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Prefeasibility Report Proposed Intermediates API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
1
Pre-Feasibility report
MANUFACTURING UNIT OF INTERMEDIATES API AND BULK
DRUGS
Project Proponent:
M/s NAARI Pharma Pvt. Ltd.
Plot 14-16 & 55-57, Sector-5
IIE Pant Nagar, Rudrapur-263153
Dist: Udham Singh Nagar
(Uttarakhand), India.
2017
Prefeasibility Report Proposed Intermediates API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
2
CONTENTS
1 EXECUTIVE SUMMARY ................................................................................................................ 4
2 INTRODUCTION ............................................................................................................................ 6
2.1 BRIEF DESCRIPTION OF THE PROJECT ......................................................................................... 6
2.2 PROJECT PROPONENT: .............................................................................................................. 6
2.3 NEED FOR THE PROJECT AND ITS IMPORTANCE TO REGION ........................................................... 6
2.4 DEMANDS-SUPPLY GAP.............................................................................................................. 7
2.5 DOMESTIC/EXPORT MARKETS: .................................................................................................... 7
2.6 EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO THE PROJECT ................................... 7
3 PROJECT DESCRIPTION ............................................................................................................. 8
3.1 TYPE OF PROJECTINCLUDING INTERLINKED AND INTERDEPENDENT PROJECTS, IF ANY .................... 8
3.2 LOCATION (SPECIFIC LOCATION AND PROJECT BOUNDARY & PROJECT LAY OUT) WITH COORDINATES8
3.3 DETAILS OF ALTERNATE SITES CONSIDERED AND THE BASIS OF SELECTING THE PROPOSED SITE,
PARTICULARLY THE ENVIRONMENTAL CONSIDERATIONS GONE INTO SHOULD BE HIGHLIGHTED .................. 8
3.4 TECHNOLOGY AND PROCESS DESCRIPTION ................................................................................. 8
3.5 MANUFACTURING PROCESS: ..................................................................................................... 12
3.6 BRIEF DESCRIPTION OF MANUFACTURING PROCESS:.................................................................. 12
3.7 RAW MATERIALS ...................................................................................................................... 14
3.8 ADDITIVES AND CHEMICALS ...................................................................................................... 16
3.9 RAW MATERIAL REQUIRED ALONG WITH ESTIMATED QUANTITY, LIKELY SOURCE, MARKETING AREA OF
FINAL PRODUCTS, MODE OF TRANSPORT OF RAW MATERIAL AND FINISHED PRODUCT. ............................ 16
3.9.1 Transportation details of Raw Materials ............................................................................ 16
3.10 AVAILABILITY OF WATER ITS SOURCE, ENERGY/POWER REQUIREMENT AND SOURCE SHOULD BE
GIVEN 16
3.10.1 Fuel ............................................................................................................................... 16
3.10.2 Quantity of waste to be generated (liquid and solid) and scheme for their management
/disposal 16
3.10.3 Waste Water Generation and utilization: ....................................................................... 16
4 SITE ANALYSIS .......................................................................................................................... 20
4.1 CONNECTIVITY ......................................................................................................................... 20
EINVIRONMENTAL SENSITIVITY ........................................................................................................... 20
4.2 CLIMATIC DATA FROM SECONDARY SOURCES ............................................................................. 21
1.1.2. Climate & Rainfall ............................................................................................................. 21
1.1.3. Seismic Considerations .................................................................................................... 22
5 PROPOSED INFRASTRUCTURE ............................................................................................... 23
5.1 INDUSTRIAL AREA (PROCESSING AREA) ..................................................................................... 23
5.2 RESIDENTIAL AREA (NON-PROCESSING AREA) ............................................................................ 23
5.3 GREEN BELT ............................................................................................................................ 23
5.4 DRINKING WATER MANAGEMENT (SOURCE & SUPPLY OF WATER) ................................................. 23
5.5 SEWAGE SYSTEM ..................................................................................................................... 23
Prefeasibility Report Proposed Intermediates API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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5.6 INDUSTRIAL WASTE MANAGEMENT ............................................................................................. 23
5.7 POWER REQUIREMENT & SUPPLY/ SOURCE ................................................................................ 23
6 REHABILITATION AND RESETTLEMENTS (R& R) PLAN ........................................................ 24
6.1 POLICY TO BE ADOPTED (CENTRAL/STATE) IN RESPECT OF THE PROJECT AFFECTED PERSONS
INCLUDING HOME OUSTEES, LAND OUSTEES AND LANDLESS LABOURERS (A BRIEF OUTLINE TO BE GIVEN) 24
7 PROJECT SCHEDULE AND COST ESTIMATE .......................................................................... 25
7.1 LIKELY DATE OF START OF CONSTRUCTION AND LIKELY DATA OF COMPLETION (TIME SCHEDULE FOR
THE PROJECT TO BE GIVEN) ............................................................................................................... 25
7.2 ESTIMATED PROJECT COST ALONG WITH ANALYSIS IN TERMS OF ECONOMIC VIABILITY OF THE
PROJECT. ......................................................................................................................................... 25
Prefeasibility Report Proposed Intermediates API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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1 EXECUTIVE SUMMARY
M/s. Naari Pharma PVT. LTD., is promoted by a team of highly qualified professionals with
vast Academic, Industrial &Marketing experience, highly motivated and involved in
manufacturing of Intermediate and Bulk Drug Unit & is going setup new establishment in
existing industrial land allotted by State Industrial Development corporation of Uttarakhand (
SIDCUL) in Uddam Singh Nagar District.
