system may be given. iv. Does the company have system of reporting of No violation of environmental non-compliances / violations of environmental norms 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 12. The Socio economic survey of the population in local Demography of the study surrounding area, to assess their felt needs may be area is given in Section 3.10. carried out in pre and post project implementation period. Based upon the findings of this survey, plans for addressing the issues according to felt need pertaining to social upliftment, habitat, drinking water, sanitation, health, educational, employment, livelihood activities etc. for the benefit to the society, may be prepared and financial provision for the same may be kept in the project. The socio- economic influence to the local community shall be
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) elaborated including CSR activities. Details in this regard may be provided in the EIA/EMP report. The PP may explore to initiate CSR activities in the area along with EIA studies as per annexure. 13. Details regarding infrastructure facilities such as Local labour hired and sanitation, fuel, restroom etc. to be provided to the adequate facility provided labour force during construction as well as to the such as sanitation, fuel, casual workers including truck drivers during restroom etc.. operation phase. 14. Enterprise Social Commitment (ESC) Adequate funds (at least 2.5 % of the project cost) Adequate funds shall be shall be earmarked for Socio-economic development earmarked which covered as activities need to be elaborated upon. CSR plan given in Section 2.15. 15. Any litigation pending against the project and/or any No Litigation 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 16. Details on solvents to be used, measures for solvent Solvent receovery system recovery and for emissions control given in Section 2.8. 17. Details of process emissions from the proposed unit Process emissions from the and its arrangement to control. proposed unit and its arrangement to control given in Section 2.12. 18. Ambient air quality data should include VOC , SO2 Ambient air monitoring and NOx, other process-specific pollutants*like details given in Section 3.5 including NH3*, chlorine*, HCl*, HBr*, H2S*, HF*,etc.,(*-as applicable) 19. Work zone monitoring arrangements for hazardous Will be carried out during chemicals. plant operation stage. 20. Detailed effluent treatment scheme including Proposed unit based on Zero segregation of effluent streams for units adopting liquid discharge concepts 'Zero' liquid discharge. 21. 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 5.4.12.
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
22. A copy of the Memorandum of Understanding signed The hazardous waste will be with cement manufacturers indicating clearly that incinerated in the incinerator to they co-process organic solid/hazardous waste the extent possible. Non generated, in case waste is proposed to be used for incinerated hazardous waste this purpose. along with incinerator ash will 23. Authorization/Membership for the disposal of liquid be disposed off to TSDF site. effluent in CETP and solid/hazardous waste in TSDF 24. Action plan for utilization of MEE/dryers salts. Details of MEE given in Section 2.11.3. 25. Material Safety Data Sheet for all the Chemicals are Material Safety Data Sheet being used/will be used. for all the Chemicals Attached as Annexure IV 26. Details of incinerator/s (if any) if to be installed. Details of incinerator given in Section 2.11 27. Risk assessment for storage and handling of Details risk assessment hazardous chemicals/ solvents (HAZOP Study). study carried out given in Action plan for handling & safety system to be Chapter 6 incorporated. 28. Arrangements for ensuring health and safety of Appropriate safety measures workers engaged in handling of toxic materials. shall be taken. Additional TOR 29. Layout plan earmarking the space for 10m wide Plant layout indicating for 10 green belt around the periphery of the plant with m wide green belt around the perennial trees shall be submitted totaling 33% of periphery of the plant, the total project area as green area. PP shall submit storage area, plant area, revised layout plan with updated details. greenbelt area, utilities etc given in Figure 2.2 30. Enterprises Social Commitment plan shall be Adequate funds shall be submitted with at least 2.5 % cost of expansion earmarked which covered as project for five years covering RO drinking water CSR plan given in Section facility/ Computer/ Smart class to the schools in the 2.15. nearby villages. 31. PP shall submit complete product list with Product list with intermediates of APIs intermediates of APIs with 32. Chemical name of the product with CAS No. number CAS No. and LC50/LD50 of and actual end use shall be provided. each product given in Table 33. Toxicity study (LC50/LD50) of the products shall be 2.2 undertaken. 34. Indoor air monitoring of the pharma unit shall be Agreed and shall be made complied 35. PP Shall explore the feasibility of alternate fuel Alternate fuel is not feasible, source. If coal is considered, then coal having coal used which have sulphur content less than 0.5% shall only be used. sulphur content less than 0.5%
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
CHAPTER 2. PROJECT DESCRIPTION
This chapter deals with the brief details of the establishment of new proposed bulk drug project; Location Consideration, Technology Description, Raw material Requirement and its source, Process flow diagram, Environmental aspects etc.
2.1. Need and Justification of Project Location Need of APIs is increasing every year due to continual growth of pharmaceutical industry. This project is expected to contribute in partially fulfilling the demand of APIs for pharmaceutical industries within Rajasthan, Gujarat &rest of India. The proposed expansion project will be located inside the RIICO Industrial Area. The RIICO Industrial Area has well developed roads, and is located near the NH 8 (within 2.4 km – South East direction), which is advantageous in terms of transportation of raw materials as well as finished goods. This justifies the proposed site location. The location map shown in Figure 2.1.
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
2.2. The Site Total plot area is 88000 SQM, existing unit of OCIPL is an area of 61200 SQM with a green belt of 20196 SQM. Expansion will be done at the adjacent plot of OCIPL having area of 26000 Sq Mt with green belt area of 8850 Sq Mtr (33% of the expansion plot area) Proposed unit located in Notified industrial area develop by RIICO, Hence Public hearing is exempted. Due to Rajasthan - Haryana state boundary at distance of 2.38 km project is falling under category A. Connectivity and surrounding area profile given in Table 2.1
Table 2.1 : Connectivity and Surrounding Area Profile Co ordinate of the Project Site 27°48'20.79"N, 76°13'29.33"E Total cost of Proposed Project 150 Crore Expansion Plot area 26800 Sq Mtr Green belt area 8850 Sq Mtr (33% of project area) Connectivity NH-8(1.80km, E) Alwar railway station is 47 km away from project site (aerial distance). Jaipur airport is approx. 128 km away from project site (aerial distance). 2.3. Land allocation within plant The land allocation at the site is presented in Table 2.2, corresponding to plant layout shown in figure 2.2
Table 2.2 : Land Distribution of at Site
Existing Area Expansion Total Area S. No. Description (sq m) Area (sq m) (sq m) 1 Manufacturing 17522 5530.25 23052 2 Green Belt 20190 8850 29040 3 Open to sky 4500 2095 6595 4 Road 14500 7318 21818 Utilities Security & Time Office 5 5288 2206.75 7495 Miscellaneous-Parking /medical dispensery etc. 6 Total 62000 26000 88000
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
2.4. Process Description The manufacturing of bulk drugs and bulk drug intermediates is a batch process and involves several stages of reactions in which different functional groups are attached to the starting key raw materials. The product formed after each stages of reaction is called as intermediate. In most of the cases the downstream processing of the reaction mixture involves various unit operations such as filtration, distillation, and precipitation etc. prior to the next reaction step. The final reaction mixture goes through multiple steps of downstream unit processing to produce the desired active product. These steps include filtration, distillation, precipitation, crystallization etc. The proposed project will have eleven streams with separate stream including the intermediates simultaneously. Exisitng facility of Otsuka India GCLE manufacturing facility capacity of 58 MTPM at RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli, Jaipur (Rajasthan) and started its commercial production in March’2008 proposed unit was the first Japanese investment in Rajasthan, even before Neemrana Japanese zone started. Today, Otsuka Chemical (India) Pvt Ltd caters to nearly 50% of GCLE requirement in the world and supplies GCLE to Indian, Chinese & Japanese companies. List of products for existing and proposed unit with capacity is given in Table 2.3 and Table 2.4. 2.5. Products List of Cephalosporin’s API (Bulk Drug, produced by (GCLE) 7-Phenyl acetamido 3- Chloromethyl cephalosporanic acid p-methoxy benzyl ester), Pen-G & 7-ACA and its intermediate Table 2.3 : List of Products manufactured in Existing unit Sr. Name of CAS NO. Toxicity Name of Intermediate Qty / No. Producs LC50/LD50 Month (Existing Unit) 1 GCLE 104146-10-3. 7-Phenyl acetamido 58 .3 MT LD50: more than 5,000mg/kg (rat 3- Chloromethyl oral) cephalosporanic acid p- methoxy benzyl ester LD50: more than 2,000mg/kg (rat percutaneous)
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Table 2.4 : List of Proposed product for expansion Sr. No. Name of API CAS NO. Toxicity Name of Intermediate Qty / (Expansion unit) LC50/LD50 Month 1. Cefexime 79350-37-1 Oral LD50 (rat): (GVNE) 7-Phenyl acetamido 3-vinyl cephalosporanic acid p- >10 gm/kg; methoxy benzyl ester (7-AVCA)7-Amino 3-Vinyl Cephalosporanic Acid Cefexime Methyl Ester 2. Cefditoren Pivoxil 117467-28-4 Oral LD50 (rat): (GCTA) p-methoxybenzyl 7-phenylacetamido-3-[4- 980 gm/kg methylthiazol 5-yl]vinyl-3-cephem-4-carboxylate (DTCA)7-amino (4-methylthiazol-5yl)3-vinyl 3-cephem 4- carboxylic acid Cefditoren Acid/Sodium 3 Cefdinir 91832-40-5 >5600mg/kg (GVNE) 7-Phenyl acetamido 3-vinyl cephalosporanic acid p- mouse methoxy benzyl ester (7-AVCA)7-Amino 3-Vinyl Cephalosporanic Acid Potassium salt of Cefdinir 22.5 4 Cefprozil 121123-17-9 Rat > 5000 mg/kg (GPRE) p-methoxybenzyl 7-phenylacetamido-3-[propen-1- MTPM yl]-3-cephem-4-carboxylate (7-APRA)7-amino-8-oxo-3-[(1Z)-prop-1-enyl]-5-thia-1- azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid Cefprozil Solvate 5. ACLE 113479-65-5 Not available. Single stage starting from GCLE 6. Ceftaroline 400827-46-5 Oral LD50 (rat): 7β-amino-3-[4-(1-methyl-4-pyridinio)-2-thiazolylthio]-3- 980 gm/kg cephem-4-carboxylate Dihydrochloride. Disodium 3-[4-(1-methyl-4-pyridinio)-2-thiazolylthio]-7β-[2-(5- phosphonateamino-1,2,4-thiadiazol-3-yl)-2(Z)- ethoxyiminoacetamido]-3-cephem-4-carboxylate. 7. Ceftibuten 118081-34-8 >10gm/kg oral rat (ANCE) 7-Amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene- 2-carboxylic acid diphenylmethyl ester
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
(DANCE) De Acetyl 7-Amino-8-oxo-5-thia-1- azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid diphenylmethyl ester Protected Ceftibuten 8. Cefpodoxime 87239-81-4 >10000 mg/kg oral (7-AMCA)7-Amino-3-Methoxymethyl-3-Cephem-4- Proxetil rat Carboxylic Acid Cefpodoxime Acid 9. Cefcapene Pivoxil 117467-24-8 rat (HACA) –3-Hydoxymethyl-7-aminocephalosporanic acid. DOSE/DURATION : >5 gm/kg 1 Cefuroxime Axetil 64544-07-06 IC50: > 100 mg/l, Hydroxy- Cefuroxime aminocephalosporanic acid 0 3 Hours, Activated Cefuroxime Acid . sludge Penicillin –G, Intermediates and its APIs Sr. No. Name of API CAS NO. Toxicity Intermediate LC50/LD50 1. Tazobactum 89786-04-9 >5 gm/kg oral rat DBTA Sodium DBSO PSOB Tazobactum Acid Sulbactum sodium 69388-84-7 DBTA 2. Sulbactum Pivoxil Not available. DBSO 3. PSOB Sulbactum acid R&D Products R&D Products under above categories 2.5 MT/ Month
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Manufacturing process (Existing Products) 2.5.1. GCLE Manufacturing
Pen G potassium is esterified and esterified product is oxidized to get para methoxy benzyl ester of Pen G sulphoxide. This intermediate is then converted into a Chlorinated intermediate, by series of reaction including disulphide formation and chlorination reaction. Chlorinated product is finally cyclized into GCLE which is then precipitated, centrifuged, washed and dried. Dry product is packed in containers and stored at 15 degrees.
Manufacturing Process (Expansion project) 2.5.2. Cefixime Manufacturing Process Cefixime is a third generation cephalosporin antibiotic use for treatment of bacterial infection, it consist of five steps comprises of witting reaction, deprotection, enzymatic hydrolysis, condensation, basic hydrolysis, and crystallization Stage-1: CFX-VI (GVNE) GCLE is converted into its bromo derivative with sodium bromide, sodium iodide in DMF then it undergoes wittig reaction in presence of triphenyl phosphine (TPP), caustic and formaldehyde in MDC. MDC is distilled off under vacuum and product is isolated by adding methanol. Filtered, washed with methanol and dried to give GVNE. Stage-2: CFX-VIII (AVNA) Deprotection of caboxylic acid and amino group is carried out with phenol and penicillin G amidase enzyme respectively. Hydrolysed mass is treated with activated carbon than crystallised by adjusting pH with dilute HCl to 4.0. 7-AVNA is filtered, washed with water and dried. Stage-3: Cefixime 7-Amino-3-vinyl-3-cephem-4-carboxylic acid (7-AVCA) is condensed with MICA Ester in methanol / water mixture at pH 8.0 in presence of TEA. After completion of reaction, reaction mixture is poured into water and its pH is adjusted. Mercaptobenzothiazol (MBT) is crystallised out as by product. It is removed by filtration. To the filtrate, ethyl acetate, EDTA and water is added and adjusted its pH with dilute HCl to get precursor of cefixime i.e. methyl ester of cefixime. Stage-4: Methyl ester of cefixime is further subjected to basic hydrolysis using sodium hydroxide. The product is crystallization by hydrochloric acid followed by centrifugation yields the Cefixime which on further drying yields the Cefixime EP in the pure form. Stage-5: Final crystallization is carried out in the clean room area of class 100000 to avoid any cross contamination.
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Chemical Reaction:
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Process Flow Diagram
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EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Material Balance for 01 MT Sr. No. Raw Material MT Recovery & Consumption (MT) Recycling (MT) 1 7-Phenyl acetamido 3- Chloromethyl 1.60 cephalosporanic acid p-methoxy benzyl ester (GCLE) 2 Di Chloro methane (MDC) 13.68 13.3 0.41 3 Sodium Bromide 0.35 4 Sodium Iodide 0.05 5 Triphenylphosphine (TPP) 0.88 6 N, N-Dimethylformamide (DMF) 2.10 2.0 0.06 7 Formaldehyde 1.40 1.4 0.04 8 Sodium Hydroxide 0.19 9 Hydrochloric Acid (Commercial) 0.84 10 Phenol 3.28 3.2 0.10 11 n-Butyl acetate 20.38 19.8 0.61 12 Sodium bicarbonate 0.47 13 Sodium chloride 0.33 14 Penicillin-G amidase enzyme (wet) 0.83 15 Sodium Carbonate 0.25 16 EDTA di sodium 0.01 17 Methyl alcohol 8.50 8.2 0.26 18 Sulfuric acid 0.50 19 Acetone 18.00 17.5 0.54 20 MICA Ester 1.20 21 TEA 0.26 0.3 0.01 22 Ethyl Acetate 1.50 1.5 0.04 23 Sodium hydro sulphite 0.03 24 Activated carbon 0.30
2.5.3. Cefditoren Pivoxil Manufacturing Process Stage-1: GCLE reacted with sodium iodide to give iodo derivative which than undergo wittig reaction with MTHA to give GCTA. Product is isolated by evaporating chloroform then addition of methanol. Deprotection of phenylacetyl group at 7-position and p-methoxy benzyl group at 4-position is carried out with phenol followed by enzymatic hydrolysis to give ATCA.
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Stage-2: 7-ATCA key starting material when subjected to condensation with the (benzothiazol-2- yl)-2-(2-aminothiazolyl-4-yl)-(Z)-2-methoxyamino thioacetate (MAEM) in the presence of acetone water mixture in triethyl amine base under cooled condition which on reaction with Sodium -2-ethyl hexanoate yields the Cefditoren sodium (Step-1). Stage-3: Reaction is monitored by the High pressure liquid chromatography to know the absence of the key starting material 7-ATCA & presence of Cefditoren in the reaction mass. Stage-4: Above Cefditoren sodium is further subjected to condensation with the Iodomethyl pivolate in the presence of dimethyl formamide & phase transfer catalyst Tetrabutylammonium bromide to yield the Cefditoren Pivoxil. Stage-5: Reaction is monitored by the High pressure liquid chromatography to know the absence of the precursor Cefditoren & presence of Cefditoren Pivoxil in the reaction mass. Stage-6: The reaction mass is further dispersed in the ethyl acetate, water and its extraction & several washings with brine solution to transfer the material in ethyl acetate layer. Stage-7: Ethyl acetate layer is further subjected to the treatment with Activated charcoal & hydro & its filtration gives the clear & colourless mass which on crystallization & further washing with cyclohexane yields the pure form of Cefditoren Pivoxil (crystalline)in pure form i.e. Step-2. Stage-8: Material on drying using the Fluid bed dryer yields the material in pure form. Stage-9: Iodomethyl pivalate used in the process is synthesized by reaction of Chloromethyl pivalate with sodium iodide in the presence of Acetone as solvent. Stage-10: Reaction is monitored by the Gas chromatography to know the absence of the starting material Chloromethyl pivalate & presence of Iodomethyl pivalate in the reaction mass. Stage-11: Cefditoren Pivoxil (crystalline) is further dissolved in acetone and pass through the spray dryer to convert in the form of Cefditoren Pivoxil amorphous.
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Chemical Reaction
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Process Flow Diagram
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GCLE 2860 Kg Sodium Bromide 686 Kg DMF 2014 Kg Sodium Chloride 572 Kg TPP 1544 Kg HCl 114 Kg Wittig reaction 148703 Kg Chloroform 92292 Kg N, propyl alcohol 4576 Kg MFT 972 Kg Sodium Meta bi sul. 143 Kg DM Water 42900 kg
Chloroform for recovery – 92292 Kg
Aq. layer Low COD to ETP- 54411 Kg
Phenol 8000 Kg Intermediate - 2000 Kg TFA 500 Kg N Butyl Acetate 26460 Kg DM Water 30000 Kg Ammonia 800 Kg De-Protection 69060 Kg Sodium Chloride 600 Kg Sodium Bi Carbonate 600 Kg Carbon 100 Kg
Phenol for recovery & Reuse – 8000 Kg Carbon Sludge 100 Kgto TSDF Butyl Acetate for recovery & Reuse – 26460 Kg Aq. Intermediate 34600 Kg
PGA Enzyme wet 2500 Kg Sodium Carbonate 400 Kg Sulphuric Acid 330 Kg Methanol 7150 Kg Enzymatic Hydrolysis – 84272 Kg Acetone 3164 Kg EDTA Sodium 8.0 Kg DM water 36000 Kg Ammonia 120 Kg
Enzyme recycling & reuse -2500 Kg
Acetone for recovery & Reuse – Qty.3164 Kg
Aq. Effluent High COD to MEE – qty. 75608 Kg ATCA - 1000 Kg
MEAM 825 Kg
Acetone 11485 Kg Condensation 15943 Kg TEA 287 Kg
DM water 1861 Kg
Sodium 2 Ethyl hexonate 825 Kg Aq. Acetone, Hexonaic acid for recovery-qty.
14943 Kg Chloro Methyl Pivilate – 800 Kg Sodium Iodide 400 Kg Cefditoren Sodium- 1000 Kg Acetone 2373 Kg
Acetone for recovery Reuse- 2373 Kg Sodium Bi Carbonate 210 Kg Ethyl Acetate 43050 Kg DM water 91000 Kg Iodo Methyl Pivilate – 1200 Kg Esterifiction 137721 Kg Carbon 75 Kg Acetone 1186 Kg
Aq. Acetone, for recovery-qty. 92396 Kg Carbon Sludge – 75 Kg to TSDF
Next Stage continue 45250 Kg
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Ethyl Acetate layer 45250 Kg
Ethyl Acetate for recovery – 43050 Kg
Residue 2000 Kg
Cyclohexane 17000 Kg Crystallization 19000 Kg
Cyclo Hexane & Ethyl Acetate mixture for recovery & Reuse – 18000 Kg
Cefditoren Pivoxil – 1000 Kg
Sr. No. Raw Material MT Recovery & Consumption Recycling (MT) (MT) 1 4-Methoxybenzyl3-chloromethyl-7-(2- 2.9 - - phenylacetamido)-3-cephem-4- carboxylate(GCLE) 2 Sodium Bromide 0.7 - - 3 Triphenylphosphine (TPP) 1.5 - - 4 4-Methyl 5-formyl thiazole 1.0 - - 5 DMF 2.1 2.0758 0.1 6 Isopropyl alcohol 4.6 4.43872 0.1 7 Sodium Chloride 1.2 - - 8 Sodium meta bi sulfite 0.1 - - 9 Phenol 8.0 7.76 0.2 10 Trifloro Acetic acid 0.5 - - 11 n-Butyl acetate 26.5 25.6662 0.8 12 Penicillin-G amidase (wet) 2.5 - - 13 Sodium bi carbonate 0.6 - - 14 Sodium carbonate 0.4 - - 15 Acticarbon ENO-PC 0.2 - - 16 Sulfuric acid 0.3 - - 17 Acetone 18.2 17.654 0.5 18 MEAM 0.8 - - 19 TEA 0.3 - - 20 Sodium 2-Ethyl Hexanoate 0.8 - - 21 Iodo methyl pivalate 1.2 - - 22 Ethyl acetate 43.0 41.71 1.3 23 Conc. HCl (35%±1%) 0.1 - - 24 Ammonia 0.1 - - 25 Cyclohexane 17.0 16.49 0.5 26 Chloro methyl pivalate 0.8 - - 27 Sodium iodide 0.4 - -
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2.5.4. Manufacturing Process of Cefprozil Cefprozil Manufacturing Process Cefprozil is a second generation cephalosporin antibiotic use for treatment of bacterial infection, it consist of four steps comprises of wittig reaction, deprotection, enzymatic hydrolysis, mixed anhydride preparation, condensation and desolvation. Stage-1: GCLE undergoes witting reaction in the presence of triphenyl phosphine, sodium iodide, acetaldehyde, dimethylformamide and methylene chloride to give GPRE (Int-I). Stage-2: Deprotection of carboxylic & amino groups in GPRE is carried out with phenol & penicillin G amidase enzyme respectivly to yield 7-APCA (Int-II). Stage-3: Silylated 7-APCA is condensed with mixed anhydride of p-hydroxy phenylgylcine dane salt at low temperature in presence of methylene chloride. Int-III is isolated in the form of dimethylformamide solvate of cefprozil by acidic hydrolysis of condensed mass. Stage-4: DMF solvate of cefprozil undergoes de-solvation in acetone / water mixture and gives cefprozil monohydrate.
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Chemical reaction
Process Flow Diagram
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GCLE 2000Kg Sodium Bromide 220 Kg Sodium Iodide 384 Kg Sodium Meta Bi Sul 800 Kg Acetaldehyde 2500 Kg IPA 22000 Kg Wittig reaction DMF 19270 Kg 144802 Kg Caustic192 Kg Sodium Chloride 500 Kg MDC 63200 Kg TPP 1132 Kg DM Water 49200 kg
IPA & DMF water mixture for recovery – Qty. 79962 Kg
MDC for recovery& Reuse –Qty. 63200 Kg
GPRE - 1640 Kg Intermediate
Phenol 6560 Kg TFA 410 Kg Ethyl Acetate 14711 Kg N Butyl Acetate 5786 Kg De-Protection 54307 Kg DM Water 24600 Kg Caustic 400Kg Sodium Chloride 200 Kg
Phenol recovery & Reuse – Qty. 6560 Kg
Butyl Acetate recovery& Reuse – Qty.5786 Kg
Ethyl Acetate recovery& reuse - Qty. 14711 Kg Aq. Intermediate 27250 Kg
PGA Enzyme 800 Kg Sodium Carbonate200 Kg Sulphuric Acid 165 Kg Methanol 3575 Kg Enzymatic Hydrolysis – 50555 Kg Acetone 3561 Kg EDTA Sodium 4.0 Kg DM water 15000 Kg
Enzyme Recycling -800 kg Acetone for recovery – Qty.3561 Kg
Aq. Effluent High COD to MEE – qty. 45538 Kg
APCA - 656 Kg MDC 7336 Kg HMDS 310 Kg PHPG Dan Salt – 933 Kg TMCS 231Kg MDC 3280 Kg Imidazole 6.5 Kg MMM 5.1 Kg Condensation 16959 kg DM water 1850 Kg ECF 994.5 Kg Sodium Meta bi sulphate 13 Kg DMF 328 Kg HCL 452 Kg Ammonia 525Kg Hydrolysis 16959 Kg
MDC, HMDS,& ECF for recovery – qty. 12151 Kg
Aq. layer 4808 Kg DMF 15088 Kg Crystallization 20486 Kg dil. Ammonia 525 Kg Carbon 65 Kg 65 Kg carbon Sludge to TSDF DMF water for recovery – qty. 19121 Kg
Ceprozil Solvate 1300 Kg
DWM 2600 Kg Acetone 1300 Kg Desolvation 5200 Kg
Acetone recovery & Reuse – 1300 kg
.4000 Kg High COD DMF water mixture to MEE 2900 Kg EQMS India Pvt. Ltd. 45 Cefprozil 1000 kg
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Material Balance for 01 MT Sr. No. Raw Material MT Recovery & Consumption Recycling (MT) (MT) 1 7-Phenyl acetamido 3- 2 Chloromethyl cephalosporanic acid p-methoxy benzyl ester (GCLE) 2 Di Chloro methane (MDC) 73.8 71.586 2.214 3 Sodium Bromide 0.22 4 Sodium Iodide 0.4 5 Triphenylphosphine (TPP) 1.1 6 Acetaldehyde 2.5 7 Isopropyl alcohol 22.0 21.34 0.66 8 Sodium Hydroxide 0.4 9 Sodium Chloride 0.2 10 Sodium meta bi sulfite 0.8 11 Phenol 6.6 6.3632 0.1968 12 Trifloro Acetic acid 0.4 13 Ethyl acetate 14.7 14.259 0.441 14 n-Butyl acetate 5.8 5.6066 0.1734 15 Penicillin-G amidase (wet) 0.8 16 Sodium carbonate 0.2 17 Acticarbon ENO-PC 0.07 18 Methanol 3.8 3.6375 0.1125 19 EDTA di sodium 0.004 20 Sulfuric acid 0.2 21 Acetone 4.9 4.7142 0.1458 22 HMDS 0.3 23 Tri Methyl Cholro Silan 0.2 24 Imidazole 0.1 25 p-Hydroxy Phenyl Glycine 0.9 Dane salt 26 DMF 15.4 14.938 0.462 27 NMM 0.0050 29 Ethyl Chloro Formate 1.0 30 HCl 0.0 32 Liq. Ammonia solution 0.5
2.5.5. ACLE manufacturing Process Description: GCLE is converted into it’schloro derivative with Phosphoraspenta Chloride, Pyridine in Methylene chloride. Then it undergoes iminoetherification in presence of Methyl iso butyl ketone and hydrolysis by adding water and Sodium Chloride. After separating organic layer and aqueous layer, ACLE was crystallized using Methyl iso butyl ketone from organic layer. Then filtration and drying, ACLE is obtained.
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Chemical Reaction:
Process flow Diagram
MDC 8856kg Preparation of PCl5-Pyridine PCl5 810kg 9975kg Pyridine 309kg
GCLE 1430kg Iminochlorination 11405kg
MIBK 1952kg Iminoetherification 13358kg
H2O 7154kg Hydrolysis NaCl 320kg 20832kg
Organic layer Aqueous layer 11874kg 8958kg
MIBK 17206kg Crystallization 29080kg
MIBK 1223kg Centrifuge & dry Mother Liquid and IPA 1199kg recover from DR 30502kg
ACLE HCl 1000kg
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Recovery & Consumption Sr. No. Raw Material MT Recycling (MT) (MT) 4-Methoxybenzyl3-chloromethyl-7- 1 (2-phenylacetamido)-3-cephem-4- 1.43 carboxylate(GCLE) 2 Phosphoras penta Chloride 0.81 3 Pyridine 0.31 0.3 0.0 4 Sodium Chloride 0.32 5 Methylene chloride 8.86 8.8 0.1 6 Methyl iso butyl ketone 20.60 20.4 0.2 7 Iso Propyl alcohol 1.20 1.2 0.0
2.5.6. Ceftaroline Fosamil Acetate Manufacturing Process Description: Stage-1:
Benzhydryl 7β-[(phenylacetyl)amino]-3-hydroxy-3-cephem-4-carboxylate is treated with methane sulfonyl chloride in the presence of a base TEA, and solvent Acetonitrile to obtain (mesylated product) which under goes to treated with methyl iodide in the presence of ethyl acetate to obtain Benzhydryl 7β-[(phenylacetyl)amino]-3-[4-(1-methyl-4- pyridinio)-2-thiazolylthio]-3-cephem-4-carboxylate Iodide. Stages-2
Benzhydryl 7β-[(phenylacetyl)amino]-3-[4-(1-methyl-4-pyridinio)-2-thiazolylthio]-3 cephem- 4-carboxylate Iodide is subjected to reaction with PCl5 in the presence of pyridine and MDC/ Ether /methanol/isobutyl alcohol to obtain Benzhydryl 7β-amino-3-[4-(1-methyl-4- pyridinio)-2-thiazolylthio]-3-cephem-4-carboxylate chloride. Stage-3
7β-amino-3-[4-(1-methyl-4-pyridinio)-2-thiazolylthio]-3-cephem-4-carboxylate dihydrochloride is reacted with 2-(5-Dichlorophosphorylamino-1,2,4-thiadiazol-3-yl)-2(Z)- ethoxyiminoacetyl chloride (in the presence of sodium acetate, water and THF/Ethyl acetate to obtain disodium 3-[4-(1-methyl-4-pyridinio)-2-thiazolylthio]-7β-[2-(5- phosphonateamino-1,2,4-thiadiazol-3-yl)-2(Z)-ethoxyiminoacetamido]-3-cephem-4- carboxylate. Stage-4:
disodium 3-[4-(1-methyl-4-pyridinio)-2-thiazolylthio]-7β-[2-(5-phosphonateamino-1,2,4- thiadiazol-3-yl)-2(Z)-ethoxyiminoacetamido]-3-cephem-4-carboxylate is treated with acetic acid in the presence of sulfuric acid , sodium acetate and water to obtain 3-[4-(1-methyl-4-
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pyridinio)-2-thiazolylthio]-7β-[2-(5-phosphonoamino-1,2,4-thiadiazol-3-yl)-2(Z)- ethoxyiminoacetamido]-3-cephem-4-carboxylate acetate i.e. (Ceftaroline fosamil acetate) Chemical Reaction Stage-01
Stage-02
Stage- 03
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Stage-04
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Process Flow Diagram
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Sr. No. Raw Material MT Recovery & Consumption Recycling (MT) (MT) 1 3-OH (GHYH) 3.919 2 2-(5-Amino-1,2,4-thiadiazol- 1.9 3-yl)-2(Z)-ethoxyiminoacetic acid 3 4-(4-pyridyl)-1,3-thiazole-2- 4 thiol 4 Acetic acid 5 5 Acetone 10 9.9 0.1 6 Acetonitrile 12.3 11.931 0.4 7 Caustic Soda Flakes 0.3 8 Conc HCl 2 9 Diisopropyl ether 19 18.43 0.6 10 Diisopropyl ethyl amine 1.03 11 Ethanol 40 39.6 0.4 12 Ethyl acetate 40 39.6 0.4 13 Isobutyl alcohol 25 24.75 0.3 14 MDC 20 19.8 0.2 15 Methane sulfonyl chloride 0.99 16 Methanol 30 29.7 0.3 17 Methyl iodide 2.6 18 Phosphorous penta chloride 1.5 19 pyridine 1.2 1.164 0.04 20 Sodium acetate 1.5 21 Sulphuric acid 0.3 22 TEA 0.5 23 THF 35 34.65 0.35
2.5.7. Manufacturing Process Ceftibuten Ceftibuten is a third generation cephalosporin antibiotic used for treatment of bacterial infection. Step I: 3-OH (GHYH) to ANCE 3-OH (GHYH) is reduced by Sodium borohydride in acetic acid and MDC solvent followed by in-situ o-mesylation by methanesulfonyl chloride-Triethylamine in MDC and finally elimination of O-mesyl group by diethylamine. Product extracted in MDC and the crystallization in methanol yields ANCE as a white solid. Step II: ANCE to DANCE
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ANCE is de-protected by PCl5-pyridine mixture in MDC-methanol solvent followed by crystallization in ethylacetate to get DANCE. Step III: DANCE to PROTECTED CEFTIBUTEN DANCE and PHE side chain is coupled with N.N’-dicyclohexyl carbodiimide in MDC solvent. Product extracted in MDC and crystallization in methanol to get the Protected Ceftibuten. Step IV: PROTECTED CEFTIBUTEN TO CEFTIBUTEN HYDRATE Protected Ceftibuten is de-protected by Aluminium chloride and anisole mixture. Reaction mass is extracted with dil. HCl and then washed with ethyl acetate. Aqueous layer is treated with DL-Malic acid, acetonitrile, acetic acid and pH adjusted with sodium hydroxide solution to get crude Ceftibuten dehydrate this crude product is dissolved in sodium carbonate solution, charcoalised and added sulfuric acid-acetonitrile mixture followed by pH adjusted with potassium carbonate solution to get the pure Ceftibuten dihydrate after washing with enough water.
Chemical Reaction H H N S N S
O N AcOH/MDC O N O OH NaBH4 O OH + O O Mol. Wt. 37.84 O O
3-OH (GHYH) GCHA (Key rawmaterial) Mol. Wt.: 502.58 Mol. Wt.: 500.57
TEA / DEA Methanesulfonyl chloride
H N S
O N O
O + O
ANCE Mol. Wt.: 484.57
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H N S
O N O O O
ANCE Mol. Wt.: 484.57
PCl5/pyridine
H2N S
N O O O
DANCE Mol. Wt.: 366.43
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H N O 2 S O N O OH + O O O S N
HN O DANCE O Mol. Wt.: 366.43
Dicyclohexyl carbodiimide MDC / Methanol PHE (side chain) (Key rawmaterials) C21H22N2O6S Mol. Wt.: 430.48
O O
S NH N O O S N O O HN O
O
Protected ceftibuten
C41H38N4O8S2 Mol. Wt.: 778.89
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O O
S NH N O O S N O O HN O
O
Protected ceftibuten
C41H38N4O8S2 Mol. Wt.: 778.89
AlCl3/anisole/ DL-Malic acid
OH O
S NH N .2H2O O O S N O OH H2N Crude Ceftibuten dihydrate Mol. Wt.: 446.43
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OH O
S NH N .2H2O O O S N O OH H2N Crude Ceftibuten dihydrate Mol. Wt.: 446.43
Sodium carbonate n-Butylacetate/ACN H2SO4/ Pot.carbonate
OH O
S NH N .2H2O O O S N O OH H2N Pure Ceftibuten dihydrate Mol. Wt.: 446.43
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Process Flow Diagram
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Material Balance for 01 MT Recovery & Consumption Sr. No. Raw Material MT Recycling (MT) (MT) 1 GHYH(3-OH) 1.00
2 MDC 86.46 83.8662 2.59 3 Acetic Acid 3.10 4 Sodium borohydride 0.68 5 Sodium chloride 0.80 6 Sodium carbonate 0.11 7 Methane Sulfonyl chloride 0.57 8 TEA 0.58 0.56551 0.02 9 Diethyl amine 0.28 0.2716 0.01 10 Dil. Hydro Chloric Acid 11.00 11 Methanol 61.70 59.849 1.85 15 PCl5 0.52 0.50052 0.02 17 Pyridine 0.30 0.29003 0.01 21 Ammonia 0.15 23 Ethyl acetate 26.87 26.0639 0.81 25 PHE (Side chain) 1.23 26 Di Cyclo Carbo Di Amide 0.65 29 Sulfuric acid 0.08 31 Sodium bicarbonate 0.075 35 Aluminium chloride 0.77 38 Carbon 0.14 40 Acetonitrile 1.88 1.8236 0.06 41 DL-Malic acid 1.86 44 Neutral Alumina 0.2 46 Potassium carbonate 1.2
2.5.8. Manufacturing Process of Tazocbactam Sodium ProcessA: DBSO 6-APAis converted into its Di-bromo derivative with Bromine/HBr/NaNO2 in water. then precipitate was filtrated, reacted with diazomethane, converted to ester compound. Ester compound is oxidized with H2O2 and formic acid mixture in Dichloromethane. Finally, crystallization is taken with MeOH, DBSO is filtered, washed with MeOH and dried. ProcessB:De-protection
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De-protection of di-bromo group is carried out with PbCl2/Aluminum in Dichloromethane. The reaction mixture is washed with water and 20% NaCl aq. Obtained organic layer is used to next step directly. Stage-3: TMPB The reaction mixture from process B is reacted with BM(2-mercaptobenzothiazole) in Toluene. Toluene is evaporated from mixture, the residue is treated with NaNO2/HCl in Dichloromethane. The mixture is reacted with 1,2,3-triazole, and then crystallization is taken with Hexane. TMPB is filtrated and dried. Stage-4: TAZB
TMPB is oxidized with KMnO4 and H2O2 aq in Dichloromethane. After reaction, crystallization is taken with MeOH, TAZB is filtered, washed with MeOH and dried. Stage-5: Tazobactam sodium De-protection of TAZB is taken in m-Cresol, Tazobactam is extracted with Sodium bicarbonate aq. and then, crystallization is taken by neutralization with HCl, wash with water and dried, and taken for lypholisation (Freeze Drying) by dissolving sodium carbonate aq. solution to get the Tezo bactum sodium Chemical Reaction
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Process flow diagram
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Material balance for 01 MT Recovery & Consumption Sr. No. Raw Material MT Recycling (MT) (MT) 1 6-APA 13.9 2 HBr 16.1
3 Br2 30.6
4 NaNO2 50.4
5 NaHSO3 23.9 6 NaOCl 67.4 7 Benzophenone Hydrazone 12.5 8 KI 1.5 9 NaOH 70.8 10 QBA-81 0.1 11 Formic acid 8.6 12 Hydroxyperoxide 8.8
13 NaHCO3 22.4 14 Dichloromethane 48 46.56 1.44 15 Mathanol 10.7 10.379 0.321 16 Toluene 7.5 7.275 0.225 17 Lead chloride 0.7 18 Aluminium 4.3
19 NH4Cl 2.9 20 NaCl 133.4 21 Hydrochloric acid 41.2 22 2-Mercaptobenzothiazole 8.3 23 Hexane 3.7 3.589 0.111 24 Ethyl Acetate 4.8 4.656 0.144 25 1,2,3-tirazole 3.7 26 m-Cresol 3.5 27 Methyl isobutylketone 11.3 10.961 0.339 28 Sodium Carbonate 0.017
2.5.9. Sulbactum Sodium Manufacturing Process Stage -01
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Pen G under goes to enzymatic hydrolysis in the presenace of enzyme penG Amidase to convert pen G in to the 6-ammino penicillinic acid. It is isolated by extraction of by product phenyl acetic acid with the organinc solvent and aq. layer adjusting the pH with ammonia soln filter wash and dried to get the 6-APA. Stage- 02 6-APA under goes further bromination reaction using the solvent MDC, reaction monitoring by HPLC and workup to isolate intermediate bromo compound by extraction with water sodium chloride solution. Stage -03 This bromo compound under goes to further oxidation reaction using KMno4 Aq. solution and ethyl acetate as solvent. Reaction completion workup carried out washing of organic layer with sodium metabi-sulpahte solution followed by sodium chloride solution washing to collect the organic layer for next stage. Stage -04 & 05 The stage 03 taken up for catalytic hydrogenation reaction using palladium charcoal hydrogen at specific temperature to produce salbactum which further crystallized as sodium salt using sodium hexonate and iso propyl alcohol as a co-solvent. Chemical Reaction: Stage –I
O H H H2N NH S CH3 S CH3 Enzymatic OH Hydrolysis CH3 O CH3 N + N O O O O HO HO 6 APA Mol wt= 334.39 Mol.wt= 216.25 Stage –II H H N H 2 CH Br S 3 S CH3 CH3 + NaNO2 + H2SO4 + Br2 Br CH3+ N2 NaHSO4 2H O N N + + 2 O O O O HO HO
6 APA Mol wt= 359.034 Mol.wt= 216.25
Stage –III
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O HO H Br Br S CH3 S CH3 KMnO4/H2SO4 Br Br CH3 CH3 N N O O O O HO HO Mol wt= 391.03
Stage –IV O O O HO H Br S CH3 S CH3 Pd/C Br CH CH3 3 N N H2 Gas O O O O HO HO Mol wt= 233.24
O O HO HO CH S CH3 S 3 Sodium ethyl hexanoate CH3 CH3 N N O O O O HO NaO Mol wt= 233.24 Sulbactum acid Mol wt= 255.223 Sulbactum sodium
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Process Flow Diagram
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Material Balance for 01 MT Recovery & Sr. Consumption Raw Material MT Recycling No. (MT) (MT) 1 Pen G 1.00 2 Ammonia 1.00 3 HCl 0.20 Penicillin-G amidase 4 0.20 enzyme (wet) 5 Methanol 1.60 1.552 0.05 6 MDC 11.60 11.252 0.35 7 Liq. Bromine 1.69 1.6393 0.05 8 Sod. Nitrite 0.654 9 Sulfuric acid 0.1 10 Sodium Bi Sulphite 0.22 11 Sodium Chloride 0.54 12 Sodium Hydroixe 0.05 13 Phosphoric Acid 0.18 14 Potasium Permagnet 1.0 15 Ethyl acetate 24.0 23.28 0.72 16 Iso propyle Alcohol 3.0 2.91 0.09 17 Sod. Hexonate 1.0 18 Eno carbon 0.1 19 Palladium Charcol 0.05 20 Hydrogen Gas 0.005
2.5.10. Manufacturing Process Cefpodoxime proxetil Cefpodoxime proxtil is a cephalosporin class of antibiotic used for the treatment of bacterial infection. It consist of eight steps namely Methoxilation, condensation side chain formation, work up charcolisation, crystallization and drying. Stage 1: Methoxylation of 7-ACA is carried out with methanol and BF3 complex at low temperature. filter and pH of the filtrate is adjusted with TEA to get 7-AMCA (Stage-I). Stage 2: 7-AMCA is condensed with MAEM in presence of methanol and TEA. Byproduct is removed by filtration. Filtered mass is treated with activated carbon. Product is isolated by adjusting its pH with sulphuric acid. It is centrifuged, washed with acetone and dried at 45°C to get Cefpodoxime acid. Stage 3 1-Iodoethyl isopropyl carbonate is further subjected to condensation with the Cefpodoxime Acid in the presence of dimethyl acetamide using the 1,8- Diazabicyclo[5,4,0] unde-7-ene(DBU) as a catalyst which on further workup with water & washing with sodium thiosulfate & sodium chloride ethyl acetate, cyclo hexane and
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treatment with Methanol & EDTA & its further crystallization using the ammonia solution for pH adjustment yields the Cefpodoxime Proxetil.
