Signature Phytochemical Industries FORM-I

Transcription

1 Signature Phytochemical Industries FORM-I

2 FORM-1 Signature Phytochemical Industries, Selaqui, Dehradun At Khasra. 122 MI, Central Hope Town, Selaqui Dehradun, Uttarakhand. Signature Phytochemical Industries

3 APPENDIX I (See paragraph- 6) FORM 1 (I) Basic Information S. Item Details 1. Name of the Project/s Manufacturing of Pharmaceutical Formulations 2. S.. in the schedule Doon Valley tification Proposed Capacity/area/ length/tonnage to be handled/ command area/lease area/ number of wells to be drilled The proposed Capacity is as under 1,Tablets & 70 Crore Number / annum Capsule 2. Ointment 12 Thousand /annum 3. Liquid Oral 15 Lakh Liter / annum 4. Aerosol Spray 800 thousand/ annum 4. New/ Expansion/Modernization New 5. Existing Capacity/ Area etc/ t Applicable 6. Category of Project i.e. A or B B2 as project site is inside Doon Valley 7. Does it attract the general condition? if yes, please specify. 8. Does it attract the specific condition? If yes, please specify Doon Valley tification Location UPSIDC Industrial Area Selaqui, Dehradun Plot/Survey/Khasra. Village Khasra. 122 Mi Selaqui Signature Phytochemical Industries

4 Tehsil District State 10. Nearest railway station/airport along with distance in kms. 11. Nearest Town, City, District Headquarters along with distance in kms. 12. Village Panchayats, ZillaParishad, municipal Corporation, Local body ( complete postal Addresses with telephone nos. to be given) Vikas Nagar Dehradun Uttarakhand Dehradun Railway Station, 18km Jolly Grant Airport, 37.13Km Dehradun km Village PanchayatSelaqui ZillaParishad -Dehradun Tehsil- Vikas Nagar 13. Name of the applicant Mr. C R. Madanan 14. Registered Address Khasra. 122 Mi, Selaqui Industrial Estate, Dehradun. 15. Address for correspondence Khasra. 122 Mi, Selaqui Industrial Estate, Dehradun. Name Designation (Owner/Partner/CEO) Address Mr. C R. Madanan General Manager Khasra. 122 Mi, Selaqui Industrial Estate, Dehradun. Pin Code E- mail madanan@habpharma.in Telephone./Mobile Fax. 16. Details of Alternative Site examined, if any location of these sites should be shown on a top sheet Signature Phytochemical Industries

5 17. Interlinked Projects 18. Whether separate application of interlinked project has been submitted t Applicable 19. If yes, date of submission 20. If no, reason t Applicable 21. Whether the proposal involves approval/clearance under: if yes, details of the same and their status to be given. (a) The Forest (Conservation0 Act, 1980 (b) The Wildlife (Protection0 Act, 1972 (c) The C.R.Z notification, Whether there is any Government Order/ Policy relevant/relating to the site Doon Valley tification Forest land involved (hectares) 24. Whether there is any litigation pending against the project and /or land in which the project is proposes to be set up (a) Name of the Court (b) Case. (c) Orders/direction of the Court, if any and its relevance with the proposed project. 25. Location/Site under consideration Geographical Location of Project Area is at Signature Phytochemical Industries

6 Latitude '37"N Longitude '53.63"E Altitude ft. 26. Size of the Project Small 27. Expected Cost of the Project INR 7,94,58, Contact Information Mr. C R. Madanan, General Manager Khasra. 122 Mi, Selaqui Industrial Estate, Dehradun, Uttarakhand Screening Category B2, Orange Category as per criteria of Doon valley tification 1989, EIA tification 2006 Capacity corresponding to sectoral activity (such as production capacity for manufacturing, mining lease area and production capacity for mineral production, area for mineral exploration, length for linear transport infrastructure, generation capacity for power generation etc.,) (II) Activity 1. Constructions, 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.. Information/Checklist confirmation Yes/ Details there of (with approximate quantities/rates, wherever possible)with source of information data 1.1 Permanent or temporary change is land use, land cover or topography including increase in intensity of land use (with respect to local land use plan) Land use is Industrial Signature Phytochemical Industries

7 1.2 Clearance of existing land, vegetation and buildings? t Required. 1.3 Creation of new land uses? 1.4 Pre-construction investigations e.g. bore holes, soil testing? Yes It will be done before starting the work. 1.5 Construction works? Yes Existing building shall be modified as per the project requirement. 1.6 Demolition works? t Required 1.7 Temporary sites used for construction works or housing of construction workers? 1.8 Above ground buildings, structures or earthworks including linear structures. cut and fill or excavations 1.9 Underground works including mining or tunneling? temporary site is required as part of the building already exists. NA NA 1.10 Reclamation works? 1.11 Dredging? 1.12 Offshore structures? 1.13 Production and manufacturing processes? Yes Enclosed in PFR Facilities for storage of goods or materials? Yes Specific area shall be provided within the premises for storage of goods or construction material Facilities for treatment or disposal of solid waste or liquid effluents? 1.16 Facilities for long term housing of operational workers? Yes During construction temporary toilets shall be provided. Municipal waste shall be disposed as per the norms. The plant site is located at a distance of 17.81Kms from Dehradun city Adequate residential facilities are available for the operational Signature Phytochemical Industries

