| Form-1 | | APPLICATION FOR PRIOR ENVIRONMENTAL CLEARANCE | | | | 1. Basic Informations | | Project Name | M/s. Shilpa Medicare Limited, 100% EOU, Unit II Expansion and Modification of the Active Pharmaceutical Ingredients (API’s) and Intermediates Manufacturing Industry with R & D Activity | Company/Organisation Name | M/S. SHILPA MEDICARE LIMITED | | Registered Address | Unit II, Plot No 30, 31, 32 & 35-39, 33, 33A & 40-47, Raichur Industrial Growth Center, Wadloor Road, Chicksugur Karnataka 584134 | Legal Status of the Company | Others |
| | 2. | | Address for the correspondence: | | (a)Name of the Applicant | Sharath K Reddy | | (b)Designation (Owner/ Partner/ CEO) | Director | | (c)Address | Unit II, Plot 30, 31, 32 and 35-39, 33, 33A and 40-47,Raichur Industrial Growth Center, Wadloor Road, Chicksugur,Raichur,Raichur,Karnataka-584134 | | (d)Pin code | 584134 | | (e)E-mail | ch.madhav@vbshilpa.com | | (f)Telephone No. | 0 | | (g)Fax No. | | | (h)Copy of documents in support of the competence/authority of the person making this application to make application on behalf of the User Agency . | Annexure-Uploaded Copy of documents in support of the competence/authority | |
| | 3. | | Category of the Project/Activity as per Schedule of EIA Notification,2006: | | (a)Major Project/Activity | 5(f)-API
| | (b)Minor Project/Activity | NIL | | (c)Category | B2 | | (d)Proposal Number | IA/KA/IND2/176934/2020 | | (e)Master Proposal Number(Single Window) | SW/176931/2020 | | (f)EAC concerned (for category A Projects only) | Industrial Projects - 3 | | (g)Project Type(New/Expansion/Modernization) | Fresh EC |
|
| | 4. | | (a)Number of States in which Project will be Executed | 1 | | (b)Main State of the project | Karnataka | |
| | Details of State of the project |
|---|
| S. No. | State Name | District Name | Tehsil Name | Village Name |
|---|
| NIL |
| | 5. | | Details of Public Consultation: | | (a)Whether the Project Exempted from Public Hearing? | Yes | | (c)Reason | -1 | | (d)Supporting Document | Copy of Supporting Document | |
|
| 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) | No | This is an existing industry and the Project site is in designated industrial area developed by KIADB. The earlier land use is now converted from agriculture to industrial and developed by KIADB. | | 1.2 | Clearance of existing land, vegetation and buildings? | No | Vacant land with rank vegetation | | 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 | Construction of additional buildings is yet to be taken up for proposed expansion | | 1.6 | Demolition works? | No | None | | 1.7 | Temporary sites used for construction works or housing of construction workers? | No | Local workers will be made use of | | 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 | | 1.9 | Underground works including mining or tunneling? | No | Not Applicable | | 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 | Facility is for manufacturing of Active Pharmaceutical Ingredients (APIs) & Intermediates with R & D activity and custom synthesis. Details of the same are covered in EMP report | | 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 for Raw materials (warehousing), process building & finished products storage are present. Additional storage facilities are proposed and will be provided. Solvents are stored in above ground level tanks; details are covered in EMP report | | 1.15 | Facilities for treatment or disposal of solid waste or liquid effluents? | Yes | Domestic solid waste: Organic wastes are composted and inorganic waste will be segregated and given to authorized agents.Liquid Waste: Domestic Sewage and Industrial effluents: Total wastewater generated in the facility will be 323.343 KLD.Wastewater generated within the plant will be treated in the in-house treatment facilities. ZLD concept will be followed and no treated water will be discharged outside. | | 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 and 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 | Only the existing infrastructure facilities will be utilized. | | 1.19 | Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements? | No | - | | 1.20 | New or diverted transmission lines or pipelines? | No | - | | 1.21 | Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers? | No | - | | 1.22 | Stream crossings? | No | - | | 1.23 | Abstraction or transfers of water from ground or surface waters? | Yes | Fresh water requirement will be met from KIADB supply (Krishna River water). | | 1.24 | Changes in water bodies or the land surface affecting drainage or run-off? | No | - | | 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 | No dismantling or decommissioning related works are proposed | | 1.27 | Ongoing activity during decommissioning which could have an impact on the environment? | No | - | | 1.28 | Influx of people to an area in either temporarily or permanently? | Yes | During construction Phase –Approximately 100 workers
Operation Phase: -Existing workers= 1000 (650 Permanent &350 Contract) -After expansion =150 (120 Permanent & 30Contract) | | 1.29 | Introduction of alien species? | No | - | | 1.30 | Loss of native species or genetic diversity? | No | - | | 1.31 | Any other actions? | No | Nil | |
| 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 | The proposed project is located in designated KIADB industrial area. This is an existing industry. | | 2.2 | Water (expected source & competing users) unit: KLD | Yes | Source- KIADB supply (Krishna River)
Total fresh water requirement – 293.114 KLD
Competing users: Industries located within the industrial area, agriculture and villages on either side of the River Krishna. | | 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 Sand: 8000 MT, Aggregates – 8000 MT, Metal – 2200 MT, Cement – 2200 MT. | | 2.5 | Forests and timber (source – MT) | No | Not applicable. Wooden furniture for the office will be procured from the market. | | 2.6 | Energy including electricity and fuels (source, competing users) Unit: fuel (MT),energy (MW) | Yes | Electric power will be sourced from Power supply from GESCOM.