M/s. Naari Pharma PVT. LTD got Consent for operation from Uttarakhand State
pollution control board for existing formulations manufacturing plant Consent No.
UEPPCB/HO/Con/J-39/2012/1494
S.No Parameter Description
1
Project Location
Naari Pharma Private Ltd. Plot 14-16 & 55-57, Sector-5, IIE
Pant Nagar, Rudrapur - 263153, Dist: Uddam Singh Nagar,
(Uttarakhand) ,India
2
Category of Project as per
EIA Notification
&Amendments
5(f)
Screening Category “B”
Respective SEAC/SEIAA is dissolve, Hence the proposal
appraised in MOEF as “A” category project.
3 Project cost 17500 lakhs
4 Plot area Total Land available: 5.93 Acres (24020m2)
Proposed to land use for construction of manufacturing facility, utility, office and roads:
3.93 Acres (15904m2)
Proposed Green belt area: 2.0 Acres (8093 m2)
5 Proposed Product
Proposed Products List is mentioned in section3.1
6 (i)Electricity Requirement
Source & Requirement of
electricity
Electricity sourced from Uttarakhand Power Supply
Corporation.
Total power will be 3000KVA
Diesel Requirement for Boilers:5 KLD
D.G. Sets
D. G. Set: 3000KVA.
(Diesel Consumption 750 LPH as per DG running hours).
Prefeasibility Report Proposed Intermediates API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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7 (ii)Water consumption The total water requirement will be 150 KLD. (One time
water requirement)
(Fresh water requirement 60 KLD and recycle water 90
KLD)
Source of water Sourced from Ground water
Waste water generation Industrial effluent of 100 KLD is generated and will be
treated in ZLD System.
Mode of disposal Zero Liquid Discharge
(iii)Boiler
Diesel Fired Boilers: 5 TPH (2Nos)
(iv)Fuel Diesel Requirement for Boilers: 5 KLD
8 Solid waste generation Mentioned in Para 3.5.1 of report
9
Nearest Highway National Highway No.1091.2 KMs
10
0
Nearest Railway Station Rudrapur railway station–5.5 KMs
11 Nearest Airport Nearest Air port - 7.0 km Pant Nagar
Prefeasibility Report Proposed Intermediates API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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2 INTRODUCTION
2.1 Brief Description of the Project
M/s. NAARI PHARMA PVT. LTD., proposed to establish bulk drugs and
intermediates manufacturing plant at Plot 14-16 & 55-57, Sector-5, II E Pant
Nagar, Rudrapur - 263153, Dist: Uddam Singh Nagar, (Uttarakhand), India.
The proposednew establishment is to manufacture Bulk Drugs and intermediates,
which are active ingredients with medicinal properties.
2.2 Project Proponent:
Shri. Prithipal S. Kochhar is the Director of the company. He has more than15years
of experience in pharmaceutical industry.
2.3 Need for the project and its importance to region
Active Pharmaceutical Ingredients (API) or bulk drugs are the principal ingredients for
finished pharmaceutical products. Intermediates are the compounds from which active
pharmaceutical ingredients are prepared. APIs cannot be administered directly to
the patient, and other in active substances called excipients are added to stabilize
the mixture. This end product, which includes the API and the excipient, is referred to
as a formulation. Formulations are the pharmaceutical products administered to
patients and can take the form of tablets, capsules, syrups, ointments, creams,
injectables, etc.
