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[Vide Notification dated 14 th September, 2006 Amendment on 1 st December, 2009] PRE-FEASIBILITY REPORT For Proposed Expansion Project MANUFACTURING OF BULK DRUG & INTERMEDIATE By M/S. VADIVARHE SPECIALITY CHEMICALS LTD. Gat No. 204, Nasik-Mumbai Highway, Vadivarhe, Taluka: Igatapuri, District: Nasik, Maharashtra, India Conducted & Prepared By GREEN CIRCLE, INC. Integrated HSEQR Consulting Engineers, Scientists & Trainers (MoEF Recognized Environment Laboratory) (An ISO: 9001, 14001, NABL/17025:2005, OHSAS: 18001 Certified Organization & GPCB approved Environment Auditor Schedule II) Gujarat High Court Stay Order for QCI NABET No. C/SCA/10311/2012 dated 24.02.2014 Corp. Office & Environmental Research Laboratory: Green Empire (Anupushpam), Above Axis Bank, Nr. Yash Complex, Gotri Road, Vadodara-390 021 (Gujarat) India |Tel: 0265-2371269 www.greencircleinc.com E: [email protected] ALSO AT BENGALURU RUDRAPUR NEW DELHI HYDERABAD PUNE RAIPUR KOLKATA GOA OVERSEAS AUSTRALIA OMAN KUWAIT AFRICA VIETNAM

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Page 1: M ANUUFFAACCTTUUR R IINNGG OOFF EBBUULLKK DDRUUGG ...environmentclearance.nic.in/writereaddata/Online/... · As per IMS Retail Drug Monitor, sales through pharmacies in thirteen leading

[Vide Notification dated 14th September, 2006

Amendment on 1st December, 2009]

PPRREE--FFEEAASSIIBBIILLIITTYY RREEPPOORRTT

For Proposed Expansion Project

MMAANNUUFFAACCTTUURRIINNGG OOFF BBUULLKK DDRRUUGG && IINNTTEERRMMEEDDIIAATTEE

By

M/S. VADIVARHE SPECIALITY CHEMICALS LTD.

Gat No. 204, Nasik-Mumbai Highway, Vadivarhe, Taluka: Igatapuri, District: Nasik,

Maharashtra, India

Conducted & Prepared By

GREEN CIRCLE, INC. Integrated HSEQR Consulting Engineers, Scientists & Trainers

(MoEF Recognized Environment Laboratory)

(An ISO: 9001, 14001, NABL/17025:2005, OHSAS: 18001 Certified Organization & GPCB approved

Environment Auditor – Schedule II)

Gujarat High Court Stay Order for QCI NABET No. C/SCA/10311/2012 dated 24.02.2014

Corp. Office & Environmental Research Laboratory:

Green Empire (Anupushpam), Above Axis Bank, Nr. Yash Complex, Gotri Road, Vadodara-390

021 (Gujarat) India |Tel: 0265-2371269

www.greencircleinc.com E: [email protected]

ALSO AT

BENGALURU RUDRAPUR NEW DELHI HYDERABAD PUNE RAIPUR KOLKATA GOA

OVERSEAS

AUSTRALIA OMAN KUWAIT AFRICA VIETNAM

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

1

INDEX

Sr. No. Description Page no.

1.0 Executive Summery 3

2.0 Introduction of project 4

2.1 Project proponent 4

2.2 Brief description of nature of the project 4

2.3 Need for the project & it’s important to the country and or

region

4

2.4 Demand supply Gap 5

2.5 Employment generation (Direct & Indirect) due to the project 5

3.0 Project description 6

3.1 Products & product capacity 9

3.2 Raw material requirement 12

3.3 Manufacturing process 12

3.4 Resource-utilize & recycling 12

3.4.1 Water Requirement 12

3.4.2 Power requirement 13

3.4.3 Fuel requirement 13

3.5 Waste Management 14

3.5.1 Waste water generation & utilization 14

3.5.2 Solid waste generation & disposal 16

3.6 Schematic representations of the feasibility drawing which give

information of EIA purpose

16

4.0 Site Analysis 18

4.1 Land Form, Land use and Land ownership. 18

4.2 Existing Infrastructure 18

4.3 Soil classification 18

4.4 Climatic data from secondary sources 18

4.5 Social Infrastructure available 19

5.0 Planning Brief 19

6.0 Proposed Infrastructure 19

6.1 Project Area 19

6.2 Residential Area 19

6.3 Green Belt 19

6.4 Social Infrastructure 19

6.5 Occupation health 19

7.0 Rehabilitation and Resettlement (R & R) Plan 20

8.0 Project Schedule & Cost Estimates 20

9.0 Analysis of proposal (Final Recommendations) 21

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

2

List of Tables & Figures

List of Tables

Sr. No. Page no.