8 workers New road, rail or sea traffic during construction or operation? t required 1.18 New road, rail, air waterborne or other transport infrastructure including new or altered routes and stations, ports, airports etc? 1.19 Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements? 1.20 New or diverted transmission lines or pipelines? 1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers? 1.22 Stream crossings? t required 1.23 Abstraction or transfers of water form ground or surface waters? Yes Proposed water requirement is 15KL/day and shall be met out from Borewell Changes in water bodies or the land surface affecting drainage or run-off? t Applicable, as the proposed activity will be undertaken within existing industrial estate Transport of personnel or materials for construction, operation or decommissioning Yes Mainly local persons will be employed. Construction material shall be purchased from the vendors available in Selaqui. Signature Phytochemical Industries

9 1.26 Long-term dismantling or decommissioning or restoration works? Long-term dismantling or decommissioning or restoration works are not involved Ongoing activity during decommissioning which could have an impact on the environment? t Applicable Influx of people to an area in either temporarily or permanently? Yes There will be influx of 50 skilled workers including the supervisory staff; this influx will not have any significant impact on the socio-economic pattern of the area as Dehradun is a well-developed commercial center. Rather it will improve the per capita income and living standards of the local people Introduction of alien species? NA 1.30 Loss of native species or genetic diversity? 1.31 Any other actions? 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.. Information/checklist confirmation Yes/ Details thereof (with approximate quantities/rates, wherever possible)with source of information data 2.1 Land especially undeveloped or agricultural land (ha) 2.2 Water (expected source & competing users) unit: KLD Yes Developed Industrial Land 12KLD Source is Bore Well. Signature Phytochemical Industries

10 2.3 Minerals (MT) Construction material - Stone, aggregates, sand/soil (expected source-mt) Yes From local vendors. 2.5 Forests and timber (source-mt) 2.6 Energy including electricity and fuels (source, competing users )unit: fuel (MT), energy (MW) Yes Proposed power consumption is expected to be400 KVASupplied by Uttarakhand Power Corporation. 2.7 Any other natural resources (use appropriate standard units) An additional DG Set220 KVAis proposed for power backup. NA 3. Use, storage, transport, handling or production of substances or materials, which could be harmful to human health or the environment of raise concerns about actual or perceived risks to human health. S.. Information/checklist confirmation Yes/ 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 ) 3.2 Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases) 3.3 Affect the welfare of people e.g. by changing living conditions? 3.4 Vulnerable like groups of people who could be affected by the project e.g. hospital patients, children, the elderly etc. Yes except diesel which will be stored as per the norms of MSIHC rules. effect envisaged. Generation of employment will provide better living conditions to local people. effect envisaged. Signature Phytochemical Industries

11 3.5 Any other causes t Applicable. 4. Production of solid wastes during construction or operation or decommissioning (MT/ month) S.. Information/checklist confirmation Yes/ Details thereof (with approximate quantities/rates, wherever possible)with source of information data 4.1 Spoil, overburden on mine wastes Applicable. 4.2 Municipal waste (domestic and or commercial wastes ) Yes Municipal waste will be separated as Biodegradable and n- Biodegradable waste, which will be disposed as per MSW rules. 4.3 Hazardous wastes (as per hazardous waste Management Rules) Yes hazardous waste shall be generated in constructionphase. 4.4 Other industrial process wastes Yes industrial process waste. 4.5 Surplus product Entire production will be based on order. 4.6 Sewage sludge or other sludge from effluent treatment Yes sludge generation for the proposed expansion. 4.7 Construction or demolition wastes Yes Construction waste shall be used for the leveling of uneven plot area. 4.8 Redundant machinery or equipment 4.9 Contaminated soils or other materials NA 4.10 Agricultural wastes 4.11 other solid wastes Signature Phytochemical Industries

12 5. Release of pollutants or any hazardous,toxic or noxious substances to air (Kg/hr ) S.. Information/checklist confirmation Yes/ 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 5.2 Emissions from production processes 5.3 Emissions from materials handling including storage or transport 5.4 Emissions from construction activities including plant and equipment 5.5 Dust or odors from handling of materials including construction materials, sewage and waste 5.6 Emissions from incineration of waste 5.7 Emissions from burning of waste in open air (e.g. slash materials, construction debris) Yes The emissions would be only due to HSD burning in the DG set. Stack height of D.G. set shall be provided as per the norms of State Pollution Control Board. The entire operation will be under closed chambers, ne of the process during manufacturing results in emissions. Water Sprinkling shall be done to reduce the dust. Water Sprinkling shall be done to reduce the dust. Water Sprinkling shall be done to reduce the dust. t Applicable 5.8 Emissions from any other sources Unit is proposing one DG setof 220 KVA.Stacks will be provided as per the norms of SPCB. Signature Phytochemical Industries