Chemical reaction
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Process Flow Diagram
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Material Balance for 01 MT Recovery & Consumption Sr. No. Raw Material MT Recycling (MT) (MT) 1 7-ACA 1.00 - - 2 BF3 Complex Sulfolane 10.65 10.3305 0.32 3 Methanol 6.60 6.402 0.20 4 Methylene Chloride 8.30 8.051 0.25 5 Triethyl amine 0.49 - - 6 MAEM 1.00 - - 7 Carbon (Eno) 0.18 - - 8 EDTA 0.01 - - 9 Sulfuric acid 0.15 - - 10 Acetone 1.58 1.53454 0.05 11 DBU 0.35 - - 12 DMAc 4.70 - - 13 IEIPC Side Chain 0.75 - - 14 Ethyl acetate 19.78 19.1866 0.59 15 Sodium thiosulphate 0.02 - - 16 Sodium chloride 0.45 - - 17 Cyclohexane 25.00 24.25 0.75 18 Ammonia 0.37 - - 2.5.11. Cefcapene Pivoxil MH HCl Manufacturing Process: Cefcapene is a third generation cephalosporin antibiotic use for treatment of bacterial infection, it consist of seven steps comprises silylation, mixed anhydride formation, condensation, side chain preparation, crystallization, deprotection, salt formation. Stage-1: HACA is silylated with BIS silylil / Acetamide in ethyl acetate at reflux temperature, mixed anhydride of BPTA side chain is formed with methane sulphonyl chloride and TEA in MDC. Condensation of silylated mass with mixed anhydride is carried out at low temperature. After reaction completion, it is hydrolysed with aq. Ammonia solution. Layers are separated. Organic layer is concentrated under vacuum. Residue so obtained is treated with Dicyclohexyl amine to isolate DCHA salt. Stage-2: Stage-1 material under goes carbomoylation reaction and product is isolated as a Cefcapene DIPA salt. Stage-3: (6R,7R)-7-[(z)-2-(2-tertbutoxycarbonylaminothiazol-4-yl)-2-pentenoylamino]-3- (carbamoyloxy methyl)-3-cephem-4-carboxylic acid diisopropyl amine salt DIPA salt is subjected to estrification with Iodomethyl pivalate in ethyl ecetate to yield the (6R,7R)-7- [(z)-2-(2-tertbutoxycarbonyl aminothiazol-4-yl)-2-pentenoylamino]-3-(carbamoyloxymethyl) -3-cephem-4-carboxylic acid pivoloylyloxymethylester. Reaction is monitored by HPLC. Stage-4:
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After completion of reaction, organic layer is separated, concentrated in vacuum & subjected to crystallization by adding cyclohexane to get BOC-Cefcapene Pivoxil. Iodomethyl pivalate used in the process is synthesized by reaction of Chloromethyl pivalate with sodium iodide in the presence of Acetone as solvent. Stage-5: BOC-Cefcapene Pivoxil is further subjected to deprotection using Boron trifluoride (BF3) gas in acetonitrile solvent to get Cefcapene Pivoxil base. Stage-6: Cefcapene Pivoxil base is further subjected to methanolic HCl in Methyl Isobutyl Ketone (MIBK) to yield the Cefcapene Pivoxil Hydrochloride hydrate. Chemical Reaction Stage: HACA to Descarbamoyl Boc cefcapene DCHA salt
H2N S H2N S BSA N OSi N OH O O COOSi COOH H O N HACA Silylated HACA S O C H N O S N 8 10 2 4 O Mol. Wt.: 230.24 .DCHA HN S DCHA N OH O H H COOH N N Descarbamoyl Boc Boc S Boc S Cefcapene DCHA N N O O Mol. Wt. 691.4 TEA/ MsCl OH OMs
BATPA Activated BATPA C13H18N2O4S Mol. Wt.: 298.36
Stage: Descarbamoyl Boc cefcapene DCHA salt to BCN DIPA salt:
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H H N N Boc S Boc S N Chlorosulfonyl N O isocyanate O .DCHA HN S HN .DIPA DIPA S N OH N O NH2 O O COOH COOH O Descarbamoyl Boc Cefcapene DCHA salt BCN-DIPA Mol. Wt. 691.4 Mol.Wt. 654.3 Stage: Chloromethyl pivalate to Iodomethyl pivalate: O NaI / Acetone O Cl O I O MDC Chloromethyl pivalate Iodomethyl pivalate
C6H11ClO2 Mol. Wt.: 150.60 C6H11IO2 Mol. Wt.: 242.05 Stage: BCN DIPA salt to Boc Cefcapene pivoxil
H N Boc S H O N Boc S N I O O N O HN Iodomethylpivalate S .DIPA HN S N O NH2 DMAc/ TBAB O N O NH2 Cyclohexane O O O O COOH O O BCN-DIPA O Mol.Wt. 654.3 Boc Cefcapene pivoxil
C28H37N5O10S2 Mol. Wt.: 667.75
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Stage:Boc Cefcapene Pivoxil to Pure Cefcapene Pivoxil hydrochloride monohydrate
H N Boc S H2N S N N O O
.HCl.H2O HN S BF3-ACN HN S
N O NH2 N O NH2 O MIBK O O O O O O O
O O
O O Boc Cefcapene pivoxil
C28H37N5O10S2 Crude Cefcapene pivoxil Mol. Wt.: 667.75 C23H29N5O8S2. HCl.H2O Mol.Wt. 622.11
OH2.ClH.H2N S H2N S N O N O NaHCO3/ acetone HN S HN S N O NH2 O N O NH2 O O O O O O O O O . O O Crude Cefcapene pivoxil O
C23H29N5O8S2. HCl.H2O Acetone solvate Mol.Wt. 622.11
Conc.HCl/ MeOH
OH2.ClH.H2N S MIBK N O
HN S
N O NH2 O O O O
Pure Cefcapene pivoxil O C23H29N5O8S2. HCl.H2O O Mol.Wt. 622.11 Material Balance for 01 MT Recovery & Consumption Sr. No. Raw Material MT Recycling (MT) (MT) 1 7-HACA 1.1 2 Ethyl acetate 92 89.24 2.76 3 Dimethyl formamide 1 0.97 0.03 Bis trimethylsilyl acetamide 4 (BSA) 2.209 - - 5 BATPA 1.424 - - 6 Triethylamine 0.68 - - 7 Methane sulfonylchloride 0.72 - -
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8 Ammonia 0.22 - - 9 Dicylcohexylamine 1.36 - - 10 Sodium sulfate 1.2 - - 11 Chlorosulfonyl isocyanate 0.6 - - 12 Acetonitrile 2 1.94 0.06 13 Sodium Chloride 2.5 - - 14 Methanol 2 1.94 0.06 Diisopropyl amine 0.44117 15 6 - - Sodium sulphate 0.58823 16 5 - - 17 Chloro methyl pivalate 1 - - 18 Sodium iodide 1.3 - - 19 Acetone 7.4 7.178 0.222 20 Methylene chloride 8 7.76 0.24 21 Sodium thiosulphate 0.22 - - 22 N,N-dimethyl acetamide 10 9.7 0.3 23 Iodomethyl pivalate 0.555 - - Tetrabutyl ammonium bromide 24 (TBAB) 0.1 - - 25 Cyclohexane 12.5 12.125 0.375 26 MIBK 25 - - 27 Eno Carbon 0.15 - - 28 HCl 0.16 - - 2.5.12. Cefdinir Manufacturing Process Cefdinir is a third generation cephalosporin antibiotic used for treatment of bacterial infection, it consist of five step namely condensation, Actylation, deactylation, purification, and finally crystallization. Stage-1: GCLE is converted into its bromo derivative with sodium bromide, sodium iodide in DMF then it undergoes wittig reaction in presence of triphenyl phosphine (TPP), caustic and formaldehyde in MDC. MDC is distilled off under vacuum and product is isolated by adding methanol. Filtered, washed with methanol and dried to give GVNE. Stage-2: Deprotection of caboxylic acid and amino group is carried out with phenol and penicillin G amidase enzyme respectively. Hydrolysed mass is treated with activated carbon than crystallised by adjusting pH with dilute HCl to 4.0. 7-AVCA is filtered, washed with water and dried. Stage-3: 7-amino-3-vinyl-3-cephem-4-carboxylic acid and 2-mercapto benzothiazolyl (Z)-2-(2- amino-4-thiazolyl)-2-acetyl oxyiminoacetate (CAEM) is subjected to condensation in the presence of triethyl amine base using Tetra hydro furan (THF) & water as solvent under cooled condition to get 7-{2-(aminothiazol-4-yl)-2-(methylcarbonyloxyimino) acetamido]- 3-vinylcepham-4-carboxylic acid.
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Acetylated protected Cefdinir Salt is further subjected to deacetylation in the presence of ammonium chloride, Potassium carbonate & potassium acetate and ph adjustment with the dilute sulphuric acid to get the Cefdinir potassium salt. Cefdinir poatassium salt dissolved in water is treated with activated charcoal, EDTA & further subjected to pH adjustment with Sulphuric Acid, centrifugation, washing with acetone & drying the material yields the Cefdinir in pure form. Chemical Reaction
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Reaction Scheme H2N H2N S N S N N + CO S O S COOH N OCOCH3 7-AVCA TEA, MDC, THF O-Acetyl Ester DM-H2O
H2N
N S
CO NH S
N N CH2 OCOCH3 O COOH Protected CEFDINIR
K2CO3/NH4Cl Pot. Acetate H2N DI Water N S
CO NH S
N N CH2 OH O CEFDINIR K+Salt COOK
Carbon/H2SO4
H2N DM-H2O
N S
CO NH S
N N CH OH 2 O COOH CEFIDINIR
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Process flow diagram
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Material Balance Material Balance for 01 MT Recovery & Consumption Sr. No. Raw Material MT Recycling (MT) (MT) 7-Phenyl acetamido 3- Chloromethyl 1 cephalosporanic acid p-methoxy 1.6 benzyl ester (GCLE) 2 Di Chloro methane (MDC) 47.700 46.269 1.431 3 Sodium Bromide 0.345 4 Sodium Iodide 0.049 5 Triphenylphosphine (TPP) 0.880 6 N, N-Dimethylformamide (DMF) 2.129 2.06513 0.064 7 Formaldehyde 1.400 1.358 0.042 8 Sodium Hydroxide 0.190 9 Hydrochloric Acid (Commercial) 0.100 10 Phenol 3.267 3.16899 0.098 11 n-Butyl acetate 20.400 19.788 0.612 12 Sodium bicarbonate 0.470 13 Sodium chloride 0.320 14 Penicillin-G amidase enzyme (wet) 3.075 15 Acetic acid 0.155 0.15022875 0.005 16 Sodium Carbonate 0.251 17 Acticorbone Eno-PC 0.164 18 EDTA di sodium 0.002 19 Sodium hydrosulfite 0.031 20 Methyl alcohol 6.280 6.0916 0.188 21 Sulfuric acid 5% 9.100 22 Acetone 8.400 8.148 0.252 23 O-Acetyl ester 2.209 24 THF 7.749 7.51653 0.232 25 TEA 0.347 0.3364542 0.010 26 Potasium Carbonate 0.912 27 Ammonium Chloride 0.750 28 Potassium Acetate 2.260
2.5.13. Cefuroxime Axetil Amorphous Manufacturing Process Cefuroxime Axetil is a cephalosporin class of antibiotic used for the treatment of bacterial infection. It consist of four steps namely Hydroxilation, rearrangement, condensation followed by spray drying. Stage 1: 3-OH Cefuroxime Compound 7-ACA is hydrolysed with caustic solution at low temperature in water / methanol mixture. SMIA is activated with phosphorous penta chloride in MDC as solvent at low temperature. Condensation is carried out with hydrolysed 7-ACA and activated side chain at low temperature. 3-OH compound is isolated by adjusting its pH with dilute HCl to 2.0.
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Stage 2: Cefuroxime Acid Chlorosulphonyl iso cyanate (CSI) is added slowly in chilled solution of 3-OH compound in acetonitrile Reaction is quenched by addition of water. pH is adjusted to 2.1 with HCl. Clear solution is obtained. Clear solution is treated with activated carbon filtered of and crystallized with thehydrochloric acid for pH adjustment. Product is filtered, washed with chilled wash with acetone and dried.
Stage 3: Cefuroxime Acid to Cefuroxime Axetil Cefuroxime acid API starting material is reacted with 1-Acetoxy ethyl bromide in thepresence of sodium carbonate and Dimethylacetamide as a solvent medium. Thereafter, pH of the reaction mass is adjusted by using the 10% sodium bicarbonate solution to 6.0-6.5; this reaction mass is further extracted with the ethyl acetate and the entire material gets transferred in the solvent. Ethyl acetate layer is further subjected to charcolization using the activated charcoal (Norit) & treated with the EDTA & passed through the sparkler filter. Ethyl acetate layer is further recovered under vacuum and the residual reaction mass gets crystallized by addition of the methanol and cyclo hexane. The above crystallized mass is filtered to get the wet Cefuroxime Axetil (crystalline) which is dried to yield the material. Dry crystalline material is further dissolved in the Acetone and pumped in the atomizer of the spray drying unit which converts the Cefuroxime Axetil in to amorphous form. Chemical Reaction Stage-I: 7-ACA TO Cefuroxime Hydroxy
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Cefuroxime Hydroxy to Cefuroxime Acid.
Cefuroxime Acid to Cefuroxime Axetil
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Process Flow Diagram
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Material Balance for 01 MT Recovery & Consumption Sr. No. Raw Material MT Recycling (MT) (MT) 1 7-ACA 1 2 SMIA 0.778 3 PCl5 0.88 4 Sodium Hydroxide 0.6 5 Methylene Chloride 10 9.7 0.3 6 Di Methyl Acetamide 6.4 6.208 0.192 7 Methanol 6 5.82 0.18 8 Acetic acid 0.092 9 Hydro 0.04 Chlorosulfonyl isocyanate 10 (CSIC) 0.6 11 Acetonitrile 10.4 10.088 0.312 12 Carbon 0.28 13 HCl 1.2 14 Sodium Carbonate 0.165 15 1-AEB 0.78 16 Ethyl Acetate 21.5 20.855 0.645 17 Sodium Bi Carbonate 0.35 18 Soduium Chloride 0.25 19 Cyclohexane 17.5 16.975 0.525
2.6. R & D Products Development of API starts with based on innovators available information , literature i.e patents journals and papers search carried out to get the updated ,specification, process , consumption norms ,analytical methods etc, to evaluate the product quality while development u/progress. Hence Otsuka also proposed 2.5 MTPM for R&D products. Product / development initiate with the ROS i.e. route of synthesis extract of literature with the confirmation of intellectual property right departments endorsement to carry out the development for any unforeseen infringement in the future. After the confirmation of ROS, procurement of raw material activity comes into the force for necessary RM procurement including synthetic chemicals. The R&D will be having integrated, analytical, QA, QC, Regulatory and IPR support according to global regulatory requirements for Intermediate or API Development.
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2.7. Solvents Management System Otsuka has a well-defined Solvent Recovery system. The existing solvent recovery is 98 %. The solvents used for expansion of APIs are tabulated below (Table 2.3) all fresh solvents listed below will be stored in tank farm area in 10-20 KL tanks. Flame arrester & dyke wall with sufficient height, width, free board (equal to the volume of maximum capacity tank) and impervious floor. All storage tanks will be under negative pressure to avoid any leakage. Condenser with brine chilling shall be provided to minimize loses.
Table 2.5 List of Solvents used in Manufacturing Process Storage Area and Storage Sl. No. Name of the Raw Material Capacity Specifications 1. Methanol 20 KL SS-304 2. Toluene 10 KL SS-304 3. Acetone 20 KL SS-304 4. IPA 10 KL SS-304 5. Ethanol 5 KL SS-304 6. Cyclohexane 10 KL SS-304 ( jacketed) 7. n-Butyl acetate 20 KL SS-304 8. Ethyl acetate 20 Kl SS-304 9. Methylene Chloride 20 KL SS-304 ( jacketed) 10. Phenol 20 Kl SS-304 11. ` Anicyl alcohol 20 Kl SS-304 2.8. Solvent Recovery System Otsuka enhance its technology and for the expansion project the solvent recovery shall be possible upto 99.5% level. The recovery and recycling of solvents in the process is a key issue in achieving productivity and an edge in competitive world. Hence, all the solvent mixtures generated from different stages of the products will be fractionated in a state of the art solvent recovery system to give 98-99% recovery depending upon composition of solvent mixtures and their boiling point. Therefore, Expansion unit of Otsuka is planned 10 distillation columns with varying specification to take care of the all the spent solvents recovered from various stages of the production.The list of solvent recovered is given in Table 2.5 and Table: 2.6 shows the design details of distillation column.
Table 2.6 List of solvent recovered. S.NO Solvent % Recovery 1 Di methyl Formamide 99.5 2 Methanol 98.8 3 Iso Propyl alcohol 99.1 4 Methylene chloride 98.6 5 1,4 Dioxane 99.4
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Table 2.7 Details of distillation system. S. Specificat Colu Colu Colu Colu Colu Colum Colum Colu Colu Column-I No. ion mn-II mn-III mn-IV mn-V mn-VI n-VII n-VIII mn-IX mn-X SS- SS- SS- SS- SS- SS- SS- SS- 1 MOC SS-316 SS-316 316 904L 316 316 316 316 316 316 Column 8.8 17.0 8.8 9.5 14.4 10.0 9.0 12.0 2 8.0 mtr 8.5 mtr height mtr mtr mtr mtr mtr mtr mtr mtr Column 600 900 600 600 700 600 400 350 700 3 750 mm dia mm mm mm mm mm mm mm mm mm Kettle 7.0 10.0 Contin Contin 10.0 4 15.0 KL 2.5 KL 5.0 KL 6.0 KL 2.0 KL Cap. KL KL ue ue KL 54.4M 71.3M 22.2M 15 52.5 15 40 2 2+ 30 M2+ 10 M2+ Condense 60.5M + 2+ 2+ M2+ M2+ M2+ M2+ 5 2 r Cap. 11.3M 54.4M 5 M2 10 M2 5.1M2 5.1M2 10M2 10 M2 10 M2 15 M2 2 Product 6 NA NA NA NA NA NA NA NA NA NA cooler Reflux 7 50 ltr NA 200 ltr 200 ltr 200 ltr 200 ltr 500 ltr 200 ltr 200 ltr 500 ltr drum Cap. cap.- cap.- cap.- cap.- cap.- cap.- cap.-10 cap.- cap.-10 10 M3 10 M3 10 M3 10 M3 10 M3 10 M3 M3 / 10 M3 Reflux M3 / hrs, / hrs, / hrs, 8 NA / hrs, / hrs, / hrs, / hrs, hrs, / hrs, pump Head -25 Head Head Head - Head - Head - Head - Head - Head - mtr -25 -25 25 mtr 25 mtr 25 mtr 25 mtr 25 mtr 25 mtr mtr mtr Struct Struct Struct Struct Struct Structu Structu Struct Struct Structure ured ured ured ured ured red red ured ured 9 Packing d Packi Packin Packin Packi Packin Packin Packin Packin Packi Packing ng g g ng g g g g ng Packed 14.5 6.1 8.0 8.5 8.0 11.0 10 6.3 mtr 6.1mtr 7.5 mtr 9.0 mtr height mtr mtr mtr mtr mtr mtr
To minimise solvent losses during distillation following measurers will be adopted: • Chilled water of +5/+10°C will be circulated in condensers to condense the solvent vapours.
• Transfer of solvents to be done through pumps instead of manual handling.
• Vent condensers to be provided on all storage tanks.
2.9. Raw Material for APIs Manufacturing The raw materials used in manufacturing process, their quantity, source, storage capacity and mode of transportation are given in Table 2.5.
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Table 2.8 Raw Material Requirement Exisitng unit Sr. Raw Name of Domestic/ Storage capacity LD50 LC50 No. Materials Supplier import (MT/KL) 1 Dimethyl Balaji Domestic 20 2800 9400 1hr Formamid Amine mg/kg mouse e Ltd. (rat) 2 Domestic 20 Oral 5628 64000ppm GNFC, Methanol mg/kg( Bharuch Rat) 3 Deepak Domestic 10 3600 16000 8 Isopropyl Fertilizer mg/kg hrs Rat Alcohal Ltd. Mouse 4 S.R. F. Domestic 20 1600 52000 1hr Methylene Ltd., mg/kg Rat Chloride Bhiwadi, (rat) Raj. 5 Domestic 20 3000mg/k 44000 GNFC, Acetone g Mouse mg/m3/4hr Bharuch Mouse 6 Kairav Domestic 50 4200 37000 1-4 Chemical mg/kg mg/m3/2hr Dioxane s (rat) Mouse 7 Para Domestic 3000mg/k Anisyl Atul Ltd g Mouse Alcohol 8 NATIONA Domestic 40 2000mg/k 2000mg/m L g 4 hrs Rat PROXIDE Hydrogen LTD, Peroxide Guljag industtrie s ltd 9 Lords Domestic 120(60+60 Oral 900 1108 ppm Hydrochlor Chloro mg/kg mouse ic Acid Alkali (Rabbit) Limited 10 Liquid R K Domestic NA TWA 35 2000 4hr Ammonia Amoonia PPM STEL 11 India Domestic 30000mg 20000mg/k PEG 400 Glycol Ltd /kg(Rat) g(Rabbit) 12 Jublient Domestic 20 4200 4ml/kg Acetic Life mg/kg Anhydride Scuience (rat) 13 Ponepure Domestic NA 3310mg/k 106mg/l Acetic chemical g (rat) 24hr Fish Acid India Pvt Ltd 14 HSD Bharat Domestic 50 NA NA
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petrolium 15 Lords Domestic NA 390Ug/L 390Ug/L 96 Chloro hour Fish Chlorine Alkali Limited 16 Ammonia R K Domestic NA TWA 35 2000 4hr gas Amoonia PPM STEL 17 Hindian Domestic 3 3360 1200mg/m Sodium bi chemical, mg/kg 3/2hr Carbonate Ganpati (mouse) mouse chemical 18 Hindian Domestic NA 4090 2300mg/m Soda Ash chemical, mg/kg 3/2hr Light Ganpati (Rat) mouse chemical 19 2- SHENZH Export NA 1158mg/k >1270mg/ Mercaptob EN g (Rat) m3 enzothiazo WINHOP le Powder E 20 SHENZH Export NA NA NA EN Domestic Sodium WINHOP Benezene E , Sulfinate Aarti durgs ltd 21 Oxalic Domestic NA RADIANT 7500mg/k Acid INDUS g (Rat) 99.5% 22 CSPC ZHONG, THE UNITED Penicillin LABORA G TIES CO, 6257mg/k 382mg/kg Potassium YIILI Export 200 g Mouse guinea pig First CHUANI Crystal NG, NCPC HEBI HUMAPU N,China 23 Vishal 120 (60+60) Chemacal , 6600 2300mg/m Caustic Lords mg/kg 3/2hr Soda Lye Domestic Chloro Mouse mouse Alkali Limited 24 Caustic Guljag 273mg/K 50mg/24H Potash industtrie Domestic g Servere
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Flakes s ltd 25 Sodium Gulshan 2825mg/k bisulphite chemical Domestic g 26 Tetra Butyl NA NA Tatava Ammoniu Chantan Domestic m Bromide 27 Otsuka GCLE chemical Domestic 28 OM NA NA Fiber drum Packing Domestic
Table 2.9 Raw Material Requirement For Proposed Expansion Project r. Raw Materials Name of Supplier Domestic/im Stora LD50 LC50 N port ge o. capac ity (MT/K L) 1 7-Phenyl Otsuka Chemical Domestic 15 acetamido 3- (india) Pvt. Ltd. Chloromethyl cephalosporanic acid p-methoxy benzyl ester (GCLE) 2 Prenyl half ester ACS Dobfar Italy Import 5 (Ceftibuten side Chain) 3 Sodium Iodide Proto Chemicals Domestic 2 Oral 1000 1135 ppm Industries, Thane mg/kg (India) (Mouse) 4 Triphenyl SHANGHAI Import 3 Oral 700 phospine JINSHAN IMP.& mg/kg( EXP. CORP. LTD., Rat) China 5 Tetrahydrofuran SRF Limited, Dahej Domestic 20 Oral 3240 18000ppm mg/kg( Rat) 6 Sodium Lords Chloro Alkali Domestic 5 N A N A hydroxide Limited 7 4-Methyl – 5 Sanghai Trusttin Import 2 formyl thiazole Chemical Co., Ltd., Sanghai 8 Methanol GNFC, Bharuch Domestic 20 Oral 5628 64000ppm mg/kg( Rat) Kriscon Chemical, Import U.A.E. 9 Phenol A.B. Import 20 Oral 270
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Enterprises,Mumbai mg/kg( Mouse) 10 Tri fluoro acetic S.R. Chemical Domestic 2 Oral 200- 10mg/lit/2hr acid Specilities, Tarnaka, 400 mg/kg( Hydrabad Rat) 11 Ethyl acetate Laxmi Organic Import 20 Oral 4100 45000mg/m3 industries. Ltd. & mg/kg /3 hr( Mouse) imported (Mouse) 12 PenG-amidase Angene Chem Ltd. Import 5 13 HCL Lords Chloro Alkali Domestic 20 Oral 900 1108 ppm Limited mg/kg mouse (Rabbit) Sri Ram Vinayl Domestic 14 Sodium G.H. C. L. Ltd. Domestic 3 3360 Bicarbonate mg/kg (Mouse) Sorastra Chemical Domestic Tata Chemical Domestic 15 Sodium G.H. C. L. Ltd. Domestic 3 4090 1200mg/m3/ Carbonate mg/kg (rat) 2hr mouse Sorastra Chemical Domestic Tata Chemical Domestic 16 Sulfuric acid Shree Pushkar Domestic 5 2140mg/kg 320mg/m3/2 Chemicals & Mouse hr mouse Fertilisers Ltd., Ratnagiri Maharastra 17 Methylene S.R. F. Ltd., Domestic 20 1600 52000 1hr Chloride Bhiwadi, Raj. mg/kg (rat) Rat 18 Tri ethyl amine A.B. Enterprises, Domestic 2 460 mg/kg Mumbai (rat) 19 MEAM Not available 5 20 Acetone GNFC, Bharuch Domestic 20 3000mg/kg 44000 Mouse mg/m3/4hr Mouse 21 Sodium ethyl A.B. Enterprises, Domestic 5 4200 1400mg/kg hexanoate Mumbai mg/kg (rat) Mouse 22 Chloro methyl Jinan Rouse Import 2 N A pivalate Industry Co., Ltd. 23 Dimethyl Balaji Amine Ltd. Domestic 20 2800 9400 1hr Formamide mg/kg (rat) mouse Chemanol, Iran Import 24 Sodium Chloride V.M. Domestic 2 3000 42000mg/m3 Chemicals,Surendr mg/kg (rat) /1hr Rat anagar, Gujarat 25 Isopropyl ether Choice Domestic 5 8470 20000mg/kg Organochem Llp, mg/kg (rat) Rabbit Mumbai 26 Sodium meta bi Swastic Chemicals, Domestic 1 1131 sulphite Delhi mg/kg (rat)
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27 n-Butyl acetate Shandong S-Sailing Import 20 10768 2000 4hr Chemical Co., Ltd., mg/kg (rat) Rat China 28 Ethanol The Cresent Group, Import 5 3450mg/kg 39000mg/m3 Mumbai Mouse /4hr Mouse 29 cyclohexane Desmo Export Ltd. , Import 10 813mg/kg 70000 Navi Mumbai Mouse mg/m3/2H, Mouse 30 Mica Ester Chempure, Mumbai Import 5 6517mg/kg 73.55mg/Lit ,Rat 6hr Rat 31 Acetaldehyde Shree Ganesh Domestic 5 661 mg/kg 23000mg/m3 Chemicals, Mumbai Mouse /4 hrs Mouse 32 Ethyl K. Rasiklal Exim Pvt Import 3 270 mg/kg 72.5 ppm Chroformate Ltd., Mumbai Rat 4hrs Rat 33 N-methyl Raisa Jin Shanghai Import 0.1 1960mg/kg 25200mg/m3 Morpholine Daeyeon Chemicals Mouse 2hrs Mouset Co., Ltd. , Sanghai 34 Tri-methyl Chemcom Specility Domestic 1 5660mg/kg N A Chlorosilane Chemical Pvt. Ltd. Rat Vadodara 35 Sodium Bromide Aniket Enterprises, import/dome 1 3500mg/kg NA Mumbai stic Rat 36 Isopropyl Alcohal Deepak Fertilizer Domestic 10 3600 16000 8 hrs Ltd. mg/kg Rat Mouse 37 Dane salt Methyl Hangzhou Import 5 potassium APIChem Technology Co., Ltd., Hangzhou, Zhejiang, Chaina 38 Imidazole Ankita Chemical impot/domest 0.5 220mg/kg N A Corporatio, Mumbai ic Rat 39 Methane Ankita Chemical impot/domest 0.5 1429mg/kg Sulphonic Acid Corporatio, Mumbai ic Birds 40 Formaldehyde jai lakshmi Agro domestic 10 42 mg/kg 454000 chemicalis pvt ltd Mouse mg/m3 4 hrs Mouse 43 Methanol GNFC, Bharuch Domestic 20 Oral 5628 64000ppm mg/kg( Rat) Kriscon Chemical, Import U.A.E. 45 EHATA Not found 2 46 Acetic Anhydride Jubilant Life Domestic 2 1780 1000 4hr Rat Sciences Limited, mg/kg (rat) Noida 47 MerceptoBenzoth Sovereign Chemical Import 2 7000 1000mg/Lit iazole Disulphide Company,Akron, mg/kg (rat) Rat MBTS USA 48 Potassium Acid india, mumbai impot/domest 1 1870 N A
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Carbonate ic mg/kg (rat) 49 Methyl Isobutyl Global Chemicals domestic 10 20001 8000 ppm Ketone Inc. mg/kg Rat (Rabbit) 50 Pyridine Ankita Chemical impot/domest 2 891 mg/kg 28500 Corporatio, Mumbai ic Rat mg/m3 1 hrs rat 51 Phosphorus khetan chemical import/dome 2 660 mg/kg 205 mg/m3 penta chloride corporation,mumbai stic Rat Rat 52 DL malic Acid NANJING Import 5 1600 N A XIANGSHENGTAI mg/kg Rat INDUSTRY CO., LTD.,Nanjing, China 53 Acetonitrile Ankita Chemical impot/domest 20 269 mg/kg 7551 8 hr rat Corporatio, Mumbai ic Mouse 54 Aluminum Oswal Chemicals, import/dome 2 3805 5 8hr Humen chloride Ahmedabad/mumba stic mg/kg i mouse 55 Methane Ankita Chemical impot/domest 2 50mg/kg NA sulphonyl Corporatio, Mumbai ic Rat chloride 56 Diethly amine Kindly check the 2 540mg/kg 4000 ppm 4 product name, is Rat hr Rat this correct 57 Sodium Ankita Chemical impot/domest 2 160mg/kgs N A borohydride Corporatio, Mumbai ic rat 58 Bis trimethylsilyl K.Raj & import 5 1580mg/kg N A acetamide (BSA) Co.,Mumbai Rat 59 Chlorosulfonyl Xiamen Aeco Import 2 N A N A isocyanate Chemical Industrial Co., Ltd. China 60 Hydroxy Daming Changda Import 5 N A N A aminocephalospo Co., Ltd., Hendan rinic acid City, Hebai, China 61 Dicyclohexylamin Lok Chemicals pvt import 5 373mg/kg N A e ltd,Mumbai Rat 62 Chloro ethyl Atul ltd., Atul, Domestic 3 300mg/kg N A isopropyl Gujarat Rabbit carbonate 63 Crown ether Jiangyin Lanyu import 0.5 55mg/kg N A Chemical Co., Ltd., Rat Jiangsu, China 64 DBU(Diaza 2 N A N A bicycle undec.7 ene) 65 BATPA 3 N A N A (Cefcapene side N A N A chain)Butyloxy amino thiazole pentatonic acid
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66 SMIA –Furyl-2 4 N A N A methoxy imino acetic acid 68 Bromine Tata Chemical Guljag 20 2600mg/kg 750 1hr Industries Rat Mouse 69 Acetoxy Ethyl 2 1350mg/kg 8115 ppm 4 Bromide Rat hr Mouse 70 2-(5-Amino-1,2,4- 1 N A N A thiadiazol-3-yl)- 2(Z)- ethoxyiminoacetic acid 71 4-(4-pyridyl)-1,3- 1 N A N A thiazole-2-thiol 72 Diethyl ether 5 1215mg/kg 31000 0.5hr Rat Mouse 73 Isobutyl alcohol 10 2460mg/kg 3400mg/kg Rat Rabbit 74 Diisopropyl ether 5 8470mg/kg 20000mg/kg Rat Rabbit 75 Diisopropyl ethyl 5 N A N A amine
Details about the raw material and finished good storage area and specifications are given in Table 2.6.
Table 2.10 Raw Material and Finished Good Storage Area and its Specifications. S. No. Entity Place of Storage Specification of storage facility 1. Raw material Warehouse of capacity Temperature proof ceiling, adequate 500 SQM, Solid ventilation , double gate inward and chemical/ RM outward separately, emergency gate additionally cemented floored, equipped with iron racking system to store 200 mt raw materials at one time, All raw materials are stored at atmospheric temperature. Warehouse of capacity Temperature proof ceiling, double gate, 300 SQM for liquid emergency gate separately, equipped chemicals with iron racking system temperature control of 25 degree. 2. Solvent Tank farms consisting Explosive storage tanks are approved storage tanks of three tank storage by chief controller of explosive. All the area of 4000 SQM, tanks are fully equipped with fire equipped with 12 tanks controller equipments, earthling of capacity ranging monitors, & emergency arrangements. from 50 KL to 80 KL. 3. Special 300 SQM Temperature control at below 50C chemicals Storage 4. Finished One warehouse Temperature controlled, cemented product storage capacity of 25 floor. Equipped with iron racking
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storage facility tons. system, emergency gate with walk in cooler facility.
The chemicals shall be stored based on compatibility analysis. The warehouse for storage of chemicals will be constructed in RCC structure in solid walls and sufficient hard floor, which is impermeable to liquids. An impervious sill or low bund will be installed to prevent spillage in outer storage area. The warehouse will be well ventilated taking into account the products stored. It will be provided with flameproof electrical fittings and equipments. It will have two emergency doors on each floor for smooth escape in case of emergency. Organic solvents such as methylene chloride, acetone, toluene, methanol, ethyl acetate etc. which are highly flammable, in 10 – 20 KL tanks in tank farm area Storage area for hazardous chemicals will be isolated from the rest of the warehouse with impervious walls, floors and provision of safe disposal of spillages. The area will be provided with emergency showers and eye wash facility as well. Hazardous gases (Chlorine, ammonia and bromine) will be stored in a separate cage type shed. 2.10. Utilities 2.10.1. Water Requirement Existing unit require 725 KLD water for manufacturing of APIs and its intermediates which will be sourced from ground water. For expansion project during construction phase 24 KLD and during operation phase 75 KLD of fresh water will be required sourced from borewell at the site.
Table 2.11 :Water Consumption for Various Activities during Operation Phase
Sl. Expansin unit After Expansion Component Existing unit (KLD) No. (KLD) (KLD)
1 Process 40 26 66
Boiler and cooling 2 630 44 674 tower Drinking & 3 15 2.5 17.5 Sanitation
4 Green Belt 40 2.5 42.5
TOTAL 725 75 800 The water balance diagram during operation phase has been shown in Figure 2.3
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2.10.2. Fuel Steam coal will be used as fuel in the boiler and High-speed diesel (HSD) will be used in DG sets. Table 2.9 gives the fuel quantity and the source.