1 Summary of Proposed Plant 3

2 The details of employment 6

3 The List Product & Production capacity is given below 9

4 water Requirement details 13

5 Hazardous Waste Quantity 16

6 Land Use plan 18

7 Project Schedule & Cost Estimates 20

8 Cost of environmental protection measures 21

List of Figures

1 Location Map of the Project site 7

2 Google Image of the Project site 8

3 Google Image of the Project site covering 5 & 10 Km radius 8

4 Flow Chart for Bulk Drug Manufacturing 12

5 ETP Flow Chart 14

6 Plant Layout 17

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

3

1.0 Executive Summery

M/s. Vadivarhe Speciality Chemicals Ltd. is existing manufacturing unit at Gut No. – 204, Nashik –

Mumbai highway, A/p – Vadivarhe, Tal. – Igatpuri, Dist. – Nashik – 422 403 (Maharashtra) for Bulk

Drugs & Drugs Intermediates.

Industry is going for Expansion of project in the same category of Product as Bulk Drugs & Drugs

Intermediates.

Table 1: Summary of Proposed Plant

Sr.No. Parameter Description

1 Name And Address M/s. Vadivarhe Specialty Chemicals Ltd. (VSCL)

Gut No. – 204, Nashik – Mumbai highway, A/p –

Vadivarhe, Tal. – Igatpuri, Dist. – Nashik – 422 403

Maharashtra

2. Name of Project Expansion of Manufacturing of Bulk Drug &

Intermediates from 12.85 to 34.868 MT/M capacity by

M/s. Vadivarhe Specialty Chemicals Ltd. (VSCL).

3 Category of Project as per EIA

Notification

5(f) “A”

4 Project Cost Rs. 22 crore

5 Area of the project Total Area - 12500 Sq. M.

6 Latitude & Longitude Latitude: 190 50.859’ N

Longitude: 730 40.737’ E

7 Product Bulk Drugs & Drugs Intermediates

8 Total Production (Existing-12.85 + Proposed-22.01815) =34.868)MT/M

9 Capacity of Boiler 850 kg/hr

10 Total water Requirement 54.41 m3/day

11 Waste Water Generation 24.71 m3/day

12 Total Power Requirement (350 KV)

13 Total Fuel Requirement 1) LDO - 500 liter/day

2) HSD – 50 Liter/day

14 Manpower Direct employment :

1. Permanent Staff : 70 nos

2. Permanent Workers : 16 nos

Indirect Employment:

1. Contract Workers – 25 nos

Total : 111 Nos

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

4

2.0 Introduction/Brief Project Description

The objective of this pre feasibility study is to provide information for the Bulk Drugs and

Intermediates manufacturing unit by M/s. Vadivarhe Speciality Chemicals Ltd. Gut No. – 204,

Nashik – Mumbai highway, A/p – Vadivarhe, Tal. – Igatpuri, Dist. – Nashik – 422 403 (Maharashtra).

M/s Vadivarhe Speciality Chemicals Ltd. is a reputed name in the Bulk Drugs & Drugs

Intermediates manufacturing. It is a limited organization engaged in manufacturing Bulk Drugs &

Drugs Intermediates manufacturing products.

The M/s. Vadivarhe Speciality Chemicals Ltd. has been incorporated with main object to

manufacture Bulk Drugs & Intermediates which have a good export potential. The ever-

increasing demand for the products in India & Abroad has prompted the promoters to undertake

manufacturing of some selected Bulk Drugs & Intermediates. As per the provision of “EIA

Notification No.S.O.1533 (E)” dated 14.09.2006 as amended on December 01, 2009, the project

comes under “Category 5 (f) A”

2.1 Project Proponent :

M/s. Vadivarhe Speciality Chemical Ltd. is incorporated in the year 2007 to manufacture Bulk

Drug & Intermediates Mr. Vasant Jagtap is the Director of this Company Having experience in

Bulk Drug manufacturing & R&D for more than 20 years.