13 Generation of ise and Vibration, and Emissions of Light and Heat: S.. Information/checklist confirmation Yes/ 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 6.2 From industrial or similar processes Yes Very nominal increase in noise levels will be observed, However all the operations shall be done in closed chambers. ise levels shall be monitored and shall be kept within the norms specified by State Pollutions Control Board. Timely maintenance of machines and proper housekeeping will be done. 6.3 From construction or demolition NA 6.4 from blasting or piling NA 6.5 From construction or operational traffic 6.6 From lighting or cooling systems 6.7 From any other sources 6. 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.. Information/checklist confirmation Yes/ Details thereof (with approximate quantities/rates, wherever Signature Phytochemical Industries

14 7.1 From handling, storage, use or spillage of hazardous materials 7.2 From discharge of sewage or other effluents to water or the land (expected mode and place of discharge) 7.3 By deposition of pollutants emitted to air into the land or into water Yes possible)with source of information data Chemical solvents used in the process shall be stored in safe and specified places. Necessary precautions for the same shall be taken. Fuel used for D.G. set shall be stored in separate storage. Sewage and industrial effluent will be treated in Septic tank/soak pit and ETP respectively. Capacity of the proposed ETP is 10 KLD. Treated water will be used in gardening and flush in washroom of plant premises only. 7.4 From any other sources 7.5 Is there a risk of long term buildup of pollutants in the environment form these sources? 7. Risk of accidents during construction or operation of the project, which could affect human health or the environment. S.. Information/checklist confirmation Yes/ 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 Necessary arrangements for firefighting are proposed. i.e. fire hydrant system and Fire extinguishers. Signature Phytochemical Industries

15 8.2 From any other causes Could the project be affected by natural disasters causing environmental damage (e.g. floods, earthquakes, landslides, cloudburst etc)? Yes There are least possibilities of the proposed project site getting flooded. However, building base has been taken 600 mm above the ground level. Buildings have been designed as per the norms for seismic zone-iv. 8. Factors which should be considered (such as consequential development)which could lead to environmental affects or the potential for cumulative impacts with other existing of planned activities in the locality. S.. Information/checklist confirmation Yes/ 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 9.2 Lead to after-use of the site, which could have an impact on the environment Selqui, Rampur, Harbatpur, Vikasnagar are well developed area city and influx of 50 skilled workers will not have significant impacts on the socio-economic pattern of the area. Rather jobs shall be created for 50local people which will improve their per capital income and living standards. The project site is on State Highway and entire infrastructure has been developed and maintained by UPSIDC Industrial area Selaqui. Signature Phytochemical Industries

16 9.3 Set a precedent for later developments A better after use scenario, which is likely to increase aesthetic beauty of the area and greenery, should set precedence for subsequent entrepreneurs who venture such projects. 9.4 Have cumulative effects due to proximity to other existing or planned projects with similar effects The project is in Industrial Area of Government of Uttarakhand. (III) Environmental Sensitivity S.. 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 Reserve Forest 3 km 2 Areas which are important or sensitive for ecological reasons - Wetlands watercourses or other water bodies, coastal zone, biospheres, mountains, forests Suvarna River Seasonal River Suvarna at a distance of 0.10 Km. Signature Phytochemical Industries

17 3 Areas used by protected, important or sensitive species of flora of fauna for breeding, nesting, foraging, resting, over wintering, migration Raja Ji National Park km 4 Inland, coastal, marine or underground waters 5 State, National boundaries state boundary within 15 Km. 6 Routes or Facilities used by the public for access to recreation or other tourist pilgrim areas 7 Defence installations IMA, Dehradun IMA is located at a distance of Kms 8 Densely populated or built-up area Selaqui, Vikasnagar, Sahaspur, Premnagar Selaqui, Vikasnagar, Sahaspur, Premnagar are located within the distance of 15 Km from the Project site. 9 Areas occupied by sensitive man made land uses (hospitals schools places of worship, community facilities) Yes School Mayadevi Institute of Technology, Shivalik College of Engineering, Hospitals-ESI Hospital & Private Dispensaries Signature Phytochemical Industries

18 10 Areas containing important, high quality or scarce resources (ground water resources surface resources, forestry, agriculture, fisheries, tourism, minerals.) 11 Areas already subjected to pollution or environmental damage. (those where existing legal environmental standards are exceeded) t Applicable. 12 Areas susceptible to natural hazard which could cause the project or present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions) There are least possibilities of the proposed project site getting flooded. However, building base has been raised sufficiently above the ground level. Buildings have been designed as per the norms for seismic zone-iv. Signature Phytochemical Industries

19 (IV) Proposed Terms of Reference for EIA studies (a) ToR is not required being a Category B2 project. (b) UNDERTAKING I hereby given undertaking that the data and information given in the application and enclosures are true to best of my knowledge and belief and I am aware that if any part of the data and information submitted is found to be false or misleading at any stage, the project will be rejected and clearance give, if any to the project will be revoked at our risk and cost. Date: For- Signature Phytochemical Industries Place: Dehradun C.R. Madanan (Authorized Signatory Signature Phytochemical Industries