The Indian pharmaceutical industry currently tops the chart amongst India's science-
based industries with wide ranging capabilities in the complex field of drug
manufacture and technology. A highly organized sector, the Indian pharmaceutical
industry is estimated to be worth $6 billion, growing at about 8to9 percent annually. It
ranks very high amongst all the third world countries , in terms of technology, quality
and the vast range of medicines that are manufactured. It ranges from simple
headache pills to sophisticated antibiotics and complex cardiac compounds, almost
every type of medicine is now made in the Indian pharmaceutical industry.
Prefeasibility Report Proposed Intermediates API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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The domestic marketaccounts for 90% of the company‟s total revenue and supplies
its products to Leading Pharma industries ofdomesticand international clients.
2.4 Demands-Supply Gap
There is a quite considerable gap between supply and demand for bulk drugs and
intermediates. Very few players are in the market who can offer continuous supply.
The company wants to bridge this gap between demand and supply by expanding the
production capacity and thereby, making good business. Company's marketing edge
comes from its direct and close contact with the customers. Their products are major
strength of their customers. Each stage of their product is been monitored /checked
for their quality to ensure quality product reaches their customer. They plan to launch
new products every year to satisfy the need of their customers as per the market
demand.
2.5 Domestic/export Markets:
The products shall cater to both domestic and export markets.
2.6 Employment Generation (Direct and Indirect) due to the project
The Estimatedgenerationfor this proposed expansion is about Indirect-100 and direct
operation after new establishment 400employees. Apart from this there will be
significant non estimatedemployment generation at the supplier firms and service
industry providing services to the company. Company shall be giving preference to
people from economically weaker sections for employment in various semi-
skilled/unskilled jobs there by contributing to their uplift the quality of life.
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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3 PROJECT DESCRIPTION
3.1 Type of Projectincluding interlinked and interdependent projects, if any
The Proposed Greenfield Project falls under „Section 5(f)‟ Manufacturing / Production of
Synthetic Organic Chemicals& „Category “B”. project is not a interlinked project.
3.2 Location (specific location and project boundary & project lay out) with
coordinates
M/s. NAARI PHARMA Pvt. Ltd proposes for new establishment its manufacturing bulk
drug and intermediate products at Plot 14-16 & 55-57, Sector-5, IIE Pant Nagar, Rudrapur
- 263153, Dist: Uddam Singh Nagar, (Uttarakhand) ,India. The site coordinates are
Latitude: 29°00'21"N and Longitude: 79°24'32"E. Google Map of the study area is
provided in Figure 1.
The site well connected to road and railway line. No archaeological, historical sites is
located within the study area. Therefore, the project site does not offer any negative
impact on the local area as because it is a new establishment in existing vacant land in
notified industrial area, but rather has a positive impact on socio economic conditions of
the area. The plant is well connected both to Highway No–109 and Railway line. Nearest
Railway station is Rudrapur city located about 5.5 km from Project site. Plant Lay Out
provided in Figure-2
3.3 Details of alternate sites considered and the basis of selecting the proposed
site, particularly the environmental considerations gone into should be
highlighted
Present site is located in an industrial land allotted by State Industrial Development
corporation of Uttarakhand ( SIDCUL) in Udham Singh Nagar District hence no alternate
site considered
3.4 Technology and Process Description
NAARI will manufacture the following type of products (Total Capacity is 16.46 MT/Month)
Table 1.1 LIST OF PRODUCTS AND IT’S INTERMEDIATE WITH QUANTITY
List of Proposed API& Intermediates ( Annexure 1)
S.No API/Intermediate Product Name Mfg in