Competing users:Industries located within the industrial area. Currently, the power requirement during operation stage is 1800 kVA and after proposed expansion power requirement will be 3,200 kVA.There are 1x750 kVA and 3 x 625kVA DG sets installed in the site. Itis proposed for additional 2x1500kVA, 1x750 kVA and 2 x 625 kVA DG sets are used only during power failure. HSD is used as fuel | | 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 are used in the manufacture process.
Dedicated storage area is proposed. MSDS for all chemicals and spill kit will be provided for storage of hazardous chemicals/solvents. Necessary safeguards will be taken as per the standard procedures for the storage and handling of such raw materials. | | 3.2 | Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases) | No | - | | 3.3 | Affect the welfare of people e.g. by changing living conditions? | Yes | There will be improvement in Socio economic condition around the project site by providing 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 | Not Applicable. | | 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 | - | | 4.2 | Municipal waste (domestic and or commercial wastes) | Yes | The total quantity of domestic wastes after proposed expansion will be about 230 kg/day of which 100 kg/day is organic and 130 kg/day is inorganic waste. Organic waste is composted and inorganic waste will be segregated and will be disposed through Local Municipality. | | 4.3 | Hazardous wastes (as per Hazardous Waste Management Rules) | Yes | After expansion, al hazardous wastes will be disposed of as listed below: - Used oil 5 KL, Spent solvents of 986.545 TPA,Distillation residues of 25 TPA &12,000 Nos. of empty barrels/containers will be disposed through Authorized recycler. -227.363 TPA of Process residue,27.052 TPA of Spent carbon & 3TPA of Date Expired Products will be sent to Incineration / co-processing. - ETP sluge of 1500TPA & MEE Salts of 0.9 TPA will be sent to TSDF. | | 4.4 | Other industrial process wastes | No | - | | 4.6 | Sewage sludge or other sludge from effluent treatment | No | - | | 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 or used for internal road construction | | 4.8 | Redundant machinery or equipment | No | - | | 4.9 | Contaminated soils or other materials | No | - | | 4.10 | Agricultural wastes | No | - | | 4.11 | Other solid wastes | No | - | |
| 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 | Existing: Boilers (1 x 10 TPH, 1 x 6TPH); Fuel: Rice Husk Thermic fluid heater (1 x 6 Lakh kcal) Fuel:FO DG sets (1 x 750 kVA, 3 x 625kVA) ; Fuel: HSD Proposed: Boiler(1 x 16 TPH); Fuel: Rice Husk Thermic fluid heater (1 x 8 Lakh kcal, 1 x 12 Lakh kcal); Fuel: FODG sets (2 x 1500 kVA, 1 x 750kVA, 2 x 625 kVA); Fuel: HSD Chimneys of adequate height and stipulated APC measures will be provided as per KSPCB norms for the proposed activity. | | 5.2 | Emissions from production processes | Yes | Scrubber with stack of 3 m ARL will be provided for process emissions.
Emissions Acid mist and VOC | | 5.3 | Emissions from materials handling including storage or transport | Yes | Materials handling is through pneumatic /pumps with minimum Fugitive emission/VOC | | 5.4 | Emissions from construction activities including plant and equipment | Yes | Construction Phase:
Fugitive dust generation during the construction phase due to handling of construction materials and activities.
Fugitive dust emission will be restricted as Ready Mix Concrete (RMC) will be used.
Dust Emission will be 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 dust emission due to handling of materials during the construction phase.
During Operation Phase:
Manufacturing process is carried out in closed system/ clean room operation. PPE will be provided to workers. | | 5.6 | Emissions from incineration of waste | No | Incinerator will not be installed. | | 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 | - | |
| 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 | Construction Phase: The machineries and equipment used during construction will be regularly maintained. Operation Phase: Manufacturing process will be in closed system. DG set,compressors, centrifuge and pumps are provided with noise and vibration control and acoustic measures as per guidelines. DG set is used only during the power failure. 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 will be marginal increase in ambient noise level due to construction activities which will be reduced by undertaking periodic preventive maintenance of construction equipments and restricting and reducing the speed of vehicles operated for the movement of construction materials apart from barricading the project site. | | 6.4 | From blasting or piling | No | Not Applicable. | | 6.5 | From construction or operational traffic | Yes | Movement of construction vehicles contribute to noise. It is temporary in nature.