Table 2.12 : Fuel quantity and source Sl. Transportation Fuel Quantity Source Storage No. Mode Covered 1. Steam Coal 40 Tonnes/day Locally By road shed 20 Kl MS 2. Diesel 20 Kl/month Locally By road tank *Note: Dg Sets will be used only during Power failure. 2.10.3. Power Existing plant load is 7500 KVA which is sourced from JVVNL. For the proposed expansion the power requirement during construction phase is 125 KVA and during operation phase is 2 MW/ 2.5 MVA. The power supply shall be from Jaipur Vidyut Vitran Nigam Limited (JVVNL), In addition there is provision of DG sets for backup. The capacity of the DG set is 125 KVA during construction phase and 2.0 MVA during operational phase. 2.10.4. Employment During operational phase for the existing unit man power will be 550 persons, Now for the proposed expansion the during construction phase Otsuka will employ 54 persons and the manpower requirement during the operation phase will be 100. Otsuka will make sure to employ local labour to the extent possible. 2.11. Generation of Pollutants The generation of pollutants associated with the Otsuka during operation of APIs Unit can be in the form of liquid effluent, solid waste, hazardous waste, air emissions and noise pollution. 2.11.1. Sewage Treatment The 4KLD quantity of sewage will be generated during the operation phase of the proposed project. The sewage will be treated through activated sludge process along with the effluent in the ETP of 101 KLD capacity. 2.11.2. Effluent Treatment Plant Exiting unit based on ZLD concept, for the proposed expansion, separate ETP will be constructed to treat the effluents from the manufacturing of APIs and Domestic Sewage installed. The capacity of new ETP is 101 KLD. In aspect of the waste water management OCIPL proposing well developed waste water management system to meet the desire limits and norm for pollution control
EQMS India Pvt. Ltd. 93 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) board with reference to existing facility of ETP, MEE, MVRE/ RO & Incinerator, the salient feature are discussed below. ▪ Separation & segregation of effluent, generating from the process • HTDS Effluent • LTDS Effluent • Organic Solvent residue & MEE first fraction ▪ HTD Effluent will be treating through MEE, after the treatment MEE condensate goes to ETP for further treatment and MEE concentrate to ATFD ▪ LTD Effluent will be treating by ETP through the Primary, secondary and tertiary treatment and treated effluent will goes to MEE& ATFD ▪ The first fraction of MEE & organic solvent residue from the solvent recovery plant are treated through the Incinerator. ▪ Cooling Tower blow down which contain about 1800ppm TDS & Nil COD, this blow down water is used in horticulture ▪ Boiler Blow down which contains about 2200ppm TDS & Nil COD, this blow down water is mixed with the final treated effluent from ETP and used in horticulture. ETP Flow chart given on Figure:
EQMS India Pvt. Ltd. 94 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 2.11.3. 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. The detail of MEE to be utilized during operation phase is provided in Table 2.11 through Table 2.16. and the MEE diagram given in figure 2.46.
EQMS India Pvt. Ltd. 95 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 2.11.4. Hazardous Wastes and Management The hazardous waste is generated at various stages of the manufacturing activity. The mode of disposal is mentioned for each category of waste as per hazardous wastes (management, handling and trans boundary movement) rules, 2008. All above waste are will be collected and stored at separate identified place and suitably disposed off to authorized agencies. The quantity of hazardous wastes anticipated to be generated from the existing and expansion unit is given in Table 2.17
EQMS India Pvt. Ltd. 96 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Table 2.13 : Quantity of Hazardous Waste to be generated. Capacity (MT/Annum) Total Sr. Type of waste Category Proposed Proposed Facility No Existing expansion after Expansion 1 Chemical Sludge 34.3 75 24 99 Collection & from wastewater Storage to HW, Treatment (ETP Transportation, sludge+Waste left disposal at after Evaporation) authorized TSDF. 2 Concentration & 37.2 1500 250 1750 Collection & evaporation Storage to HW, Residue. Transportation, disposal at authorized TSDF. 3 Ash from 36.2 3 1 4 Incineration of Hazardous waste 4 Spent Solvents 5.1 2000 2000 ltr 4000 To Registered re- cycler 5 Discarded 33.3 200 nos 200 Containers/barrel/ liners/contaminate d with wastes/chemicals 6 Used filter cloth 35.1 NA 1 1 Collection & and filter material Storage to HW, Transportation, disposal at authorized TSDF. 7 Spent Carbon 35.3 NA 50 50 Collection & Storage to HW, Transportation, disposal at authorized TSDF. The hazardous waste will be incinerated in the incinerator to the extent possible. Non incinerated hazardous waste along with incinerator ash will be disposed off to TSDF site. Incinerator The design capacity of the proposed liquid incinerator facility for on-site thermal destruction of vapour, MEE residue and solvent recovery is given in the Table: 2.18 through Table 2.21.
EQMS India Pvt. Ltd. 97 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Table 2.14 Waste Characteristics Calorific Sl. Quantity Organics Waste Form Water % Value No. Kg/Hour % Kcal/Kg 1 Process Waste Liquid 65 Nil 100 % 5000 Aqueous Volatile 2 Liquid 150 98 2 % Nil Effluent Table 2.15 Operating Conditions Operating Time per Day 12 hr to 20 hrs Waste Charging Rate 500 ltr/hr Primary Chamber Temperature 800 0C Secondary Chamber Temperature 1200 0C Water Evaporation in Quencher/Scrubber 1400 kg/hr Table 2.16 : Incinerators Configuration Dual Chamber Composite Primary Chamber Volume 6 M3 Secondary Chamber Volume 5 M3 No. of Primary Burners 02 No. of Secondary Burners 02 Fuel FO Day Tank Capacity 10 KL Furnace Lining (Primary Chamber Refectory Furnace Lining (Secondary Chamber) Refectory Furnace Shell Refectory Oil Consumption during Heating 300 Ltr/hr Oil Consumption during Incineration NA Table 2.17 : Scrubbing System Flue Gas Quantity - Flue Gas Temperature 50 0C Quencher Liquid Water Quencher MOC MS/ SS 304 Spray Nozzle 50NB 2.11.5. Solid waste management The type and quantity of solid wastes, which are anticipated to be generated from the proposed project during construction and operation phase are tabulated in Table 2.22.
EQMS India Pvt. Ltd. 98 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Table 2.18 : Type and Quantity of Solid Waste to be Generated in the Construction and Operation Phases Sl. No. Type of Solid Waste Quantity Treatment/ Disposal Method Construction Phase 1 Construction waste It will be Debris will be used for internal (debris) minimal road laying purpose & landscaping Operation Phase 2 Empty barrels (used for 200 No./ Collected and sold to authorize non-hazardous Annum recyclers after cleaning. materials) 3 Scrap metals 20.0 MTPA Collected and sold to authorize recyclers. 4 Used / Spent oil 1500 To be incinerated & ash will be ltr/Annum sent to TSDF 2.12. Air Emissions Emission control will be through multi cyclone Separator with stack of 30 m height for boiler and scrubbers (water, acid or caustic) shall be installed for process emission from the plant and incinerator. The details of air emissions are provided in Table 2.16.
Table 2.19 : Details of Air Emissions S. No. Source of air emissions Type of Pollutant Considered DG Sets (4X 1500 KVA) and 2000 1. NO ,SO , HC, PM , PM , CO. KVA 2 2 2.5 10 Incinerator (HSD fired capacity 500 NO , SO , PM , PM , CO, TOC, HCl, 2. 2 2 2.5 10 ltr/hr) total dioxins and furans Boiler (Capacity of 10 TPH – for 3. PM , PM , NOx, SOx existing unit) 2.5 10 Boiler (Capacity of 10 TPH – for 4. PM , PM , NOx, SOx expansion unit) 2.5 10 Boiler (Capacity of 10 TPH – for 5 PM , PM , NOx, SOx expansion unit as Stand by. 2.5 10 HCl, Ammonia and some other 6 Process scrubbers. constituents
All process emission from the six 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 gven below:
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Table 2.20 : Stacks in the API Plant S. Stack Stack Ht./ Dia. Velocity Stack Emission Remarks No at sampling m/s Temp. 0C Flow Port (m) m3/hr 1. Incinerator 30 Height & 0.8 11.27 142 0C 15000 Flue gases from M Dia m/s M3/hr incinerator will be scrubbed in caustic scrubber before venting through stack 2. Boiler 50 M height &1.0 11.07 100 to 24000 Multi Cyclone Separator Mtr dia m/s 120 0C M3/hr
3. Process 7.25 M height & 0.294 50 194 M3/hr Scrubber 0.5 M dia m/s Set -I Process emission will be 4. Process 7.25 M height & 0.294 50 194 M3/hr scrubbed in caustic / Scrubber 0.5 M dia m/s water/acid scrubber Set –II before venting through 5. Process 7.25 M height & 0.294 50 194 M3/hr stack Scrubber 0.5 M dia m/s Set -III 6. Process 7.25 M height & 0.294 50 194 M3/hr Scrubber 0.5 M dia m/s Set –IV 7. Process 7.25 M height & 0.294 50 194 M3/hr Scrubber 0.5 M dia m/s Set –V 8. Process 7.25 M height & 0.294 50 194 M3/hr Scrubber 0.5 M dia m/s Set -VI Table 2.21 : Pollutant Concentration Pollutant Concentration S. Stack (g/s) No PM NOx SOX HCl HBr NH3 1. Incinerator 0.208 - 0.812 0.040 - - 2. Boiler 0.33 - 1.32 - - - 3. Process Scrubber Set –I 0.002 - 0.105 0.002 0.016 4. Process Scrubber Set –II 0.002 - 0.105 0.002 0.016 5. Process Scrubber Set –III 0.002 - 0.105 0.002 0.016 6. Process Scrubber Set –IV 0.002 - 0.105 0.002 0.016 7. Process Scrubber Set-V 0.002 - 0.105 0.002 0.016 8. Process Scrubber Set –VI 0.002 - 0.105 0.002 0.016 2.13. OHS System The existing plant of Otsuka has well-organized Safety Management system with well defined “Safety Health & Environment Policy”, “Quality Policy”, “Environment
EQMS India Pvt. Ltd. 100 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Policy” and “Occupational Health & Safety Policy” which are certified by external agency of international repute. Otsuka are committed to the principles of sustainable development. As a part of this commitment, Otsuka protect the environment in which they operate and ensure the health and safety of our employees, contractors, visitors and communities. All employees are responsible for being aware about safety, health and environment needs in their area of work. The proposed plant will also have these policies in place. The significance of safety & health in chemical industries has been a vital issue in achieving productivity and an edge in competitive world. Hence, all the pollution control measures envisaged at feasibility stage will be implemented with due care. The proposed plant will be designed as per guidelines comprising of separate entry & exit for workers and material. The layout of plants will be under purview of various statutory regulations and these regulations will be reviewed regularly. All reaction vessels will be connected with scrubber so that any toxic fumes/ vapour generated during reaction gets neutralized. The proposed plant will have Air Handling Units to keep temperature <25 deg in powder processing area and filtered air will be supplied in other areas. Dust collector will be provided in powder processing area to remove dust generated during sifting/ milling of product. Workers engaged in powder processing work will be provided personal protective equipments like dust masks, respirators etc The proposed plant will be provided with sophisticated instrumentation for continuously monitoring of operating parameters. The plant premises will be strictly maintained as a “NO SMOKING “area. Fire fighting facility will be provided at site consisting of underground fire hydrant system and various fire extinguishers. For electrical instrumentation and installations, the entire plant will be sub divided into hazardous and non hazardous zone. In the hazardous zone, flameproof fittings &fixtures will be provided. Arrangements will be made in each equipment to avoid static spark. All reaction vessels will be provided safety valve, rupture disc, pressure gauges etc to avoid any explosion. Provision for inert gas purging will be there in each reactor to avoid possibility of developing any hazardous mixture. The company will have On Site Emergency Plan to handle any emergencies e.g. fire, chemical spillage and medical arising from any unforeseen reason. Workers will be trained & make them aware regarding safety and proper hygiene in plant. All workers will undergo periodic medical examination and will be provided personal protective equipments for their safety. Major hazards can be avoided by proper implementation of Maintenance and Inspection Schedule, Periodic maintenance will be in place to check the various types of compressors, pumps, fan, and blowers and monitor the vibration level.
EQMS India Pvt. Ltd. 101 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Compliance of Statuary Regulations related to Factory act and IBR in which all boilers will be hydro tested all pressure vessels will be tested for ultrasonic thickness measurement and weld joint by radiography. All hot/cold surfaces will be insulated. Waste generated during process will be removed regularly. Proper housekeeping in maintenance block, utility block will be done so as to ensure that spillage of oil, litters of maintenance material are cleared off. 2.14. Project Cost and Cost towards Environmental Protection The total estimated cost of the proposed expansion project is approximately Rs 1,50,000 lacs (~ Rs 150 Crores), which include the cost of the land, internal development and construction cost, administrative cost and associated contingencies. 2.15. Existing CSR Firm is running a mini hospital, distribution of fluoride free RO water nearby vicinity. Amount of 48.62 lach have been incurred as a CSR. 2.16. Proposed CSR Plan
Proposed Activities Proposed Amount
Company propose an expense as per prescribed guidelines within 5 2.5% of Project Cost - Rs. years on ESR activities like RO water ( fluoride free) distribution in 375 Lacs close vicinity , toilet construction in nearby schools, Tree plantation , medical facilities in nearby villages, Scholarship to financial weeks students, sanitization under “swacha bharat abhiyan “, conservation of natural resources etc. ESR Cell under the direct control of Plant Head. The ESR Cell shall implement the CSR Plan by making a Consultative ESR Committee
EQMS India Pvt. Ltd. 102 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) CHAPTER 3. : Description of the Environment
This Chapter describes the baseline environmental conditions around the Otsuka Chemical India Pvt.ltd. (OCIPL)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.
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 publications; Forest Department and other Govt. Sources. The baseline environmental data generation has been done for the period of 15th March 2017 to 15th June 2017. M/s JP Test & research center, Sahibabad, Uttar Pradeshwith 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 Proposed unit of Otsuka India (OCIPL) is located in Notified industrial area developed by RIICO, proposed site is located at SP-3, 10 &11, Riico Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan). The site is well connected to State Highway-25 through internal roads of the Keshwana Rajpoot Industrial area. NH-8(Delhi-Jaipur highway) is passing about 1.3 km southeast of the proposed plant site. there is no rail connectivity within the 10 km study area. Nearest rail station is Bawal located about 48 km from site in northeast direction. Nearest airport is IGI airport Delhi which is located about 110 km (arial) from the project site.Road connectivity map is provided in Figure 3.1.
EQMS India Pvt. Ltd. 103 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) There is no settlement within the 500m area of the project site. Nearest settlement is Keshwana Gujjar village located about 1.3 km in northwest direction. other village located near to the site are Paniyala located about 1.2 km in southeast, Mordha village located about 3.3 km east, Goneda village about 2.2 km SW, Kaloohera village about 2.2 km SW and Kherki Mukkar village is located about 1.2 km in south direction. Haryana state boundary is located about 2.3 km from site in north direction. Sota nala is dry channel which is located about 0.7 km northwest of the project site. Sahibi river is also dry which is located about 4.8 km southeast of the project site. There are no areas protected under international conventions, nationalor local legislation for their ecological, landscape, culturalor other related value. There is no national park, wildlife sanctuary, biosphere reserve and wetland is present within the study area. Topo map showing site and surrounding environment features within the 10 km area is provided in Figure 3.2 and location map provided in Figure 3.3. 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 3.1 : Salient Environmental Features of Proposed Site S. Environmental Within 500 m Within 2 km Within 10 km area No. Features area around area around around project site project site project site 1 Ecological Environment A Presence of Wildlife None None None Sanctuary/ National Park/Biosphere Reserves B Reserved /Protected None None None Forests C Wetland of state and None None None national interest D Migratory route for None None None wild animals E Presence of None None None schedule-I Fauna G Critically polluted None within 10 km study area Area 2. Physical Environment H Road connectivity RIICO Industrial NH-8 (Delhi- NH-8 (Delhi-Jaipur area road Jaipur highway) highway) 1.3 km SE 1.3 km SE I Rail connectivity None None None
EQMS India Pvt. Ltd. 104 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) J Defence Installation None None None K Densely Populated None None Behror town ~10.0 Area km NE L Other village close to None within the 500m. plant site Keshwana Gujjar ~1.3 km NW, Paniyala ~1.2 km SE, Mordha ~3.3 km E, Goneda ~2.2 km SW, Kaloohera village ~2.2 km SW, and Kherki Mukkar village about ~1.2 km in S. M Topography Plain, elevation - Plain, elevation of site ranges ranges between 310 between 130 to to 600 amsl 136 amsl M Seismicity Seismic zone-III ( Moderate damage Zone) N Surface Water None Sotanala ~0.7 Sotanala ~0.7 km Resources km NW NW (Rivers) Sahibi river~4.8 km SE O Groundwater
P Soil and Land-use Sandy, landuse Sandy loam & Sandy, Sandy loam & is Industrial clay loam clay loam landuse landuse is agriculture and industrial, settlement agriculture and settlement 3. Social Environment S Physical Setting Industrial Rural and Industrial, Rural & Industrial Urban T Physical Sensitive None School, School, Hospitals, Receptors Hospitals, Temple etc. Temple etc. U Archaeological None None None Monuments
EQMS India Pvt. Ltd. 105 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
3.1.2. Primary Data Collection: Monitoring Plan and Quality Assurance Procedures Primary baeline data has been collected as per the TOR prescribed by MOEF during 15th March 2017 to 15th June 2017 for one complete season. The study period and methodology for primary data collection is summarised in Table 3.2.
Table 3.2 : Summary of Methodology for Primary/Secondary Baseline Data Collection No. Of Frequency/ Parameters sampling Remark season locations Ambient Air Quality AAQ monitoring was carried out at 8 Twice a locations (representing upwind, 8 locations Week downwind and sensitive locations). 24 PM (10), PM(2.5), SO2,Nox (Refer Fig. For Pre hours sampling at each location was NH3, CO, VOC, HF, HBr, No.3.5 ) monsoon carried out as per CPCB guide lines season (CPCB Gazette notification dated 18.11.2009 on AAQ). Meteorology Hourly for Met station was established close to Temperature, Humidity, Wind winter the site to record the site specific speed, Direction, Rainfall etc. One location season hourly met data. Ground Water Quality Ground water: Sampling was conducted at 8 locations. Samples
8 locations were preserved, transported and Physical, chemical and biological Once in a in study analysed for different parameters parameters as per IS 10,500 Pre monsoon area based on APHA methods. Temp, season (Fig 3.5) conductivity and pH which were measured intantely at site itself. Soil Texture, bulk density, pH, 6 locations in Once in Pre conductivity, cation exchange Soil samples were collected at six study area monsoon capacity, organic matter, Total locations within the study area and (Fig 3.5) season N,P,K, and Heavy metals etc analysed as per IARI method Noise Noise monitoring was conducted 8 locations in Once in Pre within the 10 km area of project site for Noise profiling for 24 hrs study area monsoon noise profiling for 24 hrs using (Fig 3.5) season integrated sound level meter, as per CPCB guidelines. Ecology (Flora & Fauna)
EQMS India Pvt. Ltd. 106 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) No. Of Frequency/ Parameters sampling Remark season locations Once Pre Primary survey and Secondary Flora & Fauna monsoon sources season Demography & Socio-economics Once Pre Demography & Socioeconomic - monsoon Primary survey/ Secondary sources season 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 accredited/recognized laboratory. Environment smapling Map is provided in Figure 3.5. Close view Map of Project site: Close view map of project site showing coordinates of four corners of the site is presented in Figure 3.4 3.2. Physical Enviroment 3.2.1. Topography The topography of proposed site is almost plain. The site elevation ranges between 132 to 136 amsl.The slope of the project site is towards south. The topography of the study area is almost plain but slightly undulating in northwestern and south eastern part where small hillocks are present within the study area. The average elevation in 10 km study area around the site ranges between 310-600 metres above mean sea level. The higher elevation is found in hillocks region i.e. located in northwestern and south eastern part of the study area. The slope of the site is slightly towards southwest and south direction. 3.2.2. Drainage Sota nala and Sahibi river are two dry river stretches present within the study area. Both the river are is an ephemeral, rain-fed river flowing through Rajasthan andHaryana. The drainage pattern of these rivers is dendritic in nature. During rainfed condition all the drainage of the study area is controlled by these thwo rivers. These west to north-west flowing rivers originate from the western slopes of Aravalli range in Rajasthan, flow through semi-arid historical Shekhawati region, drain into southern Haryana. 3.2.3. Geology & Hydrogeology Gneisses and schists of Bhilwara Super Group are the oldest rock types overlain byquartzites, schists, conglomerates, dolomitic limestone etc. belonging to Alwar and Ajabgarh Groups of Delhi Super Group along with granite, pegmatite and amphibolite intrusives of Post Delhi age. Hard rocks in major parts of the study area are covered by Quaternary fluvial and aeolian deposits mainly composed of sand, silt, clay, gravel and kankar. 3.2.4. Depth to Ground Water Table
EQMS India Pvt. Ltd. 107 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) The study area falls in Kothputli block of Jaipur District.During premonsoon period (May, 2011), depth to water level in Kotputli block varied from 20 mbgl to 40 mbgl and During postmonsoon period (November, 2011), depth to water level in Kotputli block varied from 10 mbgl to 40 mbgl(Refer Figure 3.8). 3.2.5. Ground water resources A total groundwater resource in Kotputli block is based on water level fluctuation method is estimated to be 53.0348 ham. Draft for all use is 95.5909 ham and over all stage of development is 200.27%. Kotputali block is categorized as over exploited catogory.
EQMS India Pvt. Ltd. 108 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
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 III (moderate risk zone) of seismicity. Thus lies among the moderate-risk earthquake areas. The seismicity map of study area shown in Figure 3.9.
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 propoject site is under agriculture. As per the land use based on satellite image, about 87% of the land is Agricultural land, 3%% of the land is under settlement, about 10% land is under Land with open shrub & grass water bodies and rest of the land is under other uses (Refer Figure 3.10 and Table 3.4). Table 3.3 : Land use of the Study Area Sl. No. Class Area(Sq km) Percentage (%) 1 Agricultural land 278.51 87 2 Settlement 9.94 3 3 Water body 0.01 00 4 Land with open shrub & grass 27.92 9 5 Vegetation 3.36 1 6 Barren Land 0.46 00 Total 320.02 100 Source: Satellite Image analysis
EQMS India Pvt. Ltd. 109 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Landuse pattern of Study Area Land with open shrub & grass Vegetation 9% Barren Land 1% 0% Water body 0%
Settlement 3%
Agricultural land 87%
EQMS India Pvt. Ltd. 110 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Source: Interpretation of Satellite image Figure 3.1 Land Use Map of the Study Area (10 km Radial Zone)
EQMS India Pvt. Ltd. 111 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Figure 3.2 Wind Rose Diagram
EQMS India Pvt. Ltd. 112 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 3.4. 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 3.8. Monitoring Location map is shown in Figure 3.5. The summary of Ambient Air quality results is presented in Table 3.9 and Table 3.10. Table 3.4 Ambient Air Quality Monitoring Locations Location Location Direction Terrain features Tentative Geo- Code wrt coordinates Plant site with approx. distance AAQ-1 Project Site - Project site, topography 27°48'21.32"N plain, industrial area 76°13'37.25"E AAQ-2 Gothari 2.4 Km, NW Rural, located in up wind 27°49'24.97"N direction with plain 76°12'44.43"E topography. AAQ-3 Keshwana 1.4 Km, N Rural, located in cross 27°49'6.29"N Gujjar wind direction with plain 76°13'46.08"E topography. AAQ-4 Paniyala 1.3 Km, SE Rural, located in down 27°47'48.45"N wind direction with plain 76°14'15.96"E topography. AAQ-5 Ukhlera 5.7 Km, SE Rural, located in down 27°46'3.65"N wind direction with plain 76°16'1.24"E topography. AAQ-6 Goneda 2.9 Km, SW Rural, located in cross 27°47'48.55"N, wind direction with plain 76°11'54.87"E topography. AAQ-7 Malpura 3.6 Km, NE Rural, located in cross 27°49'50.79"N wind direction with plain 76°15'2.15"E topography. AAQ-8 Mordha 3.5 Km,E Rural, located in down 27°48'32.24"N wind direction with plain 76°15'44.91"E topography.
Table 3.5 Ambient Air Quality Monitoring Results (24-hour average)
EQMS India Pvt. Ltd. 113 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
3 3 Location Location PM2.5 (g/m ) PM10 (g/m ) Code Min Max Mean 98 Min Max Mean 98 Percentile Percentil e AAQ-1 Project 22 44 32 43 54 90 72 88 Site AAQ-2 Gothari 19 37 26 35 44 77 63 76 AAQ-3 Keshwana 23 43 30 42 50 80 67 79 Gujjar AAQ-4 Paniyala 24 47 33 46 58 95 74 93 AAQ-5 Ukhlera 18 36 26 35 45 72 61 72 AAQ-6 Goneda 21 40 28 38 50 79 65 78 AAQ-7 Malpura 24 46 34 44 56 92 75 91 AAQ-8 Mordha 18 38 27 38 42 80 63 79 Source: Primery Data Collection and analysis during study period by Laboratory
Table 3.6 Ambient Air Quality Monitoring Results (24-hour average) 3 3 Location Location SO2(g/m ) NOx(g/m ) Code Min Max Mean 98 Min Max Mean 98 Percentile Percentile AAQ-1 Project Site 5.4 9.1 7.2 9.1 14.2 25.6 19.3 24.3 AAQ-2 Gothari 4.3 7.6 6.0 7.6 12.8 17.7 15.1 17.4 AAQ-3 Keshwana 4.8 8.2 6.5 8.1 12.2 19.3 15.5 18.7 Gujjar AAQ-4 Paniyala 5.6 9.4 7.1 9.2 13.3 23.5 18.1 23.4 AAQ-5 Ukhlera 4.4 7.9 6.3 7.7 11.7 16.8 14.0 16.6 AAQ-6 Goneda 4.7 8.3 6.6 8.2 11.5 18.0 15.2 17.9 AAQ-7 Malpura 5.0 8.8 6.9 8.6 14.5 24.8 17.1 22.6 AAQ-8 Mordha 4.7 8.2 6.4 8.1 10.4 16.8 13.9 16.6 Source: Primery Data Collection and analysis during study period by Laboratory
Table 3.10 continued…… Location Location NH₃ CO, VOC HF HBr Code (µg/m³) mg/m³ (8 (µg/m³) (µg/m³) (µg/m³) hrs. Conc.) AAQ-1 Project Site 19 0.26 <0.1 <0.1 <0.1 AAQ-2 Gothari 14 0.17 <0.1 <0.1 <0.1 AAQ-3 Keshwana Gujjar 15 0.21 <0.1 <0.1 <0.1
EQMS India Pvt. Ltd. 114 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
AAQ-4 Paniyala 18 0.27 <0.1 <0.1 <0.1 AAQ-5 Ukhlera 13 <0.1 <0.1 <0.1 <0.1 AAQ-6 Goneda 14 <0.1 <0.1 <0.1 <0.1 AAQ-7 Malpura 19 0.22 <0.1 <0.1 <0.1 AAQ-8 Mordha 13 <0.1 <0.1 <0.1 <0.1 Source: Primery Data Collection and analysis during study period by Laboratory
3.4.2. Observations on Ambient Air Quality: 3 Particulate Matter (PM10): The highest PM10 level were found at Paniyala (95 µg/m ) and 3 lowest PM10 level at Mortha (42 µg/m ) were observed at Project Site while the mean 3 conc. of all location ranges between 61-75 µg/m . The PM10 level in all the monitoring locations is within permissible limit i.e. NAAQMS level 100µg/m3
3 Particulate Matter (PM2.5):The highest PM2.5 level were found at Paniyala (47 µg/m ) and 3 lowest PM2.5 level were observed at Mortha and Ukhlera (18 µg/m ) while the mean conc. 3 of all location ranges between 26-34 µg/m . The PM2.5 level in all the monitoring locations is within permissible limit i.e. NAAQMS level 60µg/m3
Sulphur Dioxide (SO2): The highest SO2 level were found at Paniyala (9.4 µg/m3) and lowest SO2 level were observed also at Gothari (4.3 µg/m3) while the mean conc. of all location ranges between 6.0-7.2 µg/m3. The SO2 level in all the monitoring locations is within permissible limit i.e. NAAQMS level 80µg/m3
3 Oxides of Nitrogen (NOx): The highest NOx level were found at Project site (25.5 µg/m ) 3 and lowest NOx level were observed at MorthaVillage (10.4 µg/m ) while the mean conc. of all location ranges between 13.9-19.3 µg/m3. The NOx level in all monitoring location are under permissible limit i.e. NAAQMS level 80µg/m3
3 Other Parmeters: NH3 were found in the rage of 13 to 19 µg/m . The 8 hour concentration of CO was detected in the rage of .<01 to 0.36 mg/m3. VOC, HBr and 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. 3.5. 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 3.8. Location wise result for day time and night time is presented in Table 3.9. Table 3.7 Ambient Noise Quality Monitoring Locations S. Location Direction Category Tentative Geo- No. wrt coordinates Plant site with approx.
EQMS India Pvt. Ltd. 115 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) distance
N-1 Project Site - Industrial 27°48'21.32"N 76°13'37.25"E
N-2 Gothari 2.4 Km, NW Residential 27°49'24.97"N 76°12'44.43"E
N-3 Keshwana Gujjar 1.4 Km, N Residential 27°49'6.29"N 76°13'46.08"E
N-4 RIICO Keshwana 1.4 Km, NE Commercial 27°48'34.61"N Indusrial area road 76°14'29.96"E
N-5 Ukhlera 5.7 Km, SE Residential 27°46'3.65"N 76°16'1.24"E
N-6 Goneda 2.9 Km, SW Residential 27°47'48.55"N, 76°11'54.87"E
N-7 Malpura 3.6 Km, NE Residential 27°49'50.79"N 76°15'2.15"E
N-8 Mordha 3.5 Km,E Residential 27°48'32.24"N 76°15'44.91"E
Table 3.8 Ambient Noise Quality in the Study Area Locatio Location Present Day Time National Night National n Code Name Category Leq Standar Time Leq Standard dB(A) d Day dB(A) Night Time Time Leq dB(A) Leq dB(A)
N-1 Project Site Industrial 59.4 75.0 54.0 70.0
N-2 Gothari Residential 49.8 55.0 41.6 45.0
N-3 Keshwana Residential 53.5 55.0 42.3 45.0 Gujjar
N-4 RIICO Commercial 62.4 65.0 52.7 55.0 Keshwana Indusrial area
EQMS India Pvt. Ltd. 116 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) road
N-5 Ukhlera Residential 50.2 55.0 42.0 45.0
N-6 Goneda Residential 51.6 55.0 40.9 45.0
N-7 Malpura Residential 53.0 55.0 42.5 45.0
N-8 Mordha Residential 48.3 55.0 40.8 45.0
Source: Analysis during study period, EQMS
3.5.2. Observation on Ambient Noise Quality: The monitored levels were compared against the 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 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). 3.6. Water Quality 3.6.1. Ground Water Quality Eight ground water samples 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. The name of ground water sampling locations is presented in Table 3.14. The analysis results of groundwater are presented in Table 3.15 and Table 3.16. Table 3.9 Ground Water Sampling Locations Location Source Distance & Coordinates S. No. Direction from site Project Site Borewell GW1 - 27°48'21.32"N 76°13'37.25"E Gothari Borwell GW2 2.4 Km, NW 27°49'24.87"N 76°12'44.33"E Keshwana Borwell GW3 1.4 Km, N 27°49'6.25"N 76°13'46.05"E Gujjar
EQMS India Pvt. Ltd. 117 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Paniyala Handpump GW4 1.3 Km, SE 27°47'48.35"N 76°14'15.76"E Handpump GW5 Ukhlera 5.7 Km, SE 27°46'3.55"N 76°16'1.14"E Borwell GW6 Goneda 2.9 Km, SW 27°47'48.45"N, 76°11'54.67"E Borwell GW7 Malpura 3.6 Km, NE 27°49'50.69"N 76°15'2.05"E Borwell GW8 Mordha 3.5 Km,E 27°48'32.14"N 76°15'44.81"E
EQMS India Pvt. Ltd. 118 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Table 3.10 Ground Water Quality in the Study Area
S.N. Parameters GW1 GW2 GW3 GW4 Method Desired Limit /Permissible
Limit
1 pH Value 7.39 7.54 7.38 7.51 APHA-4500 6.5-8.5/No relaxation
2 Temperature 0C 25.2 25.3 25.5 24.9 IS:3025:Part -- 9
3 Conductivity, 1077 825 1305 1154 APHA-4500 -- mhos/cm
4 Turbidity )NTU( <1 <1 <1 <1 APHA- 1-5 2030B
5 Total Dissolved 668 512 809 715 APHA- 500/2000 solids mg/l 2540B
6 Total Suspended <2 <2 <2 <2 APHA- -- solids mg/l 2540D
7 Total Hardness as 284 162 338 206 APHA- 200/600 CaCO3 mg/l 2340C
8 Chloride as Cl 186 102 216 186 APHA- 250/1000 mg/l 4500B
9 Total Alkalinity 286 259 332 348 IS:3025:Part 200/600 mg/l -23
10 Sulphates as SO4 38 18 33 46 APHA- 200/400 mg/l 4500E
11 Nitrates as NO3 17 12 19 21 APHA-4500 45/No mg/l relaxation
12 Fluoride as F mg/l 1.0 0.94 1.42 1.12 APHA- 1/1.5 4500D
13 Iron as Fe mg/l 0.24 0.20 0.12 0.26 APHA- 0.3/No 3111B relaxation
EQMS India Pvt. Ltd. 119 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
14 Zinc as Zn mg/l 088 0.68 1.28 1.12 APHA- 5/15 3111B
15 Calcium as Ca 56.8 35 47 45 APHA- 75/200 mg/l 3500B
16 Magnesium as Mg 34.5 17.9 52.9 22.3 APHA- 30/100 mg/l 3500B
17 Sodium as Na 198 159 308 236 APHA-3500 -- mg/l
18 Potassium as K 3.6 3.2 4.0 3.8 APHA-3500 -- mg/l KB
19 Cadmium as Cd <0.01 <0.01 <0.01 <0.01 APHA- 0.003/No mg/l 3111B relaxation
20 Copper as Cu mg/l <0.01 <0.01 <0.01 <0.01 APHA- 0.05/1.5 3111B
21 Nickel as Ni mg/l <0.01 <0.01 <0.01 <0.01 APHA- 0.02/No 3111B relaxation
22 Lead as Pb mg/l 0.088 0.076 0.10 0.12 APHA- 0.01/No 3111B relaxation
23 Mercury as Hg <0.001 <0.001 <0.001 <0.001 APHA-3112 0.001/0.001 mg/l
24 Chromium )Total <0.05 <0.05 <0.05 <0.05 APHA- 0.5/No as Cr) mg/l 3111B relaxation
25 Arsenic as As mg/l <0.025 <0.025 <0.025 <0.025 APHA-3114 0.01/0.05
26 Phenolic <0.001 <0.001 <0.001 <0.001 IS:3025:Part 0.001/0.002 compound mg/l 43
27 Total coliform Nil Nil Nil APHA- Nil MPN/100ml 9230B
Source: Water Analysis during study period
EQMS India Pvt. Ltd. 120 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Table 3.11 Ground Water Quality in the Study Area
S.N. Parameters GW5 GW6 GW7 GW8 Method Desired Limit /Permissible
Limit
1 pH Value 7.71 7.66 7.36 7.43 APHA-4500 6.5-8.5/No relaxation
2 Temperature 0C 25.5 25.0 25.6 25.2 IS:3025:Part -- 9
3 Conductivity, 2120 1326 1315 2180 APHA-4500 -- mhos/cm
4 Turbidity (NTU) <1 <1 <1 <1 APHA- 1-5 2030B
5 Total Dissolved 1314 822 815 1352 APHA- 500/2000 solids mg/l 2540B
6 Total <2 <2 <2 <2 APHA- -- Suspended 2540D solids mg/l
7 Total Hardness 353 188 315 412 APHA- 200/600 as CaCO3 mg/l 2340C 8 Chloride as Cl 286 192 230 452 APHA- 250/1000 mg/l 4500B
9 Total Alkalinity 652 517 303 663 IS:3025:Part 200/600 mg/l -23
10 Sulphates as 72 48.2 28 75 APHA- 200/400 SO4 mg/l 4500E
11 Nitrates as NO3 97 23 23 57 APHA-4500 45/No mg/l relaxation
12 Fluoride as F 2.12 1.36 1.48 1.42 APHA- 1/1.5 mg/l 4500D
13 Iron as Fe mg/l 0.28 0.22 0.15 0.14 APHA- 0.3/No
EQMS India Pvt. Ltd. 121 EIA/EMP Report for Expansion of APIs and Bulk drugs Production Unit at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 3111B relaxation
14 Zinc as Zn mg/l 1.2 0.95 1.25 1.4 APHA- 5/15 15 Calcium as Ca 108 48.8 44 94 3111BAPHA- 75/200
mg/l 3500B
16 Magnesium as 19.9 16 49.2 42..3 APHA- 30/100 Mg mg/l 3500B
17 Sodium as Na 428 299 312 432 APHA-3500 -- mg/l
18 Potassium as K 4.6 4.0 4.2 4.9 APHA-3500 -- mg/l KB
19 Cadmium as Cd <0.01 <0.01 <0.01 <0.01 APHA- 0.003/No mg/l 3111B relaxation
20 Copper as Cu <0.01 <0.01 <0.01 <0.01 APHA- 0.05/1.5 mg/l 3111B
21 Nickel as Ni <0.01 <0.01 0.03 <0.01 APHA- 0.02/No mg/l 3111B relaxation
22 Lead as Pb 0.18 0.12 0.11 0.16 APHA- 0.01/No mg/l 3111B relaxation
23 Mercury as Hg <0.001 <0.001 <0.001 <0.001 APHA-3112 0.001/0.001 mg/l
24 Chromium <0.05 <0.05 <0.05 <0.05 APHA- 0.5/No (Total as Cr) 3111B relaxation mg/l
25 Arsenic as As <0.025 <0.025 <0.025 <0.025 APHA-3114 0.01/0.05 mg/l
26 Phenolic <0.001 <0.001 <0.001 <0.001 IS:3025:Part 0.001/0.002 compound mg/l 43
27 Total coliform Nil Nil Nil Nil APHA- Nil MPN/100ml 9230B
Source: Water Analysis during study period
EQMS India Pvt. Ltd. 122 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 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 7.36 to 7.71 in all locations, which is well within the specified standard of 6.5 to 8.5. The pH of the ground water is slightly basic in natue. ➢ Electric Conductivity levels vary from 825 to 2180 µmho/cm. Total dissolved solids ranges from 512 to 1352 µg/l which is found within the permissible limit. ➢ The total hardness is an important parameter of water quality. The hardness values in ground water of the study area ranges between 162 to 353 mg/l which is well within the permissible limit. The calcium and 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 102 to 452 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 desirable limit of Indian Standard IS: 10500-2012. Ovelall the ground water quality of the study area good and found within the drinking water standard. 3.6.2. Surface Water Quality Sota River and Sahibi Riverare the source of surface water in study area. Both the surface water bodies are an ephemeral, rain-fed rivers and remains watered during monsoon season. Bothe the surface water bodies were dry during the study period hence no surface water was collected. 3.7. Soil Quality Soils may be defined as a thin layer of earth's crust that serves as a natural medium for the growth of plants. It is the unconsolidated mineral matter that has been subjected to and influenced by genetic and environmental factors. Soils serve as a reservoir of nutrients for plants and crops and also provide mechanical anchorage and favorable tilts.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 soils are 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.