MT/Month CAS
number
1 API 19-Norandrostenedione 0.67 734-32-7
2 API Androstadienedione 0.11 897-06-3
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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3 API Allylestrenol 0.11 432-60-0
4 API Cyproterone Acetate 0.03 2098-66-0
5 API Deflazacort 0.25 14484-47-0
6 API Dienogest 0.06 65928-58-7
7 API Dydrogesterone 0.04 152-62-5
8 API Estradiol 0.00 50-28-2
9 API Estradiol Benzoate 0.10 50-50-0
10 API Estradiol Cypionate 0.02 313-06-4
11 API Estradiol Valerate 0.04 979-32-8
12 API Estriol 0.10 50-27-1
13 API Estrone 0.21 53-16-7
14 API Ethinyl Estradiol 0.07 57-63-6
15 API Hydroxy Progesterone Caproate 0.26 630-56-8
16 API Levonorgestrel 0.07 797-63-7
17 API Lynestrenol 0.02 52-76-6
18 API Medroxyprogesterone Acetate 0.97 71-58-9
19 API Mifepristone IH 0.07 84371-65-3
20 API Mifepristone IP 0.17 84371-65-3
21 API Nandrolone Decanoate 0.31 360-70-3
22 API Nandrolone Phenyl Propionate 0.03 62-90-8
23 API Norethisterone 0.39 68-22-4
24 API Norethisterone Acetate 0.34 51-98-9
25 API Norethisterone Enanthate 0.08 3836-23-5
26 API Norgestimate 0.01 35189-28-7
27 API Ospemifene 0.03 128607-22-7
28 API Progesterone 4.92 57-83-0
29 API Testosterone Cypionate 0.37 58-20-8
30 API Testosterone Enanthate 0.17 315-37-7
31 API Testosterone Propionate 0.02 57-85-2
32 API Ulipristal Acetate 0.03 126784-99-4
33 Intermediate 3,3-dimethypropylenedioxy -4,5-seco-estr-9-ene-5,17-dione (G4) 1.26 NA
34 Intermediate Norandrostenedione Crude 0.80 734-32-7
35 Intermediate Estrenone (Oxide) 0.11 3646-28-4
41 Intermediate ADD NPG Ketal (Intermediate for Estrone) 0.52 13258-43-0
43 Intermediate Norandrostenedione Crude 0.41 734-32-7
44 Intermediate 3-Ethoxyestra-3, 5-(6)-diene-17-one (NET) 0.33 NA
45 Intermediate Nandrolone 0.23 434-22-0
46 Intermediate Norandrostenedione Crude 0.05 734-32-7
47 Intermediate 3-Ethoxyestra-3, 5-(6)-diene-17-one 0.04 NA
48 Intermediate Nandrolone 0.03 434-22-0
49 Intermediate Norandrostenedione Pure 0.60 734-32-7
50 Intermediate 3-Ethoxyestra-3, 5-(6)-diene-17-one ( 0.48 NA
51 Intermediate Norandrostenedione Pure 0.56 734-32-7
52 Intermediate 3-Ethoxyestra-3, 5-(6)-diene-17-one 0.45 NA
53 Intermediate Norethisterone 0.36 68-22-4
54 Intermediate Norandrostenedione Pure 0.11 734-32-7
55 Intermediate 3-Ethoxyestra-3, 5-(6)-diene-17-one ( 0.09 NA
56 Intermediate Norethisterone 0.07 68-22-4
Total 16.46
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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Figure 1 : Location map
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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Figure 2: Plant Layout
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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3.5 Manufacturing Process:
The manufacturing processof bulk drugs and intermediates consists of chemical synthesis
extending to stages ofprocessing involving different type of chemical reactions. The
generalized Flow chart for bulk drug manufacturing is shown in Figure 3.
Figure-3: Generalized Flow Chart for Bulk Drug Manufacturing
3.6 Brief Description of Manufacturing process:
Raw Material Charging: Raw materials are issued from warehouse as per Batch
Manufacturing Record issued by Quality Assurance department. These raw materials are
carried to the production area, where dedicated reactor is situated for the reaction. Solvents
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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are charged into reactor from drums with vacuum applied in the reactor. Solid raw materials
are charged through manhole in the reactor and closed the vessel for the reaction
Reaction: Chemical reaction takes place in the solvent with key raw materials. This reaction
takes place in definite physical parameters like temperature, pressure and agitation of the
vessel. Reaction is monitored by QC department and the reaction is terminated once the
entire starting material is converted into product
Quenching of reaction: Quenching/termination of reaction is done by supply of chilled water
or mixing water into the reaction mass. The reaction is also arrested by adding some other
solvents in the reaction mass
Layer separation: After termination of the reaction stirring is stopped and settling is done.
