| APPENDIX I | | (See Paragraph-6) | | CATEGORY - B | | | | Note : If space provided against any parameter is inadequate,Kindly upload supporting document under 'Additional Attachments if any' at the last part of the Form1. Please note that all such Annexures must be part of single pdf document. | | (I)Basic Informations | | | Whether proposal involved violation of EIA notification | NA | | Weather Consent to Establishment Obtained | NA | | Upload copy of CTE | NA |
| | 1. | Name of the Project | Expansion of API’s manufacturing capacity & establishment of Biopharmaceutical products manufacturing facility within the existing industry premises by M/s. Syngene International Limited, Mangalore | | Proposal No | SIA/KA/IND2/47717/2019 |
| | 2. | Project Sector | Industrial Projects - 2 |
| | 3. | Location of the project | MSEZL, Kalavar Village, Mangalore Taluk, Dakshina Kannada District, Karnataka. |
| | | | | 6. | State of the project | Karnataka |
| | Details of State of the project |
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| S.no | State Name | District Name | Tehsil Name |
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| (1.) | Karnataka | Dakshina Kannada | Mangalore |
| | 7. | Town / Village | Kalvara village |
| | 8. | Plot/Survey/Khasra No. | Plot Nos IP-39 IP-46 IP-60 and IP-25 (Part) and IP-61 of MSEZ area Mangalore |
| | 9. | S. No. in the schedule | 5(f) Synthetic organic chemicals industry (dyes & dye intermediates; bulk
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| | 10. | Proposed capacity/area/length/tonnage to be handled/command area/lease area/number or wells to be drilled | 805.916 ha. |
| | 11. | | New/Expansion/Modernization | Expansion | | MoEF file number(Previous EC) | SIA/KA/IND2/47716/2015 | | Existing capacity/area etc. | 18.78 ha. | | Uploaded EC letter | Annexure-Uploaded EC letter |
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| | 12. | Category of project | B | | | 13. | Does it attract the general condition? If yes, please specify | No | | | 15. | Does it attract the specific condition? | No | | | 16. | Is there any litigation pending against the project? | No |
| | 17. | Nearest railway station along with distance in kms. | Surathkal railway station, 4.8 km | | | 18. | Nearest airport along with distance in kms | Mangalore International Airport, Bajpe, 3.5 km | | | 19. | Nearest Town/City/District Headquarters along with distance in kms | Mangalore , 7.5 km | | | 20. | Distance of the project from nearest Habitation | 1.5 , 1.5 km | | | 21. | | Details of alternative sites examined shown on a toposheet | No |
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| | 22. | | Whether part of interlinked projects? | No |
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| | 23. | | Whether the proposal involves approval/clearance under the Forest (Conservation)Act,1980? | No |
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| | 24. | | Whether the proposal involves approval/clearance under the wildlife (Protection)Act,1972? | No |
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| | 25. | Whether the proposal involves approval/clearance under the C.R.Z notification,2011? | No |
| | 26. | | Whether there is any Government Order/Policy relevent/relating to the site? | No |
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| | 27. | | Whether there is any litigation pending against the project and/or land in which the project is proposed to be set up? | No |
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| | 28. | Project Cost(in Lac.) | 115000 |
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| 30. | Whether the proposed project/activity located in notified Industrial area(Yes/No) | N/A |
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| 1 | Construction, operation or decommissioning of the Project involving actions, which will cause physical changes in the locality (topography, land use, changes in water bodies, etc.) |
| S.No | Information/Checklist confirmation | Yes/No | Details there of (with approximate quantities/rates, wherever possible) with source of information data | | 1.1 | Permanent or temporary change in land use, land cover or topography including increase in intensity of land use (with respect to local land use plan) | Yes | There will be change in the local land use pattern due to expansion activity within MSEZ area.
