Steriods Fesaibilty API

Pre-Feasibility Report
1.0 EXECUTIVE SUMMARY

1.1 Name of the Project Proponent: : M/s Balaji Steroids And Hormones Private
Limited
1.2 Location : Plot no.: F-24, Sector 1, Special Economic Zone

Phase I, (Processing Unit), Pithampur, Dhar
(Dist), M.P.
Pin code - 454775
(Figures 1 & 2)
1.3 Office (Regd.) : 15/10 South Tukoganj, Gorani Compound Near
Treasure Island, Indore, Madhya Pradesh, India
Pin code - 452001
1.4 Name of Promoter/Director : JASMINA H AILDASANI (Director)
1.5 Proposed Project : Manufacturing of Steroids: Proposed Capacity
up to 18 MTPA, Area: 2712.0 sq.m.
1.6 Total Project Area : 2712.0sq.m.
1.7 Water Requirement : Total Water Requirement - 52 m3/day
1.8 Power Requirement : Electricity is being sourced from Madhya
Pradesh Audyogik Kendra Vikas Nigam
(Indore). DG sets of total capacity ~60 KVA
will be available in standby mode.
Total power requirement will be 125 KVA
1.9 Number of Shift : Three Shift Basis ( Round the clock)
1.10 No. of Working Days : 365 Days
1.11 Total Cost of Project : 7.0 crore
1.12 Man Power Utilization : ~100 direct and ~100 indirect
1.13 Means of Finance : Entire funding for the project will be through
Foreign Direct Investment (FDI) route.
1.14 Schedule of Implementation : Particulars Implementation
Date/Time Period
Commercial After 4 months from
Production will be Receipt of
started Environmental
Clearance
1.15 Environment Consulting Organization : Anacon Laboratories Pvt. Ltd.
Head Office: 60, Bajiprabhu Nagar,
Nagpur-440 033, MS
Lab. : FP-34, 35, Food Park, MIDC, Butibori,
Nagpur – 441122
Ph. : (0712) 2242077, 9373287475
Fax: (0712) 2242077
Email: [email protected],
[email protected]
website: www.anaconlaboratories.com
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Anacon Laboratories Pvt. Ltd.
2.0 INTRODUCTION
2.1 Identification of project and project proponent
Company Background
• Parent Company is Balaji International Hong Kong Limited (Hong Kong), which is a reputed
pharmaceutical dealer in Republic of China (Hong Kong).
• Parent Company is a USD 5 million turnover company.
• Due to initiative of the Indian Govt for “MAKE IN INDIA” and “EASE OF DOING BUSINESS” the
Company has decided to enter in to manufacturing of Basic drugs in India.
• To commence its operation in India, parent company has registered a company in India with
name, Balaji Steroids and Hormones Private Limited.
• Initially Company wish to commence operation with MSME- Medium enterprise level, and
gradually increase the capacity.
• Annual capacity of the proposed plant is to process basic drugs of approx 18000 KG/year for
various products.
MANAGEMENT: PROMOTERS/DIRECTORS PROFILE
Mr. Prem Aildasani- Head-Strategy and Marketing
He is the person behind Company’s journey over the years with step by step success. He is having
25 years of rich experience in the field of strategy and marketing for pharmaceutical industry.
Mr. Sidharth Aildasani- Director Operation
He has set the company’s operating practices as per the global standard practices. His expertise is
management of plant operation.
Mr. Akshay Aildasani- Director Finance
He is instrumental to all applicable laws and regulation and handle accounts and finance function for
the Company
2.2 Brief Description and Nature of the Project

M/s Balaji Steroids And Hormones Private Limited has proposed to manufacture following steroids
with annual capacity of 18 MT. The nature of the project falls under synthetic organic chemicals
category.
Sr. No. Product Capacity (MTPA)