2.2 Brief Description of Nature of the Project

The project is going to manufacture synthetic organic chemicals (Bulk Drug) in total capacity of

34.868-MT/M. The pharmaceutical industry includes the manufacture, extraction, processing,

purification & packing of chemical materials to be used as medicines. Pharmaceutical

manufacturing is divided into two major stages the production of active ingredient or drug

(Primary processing or manufacturing & Secondary processing) the conversion of the active

drugs into products suitable for administration.

2.3 Need for the Project & its Importance to the Country & or Region

Mumbai & Surrounding area has emerged as major drug manufacture city with a presence in

global market. Pharma industry in the state contribute more than one third to the country total

production.

Most of the companies have set up their R&D facilities in the state, thus making the state the

pharmaceutical capital of the country.

Mumbai & Surrounding has developed as major production center for bulk drugs due to the

location if the many major pharmaceutical industries such as Lupin ltd, Matrix Labs, Cipla,

Ranbaxy etc. besides a large no. of medium & small industries manufacturing Bulk Drugs of all

kinds.

The Indian Pharmaceutical Industry today is in the front rank of India’s science based industry with

wide ranging capabilities in the complex field of drug manufacture & technology.

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

5

Bulk drugs have become a part of our life for sustaining many of our day-to-day activities,

preventing & controlling diseases. Bulk drug manufacturing sector in India is well established &

has recorded a steady growth in the overall Indian industrial scenario. The bulk drug & allied

industries have been amongst the fastest growing segments of the Indian Industry.

India’s pharmaceutical industry is the third largest in the world in terms of volume. Its rank is 14th

in terms of value. India is also one of the top five active pharmaceutical ingredients (API)

producers (with a share of about 6.5%)

The ever-increasing demand for bulk drug & intermediate in India & abroad as well as

changing market condition for manufacture & sale of products has prompted the promoters

to go for manufacturing of Bulk Drug (API) & Intermediates as well as chemicals.

2.4 Demands-Supply Gap

As per IMS Retail Drug Monitor, sales through pharmacies in thirteen leading markets for the year

to August 2003 are $ 298.7 Billion. According to the IMS World Review, in 2004 global audited sales

of pharmaceuticals rose 8% (at constant dollar rate) to reach US $ 400.6 Billion. IMS world Review

tracks actual sales of approximately 90% of all prescription drugs & certain over-the-counter

(OTC) products in more than 70 countries. Using proprietor data projection methodologies to

estimate total global pharmaceutical sales, which grew to US $ 430.3 Billion in 2005. Despite

economic challenges in the world’s leading markets & a lower than normal number of new

products introduction, the global pharmaceutical industry experienced good growth in 2005.

During 2005-06, the state produced bulk drug & formulations worth US $ 2.5 billion. The exports

from the state stood at US $ 1.0 billion in 2004-05 registering an annual growth of more than 20%

the sector accounts for about 20% of the total exports from state

Imports Vs Indigenous Production

The products including third generation antibiotics are high in demand in the export market. Also

their demand is increasing in the domestic market. Production of these drugs domestically

reduces the need to import these in future along with significant scope for export in these

products.

Domestic/ Export Markets

In the initial phase the products shall comprise of mainly intermediates which shall be supplied to

domestic API firms. Subsequently when the blocks for APIs will be erected, the APIs will be

supplied to both domestic as well as export market

2.5 Employment Generation (Direct & Indirect) Due to the Project

The activities under industry would produce improvement in the socio-economic status of people

in the study area in terms of local labor employment & contract basis jobs. The proposed activity

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

6

might provide employment opportunities to the local populace, especially in business & other

services like transportation activity.

It is expected to direct or indirect employ about 50-60 people of various skills will be required

during construction as well as operation phase.

The details of employment shown in below Table 2-

Particulars N0. Of Employees Functional

Key managerial staff &

Administration

70 Finance, Marketing , Production,

Quality Control, R&D, Logistic Office

work etc

Skilled & semiskilled 41 Production process , Maintenance

stores, Safety & un Skilled workers.

Total 111

3.0 Project Description

M/s. Vadivarhe Speciality Chemicals Ltd. manufacturing unit at Gut No.204, Nashik-Mumbai

highway, A/P-Vadivarhe, Tal-Igatpuri, Dist-Nashik-422403 (Maharashtra) Location map is shown at

Figure.