There will be addition of new infrastructure facility for biopharmaceutical products within the existing premises. | | 1.2 | Clearance of existing land, vegetation and buildings? | No | - | | 1.3 | Creation of new land uses? | No | - | | 1.4 | Pre-construction investigations e.g. bore houses, soil testing? | Yes | All necessary investigation related to construction will be carried out before taking up the construction work. | | 1.5 | Construction works? | Yes | Proposed API’s products manufacturing will be within the existing industrial facility, construction work is nearby completion of the same & construction of new infrastructural facility for bio-pharmaceutical products. Construction work is yet to be taken up. | | 1.6 | Demolition works? | No | - | | 1.7 | Temporary sites used for construction works or housing of construction workers? | No | - | | 1.8 | Above ground buildings, structures or earthworks including linear structures,cut and fill or excavations and fill or excavations | Yes | All the buildings will be above ground level except Bulk solvent’s storage tanks (10 Nos.) | | 1.9 | Underground works including mining or tunneling? | No | - | | 1.10 | Reclamation works? | No | Not Applicable. | | 1.11 | Dredging? | No | Not Applicable. | | 1.12 | Offshore structures? | No | Not Applicable. | | 1.13 | Production and manufacturing processes? | Yes | Detailed in Annxure- I of Prefeasibility | | 1.14 | Facilities for storage of goods or materials? | Yes | Construction Phase
Temporary storage area will be provided at project site for storage of construction materials.
Operation Phase
Dedicated storage facilities are provided for Raw materials (warehousing) Intermediate & finished products. Separate building will be constructed for storage of biopharmaceutical raw materials & finished products.
Solvents will be stored both over ground and below ground storage tanks depending on the solvent and low volume solvents will be stored in drums a | | 1.15 | Facilities for treatment or disposal of solid waste or liquid effluents? | Yes | Liquid Effluent
The wastewater generation from APIs production block is 422 KLD from existing API’s & Non- API’s products including sewage.
Wastewater generation from proposed biopharmaceutical products will be 218 KLD including domestic sewage.
Industry has adopted Zero liquid discharge effluent treatment system for effluents generation from APIs & Non-API products. Same principle will be followed for Biopharmaceutical effluent system. The details of effluent treatment system is given | | 1.16 | Facilities for long term housing of operational workers? | No | There will be no housing facility proposed in the project site for the workers. | | 1.17 | New road, rail or sea traffic during construction or operation? | No | Existing road / transport facilities will be used during construction and operation phase. | | 1.18 | New road, rail, air water borne or other transport infrastructure including new or altered routes and stations, ports, airports etc? | No | Existing infrastructure facilities will be utilized. | | 1.19 | Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements? | No | Not Applicable. | | 1.20 | New or diverted transmission lines or pipelines? | No | Not Applicable. | | 1.21 | Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers? | No | Not Applicable. | | 1.22 | Stream crossings? | No | Not Applicable. | | 1.23 | Abstraction or transfers of water from ground or surface waters? | Yes | There is no abstraction of water from ground or surface source. The fresh water source: MSEZL from Nethravathi and Gurupur river | | 1.24 | Changes in water bodies or the land surface affecting drainage or run-off? | No | Not Applicable. Industry adopted Zero Liquid discharge system | | 1.25 | Transport of personnel or materials for construction, operation or decommissioning? | Yes | The existing road will be utilized for access to the site for transportation of material and personnel during construction and operation phase. | | 1.26 | Long-term dismantling or decommissioning or restoration works? | No | Not Applicable. | | 1.27 | Ongoing activity during decommissioning which could have an impact on the environment? | No | Not Applicable. | | 1.28 | Influx of people to an area in either temporarily or permanently? | Yes | No additional manpower requirement for APIs & Non-APIs blocks, existing manpower will be adequate even after expansionNo additional manpower requirement for APIs & Non-APIs blocks, existing manpower will be adequate even after expansion;
Manpower Requirement as per earlier EC Manpower Requirement for the proposed activity