1. Dexamethason Sodium Phosphate
2. Beta Methasone Dipropionate
3. Beta Methasone Sodium Phosphate
4. Beta Methasone
5. Beta Methasone Valerate
6. Dexamethason 18
7. Deflazacort
8. Momentason Furate
9. Triamcinolone Acetonide
10. Clobetasol Propionate
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2.3 Need for the project and its importance to the country and/or region
Due to initiative of the Indian Govt for “MAKE IN INDIA” and “EASE OF DOING BUSINESS” the
Company has decided to enter in to manufacturing of Basic drugs in India. To commence its
operation in India, parent company has registered a company in India with name, Balaji Steroids
and Hormones Private Limited, the plant will be setup on the land available in Indore SEZ Phase I
(MPAKVN), Tehsil- Pithampur, Dist.-Dhar (MP).
There is good availability of these raw materials in India.
2.4 Demand-Supply Gap
Recognition and Credibility at Hong Kong:
 Company’s turnover for the year ended 2016 is USD 4.5 million (33 million HKG dollar)
 Company’s Bankers are
- ICBC
- CITI BANK
 Company has been rated high score by Crisil
 Many Indian companies are client of the Balaji International
2.5 Imports vs. Indigenous production
There is no indigenous production. Proposed products manufacturing in the country will be very much
economical compared to Imports and export of the same will earn extra revenue generation for our
county.
2.6 Export possibility
 Company has planning to exports its products to Brazil, South and East America or East
Africa.
 Huge market for these products
 Company will get edge to export such products due to cost competitiveness and ensured raw
material supply from parent company.
2.7 Domestic/ Export Markets
There is a huge demand of the proposed products in the export market. Balaji International Hong
Kong Limited (Hong Kong) products are widely used and are in demand in the drug industry.
 Balaji International Hong Kong Limited (Hong Kong) products are used as base for many
common medicine/injections.
 All drug manufacturing companies using such products are Balaji’s potential customers.
 In Rajasthan itself, approx. 200 companies are involved in drug manufacturing.
 In India, the states like Rajasthan, Gujarat, Punjab and Madhya Pradesh which are larger state
and more populated can be potential market for the Company.
 Products of the Company are non Hazardous for human as well as for environment.
 The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in
terms of value.
 Overall drug approvals given by the US Food and Drug Administration (USFDA) to Indian
companies have nearly doubled to 201 in FY 2015-16 from 109 in FY 2014-15 an increase of 84
per cent as per analysis by USFDA.
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2.8 Employment Generation (Direct and Indirect) due to the project

Around 100 persons directly & 100 indirectly employed, which will be helping to improve quality of life
of the people.
3.0 PROJECT DESCRIPTIONS
3.1 Type of project including interlinked and interdependent projects, if any.
The proposed project is a manufacturing of steroids project falling under “B” category. It will be an
independent project that will be engaged in the production of steroids. The proposed project is an
industrial project i.e. production capacity of steroid plant is 18MT/annum at Plot no.: F-24, Sector 1,
Special Economic Zone Phase I, (Processing Unit), Pithampur, Dhar (Dist), M.P. pin code - 454775.
3.2 Location (map showing general location, specific location and project boundary and
project site layout) with coordinates.
Details about the Project area are presented in Table 1.
TABLE 1
DETAILS ABOUT THE PROJECT AREA
Plot No. Plot no.: F-24, Sector 1, Special Economic Zone Phase I, (Processing Unit),
Pithampur,
Village/Town Pithampur
Tehsil Pithampur
District Dhar
Pin Code 454775
State Madhya Pradesh
Area 2712.0 sq.m.
Toposheet No. 46 N/10
Geo-c Latitude: 22°37'39.63"N
oordinates Longitude: 75°35'49.55"E
The index map is presented in Figure 1, Location map showing 10 km radius of study area shown in
Figure 2 and layout plan is given in Figure 3.
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FIGURE 1: INDEX MAP
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FIGURE 2: STUDY AREA MAP

(10 KM RADIAL DISTANCE FROM THE PROJECT SITE)
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FIGURE 3: LAYOUT PLAN
3.3 Details of alternate sites considered and the basis of selecting the proposed site,
particularly the environmental considerations gone into should be highlighted.
The land is allotted to project proponent by Madhya Pradesh Audyogik Kendra Vikas Nigam. The
proposed plant is falling within Indore SEZ Phase I (Processing unit), Pithampur, Dist. Dhar Madhya
Pradesh State. Hence site is already selected by project proponent and no alternative site is required.
3.4 Size or Magnitude of Project.

Description Capacity
Production of Steroids 18 MTPA
Area 2712.0sq.m.
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3.5 Project description with process details

Manufacturing process in Brief
1. DEXAMETHASONE SODIUM PHOSPHATE
The manufacturing process of Dexamethasone Sodium Phosphate consists of the following steps:
The stage wise process flow diagrams for Dexamethasone Sodium Phosphate are presented in
Figures 4, 5 for Stage I & II respectively.
FIGURE 4: PROCESS FLOW DIAGRAM OF DEXAMETHASONE SODIUM PHOSPHATE STAGE-I
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FIGURE 5: PROCESS FLOW DIAGRAM OF DEXAMETHASONE SODIUM PHOSPHATE STAGE-II
2. Beta Methasone Dipropionate

The manufacturing process of Betamethasone Phosphate consists of the following steps:
The stage wise process flow diagrams for Betamethasone Phosphate are presented in Figures 6, 7
& 8 for Stage I, II & III respectively.
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FIGURE 6: PROCESS FLOW DIAGRAM OF BETAMETHASONE PHOSPHATE STAGE-I
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FIGURE 7: PROCESS FLOW DIAGRAM OF BETAMETHASONE PHOSPHATE STAGE-II
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FIGURE 8: PROCESS FLOW DIAGRAM OF BETAMETHASONE PHOSPHATE STAGE-III
3. BETAMETHAZONE SODIUM PHOSPAHTE