20 NOTE: 1. The Project involving clearance under Coastal Regulation Zone tification 1991 shall submit with the application a C.R.Z map duly demarcated by one of the authorized agencies, showing the project activities, w. r.t C.R.Z(at the stage of TOR) and the recommendation of the state coastal Zone management Authority (at the stage of EC).Simultaneous shall also be taken to obtain the requisite clearance under the provisions of the C.R.Z tification, 1991 for the activities to be located in the CRZ. 2. The project to be located within 10 km of the national parks, sanctuaries, Biosphere Reserves, Migratory Corridors of wild Animals, the project proponent shall submit the map duly authenticated by chief Wildlife warden showing these features vis-a vis the project location and the recommendations or comments of the Chief Wildlife Warden thereon (at the stage of EC) 3. All correspondence with the Ministry of Environment & Forests including submission of application for TOR/Environmental Clearance, subsequent clarifications, as may be required from time to time, participation in the EAC meeting on behalf of the project proponent shall be made by the authorized signatory only. The authorized signatory should also submit a document in support of his claim of being an authorized signatory for the specific project. Date: For- Signature Phytochemical Industries Place: Dehradun C.R. Madanan (Authorized Signatory Signature Phytochemical Industries

21 PRE-FEASIBILITY REPORT Signature Phytochemical Industries

22 Pre- Feasibility Report For Manufacturing of Pharmaceutical Formulations in Signature Phytochemical Industries, Selaqui, Dehradun At Khasra Mi, Central Hope Town Selaqui, Dehradun, Uttarakhand Signature Phytochemical Industries

23 Environment Management Plan EXECUTIVE SUMMARY 1.0 M/s Signature Phytochemical Industries proposes to manufacture a variety of products ranging from Anti Bacterial, Anti- Malarial, Anti-biotic and Anti- inflammatory etc. in the form of Tablets, Capsules and Liquids in various forms of Packing and different filling capacities. It is also intended to expand the range of products by adding branded and widely accepted medicines at competitive costs taking into consideration the vagaries of the market and its locational advantages and after careful study of details, economic viability and financial requirements of the project. The Manufacturing facility for Formulation drug products is situated at Khasra Mi, Selaqui, Dehradun Uttarakhand, India. 1.1 INTRODUCTION A) History of the Company: Mr. Krishna Kumar R. Agarwal, Mr. Sanjiv Garg, Mr. Saurabh K. Agarwal & Miss. Shristi Garg mutually agreed to enter into a Partnership agreement with each other in the year for the purpose of setting up a plant for the purpose of manufacturing, producing, exporting, importing and dealing in all kinds of Pharmaceutical Products/Chemicals and allied activities. The unit was established in the year by acquiring land and constructing the plant on the land situated at 122Mi, Selaqui, (District) Dehradun for the purpose of manufacturing Pharmaceutical Products/Chemicals and allied activities. Till date manufacturing of pharmaceutical products could not be carried out due to unforeseen circumstances. The partners of the firm now propose to enter into manufacture of Pharmaceutical Formulations such as Tablets, Capsules, Liquids etc. in the same name and style of Messrs. Signature Phytochemical Industries. The Partners have now proposed and mutually agreed to set up a manufacturing unit at the existing unit for the purpose of manufacturing Tablets and Capsules for which purpose alternations, modifications of the plant and purchase of machinery have become essential to the existing unit. B) History of the product: The Firm proposes to manufacture a variety of products ranging from Anti-Bacterial, Anti- Malarial, Anti-Biotic and Anti- inflammatory etc. in the form of Tablets, Capsules and Liquids in various forms of Packing and different filling capacities. It is also intended to further the products by adding new ranges of branded and widely accepted medicines at competitive costs taking into consideration the vagaries of the market and its locational advantages and after careful study of details, economic viability and financial requirements of the project Pharmaceutical Formulation is the process in which different chemical substances, including then active drug, are combined to produce a final medicinal product. Formulation studies involve developing and preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to appreciate that a tablet contains a variety of other substances apart from the drug itself, and the studies have to be carried out to ensure that the drug is compatible with these other substances in the process of manufacturing 1.2 Salient Features of The Project 1

24 Environment Management Plan Proponent Name Location Latitude Longitude Land use Nearest Habitate/ Town Nearest Railways Station Nearest Airport Nearest Highway Water Demand and Supply source Nearest Tourism Place Seismic Zone Altitude Proposed Production process Estimated Project Cost INR 7,94,58,185 Working Days 26 Man Power 50 Signature Phytochemical Industries Khasra Mi, Central Hope town Selaqui, Dehradun, Uttarakhand ' 37" N 77 51' 53.63" E Industrial Selaqui Dehradun 18 km Jolly grant Km NH KLD Supply of Bore well Mussoorie22 Km Zone IV 1802 ft. (549 meters) Tablets, Capsules, Ointment, Liquid Oral and Aerosol Spray 2. INTRODUCTION OF THE PROJECT /BACKGROUND INFORMATION A. Identification of the project and project proponent. Category of Project: Category B2 (Doon Valley) The project proponent is M/s Signature Phytochemical Industries is a limited company. B. Brief Description of Nature of Project. M/s Signature Phytochemical Industries proposes to manufacture Pharmaceutical formulations such as Tablets, Capsules, and Liquids etc. C. Need for the Project & Importance to the Country The Proponent has expertise in the manufacture of above dosage. There is a growing demand for the pharmaceutical products internationally as well as in the domestic market. A need has therefore been felt to establish the unit for manufacturing. 2