1. API 622 Nos.
2. Non-API 189 Nos.
3. Total 811 Nos. 1. During construction stage of biopharmaceutical production blocks – approximately | | 1.29 | Introduction of alien species? | No | Not Applicable. | | 1.30 | Loss of native species or genetic diversity? | No | Not Applicable. | | 1.31 | Any other actions? | No | Not Applicable. | |
| 2 | Use of Natural resources for construction or operation of the Project (such as land, water, materials or energy, especially any resources which are non-renewable or in short supply): |
| S.No | Information/Checklist confirmation | Yes/No | Details thereof (with approximate quantities/rates, wherever possible) with source of information data | | 2.1 | Land especially undeveloped or agricultural land (ha) | No | MSEZL allotted site for Industrial use. Total extent of land is 46.35 Acres. | | 2.2 | Water (expected source & competing users) unit: KLD | Yes | Source of water supply is Gurpur river & Nethravathi river supplied by MSEZ.
Required water of 1221 KLD for APIs & Non- APIs products is as under ( Approved in Earlier EC)
Purpose Existing (KLD)
Domestic 37
Process and washing 200
Boiler makeup 264
Cooling tower 720
Total 1221
There will be no additional water requirement for new additional APIs (06 nos.) products, as products are manufactured on campaign basis maximum 5-6 products can be manufactured at given point of time | | 2.3 | Minerals (MT) | No | Not Applicable. | | 2.4 | Construction material – stone, aggregates, sand / soil (expected source – MT) | Yes | Sand, coarse and fine aggregates etc. are sourced locally. Approximate estimated quantities are Metal – 355 MT, Cement – 20560 bags | | 2.5 | Forests and timber (source – MT) | No | Not applicable | | 2.6 | Energy including electricity and fuels (source, competing users) Unit: fuel (MT),energy (MW) | Yes | The existing power requirement for the facility will be 6 MW and additional 1.5 MW, electrical power is sourced from MSEZ and a power back up of 2 DG x 3000 KVA capacity for industrial operation and 500 KVA DG set is for Offsite ETP operation is provided and additional 2000 KVA DG set is proposed. Low Sulphur content FO or LDO/Diesel is used as fuel for DG sets.
Approximate fuel required for;
3000 KVA DG set: 600 L/Hr
2000 KVA DG set: 400 Lt/Hr
Competing users: Industries are located w | | 2.7 | Any other natural resources (use appropriate standard units) | No | Not Applicable. | |
| 3 | Use, storage, transport, handling or production of substances or materials, which could be harmful to human health or the environment or raise concerns about actual or perceived risks to human health |
| S.No | Information/Checklist confirmation | Yes/No | Details thereof (with approximate quantities/rates, wherever possible) with source of information data | | 3.1 | Use of substances or materials, which are hazardous (as per MSIHC rules) to human health or the environment (flora, fauna, and water supplies | Yes | Hazardous chemicals used in the manufacture process of APIs & Non-APIs products; storage quantity will be within the threshold limit as per the MSIHC rule.
Dedicated storage area, MSDS for all chemicals and spill kit is provided for storage of hazardous chemicals/solvents.
There will be no use of hazardous chemicals/solvent for manufacture of biopharmaceutical products. | | 3.2 | Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases) | No | Not Applicable. | | 3.3 | Affect the welfare of people e.g. by changing living conditions? | Yes | There will be marginal improvement in Socio economic condition around the project site like direct or indirect employment opportunities. | | 3.4 | Vulnerable groups of people who could be affected by the project e.g. hospital patients, children, the elderly etc. | No | - | | 3.5 | Any other causes | No | There are no causes which would affect the people around. | |
| 4 | Production of solid wastes during construction or operation or decommissioning (MT/month) |
| S.No | Information/Checklist confirmation | Yes/No | Details thereof (with approximate quantities/rates, wherever possible) with source of information data | | 4.1 | Spoil, overburden or mine wastes | No | Not Applicable. | | 4.2 | Municipal waste (domestic and or commercial wastes) | Yes | Total domestic solid waste generated is 649 kg/day, 334 kg/day of Organic waste will be treated in organic waste converter and 315 kg/day of inorganic waste will be sent to authorized recyclers. | | 4.3 | Hazardous wastes (as per Hazardous Waste Management Rules) | Yes | Hazardous waste:
Sl. No. Hazardous waste Quantity
Existing After expansion Quantity
1. Used Oil 1200 L/A 1800 L/A
2. Process residue 2.45 TPD ?7.577? TPD??????????
3. Spent catalyst 0.094 TPD ?0.434? TPD??????????
4. MEE Salts 7 TPD 11 TPD
5. Spent/Distillated solvent 143.25 TPD ?186.21? TPD??????????
6. ETP sludge 15 TPA 18 TPA
7. Detoxified container 40000 Nos 60000 Nos. | | 4.4 | Other industrial process wastes | Yes | Detailed in Prefeasibility report | | 4.5 | Surplus product | No | Not Applicable. | | 4.6 | Sewage sludge or other sludge from effluent treatment | Yes | Sludge from ETP will be sent for secured landfill approved by KSPCB. STP sludge 0.75 T/Day generated will be used as manure for greenbelt. | | 4.7 | Construction or demolition wastes | Yes | The debris generated during construction will be disposed to low lying areas in the approved disposal site identified by the local body. There is no demolition wastes from the proposed project. | | 4.8 | Redundant machinery or equipment | No | Not Applicable. | | 4.9 | Contaminated soils or other materials | No | Not Applicable. | | 4.10 | Agricultural wastes | No | Not Applicable. | | 4.11 | Other solid wastes | No | Not Applicable. | |
| 5 | Release of pollutants or any hazardous, toxic or noxious substances to air(Kg/hr) |
| S.No | Information/Checklist confirmation | Yes/No | Details thereof (with approximate quantities/rates, wherever possible) with source of information data | | 5.1 | Emissions from combustion of fossil fuels from stationary or mobile sources | Yes | Boilers - 10 TPH & 10 TPH (standby) installed for existing industrial operation and 5 TPH boiler is installed at Offsite ETP site for ETP operation.
2TPH boiler is proposed for biopharmaceutical products manufacturing facility.
DG sets of 3000 KVA x 2 Nos. and 500 KVA (at Offsite ETP) are installed and additional 2000 KVA DG set proposed as power backup. Stack of 33 m height will be provided as per KSPCB norms. | | 5.2 | Emissions from production processes | Yes | Process reactors
Wet scrubber
•?API - 4 Scrubbers
•?Non-API - 4 Scrubbers
Are provided to treat process emissions from APIs & Non-APIs products. This will be adequate to treat the proposed additional APIs (6 Nos.) products.
Scrubber:
There will be negligible quantity process emissions from biopharmaceutical products as there is no use of solvents. However, 04 scrubber will be provided to control emission from manufacturing process.
1. Acid scrubber
2. Alkaline scrubber
3. Media | | 5.3 | Emissions from materials handling including storage or transport | Yes | There will be fugitive dust generation due to handling of construction materials during transport vehicles carrying construction material.
Fugitive dust Emission is controlled by sprinkling of water and barricading the construction site with GI sheets.
Transport vehicles will be maintained in good condition by regular maintenance. | | 5.4 | Emissions from construction activities including plant and equipment | Yes | Construction Phase:
Fugitive dust generation due to handling of construction materials.
Fugitive dust emission will be restricted as Ready Mix Concrete (RMC) will be used.
Emission of fugitive dust is controlled by sprinkling of water and barricading the project surrounding with GI sheets. | | 5.5 | Dust or odours from handling of materials including construction materials, sewage and waste | Yes | There will be fugitive dust emission due to handling of materials during the construction phase.