The manufacturing process of Betamethazone sodium Phospahte consists of the following steps:
The stage wise process flow diagrams and chemical reactions for Betamethazone sodium Phospahte
are presented in Figures 9 &10 for Stage I & II respectively.
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FIGURE 9: PROCESS FLOW DIAGRAM OF BETAMETHAZONE SODIUM PHOSPAHTE

STAGE-I
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FIGURE 10: PROCESS FLOW DIAGRAM OF BETAMETHAZONE SODIUM PHOSPAHTE

STAGE-II
4. BETAMETHASONE VALERATE
The manufacturing process of Betamethasone valerate consists of the following steps:

The stage wise process flow diagrams and chemical reactions for Betamethasone valerate are
presented in Figures 11 &12 for Stage I & II respectively.
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FIGURE 11: PROCESS FLOW DIAGRAM OF BETAMETHASONE VALERATE STAGE-I
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FIGURE 12: PROCESS FLOW DIAGRAM OF Betamethasone valerate STAGE-II
5. DEXAMETHAZONE
The manufacturing process of Dexamethazone consists of the following steps:
The stage wise process flow diagrams and chemical reactions for Dexamethazone are presented in
Figures 13 &14 for Stage I & II respectively.
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FIGURE 13: PROCESS FLOW DIAGRAM OF Dexamethazone STAGE-I
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FIGURE 14: PROCESS FLOW DIAGRAM OF Dexamethazone STAGE-II
6. DEFLAZACORT
The manufacturing process of DEFLAZACORT consists of the following steps:
The stage wise process flow diagrams for DEFLAZACORT are presented in Figures 15.
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FIGURE 15: PROCESS FLOW DIAGRAM OF DEFLAZACORT
7. MOMETASONE FUROATE
The manufacturing process of Mometasone Furoate consists of the following steps:
The stage wise process flow diagrams and chemical reactions for Mometasone Furoate are
presented in Figures 16, 17 & 18 for Stage I, II & III respectively.
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FIGURE 16: PROCESS FLOW DIAGRAM OF MOMETASONE FUROATE STAGE-I
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FIGURE 17: PROCESS FLOW DIAGRAM OF MOMETASONE FUROATE STAGE-II
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FIGURE 18: PROCESS FLOW DIAGRAM OF MOMETASONE FUROATE STAGE-III
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8. TRIAMCINOLONE ACETONIDE
The manufacturing process of Triamcinolone Acetonide consists of the following steps:
The stage wise process flow diagrams and chemical reactions for Triamcinolone Acetonide are
presented in Figures19, 20, 21 & 22 for Stage I II, III & IV respectively.
FIGURE 19: PROCESS FLOW DIAGRAM OF TRIAMCINOLONE ACETONIDE STAGE-I
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FIGURE 20: PROCESS FLOW DIAGRAM OF TRIAMCINOLONE ACETONIDE STAGE-II
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FIGURE 21: PROCESS FLOW DIAGRAM OF TRIAMCINOLONE ACETONIDE STAGE-III
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FIGURE 22: PROCESS FLOW DIAGRAM OF TRIAMCINOLONE ACETONIDE STAGE-IV
9. CLOBETASOL DIPROPIONATE
The manufacturing process of Clobetasol Dipropionate consists of the following steps:
The stage wise process flow diagrams and chemical reactions for Clobetasol Dipropionate are
presented in Figures 23, 24, 25 & 26 for Stage I, II, III & IV respectively.
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FIGURE 23: PROCESS FLOW DIAGRAM OF CLOBETASOL DIPROPIONATE STAGE-I
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FIGURE 24: PROCESS FLOW DIAGRAM OF CLOBETASOL DIPROPIONATE STAGE-II
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FIGURE 25: PROCESS FLOW DIAGRAM OF CLOBETASOL DIPROPIONATE STAGE-III
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FIGURE 26: PROCESS FLOW DIAGRAM OF CLOBETASOL DIPROPIONATE STAGE-IV
3.6 Raw material required along with estimated quantity, likely source, marketing area of
final product/s, Mode of transport of raw Material and Finished Product.
Estimated raw materials quantity likely to be sourced from outside, mode of transportation is given in
Table 2.
TABLE 2
ESTIMATED RAW MATERIAL QUANTITY
Sr. Product Name Raw Material Type
No.
1. Dexamethasone sodium Dexamethasone base Active
phosphate THF solvent
Water Solvent
Pyro phosphoryl chloride reactant
Methanol Solvent
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No.
Activated carbon Decoularise
Sodium hydroxide Reactant
Acetone solvent
Ethyl acetate solvent
Water solvent
2. Betamethasone Dipropionate Betamethasone base Active
Methylene chloride solvent
Triethylorthopropionate reactant
PTSA catalyst
Acetone solvent
Orthophosphoric acid catalyst
DM water solvent
Betamethasone stage-I Active
Pyridine reactant
Propionic anhydride reactant
Betamethasone stage-II Active
Methanol solvent
Activated carbon reactant
3. Betamethazone sodium Betamethasone base Active
Phospahte THF solvent
Water Solvent
Pyro phosphoryl chloride reactant
Methanol Solvent
Sodium hydroxide Reactant
Acetone solvent
Ethyl acetate solvent
4. Betamethazone valerate Betamethasone base Active
Methylene chloride Solvent
Trimethyl orthovalerate active
Acetone solvent
DM water solvent
PTSA ( catalyst) catalyst
Stage I Active
Methanol Solvent
Acetone solvent
Water solvent
5. Dexamethason 8 DM Active
Hydrochloric acid reactant
Liquid ammonia reactant
DM water solvent
Methylene chloride solvent
Ethanol solvent
Activated carbon reactant
6. Deflazacort d-18 Intermediate
calcium oxide
calcium chloride
Iodine
glacial acetic acid
Acetone
triethylamine
water
7. Mometasone Furoate 8DM Active
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No.
Triethyl amine reactant
Methyllne sulphonyl reactant
chloride
DM water solvent
Dimethylformamide solvent
Lithium chloride reactant
Satge-I Active
Triethyl amine reactant
2-furyl chloride reactant
DM water solvent
Tetrahydrofuran solvent
Satge-II Active
Acetone Solvent
Carbon reactant
Methanol solvent
8. Triamcinolone Acetonide Acetone
Perchloric acid
Dibromentin
Potassium carbonate
Acetic acid
Water
9. Clobetasol Dipropionate Betamethasone base Active
Triethyl orhthopropionate reactant
Paratoluene sulphonyl reactant
chloride
Acetone reactant
DM water solvent
Orthophosphoric acid reactant
Pyiridine Catalyst
Methylsulfonyl chloride reactant
Dimethylformamide Catalyst
Lithium chloride reactant
Activated Carbon active
Methanol Solvent
Source: All the raw materials are available from indigenous sources
Mode of Transportation: The site has very good connectivity with road, rail and air which is being
used for the transportation of raw materials and finished products will be shipped by road upto
nearest airport or shipping port for export.
3.7 Resource optimization/ recycling and reuse envisaged in the project, if any, should be
briefly outlined.
 Indigenous, or imported, by adoption continuous improvement in technology and process the
reduction in process waste generation will be achieved.
 By proper and efficient handling of raw materials, wastages of raw materials will be reduced.
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3.8 Environmental and Infrastructural Aspects