25 Environment Management Plan D. Demand and supply gap These products are having National market and still demand is more than supply so manufacturing of these items are feasible. The Proposed Company does not see any difficulty in marketing their products as the two essential points in marketing a product i.e. product quality & packing and experience are reasonable in favour of the Promoters. E. Export Possibility Yes.Entire product shall be of export quality and possibilities of export will be explored. F. Domestic/Export Markets There is domestic market of this product but export shall also be done. G. Employment Generation (Direct & Indirect) due to the project With this proposed project direct employment generation of50persons will be there in worker/supervisor/ managerial category. Indirect generation of employment will also be there in way of contractors, transportation, suppliers, other service providers with continues chain of employment. 3. PROJECT DESCRIPTION A. Type of Project including Interlinked and Interdependent Projects, if any There is no interlinked and/or interdependent project linked with it. other allied activities and/ or services will be carried out with this project. B. Location (map showing general location, specific location, and project boundary & project site layout) with coordinates. The unit situated at Khasra Mi, Central Hope Town Selaqui, Dehradun, Uttarakhand is a welldefined and developed industrial area in Tehsil of Vikas Nagar and District of Dehradun at a distance of 18Km west of Dehradun on National Highway 72 to Chandigarh. C. Details of alternate sites considered and the basis of selecting the proposed site,particularly the environmental consideration gone into should be highlighted. alternate site. 3

26 Environment Management Plan D. Size and Magnitude of the operation. S.. Items of Manufacture/ Type of Service Quantity per annum 1. TABLETS & CAPSULE 70 Crore 2. OINTMENT 12 Thousand 3. LIQUID ORAL 15 Lakh Litre 4. AEROSOL SPRAY 800 Thousand E. Project description with process details (a schematic diagram/flow chart showing theproject layout, components of the project etc. should be given) The process involves following steps for various pharmaceuticals product. 1. TABLETS: A) GRANULATION: The raw material (various ingredients), viz the powder is sieved through a sifter so as to have the powder of equal mesh sizes after which, it is finely grind (through a Multi Mill) and mixed homogenously in a Mass- Mixer. This mass is then kept for drying (in a fluid bed dryer) for varying time and temperatures depending upon the quality of the product. The dried powder is ready to be converted in tablet form in the compression department. B) COMPRESSION: The dried powder from the granulation department is fed through a hopper to a Rotary Tableting machine where it is compressed into tablets, which can be of different sizes depending upon the requirements. The process is carried out under controlled temperature, which is done by Air- conditioning. C) COATING: This is an optional process depending on the customer s requirement. At the same time it is also essential in order to maintain highest quality standards. In this process, the compressed tablets are coated (in a Tableting machine) with the help of a compressor. The tablets may be coated by sugar, material cellulose or any other material. Again the work area shall be Air-conditioned. The tablets are ready for packing which is done in a Blister Pack Machine. The general pack size is of ten tablets. 2. CAPSULES: In order to maintain Good Manufacturing Practices (GMP) standards, it is necessary to have two capsule sections. One is for general capsules and the other is for sensitive penicillin or ampicillin group capsules. Both the sections are separate with proper Airconditioning and controlled relative humidity with the help of de- humidifier. In both the cases, the process is the same. The powder of various pharmaceutical raw materials is thoroughly mixed in a double cone blender for a fixed length of time. After mixing is complete, the powder is filled in empty capsules on a capsule filling machine which after fillings are closed and sealed. The capsules are then ready for packing on the Blister Packing Machine. Again the pack sizes if generally of ten capsules. 3. LIQUIDS: In preparing Liquid, utmost care is taken in purifying the water. The water s purified with the help of de-mineralizer plant. Only then it is used for manufacturing purposes. From the demineralizer the water is collected in a stainless steel tank. The necessary ingredients are 4

27 Environment Management Plan added into it and mixed with the help of an electric stirrer. If suspensions are to be manufactured, then it is churned with the help of homogenizer. Further, they are also churned by a Colloid Mill, which mixes the fine particles of water insoluble compound into an emulsion. After sometime, the stirred/churned liquid is passed through a volumetric filling machine into bottles/jar as required. The Bottle is then sealed with the help of a sealing machine. It is then visually checked under light for any foreign particles in the syrup. After labeling the bottle is ready for dispatching. The bottles used in filling the liquids are thoroughly washed with the help of Bottle Washing machine and then dried in Bottle Dryer for sterilization. This is a very important process for the product to be of best quality. 5

