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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

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Page 1: EIA & EMP for 100 MW Thermal Power Plant at Delhienvironmentclearance.nic.in/writereaddata/Online/TOR/16... · 2017-09-16 · Prefeasibility Report Proposed Intermediates API & Bulk

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

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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

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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

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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).

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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

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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.

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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.

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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

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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

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Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur

NAARI Pharma Pvt. Ltd.

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Figure 1 : Location map

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Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur

NAARI Pharma Pvt. Ltd.

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Figure 2: Plant Layout

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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

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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.

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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

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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

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Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur

NAARI Pharma Pvt. Ltd.

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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.

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Prefeasibility Report Proposed API & Bulk Drug Manufacturing Unit at Rudrapur

NAARI Pharma Pvt. Ltd.

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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

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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

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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

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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

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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.

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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

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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

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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.