Availability of water its source, Energy/ Power requirement and source:
3.8.1 Availability of water and its source:
Water will be sourced from Madhya Pradesh Audyogik Kendra Vikas Nigam (Indore) ~ 52 m3/day
water will be required for plant activities.
TABLE 3
WATER REQUIREMENT (m3/day)
Sr. No. Purpose Requirement
1. Domestic 4
2. Industrial Processing 25
3. Industrial Cooling 8
4. Boiler 10
5. Other 5
Total 52
3.8.2 Energy/ Power requirement and source:

Electricity is being sourced from Madhya Pradesh Audyogik Kendra Vikas Nigam (Indore). DG sets of
total capacity ~60 KVA will be available in standby mode. Total power requirement will be 125 KVA.
3.9 Quantity of wastes to be generated (liquid and solid) and scheme for their
Management/disposal
3.9.1 Wastewater generation & management plan
The wastewater generation will be from the proposed plant is 39.5 m3/day (Table 4). Industry shall
reuse the treated effluent in order to reduce the fresh water requirement. The industrial effluent will be
treated in proposed effluent treatment plant with capacity of 45 m3/d. The industry shall reuse the
treated effluent in order to reduce the fresh water requirement.
TABLE 4
WASTE WATER GENERATION (m3/day)
Sr. No. Purpose Wastewater Generation Losses
1 Domestic 3.2 0.8
2 Industrial Processing 22.5 2.5
3 Industrial Cooling 4.8 3.2
4 Boiler blow & steam condensate 4 6
5 Other 5 0
Total 39.5 12.5
Domestic wastewater: Domestic effluent will be treated in Aeration Tank. After treatment of
wastewater will be used for gardening.
Industrial Wastewater: Total industrial effluent generation due to proposed facility will be 39.5 m3/d.
This industrial effluent will be treated in effluent treatment plant with capacity of proposed ETP 45
m3/d on the project site.
3.9.2 Effluent Treatment scheme
Effluent treatment plant will be consists of the Primary treatment (Advance Oxidation, Fenton
treatment, Flash Mixer, Primary clarification), Secondary treatment (Aerobic treatment, Clarification),
Tertiary treatment (Sand filter, Carbon Filter).
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Low COD waste streams collected direct into collection tank, except sewage effluent while high COD
waste streams collected in advanced oxidation tank (Photo Fenton Treatment) for pre-treatment and
after treatment, it is allowed to mix with low COD waste streams in to collection tank.
Advance oxidation (Photo Fenton Treatment): Fenton’s reagent consists of hydrogen peroxide (H2O2)
and Ferrous ion (Fe2+). This method has been used for wastewater treatment that contains organic
pollutant. Zero discharge will be maintained.
Detailed note on WTP will be provided in EIA
Total water balance
The water requirement for the plant is estimated to be 52 m3/d. This raw water will be treated in water
treatment plant having softening, D.M. and RO treatment systems and soft water generated will be
used in the plant activities. Total water balance is shown in below Table 5.
TABLE 5
TOTAL WATER BALANCE (m3/d.)
Sr. No. Purpose Requirement Wastewater Generation Losses
1. Domestic 4 3.2 0.8
2. Industrial Processing 25 22.5 2.5
3. Industrial Cooling 8 4.8 3.2
4. Boiler 10 4 6
5. Other 5 5 0
Total 52 39.5 12.5
3.9.3 Solid/hazardous waste generation and Management plan
Generated solid waste during manufacturing process will be send to TSDF site.
3.9.4 Stack details and air pollution measures