The Co-ordinates (Latitude and Longitude) of the project site are given below-

Corner Location (at Project site) Co-ordinates

Near ETP 190 50.859’ N and 730 40.737’ E

Near Reception building 190 50.861’ N and 730 40.807’ E

Near Boiler House 190 50.814’ N and 730 40.800’ E

Near D.G. Set 190 50.812’ N and 730 40.746’ E

There are no archaeological, historical sites located near project site. Therefore, the project site

does not offer any negative impact on the local area. But rather have a positive impact on socio

economic conditions of the habitants around it.

The plant is well connected with National Highway No.3 (NH-3) at 0.5 KM from Site & Railway line

at Igatpuri Railway station at 20.87 km & Nashik Railway station at 20.25 km. The total of about

12500 Sq. Mt. of land is acquired for this project.

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

7

Figure 1: Location Map of the Project site

Figure 1: Location map of Project site

Project Site

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

8

Figure 2: Google Image of the Project site

Figure 3: Google Image of the Project site covering 5 & 10 Km radius

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

9

3.1 The List Product & Production capacity is given below in Table 3.

Sr. No. Product Name Monthly Production

Quantity Unit

Existing Product-

1 Trimethyl ortho Proplonate (MOP) 0.25 MT

2 Tributyl ortho Propionate (BOP) 0.1 MT

3 Tri methyl Ortho Valerate (MOV) 0.2 MT

4 Tributyl ortho Valerate (BOV) 0.25 MT

5 Trimethyl ortho Butyrate (MOBu) 0.05 MT

6 Trimethyl ortho Benzoate (MOB) 0.05 MT

7 4-Aminomorpholine (4AM) 0.4 MT

8 Ethyl –N-Dodecanoyl-L-Arginate Hydrochloride 0.5 MT

9 Ethyl Atropate(EA) 0.5 MT

10 3-Aminophthalhydrazide (3APH) 0.2 MT

11 3-Aminophthalhydrazide Sodium Salt 0.05 MT

12 1-Bromo 4-Tert Butyl Benzene 0.5 MT

13 N-N Dimethyl Formamide Dimethyl Acetal (DMFDMA) 0.2 MT

14 Tert –Butoxy bis (dimethyl amino ) methane (TBTMMDA) 0.2 MT

15 Briji (Wax) 3.0 MT

16 Hydol (Wax) 3.0 MT

17 Stereoamido propyl dimrthyl amine (Wax) (SAPDMA) 3.0 MT

18 Sodium Thieoglycolate (NaTG) 0.1 MT

19 Calcium Thieoglycolate (Ca TG) 0.1 MT

20 Misc. Chemicals in R&D Lab 0.2 MT

Total-12.85 MT/M

Proposed products

21 Quinoline-6- Carboxylic acid 0.08 MT

22 Di methyl Malonic acid 0.008 MT

23 4-Chloro-3-Nitroanisole 0.08 MT

24 Sodium Hippurate hydrate 0.08 MT

25 4-Morpholinoaniline 0.008 MT

26 N-Benzylglycine ethyl ester 0.04 MT

27 6-Methoxyquinoline 0.008 MT

28 1-Bromo-2-methyl propane 0.004 MT

29 Indole-3-methanol (Indole-3-carbinol) 0.008 MT

30 Indole-3- carboxylic acid 0.008 MT

31 Indole-5- carboxylic acid 0.008 MT

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

10

32 3-(Demethylaminomethyl)Indole (Gramine) 0.0008 MT

33 Trimethyl Orthoacetate 0.04 MT

34 Cheamide 0.41 MT

35 L-Cystine disodium Salt 0.008 MT

36 Methdilazine hydrochloride 0.04 MT

37 Indole-3-carboxaldehyde (Indole-3-aldehyde) 0.008 MT

38 3- Cyanoindole 0.008 MT

39 Tert-Butoxy-bis (dimethyl amino)methane (Bredereck”s

reagent) 0.2

MT

40 Propionyl chloride 0.04 MT

41 Phenyl phosphate disodium salt 0.008 MT

42 Aloe Vera juice (Stabilised) 8.33 MT

43 Lecithin powder 0.008 MT

44 Ammonium Thioglycolate(solution) 0.08 MT

45 5-Bromo,5-Nitro,1:3 Dioxane 0.004 MT

46 Phenylepherin Hydrochloride (PPH) 0.04 MT

47 Heck Coupled Product 0.008 MT

48 Chloro Atavaquinone 0.008 MT

49 Immidazolyl acetic acid 0.0082 MT

50 2-Amino-4-HydroxyAcetophenone Hydrochloride 2.66 MT

51 Adapalene 0.0005 MT

52 Tazarotene 0.002 MT

53 Glimepiride 0.025 MT

54 Telmisartan 0.05 MT

55 Rosuvastatin Calcium 0.75 MT

56 Montelukast sodium 0.05 MT