As solvents and chemicals are used in the manufacturing process. There is possibility of odour in process handling materials.
Odour is controlled by AHU system and manufacturing process will be in controlled system as per cGMP guidelines. | | 5.6 | Emissions from incineration of waste | No | Not Applicable | | 5.7 | Emissions from burning of waste in open air (e.g. slash materials, construction debris) | No | Not Applicable | | 5.8 | Emissions from any other sources | No | Not Applicable | |
| 6 | Generation of Noise and Vibration, and Emissions of Light and Heat: |
| S.No | Information/Checklist confirmation | Yes/No | Details thereof (with approximate quantities/rates, wherever possible) with source of information data | | 6.1 | From operation of equipment e.g. engines, ventilation plant, crushers | Yes | Noise:
Construction Phase:
The machineries and equipment used during construction.
Noise will be controlled by regular maintenance of equipment.
Operation Phase:
DG sets and pumps.
DG sets are provided with acoustic enclosures.
Development of greenbelt area will suppress the noise level and restrict to industry premises. | | 6.2 | From industrial or similar processes | No | - | | 6.3 | From construction or demolition | Yes | There is no demolition works involved in proposed project.
There will be marginal increase in ambient noise level due to construction activities. It will be reduced by preventive maintenance of construction equipment. | | 6.4 | From blasting or piling | No | Not Applicable. | | 6.5 | From construction or operational traffic | Yes | Movement of construction vehicles contribute to noise and it is temporary in nature. Vehicular movement in the premises will be controlled by regulating the speed.
As industry is located in MSEZ industrial area existing road will be used for regular operation. | | 6.6 | From lighting or cooling systems | No | - | | 6.7 | From any other sources | No | Not Applicable | |
| 7 | Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface waters, groundwater, coastal waters or the sea: |
| S.No | Information/Checklist confirmation | Yes/No | Details thereof (with approximate quantities/rates, wherever possible) with source of information data | | 7.1 | From handling, storage, use or spillage of hazardous materials | Yes | The hazardous materials are stored in the warehouse with proper secured flooring. The transfer of solvents is through pipelines and spillages will be avoided by monitoring.
Training is given for workers for handling of solvents and hazardous chemicals. | | 7.2 | From discharge of sewage or other effluents to water or the land (expected mode and place of discharge) | No | Domestic sewage generated during construction will be treated in existing onsite ETP.
Zero Liquid discharge system is adopted for existing effluents and proposed to adopt the same for expansion project. | | 7.3 | By deposition of pollutants emitted to air into the land or into water | Yes | There is no deposition of pollutants. | | 7.4 | From any other sources | No | Not Applicable. | | 7.5 | Is there a risk of long term build up of pollutants in the environment from these sources? | No | Not Applicable. | |
| 8 | Risk of accidents during construction or operation of the Project, which could affect human health or the environment |
| S.No | Information/Checklist confirmation | Yes/No | Details thereof (with approximate quantities/rates, wherever possible) with source of information data | | 8.1 | From explosions, spillages, fires etc from storage, handling, use or production of hazardous substances | Yes | Storage, Handling and use of hazardous substance in the process pose risk of explosion, fire etc.,
All bulk storage will be in well-engineered storage vessels.
MSDS for all hazardous substances are in place. Risk analysis is carried out for existing API products and for proposed products risk assessment & HAZOP studies will be carried out.
No hazardous substance will be produced. | | 8.2 | From any other causes | No | Not Applicable. | | 8.3 | Could the project be affected by natural disasters causing environmental damage (e.g. floods, earthquakes, landslides, cloudburst etc)? | No | Natural calamities cannot be ruled out. However, all precautions will be in place to meet the eventualities to reduce the damage/ impact. | |
| 9 | Factors which should be considered (such as consequential development) which could lead to environmental effects or the potential for cumulative impacts with other existing or planned activities in the locality |
| S.No | Information/Checklist confirmation | Yes/No | Details thereof (with approximate quantities/rates, wherever possible) with source of information data | | 9.1 | Lead to development of supporting utilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.:
- Supporting infrastructure (roads, power supply,waste or waste water treatment, etc.)