One DG set one each of app.60 kVA will be required for power supply in case of power failure and
one boiler of capacity 0.5 TPH (HSD based). The expected pollutants emitted from the DG set &
boiler will be PM, SO2, NOx and CO. There will not be any impact on surrounding area as this will be
the occasional activities.
4.0 SITE ANALYSIS

4.1 Connectivity.
The proposed project area falls Indore SEZ, Plot no.: F-24, Sector 1, Special Economic Zone Phase I,
(Processing Unit), Pithampur, Dhar (Dist), M.P.
The site is well connected with Road/Rail. The details are as follows:
 Mhow Railway Station ~19.6 Km, ESE
 Indore Railway Station ~29.6 Km, ENE
 Devi Ahilyabai Holkar (Indore) Airport ~24 Km, ENE

4.2 Land Form, Land use and Land ownership.
The proposed activities will be within the Indore SEZ. The total land identified for the proposed project
is 2709.64 sq/m. It is under Indore SEZ
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The details regarding the breakup of the land for the various activities of the proposed project is as
follows (Tables 6)
TABLE 6
AREA STATEMENT
Sr. No. Description Area in Sq. M. Area in %
1. Production block 468.0 17.3
2. Utility/ Boiler Block 66.50 2.5
3. RM & FP store above 104.00 3.8
QA, QC and R&D ADM Block
4. Drum store area 52.50 1.9
5. ETP Plant 56.00 2.1
Solid waste, empty drum
6. Security office 15.00 0.6
7. Transformer Yard 40.00 1.5
8. Road, open area for solid waste 1584.56 58.4
9. Green Belt 325.44 12.0
Total area of site 2712.0 100.0
4.3 Topography of the project area

The project area proposed in the, Plot no.: F-24, Sector 1, Special Economic Zone Phase I,
(Processing Unit), Pithampur, Dhar (Dist), M.P. Pin code -454775. Flat terrain, under Industrial Area,
SEZ, Barren land. The project site lies at the Latitude: 22°37'39.63"N & Longitude: 75°35'49.55"E on
the Topo sheet No.46 N/10. The site specific Topography map is given in Figure 27.
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FIGURE 27: SITE SPECIFIC TOPOGRAPHY MAP (10 KM Radius)

4.4 Existing land use pattern (agriculture, non-agriculture, forest, water bodies
(distance from HFL to the river), CRZ. In case of notified industrial area, a copy of Gazette
Notification should be given:-
The proposed project is located within Indore SEZ Phase I, Pithampur, Dist. Dhar State Madhya
Pradesh. Proposed land use is SEZ. The land is being used for Industrial Purpose. Land allotment
letter is enclosed as Appendix – I.
There is no forest, national park, wild life sanctuary, eco sensitive areas in surrounding 10 Km from
the plant boundary. CRZ is not applicable to the project.
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Existing infrastructure
Proposed project site is clear, barren land. Photographs are attached in following Figure 28.
FIGURE 28: PROPOSED PROJECT SITE PHOTOGRAPHS
5.0 PLANNING BRIEF

5.1 Planning concept (type of industries, facilities transportation Town and Country
Planning Development authority Classification.
Type of Industry
Drug manufacture (Steroid production)
Town and Country Planning Development authority Classification
The proposed project falls under within Indore SEZ Phase I, Pithampur, Dist. Dhar State Madhya.
Town and country planning department has already classified land as Special Economic Zone.
Adequate road facilities are already available for transportation of raw materials as well as finished
products.
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5.2 Population Projection