57 Olanzapine 0.05 MT

58 Moxifloxacin hydrochloride 2 MT

59 Topiramate 0.25 MT

60 Risperidone 0.05 MT

61 Olopatadine hydrochloride 0.0004 MT

62 Escitalopram oxalate 0.1 MT

63 Brimonidine tartrate 0.0015 MT

64 Strontium ranelate 0.1 MT

65 Nepafenac 0.0008 MT

66 Desloratidine 0.2 MT

67 Olmesartan Medoxomil 0.008 MT

68 Nitazoxanide 0.25 MT

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

11

69 Atorvastatin calcium 2 MT

70 Bromfenac sodium 0.0015 MT

71 Febuxostat 0.25 MT

72 Prasugrel hydrochloride 0.01 MT

73 Alcaftadine 0.0003 MT

74 Cinacalcet hydrochloride 0.008 MT

75 Dapoxetine hydrochloride 0.025 MT

76 Dimethyl Fumarate 0.01 MT

77 Losartan Potassium 1.5 MT

78 Pitvastatin Calcium 0.005 MT

79 Flavoxate hydrochloride 0.005 MT

80 Flovoxamine Maleate 0.05 MT

81 Timolol maleate 0.005 MT

82 Ketoprofen 0.41 MT

83 Clopidogrel Bisulfate 0.041 MT

84 Tetrabenazine 0.01 MT

85 Agomelatine 0.01 MT

86 Rupatadine Fumarate 0.1 MT

87 Lymecycline 0.2 MT

88 Dexketoprofen trometamol 1 MT

89 Trospium chloride 0.008 MT

90 Dronedarone hydrochloride 0.08 MT

91 Lurasidone hydrochloride 0.0008 MT

92 Milrinone 0.0001 MT

93 Pramipexole dihydrochloride 0.0005 MT

94 Pregabalin 0.1 MT

95 Teriflunamide 0.005 MT

96 Roflumilast 0.0001 MT

97 Solefenacinsuccinate 0.00025 MT

98 Tolperisone hydrochloride 0.008 MT

99 Clonidine HCL 0.0004 MT

100 Darifenacin HBr 0.004 MT

101 Duloxetine HCL 0.041 MT

TOTAL 22.01815 MT

(Existing-12.85 +Proposed-22.01815) = 34.868)MT/M

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

12

3.2 Raw material requirement

All the raw materials required for manufacturing of above products will be sourced from local

market- List is attached as Annexure – V.

3.3 Manufacturing Process: The manufacturing process of bulk drug consist of chemical synthesis

extending to stages of processing involving different type of chemical reaction. The generalized

flow chart for bulk drug manufacturing and mass balance is shown in Flow chart List attached as

Annexure-VI.

Generalized flow chart for Bulk Drug Manufacturing-

Figure 4: Flow Chart for Bulk Drug Manufacturing

3.4 Resource – Utility & Recycling

3.4.1 Water Requirement

Water requirement for the existing facility is 26.41 m3/day, which is met from Tankers/ Borewell.

Total Water requirement of the project after expansion for domestic & Industrial activity during

operation phase will be 54.41 m3/day. Water will be drawn from borewell and tankers after

expansion. Necessary permission for ground water withdrawal, will be taken from concerned

authority. The detailed water requirement shown in below Table

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

13

Table 4 water Requirement details

Purpose Water Consumption Losses Effluent Disposal

of

Treated

Effluent

Exist

Water

Cons.

(m3/d)

Prop.

Water

Cons.

(m3/d)

Total

Water

Cons.

(m3/d)

Loss

Exist.

Water

(m3/d)

Prop.

Water

(m3/d)

Total

Loss

(m3/d)

Effluent

Exist.

(m3/d)

Effluent

Prop.

(m3/d)

Total

Effluent

after

Expansion

(m3/d)

Industrial

processing

6.41 18.0 24.41 0.20 5.51 5.71 6.21 12.50 18.71

Floor

Wash

/Reactor

Wash-

5.0m3

Scrubber

use-5 m3

Industrial

cooling

and Boiler 18.0 5.0 23.0 17.0 4.2 21.2 1.0 0.8 1.8

Cooling

Tower-

4.71 m3

Domestic 2.0 3.0 5.0 0.2 0.6 0.8 1.8 2.4 4.2 ----

Gardening --- 2.0 2.0 --- 2.0 2.0 Nil Nil Nil 10.0 m3

Total 26.41 28.00 54.41 17.4 12.31 29.71 9.01 15.70 24.71 24.71m3

3.3.2 Power Requirement

The Total power requirement will be 350 KVA. The main source of power is MSEB. The back-up will

be provided from DG Sets having capacity of 250 KVA in case of power failure.