- housing development
- extractive industries
- supply industries
- Other
| Yes | • Supporting infrastructures are already in place.
• Employees are mostly from surrounding villages. However, the district may expect demand for housing.
• The supporting ancillaries are already in the district. | | 9.2 | Lead to after-use of the site, which could have an impact on the environment | No | - | | 9.3 | Set a precedent for later developments | Yes | Net positive impact in terms of overall development of the area is expected from the proposed project. | | 9.4 | Have cumulative effects due to proximity to other existing or planned projects with similar effects | No | - | |
| (III) | Environmental Sensitivity | | S.No | Areas | Name/Identity | Aerial distance (within 15km.) Proposed project location boundary | | 1 | Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value
| No | Not Applicable. | | 2 | Areas which are important or sensitive for ecological reasons - Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests | Yes | The Pilikula Nisarga Dhama Bological Park is located in 7.2 km from the project site. This park is developed by local government.
There is no reserve forest or protected area within 10 Km radius from the project site.
Water bodies
• Gurpur river is at 5.3 km in South direction
• Arabian sea is at 6.5 km in West direction
• Kulai Baggundi Lake is at 4.2 km in South west direction
• Pilikula Nisarga Dhama Lake is at 6.5 km in south east direction
• Kavoor Lake is at 6.6 km in South west | | 3 | Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration | No | There are no notified areas protected, important or sensitive species of flora or fauna for breeding/resting / migration. | | 4 | Inland, coastal, marine or underground waters | No | - | | 5 | State, National boundaries | No | - | | 6 | Routes or facilities used by the public for access to recreation or other tourist, pilgrim areas | Yes | About 7 km at Suratkal on west side boundary of MSEZL. | | 7 | Defence installations | No | - | | 8 | Densely populated or built-up area | Yes | About 7 km at Suratkal on west side boundary of MSEZL. | | 9 | Areas occupied by sensitive man-made land uses (hospitals, schools, places of worship, community facilities) | Yes | Hospitals:
• MRPL Hospital - Occupational health service, Katipalla, Kuthethur PO, Mangalore is at 2.2 km in north west direction
• Venus Hospital, Maidan Rd, Hosabettu, Surathkal, Mangalore is at 5.8 km in North east direction
• A.J. Hospital & Research Centre - General hospital, NH 66, Kuntikana, Mangalore is at 9 km in South west directionReligious Places:
• Kashi Vishwanateshwara Temple, Talakala, Kolambe Proper, Mangalore is at 4 km in South east direction
• Shri Janardhana Temple | | 10 | Areas containing important, high quality or scarce resources.(ground water resources,surface resources,forestry,agriculture,fisheries,tourism,minerals) | No | - | | 11 | Areas already subjected to pollution or environmental damage.(those where existing legal environmental standards are exceeded) | No | - | | 12 | Areas susceptible to natural hazard which could cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions) similar effects | Yes | Natural calamities cannot be ruled out. However, all precautions will be in place to meet the eventualities to reduce the damage/ impact in coordination with the District Authority. | | | (IV) | PROPOSED TERMS OF REFERENCE FOR EIA STUDIES | | | ADDITIONAL MULTIPLE ENTERIES | | (V) | Undertaking | | The aforesaid application and documents furnished here with are true to my knowledge | | V.(i) | | Name | M/S. SYNGENE INTERNATIONAL LIMITED | | Designation | SiteHeadMSEZCommercialmanufacturing | | Company | M/S. SYNGENE INTERNATIONAL LIMITED | | Address | Biocon Park, SEZ, Bommasandra Industrial area, Phase-IV, Bommasandra-jigani Link road, Bangalore |
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