28 Environment Management Plan 6

29 Environment Management Plan PLANT AND MACHINERY Sr.. PARTICULARS Quantity TABLET SECTION GRANULATION SECTION 1. Multi Mill (Granulator) GMP Model with accessories and Motor One 2. Vibro Sifter 20 Model with screen size 550 mm dia. One 3. Mixer Granulator- 220 ltrs with accessories and motor One 4. Fluid bed dryer 60 kg with 225 ltrs capacity of trolley & One accessories 5. Hexagonal Blender Mixer GMP Model 1000 ltrs capacity One COMPRESSION SECTION Stn Rotary Machine, D- tooling with A.C. drive and upper One punch 7. Dust Extractor 150 CFM Model GMP with 1 HP motor One COATING SECTION 7

30 Environment Management Plan 8. Coating Pan 48 with Hot Air Blower, 3 HP motor, 1440 RPM One & 600 FM Blower PACKING SECTION 9. Alu- Alu mach1, Blister pack machine along with change parts One 10. Blister Pack machine, type Model 2200 Ch along with change One parts CAPSULES SECTION 1 Double Cone Blender-75 Kgs capacity One 2 Automatic Capsule Loading machine with interchangeable One section with loading trays 3 Manually operated capsule filling machine with interchangeable section with loading trays. One F. Raw Material Required Along Estimated Quantity, Likely Source, and Marketing Area Of Final Product/s Mode Of Transport Of Raw Material And Finished Product. LIST OF RAW MATERIALS Sr.. Name of the Raw Material Quantity per month 1. Paracetamol 20 Tonnes 2. Ibubrofen 10 Tonnes 3. C.P.M. 150 kg 4. Ceferoxin 300 kg 5. Cetrasine 200 kg 6. Befamethaxine 5 kg 7. Dexamethaxine 10 kg 8. PVRK kg 9. Cetobtyl alcohol 2100 ltr 10. Prochlorparasine molecule 200 kg Availability of Raw materials: The raw materials such as basic salts and excipients are freely available in the open market in almost all commercial cities. There are no price controls or distribution controls on the same. They can be manufactured indigenously and can be procured directly from the manufacturers in case of bulk purchases. As regards the cost of raw materials, the rates of different basic salts and excipients are different and fluctuating. Availability of Packing Materials: The presentation of any product is an important factor. However, this factor assumes special attention in Pharmaceutical Industry due to various reasons such as shelflife, hygiene, quality, stability, durability, easy to use etc., as also steady flow of finished product as per the requirement of market. Keeping these factors in mind there are many methods of packing too viz glass bottles, strips & blisters (in foils & PVC s), plastic pouches, tubes etc. Because of the variety and different types of methods used in packing pharmaceutical products, it is difficult to ascertain the exact cost of packing per unit. 8

31 Environment Management Plan G. Power Requirement: Total Power requirement is 400 KVA and will be met from Uttarakhand electricity board, also DG set of 220 KVA is proposed. DG set shall be used at the time of power failure only. H. Water Requirement: Proposed water requirement is12kld and shall be met from bore well. 4. SITE ANALYSIS A. Connectivity Well connected with Road, Rail and air service Dehradun Chandigarh highway 2 km Dehradun Railway Station 18 km Dehradun Airport km B. Land form, Land use and Land owner ship Plain and flat land having Industrial use falling UPSIDC Industrial Estate Selaqui, Dehradun. C. Topography Land is plane and flat with inclination towards South D. Existing land use pattern The existing land use is Industrial. E. Existing Infrastructure All infrastructures have been developed by UPSIDC Industrial Estate Selaqui, Dehradun.. F. Climatic data from secondary sources 9

32 Environment Management Plan Monthly mean maximum & minimum temperature and total rainfall based upon data: Month Mean Temperature o C Mean Rainfall in mm Maximum Minimum January February March April May June July August September October vember December Source- G. Social Infrastructure The area is under Selaqui and Vikas Nagar Tehsil,Entire social infrastructure has been developed by State Govt. I. Drinking Water Management ( Source & Supply of water) The source of the drinking water is Borewell J. Sewage System. Soak pit and septic tank arrangement shall be provided for the waste generated from toilets and domestic use. K. Industrial Waste Management. Effluent Treatment Plant is proposed for industrial waste. Capacity of ETP shall be 10 KLD L. Solid Waste Management 10

33 Environment Management Plan 1. Solid waste generated from sludge drying beds of ETP shall be disposed to TSDF as per the norms of State Pollution Control Board. 2. Used oil shall be disposed to authorized recycler. 3. Expired drugs shall be disposed as per the norms of State Pollution Control Board. M. Power Requirements & Supply/ source. Total Power requirement is 400 KVA and will be met from Uttarakhand electricity board, capacity DG set of 220 KVA is proposed. DG set shall be used at the time of power failure only. 5.0 PLANNING BRIEF A. Planning concept (type of industries, facilities, transportation etc) town and country planning/development authority Classification. The proposed industry is small scale and established in a developed UPSIDC Industrial Estate Selaqui, Dehradun. 6.0 PROPOSED INFRASTRUCTURE A. Industrial Area (Processing Area) additional infrastructure is proposed B. Resident Area (n Processing Area) as only local person will be given employment, no residential area/ housing is proposed. C. Green Belt - 33% area has been reserved for green belt Company has been developed dense green belt around the plant premises with plant species. D Hazardous waste Management: Company shall get the Authorization under Rule-5 of the Hazardous Waste (Management, Handling & Trans-boundary Movement) Rule, 2008, and maintain proper storage & safety management for Hazardous material. All Hazardous waste shall be disposed through authorized vendor.quantities of various hazardous wastes are given below: LTR/annum Waste oil MTA Dried ETP sludge MTA Expired finished product and raw materials. 7.0 REHABILITATION AND RESETTLEMENT (R & R) PLAN The unit is in developed industrial estate, so R & R plan is not required. 8.0 PROJECT SCHEDULE AND COST ESTIMATES Project is expected to be complete in next 3-4 months Funds requirement shall be Rs 7, 94, 58,185/- including the machinery and plant. 11