EQMS India Pvt. Ltd. 123 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 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. 3.7.1. General Characteristics of the Soil in the District The soil Profile of Jaipur district reveals that soils are grayish brown to brown and yellowish brown colored, light to medium textured and deep to very deep. These soils can be classified in Entisols order by 7th approximation classification. Some soils belong to Ardisols order. Jaipur region is covered with several soil units and also some other physical features such as sand dunes, rocky outcrops, water bodies etc., Sandy soil with severe erosion, salinity and shallow skeletal soils are major limiting factors affecting crop choice in the region. Soils of the Aravalli landscape are mainly derived from the argillaceous deposits composed of slates, phyllites and mica schist along with granite and quartzite. The Jaipur region represented as a traditional zone between the humid in the east and arid in the west. The Jaipur region area is specially spread with soil erodible nature and there are different type of soil erosion have been occurs. These soil erosion types2 are as (i) Gully Erosion (ii) Sheet Wash (iii) River Bank Erosion (iv) River Land Use Abstracted. Soils in the district may be classified as Loamy Sand to Sandy Loam, Sandy Clay Loam, Sandy Clay, Windblown Sand and River Sand.Soil Map of the district is presented as Figure: 3.13 and given as follows;
3.7.2. Cropping Pattern Cropping Pattern of Jaipur District for Kharif and Rabi season is presented in Table: 3.17 & 3.18 which are given as follows; Table 3.12 Area under Major Field Crops & Horticulture, 2007-08 (as per latest figures)3 Area (‘000 ha) Major Kharif Rabi Grand Cultivated Total Field Crops Irrigate Rain Tota Irrigate Rain Tota d fed l d fed l Summe r Pearl millet 21.8 273.9 295. nil nil nil nil 295.7 7 Kharif 0.0 84.5 84.5 “ “ “ “ 84.5 Pulses
2(Source-https://www.jaipurjda.org/pdf/MDP/Vol1.pdf)
3(Source-http://agricoop.nic.in/Agriculture%20contingency%20Plan/Rajasthan/RAJ1-Jaipur%203.2.2011.pdf)
EQMS India Pvt. Ltd. 124 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Groundnut 36.2 10.0 46.2 “ “ “ “ 46.2 Wheat nil nil nil 136.5 0.3 136. “ 136.8 8 Barley “ “ “ 51.3 0.3 51.6 “ 51.6 Gram “ “ “ 6.3 22.3 28.9 “ 28.9 Mustard “ “ “ 81.8 56.1 137. “ 137.9 9 Horticultural Crops-Fruits Mango 0.3 Guava 0.0 Ber 0.04 Aonla 0.04 Lime 0.1 Vegetables Tomato 3.1 Brinjal 1.9 Cucumber 0.06 Carrot 0.1 Pea 7.5 Radish 0.05
Table 3.13 Production and Productivity of major crops (Average of last 5 years: 2004-08)4 Name of crop Kharif Rabi Summer Total Prodn. Prod. Prodn. Prod. Prodn. Prod. Prodn. Prod. ('000 t) (kg/ha) ('000 t) (kg/ha) ('000 t) (kg/ha) ('000 t) (kg/ha) Major field crops (crops to be identified based on total acreage) 1.Pearl millet 385.5 1322 nil nil nil nil 385.5 1322 2.Kharif Pulses 36.6 451 nil nil nil nil 36.6 451 3.Groundnut 88.4 1851 nil nil nil nil 88.4 1851 4.Wheat nil nil 392.7 2724 nil nil 392.7 2724 5.Barley nil nil 113.1 2388 nil nil 113.1 2388 Others(Gram) nil nil 26.3 824 nil nil 26.3 824
4Source-http://agricoop.nic.in/Agriculture%20contingency%20Plan/Rajasthan/RAJ1-Jaipur%203.2.2011.pdf
EQMS India Pvt. Ltd. 125 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Major horticultural crops (crops to be identified based on total acreage) 1.Tomato nil nil nil nil nil nil 24.0 75893 2. Brinjal nil nil nil nil nil nil 2.4 12464 3.Cucumber nil nil nil nil nil nil 0.1 10490 4. Carrot nil nil nil nil nil nil 0.8 64444 5.Pea nil nil nil nil nil nil 17.8 23503 Others nil nil nil nil nil nil 0.2 39444 (Radish) Source-http://agricoop.nic.in/Agriculture%20contingency%20Plan/Rajasthan/RAJ1- Jaipur%203.2.2011.pdf
3.7.3. Methodology The soil samples were collected from Six (06) selected locations during the pre-monsoon season. The samples collected from all the locations were homogeneous representative of each location. At random five sub-locations were identified at each location and soil samples were collected from 5 to15-cm below the surface. It was uniformly mixed before homogenizing the soil samples. The samples about 500-gms were packed in polythene bags labeled in the field with location & number and sent to the laboratory for the analysis of physicochemical parameters. 3.7.4. Soil Sampling Locations Soil sampling was conducted once during the study period of pre-monsoon season. Six (06) soil samples were collected from selected locations in the vicinity of the proposed project. For studying soil quality 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 proposed project site are presented in Table 3.17. Table 3.14 Soil Sampling Locations Location Sampling Distance and Cordinates Code Locations Direction
S-1 Project Site - 27°48'21.32"N 76°13'37.25"E
S-2 Gothari 2.3 Km, NW 27°49'24.77"N 76°12'44.23"E
S-3 Keshwana 1.3 Km, N 27°50'12.88"N 76°14'17.90"E Rajput
S-4 Paniyala 1.3 Km, SE 27°47'48.25"N 76°14'15.66"E
EQMS India Pvt. Ltd. 126 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) S-5 Ukhlera 5.5 Km, SE 27°46'3.45"N 76°16'1.04"E
S-6 Goneda 2.7 Km, SW 27°47'48.35"N, 76°11'54.57"E
3.7.5. 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 project site. Physicochemical characteristics of soil are presented in Table 3.18.
EQMS India Pvt. Ltd. 127 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Table 3.15 Physicochemical Characteristics of Soil S. Project Gothari Keshwana Paniyala Ukhlera Goneda No. Parameters Unit Site (S-2) Rajput (S-4) (S-5) (S-6) (S-1) (S-3) Physical Characteristics 1 Color/ - Yellowish Yellowish Yellowish Yellowish Brownish Brownish Appearance Brown Brown Brown Brown 2 Texture USDA Sandy Sandy Sandy Sandy Sandy Clay Loam Loam Loam Loam i) Sand % 53 58 62 55 68 25 ii) Silt % 30 27 20 31 17 43 iii) Clay % 17 15 18 14 15 32 4 Porosity % 46.4 43.0 48.7 47.9 45.3 52.5 5 Bulk gm/cc 1.42 1.51 1.36 1.38 1.45 1.25 Density (BD) 6 Water % 28.5 29.6 30.9 30.5 28.6 32.8 Holding Capacity (WHC) 7. Permeability cm/hr 1.09 1.36 0.91 1.57 1.32 0.38 Chemical Characteristics 8. pH 20% Slurry 7.55 7.46 7.68 7.76 7.82 7.68 9. Conductivity µmhos/cm 242.8 280.6 292.5 266.2 275.4 285.9 (EC) 10. Organic % 0.78 0.85 0.69 0.66 0.72 0.62 Matter (OM) 11. Organic % 0.45 0.49 0.40 0.38 0.42 0.36 Carbon (OC) 12. Cation meq/100gm 10.8 12.5 10.2 11.6 9.8 19.2 Exchange Capacity (CEC) 13. Iron as Fe mg/kg 2.65 1.98 2.44 2.28 2.16 2.35 13. Zinc as Zn mg/kg 0.48 0.45 0.37 0.58 0.54 0.52 14. Copper as mg/kg 0.35 0.42 0.27 0.31 0.38 0.26 Cu 15. Manganese mg/kg 2.36 3.34 3.12 1.85 3.55 2.78 as Mn 16. Boron as B mg/kg <0.1 <0.1 <0.1 <0.1 <0.1 <0.1 Available Nutrients i) Nitrogen as kg/ha 274.5 282.8 248.4 256.2 246.7 264.6 N ii) Phosphorus kg/ha 18.5 17.8 19.4 16.6 14.6 15.5 as P
EQMS India Pvt. Ltd. 128 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) iii) Potassium kg/ha 144.5 157.8 149.5 168.2 157.6 136.8 as K 17. SAR % 1.44 1.45 1.55 1.38 1.36 1.51 Source: Primery Data Collection and analysis during study period by Laboratory
EQMS India Pvt. Ltd. 129 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 3.7.6. Observation on Soil Quality Physical property Soil Texture: The mineral components of soil are sand, silt and clay, and their relative proportions determine a soil's texture. Properties that are influenced by soil texture, include porosity, permeability, infiltration, shrink-swell, water-holding capacity, and susceptibility to erosion. The soil in which neither sand & silt nor clay predominates is called "loam". The mineral constituents of a loam soil might be 40% sand, 40% silt and the balance 20% clay by weight. Soil texture affects soil behavior, in particular its retention capacity for nutrients and water. Texturally the soils of study area are observed as Sandy, Sandy Loam & Clay Loam Soils. Bulk Density: Bulk density of soil relates to the combined volumes of the solids and pore spaces. Soil with a high pore space with loose solid particles will have lower bulk density than those that are more compact and have less pore space. This is directly related to the movement of air and water through soil thus affecting the productivity. The bulk density of the soils was found in the range of 1.25 to 1.51-gm/cm3. Water Holding Capacity: Water-holding capacity is usually defined as the amount of water that soil can hold. Soil that have fine particles are able to hold more water than coarse soils while rock fragments cannot hold any water and contribute negatively to soil water- holding capacity. The type and composition of soil are the controlling factors in this case. Water Holding Capacity of study area soils was observed as 28.5 to 32.8%. Permeability: Permeability is the measure of the ability of a soil to transmit water under a unit hydraulic gradient. For a particular soil, it represents its average water transmitting properties, which depends mainly on the number and the diameter of the pores present. The results show Permeability values were found to vary from 0.38 to 1.57-cm/hr under Sandy Loam textured soil in the study area. Chemical Property Soil Reaction Classes and Critical Limits for Macro & Micro Nutrients in Soil: According to According to Soil Survey Manual (IARI, 1970), the soils are grouped under different soil reaction classes viz; extremely acidic (pH<4.5), very strongly acidic (pH 4.5-5.0 ), strongly acidic (pH 5.1-5.5), moderately acidic (pH 5.6-6.0), slightly acidic (pH 6.1-6.5), neutral (pH 6.6-7.3), slightly alkaline (pH 7.4-7.8), moderately alkaline (pH 7.9-8.4), strongly alkaline (pH 8.5-9.0).The soils are rated as low (below 0.50 %), medium (0.50-0.75 %) and high (above 0.75 %) in case of organic carbon, low (<280-kg/ha), medium (280 to 560-kg/ha) and high (>560-kg/ha) in case of available Nitrogen, low (<10-kg/ha), medium (10 to 25- kg/ha) and high (>25-kg/ha) for available Phosphorus, low (<108-kg/ha), medium (108 to 280-kg/ha) and high (>280-kg/ha) for available Potassium and low (<10-mg/kg), medium (10-20-mg/kg) and high (>20-mg/kg) for available Sulphur (Singh et. al. 2004, Mehta et. al.1988). Critical limits of Fe, Mn, Zn, Cu and B, which separate deficient from non- deficient soils followed in India are, 4.5, 2.0, 0.5, 0.2 & 0.5-mg/kg respectively. (Follet & Lindsay-1970 and Berger & Truog-1940)
EQMS India Pvt. Ltd. 130 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Soil Reaction: Soil pH is an important soil property, which affects the availability of several plant nutrients. It is a measure of acidity and alkalinity and reflects the status of base saturation. The soil pH ranges from 7.46 to 7.82 thereby7 indicating the soils are slightly alkaline in nature. Organic Carbon: The effect of soil organic matter on soil properties is well recognized. Soil organic matter plays a vital role in supplying plant nutrients, cation exchange capacity, improving soil aggregation and hence water retention and soil biological activity. The Organic Carbon content of soil varied from 0.36 to 0.49 %( 0.62 to 0.85 % as Organic Matter) thereby implying that soils are low in organic content. Macronutrients Nutrients like nitrogen (N), phosphorus (P) and potassium (K) are considered as primary nutrients and sulphur (S) as secondary nutrient. These nutrients help in proper growth, development and yield differentiation of plants and are generally required by plants in large quantity. Available Nitrogen: Nitrogen is an integral component of many compounds including chlorophyll and enzyme essential for plant growth. It is an essential constituent for amino acids which is building blocks for plant tissue, cell nuclei and protoplasm. It encourages aboveground vegetative growth and deep green color to leaves. Deficiency of nitrogen decreases rate and extent of protein synthesis and results into stunted growth and develop chlorosis. Available nitrogen content in the surface soils ranges between 246.7 & 282.8-kg/ha, thereby indicating that soils are low in available nitrogen content. Available Phosphorus: Phosphorus is an important component of adenosine di-phosphate (ADP) and adenosine tri-phosphate (ATP), which involves in energy transformation in plant. It is essential component of deoxyribonucleic acid (DNA), the seat of genetic inheritance in plant and animal. Phosphorous take part in important functions like photosynthesis, nitrogen fixation, crop maturation, root development, strengthening straw in cereal crops etc. The availability of phosphorous is restricted under acidic and alkaline soil reaction mainly due to P-fixation. In acidic condition it gets fixed with aluminum and iron and in alkaline condition with calcium. Available phosphorus content ranges between 14.6 & 19.4-kg/ha, thereby indicating that soils are medium in available phosphorus. Available Potassium: Potassium is an activator of various enzymes responsible for plant processes like energy metabolism, starch synthesis, nitrate reduction and sugar degradation. It is extremely mobile in plant and help to regulate opening and closing of stomata in the leaves and uptake of water by root cells. It is important in grain formation and tuber development and encourages crop resistance for certain fungal and bacterial diseases. Available potassium content in these soils ranges between 136.8 & 168.2- kg/ha, thereby is indicating that the soils are medium in potassium content. Micronutrients Proper understanding of micronutrients availability in soils and extent of their deficiencies is the pre-requisite for efficient management of micronutrient fertilizer to sustain crop
EQMS India Pvt. Ltd. 131 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) productivity. Therefore, it is essential to know the micronutrients status of soil before introducing any type of land use. Available Manganese: Manganese is essential in photosynthesis and nitrogen transformations in plants. It activates decarboxylase, dehydrogenize, and oxides enzymes. The available manganese content in surface soils was recorded as 1.85 to 3.55-mg/kg as the critical limit of available manganese is 2.0-mg/kg. Available Zinc: Zinc plays role in protein synthesis, reproductive process of certain plants and in the formation of starch and some growth hormones. It promotes seed maturation and production. The available zinc in surface soils of the study area ranges from 0.37 to 0.58-mg/kg. As per the critical limit of available zinc as 0.5-mg/kg, most of the study area soils are with sufficient available zinc level in the vicinity of the project. Available Boron: Boron increases solubility and mobility of calcium in the plant and it act as regulator of K/Ca ratio in the plant. It is required for development of new meristematic tissue and also necessary for proper pollination, fruit and seed setting and translocation of sugar, starch and phosphorous etc. It has role in synthesis of amino acid and protein and regulates carbohydrate metabolism. The available boron content in the soils observed as <0.1-mg/kg. The critical limit for deficiency of the available boron is 0.5-mg/ kg 3.8. Biological Environment (Project Site And Zone Of 10 Km Radius) The Botanical and wildlife species in an area depend on the availability of suitable habitat for survival. Habitat loss and increasing habitat fragmentation are the primary causes of species decline in these environments. Present study has been carried out to inventorise the biodiversity existed in and around the study area and to evaluate the possible impacts on biodiversity during construction and operation phases of proposed Industrial Area. This section provides an overview of flora and fauna observed in study area during site visit. The baseline ecological surveys were carried out, based on various secondary sources (Forest Department Data, Scientific Studies etc.) which further validated from various primary surveys, and also through interviewing local people. Present biological studies were carried out in two zones: core zone (project area) and buffer zone (10 km surrounding the core area). 3.8.1. Flora Proposed plant unit is already located in RIICO industrial area. It is an industrial plot and already in possession of Otsuka. No trees were present within the proposed project site at the time of the allotment.Now Otsuka had developed a three tier dense greenbelt all along the peripheryof the proposed site. Most of the land around the study area (10 km radius around the project site) is under agriculture and residential uses. No national parks, wild life sanctuary, biosphere reserve is present within 10 km area of the project site. No Reserve Forest and protected forests are present within the study area. Because there is no forest in the study area and the vegetation is restricted along road side and other open areas along the agriculture feilds. Flora Core Zone: No major vegetation is present in the core zone. The vegetation is mainly in the form of plantation and restricted along road side. Trees species observed in
EQMS India Pvt. Ltd. 132 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) core zone include Acacia nilotica, Acacia arabica, Ailanthus excels, Ficus religiosa, Acacia catechu, Azadirachta indica, Magnolia champaca and Delbergia sissoo. The herbs and shrubs include Calotropis gigantea, Tribulus terrestris, Parthenium hysterophorus and Dhatura metel were observed in the core zone. Among the grasses species Cynodon dactylon and Saccharum munja observed in the core zone. Flora in Buffer Zone: The vegetation is meager in spite of the favorable environmental conditions. The general appearance of the vegetation is entirely dominated by one species i.e. Acacia nilotica. Its main associates are Prosopis cineraria, Acacia leucophloea, Ailanthus excels, Ficus religiosa, Azadirachta indica and Delbergia sisoo etc. Ground vegetation covered by dominant shrubs and herbs is Zyziphus mauritiana, Argemone mexicana, Solanum surattense, Xanthium strumarium, Ipomea cornia, Ipomea fistulosa, Dhatura metal, Calotropis procera, Sida cordifolia, Canabis sativa, Chenopodium album, Cyanodon dactylon, Parthenium hysterophorus, and Helienthus annum The comprehensive list of the plant species (tree, shrubs, herbs, climbers and grasses) observed in the study area is given Table 3.21. Table 3.16 List of Common Plant Species Present in Study Area Sr. No. Botanical Name Local Name Family A Trees 1. Acacia arabica Babul Mimosaceae 2. Acacia nilotica Babul Mimosaceae 3. Ailanthus excelsa Mahaneem Simarubaceae 4. Albizza lebbeek Siris Mimosaceae 5. Albizza procera Asfed siris Mimosaceae 6. Azadiracta indica Neem Meliaceae 7. Bauhinia varigata Kachnar Leguminoseae 8. Cassia fistula Amaltas Leguminoseae 9. Dalbergia latifolia Shisham Fabaceae 10. Dalbergia sissoo Sissoo Fabaceae 11. Delonix regia Gulmohar Caesalpiniaceae 12. Emblica officinalis Aonla Euphorbiaceae 13. Ficus bengalensis Bar Moraceae 14. Ficus glomarata Gular Moraceae 15. Ficus religiosa Pipal Moraceae 16. Prosopis Cineraria Vilayati babool Mimosacceae 17. Pongamia pinnata Venl Karanj Fabaceae 18. syzygium cumini Jamun Myrtaceae 19. Terminalia indica Imli Combretaceae 20. Terminalia arjuna Arjun Combretaceae 21. Zizyphus mauratiana Ber Rhamnaceae
EQMS India Pvt. Ltd. 133 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Sr. No. Botanical Name Local Name Family B Shrubs 1. Calotropis procera Ak Asclepediaceae 2. Murraya Koenigii Mithaneem Rutaceae 3. Ipomea spp. Besharm Convolvulaceae 4. Lantana camara Raimunia Verbenaceae 1. Nyctanthes arbortristis Harsingar Oleaceae 2. Sida cardifolia Mamas Malvaceae 3. Vitex negundo Nirgudi Verbenaceae 4. Dhatura metel Dhatura Solanaceae
C Herbs 5. Argemone Mexicana Pilikateri Papaveraceae 6. Cassia tora Puar Caesalpiniaceae 7. Chenopodium album Bathua Amaranthaceae 8. Euphorbia hirta Dudhi Euphorbiaceae 9. Indigofera caerulea - Fabaceae 10. Parthenium hysterophorus Gajarghas Asteraceae 11. Sida acuta Mahabala Malvaceae 12. Sida cordifolia Bala Malvaceae 13. Solanum surattense Bhatkataiya Solanaceae 14. Tridax procumbens Ghamra Asteraceae 15. Triumfetta pentandra - Tiliaceae 16. Vernonia cinerea Sahdevi Asteraceae 17. Xanthium strumarium Gokharu Solanaceae 18. Amaranthus spinosus Jangli cahulai Amaranthaceae D Grasses & other 1. Cenchrus ciliaris - Poaceae 2. Cenchrus satiger - Colubridae 3. Cynodon dactylon Dub Poaceae 4. Saccharum munja Munja Gramineae 5. Aristida funiculata Lapusari Poaceae
EQMS India Pvt. Ltd. 134 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Medicinal Plants: As no major vegetation is present in the study area however the medicinal plants are also observed in which Azadirachta indica and Emblica officinalis, are the common. Rare and Endangered Plant Species in the Study Area: In the study area, no rare and endangered plant species was observed (Source: Red Data Book of Indian Plants, N.P Nayar and A. P. K. Sastry, B.S.I. 1988). 3.8.2 Fauna Most of the land around the study area (10 km radius around the project site) is under agriculture and residential or commercial uses. No national parks, wild life sanctuary, biosphere reserve is present within 10 km area of the project site. No Reserve Forest and protected forests are present within the study area. The Sariska Tiger Reserve is located more than 20 km away from the site. The information on fauna was collected by visual observations, random survey at different locations and discussion with the local people. The secondary data from different Govt. Sources and available literature was also referred in this study. The fauna study is carried for core zone as well as for buffer zone i.e. 10 km area around the project site, which is describes in following sections. A. Fauna in Core zone: Proposed plant site is located in industrial area and already in possession of Otsuka. No tree cutting is required. No vegetation present within the core zone hence no wildlife exists within the core zone. However, the presence of commonly found reptiles and amphibian species has been reported by the local people. Common avifaunal species has also been observed in the core zone.
B. Fauna in Buffer Zone: Wildlife in the study area is restricted to commonly found mammal species this is mainly due to the urbanisation and industrialization of the area. List of fauna found in buffer zone (10 km study area) is provided in Table 3.3.
Mammals: No significant carnivorous and herbivorous wild animals are found in the area Blue bull (Boselaphus tragocamelus), Mongoose (Herpestes edwards) and Jungle Cat (Felis chaus) are the common mammals observed in the area. However, the presence of fox and hare has also been reported in the area by the local people during public consultation. List of mammals observed in the study area is provided in Table 3.3. Amphibian & Reptiles (Herpetofauna): Frog, Indian bull frog, snake like Indian cobra (Naja naja); Dhaman (Lycodonaulicus), and \lizard are encountered at various places in study area (refer Table 3.4). Table 3.17 Mammalian Fauna reported in study area S. No. Name Scientific Name Order Family Schedule 1. Common Herpestes edwardsi Carnivora Herpestidae II Mangoose 2. Felidae Felis chaus Carnivora Felidae II 3. Indian Hare Lepus nigricollis Lagomorpha Leporidae IV
EQMS India Pvt. Ltd. 135 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 4. Blue bull Boselaphus tragocamelus Cetartiodactyla Bovidae III 5. Five striped Funambulus pennanti Rodentia Sciuridae IV squirrel 6. Common Rattus rattus Rodentia Muridae IV House rat 7. Indian field Mus booduga Rodentia Muridae IV mouse 8. Common Presbytis entellus Primates Cercopithecidae II langur
Table 3.18 : Reptiles and Amphibian observed in Study Area
S. Common Vernacular Feeding Schedule Scientific Name Family N. Name Name Status Amphibians 1 Frog Rana tigrina - - C IV 2 Indian bull frog Hoplobatrachus - - C IV tigerinus Reptiles 3 Binocellate Naja naja Nag Elapidae C II cobra 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 Forest Lizard Calotes versicolor - Agamidae C II 8 House geeko Hemidactylis brukaii - Gekkonidae C II
Avifauna 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. Due to presence of the favorable habitats for avifauna, some of the resident avifauna observed in the study area. The list of avifauna observed in the study area is given in Table 3.5. Table 3.19 : Avifauna Sighted during the primary survey S. No. Name Scientific Name Order Family 1. Indian Ring Dove Streptopelia decaocto Columbiformes Columbidae 2. Rose-ringed Parakeet Psittacula Krameri Psittaciformes Psittacidae
EQMS India Pvt. Ltd. 136 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 3. Common Myna Acridotheres tristis Passeriformes Sturnidae 4. Short eared Owl Asio flammeus Strigiformes Strigidae 5. Little Green Bee-eater Merops orientalis Coraciiformes Meropidae 6. Weaver bird Ploceus philippinus Passeriformes Ploceidae 7. House crow Corvus splendens Passeriformes Corvidae 8. Common bulbul Pycnonotus barbatus Passeriformes Pycnonotidae 9. Indian Robin Saxicoloides fulicatus Passeriformes Muscicapidés 10. House sparrow Passer domesticus Passeridae Passeridae 11. Common Peafowl Pavo Cristatus Galliformes Phasianidae
12. Jungle babbler Turdoides striatus Passeriformes Leiothrichidae
13. Lapwing Vanellus duvaucelii Charadriiformes Charadriidae
14. Black Drongo Dicrurus macrocercus Passeriformes Dicruridae 15. Indian Rock pigeon Columba livia Columbiformes Columbidae
Threatened and Endangered Mammals: The listed fauna found in study area has been cross-checked with Red Data Book of Indian Animals (Zoological Survey of India). There is no endangered or Schedule-I faunal species present in the study area except Pavo cristatus which is a schedule-I species. The Indian Peafowl is categorized as ‘Least Concerned’ in the International Union for Conservation of Nature’s (IUCN) Red List. A least concern (LC) species is a species which has been categorized by the International Union for Conservation of Nature as evaluated but not qualified for any other category. As such they do not qualify as threatened, near threatened, or (before 2001) conservation dependent. 3.9. Socio-Economic Environment Demographic and Socio-Economic Features5 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 and Socio-Economic Features’ of the area, census data of 2011,forthe concerned District Jaipur, in Uttar Pradesh State was compiled and placed in the form of tabulation and graphical representation. As per the census records 2011 Jaipur district has a population of 6,663,971persons.The district has a population density of 598 inhabitants per square kilometre. Its population growth rate over the decade 2001-11 was recorded as 26.9%. Jaipur district has a sex ratio of 910 females for every 1000 males and a literacy rate of 76.4%. The sex ratio of Jaipur district is significantly lower than the state sex ratio recorded as 928 females for every 1000 males. The main language of Jaipur is Rajasthani, Dhundhari, Marwari, Hindi and English are also spoken in the city. Religion wise breakup of Jaipur district is given as follows
5 Source: Census 2011
EQMS India Pvt. Ltd. 137 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) . Religion in Jaipur District Religion Percent Hinduism 89.00 % Islam 7.00 % Jainism 3.00 % Christianity 0.47 % Buddhism 0.03 % Other Religions 0.53 % TOTAL 100%
Source-https://en.wikipedia.org/wiki/Jaipur_district
Population Distribution in the Study Area As per the census records 2011, the total population of the 10-km radius study area was recorded as 134916 persons of 56 revenue villages/towns of mainly three (03) districts namely Jaipur & Alwar of Rajasthan &Mahendergarh of Haryana state respectively. All study area revenue villages are under Six (06) tahsils namely Kotputli of Jaipur district, Behror, Mandawar, Kishangarh Bas & Bansur of Alwar district in Rajasthan and Narnaul of Mahendergarh District in Haryana. Total number of ‘Households’ was observed as 22550 in the study area. Male-female wise total population was recorded as 71044 males and 63872 females respectively. Caste-wise population distribution of the study area revenue villages/towns, is shown in Table 3.24 Table 3.20 Caste-wise Population Distribution of Study Area Villages Name No of Total Population Scheduled Scheduled Tahsil / Hous Castes Tribes District ehold Person Male Female Male Female Male Female s s Keshwana 67 425 235 190 12 10 4 1 Kotputli/ Gujar Jaipur Paniyala 712 4476 2381 2095 262 255 274 222 Kherki Mukkar 320 1969 1030 939 295 258 99 74 Ramgarh 197 1294 659 635 7 9 0 0 Hasanpura 88 518 268 250 64 63 0 0 Raikaranpura 426 2508 1368 1140 459 360 76 70 Bakhrana 319 1798 939 859 121 109 61 65 Amarpura 224 1435 759 676 44 47 0 0 Nangal 318 1863 957 906 140 135 59 44 Checheeka Gopalpura 558 3590 1929 1661 397 378 148 124 Karwas 298 1665 862 803 191 162 131 116 Banka 228 1691 862 829 77 84 46 47 Gonera 504 3626 1924 1702 449 380 70 56 Keshwana 355 1875 1007 868 360 316 16 13
EQMS India Pvt. Ltd. 138 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Rajput Malpura 318 1998 1054 944 228 194 55 46 Mordha 365 2439 1255 1184 335 326 6 2 Beenjahera 131 911 491 420 46 41 6 3 Shekhupur 152 838 413 425 50 58 0 0 Molahera 456 3254 1709 1545 126 131 66 57 Kherki 354 1999 1069 930 335 260 42 35 Veerbhan Kharkhari 191 1178 616 562 87 91 52 46 Ramsinghpura 350 2165 1157 1008 136 124 93 66 Ajeetpura 112 776 414 362 80 72 0 0 Khurd Navrangpura 208 1359 717 642 240 196 0 0 Chanchaki 106 711 376 335 22 17 0 0 Tapri 327 2016 1036 980 230 248 22 17 Barabas 350 2035 1047 988 122 108 174 165 (Rural) Sarbilandpura 89 518 271 247 0 0 24 30 Behror/ Taseeng 506 2708 1429 1279 419 362 5 9 Alwar Kharkhara 260 1458 771 687 108 102 0 0 Kankarchhaja 235 1346 703 643 76 91 0 0 Gadoj 580 3146 1673 1473 239 216 0 0 Nalota 155 938 501 437 56 45 0 1 Goonti 703 4055 2103 1952 526 455 274 258 Shyampur 104 693 356 337 63 60 0 0 Shimla 149 870 459 411 92 84 0 0 Mosampur @ 213 1520 804 716 96 85 0 0 Kankara Jainpurbas 666 4222 2210 2012 322 274 36 30 Pahari 630 4027 2174 1853 300 258 88 70 Behror (M) 5484 29531 1557 13961 2325 2141 515 425 0 Dhidhor 208 1297 718 579 4 3 0 0 Gothari 93 512 279 233 217 188 0 0 Kishang arh Bas/Alw ar Morodi 296 1737 907 830 193 195 9 6 Bansur/ Parsa Ka Bas 230 1302 664 638 111 102 0 0 Alwar Nangal Lakha 277 1860 980 880 258 250 0 0 Kothiya 245 1452 752 700 311 288 0 0 Ukhalhera 68 538 275 263 26 23 0 0 Babera 302 2047 1069 978 89 71 67 49
EQMS India Pvt. Ltd. 139 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Bhoori Doongri 39 213 122 91 0 0 0 0 Buteri 590 3385 1771 1614 209 196 78 73 Asrawas 276 1700 854 846 90 97 0 0 Narnaul Morund 309 2054 1066 988 101 98 0 0 / Rai Malikpur 258 1638 881 757 170 150 0 0 Mahend Budhwal 601 3220 1720 1500 327 290 0 0 ragarh Thanwas 712 5026 2657 2369 190 181 0 0 Amarpura 238 1491 771 720 212 203 0 0 TOTAL 22550 134916 7104 63872 1204 10940 2596 2220 4 5 Source-Census Records 2011
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 Jaipur& Alwar district of Rajasthan and Mahendergarh district of Haryana state respectively. The ‘Sex Ratio’ was observed as 909 females per 1000 males in the Jaipur District. The same was recorded as 899 females for every 1000 males in the study area. The child sex ratio of the district was observed as 858 female children per 1000 male children. The village wise male-female population distribution for the study area is depicted and shown by graphical representation in Figure 3.14.
Scheduled Caste & Scheduled Tribe Population On the basis of the village/town wise SC & ST population distribution of the study area during 2011, the ‘Scheduled Castes’ population was observed as 22985 persons consisting of 12045 males and 10940 females respectively in the study area which accounts as 17.0% to the total population (134916 persons) of the study area. ‘Scheduled Tribes’ population was observed too meagre as 4816 persons, accounting as 3.6% to the total population of the study area consisting of 2596 males and 2220 females. It implies that the rest 79.4% of the total population belongs to the General category. Male-female wise distribution of SC & ST population in the study area is graphically shown in Figure 3.15 & Figure 3.16 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 3.25. Total literates population was recorded as 84156 persons (62.4%) in the study area. Table
EQMS India Pvt. Ltd. 140 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 3.25reveals that Male-Female wise literates are observed as 52060 & 32096 persons respectively, implies that the ‘Literacy Rate’ is recorded as 62.4% with male-female wise percentages being 38.6% & 23.8% respectively. The total illiterate’s population was recorded as 50760 persons (37.6%) in the study area. Male-Female wise illiterates were 18984 (14.1%) and 31776 (23.6%) respectively. The Male-Female wise graphical representation of literates & illiterates population in study area villages/town is shown inFigure 3.17. Table 3.21 Male-female wise Literates & Illiterates Total Literates Illiterates Name of Village Population Persons Males Females Persons Males Females Keshwanagujar 425 216 156 60 209 79 130 Paniyala 4476 2464 1610 854 2012 771 1241 Kherki Mukkar 1969 1183 739 444 786 291 495 Ramgarh 1294 846 474 372 448 185 263 Hasanpura 518 322 193 129 196 75 121 Raikaranpura 2508 1667 1044 623 841 324 517 Bakhrana 1798 1118 691 427 680 248 432 Amarpura 1435 812 528 284 623 231 392 Nangal Checheeka 1863 1001 641 360 862 316 546 Gopalpura 3590 2157 1414 743 1433 515 918 Karwas 1665 1062 633 429 603 229 374 Banka 1691 1040 626 414 651 236 415 Gonera 3626 2059 1284 775 1567 640 927 Keshwana Rajput 1875 1171 733 438 704 274 430 Malpura 1998 1127 749 378 871 305 566 Mordha 2439 1408 903 505 1031 352 679 Beenjahera 911 586 355 231 325 136 189 Shekhupur 838 542 327 215 296 86 210 Molahera 3254 1825 1182 643 1429 527 902 Kherki Veerbhan 1999 1277 801 476 722 268 454 Kharkhari 1178 705 438 267 473 178 295 Ramsinghpura 2165 1365 883 482 800 274 526 Ajeetpura Khurd 776 474 277 197 302 137 165 Navrangpura 1359 697 468 229 662 249 413 Chanchaki 711 419 264 155 292 112 180 Tapri 2016 920 614 306 1096 422 674 Barabas (Rural) 2035 1268 788 480 767 259 508 Sarbilandpura 518 344 211 133 174 60 114 Taseeng 2708 1859 1117 742 849 312 537 Kharkhara 1458 999 626 373 459 145 314 Kankarchhaja 1346 896 551 345 450 152 298 Gadoj 3146 2186 1369 817 960 304 656 Nalota 938 515 342 173 423 159 264
EQMS India Pvt. Ltd. 141 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Goonti 4055 2689 1604 1085 1366 499 867 Shyampur 693 479 264 215 214 92 122 Shimla 870 509 312 197 361 147 214 Mosampur @ Kankara 1520 800 545 255 720 259 461 Jainpurbas 4222 2492 1563 929 1730 647 1083 Pahari 4027 2243 1519 724 1784 655 1129 Behror (M) 29531 21656 12462 9194 7875 3108 4767 Dhidhor 1297 700 485 215 597 233 364 Gothari 512 378 229 149 134 50 84 Morodi 1737 855 591 264 882 316 566 Parsa Ka Bas 1302 712 435 277 590 229 361 Nangal Lakha 1860 870 574 296 990 406 584 Kothiya 1452 933 562 371 519 190 329 Ukhalhera 538 251 158 93 287 117 170 Babera 2047 1065 692 373 982 377 605 Bhoori Doongri 213 94 71 23 119 51 68 Buteri 3385 1923 1222 701 1462 549 913 Asrawas 1700 954 606 348 746 248 498 Morund 2054 1214 760 454 840 306 534 Rai Malikpur 1638 928 633 295 710 248 462 Budhwal 3220 2081 1313 768 1139 407 732 Thanwas 5026 2827 1840 987 2199 817 1382 Amarpura 1491 973 589 384 518 182 336 TOTAL 134916 84156 52060 32096 50760 18984 31776 Source-Census Records 2011 3.9.2. 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 .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
The Economy of the Jaipur district is mainly dependant on other workers, accounting 60.8% to the total population of the district. In Jaipur district among the workers the
EQMS India Pvt. Ltd. 142 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) percentage of cultivators, agricultural labourers, workers in household industry and other workers (category of workers) are 30.2, 5.3, 3.7 and 60.8 percent respectively. The minerals found in the district are Quartz, Dolomite, Silica Sand, Soapstone, Limestone, China clay, Iron ore, Feldspar and Calcite
3.9.3. Workers Scenario ‘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. In the study area the Main and Marginal Workers population was observed as 43035 (31.9%) and 16956 (12.6%) respectively of the total population (134916) while the remaining 74925 (55.5%) 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 Table3.26&Figure 3.18respectively as follows
EQMS India Pvt. Ltd. 143 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Table 3.22 Village wise Occupational Pattern in the Study Area Name of Village MAIN MAI MAIN MAIN MAIN MAR MAR MA MAR MAR WOR N_C _AL_ _HH_ _OT_ GWO G_CL RG_ G_H G_O K_P L_P P P P RK_P _P AL_ H_P T_P P Keshwana Gujar 100 54 2 0 44 34 17 2 0 15 Paniyala 950 599 64 11 276 1256 702 444 10 100 Kherki Mukkar 489 211 2 8 268 254 15 10 1 228 Ramgarh 546 482 6 5 53 140 118 16 0 6 Hasanpura 221 174 39 0 8 24 24 0 0 0 Raikaranpura 709 471 56 5 177 293 43 73 3 174 Bakhrana 689 528 21 1 139 150 42 77 0 31 Amarpura 320 195 19 2 104 293 248 18 0 27 Nangal 436 310 36 16 74 376 181 189 0 6 Checheeka Gopalpura 779 410 64 8 297 404 207 23 8 166 Karwas 512 286 89 7 130 28 3 9 0 16 Banka 867 734 97 5 31 43 24 8 0 11 Gonera 864 532 171 9 152 761 450 186 6 119 Keshwana 480 216 110 0 154 304 155 144 1 4 Rajput Malpura 551 320 1 0 230 217 21 7 0 189 Mordha 877 607 67 27 176 238 22 172 2 42 Beenjahera 170 125 15 0 30 275 237 30 1 7 Shekhupur 305 183 11 8 103 36 33 0 0 3 Molahera 1261 975 16 11 259 563 430 104 5 24 Kherki Veerbhan 520 171 11 8 330 160 30 109 4 17 Kharkhari 470 281 32 0 157 63 14 27 0 22 Ramsinghpura 389 163 5 2 219 652 512 50 1 89 Ajeetpura Khurd 217 167 23 5 22 173 153 18 2 0 Navrangpura 428 201 24 2 201 196 99 50 1 46 Chanchaki 169 148 0 1 20 162 41 3 0 118 Tapri 831 521 268 0 42 143 1 2 2 138 Barabas (Rural) 837 441 99 1 296 128 0 78 0 50 Sarbilandpura 160 142 0 0 18 95 51 0 0 44 Taseeng 961 522 61 22 356 216 14 51 17 134 Kharkhara 780 523 109 0 148 96 76 12 0 8 Kankarchhaja 684 331 11 4 338 74 40 8 3 23 Gadoj 1466 1071 15 1 379 601 362 143 1 95 Nalota 526 489 11 8 18 16 11 2 1 2 Goonti 1508 990 62 15 441 296 83 88 1 124 Shyampur 352 226 0 1 125 51 7 21 1 22 Shimla 304 202 6 31 65 167 92 29 33 13 Mosampur @ 619 431 70 0 118 34 24 9 0 1 Kankara Jainpurbas 1861 1191 233 38 399 582 362 175 7 38 Pahari 1364 828 102 28 406 545 437 71 10 27
EQMS India Pvt. Ltd. 144 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Behror (M) 8462 981 247 354 6880 1477 401 250 107 719 Dhidhor 723 612 22 3 86 11 10 0 0 1 Gothari 153 62 41 0 50 57 39 15 0 3 Morodi 636 557 65 0 14 55 35 14 2 4 Parsa Ka Bas 530 333 138 3 56 364 280 69 0 15 Nangal Lakha 880 857 1 0 22 217 214 2 0 1 Kothiya 668 565 63 1 39 171 144 24 1 2 Ukhalhera 289 227 27 0 35 93 88 2 0 3 Babera 618 545 24 0 49 579 554 20 0 5 Bhoori Doongri 75 44 0 0 31 19 1 9 0 9 Buteri 1036 706 11 9 310 1122 1044 20 0 58 Asrawas 301 164 1 1 135 453 340 35 0 78 Morund 370 241 29 0 100 314 62 243 0 9 Rai Malikpur 432 185 48 2 197 329 183 122 2 22 Budhwal 713 465 39 16 193 683 383 178 5 117 Thanwas 1216 617 188 12 399 667 294 288 2 83 Amarpura 361 148 4 7 202 206 104 10 7 85 TOTAL 43035 2376 2976 698 1560 16956 9557 3759 247 3393 0 1 List of 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 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 2011)
Distribution of work participation rate of the study area population is shown in Table 3.27 as follows; Table 3.23 Distribution of Work Participation Rate Occupation Class 2011 Main Workers 43035 (31.9 %) Male 30150 (70.1 %) Female 12885 (29.9 %) Marginal Workers 16956 (12.6 %) Male 5155 (30.4 %) Female 11801 (69.6 %) Non-Workers 74925 (55.5 %) Male 35739 (47.7 %) Female 39186 (52.3 %)
EQMS India Pvt. Ltd. 145 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Total Population 134916 (Source: Census of India Records, 2011) Composition of Main Workers: The ‘Main Workers’ were observed as 43035 persons (31.9%) to the total population of the study area and its composition is made-up of Casual laborers as 23760 (55.2%), Agricultural laborers as 2976 (6.9%), Household workers 698 (1.6%) and other workers as 15601 (36.3%) respectively. Composition of Main workers is shown below as Figure 3.19. Composition of Marginal Workers: The total marginal workers are observed as 16956 which constitute 12.6% of the total population (134916) comprise of Marginal Casual Laborers as 9557 (56.4%), Marginal Agricultural Laborers as 3759 (22.2%), Marginal Household laborers as 247 (1.4%) and marginal other workers were also observed as 3393 (20.0%) of the total marginal workers respectively. Details about marginal workers in the study area are tabulated in Table 3.27. Composition of Marginal workers is shown in Figure 3.20 as follows.