After settling, layer is separated and solvent with product is transferred to another reactor for
workup and crystallization
Crystallization: Solvent with product is distillated under vacuum to reduce the volume around
1/10th of the initial volume. After distillation, chilling is applied in the jacket to reduce the
temperature of the reaction mass, 0 ˚C or below to crystallize the product under slow stirring
Filtration: After crystallization, first crop product is filtered in closed Nutsche filter under
vacuum. The mother liquor is recycled to second time crystallization to recover the second
crop product
Drying: Filtered product is unloaded from the Nutsche filter and loaded in the vacuum tray
dryer or rotary vacuum dryer. After drying 12-16 hours Loss of Drying (LOD) is tested in QC
laboratory. If the LOD is high, the drying process is further continued till desired LOD limit is
achieved.
Packing: When the finished good is released by QC, it is transferred to warehouse for further
packing of the material. This packing is done in 3 containment system like primary, secondary
and tertiary packing
Dispatch of finished goods: After receiving the sales order from the sales team, material is
planned to be dispatched from the site.
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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3.7 Raw Materials
All the raw materials required for manufacturing of above products will be sourced from local
market. The products wise required raw materials and quantities are enclosed. Provided in
Table below:
Table 1.2 List of Raw Material
Sl.No Name of Raw Materail UOM ( MT/KL)
Consumption /Month
1 ADD MT 0.8
2 Thinner (ARS-Hexane) KL 5
3 Neo Pentyl Glycol MT 1
4 Pyridine MT 5
5 p-TSA MT 0.15
6 Tri ethyl Amine MT 0.1
7 Methanol KL 8
8 ADD NPG Ketal MT 0.8
9 Tetrahydrofuran (THF) KL 7
10 Diphenyl methane MT 0.5
11 Phenanthrene MT 0.1
12 Lithium MT 0.05
13 Sulphuric acid MT 1.5
14 Sodium Hydroxide MT 1
15 Toluene KL 6
16 Sitolactone (D) [SSM (D) ] MT 1.56
17 CKT MT 1.85
18 Diethyl Ether (Ether) KL 3.5
19 *Magnesium Turnings (Mg Metal) MT 0.36
20 Ethylene Di bromide (MGA) MT 0.1
21 THF KL 8
22 Ammonium Chloride MT 0.7
23 Hyflo Supercel (Dicalite) MT 0.4
24 Chlorine Gas Cylinder MT 0.8
25 Sodium Sulphite MT 1.8
26 Soda Ash (Sodium Carbonate) MT 2
27 Potassium Hydroxide Pellets (KOH) MT 2.5
28 G4 wet MT 2.4
29 RSX(D)/RSX Fresh KL 5
30 Palladium on carbon (Fresh/regenerated) MT 0.06
31 Phosphoric acid MT 2.5
32 XRNG-III MT 0.3
33 Potassium Hydrogen Sulphate KL 0.18
34 Methylene Chloride MT 12
35 Active Carbon MT 0.3
36 Aluminium oxide Neutral MT 0.25
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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37 Ethyl Acetate KL 6
38 DP-15 Ketal (Ethylene deltanone) MT 0.06
39 Ethyl bromide (m/c: ≤ 0.05%) KL 0.05
40 Propyne gas MT 0.03
41 Sodium chloride MT 0.6
42 Hexachloro acetone KL 1.5
43 50% Hydrogen peroxide KL 0.09
44 Sodium Thio sulphate MT 0.015
45 Sodium Bicarbonate MT 0.015
46 Sodium Sulphate Anhydrous (DHA) MT 0.25
47 Iodine MT 0.05
48 N, N Dimethyl para bromo Aniline MT 0.12
49 Cuprous chloride MT 0.02
50 NET MT 1.4
51 Acetone KL 10
52 Potassium t-butoxide (TKB) MT 0.6
53 Hydrochloric Acid KL 1.5
54 Hydroxy Progesterone (HP) MT 0.4
55 N-Caproic anhydride KL 0.3
56 Isopropyl Alcohol KL 5
57 Nandrolone (PET) MT 0.3
58 Decanoyl Chloride (DECOL) KL 0.25
59 N-Pentane KL 1
60 Oxide (Estrenone) MT 0.1
61 Allyl Bromide (HALOM) MT 0.2
62 Acetonitrile (SOC) KL 1
63 Methoxydienone {18-Methyl (LNG)} MT 0.01
64 Norethisterone (NETP) MT 0.25
65 Acetic Acid MT 0.5
66 Acetic anhydride MT 0.15
67 Zinc Chloride Anhydrous MT 0.015
68 Hexane KL 6
69 n-Heptane KL 0.65
70 Norethisterone Enanthate for seeding MT 0.025
71 70% Perchloric acid KL 0.015
72 Dienogest Crude MT 0.025
73 Dienogest Semi Pure MT 0.025
74 Estrone MT 0.25
75 Sodium Borohydride MT 0.015
76 Ethanol KL 3
77 Estradiol MT 0.25
78 Benzoyl Chloride KL 0.1
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
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3.8 Additives and Chemicals
No
3.9 Raw material required along with estimated quantity, likely source, marketing area
of final products, mode of transport of raw material and finished product.