The proposed industry will be providing employment to about 200 people directly and indirectly. Since
the proposed plant is located in the Dhar district in which trained manpower are readily available,
therefore the employment will be given mostly to local people, so there will not be any substantial
increase in the population of local villages. However, due to increase economic growth, the local
youth will be benefited with respect to employment.
5.3 Land use planning (breakup along with green belt etc.)
Green belt area will be in approx. 12%. Total plot area is 2472.0 sq.m., proposed greenbelt area will
be around 296.64 sq.m.
The breakup of the land for the proposed project is given in Table 7.
TABLE 7
LANDUSE BREAKUP ALONG WITH GREENBELT
Sr. No. Description Area in Sq. M. Area in %
10. Production block 468.0 17.3
11. Utility/ Boiler Block 66.50 2.5
12. RM & FP store above 104.00 3.8
QA, QC and R&D ADM Block
13. Drum store area 52.50 1.9
14. ETP Plant 56.00 2.1
Solid waste, empty drum
15. Security office 15.00 0.6
16. Transformer Yard 40.00 1.5
17. Road, open area for solid waste 1584.56 58.4
18. Green Belt 325.44 12.0
Total area of site 2712.0 100.0
5.4 Assessment of Infrastructure Demand

The basic infrastructure (Connective roads, Water resource vicinity) is required for the proposed
project is available at the project site as the proposed project is within Special Economic Zone. Apart
from that the additional infrastructure will be developed by the company as per the requirement.
5.5 Facilities Availability

Major basic facilities are available for the proposed project. Road, electricity, water, transportation
facility etc. are well developed in the surrounding area. The major new facilities required to be set for
the proposed project will be installation of process equipment at site within the premises along with all
the necessary infrastructures like storage house, internal access roads, office buildings, and
equipment sheds etc.
6.0 PROPOSED INFRASTRUCTURE
6.1 Industrial Area (Processing Area)
The proposed project activities will be within the Indore SEZ. The total land identified for the proposed
project is 2712.0 sq.m. Proposed built-up area is 802.0 sq.m. Remaining open area will be for future
development as well as green belt development, parking bay, etc. as given in land use statement
(Table 7).
6.2 Residential Area (Non Processing Area)
There is no residential area proposed in for the project, as the existing villages have adequate
facilities to accommodate the additional manpower for residential requirements. Most of the local
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people will only be employed so the need of the additional residential colony in the plant will not
require.
6.3 Green Belt
Green belt area will be in approx. 12%. Total plot area is 2712.0 sq.m., proposed greenbelt area will
be around 325.44 sq.m.
6.4 Social Infrastructure
The project area lies within the district of Dhar. There is no requirement to build any social
infrastructure within the proposed plant area.
6.5 Connectivity (Traffic and Transportation Road, Rail/Metro/Waterways etc.).
The proposed project is situated at Pithampur village, Tehsil- Pithampur, Dhar district, State of
Madhya Pradesh. The project is located within the SEZ. The site is well connected with Road/Rail.
The details are as follows:
 Mhow Railway Station ~19.6 Km, ESE
 Indore Railway Station ~29.6 Km, ENE
 Devi Ahilyabai Holkar (Indore) Airport ~24 Km, ENE

6.6 Drinking Water Management (Source & Supply of water)
The total water requirement for the proposed plant is estimated to be 52 m3/day. The water is being
sourced from AKVN and used for plant activities and domestic use. The permission for water supply
has been granted from AKVN.
6.7 Sewerage system

Infra-structural services including water supply, sewage, drainage facilities and electrification will be
made. Domestic wastewater generated will be treated in Aeration tank. Wastewater drainage system
for the proposed plant will be well connected to the sewerage channel facilities of SEZ to ensure
minimum impact on the environment.
6.8 Industrial Waste/ Solid Waste Management

The industrial wastes generated in the form of solid wastes, and hazardous wastes will be collected,
segregated and disposed off as per CPCB guideline.
7.0 REHABILITATION AND RESETTLEMENT (R&R) PLAN

7.1 Policy to be adopted (Central/ State) in respect of the project affected persons
including home oustees, land oustees and landless laborers (a brief outline to be
given).
The proposed project does not have any directly displaced persons, due to acquisition of land. There
are also no land oustees or project affected persons or home oustees, thus R&R plan is not
applicable here. However, the priority for employment will be given to local persons living in the
adjoining villages. In addition to this, promoter will also contribute for the welfare of the people of local
surrounding under company’s CSR policy.
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DETAILS OF CORPORATE SOCIAL RESPONSIBILITY BY BALAJI STEROIDS AND HORMONES