Composition of Non-Workers: The total Non-workers population was observed as 74925 which constitute 55.5% to the total population (134916) of the study area. Male-female wise Non-workers population was recorded as 35739 Males (47.7%) and 39186 Females (52.3%) respectively. Details about total Non-workers of the study area with Graphical representation are compiled Table 3.28. Graphical representation of Non-workers population is shown in Figure 3.21 as follows; Table 3.24 Composition of Non-Workers Non-Workers Population Persons Males Females 74925 35739 (47.7%) 39186 (52.3%)
3.9.4. Basic Infrastructure Facilities Availability (as per the Census records of 2011) 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 2011. All the revenue villages of study area are mainly under Six (06) tahsils namely Kotputli (of Jaipur district), Behror, Mandawar, Kishangarh Bas and Bansur of Alwar district in Rajasthan and Narnaul of Mahendergarh District respectively in Haryana. 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 one town namely Behror (M). 3.9.5. Education Facilities As per the Census Records of India 2011, there are a total 56 revenue villages/towns of Jaipur & Alwar district of Rajasthan and Mahendergarh District of Haryana. All the revenue villages/towns are mainly under six (06) tahsils namely Kotputli (of Jaipur district),
EQMS India Pvt. Ltd. 146 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Behror, Mandawar, Kishangarh Bas and Bansur of Alwar district in Rajasthan and Narnaul of Mahendergarh District respectively in Haryana. There are about sixty six (66) Primary Schools existing in the revenue villages as rural part of the study area. Middle schools are thirty nine (39 no’s) in the rural part of the study area. Only twenty two (22 no’s) Higher Secondary Schools are available in the rural part of the study area. Senior Secondary School facility is available in eight (08) 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 fifty six (56) revenue villages/towns of the study area two (02) revenue villages namely Keshwana Gujar and Bhoori Doongri do not have primary school facility and children of these villages have to travel less than 5.0-km for their primary schooling. 3.9.6. Medical Facilities The medical facilities are provided by different agencies like Govt. & Private individuals and voluntary organizations in the study area. As per the district census handbook information of 2011, only one (01) community health centre (CHC) and six (06) primary health center (PHC) also exists in the study area; most of the study area villages depend upon the towns / district HQ of the study area having such facility. Sixteen (16) Primary Health Sub-centers (PHSC) are exists in the rural part of the study area. Mother & Child Welfare Centre / MCWC are available in twelve (12) revenue villages of the study area. Family welfare centre (FWC) exists only in one village namely Molahera of the study area. Hospital facility is available in nine (09) revenue villages of the study area rest of the villages are depending upon these villages for such type of medical facility. Medical dispensary facility was available only in three villages namely Goonti, Jainpurbas and Pahari. Overall study area villages are served by average medical facilities. Specialized medical facilities are available in towns and District Headquarter (HQ) only. 3.9.7. 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 80.4%) having Hand Pumps (HP) as potable water facility. Out of total fifty six (56) revenue villages/towns only eight (08) villages (14.3%) named Paniyala, Raikaranpura, Banka, Molahera, Kherki Veerbhan, Ramsinghpura, Nangal Lakha and Ukhalhera of Jaipurdistrictare served with River/Canal water as drinking water in the study area. As per the census records of 2011, about seventeen (17) villages (30.4%) are being served with Tank/Pond/Lake in the study area. In the majority of the villages, hand pumps are commonly observed in the study area. Good potable water facilities are available in the study area. There are a two dry river named Sota at 0.1-km in the West of the site and Sahibi River is passes at a distance of 4.43-km in SE direction to the proposed project site.
EQMS India Pvt. Ltd. 147 EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 3.9.8. Communication, Road, Transport Facilities Apart from Post &Telegraph (P & T) services, transport is the main communication linkage in the study area. Out of fifty six (56) villages /towns of the study area, only one (01) village named Jainpurbas is served with Post Office facilities in the study area, remaining villages are depending upon this villages and towns of the study area. The study area has good road network, passes from the area. National Highways No-8, 11 and 12 pass through the district. The national highway covers the district with a network of 453-kms in the year 2010-11. Jaipur district is connected by road to all the districts of the state. National Highway (NH-8) is 1.8-km away from the proposed site in the east direction to the proposed project site. Only one (01) village named Beenjahera 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 Alwar at about 47-km away from the proposed project site. Nearest town/city is Kotputli at about 3.00-km away from the project site. Jaipur Airport is about 128-kms away from the proposed site. The villages in the study area which do not have such facility can reach within 5 to 10-km range. Mainly four (04) towns named Kotputli, Behror, Alwar and Narnaul are available within the distance range of 01 to 43-kms from the villages of the study area. About 47% villages are served with Pucca road facility in the study area. There is a state boundary of Haryana at distance of 2.38-km, in the NW direction to the proposed project site 3.9.9. Banking Facility The study area has almost all the schedule commercial banks with ATM facility at urban areas and the district HQ. 3.9.10. Power Supply It is revealed from the compiled information on amenities availability as per the census record of 2011; twenty eight (28) villages (about 50%) are electrified for all purpose in the study area. Village/town wise ‘Basic infrastructure and amenities’ availability data for the entire study area is compiled and presented in Table 3.29 as follows;
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Table 3.25 Village wise Basic Amenities Availability in the Study Area Village Name Educational Medical Drinking Water Communication and Approach Power Nearest Town & Transport to Village Supply Distance, km P M SS S C PH P M H D F T W H T R Tk O P S P T M B R PR K FP E EA E E S H C H C W P W O P T e o S S R D g. C A S C S W C O O l. b C C . Keshwana Gujar 0 0 0 0 0 0 0 0 0 0 0 2 2 1 1 2 1 2 2 2 2 2 1 1 2 2 1 1 1 1 1 1 Kotputli, 12.0km Paniyala 3 1 1 0 0 0 1 1 1 0 0 1 1 1 1 1 2 2 2 1 2 1 1 2 2 1 1 1 1 1 1 1 Kotputli, 13.0km Kherki Mukkar 1 1 1 0 0 0 0 0 0 0 0 1 2 1 1 2 2 1 2 1 2 1 1 2 2 2 1 1 1 1 1 1 Kotputli, 11.0km Ramgarh 1 1 0 0 0 0 1 0 0 0 0 2 1 1 1 2 1 1 2 2 2 1 1 2 2 2 1 1 1 1 2 2 Kotputli, 20.0km Hasanpura 1 0 0 0 0 0 1 0 0 0 0 1 1 2 1 2 1 1 2 2 2 1 1 2 2 2 1 1 1 1 2 2 Kotputli, 15.0km Raikaranpura 1 1 1 0 0 0 1 1 0 0 0 1 1 1 1 1 2 2 2 1 2 1 1 2 2 1 1 1 1 1 2 2 Kotputli,15.0km Bakhrana 1 1 1 0 0 0 0 0 0 0 0 1 1 1 1 2 1 1 2 1 2 1 1 2 2 2 1 1 1 1 2 2 Kotputli, 15.0km Amarpura 1 1 0 0 0 0 0 0 0 0 0 2 1 1 1 2 2 2 2 2 2 1 1 2 2 2 1 1 1 1 1 1 Kotputli, 12.0km Nangal Checheeka 1 1 1 0 0 1 0 0 0 0 0 2 1 1 1 2 2 2 2 1 2 1 1 1 2 2 1 1 1 1 2 2 Kotputli, 12.0km Gopalpura 2 1 1 0 0 1 0 1 1 0 0 1 2 1 1 2 1 2 2 1 2 1 1 2 2 1 1 1 1 1 2 2 Kotputli, 6.0km Karwas 1 1 0 0 0 0 0 0 0 0 0 1 2 1 1 2 2 2 2 1 2 1 1 2 2 2 1 1 1 1 2 2 Kotputli, 10.0km Banka 1 1 0 0 0 0 0 0 0 0 0 2 2 1 1 1 2 2 2 1 2 1 1 2 2 2 1 1 1 1 2 2 Kotputli, 5.0km Gonera 1 1 1 1 1 1 0 1 1 0 0 1 1 1 1 2 2 1 2 1 2 1 1 1 2 1 1 1 1 1 2 2 Kotputli, 12.0km Keshwana Rajput 1 1 1 0 0 0 1 0 0 0 0 1 2 1 1 2 2 2 2 1 2 1 1 2 2 1 1 1 1 1 2 2 Kotputli, 17.0km Malpura 1 1 1 1 0 0 0 0 0 0 0 1 2 1 1 2 2 2 2 1 2 1 1 1 2 2 1 1 1 1 2 2 Kotputli, 14.0km Mordha 1 1 0 0 0 0 0 0 0 0 0 2 2 1 1 2 1 2 2 1 2 1 1 2 2 1 1 1 1 1 2 2 Kotputli, 14.0km Beenjahera 1 0 0 0 0 0 0 0 0 0 0 2 2 1 1 2 2 2 2 2 2 2 1 2 1 2 1 1 1 1 1 1 Kotputli, 13.0km Shekhupur 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 2 2 2 2 2 2 1 1 2 2 2 1 1 1 1 1 1 Kotputli, 5.0km Molahera 2 1 0 0 0 0 1 1 1 0 1 1 2 1 1 1 1 1 2 1 2 1 1 2 2 1 1 1 1 1 1 1 Kotputli, 5.0km Kherki Veerbhan 1 1 0 0 0 0 0 0 0 0 0 1 1 1 1 1 2 2 2 1 2 1 1 2 2 2 1 1 1 1 1 1 Kotputli,1.0km Kharkhari 1 0 0 0 0 0 0 0 0 0 0 2 2 1 1 2 2 2 2 2 2 1 1 2 2 2 1 1 1 2 2 2 Kotputli, 3.0km Ramsinghpura 2 1 1 1 0 0 0 0 0 0 0 2 2 1 1 1 1 1 2 1 2 1 1 2 2 1 1 1 1 1 1 1 Kotputli, 3.0km Ajeetpura Khurd 1 0 0 0 0 0 0 0 0 0 0 2 2 1 2 2 2 2 2 2 2 1 1 2 2 2 1 1 1 1 2 2 Kotputli, 12.0km
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Navrangpura 1 1 0 0 0 0 0 0 0 0 0 2 1 1 1 2 2 2 2 2 2 1 1 2 2 2 1 1 1 1 1 1 Kotputli, 3.0km Chanchaki 1 0 0 0 0 0 0 0 0 0 0 2 2 1 1 2 2 2 2 2 2 1 1 2 2 2 1 1 1 1 1 1 Kotputli, 3.0km Tapri 1 1 0 0 0 0 0 0 0 0 0 1 1 1 1 2 1 1 2 1 2 1 1 2 2 1 1 1 1 1 2 2 Kotputli, 5.0km Barabas (Rural) 1 1 1 1 0 1 0 0 0 0 0 2 2 1 1 2 1 1 2 1 2 1 1 2 2 1 1 1 1 1 2 2 Kotputli, 1.0km Amarpura 1 1 0 0 0 0 0 0 0 0 0 1 2 2 1 2 2 2 2 2 2 1 1 1 2 1 1 1 1 1 1 1 Narnaul Thanwas 3 1 1 0 0 0 1 0 0 0 0 1 2 2 1 2 2 2 2 1 2 1 1 1 2 1 1 1 1 1 1 1 Narnaul Asrawas 3 0 0 0 0 0 0 0 0 0 0 1 2 2 1 2 2 2 2 2 2 1 1 1 2 1 1 1 1 1 1 1 Narnaul Morund 1 1 1 0 0 0 0 0 0 0 0 1 2 2 1 2 2 2 2 2 2 1 1 1 2 1 1 1 1 1 1 1 Narnaul Rai Malikpur 1 1 0 0 0 0 0 0 0 0 0 1 2 2 1 2 2 2 2 2 2 1 1 1 2 1 1 1 1 1 1 1 Narnaul Budhwal 1 1 1 1 0 1 0 1 0 0 0 1 2 2 1 2 2 2 2 1 2 1 1 1 2 1 1 1 1 1 1 1 Narnaul Sarbilandpura 1 0 0 0 0 0 0 0 0 0 0 1 1 1 1 2 2 2 2 2 2 1 1 2 2 2 1 1 1 1 2 2 Behror, 3.0km Taseeng 1 1 1 1 0 1 1 1 0 0 0 1 1 2 1 2 1 1 2 1 2 1 1 1 2 1 1 1 1 1 2 2 Behror, 8.0km Kharkhara 1 1 0 0 0 0 0 0 0 0 0 1 2 1 1 2 1 1 2 2 2 1 1 1 2 2 1 1 1 1 1 1 Behror, 5.0km Kankarchhaja 1 1 0 0 0 0 0 0 0 0 0 1 1 1 1 2 2 2 2 1 2 1 1 2 2 2 1 1 1 1 2 2 Behror, 8.0km Gadoj 2 1 1 0 0 0 1 1 1 0 0 1 2 2 1 2 1 1 2 1 2 1 1 1 2 1 1 1 1 1 1 1 Behror, 10.0km Dhidhor 1 1 0 0 0 0 0 0 0 0 0 2 2 2 1 2 2 2 2 2 2 1 1 2 2 2 1 1 1 1 1 1 Behror, 15km Nalota 1 0 0 0 0 0 1 0 0 0 0 2 2 2 1 2 2 2 2 2 2 1 1 2 2 2 1 1 1 1 2 2 Behror, 8.0km Goonti 1 1 1 0 0 0 1 1 1 1 0 1 1 1 1 2 1 2 2 1 2 1 1 2 2 1 1 1 1 1 1 1 Behror, 5.0km Shyampur 1 0 0 0 0 0 0 0 0 0 0 2 2 1 1 2 1 2 2 2 2 1 1 2 2 2 1 1 1 1 1 1 Behror, 8.0km Shimla 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 2 1 1 2 2 2 1 1 2 2 2 1 1 1 1 1 1 Behror, 7.0km Mosampur @ Kankara 1 0 0 0 0 0 0 0 0 0 0 1 2 1 1 2 2 2 2 1 2 1 1 2 2 2 1 1 1 1 1 1 Behror, 9.0km Jainpurbas 3 1 1 1 0 0 1 1 1 1 0 1 1 1 1 2 2 2 1 1 1 1 1 2 2 1 1 1 1 1 1 1 Behror, 10.0km Pahari 2 1 1 1 0 0 1 1 1 1 0 1 1 1 1 2 2 1 2 1 2 1 1 2 2 1 1 1 1 1 1 1 Behror, 13.0km Behrod(M) Urban Area Gothari 1 0 0 0 0 0 1 0 0 0 0 2 2 1 1 2 2 2 2 2 2 1 1 2 2 2 1 1 1 1 2 2 Alwar, 43.0km Morodi 1 1 1 0 0 0 1 0 0 0 0 2 2 1 1 2 2 2 2 1 2 1 1 2 2 2 1 1 1 1 2 2 Behror, 12.0km Parsa Ka Bas 1 1 0 0 0 0 0 0 0 0 0 2 2 1 1 2 2 2 2 2 2 2 1 2 2 2 1 1 1 1 2 2 Kotputli, 16.0km Nangal Lakha 1 1 1 0 0 0 0 0 0 0 0 2 2 1 1 1 2 2 2 1 2 1 1 2 2 1 1 1 1 1 2 2 Kotputli, 13.0km Kothiya 1 1 0 0 0 0 0 0 0 0 0 2 2 1 1 2 2 2 2 2 2 1 1 2 2 2 1 1 1 1 2 2 Kotputli, 4.0km
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Ukhalhera 1 0 0 0 0 0 0 0 0 0 0 2 2 1 1 1 2 2 2 2 2 2 1 2 2 2 1 1 1 1 2 2 Kotputli, 9.0km Babera 1 1 0 0 0 0 0 0 0 0 0 2 2 1 1 2 2 1 2 1 2 1 1 2 2 1 1 1 1 1 1 1 Kotputli, 13.0km Bhoori Doongri 0 0 0 0 0 0 0 0 0 0 0 2 2 1 1 2 2 2 2 2 2 2 1 2 2 2 1 1 1 1 2 2 Kotputli, 12.0km Buteri 1 1 1 0 0 0 1 1 1 0 0 1 1 1 1 2 1 1 2 1 2 1 1 2 2 1 1 1 1 1 1 1 Kotputli, 10.0km 6 1 Total 6 39 22 8 1 6 6 12 9 3 1 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
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EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) CHAPTER 4. : Anticipated Environmental Impacts And Mitigation Measures
4.1. General In this chapter, we: • Identify project activities that could beneficially or adversely impact the environment • Predict and assess the environmental impacts of the such activities • Identify possible mitigation measures for these project activities and select the most appropriate mitigation measure, based on the reduction in significance achieved and practically in implementation For proper assessment of significance and magnitude of environmental changes due to construction and operational phases of the plant, the impacts are analyzed in the 10 km radius of study area around the proposed plant site for each environmental parameter. Impact assessment study for the existing unit is carried out by predicting net contribution of pollutants (qualitative as well as quantitative) on overall qualitative assessment of various environmental indicators. Prediction of impacts is an important component in environmental impact assessment process. Several techniques and methodologies are in vogue for predicting the impacts due to existing and proposed industrial development on physico -ecological and socio-economic components of environment. Such predictions delineate contribution in existing baseline data for the operational project and superimpose over the baseline (pre-project) status of environmental quality to derive the ultimate (post-project) scenario of the environmental conditions due to the proposed project. The quantitative prediction of impacts lead to delineation of suitable environmental management plan needed for implementation during the construction and operational phases of the proposed project in order to mitigate the adverse impacts on environmental quality. 4.2. Construction Phase The activities of proposed program will be confined to the project site within the boundary of Plant complex (Plant in RIICO Industrial Estate).The proposed project will not cause any significant loss of any important flora. 4.2.1. Air Environment The potential impact on air quality due to proposed project will be temporary rise in SPM and RSPM level likely to result from • Fugitive dust emissions at the construction site • Use of unpaved roads and truck tracks by the construction activities • Operation of the concrete, asphalt and hot mix plants These pollutants can affect the surrounding vegetation and nearby agricultural crops. Construction activity is limited only to the project site and hence unlikely to cause any
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EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) change in the ambient air quality around the proposed project. As the emission level is very low and intermittent, quantitative predictions are not possible due to limitations of the dispersion model. Therefore, considering all the air pollutants, it is not expected that air emissions due to construction will exceed air quality standards (NAAQMS). There might be some impact on air quality that may take place during construction, which would be caused by emission of dust during excavation as well as from the earth material stored at the site. The potential for dust in the form of particulate matter to be emitted during construction strongly depends on the type of activities taking place, such as the movements of vehicles, speed, soil stripping, excavation, back filling and reinstatement. Sprinkling water on the deposited earth material shall minimize emissions of particulate. The rate of emission of dust, its predicted rates of deposition and the temporary nature of the dust generating activities is expected to be well within acceptable limits. Also vehicles transporting earth and other construction material to the site will be covered to ensure their dust particles do not escape into the air. During construction all earth material will be kept covered to minimize impact on the ambient air quality. Traffic to the site during construction will be slightly more intensive than at present. However, well connectivity National Highway NH-8, will not have any significant stress on the traffic. The present road conditions are good for the proposed additional movement of vehicular traffic. Hence the impacts on the ambient air quality during construction phase will be temporarily for short duration and reversible in nature and restricted to small area. 4.2.2. Operation Phase 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, 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. 3. To assess the impact of air emissions from various continuous point sources, air dispersion modelling study has been conducted with the help of Industrial Source Complex Short Term Model (ISCST3) View 6.2 model of Lakes Environmental. Detailed description has been given in the following sub- sections: 4.2.3. Model Details 1. Air dispersion modelling can be used to predict atmospheric concentrations of
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particulate matter less than 10 microns (PM10), particulate matter less than 2.5
microns (PM2.5) and Hydrogen Bromide (HBr), Hydrochloric acid (HCl), Chlorine (Cl2) and many more concentration using ISCST3. 4. The options used for short-term computations are: 5. The plume rise is estimated by Briggs formulae, but the final rise is always limited to that of the mixing layer 6. Stack tip down-wash is not considered 7. Buoyancy induced dispersion is used to describe the increase in plume dispersion during the ascension phase 8. Calms processing routine is used by default 9. Wind profile exponents is used by default 10. Flat terrain is used for computation 11. Pollutants do not undergo any physico-chemical transformation 12. No pollutant removal by dry deposition 13. Universal Transverse Meter (UTM) coordinates have been used for computation A uniform polar grid was used for the computation and extended to 10 km from the center of the proposed project. In addition to that, receptors were also placed at the sampling locations 4.2.4. Predicted GLC due to Proposed Project The main sources of air pollution due to the operation of the plant are the Incinerator, Boiler and Process stack. The contribution to GLCs for the pollutants i.e. particulate
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EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) matter, SOx, NOx, HCl, HBr,NH3 etc. were predicted over the study area proposed project considering the worst scenario. The emission load from proposed project is given in Table below. 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. The additional contribution to GLC is also given below in Table 4.1. Table 4.1 : Stack Parameters and Emission Details of Proposed Project S. No Stack Stack Dia. (m) Velocity Stack Emission Ht. m/s Temp. Flow m3/hr 0C 1 Incinerator 30 0.8 11.27 142 0C 15000 M3/hr 2 Boiler 50 1.0 11.07 100 to 24000 M3/hr 120 0C 3 Process Scrubber 7.25 0.5 0.294 50 194 M3/hr Set -I 4 Process Scrubber 7.25 0.5 0.294 50 194 M3/hr Set –II 5 Process Scrubber 7.25 0.5 0.294 50 194 M3/hr Set -III 6 Process Scrubber 7.25 0.5 0.294 50 194 M3/hr Set –IV 7 Process Scrubber 7.25 0.5 0.294 50 194 M3/hr Set –V 8 Process Scrubber 7.25 0.5 0.294 50 194 M3/hr Set -VI S. No Stack Pollutant Concentration(g/s) PM NOx SOX HCl HBr NH3 1. Incinerator 0.208 - 0.812 0.040 - - 2. Boiler 0.33 - 1.32 - - - 3. Process Scrubber 0.002 - 0.105 0.002 0.016 Set –I 4. Process Scrubber 0.002 - 0.105 0.002 0.016 Set –II 5. Process Scrubber 0.002 - 0.105 0.002 0.016 Set –III 6. Process Scrubber 0.002 - 0.105 0.002 0.016 Set –IV 7. Process Scrubber 0.002 - 0.105 0.002 0.016 Set –V 8. Process Scrubber 0.002 - 0.105 0.002 0.016 Set –VI
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4.2.5. Meteorological Data The meteorological data consists of wind speed, direction, temperature, humidity, solar radiation, cloud cover and rainfall recorded during the months of mid-March, 2017, through mid-June, 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 ISCST3. 4.2.6. Receptor Locations A total of about 186 receptors – 180 receptors of which were generated with a polar grid from the centre of the proposed project and extended to 10 km. Apart from these receptors, the sampling locations were also taken into account to assess the incremental load on the baseline environmental scenario. 4.2.7. Summary of Predicted GLC’s The summary of maximum ground level concentrations (GLC) for the proposed project is listed in Table 4.3. Table 4.2 : Summary of Maximum 24-hour Incremental GLC due to the Proposed Project Stacks Maximum incremental GLC Distance Parameters Direction (µg/m³) (Km) PM 1.92 1.30 SE SO2 6.0 1.30 SE NOx 1.0 1.30 SE HCL 0.200 1.30 SE NH3 1.0 1.30 SE (Source: Modeling output results) Maximum 24 hourly average incremental in GLCs of PM, SO2, NOx; HCl,and NH3 due to proposed project during operation phase are predicted and given in Table 4.3. The isopleths of the pollutant concentration due to the impacts associated with the operation of the proposed project are shown in Figures 4.1 through 4.5 for PM, HCl, NH3, SO2 and NOx respectively. Contours of the incremental GLCs depict that the travel of emissions from the proposed project would be mainly in SE, quadrant. Besides the worst GLC (maximum) predictions the GLC incremental at the sensitive receptors (where the ambient air monitoring was carried out) was also predicted. The predicted incremental GLC for pollutants are given in underneath Table 4.4. Table 4.3 Ambient Air Quality Monitoring Results (24-hour average) Location PM(g/m3) Existing baseline Mean Incremental Net Incremental GLCs GLCs Project Site 72 0.10 72.10 Gothari 63 1.90 64.90 Keshwana Gujjar 67 0.50 67.50
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Table 4.4 Ambient Air Quality Monitoring Results (24-hour average) 3 3 Location SO2(g/m ) NOx(g/m ) Existing Incremental Net Existing Incremental Net baseline GLCs Incremental baseline GLCs Incremental Mean GLCs Mean GLCs Project 7.2 0.60 7.80 19.3 0.30 19.60 Site Gothari 6.0 1.0 7.00 15.1 1.0 16.10 Keshwana 6.5 1.0 7.50 15.5 1.0 15.60 Gujjar Paniyala 7.1 6.5 13.50 18.1 1.0 19.10 Ukhlera 6.3 1.0 7.40 14.0 1.0 14.10 Goneda 6.6 1.0 7.60 15.2 1.0 16.20 Malpura 6.9 00 6.90 17.1 00 17.10 Mordha 6.4 1.0 7.40 13.9 00 13.90
Table 4.5 Ambient Air Quality Monitoring Results Location NH₃ (µg/m³) Existing Incremental GLCs Net Incremental baseline Mean GLCs Project Site 19 0.10 19.10 Gothari 14 1.0 15.00 Keshwana Gujjar 15 0.30 15.30 Paniyala 18 1.0 19.00 Ukhlera 13 00 13.00 Goneda 14 0.70 14.70 Malpura 19 00 19.00 Mordha 13 00 13.00
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Discussion of the Cumulative Impacts at monitoring locations: The nearest settlement in downwind direction is Paniyala village (towards SE) at a distance of 1.30 km. As per baseline data of AAQ maximum GLC for PM at Paniyala village is 74 µg/m³ and with this proposed project, 1.90 µg/m³ rise in GLCs so PM level will be 75.90 µg/m³. The Particulate Matter in the study area is contributed mainly by commercial activities and traffic movement (vehicular emissions), re-suspended dust from paved and unpaved roads and open uncovered areas as well as from industrial activities. Maximum baseline GLC for SO2 (Process and utilities) at downwind direction (SE) was as 7.10 µg/m³ observed at Paniyala village. With thisproposed project SOx level may increase by 6.5 µg/m³ so post project level of SOx is 13.50µg/m³. Maximum baseline GLC for NOx was as 18.70 µg/m³ observed at Paniyala village and project site. With thisproposed project NOx concentration is 1.0 µg/m³ so rise in GLC of NOx concentration is 19.10 µg/m³. It can be concluded that with the proposed project all the AAQ parameters will remain within the NAAQ norms. As is evident from the table and discussion above, there will be no adverse impacts on the surrounding area (all pollutants post project GLC will be well within NAAQ norms except PM which is already high due to natural and other commercial and traffic causes). Highly efficient air pollution control systems have been adopted to mitigate particulate matter as well as gaseous emissions in the ambient environment. 4.3. Noise Environment 4.3.1. Construction Phase During construction phase, there will be noise generation due to use of bulldozers, JCB, vehicle movement, vibrators, heavy fabrication work for erecting major plant equipment including crane, hydra etc. The ear plug/ear muffs will be provided to the Workers and use shall be ensured. 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 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. It is, therefore, expected that noise level at the plant boundary will be within the prescribed
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EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 2.10. Site Preparation leading to Change in Land Use During Construction phase During the entire construction, domestic waste and sewage from labour camps in the nearby villages would also cause land degradation. It seems in this project the workers can be tapped from nearby village so there will be no issue of domestic waste and sewage from labour camps. During Operation Phase The storage and handling of raw materials shall be done properly to prevent any spillage. The hazardous waste generated during the operation phase, will properly disposed so that there is no spill and contamination of land. The hazardous waste will be sent for disposal to authorized TSDF, incinerator, co-processing, etc. on regular basis. 4.6. 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 Likely Impacts on Impact Mitigation Type Description Ecology and Consequence - measures Biodiversity (EB) Probability Description / Justification Pre Construction Stage Impacts Removal of site • site specific loss • As the site is an Otsuka has Short term vegetation like of common floral industrial plot already developed herbs, shrubs and diversity already a dense greenbelt / grasses developed. all around the • No vegetation is project premises. present except few grasses. • No threat of loss of faunal diversity as no faunal species reported at site. Construction Stage Impacts Dust and Noise Dust settlement on No endangered Subject to periodic Short term Generation due to vegetation fauna reported form monitoring and movement Disturbance to the site as well as in surveillance. of JCBs, other faunal species is study area. Water sprinkling machinery, and surroundings The species for Dust other construction reported from suppression. activities project site and Construction buffer zone are activities shall be
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EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) common / generalist restricted in night species and not time. very sensitive to the routine activities, so there will be no threat of facing disturbance. Operation Stage Impact Emission of PM, Impact on Though the Operation subject Long term SO2, NOx and HBr surrounding emission levels of to management by (insignificant) due to operation vegetation and all pollutants will be operational (Indirect impact on associated kept within controls. Emission crops, trees and biodiversity. permissible limits. levels of all shrubs of vicinity APCD shall be used pollutants will be due to to control dust kept contamination of emissions from within permissible ambient air, dust various sections of levels through emission, vehicular plant. various exhaust) Modeling studies engineering control Noise Generation proves that the measures. (Disturbance to incremental air However, green sensitive pollution will not belt development terrestrial fauna violate the air with suitable due to quality standards. species will help to noise pollution) Proposed plant is mitigate likely zero liquid cumulative discharge basis so impacts. no waste water will be discharged. Greenery development has been already started. Such measures will be adequate to protect the noise and air pollution impacts.
Construction Stage Impacts 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. 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 and greenbelt development. 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
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EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Proposed project will generate employment opportunities some through direct employment and more so indirectly through services for the plant. Proposed project will have some impacts also on socio – economic environment of the study area- some are as given below: • Proposed project of the plant would result in handling of more product and raw material, which will increase manpower requirement at some stages directly, or indirectly resulting in more income of people. • Proposed project would increase requirement from ancillary and auxiliary industries in the vicinity. • With more load on infrastructure facilities – roads and rails; these facilities would need improvement. • More income to Government through more taxes on higher amount of production. 4.8. Infrastructure The raw material (solid, liquid and also gaseous etc.) will be transported from suppliers Approximately 2 to 3 trucks/ day will come to the plant. The final product (APIs/intermediate) will be dispatched from plant to various parts of the country through the State and National high way and railways, for which nearly 14 to 15 small vehicles will be used for the same. Based on the estimation, approximately 2-3vehicles per day will remain at the project site. Hence, due to the project activities the increase in the vehicular traffic density in the study area will be neglisible. However, adequate parking facility provided the project site along with rest room and canteen facilities within the premises of the factory for drivers will be provided. The project site is only about 1.27 km away fromNational Highway (NH-8), Hence, this marginal increase in the traffic, will not affect the road infrastructure of the study area.
4.9. Proposed Project Impact Matrix An attempt has been to analyse and prepare an impact matrix considering major projectactivities (generic operations) and stage-specific likely impacts which is given in Table 4.6.The impact matrix considered a set of components and phase-specific project activities for determination of likely impacts.The analysis shows that during construction stage total adverse impacts are estimated to be –40 which are reduced to –13 with proper implementation EMP. During operation stage likely impacts are estimated to be ‘+1’ which after implementation of EMP are likely to be “+15”.
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Table 4.1: (A) Evaluation of Environmental Impacts during Construction Phase Without EMP Loading & Solid waste Liquid Gaseous Service waste Total Parameters Excavation Accidents Transport disposal effluent Emissions Facilities recycling score Land Use Soil erosion -2 -1 -3 Existing landuse -2 -2 -1 -5 Sensitive area- like mountains, sanctuaries, Monuments etc Aesthetic beauty -1 -2 -3 Water Surface Suspended solid -2 -2 Effect of Aquatic life Ground water Quality -2 -2 -4 Air Dust -3 -2 -2 -7 Emissions of -3 -3 -6 gases (NOx, SOx, CO) Noise Nuisance to Inhabitants -2 -2 -2 -6 Scaring of Wildlife 0 Ecosystem Wildlife protection Rare & endangered flora & fauna Socio-Economics effect of economy 1 3 2 6 Infrastructural & service facilities -1 -1 Health -2 -2 -2 -6 Agricultural production -2 -1 -3 -40
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(B) Evaluation of Environmental Impacts During Construction Phase with EMP Loading Solid Liquideffl GaseousE ServiceFac wasterec Total Parameters Excavation &Transpor wastedispo Accidents uent missions ilities ycling score t sal Land Use Soil erosion -1 -1 -2 Existing landuse -1 -1 -1 -3 Sensitive area- like 0 mountains, sanctuaries, Monuments etc Aesthetic beauty 2 2 Water Surface Suspended solids -1 -1 Effect of Aquatic life 0 Ground water Quality -1 -1 Air Dust -1 -1 -1 -3 Emissions of -2 -2 -4 gases (NOx, SOx, CO) Noise Nuisance to Inhabitants -1 -1 -1 -3 Scaring of Wildlife 0 Ecosystem Wildlife protection rare & endangered flora & fauna Socio-Economics Effect of economy 1 3 2 6 Infrastructural & service facilities -1 -1 Health -1 -1 -1 -3 Agricultural production
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Loading Solid Liquideffl GaseousE ServiceFac wasterec Total Parameters Excavation &Transpor wastedispo Accidents uent missions ilities ycling score t sal Total Score -13
(C): Evaluation of Environmental Impact during operation phase without EMP Tota Loading Solid Aestheti Excavatio Liquidefflue GaseousEmissio ServiceFaciliti Accident wasterecycli l Parameters &Transpo wastedispos c n nt ns es s ng scor rt al beauty e Land Use Soil erosion 0 Existing 2 2 landuse Sensitive 0 area- like mountains, sanctuaries, Monuments etc Water Surface Toxic -3 -3 substance Suspended 0 solid Effect of 0 Aquatic life Groundwat -3 -3 er Quality Air Dust 0
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Tota Loading Solid Aestheti Excavatio Liquidefflue GaseousEmissio ServiceFaciliti Accident wasterecycli l Parameters &Transpo wastedispos c n nt ns es s ng scor rt al beauty e Emissions -3 -3 of gases (Nox, Sox, CO) Noise 0 Nuisance to -1 -1 Inhabitants Scaring of 0 Wildlife Ecosystem 0 Local flora 0 & fauna Wildlife protection rare & endangered flora & fauna Socio- Economics Effect of 3 3 economy Infrastructur 2 2 al & service facilities Health population density
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Tota Loading Solid Aestheti Excavatio Liquidefflue GaseousEmissio ServiceFaciliti Accident wasterecycli l Parameters &Transpo wastedispos c n nt ns es s ng scor rt al beauty e agricultural 4 4 production 1
(D): Evaluation of Environmental Impacts during operational phase with EMP Solid Loading & Liquid Gaseous Service Aesthetic waste Total Parameters Excavation wastedisp Accidents Transport effluent Emissions Facilities beauty recycling score osal Land Use 0 Soil erosion 0 Existing landuse 4 4 Sensitive area- like mountains, 0 sanctuaries, Monuments etc Water Surface 0 Toxic substance -1 -1 Suspended solid 0 Effect of Aquatic life 0 Ground water Quality 0 Air 0 Dust 0 Emissions of -2 -2 gases (Nox, Sox, CO) Noise 0 Nuisance to Inhabitants 0 Scaring of Wildlife 0 Ecosystem 0 Local flora & fauna 2 2 Wildlife protection 0
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Solid Loading & Liquid Gaseous Service Aesthetic waste Total Parameters Excavation wastedisp Accidents Transport effluent Emissions Facilities beauty recycling score osal rare & endangered flora & fauna 0 Socio-Economics 0 effect of economy 3 3 Infrastructural & service facilities 4 4 Health 0 population density 1 1 agricultural production 4 4 15
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EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) CHAPTER 5. Environment Management Plan
5.1. Introduction Prediction of the potential adverse environmental and social impacts arising from development interventions is at the technical heart of EIA process. An equally essential element of this process is to develop measures to eliminate, offset, or reduce impacts to acceptable levels during implementation and operation of projects. The integration of such measures into project implementation and operation is supported by clearly defining the environmental requirements within an Environmental Management Plan (EMP). Normally, potential impacts are identified early during the initiation of project, and measures to avoid or minimize impacts are incorporated into the alternatives being considered. In this respect, some of the most important measures to protect the environment and local communities become integral to the project design, and may not be reflected in a formal EMP. OTSUKA by way of EIA study propose to identify all the likely potential impacts, collect data information and incorporate all the measures necessary to avoid or minimize impacts on surrounding environment. Many of the mitigation measures are already taken up in the engineering design itself. 5.2. Objectives of EMP Overall objective of EMP: • Prevention: Measures aimed at impeding the occurrence of negative environmental impacts and/or preventing such an occurrence having harmful environmental impacts. • Preservation: Preventing any future actions that might adversely affect an environmental resource or attribute. • Minimization: Limiting or reducing the degree, extent, magnitude, or duration of adverse impacts. 5.3. Components of EMP EMP for OIPL to set up manufacturing unit of APIs intermediates considers the following aspects: • Description of mitigation measures • Description of monitoring program • Institutional arrangements • Implementation schedule and reporting procedures Institutional framework includes the responsibilities for environmental management as well as responsibilities for implementing environmental measures. 5.4. Air Environment Construction Phase:
• Excavators shall be used for construction. The excavated material shall be stacked at safe places for backfill at a later stage of construction.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • To control the fugitive emission during construction phase adequate water sprinking system will be developed
Operation Phase (Fugitive Dust): • 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. 5.4.1. Air Pollution Control Measures Measures for Reducing Stack Emissions The emission from expansion project is from process stack and boiler. Multi cyclone separator with stack height of 30 mtr shall be installed for dispersion of particulate matter from Boiler. All process vents/ incinerator vents will be routed through dedicated two stage ventury scrubbing system. DG set will be used only during the power failure and will be connected with a separate stack. The recovery and recycling of solvents in the process is a key issue in achieving productivity and an edge in competitive world. Hence, all the solvent mixtures generated from different stages of the products will be fractionated in a state of the art solvent recovery system to give 95-98% recovery depending upon composition of solvent mixtures and their boiling point. Chilled brine will be used in condensers to recover the solvents. Similarly all the reaction vessels (six streams) will be connected with the individual scrubbing system so that any toxic fumes and vapours generated during reaction get neutralised.The scrubber stack will meet existing norms emission. Otsuka to ensure no leakage occurs from various process equipments (equipment flanges, pumps, drains, sample points etc.) to pollute the working area. Measures for Fugitive Emissions The fugitive emissions of organic chemicals and VOCs may come from leakage through valves, fittings, pumps, etc. Though this is not expected to be significant, it may be reduced further by adopting the following measures: • LDAR system should be strictly followed.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
• All process drains/ equipment washing should be collected in closed pit (to avoid fouling of work area through odour etc.) and taken to ETP. • Regular maintenance of valves, pumps and other equipment to prevent leakage and thus minimizing the fugitive emissions of VOCs. • Regular monitoring of VOCs shall be conducted in the areas prone to fugitive emissions. • The monitoring at working environment shall be carried out and shall be recorded in the prescribed form of the Factories Act. • The operation of centrifuging/ filter will be done in closed equipment to avoid any vapours coming out in the local atmosphere. The 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. • Adequate systems shall be provided to capture the odour /emissions from process plants & maintain the emission quality as per recommended guidelines with central scrubber having caustic solution, before venting it in to the atmosphere • The design features as suggested in Table 5.1for new equipment may be considered.