3.4.3 Fuel Requirement

Sr.

No.

Stack Capacity Status Stack

Height

(m)

Stack

Dia

(mm)

Fuel name &

Quantity

Stack

Gas

Temp.

(0C)

Air Pollution

Control Measure

1 Boiler 850 Kg/hr Existing 20 150 LDO – 500

Lit./day

110 Sufficient Stack

Height

2 D.G.

Set

250 KVA Existing 5 100 HSD – 50

Lit./day

90 Sufficient Stack

Height

3 Process

Reactor

2000 cfm Existing 15 152 - - Sufficient Stack

Height with

Scrubber

Sr. No. Particulars Source Existing Expansion Total

1 Total

Demand

MSEB 350 KV - 350 KVA

2 Back-up D.G. set 250 KVA - 250 KVA

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

14

3.5 Waste Management

3.5.1 Waste Water Generation, Utilization & Treatment

Total effluent (Domestic + Industrial) generated in the project is 24.71 M3/day. The treated water

will be recycled for plant operations and reused for Gardening. Hence, no waste water will be

discharged outside plant premises.

Figure 5 ETP Flow Chart

Waste Water Treatment

Effluent generated from the project will be treated through effluent treatment plant. Existing ETP

having Capacity 50 CMD. Total Effluent generation after expansion will be 24.71 KLD [9.01 KLD

(Existing) + 15.70 KLD (expansion)], which after treatment in ETP, will be recycled and reused for

Gardening, Floor washing, Scrubber and Cooling Tower make-up. Domestic waste water will also

be treated in existing ETP. ETP flow chart is given above.

Process of the Effluent water treatment:

Industry had provided Full-fledged E.T.P. consisting of Following Units. Additional Effluent after

Expansion will also be treated in this Facility. E.T.P. is designed for 50 CMD considering future

Expansion.

Air Blower

Process

Effluent

Domestic

effluent

Oil & grease trap

Eqn/Neutn tank -2 no

Anaerobic digester

SAFF

Bioreactor Sec clarifier tank

Filter press

Sand filter & Carbon filter

Treated Water Effluent pump

Treated Water Tank

Clar water tank

Primary Parallel plate settler tank

Filter Cake

Filtrate

Title : Flow Diagram of E.T.P.

Client : Vadivharhe Specialty Chemicals Ltd,Nasik

By Universal Associates

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

15

I. Equalization Cum Neutralization Tank: Two No.(One Stand by )

The effluent is collected & equalized here to equalize the whole mass of the effluent to the

average concentration .All the floating material also being separated here by Course screen

& Fine screen. The online screens installed for the same. As the most efficient digestion occurs

at neutral pH,it is necessary to neutralize the incoming waste to a pH of 7.

II. Primary Clarifier Tank with Flash Mixing Tank: One no.

After Neutralization, the effluent is pumped to Flash Mixer Tank. The Alum & Poly Electrolyte

dosing is added for the Sedimentation & coagulation.

After Equalization & Neutralization, the industrial waste water enters the Primary Clarifier Tank

through Flash Mixer. To avoid the Turbulence created due to the Pressure Pumping Flash

Mixing Tank provided

Here the Suspended Particles heavier than water settles down at the bottom. The Settled Solid

is Separated as Sludge & dewatered to Sludge drying Bed. After sludge drying, the sludge is

sent to CHWSTDF.

III. Anaerobic Digester:

After Primary Clarification,the Effluent enters to Anaerobic Digester. Here the effluent is treated

with anaerobic culture.

IV. Bioreactor Tank /Aeration Tank: 1 No

After Anaerobic digester, the effluent enters to the Aeration Tank. Here the activated sludge

process achieved, to reduce the Organic load to the desired standards by providing a

sufficient detention time & activating the Bacterial culture.

For Oxygenation (aeration) of waste water these tanks provided with fixed Air Blowers. These

Air Blowers are capable of providing sufficient amount of Dissolved Oxygen (D.O.) required

by the micro organisms for synthesis or degradation of organic matter.