PRIVATE LIMITED:
CSR Programs
Company will be giving preference for spending the amount earmarked for CSR activities for the local
area where it operates. CSR activities will be either implemented by the company on its own or
through specialized agencies. Only such agencies will be assigned responsibility that carry a good
track record of undertaking and implementing such activities successfully. CSR plans will be finalized
in consultation with local body.
Monitoring
CSR committee authorized by board of directors will be monitor CSR activities and proper utilization
of funds. The CSR committee will be fully authorized to delegate appropriate authority to any
employee of the company for properly carrying out CSR activities.
Environment Impacts and Measures
Schematic representations of the feasibility drawing which give information of EIA purpose:
S. No. Particulars Impacts Remediation Proposed
1. Change in There will be change in land  The proposed project location is
land use. use on permanent basis due already in a SEZ area, devoid of
to installation of machineries vegetative tree cover and the grass
and equipment. cover, barren land.
 The land is allotted to project
proponent by Madhya Pradesh
Audyogik Kendra Vikas Nigam. The
plant is falling within Special Economic
Zone Phase I, (Processing Unit),
Pithampur, Dhar (Dist), M.P.
 Water will be sourced from AKVN, no
groundwater will be abstracted for the
project activities hence, and natural
recharge of groundwater level will not
be affected through proposed project
activities.
2. Transportation The existing network of The proposed activity will marginally
of material transport gets pressurized increase in Traffic density. The project lies
within SEZ thus, infrastructural
facilities/road accessibility are already
developed. However, will maintain the
existing road.
3. Gaseous and Air quality All necessary steps will be followed to
Particulate minimize the emission from point sources
Emission to as well as line sources. Thus the
The standards of Stack Emission and Ambient
atmosphere Air quality will be maintained as per
prescribed limits.
4. Discharge of Impact of water quality. Zero discharge is proposed.
effluent
5. Withdrawal of Availability of ground/surface Water will be sourced from AKVN, no
40
S. No. Particulars Impacts Remediation Proposed

ground / water is affected. ground water will be abstracted for the
surface water project activities hence, and natural
recharge of groundwater level is not
affected through project activities.
Permission regarding drawl of river water
is granted from water resource
department.
6. Operation of Impact on human health due All the process equipment will be installed
equipment to excess noise level beyond on anti-vibration pad with sufficient
and vehicles permissible level. provisions to minimize generation of
likely to noise. The high noise generating
generate equipment like generator will be enclosed
noise. with noise suppressing enclosures.
The buildings as well as boundary wall
and green belt will ensure the attenuation
of noise outside the boundary within the
prescribed limits.
7. Fire Hazard Risk to the surrounding Necessary precautions to prevent fire and
due to storage habitation. all the provisions to control fire shall be
of fuel etc. provided.
8. Employment Socio-economic disparity with Priority of employment will be given to
to outsiders local community local people, as already sufficient
qualified and trained local youth area
available.
9. Cultural impact Local population feels The promoters proposed to employ local
isolated masses in the project hence no such
impact on cultural diversity is likely to take
place.
10. Disposal of Create odorous problem, Domestic wastes will be segregated for
solid and nuisance condition related to organics and Inorganics. Organic wastes
hazardous the disposal of solid wastes. will be used for composting and
wastes Deterioration of soil, inorganics for approved vendors.
productivity pollution in Disposal of hazardous wastes will be
ground water/surface water done as per hazardous wastes handling
due to leaching and surface and disposal rule.
runoff.
8.0 PROJECT SCHEDULE & COST ESTIMATES

SCHEDULE FOR APPROVAL AND IMPLEMENTATION
 Proposed Project
Activities at the site will be carried out after grant of Environmental clearance from Ministry of
Environment & Forests. The schedule for implementing the proposed project is given in Table 8.
TABLE 8
PROJECT IMPLEMENTATION SCHEDULE
Particulars Implementation Date/Time Period
Start of Construction After 4 months from Receipt of Environmental
Clearance And NOC
41
Particulars Implementation Date/Time Period

Construction Period
Proposed product and their Installed Capacity 6-9 Months
Commercial Production Period
Commercial Production will be started 6-9 Months
8.2 Estimated project cost along with analysis in terms of economic viability of the project.
The proposed project cost is estimated to be Rs. 7.0 Crore.
9.0 ANALYSIS OF PROPOSAL (FINAL RECOMMENDATIONS)
9.1 Financial and social benefits with special emphasis on the benefit to the local People
Including Tribal Population, If Any, in the Area.
On overall assessment of the project with consideration of technical and financial aspects, it is
concluded that the proposed manufacturing of steroid plant is technically highly feasible and
financially highly profitable. Project will create direct & indirect employment opportunities within the
surrounding region. Unit will use good faith efforts to employ local people from the nearby villages
depending upon the availability of skilled & un-skilled man-power surrounding the project site.
Employment Generation for approx. 100 direct and 100 indirect Manpower, since it’s a labour centric
process with lot of manual working. Revenue generation to State and local administration. Socio- Eco
benefit for the society with Company’s employment and CSR activities. Attract more investment in the
region from overseas.
42
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Pre-Feasibility Report

1.0 EXECUTIVE SUMMARY

1.2 Location : Plot no.: F-24, Sector 1, Special Economic Zone

Pin code - 454775

• Parent Company is a USD 5 million turnover company.