34 Environment Management Plan 9.0 ANALYSIS OF PROPOSAL (FINAL RECOMMENDATIONS) The Indian pharmaceutical industry is a success story providing employment for millions and ensuring that essential drugs at affordable prices are available to the vast population of this subcontinent. Also Improvement of infrastructure as well up-liftment of social structure in the area. The people residing in the nearby areas have been benefited directly & indirectly. 12

35 Environment Management Plan ENVIRONMENT MANAGEMENT PLAN 13

36 Environment Management Plan ENVIRONMENTAL MANAGEMENT PLAN Signature Phytochemical Industries, Selaqui, Dehradun At Khasra Mi, Central Hope Town, Selaqui, Dehradun. 14

37 Environment Management Plan WATER POLLUTION FROM PROCESS Items Water consumption Waste water generation Treatment Method From Process 10 KLD 9 KLD ETP Domestic 2 KLD 1.6 KLD Septic Tank and Soak pit. Generation of wastewater The waste water is generated because of the following factors:- Accidental and unintentional spillages. Dripping allowed escaping into the water. Washings from equipment and bottle cleaning. The small quantity of waste generated will be treated in existing ETP having following details. TABLE 3.1: QUANTITY & CHARACTERISTICS OF EFFLUENT Raw Effluent Characteristics: Sr.. Details Concentration Units 1. ph Total Suspended solids 300 Mg/lt 3 Chemical Oxygen Demand Mg/lt 4 Biochemical Oxygen Demand, 3 day, Mg/lt 27 0 C 5 Oil & Grease ~60 Mg/lt 15

38 Environment Management Plan Outlet Characteristics: Sr.. Details Concentration Units 1. ph Total Suspended solids Less than 5 Mg/lt 3. Chemical Oxygen Demand Less than 30 Mg/lt 4. Biochemical Oxygen Demand, 3 day, 27 0 C Less than 10 Mg/lt 5. Oil & Grease Less than 1 Mg/lt TREATMENT SCHEME Primary Treatment: Raw Effluent generated shall be passed through Screen Chamber. Bar screens shall be provided for removing any type of floatable matter in the raw Effluent which shall be scrapped out and collected in drums. Clear Effluent shall be collected in Equalization/ Collection Tank for equalizing the Effluent. Aeration grids shall be provided for mixing purpose. Equalized Effluent shall be pumped to MBBR tank for further treatment. Flash Mixer and Primary Tube Settler: Equalization ensures that the effluents have uniform characteristics in terms of pollution load, ph and temperature. The equalization tank shall be equipped with diffused aeration system. Aeration system helps in the homogenization of waste water and at the same time it also helps in preventing odorous condition. The aeration also reduces BOD and COD load. The homogenized aerated effluent from equalization tank shall be pumped for physic-chemical treatment plant. The physic-chemical treatment system consists of lime dosing, coagulant dosing in flash mixer tank and flocculation in flocculate followed by settling in settling tank. The chemical treatment helps in reduction of color and suspended solids. Further reduction in BOD and COD values can be achieved. Secondary Treatment: The Moving Bed Bio-film Reactor shall be filled with the specified quantity of bio media made of light weight plastic material to enhance the surface area for bio-growth. Oxygen required for the bacterial growth shall be supplied through Fine Bubble Diffuser systems. The system envisages better oxygen transfer because of fine bubbles and increased contact with the Effluent. The overflow from MBBR tank shall be gravitating to Secondary Tube Settler. To increase the retention time of settling tank, PVC tube settler shall be provided. This unit I provided to arrest the sludge from leaving the system. The arrested sludge shall be pumped backed to the MBBR tank to maintain the growth of biomass in system and excess sludge shall be taken to the Sludge Holding Tank. Collected sludge shall be pumped to the Filter Press for de-watering. The filtrate from filter press shall be taken to the equalization cum collection tank. Clear overflow from tube settler shall be gravitated to further tertiary treatment. Dried sludge from filter press can be used as manure or can be disposed off as per statutory norms. 16

39 Environment Management Plan Tertiary Treatment: Overflow from the tube settler shall be gravitated to Chlorine Contact Tank where provision shall be made for hypochlorite dosing as required for disinfection. Dosing shall be done by pumping. Treated Effluent shall be pumped to Pressure Sand Filter followed by Activated Carbon Filter. Treated Effluent from carbon filter shall be used for gardening and flushing. 17