V. Secondary Settling Tank:

For the settlement of the mixed liquor, the waste led to a Secondary Clarifier tank. Waste led

to the tank through a pipe to centre feed well from where it flow downwards and then

outwards launder. The settled mixed liquor returned back to aeration tank to improve mixed

liquor in the tank and the excess mixed liquor drained to the existing sludge drying beds

VI. Clarified Water Tank:

The Clear effluent from Secondary Clarifier Tank is collected here .The polishing aeration with

Chlorination treatment is operated here.

From this Tank the Effluent after chlorination pumped to the Sand & Activated Carbon Filter.

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

16

VII. Pressure Sand & Activated Carbon Filter:

The Clarified supernant effluent is then passed through the Sand & Carbon filter for Final

Purification. To remove the suspended solids from Sand & Carbon Filter, back wash operation

to be carried out. The effluent is then transferred to Treated Water Tank

VIII. Treated Water Tank:

Such Treated Clear Effluent is then recycled /reused in the Process to the maximum extent for

cooling Tower and /or For Floor Wash and excess if any shall be discharged to Gardening

IX. Sludge Drying Beds:

The Waste sludge is drained to Sludge Drying Bed and after drying sent to CHWSTDF

3.5.2 Solid waste generation & disposal

The types of Hazardous and non Hazardous wastes are generated from the project. Method of

handling and disposal is shown in below table

The Solid waste will be classified into hazardous waste and other waste which is being handled

under the agency of Pollution Control Board. The industry entered into an agreement with

Common hazardous waste treatment and disposal facility (CHWTSDF) where the waste is

characterized and scientifically disposed off in a secured Landfill after Stabilization to prevent any

sought of impact on environment

Table 5: Hazardous Waste Quantity

Sr. No. Cat. Name of

Hazardous Waste Existing Qty Proposed Total Disposal

1 20.3 Distillation Residues 75

Kg/M

Nil

75

Kg/M

CHWTSDF

2 28.1 Waste Residue Nil CHWTSDF

3 28.5 Spent Solvent Nil CHWTSDF

4 34.3 ETP Sludge 0.06 MT/M 0.53 MT/M 0.59

MT/Month CHWTSDF

5 35.1 Filter Cloth 5 Kg/M Nil 5 Kg / M CHWTSDF

3.6 Schematic representations of the feasibility drawing which give information of EIA purpose.

The applicability of the S.O. 1533 for the proposed project was explored by considering different

possibilities & provision made in the said Notification. Considering the products & project location

of the proposed project it is noiticed that the proposed project falls under category 5 (F) “A” of

the Schedule – I of EIA Notification S.O. 1533.

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

17

Figure 6: Plant Layout

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4.0 Site Analysis

M/s. Vadivarhe Speciality Chemicals Ltd. is located at Gut No. – 204, Nashik – Mumbai highway,

A/p – Vadivarhe, Tal. – Igatpuri, Dist. – Nashik – 422 403 (Maharashtra).

The nearest habitation from the site is Vadivarhe (Village) at a distance of 1.2 KM.

The nearest railway station is Igatpuri at a distance of 20.87 KMs from the site.

The nearest airport is Nashik Air port at a distance of 40 KMs

The Nearest road ways National (NH – 3)

4.1 Land Form, Land use and Land ownership.

The proposed land for setting bulk drug unit is in area of 12500 Sq. Mtr. The land is acquired by

M/s. Vadivarhe Speciality Chemicals Ltd. for their Manufacturing Facility.

The land use break-up is given below Table 6-

1 Process area 4455.0 Sq. M

2 Green Belt area 6000.0 Sq. M

3 Utility block 443.0 Sq. M.

4 Road & Open

space

1002.0 Sq. M.

5 ETP 600.0 Sq. M.

Total Area 12500 Sq. M.

4.2 Existing Infrastructure.

The Industry is having existing Infrastructure at this site and going for Expansion in the same in-

House Facility.

4.3 Soil classification

The district is mainly covered by three types of soils Viz. red sandy soil (Dubbas and Chalkas) Red

earth (with loamy sub-soils and Chalkas) and black cotton soils. Red soils and red earth are

permeable and well drained.

4.4 Climatic data (from secondary sources)

The climate of Nashik district is characterized, by dryness except in the south-west monsoon

season. The year may be divided into four seasons, The cold season from December to February

followed by the hot season from March to May and the south-west monsoon season from June to

September followed by the post-monsoon season during October and November.