3.9.1 Transportation details of Raw Materials
The transportation of raw materials will be done by trucks as per MSHIC rule.
3.10 Availability of water its source, energy/power requirement and source should be
given
The unit is located in Notified Industrial Estate. Total water requirement will be 150 KLD,
which is sourced from bore well. Permission for drawl of 150 KLD ground water shall be
obtained from concerned authority. Water Balance diagram is provided in Figure 4.
3.10.1 Fuel
Diesel shall be used as fuel in the boiler and High-speed diesel (HSD) will be used in DG
sets. Table gives the fuel quantity and the source. Details as below:
D. G. Set: 3000KVA. (Diesel Consumption 750 LPH as per DG running hours).
Diesel Fired Boilers: 5 TPH (2Nos) Diesel Requirement for Boilers:5 KLD
DG Sets will be used only during Power failure.
3.10.2 Quantity of waste to be generated (liquid and solid) and scheme for their
management /disposal
3.10.3 Waste Water Generation and utilization:
Total effluent generated is 100 KLD effluent (which includes MEE condensate and ETP RO
reject ) propose treat in-house zero liquid discharge system. Recycled effluent is proposed to
use for utility operations, floor washing and toilet flushing‟s.
Total sewage waste water generated is 18 KLD proposed to treat in-house sewage treatment
plant. Treated sewage effluent proposed to use for gardening purpose.
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
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Figure 3: Water Balance Diagram
Table 3.5: Waste water generation and Treatment Method
Unit
HTDS KLD
LTDS KLD
Sewage waste water
Remarks
Treatment Method
Process 30 - - High TDS
effluent proposed to treat in MEE
and ATFD. Low TDS
ETP RO reject (*25) - *Generated
from low TDS effluent stream
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
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Washings - 40 - effluent
proposed to treat in ETP & ETP
RO. Sewage waste water proposed
to treat in sewage
treatment plant
Utility operations - 30 -
MEE condensate - (*45) -
*MEE condensate
generated from high TDS effluent
treatment stream
Process ,washing and utility and ETP RO
reject - - -
Domestic waste water - 0 18 -
Total 30 70 18
ETP RO reject and MEE condensate quantity not considered in total effluent generation
Hazardous waste will be disposed off to TSDF site
Category of waste
Name of the
Hazardous Waste
Quantity (MT/KL
/Annum)
DisposalMethod
1
Chemical sludge from waste water treatment
20 Sent to SPCB Authorized Agencies
for TSDF
2
Used or Spent Oil 10 Sent to SPCB Authorized Agencies
for reprocessing or recycling
4
Salt from MEE 650 Sent to SPCB Authorized Agencies
for TSDF
5 Spent Solvent 900 Sent to SPCB Authorized
Agencies for reprocessing or recycling
6
Off Specification Product 10 Sent to SPCB Authorized Agencies
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
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7
Empty barrel or containers or liners contaminated with Hazardous
chemicals 3000 No‟s
After Detoxification sent to outside SPCB Authorized agencies
8
Spent Carbon or Filter medium 6 Sent to SPCB Authorized Agencies
for TSDF
9
Used Batteries
250 No‟s/ Year
Send back to suppliers for buy back of New Batteries
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
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4 SITE ANALYSIS
4.1 Connectivity
Plot Survey / Khasra No. Plot 14-16 & 55-57 (Industrial Area)
Village
Tehsil / Taluka / Mandal Rudrapur
District Udhamsingh Nagar
State Uttrakhand
Nearest railway station / airport / along with distance in
km.