40 Environment Management Plan PROCESS FLOW DIAGRAM OF EFFLUENT TREATMENT PLANT 18

41 EQUIPMENT SIZING Sr.. MS UNIT TABLE 3.2: CIVIL UNITS OF THE EQUIPMENTS QTY SIZE 1. Screen Chamber 1 1.0m x 1.0m x 1.0m SWD 2. Equalization cum Collection Tank 1 3.0m x2.0m x 2.0m SWD 10 cum / day RETENTION TIME (hrs) MOC -- MS angles with PVC mesh -- RCC 3. MBBR Tank MS 4. Secondary Tube MS Settler 5. Chlorine Contact MS Tank 6. Final Water Tank 1 4.0m x 3.0m x 2.0m SWD RCC 7. Operating & Control Panel Room TABLE 3.3: MECHANICAL UNITS OF THE EQUIPMENTS: Sr. EQUIPMENT 10 cum / day. QTY CAPACITY MOC 1. Bar Screen 1 Suitable SS Raw Effluent Transfer 1 1m 3 8m CI Pumps WC 3. Air Blower 1 40 m 3 /hr CI 4. Membrane Diffusers Lot Dia 63 mm x 950 EPDM mm Long 5. MBBR biomedia Lot Suitable PVC 6. Final Water Tank Lot Suitable PVC 7. Sludge Return Pumps m 3 /hr CI 8. Filter Feed Pumps 1 1m 3 CI 35m WC 9. Pressure Sand Filter mm dia x FRP 1200mm HOS 10. Activated Carbon mm dia x FRP Filter 1200mm HOS 11 Electrical Control Panel 1

42 AIR POLLUTION Table 3.4: Sources of air pollution and control measures. Source of Air Pollution Preventive/ Control Measures 1. Vehicular Emissions. Entry of Vehicles inside the industrial premises will be restricted. Inspections at regular intervals of all operational Vehicles making them strictly undergo regular maintenance and pollution checkup. 2. Emissions from the DG Set. There will be one DG set of 220 KVA capacities for the standby power backup. DG set will operate only when UPCL power will not be available Stack of appropriate height as per the CPCB norms will be installed on the DG set to clear the exhaust and acoustic insulation will be done by supplier of the DG Set. SOLID WASTE MANAGEMENT Table 3.5: Sources and Prevention/ Control of SWM. Sources of Solid Waste Packing Material (approx. quantity will be100 Kg/month) Preventive/ Control Measures Packing material will be sold to a Recycler. HAZARDOUS WASTE MANAGEMENT Table 3.6: Sources and Management of Hazardous waste Hazardous waste Schedule I -5.1 Lube oil Schedule I ETP Sludge. Schedule I-28.4 Expired finished products and raw QTY Management Plan 400Ltr/annum Recyclable. Will be sold to authorized recycler 1.2 MTA Will be send to authorized secured land fill site. 3.0 MTA As per rules.

43 materials GREEN BELT DEVELOPMENT. 33% of the total plot area is proposed to be developed as green beltfor further attenuation of the noise. Green Belt will also add aesthetic Beauty to the Plant and also help in maintaining the Ecological Balance. Table 3.7: Cost of proposed Environmental Measures S. N o Particulars Qty Size Price (INR) Cost of ETP 1 set 10 KLD 7.0 Lakh Green Belt development LS As required 3.0 Lakh Cost of Rainwater Harvesting System Annual operation cost of Environmental measures Total LS As required 3.0 Lakh 5.00 Lakh 18 Lakhs NOISE ENVIRONMENT Pollution Sources The significant noise generating sources identified for the project are as following: During operation of the project the sources of noise will be: i ii Vehicular traffic Standby DG Set Control Measures: The following control and mitigation measures are proposed to keep the noise levels within the permissible limits. Proper maintenance and greasing of noise generating equipment s and vehicles. There will be restriction in speed of vehicles in factory. The proposed DG set will be attached with Acoustic Enclosure.

44 FIRE SAFETY AND FIRE FIGHTING DEVICES A comprehensive fire- fighting system is proposed containing fire hydrant system, fire water tank, fire water pump, jockey pump. Fire extinguishers are also proposed as approved by fire department. Sand Buckets for fighting shall be provided in sufficient numbers in whole of the plant. Proper use of Personal Protective Equipment (PPE) like helmet, goggles, safety shoe, ear plugs, musk, etc. is being assured. All electrical equipment and machinery have been properly grounded. Control switches have been properly located at the point of operations best suited to control the equipment. Informatory hoarding have been displayed to handle the by chance situations. Information for good housekeeping will be displayed. Supervisors and employees are properly trained to operate power Equipment or machinery and also in their safe operation. An Effective communication system is being practiced in case of any un favorable conditions RAIN WATER HARVESTING Rain Water Harvesting is collection and storage of rain water for suitable uses. For rain water harvesting, water is captured and stored either above the ground or used as to recharge the ground water to be used later on. The Rain Water Harvesting System shall consist of seepage/percolation pits. The Rainwater shall be diverted from the rooftop using rain water pipes to the rainwater harvesting system. Proper precautions will be taken to ensure that rain water collected is free of any pollutants.