Temperature Maximum: 35.9 °C

Minimum: 12.5 °C

Average annual rainfall 814 mm

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

19

4.5 Social Infrastructure available

The social infrastructure facilities are available near to proposed site.

5.0 Planning Brief

The Already Existing Production activity are going on at Plant Level and the production related to

the Proposed Product in Expansion will be started after getting statutory clearance form related

authorities. Further Activities related to the New Production will take care of all the rules and

regulation of statutory authority and provide the control measure and devices to achieve the

standard norms.

6.0 Proposed Infrastructure:

6.1 Project Area

Basic infrastructure is already Existing and partially to be developed along with installation of

required plant and machineries for new Products.

6.2 Residential Area

No residential area is involved in the project area. The employees are accommodated in nearby

Residential areas.

6.3 Green Belt:

The unit has already developed green belt area @ 3500 sq. m within and on the surrounding of

the existing premises and will also increases the green belt (Total after expansion will be around

6000 sq. m). Which will not only improve the soil conditioning but will also prevent soil erosion and

the landscape will help for conservation of Environment & give slight beneficial impact on the

land usage.

6.4 Social Infrastructure

The Vadivarhe Specialty Chemicals Ltd. project has generated a fair amount of direct and

indirect employment in the study region. The local economy has received a boost due to

employee spending and services generated by Vadivarhe Specialty Chemicals Ltd. Migration

into the existing area or displacement of existing population is insignificant. Housing, transport,

water, power supply, medical, educational and other civic amenities are not adversely affected

nor appear to get affected in future.

6.5 Occupation health

Various precautions have been taken by the unit to reduce health hazardous and medical

check-up is also carried out regularly to avoid occupational hazard.

Drinking water supply for the employees is provided by the project proponent and the

standard of the drinking water is as per WHO guidelines.

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

20

Proper sanitary facilities are made available by the project proponent so that employees

do not suffer from any health ailments.

Training includes information on accident prevention, proper control and maintenance of

equipment and safe material handling practices.

MSDS of the chemical used are made available at the place of use.

Storage and process areas are posted with “No Smoking” signs. Smoking is prohibited

throughout the factory. All management staff, Executives on their rounds to factory

ensures the compliance.

Pre-employment medical check-up at the time of employment.

The unit has appointed the medical officer cum industrial hygienist for the regular medical

examination and treatment of the employee.

Certificate of fitness of employ is maintained.

Equipment required for personal safety like water jet blankets, gloves, helmets, safety

belts, first aid boxes etc. are provided.

7.0 Rehabilitation and Resettlement (R & R) Plan

Rehabilitation & Resettlement (R&R) plan is not applicable as already the unit is Existing and no

any Rehabilitation causing due to this Expansion Activity

8.0 Project Schedule & Cost Estimates

The unit is already established and the Expansion activities will be started after getting statutory

clearance form related authorities and the Activity will be completed within one years of getting

the statutory clearance.

The cost estimate is given below in Table 7 -

Sr. No. Particulars Amount (INR)

1 Land Rs. 44,72,000/-

2 Factory Building Rs. 6,41,81,068/-

3 Plant & Machinery & Equipments Rs. 933,11,969/-

4 Furniture & Fixture Rs. 22,05,789/-

5 Other Movable/ Immovable Fixed

assets

Rs. 458,49,088/-

Total : Rs. 21,00,19,914/-

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Project: Manufacturing of Bulk Drug & Intermediates PRE-FEASIBILITY REPORT

Project Proponent: M/s. Vadivarhe Specialty Chemicals Ltd.

21

Table 8 Cost of environmental protection measures (Rs. Lakhs)

No. ITEM Capital Cost

(Rs, Lacs)

Recurring Cost per

annum (Lacs)

1 Air Pollution Control 20 5

2 Water Pollution Control 75 10

3 Noise Pollution Control 5 1

4 Environment Monitoring and Management 10 2

5 Rain Water Harvesting 15 1

6 Occupational Health 10 2

7 Green Belt 5 2

8 Safety management. 5 2

9 Laboratory and chemicals 10 3

10 Operation & Maintenance of ETP - 12

Total 170 35

9.0 Analysis of proposal (Final Recommendations)

Already the Existing Unit is beneficial to the local People. After expansion activity will also provide

additional benefits to the local people in terms of financial and social welfare.

Local people will get direct financial benefit by way of employment.

Local people will get some contracts of supply and services to get indirect income.

Company will contribute in improving education and health facilities in nearby area.