Rudrapur railway station–5.5 kms Nearest Air port - 7.0 km
Nearest town, city, district headquarters along with
distances in km
Rudrapur 3.5 km SSE
Village Panchayat, ZilaParisad, Municipal
Corporation, Local Body (complete postal address with
telephone nos. to be given)
Rudrapur Municipal corporation
Einvironmental Sensitivity
1 Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value
No
There are no areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value There is forest block called Tanda forest Range at a distance of 4.62km(N)
2 Areas which are important or sensitive for ecological reasons -Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests
Yes There is Chakferi River, at a distance of 6.19 km, E
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 areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value There is forest block called Tanda forest Range at a distance of 4.62km(N)
4 Inland, coastal, marine or underground waters
No There is Chakferi River, at a distance of 6.19km,E
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
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5 State, National boundaries No
Uttar Pradesh State boundary : 5.77km,SW
6 Routes or facilities used by the public for access to recreation or other tourist, pilgrim areas
No NH-87, 0.91 km, W
7 Defense installations No
There are no Defense installations
8 Densely populated or built-up area Yes
Rudrapur Town, 1.94 km, S
9 Areas occupied by sensitive man-made land uses (hospitals, schools, places of worship, community facilities)
Yes
National Public School, 2.60 km (S) Jeevan deep hospital & diagnostic centre,3.89km(SW)
10 Areas containing important, high quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals)
Yes -
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)
No The project is located in High damage Risk zone(Zone IV) as per IS: 1893 (Part-1) 2002.
4.2 Climatic data from secondary sources
1.1.2. Climate & Rainfall
The climate is warm and temperate in Rudrapur. The is a great deal of rainfall in Rudrapur, even
in the driest month. This location is classified as Cfa by Köppen and Geiger. In Rudrapur, the
average annual temperature is 24.3 °C. The rainfall here averages 1302 mm. The driest month
is April, with 3 mm of rainfall. The greatest amount of precipitation occurs in August, with an
average of 387 mm. Climate graph of Rudrapur is provided in Figure- 4.
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Figure 5 : Climate Graph of Rudrapur
(Source: https://en.climate-data.org/location/33827/)
1.1.3. Seismic Considerations
According to the seismic-zoning map of India, the state of Uttrakhand falls in a region of
moderate to high seismic hazard.As per the 2002 Bureau of Indian Standards (BIS) map, study
area falls in High damage Risk zone(Zone IV) as per IS: 1893 (Part-1) 2002.
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
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5 PROPOSED INFRASTRUCTURE
5.1 Industrial Area (processing area)
Not applicable
5.2 Residential Area (non-processing area)
Not applicable
5.3 Green belt
33% of total plot i.e. 2.0 Acres (8093 m2) area will be developed as greenbelt.
5.4 Drinking water management (source & supply of water)
150 KLD water required. Source through Bore well (Ground water abstraction).
5.5 Sewage system
Sewage waste water is treated in sewage treatment plant .Treated sewage waste water
proposed to use for gardening purpose.
5.6 Industrial waste management
Generated waste has been categorized in below categories. Water balance diagram is provided
in Figure 4.
Domestic waste
Solid waste (Non hazardous)
Hazardous waste
5.7 Power requirement & supply/ source
Details of power requirement, source and emergency power requirement is provided as below:
o Electricity sourced from Uttarakhand Power Supply Corporation.
o Total power will be 3000KVA
o D. G. Set: 3000KVA. (Diesel Consumption 750 LPH as per DG running hours).
o Diesel Fired Boilers: 5 TPH (2Nos) Diesel Requirement for Boilers:5 KLD
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
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6 REHABILITATION AND RESETTLEMENTS (R& R) PLAN
6.1 Policy to be adopted (central/state) in respect of the project affected persons
including home oustees, land oustees and landless labourers (a brief outline to be
given)
Not Applicable
Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur
NAARI Pharma Pvt. Ltd.
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7 PROJECT SCHEDULE AND COST ESTIMATE
7.1 Likely date of start of construction and likely data of completion (time schedule for
the project to be given)
It is estimated that the project can be fully implemented in by 2019-20 with concurrent sanction
of funds. Complete project will be implemented and commissioned in 2020.
This is a tentative schedule in which flexibility can be exercised depending upon the market
demand and fund availability.
7.2 Estimated project cost along with analysis in terms of economic viability of the
project.
Cost of Estimates of the Greenfield Project is17500 lakhs (INR). Project work will be start after
getting the environmental clearance.