Table 5.1 : Design Features for Minimization of Fugitive Emissions
S. No. Equipment Design Features Control Efficiency, % Seal less design 100 1 Pumps Dual Mechanical Seal 100 2 Valves Seal less Design 100 3 Compressor Dual Mechanical Seal 100 4 Connectors Weld together 100 5 Pressure Relief Devices Rupture Disc 100 6 Sampling Connection Closed loop sampling 100
Table 5.2 :Ambient air environment impact and management plan
S.No. Env. Stages and Source Impact Area Management Plan Elements 1. Air Construction Phase: Within Plant Sprinkling water on boundary excavated earth Environment Construction activity is material. limited may caused by emission of dust such as the movements of vehicles, speed, soil
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) stripping, excavation, back filling and reinstatement Operational Phase: Within Plant Truck mounted vacuum boundary cleaning system Truck Movements Process emission Emission with Adequate pollution in NAAQMS control equipment Standards provided within study area
5.5. Noise Environment Construction Phase Noise will be generated due to operation of heavy equipment and increased frequency of vehicular traffic in the area. However, these impacts will be short term and intermittent in nature. The noise effect on the nearest inhabitants during the construction activity will be negligible, as the noise levels will be dissipated within the existing plant area itself. Nevertheless, the following mitigation measures shall be adopted: • The on-site workers shall be made to use noise protection devices like ear muffs/ ear plugs; • The construction equipment shall be maintained and serviced regularly such that the equipment based noise standards are maintained as per the design specifications; and • Further, no worker shall be allowed to expose to more than 90 dB (A) in an 8- hour shift and under no circumstances the noise level from any equipment shall be greater than 115 dB (A). Operation phase: All the design/installation precautions as specified by the manufacturers with respect to noise control shall be strictly adhered to; • High noise generating sources shall be insulated adequately by providing suitable enclosures; • Design and layout of building to minimise transmission of noise, segregation of particular items of plant and to avoid reverberant areas; • Acoustic design of building; • The noise control system will be designed to form an integral part of the plant; • Other than the regular maintenance of the various equipment, ear plugs/muffs are recommended for the personnel working close to the noise generating units; • All the openings like covers, partitions shall be designed properly; and
Inlet and outlet mufflers shall be provided which are easy to design and construct.
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• The green belt in and around the plant periphery will attenuate the noise level.
Table 5.3 : Ambient noise environment impact and management plan
S.NO Components Stages and sources Impact Zone Management Plan 1. Noise During Construction Within Plant Regular maintainance Environment Phase: Boundary of the construction equipments. Movement of heavy equipments
Provision of protective devices like ear muff/plugs to the workers. During Operation Phase: Provision of rubber padding/ noise Increase in ambient Noise isolators level from equipments, pump DG sets and Provision of silencers compressors. However to modulate the noise incremental level is generated by insignificant due to machines provision of acoustic Provision of protective enclosures for noise devices like ear generation sources. muff/plugs to the workers.
Greenbelt development in and around the plant periphery 5.6. Water Environment 5.6.1. Construction Phase: The water environment is susceptible to change during construction because of the effluents from sanitary facilities for the construction workers, washing of vehicles and spillage of fuels. Following mitigation measures shall be adopted: • Suitable treatment measures like septic tank and soak pits shall be provided at construction site; • The vehicle maintenance area shall be located in such a manner as to prevent contamination of surface and ground water sources by accidental spillage of oil; • The washing effluents from the vehicle maintenance area are likely to contain suspended solids and oil & grease. Hence, a oil trap followed by settling tank shall be provided for the treatment of these effluents; and
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • The waste oil collected in the oil trap shall be sold to authorized re-refiners for off-site recycling. Sanitation The construction site shall be provided with sufficient and suitable toilet facilities for workers to meet the proper standards of hygiene. These facilities shall be connected to a septic tank and soak pit. Operation Phase: Existing unit based on ZLD concepts and the expansion unit is also follow the same i.e. ZLD concepts, all the process effluent generated from the proposed expansion project will be treated in proposed ETP & recycled back in the process and there will not be any disposal of industrial effluent. Domestic effluent which will be treated in proposed sewage treatment plant and treated water utilised in green belt development. No impact on ground or surface water is envisaged due to the project.However, rainwater harvesting and recycle & reuse of all the industrial effluent have been adopted in the project to conserve the water resources.
Table 5.4 : Water environment impact and management plan
S.NO Components Expected Impact Impact Management Plan Zone 1. Water During Construction Phase: Within Domestic waste Environment Plan water sends to
Boundary soakpit. Water will be needed mainly for construction and domestic purpose i.e. for drinking and sanitation During Operation Phase: ETP & recycled back in the
processand Generation of high TDS and achieve ZLD. HighCOD effluent. Zero
Discharge Domestic waste water sends to STP. 5.6.2. Strom water management Storm water collected through storm drains will be stored and reused saving of even small drop of water can make considerable saving in wider spectrum over a period of time & is also be helpful in creating awareness for water conservation amongst people. It also improves our input water quality.
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5.7. Biological Environment Ecological base line surveys in the core and buffer zones, reveals no exceptional features of wildlife interest. The survey based on following criteria.
Table 5.5 : Ecological criteria & Observations
Land use The proposed site is an industrial plot and already developed by RIICO. No natural vegetation present in site except some grasses. No sensitive ecosystems are present within 10 km area of the project site. Diversity Species diversity of flora as well as fauna species is restricted to agro ecosystem. Rarity There is no endemic, rare or threatened species in site as well as in study area. Proximity There are no Biosphere Reserve, National Park, Wildlife Sanctuary, present within 10 km area of the site Potential value Wide and dense greenbelt development in project has been already started by Otsuka which will increase habitat condition especially for avifauna.
Based on the ecological baseline study following mitigation measures have been suggested: Regeneration / restoration of rare plants and animals: No rare plants and wildlife species exists in the core and buffer zone, hence protection and conservation plan is not required. Improvement of biodiversity: Environment management cell of the project proponent will look after the day to day environment monitoring requirement and Greenbelt development in and around the project site. Green Belt development plan 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 Otsuka Ltd. The green canopy not only absorbs some of these pollutants as carbon sink but also improves the aesthetic environment, besides attenuating the noise levels. Otsuka Chemical has developed a three tier and 10 m wide greenbelt all around the proposed plant premises. As per CPCB/MoEF guidelines 33% (8844 m2) of the total land area (26800 m2) has been kept as greenbelt. Photographs of the greenbelt developed by Otsuka is provided in Figure 5.2.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Figure 5.1 : Photographs of Greenbelt Developed by Otsuka Chemicals 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 5.6).
Table 5.6 : Species suggested for plantation under Greenbelt Development Progaramme Evergreen Botanical / Habit/ (E)/ Crown S.No. Tree Name Family Scientific name Height Deciduous Shape (D) 1 Sheesham Dalbergia sissoo Fabaceae Tree, 25 m E light crown 2 Balam khira Kigelia Bignoniaceae Tree, 20 m D Crown 3 Jamun Jambul Myrtaceae Tree, 30 m E Spreadig 4 Ashok sorrow-less Fabaceae Tree, 20 m E Spreadig 5 Pipal Ficus religiosa Moraceae Tree, 30 m D Spreadig 6 Shahtoot Morus nigra Moraceae Tree, 12 m E Spreadig holoptelea 7 Papri integrifolia Moraceae Tree, 15 m E Crown 8 Pilkhan Ficus virens Fabaceae Tree, 30 m E umbrella 9 Bar Banyan Reunions Tree, 30 m E Spreadig Crown 10 Arjun Terminalia arjuna Combretaceae Tree, 25 m E canopy 11 Neem Azadirachta indica Meliaceae Tree, 20 m E Spreadig
Budget for Greenbelt: Otsuka chemical has already developed a dense greenbelt in about 8844 m2(33%) of the area within the plant. More than 600 trees has been already planted. Rs. 10 lacks has been already spent by Otsuka for greenbelt plantation and maintenance. Further Otsuka chemical has earmarked a budget of Rs. 8 lacks/year for development of lawns and other form of greenery and maintenance (including manure/ watering and labour charges etc.) of the existing greenbelt. 5.8. Land Environment Construction phase Following materials shall be stored and handled carefully under applicable safety guidelines. Some of the precautions of storage include the following: • Dyked enclosures shall be provided;
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Diesel and other fuels shall be stored in separate storage tanks with dyke enclosures; • PPE and Fire extigusher/tenders will be provided. Site Security Adequate security arrangement shall be made to ensure that the local inhabitants and the stray cattle are not exposed to the potential hazards of construction activities. Availability of boundary wall shall be helpful in meeting this objective. Operation phase
Hazardous waste will be disposed as mentioned in the Chapter 2. There will be no major source of hazardous waste generation due to the proposed expansion project that would be causing harm to the environment, as major solid waste is gypsum which will be sold to cement industries and hazardous wastes are ETP Sludge & used oil which will be disposed as per Hazardous Waste (Management, Handling & Transboundary Movement) Rules, 2016 and its amendments.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Hazardous wastes will be stored at earmarked area with impervious flooring and with shed to eliminate chances of contamination of land and ground water.
Following measures will be implemented. • Maintain records of hazardous waste generation and disposal as per HWM rules 2016. • Ensure all necessary precautions are taken during handling, loading and unloading of hazardous wastes. • Ensure training to persons involved in handling/ transportation of hazardous chemicals/ wastes. • Ensure availability of MSDS of hazardous materials, whenever required. • Ensure required PPE’s are provided to the persons involved in handling/ transportation of hazardous chemicals/ wastes
Table 5.7 : Impact and management plan
S.NO Components Stages and Sources Impact Zone Management Plan 1. Land During Construction Within plant Top soil generated Environment Phase: boundary from various Soil Excavation activities like excavation etc. will be stored and preserved to use in greenbelt development. During Operation Phase: Hazardous waste Solid waste disposal and shall be disposed off Hazardous waste as per HWM rules generation storage. 2016. Periodic monitoring shall be carried out. Zero liquid discharge will be maintained. 5.9. Resource Conservation/ Waste Minimization Otsuka has proposed to take adequate resource conservation measures in the proposed expansion plant. Key measures taken for natural resource and energy conservation are as given below:- • Used oil will be stored in covered storages / hard flooring in order to preventany contamination in soil/ ground water.
• Proper scheduling of preventive maintenance of critical machines will minimize used oil generation.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Energy efficient drives / LED lights to be used.
• Reduction of lighting power consumption by optimum use of electrical lights in plants by installing timers.
• Use of variable frequency drive in plant.
• Enough care will be taken to prevent/minimize energy losses at each stage.
• Period Energy audit will be done.
• Zero liquid discharge will be maintained for reduction in fresh water consumption. Also use of Energy Efficient Lighting, Transformers, HVAC system, Use of Energy Efficient Motors, electrical appliances to minimize the energy consumption in addition to Process Planning. 5.10. Facilities for Employees In the existing unit company give the preference to the local person and also hire the local person for the proposed expansion. Company will give preference to local people (Skilled People) for employment The Company is more concern for the safety and health of its people, including the larger community outside of the company and the environment as a whole. All employees will be trained to work on sites in the safest possible manner and shall be made aware of the consequences of unsafe act. Company will also provide the shelter, safe drinking water, sanitation facility. The company willallocate adequate budget for safety and Occupational health management of the employees.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 5.11. Otsuka HSE Policy
5.12. Environment Management Cell Existing EHS status at Otsuka : DRIVING EHS AT Otsuka • Otsuka’s EHS policy drives the priority across the organization • EHS performance reviewed monthly by Business Management Group chaired by Chief Operating Officer • Mostly Operating units are certified for ISO:14001, ISO-9001, OHSAS-18001, • Proposed unithave Modern Environment Laboratory, Micro meteorological station, online stack monitoring and latest ambient air monitoring facilities • Full-fledged Occupational Health Centres are operational at most of the locations • Qualified/ Specialized EHS team works closely with operation team • The proposed unit will have an adequate Environmental Management Cell to assure the regular and efficient working /operation of the environmental management plan. The structure of the EMC has been presented in Figure 5.1.
The function of HSE department includes the following: • Implement HSE directives and guide line as per Otsuka global 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. • 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.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 5.12.1. Post – Operational Monitoring Program Otsuka will carry out environment monitoring as per monitoring plan proposed as follows:
Discipline Location Parameter Frequenc Remarks y Meteorology One Temp.{max.; min.}; Daily Being complied Relative humidity; Rain fall; Wind speed and direction. Ambient Air Four Ambient air monitoring Parameters as Quality of parameters specified Once a applicable /as per by RSPCB in their air Month products being consent from time time manufactured to time within plant Stack Emission All Emission monitoring of Parameters as continuous process/flue gas stacks Once a applicable /as per stacks set as given in air Month products being consent from time to manufactured time Effluents Final --- Once a Parameters as effluents day. applicable /as per discharge products being point manufactured Ground Water Four Quarterly Parameters as piezometric Quality (Four Parameters are essential applicable /as per wells within peizometric parameters as per IS products being wells) plant manufactured premises 10500:2012. Noise Plant area Day & Night time noise Monthly &periphery level Soil Plant area pH, conductivity, Once a sulphate, calcium and year magnesium etc. Health Check All Plant Diseasesrelated to Annually Up Personnel chemical unit
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 5.12.2. Budget for environmental management plan The environmental Budget proposed for the project is mention below. Table 5.8 : Budget for environmental management plan Proposed Proposed EMP EMP Cost Cost (Rs. in Particulars Basis for cost estimates (Rs. in Lacs) Lacs/annum) Capital Recurring Air pollution Air pollution controlling equipments, control Monitoring of Air Environment, &Noise 50 5 Ambient noise monitoring, acoustic Pollution hoods / enclosures, noise mapping, Monitoring hearing protection Capital cost would include cost of ETP and STP including Civil work, Water mechanical work, and electrical work Pollution 100 75 and piping work is included. Recurring control cost is cost of treatment of waste water at site Solid and Capital cost would include cost of hazardous providing storage space for hazardous 20 10 waste waste. Recurring cost would include management cost of transportation & disposal Environment The recurring cost would be incurred monitoring on hiring of consultants and payment 0 20 and of various statutory fees to regulatory management agencies. Occupational 0 10 Periodic Health checkup, PPEs etc Health Capital cost would include cost of plant species and labor cost and Green belt & recurring cost would include cost of Rainwater 30 25 maintenance of that green belt Harvesting including cost of required water for plant growth Total 200 145
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) CHAPTER 6. ADDITIONAL STUDY
This Chapter provides the details about the Risk Assessment and on-site emergency plan as proposed for the project .
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 Quantitative Risk 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.It may happen usually as the result of a malfunction of the normal operating procedures. It may also be precipitated by the intervention of an outside force such as a cyclone, flood, earthquake or deliberate acts of arson or sabotage. This chapter deals with the risks associated with the Plant, its mitigation and the Disaster Management Plan.
6.2. Scope of Work The scope of the study is to model and appraise the risks associated with all toxic and flammable hazards resulting from potential loss of containment accident scenarios from Otsuka proposed expansion project Operations and developing a Disaster Management Plan.
6.3. Objectives The specific objectives of the study are to identify:
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Hazardous materials associated with the project • Potential consequences of identified threats • Recommend risk prevention and reduction measures to ensure that all risks are within ALARP. • Defines the actions to be taken in case of emergencies.
6.4. Methodology of HIRA Hazard Identification and Risk Assessment: Hazard is defined as a chemical or physical conditions those have the potential for causing damage to people, property or the environment. In this chapter the hazards associated with only the proposed expansion project have been discussed. The primary step of the Hazard identification is the risk analysis and entails the process of collecting information on: • the types and quantities of hazardous substances stored and handled at the plant, • the location of storage tanks & other facilities, and • Potential hazards associated with the spillage and release of hazardous chemicals. 6.4.1. Identification of Hazards The main hazard potentials in the proposed expansion project ofOtsukaare categorized as below: • Material hazards;Associated with Hazardous Materials Storage Facilities. • Process hazardsdue to loss of containment during handling of hazardous materials or processes resulting in fire, explosion, etc • Mechanical hazardsdue to "mechanical" operations such as welding, maintenance, falling objects etc. - basically those NOT connected to hazardous materials. • Electrical hazards: electrocution, high voltage levels, short circuit, etc. Out of these, the material and process hazards are the one with a much wider damage potential as compared to the mechanical and electrical hazards, which are by and large limited to very small local pockets. 6.5. Hazardous Materials Bulk Storages at the Otsuka Plant The major hazardous chemical to be stored at the Otsuka site will be Chlorine, Bromine, Ammonia and other organic/inorganic hazardous chemicals etc. as given below in the Table: Table 7.1. Bulk Storages
Storage Area and Storage Sl. No. Name of the Raw Material Capacity Specifications
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Storage Area and Storage Sl. No. Name of the Raw Material Capacity Specifications 1. Methanol 20 KL SS-304 2. Toluene 10 KL SS-304 3. Acetone 20 KL SS-304 4. IPA 10 KL SS-304 5. Ethanol 5 KL SS-304 6. Cyclohexane 10 KL SS-304 ( jacketed) 7. n-Butyl acetate 20 KL SS-304 8. Ethyl acetate 20 Kl SS-304 9. Methylene Chloride 20 KL SS-304 ( jacketed) 10. Phenol 20 KL SS-304 11. Anicyl alcohol 10 KL SS-304 12. Bromine 20 KL Bullet
13. Chlorine 900 Kg Tonners 14 nos. 14. Ammonia 400 kg Cylinders 10 nos. 15. Diesel 20 Kl
6.5.1. Hazardous Analysis of Bulk Storage Materials Otsuka will be using a number of raw materials but only few are stored in bulk and few chemicals are listed under “List of hazardous and Toxic Chemicals” category under MSIHC Rules, 1989. The raw materials coming under hazardous category as specified by MSIHC Rules, 1989 (including subsequent amendments) is given in Table below
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Table 7.2. Hazard Analysis of Bulk Storage Materials
S. No Material S. No & Threshold Quantity (TQ in Hazards Potential Remarks MT) as per MSHIC Rules Schedule- Schedule- Schedule- Hazards Toxic 1, Part-II 2, Part-I 3, Part-I DT->---mg/Kg; OT----mg/Kg; IT----mg/l; (Rats) 1. Methanol 377 A colorless fairly ERPG-1: 200 Health Hazards: CAS No:67-56-1 volatile liquid with a ppm Exposure to faintly sweet pungent excessive vapor UN No:1230 ERPG-2: 1000 odor like that of ethyl causes eye irritation, ppm alcohol. head- ache, fatigue ERPG-3: 5000 and drowsiness. Highly Flammable; ppm 50,000 ppm will Behavior in Fire: probably cause Containers may IDLH: 6000 ppm death in 1 to 2 hrs. explode. Swallowing may cause death or eye damage. 2. Toluene CAS 628 ------A clear colorless liquid ERPG-1: 50 ppm Health Hazard No: 108-88-3 UN with a characteristic ERPG-2: 300 Vapors irritate eyes No: 1294 aromatic odor. Flash ppm and upper point 40°F respiratory tract; ERPG-3: 1000 Flammability: Ignites at cause dizziness, ppm
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
S. No Material S. No & Threshold Quantity (TQ in Hazards Potential Remarks MT) as per MSHIC Rules Schedule- Schedule- Schedule- Hazards Toxic 1, Part-II 2, Part-I 3, Part-I DT->---mg/Kg; OT----mg/Kg; IT----mg/l; (Rats) normal temperatures; headache, IDLH: 500 ppm Vapor is heavier than respiratory arrest. air and may travel a Liquid irritates eyes considerable distance and causes drying of to a source of ignition skin. If aspirated, and flash back; causes coughing,. If ingested causes vomiting, griping, diarrhea, depressed respiration. 3. Acetone 4 -- -- Hazardous in case of ORAL (LD50): [C3 H6 O] skin contact (irritant), Acute: 5800 of eye contact (irritant), mg/kg [Rat]. CAS No: 67-64-1 of ingestion, of VAPOR (LC50): Colourless liquid; inhalation. Slightly Acute: 50100 Pleasant Etheral hazardous in case of odour mg/m 8 hours skin contact [Rat]. BP-56.2 0C (permeator). Flammable: Limits-
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
S. No Material S. No & Threshold Quantity (TQ in Hazards Potential Remarks MT) as per MSHIC Rules Schedule- Schedule- Schedule- Hazards Toxic 1, Part-II 2, Part-I 3, Part-I DT->---mg/Kg; OT----mg/Kg; IT----mg/l; (Rats) Lower-2.6%; Upper- 12.8% 4. Isopropyl Alcohols 334 Flash Pt: 55.00 F -- CAS No: 67-63-0 Method Used: TCC Explosive Limits: LEL: 2.5% UEL: 12.1% LD 50/ LC 50: Acute dermal Rabbit 1300 mg/kg; Acute inhalation Rat (8 hours) 12000 ppm. 5. Ethanol 248 ------Colourlessliquid Flammable: FP- 16.6 CAS No; 64-17-5 0C; Causes respiratory A clear colorless tract irritation. May liquid with cause liver, kidney and pleasant odor heart damage. Causes moderate skin / eye irritation. On ingestion
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
S. No Material S. No & Threshold Quantity (TQ in Hazards Potential Remarks MT) as per MSHIC Rules Schedule- Schedule- Schedule- Hazards Toxic 1, Part-II 2, Part-I 3, Part-I DT->---mg/Kg; OT----mg/Kg; IT----mg/l; (Rats) may cause gastrointestinal tract irritation, vomiting and diarrhoea. 6. Cyclohexane Slightly hazardous in OT (LD50): C6H12 case of skin contact Acute: 12705 (irritant, permeator), of mg/kg [Rat]. DT CAS No:110-82-7 eye contact (irritant), of (LD50): Acute: Highly flammable ingestion, of inhalation. 18000 mg/kg liquid with mild sweet odour [Rabbit] BP: 80.7 0C IT---- NA
7. N – Butyl Acetate ------Very hazardous in OT (LD50): case of ingestion. Acute: 10768 CH3COO(CH2)CH3 Hazardous in case of mg/kg [Rat]. DT CAS No:123-86-4 skin contact (irritant), (LD50): Acute: of eye contact (irritant), Flammable liquid 17601 mg/kg of inhalation. Slightly
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
S. No Material S. No & Threshold Quantity (TQ in Hazards Potential Remarks MT) as per MSHIC Rules Schedule- Schedule- Schedule- Hazards Toxic 1, Part-II 2, Part-I 3, Part-I DT->---mg/Kg; OT----mg/Kg; IT----mg/l; (Rats) [Rabbit] hazardous in case of skin contact IT---- NA (permeator). 8. Ethyl Acetate 247 ------Hazardous in case of (LD50): Acute: (C4 H8 O2) ingestion, of inhalation. 5620 mg/kg Slightly hazardous in [Rat]. 4100 CAS No: 141-78-6 case of skin contact mg/kg [Mouse]. Colourless liquid; (irritant, permeator), of VAPOR (LC50): Pleasant Etheral eye contact odour 16000 ppm 6 (irritant). hours [Rat]. BP-77 0C FLAMMABLE: FP (Closed Cup)- -4.4 0C Flammable Limits_ Lower 2.2%;Upper-9% 9. Methylene Chloride Very hazardous in OT (LD50): C-H2-Cl2 case of eye contact Acute: (irritant), of ingestion, 1600mg/kg [Rat]. CAS NO:75-09-2
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
S. No Material S. No & Threshold Quantity (TQ in Hazards Potential Remarks MT) as per MSHIC Rules Schedule- Schedule- Schedule- Hazards Toxic 1, Part-II 2, Part-I 3, Part-I DT->---mg/Kg; OT----mg/Kg; IT----mg/l; (Rats) of inhalation. Hazardous liquid ; DT (LD50): Hazardous in case BP:39.75 0C Acute: of skin contact (irritant, ---- mg/kg permeator). IT---- 52000 (Rat ; 1 hr) 10. Phenol 481 IDLH: 250 ppm
C6H6O Will burn eyes and AEGL (30 skin. The analgesic Min):1—19 ppm CAS No: 108-95-2 action may cause loss AEGL:229ppm UN No:2821 of pain sensation. AEGL: 3 --- A colourless liquid Readily absorbed when pure, through skin, causing otherwise pink or increased heart rate, red. Combustible. convulsions, and death. BP – 3600F Unburned vapor is toxic
11. Anicyl alcohol Harmful if swallowed. No data available
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
S. No Material S. No & Threshold Quantity (TQ in Hazards Potential Remarks MT) as per MSHIC Rules Schedule- Schedule- Schedule- Hazards Toxic 1, Part-II 2, Part-I 3, Part-I DT->---mg/Kg; OT----mg/Kg; IT----mg/l; (Rats) May be harmful in
contact with skin. CAS No:105-13-5 Causes skin irritation. Flammable liquid May cause an allergic with characteristic skin reaction. Causes odour. BP:259 0C serious eye damage. 12. Bromine 84 17 106 Stable. Incompatible OT (LD50): with reducing agents, Acute: CAS No:7726-95-6 TQ-1: 10 TQ-1: alkali metals, 2600mg/kg [Rat]. UN No:1744 50 MT 40 MT powdered metals, DT (LD50): TQ-2: TQ-2: steel, iron, copper, Acute: 500 MT organic materials. 500 MT 17601 mg/kg [Rabbit] Toxicology IT---- 750 May be fatal if inhaled. (mouse) Highly toxic by inhalation, ingestion or IDLH: 3ppm skin contact. Causes severe burns.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
S. No Material S. No & Threshold Quantity (TQ in Hazards Potential Remarks MT) as per MSHIC Rules Schedule- Schedule- Schedule- Hazards Toxic 1, Part-II 2, Part-I 3, Part-I DT->---mg/Kg; OT----mg/Kg; IT----mg/l; (Rats) Lachrymator. Typical TLV 0.1 ppm. Typical STEL 0.3 ppm
13. Chlorine 119 5 108 (Gas); Non ERPG-1: 1.0 Combustible; May ppm CAS No:7782-50-5 TQ-1: TQ-1: ignite other UN No:1017 10MT 10MT ERPG-2: 3.0 combustible materials ppm A greenish yellow TQ-2: 25 TQ-2: 25 (wood, paper, oil, etc.). gas with a pungent MT MT Mixture with fuels may ERPG-3: 20 ppm suffocating odour. cause explosion. Toxic by inhalation. IDLH: 10 ppm Health Hazards: Poisonous; may be fatal if inhaled. Contact may cause burns to skin and eyes. Bronchitis or chronic lung conditions 14. Ammonia 31 2 105 Fire Hazards: (Gas); DT: Not Prolonged skin
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
S. No Material S. No & Threshold Quantity (TQ in Hazards Potential Remarks MT) as per MSHIC Rules Schedule- Schedule- Schedule- Hazards Toxic 1, Part-II 2, Part-I 3, Part-I DT->---mg/Kg; OT----mg/Kg; IT----mg/l; (Rats) Mixing of ammonia available contact may result in CAS No:7664-41-7 TQ-1: 60 TQ-1: 50 with several absorption of MT MT OT: Not Toxic and flammable chemicalscan cause harmful material. gas, Totally Soluble available TQ-2: 600 TQ-2: 500 fire hazards, / or in water; BP:--33.4 MT MT IT: 7338 ppm (1 0C explosions; vapours are toxic- irritation to hr rat) eyes and respiratory tract. IDLH: 300 ppm
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
The petroleum materials (Diesel) used in Otsuka plant and their hazardous nature are as below: Table 7.3. : Petroleum Products in Otsuka and hazardous nature
Item Physical Impact on Man, Animal & Eco-System Physical Chemical LDO/HSD BP- 150 – LEL -0.6% (V/V) Entry through inhalation, 400°C ingestion and skin; UN No.-1202 UEL – 7.5% Vapour (V/V) Inhalation Effects: Dizziness Flammable Pressure and headache, Aspiration – Liquid-Class-3 Flash Point > (35°C)- <1 mm Rapidly developing, potential 32°C Hazardous at 38°C fatal chemical pneumonities Waste ID No.-17 Auto ignition Specific Ingestion Effect: Nausea and Temp.-256°C Hazchem Code- Gravity-0.81 – Vomiting; 3Y* 0.91 at 20°C Stable Contact Effects: Irritation, compound NFPA Eyes- Irritation; Dermatitis may HazardsSignals develop on prolonged contact.
Health-0 Solubility in Incompatible LD50 (oral rat)- 2800 mg/kg; Flammability-2 water- with oxidizing LD50 -200;TLV(ACGIH)- 5 Insoluble agents. mg/kg; STEL- 10 mg/kg Reactivity/ Stabilty-0
None of Otsuka 13 products have been mentioned in MSHIC Rules and as such are not considered hazardous. Among the 14 raw materials stored in bulk 13 have been mentioned in MSIHC Rules. Chlorine, Bromine and Ammonia are the gases stored and are highly toxic. Four materials namely Methanol, Toluene and Methylene Chloride and Ethyl Acetate are Toxic (though flammable also) . Other raw materials stored in bulk are combustible. The solid raw materials will be received in bags or drums and will be stored in chemicals godowns. The products (liquid or solid) will be packed in drums and stored in product godowns as per market demand. The bulk storages of liquid hazardous materials are given in the Table 7.1. The solid materials 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 in covered area will move to short distance only.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) The risk is through liquid and gaseous materials 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. The liquid products will be packed in drums (50 / 200 litres drums).
6.6. Detailed QRA Approach: Rule Sets and Assumptions 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 as Table 7.4: Table 7.4. Risk Classification
Stage Description
High A failure which could reasonably be expected to occur within the expected life time of the plant. (> 10-2/yr.) 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 A failure or sequence of failures which has a low probability of occurrence within the expected lifetime of the plant. (10-2 --10- 4/yr.) 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 A failure or series of failures which have a very low probability of occurrence within the expected lifetime of plant. (<10-4) Examples of ‘low’ likelihood are multiple instruments or valve failures or multiple human errors, or single spontaneous failures of tanks or process vessels.
Minor Impact limited to the local area of the event with potent for ‘knock – on- Incidents events’
Serious One that could cause: Incident 1. Any serious injury or fatality on/off site; 2. Property damage of $ 1 million offsite or $ 5 million onsite.
Extensive One that is five or more times worse than a serious incident. Incident
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Assigning a relative risk to each scenario provides a means of prioritising associated risk mitigation measures and planned actions. 6.6.1. 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.Tables 7.5, 7.6 and Table 7.7 (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 range. Thermal hazards have been considered for various scenarios including:Fire in fuel storage tank. Table 7.5. Effects due to Incident Radiation Intensity
Incident Radiation Damage Type kW/m2 0.7 Equivalent to Solar Radiation 1.6 No discomfort on long duration Sufficient to cause pain within 20 sec. Blistering of skin (first degree burn are 4.0 likely). 9.5 Pain threshold reached after 8 sec. Second degree burn after 20 sec. Minimum energy required for piloted ignition of wood, melting of plastic 12.5 tubing etc. Minimum Energy required for piloted ignition of wood, melting, plastic tubing 25 etc. 37.5 Sufficient to cause damage to process equipment. 62.0 Spontaneous ignition of wood.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Table 7.6. Thermal Radiation Impact to Human
Exposure Radiation Energy {1% Radiation Energy for Radiation Energy for Duration lethality; kW/m2} 2nd degree burns; 1st degree burns; kW/m2 kW/m2 10 sec 21.2 16 12.5 30 9.3 7.0 4.0
Table 7.7. Tolerable Intensities for Various Objects
Sl. No Objects Tolerable Intensities (kw/m2) 1 Drenched Tank 38 2 Special Buildings (No window, fire proof 25 doors) 3 Normal Buildings 14 4 Vegetation 10-12 5 Escape Route 6 (up to 30 sec.) 6 Personnel in Emergencies 3 (up to 30 sec.) 7 Plastic Cables 2 8 Stationary Personnel 1.5
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. As a safety measure Otsuka is storing highly hazardous raw materials in isolated places with full safety measures. Damage estimates based on overpressure are given in Table 7.8below: Table 7.8. Damage due to Overpressure
S.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
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 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
In Otsuka case explosion possibility is little. 6.6.2. Toxic Release Hazardous materials handled and stored in bulk in Otsukacomplex are toxic gases (Chlorine, Bromine and Ammonia)/ chemicals (as detailed in Table 7.1) and raw materials as defined in MSHIC rules and indicated in Table 7.2. 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 (IT) data for rats’ are considered. 6.6.3. Data Limitations It is also observed that little data or information (regarding physicalproperties required for modelling) is available about for some of the chemicals.. 6.7. Effect & Consequence Analysis As a part of risk assessment study, maximum credible accident analysis (MCA) is carried out to determine the maximum loss scenario from this analysis. It is an eventuality, which is possible and will have maximum consequential distances for the particular hazardous chemicals under evaluation. The selection of the accident scenarios is based on the engineering and professional judgment, accident descriptions of the past in similar type of plants & the expertise in risk analysis studies. 6.7.1. 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 7.9 below: Table 7.9. Different Failure Scenarios
S. No. Scenario Remark RM-1 Methanol Toxic RM-2 Toluene Toxic RM-3 Cyclo Hexane Thermal
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
S. No. Scenario Remark RM-4 Ethyl acetate Toxic RM-5 Bromine Toxic RM-6 Chlorine Toxic RM-7 Ammonia Toxic RM-8 Diesel Thermal
6.7.2. 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) 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. 6.8. Hazardous Incidents Impact The identified failure scenarios in Table7.10 have been analysed (Using ALOHA and EFFECT Modules) for the impact zones considering damage due to thermal and toxic impacts. Similar impacts are considered for expansion units. 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 7.11. Table 7.10. Hazards Scenario Impact
Scenario No. Scenario Impact Remarks Zone (m)
Scenario Raw Material RM-1 ❖ < 10 Methanol IDLH; Stability Class D RM-2 ❖ < 10 Toluene IDLH; Stability Class D RM-3 ❖ 15 Cyclo Hexane 1st Degree Burn ;Template-1 RM-4 ❖ 14 Ethyl acetate 1st Degree Burn ;Template-2 RM-5 ❖ 897 Bromine IDLH; Stability Class D; Template -3 ❖ 711 IDLH; Stability Class F; Template -4 RM-6 ❖ 1000 Chlorine IDLH; Stability Class D; Template -5 ❖ 1200 IDLH; Stability Class F; Template -6
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Scenario No. Scenario Impact Remarks Zone (m)
Scenario Raw Material RM-7 ❖ 179 Ammonia (Line IDLH; Stability Class D; Template -7 Leakage) ❖ 761 IDLH; Stability Class F; Template -8 RM-8 ❖ ~19 Diesel 1st Degree Burn
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Template 1. Cyclohexane Burning Puddle—Impact Zone
Template 2. Ethyl Acetate Burning Puddle –Impact Zone
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Template 3. Toxic Impact Zone Bromine Vessel Leakage; Stability Class D
Template 4. Toxic Impact Zone Bromine Vessel Leakage; Stability Class F
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Template 5. Toxic Impact Zone Chlorine Tonner Leakage; Stability Class D
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Template 6. Toxic Impact Zone Chlorine Tonner Leakage; Stability Class F
Template 7. Ammonia Line Leakage (Stability Class- D)
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Template 8. Ammonia Line Leakage (Stability Class- F)
6.9. Consequence Analysis Since the materials involved in this study is toxic as well as flammable, the possible scenarios are toxic impacts, pool fire, flash fire, dispersion and Jet fire. 6.9.1. Toxicity Toxic hazards are mainly due to gases (Chlorine, Bromine and Ammonia) and other toxic chemicals leakageand the impact can cross the plant boundary (incase of chlorine, bromine and Ammonia only)if not controlled in timedepending upon wind direction. Other hazardous chemicals including products their impact will be limited to spillage area. The acid 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. 6.9.2. Thermal Hazards Thermal hazards are mainly due to solvents/ other organic chemicals storage which are limited within plant boundary. Thermal impacts are limited to ~ 19 m only i.e. within the plant boundary limit. However the thermal impact can go further due to domino effect.
6.10. Conclusions and Recommendations
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Risk Assessment is carried out with the objective to identify the potential hazards from bulk storage facilities. Important conclusions and recommendations arising out of the Risk Analysis for Proposed Plant are listed below. • Thermal radiation from pool fires are well within the boundary. • It is recommended that the adjacent tanks shall be thermally protected by firewater. • Use corrosion-resistant structural materials and lighting and ventilation systems in the storage area. • Storage tanks should be above ground and surrounded with dikes capable of holding entire contents. • Limit quantity of material in storage up to 80 %. • Restrict access to storage area. • Post warning signs when appropriate. • Keep storage area separate from populated work areas. • Inspect periodically for deficiencies such as damage or leaks. • Have appropriate fire extinguishers available in and near the storage area. The following measures are suggested for reducing the risk involved in pipeline systems. Preventive Maintenance Routinely inspect and conduct preventive maintenance of equipment / facilities at the unit. Instruments: All the instruments like pressure, temperature transmitters/gauges and alarms switches and safety interlocks should be tested for their intended application as per the preventive maintenance schedule. Similarly, the emergency shutdown system should be tested as per the preventive maintenance schedule. Otsuka is multinational company and has been following preventive maintenance and other EHS system.
6.11. Occupational Health and Safety Otsuka is multinational company and has been following OHS system. Fire hydrant pumping system is installed at one place in Otsuka complex. A good Hydrant system meeting Tariff Advisory Committee's (TAC) and NFPA norms is installed all around the plant area. All inflammable liquid storage & handling installations are covered by hydrant system. Safety in the workplace is critical to the success of running a business, no matter what size it is. Otsuka has well established SHE System under the guidance of Senior Management. However few Safety/ EHS guidelines are as given below:
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Preventing Fires & Explosions • Fires & explosions in boiler can also result from the ignition of volatile materials and fuels. The most hazardous procedures are during the firing- up and shutting-down procedures. Coal-fired boiler should have safeguards to ensure that unspent fuel does not accumulate and ignite. The fuel supply to boiler should be fitted with an automatic shut-off mechanism. • Operators should be trained in safe systems of work. The building should be designed to be non-combustible, with automatic fire suppression engineered or designed into the process where appropriate. • Risk assessments should be carried out to consider the potential dispersal of toxic chemicals from non-furnace processes & combustion products, and the potential impact of an explosion on the surrounding areas. • Regular safety audits should be undertaken to ensure that hazards are clearly identified and risk-control measures maintained at an optimum level. • Boiler should not be operated beyond their safe lives/ safety limits (pressure / temperature).