As project site is located in industrial area existing road will be used for regular operation. There will be marginal increase in traffic due to movement of vehicles from the project. | | 6.6 | From lighting or cooling systems | Yes | Cooling tower will be used in operation | | 6.7 | From any other sources | No | No | |
| 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 raw materials will be stored in the warehouse with proper secured flooring. The transfer of solvents will be done through pipelines and spillages will be avoided by monitoring.
Risk assessment for proposed products manufactured is prepared. Extra care will be taken while handling the hazardous materials.
Training will be 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) | Yes | ZLD concept will be followed and no treated water will be discharged outside. | | 7.3 | By deposition of pollutants emitted to air into the land or into water | Yes | Necessary air pollution control measures are installed to the air pollution sources. | | 7.4 | From any other sources | Yes | - | | 7.5 | Is there a risk of long term build up of pollutants in the environment from these sources? | No | - | |
| 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 | There will be no bulk storage of hazardous chemicals.
MSDS for all products and raw materials will be in place. Risk analysis and HAZOP studies will be carried out before commencement of the manufacturing activity.
Onsite emergency plan has been prepared and approval has been taken from the competent Authority. Necessary information and input will be given to District Authority to prepare off-site Emergency plan | | 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 | There are no possibilities of floods, earthquakes, landslides. However, other natural calamities cannot be ruled out. 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 | There will not be any additional development of supporting infrastructure, housing development supply industries as it is an expansion activity in an established Industrial Area. | | 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 | No | It is an independent activity with no collateral developments. | | 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 | No | There are no ecologically sensitive areas within 10 km radius around the project site. | | 3 | Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration | No | - | | 4 | Inland, coastal, marine or underground waters | Yes | • Krishna River – 7.7 km towards North direction
• Merched Kere – 6.5 km towards SW direction
• Machalapur Lake – 7.84 km towards SW direction | | 5 | State, National boundaries | No | The project site is at about 8.25 km away from the state boundary of Telangana | | 6 | Routes or facilities used by the public for access to recreation or other tourist, pilgrim areas | No | - | | 7 | Defence installations | No | - | | 8 | Densely populated or built-up area | Yes | Raichur City is at 10 km towards South direction | | 9 | Areas occupied by sensitive man-made land uses (hospitals, schools, places of worship, community facilities) | Yes | Details of hospitals, schools and place of worship near to the project site are provided in Section 2.9.1.14, Chapter 2 of EMP report | | 10 | Areas containing important, high quality or scarce resources.(ground water resources,surface resources,forestry,agriculture,fisheries,tourism,minerals) | Yes | Krishna River is about 7.7 km towards North direction from the project site | | 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 | No | - | | | Essential Details Sought |
|---|
| S. No. | EDS Sought Date | EDS Sought | Letter |
|---|
| (1.) | 23/11/2020 | The correction have been made as per the instruction received | | | (2.) | 29/10/2020 | (i) This is an expansion proposal accordingly, the PP shall submit the certified compliance report to the EC/CTO conditions from the RO,MoEFCC/SPCB.
(ii) Based on the information submitted by PP it is Category B2 project, PP submitted this application at Central Level. The Notification dated 27.03.2020 is only for API not for intermediates. If the proposal is for API & Intermediate, please apply for TOR. Please check your proposal once again.
(iii) All old CTOs to be uploaded to verify the violation, if any done by PP.
(iv) Details of earlier production capacity needs to be authenticated and uploaded to check the violation, if any.
(v) It is mentioned that the processing of EC proposal, in the Ministry, is through Parivesh Portal only, therefore providing the requisite information/documents shall be submitted. It is also mentioned that after acceptance the Proposal, proposal can not be revise. Therefore, PP/Consultant is requested to kindly do needful accordingly. | |
| | | Undertaking | | I hereby give undertaking that the data and information given in the application and enclosures are true to be best of my knowledge and belief. And I am aware that if any part of the data and information found to be false or misleading at any stage, the project will be rejected and clearance given, if any to the project will be revoked at our risk and cost. In addition to above, I hereby give undertaking that no activity/ construction/ expansion has since been taken up. | | | | Name of Applicant | Sharath K Reddy | | Designation | Director | | Name of Company (Applicant Name should not be given here) | M/S. SHILPA MEDICARE LIMITED | | Address | Unit II, Plot No 30, 31, 32 & 35-39, 33, 33A & 40-47, Raichur Industrial Growth Center, Wadloor Road, Chicksugur |
|
|