MANAGEMENT: PROMOTERS/DIRECTORS PROFILE

Mr. Prem Aildasani- Head-Strategy and Marketing

Mr. Sidharth Aildasani- Director Operation

Mr. Akshay Aildasani- Director Finance

2.2 Brief Description and Nature of the Project

Sr. No. Product Capacity (MTPA)

2.8 Employment Generation (Direct and Indirect) due to the project

FIGURE 1: INDEX MAP

FIGURE 2: STUDY AREA MAP

FIGURE 3: LAYOUT PLAN

3.4 Size or Magnitude of Project.

3.5 Project description with process details

FIGURE 4: PROCESS FLOW DIAGRAM OF DEXAMETHASONE SODIUM PHOSPHATE STAGE-I

FIGURE 5: PROCESS FLOW DIAGRAM OF DEXAMETHASONE SODIUM PHOSPHATE STAGE-II

2. Beta Methasone Dipropionate

FIGURE 6: PROCESS FLOW DIAGRAM OF BETAMETHASONE PHOSPHATE STAGE-I

FIGURE 7: PROCESS FLOW DIAGRAM OF BETAMETHASONE PHOSPHATE STAGE-II

FIGURE 8: PROCESS FLOW DIAGRAM OF BETAMETHASONE PHOSPHATE STAGE-III

3. BETAMETHAZONE SODIUM PHOSPAHTE

FIGURE 9: PROCESS FLOW DIAGRAM OF BETAMETHAZONE SODIUM PHOSPAHTE

FIGURE 10: PROCESS FLOW DIAGRAM OF BETAMETHAZONE SODIUM PHOSPAHTE

The manufacturing process of Betamethasone valerate consists of the following steps:

FIGURE 11: PROCESS FLOW DIAGRAM OF BETAMETHASONE VALERATE STAGE-I

FIGURE 12: PROCESS FLOW DIAGRAM OF Betamethasone valerate STAGE-II

FIGURE 13: PROCESS FLOW DIAGRAM OF Dexamethazone STAGE-I

FIGURE 14: PROCESS FLOW DIAGRAM OF Dexamethazone STAGE-II

FIGURE 15: PROCESS FLOW DIAGRAM OF DEFLAZACORT

FIGURE 16: PROCESS FLOW DIAGRAM OF MOMETASONE FUROATE STAGE-I

FIGURE 17: PROCESS FLOW DIAGRAM OF MOMETASONE FUROATE STAGE-II

FIGURE 18: PROCESS FLOW DIAGRAM OF MOMETASONE FUROATE STAGE-III

FIGURE 19: PROCESS FLOW DIAGRAM OF TRIAMCINOLONE ACETONIDE STAGE-I

FIGURE 20: PROCESS FLOW DIAGRAM OF TRIAMCINOLONE ACETONIDE STAGE-II

FIGURE 21: PROCESS FLOW DIAGRAM OF TRIAMCINOLONE ACETONIDE STAGE-III

FIGURE 22: PROCESS FLOW DIAGRAM OF TRIAMCINOLONE ACETONIDE STAGE-IV

FIGURE 23: PROCESS FLOW DIAGRAM OF CLOBETASOL DIPROPIONATE STAGE-I

FIGURE 24: PROCESS FLOW DIAGRAM OF CLOBETASOL DIPROPIONATE STAGE-II

FIGURE 25: PROCESS FLOW DIAGRAM OF CLOBETASOL DIPROPIONATE STAGE-III

FIGURE 26: PROCESS FLOW DIAGRAM OF CLOBETASOL DIPROPIONATE STAGE-IV

Sr. Product Name Raw Material Type

Sr. Product Name Raw Material Type

3.8 Environmental and Infrastructural Aspects

3.8.2 Energy/ Power requirement and source:

Detailed note on WTP will be provided in EIA

Total water balance

3.9.3 Solid/hazardous waste generation and Management plan

3.9.4 Stack details and air pollution measures

4.0 SITE ANALYSIS

 Indore Railway Station ~29.6 Km, ENE

 Devi Ahilyabai Holkar (Indore) Airport ~24 Km, ENE

4.3 Topography of the project area

FIGURE 27: SITE SPECIFIC TOPOGRAPHY MAP (10 KM Radius)

FIGURE 28: PROPOSED PROJECT SITE PHOTOGRAPHS

5.0 PLANNING BRIEF

5.2 Population Projection