6.12. Personal Protective Equipment (PPE) General Provisions As a supplementary protection against exposure to hazardous conditions in the industry where the safety of workers cannot be ensured by other means, such as eliminating the hazard, controlling the risk at source or minimizing the risk, suitable and sufficient PPE, having regard to the type of work and risks, and in consultation with workers and their representatives, should be used by the worker and provided and maintained by the employer, without cost to the workers. • Items of PPE provided should comply with the relevant national standards and criteria approved or recognized by the competent authority. • Those responsible for the management and operation of the personal protection programme should be trained in the selection of the proper equipment, in assuring that it is correctly fitted to the people who use it, in the nature of the hazards the equipment is intended to protect against, and provide adequate comfort, and in the consequences of poor performance or equipment failure. • PPE should be selected considering the characteristics of the wearer and additional physiological load or other harmful effects caused by the PPE. It should be used, maintained, stored and replaced in accordance with the standards or guidance for each hazard identified at the facility and according to the information given by the manufacturer. • PPE should be examined periodically to ensure that it is in good condition. • Different PPE & their components should be compatible with each other when worn together.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • PPE should be ergonomically designed and, to the extent practicable, should not restrict the user’s mobility or field of vision, hearing or other sensory functions. • Employers should ensure that the workers who are required to wear PPE are fully informed of the requirements and of the reasons for them, and are given adequate training in the selection, wearing, maintenance and storage of this equipment. • When workers have been informed accordingly, they should use the equipment provided throughout the time they may be exposed to the risk that requires the use of PPE for protection. • The PPE should not be used for longer than the time indicated by the manufacturer. • Workers should make proper use of the PPE provided, and maintain it in good condition, consistent with their training and be provided with the proper means for doing so. Head Protection • Any helmet that has been submitted to a heavy blow, even if there are no evident signs of damage, should be discarded. • If splits or cracks appear, or if a helmet shows signs of ageing or deterioration of the harness, the helmet should be discarded. • Where there is a hazard of contact with exposed conductive parts, only helmets made of non-conducting material should be used. • Helmets for persons working overhead should be provided with chin straps. • In addition to safety, consideration should also be given to the physiological aspects of comfort for the wearer. • The helmet should be as light as possible, the harness should be flexible and should not irritate or injure the wearer and a sweatband should be incorporated. • All protective headgear should be cleaned and checked regularly. Face & Eye Protection • Face shields or eye protectors should be used to protect against flying particles, fumes, dust and chemical hazards. • Face shields should be used in boiler operations and other hot work involving exposure to high-temperature radiation sources. Protection is also necessary against sparks or flying hot objects. Face protectors of the helmet type and the face-shield type are preferred. • With the use of face and eye protectors, due attention should be paid to greater comfort and efficiency. • The protectors should be fitted and adjusted by a person who has received training in this task.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Comfort is particularly important in helmet and hood type protectors as they may become almost intolerably hot during use. Air lines can be fitted to prevent this. • Face and eye protectors should give adequate protection at all times even with the use of corrective vision devices. • Eye protectors, including corrective lenses, should be made of appropriate high-impact material. Respiratory Protective Equipment • When effective engineering controls are not feasible, or while they are being implemented or evaluated, respirators, appropriate to the hazard and risk in question, should be used to protect the health of the worker. • When the hazard and risk cannot be assessed with sufficient accuracy to define the appropriate level of respiratory protection, employers should make positive pressure airsupplied respiratory protective devices available. • When selecting respirators, an appropriate number of sizes and models should be available from which a satisfactory respirator can be selected. Different sizes and models should be available to accommodate a broad range of facial types. Workersshould be fit-tested for respirators. • Respirators should be cleaned and sanitized periodically. Respirators intended for emergency use should be cleaned and sanitized after each use. • The user should be sufficiently trained and familiar with the respirator in order to be able to inspect the respirator immediately prior to each use to ensure that it is in proper working condition. Inspection may include the following : • tightness of connections; • the condition of the respiratory inlet and outlet covering; • head harness; • valves; • connecting tubes; • harness assemblies; • hoses; • filters; • cartridges; • end of service life indicator; • electrical components; • shelf life date; • The proper function of regulators, alarms and other warning systems. • Respirators should be properly stored. Damage may occur if they are not protected from physical and chemical agents such as vibration, sunlight, heat, extreme cold, excessive moisture or damaging chemicals. • Each respirator should be used with an understanding of its limitations, based on a number of factors such as the level and duration of exposure, the characteristics of the chemical and the service life of a respirator.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Workers should be medically evaluated for their ability to wear a respirator safely before they are required to do so. Hearing Protection • When effective engineering controls are not feasible or while they are being implemented or evaluated, hearing protection should be used to protect the health of workers. • Hearing loss of speech frequencies may occur with elevated long-term exposure to noise. The use of hearing protectors gives the best results to users who are well informed of the risks and trained in their use. If earplugs are used, special attention should be paid to the proper fitting technique. • Hearing protectors should be comfortable, and the users should be trained to use them properly. Special attention should be paid to possible increased risk of accidents due to the use of hearing protectors. Earmuffs reduce the capacity to locate sound sources and prevent warning signals from being heard. This is especially true for workers with considerable hearing loss. • No model is suitable for all persons. Those wearing hearing protectors should be able to choose from alternative products that meet the attenuation criteria. Earplugs should not be the only solution as not all people can wear them. • Hearing protectors should be made available at the entrance to the noisy area and they should be put on before entering the noisy area. Noisy areas should be indicated by appropriate signs. • The attenuation of hearing protector’s works well only if they are well maintained. Good maintenance consists of cleaning, changing replaceable parts such as cushions, and overall monitoring of the state of the hearing protector. • Hearing protectors should be evaluated through an audiometric test programme for exposed workers. • Protection from fall • When other measures do not eliminate the risk of falling, workers should be provided with and trained in the use of appropriate fall protection equipment, such as harnesses and lifelines. Workplaces and traffic lanes in which there are fall hazards or which border on a danger zone should be equipped with devices which prevent workers from falling into or entering the danger zone. • Devices should be provided to prevent workers from falling through floors and openings. • Safety harnesses should be worn where required and the lifeline should be attached to an adequate anchor point. • Harnesses should be chosen that are safely used with other PPE that may be worn simultaneously. • Appropriate and timely rescue should be provided when using fall-arrest equipment to prevent suspension trauma.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 6.13. Occupational Health – Proposal for Surveillance • The choice and the implementation of specific measures for preventing workplace injury and ill health in the work-force depend on the recognition of the principal hazards, and the anticipated injuries and diseases, ill health and incidents. Below are the most common causes of injury and illness: • Slips, trips and falls on the same level; falls from height; unguarded machinery; falling objects; • Engulfment; working in confined spaces; moving machinery, on-site transport, forklifts and cranes; • Exposure to controlled and uncontrolled energy sources; exposure to mineral wools and fibers; inhalable agents (gases, vapors, dusts and fumes); • Skin contact with chemicals (irritants acids, alkalis), solvents and sensitizers); contact with hot objects; • Fire and explosion; extreme temperatures; radiation (non-ionizing, ionizing); • Noise and vibration; electrical burns and electric shock; • Manual handling and repetitive work; failures due to automation; ergonomics; • Lack of OSH training; poor work organization; • Inadequate accident prevention and inspection; inadequate emergency first- aid and rescue facilities; lack of medical facilities and social protection • Dust may enter into the systemic circulation and thereby reach the essentially all the organs of body and affects the different tissues. • Working near heavy noise generating equipment may cause hearing and blood pressure related diseases • Continuous working and improper working position leading to pain & exhaustion. Plan of evaluation of health of workers • By pre designed format during pre-placement and periodical examinations. • Proper schedule will be devised and followed with help of occupational health experts and doctors. • Health effects of metals used and health hazard plans based on monthly correlation of these metal related diseases and people affected. Schedule of medical check-up during operational phase • Comprehensive Pre-employment medical check-up for all employees • General check-up of all employees once every year. • Medical examination will be done for all the employees after retirement and all those employees with more than 5 years of service leaving the company. After retirement, medical examination facility will be provided for a period of 5 years. • Dispensary and ESI facility will be provided to all workers as applicable • All safety gears will be provided to workers and care will be taken by EMC that these are used properly by them. All safety norms will be followed
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
CHAPTER 7. DISASTER MANAGEMENT PLAN
This Chapter provides details of Disaster management plan and giving general considerations, directions and procedures for handling emergencies likely to arise from planned operations
The Disaster Management Plan (DMP) is a guide, giving general considerations, directions and procedures for handling emergencies likely to arise from planned operations. The DMP must also be revaluated prior to start of operations and the Plant Manager shall be responsible for carrying out the same requirement. The DMP has been prepared for Otsuka on the basis of the Risk Assessment and related findings covered in the earlier chapters of this report. The results of consequence assessment for the credible scenarios indicate that the risk contours are confined within the site boundary only. 7.1. Disaster Management Plan: Structure The DMP is a dynamic, changing, document which focuses on continual improvement of emergency response planning and arrangement. A structure working on a Plan, Do, Check and Review (PDCR) cycle has been therefore suggested. Another advantage of doing this is to have a system that is in synchronicity with commonly used EHS system such as ISO 14001 and OHSAS 18000. The DMP is covered in further details in the remaining sections of this Chapter. 7.2. Policy The Environment, Health and Safety (EHS) policies are to be made accessible to all at site and to other stakeholders. The policies must be framed considering legislative compliance, stakeholder involvement, continual improvement, and management.Planning 7.2.1. Identification and Prevention of Possible Emergency Situations
Identification of Emergencies Possible emergency situation can broadly be classified into toxic release, fire or explosion, while doing so, it is stressed that these results are only for the modeled scenarios and, that the distances as well as damages can change depending upon the actual development of a scenario. Additional emergency situations can be developed on the basis of audit / HAZOP or other procedures prior to commencement of operations.
Emergency Prevention Some of the ways of preventing emergencies are as follows:
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Preparation of a Preventive Maintenance Schedule Programme covering maintenance schedules for all critical equipments and instruments as per recommendations of the manufacturers user manuals, • Establishment of a computerized Failure Modes Effects and Criticality Analysis (FMECA) or similar procedure to generate data on failures of critical equipments and instruments based on mode wise failures and their criticality. This requires codification of equipments, instruments and their modes of failure and their criticality. Consideration may be given to the use of appropriate software for processing FMECA data for review of the Preventive Maintenance Schedule and for improvement of the same to ensure critical failures, • Establishment of a Non Destructive Testing (NDT) system as necessary. This may not be feasible in-house but there are specialized organizations who undertake the work, and the same may be used. • Importantly, it is of great importance to collect and analyze information pertaining to minor incidents and accidents at the site, as well as for recording near-misses or emergencies that were averted. This information gives an indication of how likely or unlikely it is for the site to face actual emergencies and what should be further done to prevent them from occurring. • Establishment of an ongoing training and evaluation programme, incorporating the development of capabilities amongst employees about potential emergencies and ways and means of identifying and averting the same. Most emergencies do not occur without some incident or an abnormal situation. So there is always sometime of few seconds to few minutes to arrest an incident of abnormal situation from turning in to an emergency. This is the role of the shift in-charge who is the incident controller (IC) along with his shift team. • Material Safety Data Sheets (MSDS) or chemical information sheets (CIS) should be kept handy. • Fire and emergency alarms should be provided; alarm recognition training should be given to every employee. • Regular mock drills should be conducted on a specific potential disaster scenario as determined through risk assessment study • Safe operating procedures including safe emergency and normal shut down procedures and safe maintenance procedures should be adopted. • The roles and responsibilities of all responsible for the control of emergency should be clearly defined. • List of key personnel and authorities (including police, factory inspector, district magistrate, state and central level authorities, experts, doctors, village leaders) along with their location should be kept handy. • Personal Protective Equipments (PPEs) and safety torches should be made available.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Sufficient antidotes and first aid facilities like stretchers, beds, wheel chairs etc should be made available in the factory dispensary/hospital to cope with emergency. • Liaison with outside agencies, home guards and civic authorities for co-operation in mitigating the emergency consequences. 7.2.2. Identification and Compliance with Legislative Requirements: The following EHS regulatory requirements are applicable to the activities being planned, may be taken into consideration prior to actual commencement of operations. This checklist requires to be reviewed at quarterly intervals.
Table 7.1 : Applicable EHS regulatory requirements – Otsuka
Sr. Applicable Requirement Action Required / No. Legislation / Rule / Timing of Action Permit 1. NOC from the RSPCB A general permit to establish NOC to be applied for facilities for establishment of along with the plant operations. completed EIA report 2. License from the A general permit to On completion of Directorate of undertake plant activities detailed plant layout Industrial Safety and from a safety and and prior to Health / Factory occupational health commencement of Inspectorate viewpoint. operations. 3. Consent under the Air Permit to discharge air Application to be filed Act from the RSPCB emissions from the flue gas with the RSPCB once stacks and process stacks the NOC is obtained 4. Consent under the Permit to discharge Application to be filed Water Act from the wastewater resulting from with the RSPCB once RSPCB the project activities the NOC is obtained 5. Authorization to Permit to generate and Application to be filed generate, transport dispose hazardous wastes with the RSPCB once and dispose the NOC is obtained hazardous wastes from the RSPCB 6. Applicable permits Requirements of permits to If required, applications from the CCE, Nagpur be ascertained prior to to be filed and required for storage of establishment of facilities. permits to be obtained. explosive / flammable material 7. The Manufacture, Listing of hazardous If required, safety audit Storage and Import of materials; thresholds and safety report to be Hazardous Chemicals against which Safety Audit prepared. Rules, 1989 (as and Safety Report has to be amended till date) maintained; Requirements of disclosure of information; Availability of MSDS’;
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Sr. Applicable Requirement Action Required / No. Legislation / Rule / Timing of Action Permit 8. The Public Liability PLI Insurance to be taken Check whether The Act, 1991 (PLI) out company’s insurance under PLI covers the project under consideration 9. Chemical Accidents Preparation of Local and Identify whether Local (Emergency Planning, District Level Crisis Groups, or District Level Crisis Preparedness and for management of offsite Groups exist at site and Response) Rules, emergencies take proactive part in 1996 preparing Offsite DMP. 10. Factory License from A basic safety license to run Application prior to the DISH (Department the Factory. construction of Industrial Safety Health) 7.2.3. Identification of and communication with relevant Stakeholders This includes identifying, communicating and developing working relations with relevant offsite agencies that have an interest (either due to regulatory requirements or otherwise) in the continued safe operations of the site. On the basis of the Chemical Accidents (Emergency Planning, Preparedness and Response) Rules, 1996, (referred to as The Chemical Accidents Rules), following persons may be considered as relevant stakeholders with regard to the maintenance of Company’s emergency response at the district level: • District Collector • Inspector of Factories • District Energy Officer • Chief Fire Officer • District Information Officer • Controller of Explosives • Chief, Civil Defense • Deputy Superintendent of Police • District Health Officer/Chief Medical Officer • Commissioner, Municipal Corporations • Representative of the Department of Public Health Engineering • Experts (Industrial Safety, Health and Environment) • Commissioner (Transport) Following persons may be considered as relevant stakeholders at the local level:
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Sub-divisional Magistrate • Inspector of Factories • Representative of Industries in the District • Transporters of Hazardous Chemicals • Fire Officer • Station House Officer (Police) • Block Development Officer • One Representative of Civil Defence • Primary Health Officer • Editor of local News paper • Community leader / Sarpanch / Village • Non-Government Organization representatives • Eminent Doctors in the Local area 7.2.4. Formation of Emergency Plan Objectives Specific objectives of the Emergency Response Plan are to be clearly listed with regard to the responses required for successful management of the possible emergency situations. Suggested objectives could, initially include: • Formulation of suitable onsite / offsite fire release response • Improved awareness of safety issues amongst site personnel • Training of key persons in cardio-pulmonary resuscitation and other first aid Specific objectives as per requirement of the project shall be evolved eventually with the development of the project. Responsibilities, resources and timeframes are required to be allocated for implementing the objectives. 7.3. Implementation 7.3.1. Allocation of Resources Otsuka would ensure allocation of suitable resources for effective implementation of the Emergency Response Plan. The resources which shall be allocated would include both human and financial resources. 7.3.2. Emergency Structure and Responsibility
Emergency Organisation Structure The emergency organization is a network system with focus on the Emergency Control Centre (ECC), the Incident Controller (IC), and the Incident Site (IS). The following are office bearers of the Emergency Organisation: 7.3.3. OCIPL Disaster Prevention Committee (DPC) OCIL Disaster Prevention Committee with following member
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
Disaster Prevention Committee Member Takae Yamada Dr. Arun Malhotra Kiochi Sorajo Dr. K.K.Khemani Advisor Ajeet Dubey
When the accident has happened, Chief of committee will convene the DPC meeting. Till DPC meeting date, each responsible section manager must prepare a report. The report must include “accident summary, cause and proper measure as draft”. DPC will evaluate the report and they will judge whether the report is reasonable or not. DPC will have a right to take a decision and make a suggestion into the report.
When serious disaster has happened, Factory must not re-start the operation until committee gives the permission. After correcting the measures, members of committee will have an inspection and approval. This DPC managed matter will be called “Level A accident”.
Role & Responsibility of DPC
The accident finder must make an incident/accident report and then Director will make a decision that the accident is critical or not. If it is a critical accident, then the chief of committee will conduct a meeting. If it is not a critical accident, then the responsible manager will discuss with the Safety In charge and take a proper measure and ensure that similar incident/accident does not happen in future.
7.3.4. Emergency Control Center (EHS OFFICE)
Considering the wind direction at the moment, the Emergency Control Center will be selected near the scene of Emergency at a safe location.
The Emergency Control Center Room is the place under the control of Main Emergency Controller, from where the operations to handle the emergency are directed and co- ordinate. The centre of RESOURCES MOBILISATION, INFORMATION and MEDIA COMMUNICATION are to be installed by the advices of DPC and Main Emergency Controller.
FUNCTIONS:
The Emergency control center should be equipped to receive and transmit information and directions from and to from the Emergency Main Controller, areas of the incident, emergency services, public, mutual aids, private organizations and other sources.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
ESSENTIAL REQUIREMENTS:
The Emergency Control Room will work as directed by the Main Emergency Controller.
1) Communication facilities 1. Direct Telephone number 2. Telephone for attending incoming calls 3. Walkie-talkie
2) Telephone numbers of 1. Plant intercom 2. Nearby industries 3. Civil Authorities/NGO
3) Address data 1. All key personnel 2. All nearby emergency services like fire, medical services etc.
4) List of key personnel 1. Emergency Responder / First-aider 2. Emergency contact Nos. display board to contact with other emergency services
5) Documented Emergency plan 1. On Site
6) Office Stationary items 1. Writing Pad 2. Pen and Pencil 3. Tape recorders, camera and/ or video to record incident and evidence
7) Adequate number of PPEs.
8) Display of charts and maps indicating:
I. Road map to RIICO Factories II. Assembly points & shelters III. Details in respect of railway level crossing, water sources, parking points, police station, fire stations.
9) Layout of the plant indicating the location of
1. Assembly points 2. Hydrant System 3. Water spray System
7.3.5. (A) Emergency Control Action Plan
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 1. Receiving the information of Emergency Call to EHS (222)/Wireless (Chanel No. 12)/ Manual Call Points by plant/First Eye witness. 2. First-Aid /Primary Fire Fighting by Plant Personnel and Emergency Responder. 3. Declaration of emergency – by DPC Members/ /Incident Controller/ Main Emergency Controller (EHS)/Firemen. 4. Activate siren – Audio Alarm. 5. Security allows all vehicles to go inside if required. 6. All vehicles going inside should be parked (Near Fire Pump House) so that they do not obstruct the path way & they do not travel in Zones that have the probability of organic vapors. 7. Establish main emergency control center and on site emergency control center. 8. Responsible officer or the second line in command will report to Plant Control Center or Main Emergency Controller. 9. Medical officer or Medical Coordinator must remain in medical center. 10. Head count of all persons who are at assembly points by HR Deptt. 11. Essential staff will remain in control room. 12. Wait for new instructions & if instructed evacuated to pre-designated assembly points (Near Main Gate & Material Gate) looking at the wind direction. 13. Non essential staff – Contract manpower, Contract Supervisors, Civil Manpower will go to assembly points. 14. Barricading of road & traffic control by security Deptt.
15. Head count of all evacuated non-essential staff at assembly point & their transporting out to a safe location. 16. Collection of all Truck/ tankers drivers & assuring they do not obstruct the main pathway. 17. Communication to all-important stakeholders if needed to keep gossips under control. 18. Managing the Emergency A. Fire Fighting B. Rescue C. First Aid & Transfer to Medical center Stores to be opened to issue all essential materials as rope, shovels etc. 19. If required declaration of offsite emergency plan. 20. Information to district authorities, outside fire fighters, Director of factories. 21. Authorized person will report to media. 22. Declaration of completion of emergency. 23. Second line persons will be informed by HODs. .
7.3.6. Setting up of Emergency Infrastructure To enable the key persons to implement the EP, the following infrastructure will require to be set up:
Site Map with Escape Routes and Safe Assembly Points marked on it Site layouts have to be put up at key areas where assembly is to be done. These points could vary depending upon the atmospheric stability and location and intensity of the emergency.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) With the onset of emergency, all non-essential workers (those workers not assigned emergency duty) shall evacuate the area and report to the specified emergency assembly point.
Wind Sock It is required to install wind sock at the top of any tall structure in the vicinity of the site. In case there is a risk of the structure getting damaged during the emergency, it is desirable to have alternate wind sock(s) as required. At least one wind sock should be visible from any part of the site. Site personnel have to be trained in reading the atmospheric conditions on the basis of the status of the wind sock.
Evacuation, Escape and Rescue (EER) Plan In case of major emergency, it will be necessary to evacuate personnel from affected areas and as a precaution / measure to further evaluate non-essential workers from areas likely to be affected. Whether evacuation is required or not can be decided by the Incident Controller, and arrangements made to communicate with employees in this regard. Arrangements could include announcements over the public address system, or through other suitable means. On evacuation, employees should be directed to pre-determined assembly points already explained earlier. If they are required to be evacuated outside the site and at a remote place, their transportation will be necessary for which vehicles will be required. At remote shelters their care and welfare will also be through beforehand. Use own vehicles fist and then use, if necessary, the mutual aid system or hired vehicles from elsewhere. The vehicle may be needed to warn public also. The safe authorize passages/routes for escape shall be decided and marked by arrows in the plans as explained under as details of Emergency Control Centre
a. Safe Assembly Points In affected sites, all non-essential workers (who are not assigned any emergency duty) shall evacuate the area and report to a specified assembly point. The need to evacuate non-essential workers from non-affected areas will be determined by the foreseeable rate at which the incident may escalate. Plan layout showing evacuation path is required. Each assembly point must be situated in a safe place, well away from areas of risk and least affected by down wind direction. It may be in the open or in a building depending on hazard involved. Before reaching an assemble point, or subsequently, if it is required to pass through an effected area, suitable personal protective equipment (PPC) including respirator, helmets etc., should be available to the people
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) b. Emergency Control Centre An Emergency Control Centre (ECC) is the primary area from where emergencies are handled. An ECC should contain various items as listed. The Main Control Centre, or any structure on the site, that is designed to withstand overpressure and radiation stress should be designated at the ECC. For communication: • Siren, or other suitable alarm system • Intercom sets • External phone sets • Telephone directory • Company Directory • List of Important phone numbers • Walkie-talkies • Wireless set • Mobile phone Documents for ready reference: • Site Plan • Layout plan with hazard zones, assembly points marked and location of siren, safety/fire system shown (Display) • Stock list of Fire extinguishers • Fire-water system and additional sources of water • Emergency Response Plan and CP Flip chart, • Copy of First Aid • Mutual Aid Members list. • List of employees and their addresses and phones numbers. Wall display: • Site plan • Layout plan • Emergency Organization Besides these, it should also contain stationery, recording system, utility items (such as torches and umbrellas) and a first aid box. 7.3.7. Awareness, Training, and Competence
a. Awareness General awareness is to be invoked in all site personnel (including contractor’s employees) with regards to the importance of safety in general and emergency procedures in particular. Awareness can be generated in a number of ways, some of which are: • Awareness of Expanded Incorporation’s Environment, Health and Safety Policies, and the role of each employee in achieving what is covered under the policies.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Awareness of the importance of carrying out tasks as mentioned in the Standard Operating Procedures and the potential impacts of not doing so. • The importance of wearing personal protective equipment • Awareness with regards to relevant recommendations issued in this report. • Awareness about relevant portions of the safety instructions covered in equipment manuals used at site.
b. Training Specific training requires to be given to key employees. Examples of such training include: • Testing of critical equipment and controls • Training in Cardio-Pulmonary Resuscitation • Use of firefighting equipment • Emergency Evacuation and Rescue (EER) procedures. • Training in use of communication procedures to be followed in case of emergencies. • Training needs identification exercises should be undertaken prior to commencement of operations and the same must cover environment, health and safety issues.
c. Competence Competence is a function of training, experience and education. Key persons involved in administering the EP, should be competent. The level of competence can be decided for each key task and a clearly defined competence chart should be prepared. 7.3.8. Communication Communication is vital during emergencies. Under the Factories Act, as well as the MSIHC Rules, communication is important and it is required to divulge the potential emergencies that could arise out of the operations related to hazardous units. After undertaking an assessment of risks and their possible environmental impacts, and setting up an organization for the preparedness to control the emergency, including related infrastructure, the next step is operational zing the communications system. Depending upon the severity of the event, communications may have to be made with: • Persons inside the site premises • Key personnel outside the site premises during their non-working hours • Outside emergency services and authorities, and • Neighboring businesses, industries and general public.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Requirements pertaining to communication during emergencies are covered in this section.
a. Levels of Emergency Three levels of emergencies are to be recognized: • First level: Confined to a particular unit of the entire site, • Second level: A spreading emergency, that requires outside help, and • Third level: A major emergency requiring neighboring population to be alerted. Suitable alarms require to be made for each of these potential emergencies. The alarm should be audible in every part of the site. In areas of high noise levels, an alternative to an audible alarm, such as flashing lights may be installed.
b. Communication of Emergency There should be an effective system to communicate emergency: • Inside the factory, i.e. to the workers including key personnel and essential workers on duty, and inside normal working hours, • To the key personnel and essential workers not on duty and outside during normal working hours • To outside emergency services and the government authorities, and • To the neighboring businesses, and public in general
c. Communication inside with Personnel inside the Site during the Incident Relevant statutory information pertaining to the site must be made available beforehand, preferably in the form of a booklet, to workers so that they can prepare themselves to prevent or control the emergency. In all cases, once the communication of emergency is done, through an alarm, all personnel should be ready to undertake their roles in the same.
d. Communication with Personnel outside the Site during the Incident Because of the suggested planning, key personnel will typically be available in all shifts or on short call. But due to some reason, if some are outside or not on duty and if their help is required, their updated details should be kept in the ECC for communication.
e. Communication inside with External Emergency Services and Relevant Authorities Communication with external agencies is important and essential, both to control the emergency and as per regulatory compliance requirements. This is specially so for reportable (lost time) accidents. In such cases, it is essential that the outside emergency
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) services as well as relevant outside agencies be informed in the shortest possible time. Liaison at the local level will help determine the best means for achieving this. Relevant agencies that provide emergency services include the fire brigade, nearby hospitals and doctors, and the police, besides senior local and district administration personnel. Statutory information, given to such agencies in advance will help them in arranging emergency services.
f. Communication with Neighboring Firms and the General Public In the study area, since there are other major industries, contact with these industries in the study area with a view of receiving mutual aid, may be practical. The public in the area, in some circumstances, may require to be informed about the emergency, which as stated earlier, should be done after careful evaluation.
g. Communication with District Crisis Group and the Local Crisis Group In addition to the general public communication will require being provided to the district administration and this may be done by liasioning with different agencies. 7.3.9. Emergency Documentation and Document Control
Documentation Emergency documentation consists of: • The Emergency Plan • The Contingency Plan • Related Formats and Records showing compliance with these documents The EP and CP need to be approved by the project in-charge prior to use. All documents should be easily accessible at site.
Document Control • Documents should be legible • All documents should be protected against damage, deterioration and loss • Changes, if any, should also be approved by the project in-charge • Copies of the approved EP and CP are to be kept with the project in-charge at the project office, as well as at each site, in the Emergency Control Centre, with the site in-charge / Site Main Controller • Obsolete documents should be marked as such, and copies of such documents are to be collected and prevented from being used 7.3.10. Emergency Control In case of emergencies, actions can broadly be categorized into the following activities:
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Saving of human lives • Controlling the spread of the emergency and ultimately stopping it from further developing On the basis of the issues covered in this chapter, the following are required to be incorporated into the CP for implementing this EP’s requirements: • Onsite Emergency Control • Shut down and Isolation: Raising the alarm, followed by immediate safe shut down of the power supply, and isolation of affected areas. • Escape, Evacuation and Rescue: Safeguarding human lives at site by commencement of the Emergency Evacuation and Rescue Plan. Ensuring that all personnel are accounted for and carrying out a head count of persons evacuated. Notification and commencement of offsite emergency plan in case offsite impacts are possible. • Stopping the development of the emergency: Control or response to the emergency depending upon its nature (fire or explosion). • Treatment of injured: First aid and hospitalization of injured persons. • Protection of environment and property: During mitigation, efforts should be made to prevent impacts on environment and property to the extent possible. • Welfare of the personnel managing the emergency: Changeover, first aid and refreshments for the persons managing the emergency. • Informing and collaborating with statutory, mutual aid and other authorities including those covered in the Local Crisis Group. • Informing and assisting relatives of the victims. • Informing the news and electronic media. • Preserving all evidences and records: This should be done to enable a through investigation of the true causes of the emergency. • Investigation and follow up: This requires to be carried out to establish preventive measures for the future and a review of the EP and CP to fill up the deficiencies in the emergency planning procedures. • Ensuring safety of personnel prior to restarting of operations: Efforts require to be made to ensure that work environment is safe prior to restarting the work.
Off-site Emergency Response Plan The following are the Expanded Incorporation’s responsibilities towards generation of the Offsite Emergency Plan: • To provide basic information on Risk and Environmental Impact Assessment to the Local/District Authority, Police, Fire Brigade, Doctors, surrounding industries and the public and to appraise them on the consequences and the
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) protection/prevention measures and control plans and seek their help to manage the emergency. • To assist the District Authorities in preparing the Off-site Emergency Plan. An off-site emergency plan organization has essentially two parts: • Formation of the Local Crisis Group: This Group is headed by the Deputy Collector or the Magistrate of the Industrial area and is responsible for the management of any industrial emergency confined to the local area. • Formation of the District Crisis Group: This Group is headed by the District Collector of the District and is responsible for any major Industrial emergency affecting Local and beyond any industrial area of the District. The composition of the Off-site crisis is covered in. since, the actual offsite plan requires the participation of outside agencies; this report does not dwell further on the issue.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 7.4. Checking and Corrective Action 7.4.1. Monitoring and Measurement Monitoring of the planned arrangements and the implementation of the EP are essential to deliver the required output and enhance emergency preparedness. This includes: • Provisions for NDT, FMECA and other tests to identify failure of critical equipment, before it actually takes place. • Monitoring compliance to permits and statutory requirements laid down by regulatory authorities. • Conducting mock drills (including fire drills and toxic release drills) to check whether the planned arrangements are working as per the required norms or not. • Testing of critical equipment, and • Identifying minor leaks, accidents, near misses and others incidents that can lead to emergencies. A detailed monitoring checklist requires being prepared and the required actions carried out, prior to start of work. 7.4.2. Records Records are a means of evaluating performance. Records include (but are not limited to): • Regulatory records, such as permits and related documents • Monitoring and test records • Correspondence with relevant offsite and onsite agencies Site management will ensure that records are properly maintained and available. It is desirable to keep copies of all records at the site, to prevent their loss. The retention time for these records will depend upon their criticality and an ultimate decision will require to be taken by The Company in this regards. Legal records should be kept permanently. 7.4.3. EP Audit, Non Conformance and Corrective Action and Preventive Action Since this EP has been designed as a dynamic document, it is required that its performance be audited at regular intervals. Ideally, persons auditing the EP should be external auditors (i.e. not employed at the site being audited). The audit should result in a set of findings that are put before the site management for review. 7.5. Review of Emergency Performance The site / office management will review the findings of the audit and the non- compliances. It will consider whether the EP is providing adequate safety assurance to the management, delivering performance as desired, and whether it continues to be in the spirit of Expanded Incorporation’s Environment, Health and Safety Policies, and changing requirements. On the basis of these, the Expanded Incorporation’s management will record its steps and consider modifying the EP, as deemed appropriate. 7.6. The Contingency Plan
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) The Contingency Plan (CP) is meant to be a ready reference flip chart that is site specific. It contains forms that require to be filled up prior to commencement of actual fieldwork. Guidelines provided in the EP, may be taken into account prior to filling up of the CP. 7.6.1. Contents of the Contingency Plan The CP should first be completed in respect of the names, addresses and contact phone numbers of all the members of the emergency organization. In addition, the names, addresses and phones numbers of nearest police station, local authorities, media, doctors, hospitals, fire brigade, voluntary organizations, and home guards also require to be collected. Once this, (and other) updating of CP has been done for the site, the same may be got printed and kept with each officer, work sites and security, and other relevant persons as may be needed. The items covered in the CP are: • Emergency organization • Siren code • Site map with escape routes and safe assembly points • Emergency control centers • Role of site main controller • Role of incident controller • Role of deputy incident controller • Role of fire safety services • Pollution control • Medical services • Engineering services • Welfare services • Security services • Replenishment services • Mutual aid • Internal emergency reporting and communication system • Safe assembly points • Evacuation, escape and rescue (EER) plan • MCLS • Atmospheric stability class prevalence (ASCLAP) in the area • Hazard distances of gas dispersions under different stability classes • Mutual aid organizations • Mock drill and review procedure • Offsite plan components 7.7. Emergency Organization
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Emergency Organization would be develop and plan as per formate and promittent display in the organization. The emergency organization formate given in Table 7.2 .
Table 7.2 : Emergency Organization EMERGENCY POSITION NAME PHONE OFFICE MOBILE Chief of Disaster Prevention Committee Takae Yamada 101 Disaster Prevention Committee 103 Member Dr. Arun Malhotra Disaster Prevention Committee 104 7023000538 Member Kiochi Sorajo Disaster Prevention Committee 201 8003899891 Member Dr. K.K.Khemani S.K. Singh 203 9660019026 Emergency Process Coordinators Vijay Mahajan 418 9672976611 Emergency Mechanical Coordinator Jaswant Singh 204 9672996641 Emergency Commercial Coordinator Mahender Banga 123 9784002081 Emergency Utility Coordinator C.S. Panisha 202 9784002082 Emergency Communications 122 9799499794 Coordinator Surendra Dhaka Emergency Instrumentation 206 9672976624 Coordinator Ritesh Kumar Emergency Medical Coordinator Kailash Hospital 9351161611 Emergency HR Coordinator Ankit Kumar Dubey 131 76654366887 Emergency Electrical Coordinator Manoj Kumar 207 9950588713 Emergency Security / Administration 301 9887169234 Coordinator Anurag Shivhare Main Emergency Controller Ajeet Dubey 300 9636066656
7.8. Incident Controllers E & S Processes S.K.Singh / Shift In charge S-501 Process Ajeet Dubey / Shift In charge C, SR & G1 Yard Vijay Mahajan / Shift Incharge Engg, Building, Engg store, Mech, W/S Jaswant Singh / Shift Incharge LTPCC-01, 02 & MCC Rooms Manoj Kumar / Shift Incharge ETP Anil Dohare / Shift Incharge Boiler, MEE, Incinerator C.S.Panisha / Shift Incharge Warehouses, Tank Farms, Admin Block, Gathering Hall Mahendra Banga / Shift Incharge QA/QC S.S.Dhaka / Shift Incharge Utility C.S.Panisha / Shift Incharge
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 7.9. Site Layout Plan with Escape Routes and Assembly Points A layout of site is to be prepared incorporating escape routes and assembly points. Location of the emergency control center(s) are to be marked on the map. 7.10. Escape, Evacuation and Rescue (EER) Plan 7.10.1. Escape Non-essential personnel have to escape through safe escape route towards the nearest assembly point. 7.10.2. Evacuation All non-essential personnel who have assembled at the safe assembly points have to be evacuated from the site, then noted down as part of head count and evacuated to temporary shelter outside, like nearest village school, panchayat office or other area as previously determined. 7.10.3. Rescue On receipt of Incident information, any trapped personnel have to be rescued. This requires rigorous training. The rescuers must first ensure their own safety. There should be at least two rescuers for each victim to be rescued. The following procedure may be followed: • Preplan the rescue operation as to who will hold shoulders and who the legs of the victim, • Ensure appropriate gas mask and other PPE is worn by each rescuer, • See the nearest windsock and approach the site of victim from upwind. If no PPE is available nearby, then take a deep breath, hold breath and approach, • Undertake rescue operation swiftly and confidently, • Check victims first needs • Impart first aid as appropriate, including CPR and oxygen breathing, • Call for ambulance and shift victim to nearest doctor/hospital. 7.11. Credible Loss Scenarios The results of the consequence analysis lead to the possibility of the Credible Loss Scenarios results. 7.11.1. Atmospheric Stability Class Prevalence (ASCLAP) for nearest Observatory Atmospheric Stability Class is the vertical and horizontal mixing of air and depends on the solar radiation and cloud condition. Information pertaining to the nearest IMD station is to be collected and kept for use. 7.12. Mutual Aid Organizations A table showing various mutual aid organizations and their contact details should be prepared and kept ready.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) 7.13. Mock Drill and Review Procedure The mock drill and review procedures are as follows: • Everyone should synchronize his watch daily with the main clock at security gate to ensure the timings recorded by observers match with each other, • One mock drill is to be conducted once in a period of 6-Months, • The plan of mock drill should be known to Site Main Controller and Incident Controller and observers only, • Mock drill should be against one of the MCLS studied in the EP-CP Report, • There should be at least two mock victims, • All the steps of CP from available incident report raised by a trained or untrained observer to the all clear siren are to be rehearsed, • Observers to be set up at the Incident Site, at each Assembly point, ECC and First Aid Center. • Observers should record each activity with timings and head counts etc., • All clear siren to be sounded only after head count tallies with gate entry list. • After all clear is sounded, all personnel belonging to Emergency Organization should assemble at the pre decided conference room for Mock drill review, • Review to be conducted to check effectiveness of CP-Implementation in terms of the following: o The first witness’ incident call, o Actions by Incident Controller to prevent Incident o EER operations, o Communication system, o Other activities, o Review CP to overcome deficiencies in the Mock Drill. 7.14. Offsite Plan Components Based on the details of the hazard distances of identified containment loss scenarios, the detailed offsite plan may be drawn up in consultation with the Local Authorities. 7.15. Recommendations Recommendations are made for different aspects of the project and are given in subsequent paragraphs. 7.15.1. Storage of Hazardous Chemicals in Bulk • Attempt should be made to find suitable less hazardous alternate chemicals, to replace the hazardous chemical. The inventory of all hazardous chemicals for that matter must be kept as minimum as possible • The tanks should be located so as not to pose safety problems due to leakage and reaction with other chemicals stored nearby
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • The storage area should be declared as a prohibited area and should be provided with fencing having at least two exits / “No Smoking” and/or “Prohibited Area” display boards, as applicable should be provided at site • The storage tank and foundation should be of suitable material of construction to prevent corrosion • The connections and openings to the tank should be as less as possible so that the possibility of leakage and maintenance hazards is minimized • Each storage tank should have necessary instruments to monitor its level, pressure and temperature • The storage tanks / area should have suitable fire protection and fire fighting facility • The name of chemical, type of hazard, emergency operational instructions, antidote first aid etc. should be displayed near each tank • All cables and electric fittings shall be constructed, installed, protected, operated and maintained in such a manner so as to prevent risk of open sparking 7.15.2. Storage of Hazardous Chemicals in Drums and other Containers • The drums should never be filled full with the liquid chemical. There should be sufficient space to take care of thermal expansion • The drums should preferably be stored in a well ventilated shed (preferably away from process units) with impermeable floor sloping away from drums • Periodic site inspection should be carried out to ensure that there is no leakage from any of the drums 7.15.3. Unloading of Tank Trucks • Before the tanker enters the industry premises, the tanker is to be inspected for authorized entry and safe and sound condition of the tanker, its contents and that of the prime mover. Tankers entering plant are to be fitted with flare arresters on their exhaust • Static charge neutralizing at gate entry only • The quality of the chemical in the tanker should be ascertained before unloading to avoid contamination of chemical already at storage • Coupling used for connecting hose to tanker must be leak proof • For flammable chemicals, the tanker and the hose are to be properly earthed before starting unloading operation • Unloading should be done under personal supervision of responsible staff authorized by the management • Provision of sample quantity of water / neutralizing medium to take care of leakage / spillage must be made. Also steam and inert gas hose stations must be available at unloading point
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Fire alarm and fire fighting facility commensurate with the chemical should be provided at the unloading point 7.15.4. Hazardous Waste Transport The occupier of hazardous substance shall prepare six copies of the manifest (transporting documents) in Form 9 comprising of colour code indicated below (all six copies to be signed by the transporter): • Copy 1 (white): to be forwarded by the occupier to the State Pollution Control Board or Committee • Copy 2 (yellow): to be retained by the occupier after taking signature on it from the transporter and rest of the four copies to be carried by the transporter • Copy 3 (pink): to be retained by the operator of the facility after signature • Copy 4 (orange): to be returned to the transporter by the operator of facility after accepting waste • Copy 5 (green): to be returned by the operator of the facility to State Pollution Control Board / Committee after treatment and disposal of wastes. • Copy 6 (blue): to be returned by the operator of the facility to the occupier after treatment and disposal of wastes The occupier shall forward copy number 1 (white) to the State Pollution Control Board or Committee and in case the hazardous waste is likely to be transported through any transit State, the occupier shall prepare an additional copy each for such State and forward the same to the concerned State Pollution Control Board or Committee before he hands over the hazardous waste to the transporter. No transporter shall accept hazardous wastes from an occupier for transport unless it is accompanied by copy numbers 2 to 5 of the manifest. The transporter shall return copy number 2 (yellow) of the manifest signed with date to the occupier as token of receipt of the other four copies of the manifest and retain the remaining four copies to be carried and handed over to respective agencies as specified in sub-rule (4). 7.16. General Safety Practices 7.16.1. Work Permit System • It is recommended that plot plans of the installation and the operating blocks should be displayed in the fire and concerned unit control rooms respectively and site of hot jobs under progress should be indicated on these plot plans with red pins • No hot/cold work shall be undertaken without a work permit except in the areas pre-determined and designated by the owner-in-charge • Permit should be issued only for a single shift and its validity should expire at the termination of the shift. However, where the work has to be continued, the same permit may be revalidated in the succeeding shift, by authorized person after satisfying the normal checks
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Equipment or area where work is to be conducted should be inspected to ensure that it is safe to carry out the work and assess other safety requirements / stipulations • Unsafe conditions for performance of work may arise from surrounding area. It should be cleaned-up to remove flammable material such as oil, rags, grass etc • Other activities (routine / non-routine) being carried out near-by which can create conditions unsafe for performance of the permit work, should be taken into consideration and the concerned persons should be alerted accordingly • Running water hose and portable fire extinguisher are required respectively to flush / dilute in case of release of any hazardous chemical or to quench sparks and to put out small fires immediately • In order to meet any contingency, it should be ensured that the fire water system including fire water pumps, storage, network etc. is checked and kept ready for immediate use • Equipment / Vessel, on which the work permit is being issued, should be completely isolated from the rest of the plant with which it is connected during normal operation, in order to ensure that there is no change in the work environment with respect to presence of toxic / flammable gases, liquids, hazardous chemicals etc. in the course of the work • Equipment under pressure should be depressurized after isolation. This will be followed by draining / purging / water flushing etc. as the case may be • Proper means of exit is required in case of emergencies developed on account of the work or otherwise. Availability of an alternate route of escape should be considered 7.16.2. Contractor Safety Duties and responsibilities of the contractor should include the following: • To implement safe methods and practices, deploy appropriate machinery, tools and tackles, experienced supervisory personnel and skilled work force etc. required for execution • To prepare a comprehensive and documented plan for implementation, monitoring and reporting of Health, Safety and Environment (HSE) and implement the same after its approval • To nominate qualified and trained Safety Engineers / Officers reporting to the Site in charge, for supervision, co-ordination and, liaison for the implementation of the safety plan • To arrange for fire protection equipment as per the advice of owner • To ensure that its employees have completed appropriate health and safety training as required by the statute / regulation and also as per requirements of the Owner / Consultant • To comply with all the security arrangements of owner • To ensure availability of First Aid boxes and First Aid trained attendant
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • To ensure that all incidents including near misses are reported to all concerned immediately • To ensure strict compliance with work permit system by carrying out work only with appropriate work permits and after ensuring that all safety precautions / conditions in the permit are complied with and closing the same after job completion • To ensure that the workers likely to be exposed to hazardous chemicals/materials have access to appropriate Material Safety Data Sheets (MSDS), wherever applicable, and provide necessary mitigation measures • To ensure that appropriate warning signboards or tags are displayed • To ensure that workers have proper training for their job assignments, including use of appropriate PPE and first aid fire fighting equipment • To comply with all applicable safety and health standards, rules, regulations and orders issued by competent authority pertaining to the assigned activities • To conduct daily inspections to ensure compliance with safety standards, codes, regulations, rules and orders applicable to the work concerned 7.16.3. Static Electricity • Ensure no metal objects/appurtenances projecting from roof/shell plates, which will attract highly charged spots in fuel for dissipation • Ensure reduced rate of flow initially into tank/vessel until fill point/nozzle is completely submerged in fluid • Ensure periodic checking and recording of earthing test for tanks and piping systems are maintained • Agitation with air, steam gas, jet nozzle or mechanical mixtures should be avoided • Ensure no personnel is allowed on tank roof for gauging / sampling during product transfer unless dip pipes extend to bottom of tanks. Use only mechanical gauges for ascertaining product transferred during transfer operations otherwise • Protective bonding is required when fill open containers where the product to be handled has a flash point below 54.5 oC (130 oF) or, in the case of a higher flash point product, when it is heated to within 6.0 oC (15 oF) of its flash point. The purpose is to keep the nozzle and container at the same electrical potential, thus avoiding a possible static spark in the area of a flammable mixture • Small containers made up of plastic or other non-conductive materials should not be used for filling of fuels • Water washing is safe from a static electricity stand-point. However, there should be no insulated conductive objects within the tank 7.16.4. Lightning Protection • Measures to control fugitive emission from storage tanks should be given special consideration • Structures of exceptional vulnerability by reason of explosive or highly flammable contents need special consideration and every possible protection need to be provided even against the rare occurrence of a lightning discharge
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • A lightning protection system (Conventional Air Terminal System) consists of the following three basic components - Air terminal, Down conductor and Earth connection • Non-conducting chimneys whose overall width or diameter at top is upto 1.5m shall be provided with one down conductor, and chimneys with overall width or diameter at top more than 1.5m shall be provided with 2 no. down conductors • Metal stacks shall be properly earthed at the bottom • Flammable liquids shall be stored in essentially gastight structures • Openings where flammable concentrations of vapour or gas can escape to the atmosphere shall be closed or otherwise protected against the entrance of flame • Structures and all accessories e.g. dip-gauge hatches, vent valves shall be maintained in good and sound operating conditions • Flammable air-vapour mixtures shall be prevented to the greatest possible extent from accumulating outside storage tanks • Potential spark-gaps between metallic conductors shall be avoided at points where flammable vapours may escape or accumulate • A properly designed / constructed gas tight storage tanks considered to be self- protected against lightning provided it is properly earthed and bonded. Such a structure may not require any additional means of lightning protection 7.17. Personnel Safety 7.17.1. Personnel Protective Equipment • All entrances to areas where fungicides are manufactured, formulated, repackaged, stored or otherwise handled shall be posted with signs specifying. • Special clothing and personal protective equipment necessary for entry. • Protective equipment should be inspected frequently to ensure that it is in good condition. Frequency of checking can be decided depending upon the usage. • After the use of protective equipment, it should be cleaned and disinfected before being issued to another person • Glove materials must resist the product’s active ingredients and its solvents. it should allow adequate grip so that applicators can safely carry out their jobs(e.g. change nozzles and screens) • Never leave Drug contaminated gloves or clothes behind the seat, on the floor board, above the visor, on the stick shift or in the bed of the truck because drugs residues may transfer to such surfaces. • For protection of eyes always use goggles, polycarbonate lenses are preferred to protect eyes from flying objects. Face shields are secondary means of eye protection and are designed to be worn over safety spectacles or goggles for full face protection.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • When purchasing eye protection, make sure it complies with ANSI Z87 for occupational and educational eye and face protection. • Sleeve guards should be use when handling hazardous materials to avoid the splashing effect of material. • Wash contaminated clothing and other PPE daily, as soon as possible after wearing. Delay in laundering will reduce the likelihood of total residual removal • Follow the work instruction/checklist. • Know about MSDS of hazardous chemicals used. • A person not-familiar with MSDS and trained in use of appropriate shall not commence any work with hazardous chemicals. • Frequently refer to the MSDS and use of appropriate PPE • Display prominently requisite information on MSDS and use of PPE through illustrations • It is essential that right type of PPE and in sound condition be used. • All stocks of PPEs should be periodically inspected, serviced and maintained and unusable ones removed from stock of usable PPEs and sent for disposal. • All PPEs should be cleaned for personal hygiene and kept packed in poly bags. • All PPEs should be inspected before and after each use. 7.17.2. Training • Participant’s reaction should be obtained in respect of the course content; training methods/techniques used by the faculty, quality of course material etc. • Before employees are exposed to any API formulation, inert or raw material, they should be fully apprised of the following. a. Identification by name, characteristics (smell, appearance, etc) and physical properties. b. Hazards of toxicity. c. Signs and symptoms of overexposure d. Fire and explosion hazards. e. Precaution of safe handling f. Emergency first aid treatment for over exposure. • It should be ascertained whether participants’ are learning in terms of knowledge and skills in specific areas or activities e.g. safe operating and maintenance procedures, fire prevention and control etc. have improved after the training. • It should be checked in what ways and to what degree/extent the attitude of the participants (values or beliefs) have been influenced by the training programme. An evaluation of their behavior on the job is necessary for this purpose. • Change in participants’ performance at their place of work as a result of the training, should be evaluated.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • The effectiveness of faculty in each training programme should be evaluated and necessary changes if need be, should be made in subsequent training programme. • The impact of the training programme on the performance standards of the organization and attainment of tangible results with respect to safety should be evaluated. • Records of training should be maintained in respect of every employee indicating the types and the period of training programme attended, performance evaluation and the need for future training. • The impact of training programme should be evaluated in terms of overall safety objectives achieved. 7.18. Safety of Plant Equipment 7.18.1. Thermal Insulation • Frequency of Visual Inspection shall be once a year for plants and mobile equipment. This visual inspection shall be preferably carried out before monsoon, to check for any damage/deterioration, and record the same. • Like equipment, insulation also shall be checked and maintained at regular intervals. Preventive maintenance of insulation is very much necessary for safe and economic operation. 7.18.2. Electrical Equipment • Before initiating the inspection of electrical equipment and associated circuits, Inspector should familiarize himself with the complete previous history of the equipment/circuits, design parameters, service, and likely areas of concern, manufacturer’s recommendations and such other pertinent data to arrive at the appropriate inspection procedure. • The field inspection of electrical equipment in an operating unit is classified into following three types as follows: On Stream Inspection This covers audio visual inspection items (instrument aided or otherwise) for checking of general equipment conditions, while the equipment is in operation. (e.g. an abnormal nose or vibration of motor, leakage of transformer oil or overheating of equipment etc., can be accessed through such inspections). Shutdown Inspection This covers those inspection items for checking conditions of equipment and systems which cannot be revealed through on-stream inspection (such as internal condition of equipment). This inspection shall be carried out after taking the shutdown of the related equipment after obtaining the Electrical Line Clearance and Work Permit requirements Inspection of Standby Equipment and Spare Parts
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) The standby electrical equipment electrical equipment shall be inspected on the same basis and schedule applicable under shutdown inspection, so that changeover from normal to standby equipment shall be possible without any downtime of unit operation. 7.18.3. Reactors Reactors will be designed such that the safe working pressure of the reactors is never exceeded. As per the American Society of Mechanical Engineers (ASME), the safe working pressure of a vessel should always be higher of the two conditions mentioned: • 10% higher than the maximum operating pressure, or • 2 kg/cm2 more than the maximum operating pressure • Minimum statutory requirements include: • Safety relief valves or rupture discs • Pressure gauges • Isolation valves or valves to prevent connected equipment over-pressurization • Drain valve at the bottom to drain of condensates Vents of pressure relief systems should lead to a surge tank whose vent should lead to a scrubbing system that should have reserve overhead water tank with interlock with critical operating parameters such as pressure. Other safety devices that may be considered include: • High / low pressure alarms, and • Interlocking equipment to prevent over-pressurization; such as between compressors and connected equipment. Pressure relief devices and rupture discs are always the last resort. Engineered design should include high / low pressure alarms, auto trips that are set up at pressure above the operating pressure but below the relief systems. In general, all reactors and pressure vessels will conform to rules laid down in The Static and Mobile Pressure Vessels (Unfired) Rules 1981. 7.18.4. Equipment Safety
Pumps Pre-starting procedure
• Equipment: Pump shall be thoroughly cleaned • Piping: Assembly of all piping shall be checked to ensure that they are as per the design drawing. Piping shall be thoroughly flushed to remove rust preventive/foreign material • Support: Relevant pipe supports shall be checked to ensure that they are as per design drawing • Alignment: Alignment of pump and prime mover shall be carried out
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Bearing: Bearings shall be lubricated with correct lubricant wherever applicable • Prime mover: The prime mover shall be prepared for operation as manufacturer’s instruction. In case of Electric Drive correct direction of rotation shall be ensured in decoupled condition. Insulation value of motor and cable shall be checked and recorded • Packing: For gland packing and mechanical seal, cooling and flushing shall be ensured. Mechanical Seals (if applicable) shall be installed as per manufacturer’s recommendations • Heating up before startup: Pumps on high temperature service shall be heated up gradually to an even temperature before putting on service • Balancing drum leakage: For pumps equipped with balancing drums, any valve in the line shall be locked open for ensuring leakage return to pump suction or to the vessel Start-up Procedure • The free rotation of the pump shall be checked • Ensure all instruments are installed as per diagram • Ensure that strainer is provided in the suction line • Discharge valve shall be closed (if not already closed) • On pumps having externally sealed stuffing boxes, the injection line valves shall be opened and sealing fluid allowed to flow to the seal cages • Pump shall be properly primed • Prime mover shall be started as per prescribed recommendation Post-start Checks • All instrument readings shall be checked and recorded periodically • Vibration readings shall be checked and signature shall be taken as necessary • Stuffing box packing shall be checked for overheating • Temperature rise, vibration and any abnormal sound from bearings shall be checked • Cooling water flow shall be checked frequently • Suction and discharge pressure shall be monitored to ensure proper operating condition Diesel Engines • Fuel, oil, water and exhaust shall be checked for leaks • Air cleaner oil level shall be checked • Oil level in hydraulic governor shall be checked, if provided
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • The following checks shall be carried out after every 250 hours - condition of entire oil, the filter elements for metal particles and oil sludging, element holes and tears, oil in aneroid control, if provided, belts, fan hub and drives
Mechanical Seals Inspection of Seal Components Prior to Installation: • It should be ensured that all parts are kept clean; especially the running faces of the seal ring and insert • The seal rotary unit should be checked to ensure that the drive pins and/or spring pins are free in the holes or slots • The set screws in the rotary unit collar should be checked to ensure that they are free in the threads • The thickness of all gaskets should be checked against the dimensions shown on the assemble drawing. Improper gasket thickness will affect the seal setting and the spring load imposed on the seal • The fit of the gland ring to the equipment should be checked to ensure that the gland ring pilot enters the bore with a reasonable guiding fit for proper seal alignment. It should be ensured that there is no interference or binding on the studs or bolts or other obstructions • It should be ensured that all rotary unit parts of the seal fit over the shaft. ‘V’ ring should be placed on the shaft individually, and never be installed on the shaft while they are seated in the seal ring or rotating assembly • Both running faces of the seal should be checked to ensure that there are no nicks or scratches. Imperfections of any kind on either of these faces will cause seal leakage Fixing of mechanical seal • The complete seal assembly drawings and instructions should be carefully studied before starting installation • All burrs and sharp edges should be removed from the shaft or shaft sleeve including sharp edges on key-ways and threads. Worn shaft or sleeves should be replaced • The stuffing’s box bore and stuffing box face should be checked to ensure that they are clean and free of burrs • The shaft or shaft sleeve should be marked with various reference marks required for installation of seal as per assembly drawings • The shaft or sleeve should be oiled lightly prior to seal assembly to allow the seal parts to move freely over it • The rotary units should be installed on the shaft or sleeve in proper sequence • The back of the collar should be set at the proper distance from the original reference mark on the shaft or sleeve. Tighten all set screws firmly and evenly
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • The seal faces should be wiped clean and a thin oil film applied prior to completing the equipment assembly • The gland ring should be inserted with insert over the shaft carefully. Complete the equipment assembly taking care when compressing the seal into the stuffing box • The gland ring and gland ring gasket should be seated to the faces of the stuffing box by tightening the nuts or bolts evenly and firmly enough to affect a seal at the gland ring gasket
Rotating Equipment • Maintenance work on any rotating equipment should be started only after obtaining the work permit from the concerned department. Ensure that the equipment is electrically isolated • During opening of equipment such as pumps and compressors, it is a good practice to treat the equipment as if it were under considerable pressure even though all steps have been taken to relieve the pressure • Vehicle entry permit should be obtained from the concerned authority before bringing any crane or any other equipment for removing the pump
Inspection of Storage Tanks • Inspection of tanks during fabrication shall be carried out as per the requirements of the applicable codes, specifications, drawings etc. This inspection requires regular checks on the work at various stages as it progresses. During fabrication, a thorough visual check should be undertaken and the tank should be checked for foundation pad and slope, slope of the bottom plates, proper welding sequence and external and Internal surfaces etc. • Roof plates shall be inspected for defects like pin holes, weld cracks, pitting etc., at water accumulation locations • Tanks pads shall be visually checked for settlement, sinking, tilting, spelling, cracking and general deterioration • Anchor bolts wherever provided shall be checked for tightness, and integrity by hammer testing • All open vents, flame arrestors and breather valves shall be examined to ensure that the wire mesh and screens are neither torn nor clogged by foreign matter or insects • If a tank is insulated, the insulation and weather proof sealing shall be visually inspected for damage • Grounding connections shall be visually checked for corrosion at the points where they enter earth and at the connection to the tank • The tanks shall be inspected for any obvious leakage of the product. Valves and fittings shall be checked for tightness and free operations
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • The tanks shell shall be visually examined for external corrosion, seepage, cracks, bulging and deviation from the vertical
Pipes, Valves and Fittings • The inspection of piping during fabrication shall be carried our as per the requirement of applicable codes, specifications, drawings, etc. This inspection requires regular checks on the work at various stages as it progresses. The inspection shall include Identification and inspection of material, approval of welding procedures in accordance with code and tender requirement, carrying out of performance qualification test and hydrostatic testing. • Visual inspection shall be made to locate leaks. Particular attention should be given to pipe connections, the packing glands of valves and expansion joints. • Pipe supports shall be visually inspected for condition of protective coating or fire proofing if any. If fireproofing is found defective, sufficient fireproofing should be removed to determine extent of corrosion. • If vibrations or swaying is observed, inspection shall be made for cracks in welds, particularly at points of restraint such as where piping is attached to equipment and in the vicinity of anchors. • Line shall be checked for bulging, bowing and sagging in between the supports. • Conditions of paint and protective coating shall be checked. • Pipelines shall be inspected for cracks. Particular attention should be given to areas near the weld joints. • Externally coverts lined piping shall be visually inspected for cracking and dislodging of concrete. • All piping, which cannot be checked on the run, shall be inspected during shutdown. These are mostly high temperature piping. During shutdown inspection, hammer-testing and hydro testing as applicable should be carried out in addition to visual, ultrasonic and radiographic inspections. • Pipelines in some of the services like water, phenol and steam are prone to pitting corrosion. Neither ultrasonic nor radiographic testing will reveal the actual internal condition of the pipes in such service. In such cases samples shall be cut for thorough internal examination, at scheduled comprehensive inspections. The samples shall be split open in two halves and internal surfaces inspected for pitting, grooving, etc. • Piping shall be opened at various locations by removing valves at flanged locations to permit visual inspection. When erratic corrosion or erosion conditions are noted in areas accessible for visual examination, radiographic examination or ultrasonic testing shall be performed to determine thickness. • The gasket faces of flange joints, which have been opened, shall be inspected visually for corrosion and for defects such as scratches, cuts and grooving which
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) might cause leakage. Ring gaskets and joints shall be checked for defects like dents, cuts, pitting and grooving. • Inspection shall be made for hot spots on internally insulated piping. Any bulging or scaling shall be noted for further inspection when the equipment is shut down.
Pressure Relieving Devices • All pressure relieving devices shall be bench tested for set pressure, blow down and leakage as applicable prior to installation. • The following inspection checks shall be carried out once in every six months for breather valves on storage tanks - discharge opening should be checked for obstruction, flame arrestor wherever provided shall be inspected for fouling, bird nests or clogging, element shall be inspected for mechanical damage, deposits, scaling etc. and cleaned before onset of monsoon, oil filled type liquid seal valve shall be inspected for oil level, fouling, bird nests, foreign material etc. and free movement of pallet shall be checked. • Visual inspection of different parts of safety valve shall be done after dismantling to check the condition of flanges for pitting, roughening, decrease in width of seating surface etc. 7.19. Tank Farm Safety 7.19.1. Inspection of Flammable Solvent Storage Tanks • All vents storages and reactors and safety relief valve vents to be taken above the roof- top if inside the building or taken above the nearest roof of the building and fitted with flame arrestors. • All electrical equipments should be flame proof. • Smoke/heat sensors with fore alarm should be installed. • Electrical bonding and earthing of flanges/piping and vessels must be carried out. 7.19.2. Emergency Response
Onsite Emergency Response • Shut down and Isolation: Raising the alarm, followed by immediate safe shut down of the power supply, and isolation of affected areas • Escape, Evacuation and Rescue: Safeguarding human lives at site by commencement of the Emergency Evacuation and Rescue Plan. Ensuring that all personnel are accounted for and carrying out a head count of persons evacuated. Notification and commencement of offsite emergency plan in case offsite impacts are possible • Stopping the development of the emergency: Control or response to the emergency depending upon its nature (fire, toxic release or explosion). Fire can be somewhat better controlled through fire fighting, while toxic release impacts can be partially controlled through proper communication with affected population. Impacts of explosions impacts cannot be controlled once they occur, hence efforts
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) will require focusing on provision of relief or control of secondary impacts (such as property damage or fires) resulting from explosions • Treatment of injured: First aid and hospitalization of injured persons • Protection of environment and property: During mitigation, efforts should be made to prevent impacts on environment and property to the extent possible • Welfare of the personnel managing the emergency: Changeover, first aid and refreshments for the persons managing the emergency • Informing and collaborating with statutory, mutual aid and other authorities including those covered in the Local Crisis Group • Informing and assisting relatives of the victims • Informing the news and electronic media • Preserving all evidences and records: This should be done to enable a through investigation of the true causes of the emergency • Ensuring safety of personnel prior to restarting of operations: Efforts require to be made to ensure that work environment is safe prior to restarting the work
Off-site Emergency Response Plan An emergency may affect areas offsite of the works as for example, an explosion can scatter debris over wide areas and the effects of blast can cover considerable distances, wind can spread burning brands of gases. In some cases e.g. as the result of an explosion, outside damage will be immediate and part of the available resources of the emergency services may need to be deployed in the affected areas. In any case, the possibility of further damage may remain, e.g. as the result of further explosion or by the effect of wind spreading burning brands of hazardous material. It will be necessary to prepare in advance simple charts or tables relating the likely spread of the vapors cloud taking into account its expected buoyancy, the local topography and all possible weather conditions during the time of release. It may also be desirable to install instruments indicating wind speed and direction, which could be done jointly with surrounding industries.
7.19.3. Inspection of Fire Fighting Equipment and Systems • The internal and external surfaces of the cylinder body shall be coated with Zinc or lead-tin alloy • Material used for the cylinder shell shall be identified to ensure conformity with manufacturing standard. • Extinguisher (DCP Vessel) is prone to internal corrosion at the interface between the dry powder top level and empty space; periodic inspection should therefore be undertaken.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • The shell of the DCP extinguisher shall be visually inspected externally once a month and internally once every three months to check for any mechanical damage or corrosion. • A DCP extinguisher body shall be removed from service and destroyed when it is corroded or damaged to such an extent at repair is required, when the shell threads are damaged, when it has failed in hydro testing or when the extinguisher has been exposed to high temperatures due to proximity of fire. • The internal coating and external painting shall be checked for damage/deterioration once in three months. • The safety valve shall be visually inspected for corrosion or damage once every three months. The safety valve shall be bench tested at rated test pressure once every three years. • All DCP extinguishers shall be permanently punched at the bottom ring with Manufacturer’s name, year of manufacture, manufacturer’s Sr. No. and Inspectors stamp. • Equipment, which will automatically detect heat, flame, smoke, flame of solvent, gases, or other conditions likely to produce fire or explosion and cause automatic actuation of alarm, fire alarm system and protection equipment should be provided. 7.19.4. Recommendations on Individual Accident Risks • Fall of persons from height: Training, use of life harness for working at height, providing platforms with railing at height, barricading pits and eliminating piping and other trips in passages are needed to prevent fall accidents of individuals. • Fall of objects from overhead work: Helmet use is essential for all project personnel, irrespective of their job nature; use of proper tools properly and handling non-greasy tools is important in preventing falls of objects; use of MS plates on overhead platforms to help restrict the fall of objects since even nuts and bolts can cause injuries. • Object hits on the body causing injuries: These accidents are prevented by providing appropriate guards and barricades for all moving parts and in-running nips. • Hand and foot injuries: Training may be given to workers pertaining to these techniques. Use of safety shoes with toe protection cup and use of appropriate hand gloves for specific activities are required in addition to use of correct tools and correct methods. • Flying objects and splinters causing face injuries: Use of face shields is required wherever such hazards exist. • Falls, vehicle accidents, flying objects and falling objects causing head injury: Head injury is a very serious injury. Use of helmet should be mandatory. Helmet should be worn with snugly fitting chin belt. This is very important, as the chin
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) belts are never used in India. Non-use of chin belt, leads to the helmet flying off before the head hits during falls exposing the head for injuries. • Collisions of vehicles with other vehicles, other structures and human beings: Vehicular movement restrictions and routes need to be displayed. Backing of vehicles has high risk of accidents. Backing alarm signal (Not musical one) is made mandatory on all vehicles. For fork lift trucks now they come fitted with infra red sensors to detect objects behind about one meter away are available. All such measures are ensured to prevent collisions.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) CHAPTER 8. SUMMARY AND CONCLUSION Project & Project Proponent M/s Otsuka Chemical India Pvt Ltd have production unit of APIs and Bulk drugs at SP-3, 10 & 11, RIICO Industrial area, Village Keshwana Rajdoot (Kotputli) Rajasthan. Total area is 88000 sqm. Company will set up a multipurpose plant to produce several products. Proposed unit planning for expanding its exisiting unit by addition of new product the adjacent location in an area of 26,800 sq.m with green belt of 33%. Estimated cost for the proposed expansion project is INR 150.00 Crores Connectivity: The proposed site is located in notified industrial area develop by RIICO. National Highway 8 is at a distance of 1.81 km in E. Nearest Railway station is Alwar railway station 47 km from the project site and Jaipur airport is approx. 128 km away from project site (aerial distance). No National Parks, Wildlife Sanctuaries, Tiger/ Elephant Reserves, Wildlife Corridors etc. falls within 10 km radius from the plant site. The present EIA study covers the production of APIs and bulk drugs. Terms of Reference (TOR) was issued by MoEF&CC vide their letter No: J-11011/190/2017-IA II (I) dated 30th May 2017 for preparation of EIA/EMP. During 33rd EAC meeting held on 22 jan 2018 for EC presentation. Hence committee suggested for submitting the compliance status of existing EC conditions so the report will expressed as expansion project. Description of Environment: Primary baseline data has been collected as per the TOR prescribed by MOEF during 15th March 2017 to 15th June 2017 for one complete season Baseline Data was generated by following the standard procedures of the Ministry of Environment & Forests and the Central Pollution Control Board. Air Environment: Ambient air quality was monitored at eight locations in the study area.
The locations were selected as per CPCB guidelines. Highest PM10 level at Paniyala (95 3 3 µg/m ) and lowest PM10 level at Mortha (42 µg/m ) were observed at Project Site. Mean 3 conc. of all location ranges between 61-75 µg/m . Highest PM2.5 level at Paniyala (47 3 3 µg/m ) and lowest PM2.5 level at Mortha and Ukhlera (18 µg/m ). Mean conc. of all 3. location ranges between 26-34 µg/m Highest SO2 level at Paniyala (9.4 µg/m3) and lowest SO2 at Gothari (4.3 µg/m3).Mean conc. all location ranges between 6.0-7.2 µg/m3. 3 Highest NOx level at Project site (25.5 µg/m ) and lowest NOx level at Mortha Village 3 3 (10.4 µg/m ). Mean conc. of all location ranges between 13.9-19.3 µg/m . NH3 range between 13 to 19 µg/m3. The 8 hour concentration of CO.<01 to 0.36 mg/m3. VOC, HBr and HF were not detected in the study area. Noise Environment:The ambient noise level of all the monitoring locations were found well within the 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)
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Water Quality: Eight groundwater samples were collected from the area for chemical and biological analysis. Overall the ground water quality of the study area is found well within the permissible limits. No metallic and bacterial contaminations were observed in ground water samples. Surface water bodies were dry during the study period hence no surface water was collected Soil Quality: The soil quality of study area is sandy and sandy clay. The pH and conductivity of the soil is within acceptable range. The soil analysis describes that the soil of the study area is moderately fertile. Sensitive Ecosystem:There are no environmentally sensitive components such as National Park, Wildlife Sanctuary, Elephant / Tiger Reserve, migratory routes of fauna and wet land present within 10 Km radius of plant site. Socio economic environment: As per the census records 2011, the total population of the 10-km radius study area was recorded as 134916 persons of 56 revenue villages/towns of mainly three (03) districts namely Jaipur & Alwar of Rajasthan &Mahendergarh of Haryana state respectively. All study area revenue villages are under Six (06) tahsils namely Kotputli of Jaipur district, Behror, Mandawar, Kishangarh Bas & Bansur of Alwar district in Rajasthan and Narnaul of Mahendergarh District in Haryana. Total number of ‘Households’ was observed as 22550 in the study area. Male-female wise total population was recorded as 71044 males and 63872 females respectively.
Environmental Impact and Mitigation Measures Air Quality: The main sources of air pollution due to the operation of the plant are the Incinerator, Boiler and Process stack. The contribution to GLCs for the pollutants i.e. particulate matter, SOx, NOx, HCl, HBr,NH3 etc. were predicted over the study area proposed project considering the worst scenario. For the proposed project, computations of 24-hour average ground level concentrations were carried out using ISCST3 model, which is a recommended model by USEPA for prediction of air quality from point area.
Table: Summary of Maximum 24-hour Incremental GLC due to the Proposed Expansion Project Stacks Maximum incremental GLC Distance Parameters Direction (µg/m³) (Km) PM 1.92 1.30 SE SO2 6.0 1.30 SE NOx 1.0 1.30 SE HCL 0.200 1.30 SE NH3 1.0 1.30 SE
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) The nearest settlement in downwind direction is Paniyala village (towards SE) at a distance of 1.30 km. As per baseline data of AAQ maximum GLC for PM at Paniyala village is 74 µg/m³ and with this proposed project, 1.90 µg/m³ rise in GLCs so PM level will be 75.90 µg/m³. The Particulate Matter in the study area is contributed mainly by commercial activities and traffic movement (vehicular emissions), re-suspended dust from paved and unpaved roads and open uncovered areas as well as from industrial activities. Maximum baseline GLC for SO2 (Process and utilities) at downwind direction (SE) was as 7.10 µg/m³ observed at Paniyala village. With thisproposed project SOx level may increase by 6.5 µg/m³ so post project level of SOx is 13.50µg/m³. Maximum baseline GLC for NOx was as 18.70 µg/m³ observed at Paniyala village and project site. With thisproposed project NOx concentration is 1.0 µg/m³ so rise in GLC of NOx concentration is 19.10 µg/m³. It can be concluded that with the proposed project all the AAQ parameters will remain within the NAAQ norms. Noise Quality: 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. Material handling operations and movement of vehicles will be properly scheduled to minimize construction noise. Workers working in noisy areas will be given ear plugs. The noise level will be restricted within the plant boundary to meet the standards. Existing 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. Water Quality: Existing unit require 725 KLD water for manufacturing of APIs and its intermediates which will be source from ground water. For expansion project during construction phase 24 KLD and during operation phase 75 KLD of fresh water will be required sourced from borewell at the site. 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.No process effluent will be discharged outside the plant premises. 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. There will not be any discharge of wastewater on the land. Besides, there will be separate storm water and industrial wastewater drains to eliminate chances of mixing of rainwater withwastewater. 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 entering into the storm water drain.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) No significant adverse impact on the surface and ground water or soil quality is envisaged in viewof the proposed mitigative measures.
Solid and Hazardous Wastes Disposal: All the solid and hazardous waste generated from the proposed unit shall be disposed as per the norm. Minor quantities of construction waste will be generated in the form of packaging material and construction waste. Proper care will be taken for handling and reduction of the solid waste generated during construction phase. ETP sludge/ process residue generated during operation phase shall be disposed as per the hazardous wastes management, handling and Trans-boundary movement Rule 2016 and amendment thereof. Impact on Ecology: No national park, wildlife sanctuary, biosphere reserve exists within 10 km area of the project. No endangered or rare or threatened plant or animal species was observed within 10 km area of the project site. 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. However the AAQ modeling proves that in worst condition the concentration of the PM and other gaseous emission will not exceeds the AAQ standards. Further the mitigation measures have been suggested for the same. By adopting the mitigation measures suggested the impact due to operation of the proposed expansion will be negligible. Risk Assessment and Disaster Management Plan: The hazard potential of chemicals and estimation of consequences in case of their accidental release during storage, transportation and handling has been identified and risk assessment has been carried out to quantify the extent of damage and suggest recommendations for safety improvement for the proposed facilities. Risk mitigation measures based on MCA analysis and engineering judgments are incorporated in order to improve overall system safety and mitigate the effects of major accidents. An effective Disaster Management Plan (DMP) to mitigate the risks involved has been prepared. This plan defines the responsibilities and resources available to respond to the different types of emergencies envisaged. Training exercises will be held to ensure that all personnel are familiar with their responsibilities and that communication links are functioning effectively.
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 investment towards environment management is estimated to be Rs.200 lacs and recurring cost will be Rs. 145 lacs. This amount shall be used for procurement of air and water pollution control devices, noise pollution control, monitoring devices, strengthening of environment Cell, occupation health and safety department, green belt development, etc.
ENVIRONMENT MONITORING PROGRAM
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Post project environmental monitoring is important in terms of evaluating the performance of pollution control equipment’s installed in the project. The sampling and analysis of the environmental attributes will be as per the guidelines of CPCB/SPCB. The frequency of sampling and location of sampling will be as per the directives of Punjab Pollution Control Board. Green belt development: Total area is 88000 sqm. Company will set up a multipurpose plant to produce several products. Proposed unit planning for expanding its exisiting unit by addition of new product the adjacent location in an area of 26,800 sq.m with green belt of 33%. For the proposed project Otsuka chemical has already developed a dense greenbelt in about 8844 m2(33%) of the area within the plant. More than 600 trees has been already planted. Rs. 10 lacks has been already spent by Otsuka for greenbelt plantation and maintenance. Further Otsuka chemical has earmarked a budget of Rs. 8 lacks/year for development of lawns and other form of greenery and maintenance (including manure/ watering and labour charges etc.) of the existing greenbelt. CSR Plan: Existing CSR Plan Firm is running a mini hospital, distribution of fluoride free RO water nearby vicinity. Amount of 48.62 lach have been incurred as a CSR. Proposed CSR/CER Plan
Proposed Activities Proposed Amount
Company propose an expense as per prescribed guidelines within 5 2.5% of Project Cost - Rs. years on ESR activities like RO water ( fluoride free) distribution in 375 Lacs close vicinity , toilet construction in nearby schools, Tree plantation , medical facilities in nearby villages, Scholarship to financial weeks students, sanitization under “swacha bharat abhiyan “, conservation of natural resources etc. ESR Cell under the direct control of Plant Head. The ESR Cell shall implement the CSR Plan by making a Consultative ESR Committee
Project Benefits
• Proposed expansion project will result in considerable growth of stimulating the industrial and commercial activities in the state. Small and medium scale industries may be further developed as a consequence.
• The project will be beneficial in govt’s target of increase the production capacity and yield in the field of pharmaceuticals.
• Increased revenue to the state by way of royalty, taxes and duties;
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) • Overall Growth of the neighbouring area viz. Health and family welfare; Watershed development; Sustainable livelihood and strengthening of village Self Help Groups; and Infrastructure development.
• In operation phase, the proposed plant would require significant workforce of non- technical and technical persons.
• Migration of persons with better education and professional experience will result in increase of population and literacy in the surrounding villages.
• Civic amenities will be substantial after the commencement of project activities. The basic requirement of the community needs will be strengthened by extending healthcare, educational facilities to the community, building/strengthening of existing roads in the area.
• The local population will be given preference to employment on the basis of their eligibility and company requirement. The employment potential will ameliorate economic conditions of these families directly and provide employment to many other families indirectly who are involved in business and service oriented activities. The employment of local people in primary and secondary sectors of project shall upgrade the prosperity of the region. This in-turn will improve the socio-economic conditions of the area.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) CHAPTER 9. Disclosure of Consultants
PRELUDE
Declaration by Experts Contributing To the EIA/EMP REPORT for setting up of new production unit of APIs and bulk drug at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)by M/s Otsuka Chemical India 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 Involvement Functional Name of the (Period and Task**) Signature Areas Expert December 2016 to finalization of report • Air pollution monitoring. • Meteorological parameter Air Pollution S K JAIN measurement. Monitoring & Control (AP) • Identification & assessment of quantum of emission and its Mitigation measures. • Ambient Air Quality monitoring network designing. Air Quality • Processing of Modeling Mr. Sanjeev micrometeorological data and Sharma for using in model. Prediction • Air quality modelling (AQ) through ISC- Aermod for proposed prediction of impact
Mr. Sanjeev • Monitoring of noise levels of Noise Sharma the project site and surrounding area.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan) Involvement Functional Name of the (Period and Task**) Signature Areas Expert December 2016 to finalization of report • Assessment of noise level and vibration potential due to proposed project and its mitigation measures. • Water Quality monitoring network designing. • Sampling of water samples (surface and ground water). Water • Monitoring of water quality. Pollution Y Bordia • Water Balance (WP) • Identification & assessment of quantum of water pollution and its Mitigation measures. • ETP Suggestion. • Conducted Ecological survey & preparation of status report. • Application of taxonomy in Ecology and Ratnesh resource inventory (Flora & Bio-diversity Kotiyal Fauna) Conservatio • List of species animals and n (EB) plants report. • Identification & assessment of ecological impact due to proposed project and its Mitigation measures. • Identification of hazardous Solid and and non hazardous wastes. Hazardous • Reuse and recycling of solid Waste Y Bordia wastes. Managemen • Handling and disposal of t (SHW) Non- Hazardous solid waste & Hazardous waste. • Identification of hazards due to proposed project. • Identification of hazardous Risk and substances in the proposed Hazards S K Jain project. (RH) • Preparation of risk assessment report and onsite emergency plan.
EIA/EMP Report for Setting up of New Production Unit of APIs and Bulk drugs (25 MTPM) at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)
*Following category ‘B’ FAEs have worked as support FAE to category ‘A’ FAEs. Mr.Om Prakash for Air and Water Environment Ms.Sweta Gupta for Noise and Vibration. Ms. Pratibha worked as a team member for AQ and WP ** Mr Om Prakash 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 production unit of APIs and bulk drug at SP-3, 10 & 11, RIICO Industrial Area, Village Keshwana Rajpoot, Kotputli (Rajasthan)by M/s Otsuka Chemical India 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/RA11/007, 19th May, 2014