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PRE FEASIBILITY REPORT For PROPOSED BULK DRUGS AND INTERMEDIATES MANUFACTURING UNIT at SY No: 168/3, ANTHAMPALLY (VILLAGE), BHIKNOOR (MANDAL), KAMAREDDY (DISTRICT), TELANGANA STATE. By M/s. OCTANE CHEMICALS PVT LTD Plot No.95, Maruti Maithri Enclave, Yaparal Village, Ranga Reddy District - 500087, Telangana State

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Page 1: PRE FEASIBILITY REPORTenvironmentclearance.nic.in/writereaddata/Online/TOR/08_Jun_2017... · give information of EIA purpose. 11 4.0 Site Analysis 11 4.1 Connectivity 11 4.2 Land

PRE FEASIBILITY REPORT

For

PROPOSED BULK DRUGS AND

INTERMEDIATES MANUFACTURING UNIT

at

SY No: 168/3, ANTHAMPALLY (VILLAGE), BHIKNOOR (MANDAL),

KAMAREDDY (DISTRICT), TELANGANA STATE.

By

M/s. OCTANE CHEMICALS PVT LTD

Plot No.95, Maruti Maithri Enclave, Yaparal Village,

Ranga Reddy District - 500087, Telangana State

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Contents

S. No. Description Page no.

1.0 Executive Summary 1

2.0 Introduction of The Proposed Project 2

2.1 Project Proponent 2

2.2 Brief description of nature of the project. 2

2.3 Need for the project and its importance to the country and

or region 2

2.4 Demand-Supply Gap. 3

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

3

3.0 Project description 4 - 6

3.1 Products, By-Products and their Production Capacities 7 - 8

3.2 Raw materials required and Quantities 8

3.3 Manufacturing Process 8

3.4 Resource – Utilize and Recycling 9

3.4.1 Water 9

3.4.2 Power Requirement 9

3.4.3 Fuel Requirement 9

3.5 Quantity of wastes to be generated 9

3.5.1 Waste Water Generation and utilization 9 - 10

3.5.2 Solid waste generation and Disposal 10

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

11

4.0 Site Analysis 11

4.1 Connectivity 11

4.2 Land Form, Land use and Land ownership. 12

4.3 Existing Infrastructure 12

4.4 Soil classification 12

4.5 Climatic data from secondary sources. 12

4.6 Social Infrastructure available. 12

5.0 Planning brief 12

6.0 Proposed infrastructure 12

6.1 Industrial Area 13

6.2 Residential Area 13

6.3 Green Belt: 13

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6.4 Social Infrastructure 13

6.5 Water management 13

6.6 Sewerage System 13

6.7 Industrial Waste Management 14

7.0 Rehabilitation and Resettlement (R&R) Plan 14

8.0 Project Schedule and Cost estimates 14

9.0 Analysis of project 14

LIST OF TABLES

Table No Description Page no.

3.1 Existing Product And Quantity 7 3.2 List Of Proposed Products And Quantities 7 3.3 List of by-products 8 3.4 Water Requirement Details 9 3.5 Wastewater generation and Treatment Method 10 3.6 Solid and hazardous waste generation and Disposal 10 - 11

LIST OF FIGURES

Figure No Description Page no.

1.1 Location Map 5 1.2 Google Earth Map Showing Octane Chemicals Pvt ltd 6

LIST OF FLOW CHART

Flow Chart No Description Page no.

3.1 Generalized Flow Chart for Bulk Drug

Manufacturing

8

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PRE FEASIBILITY REPORT

Octane Chemicals Pvt Ltd Page 1

1.0 EXECUTIVE SUMMARY

Octane Chemicals Pvt Ltd was incorporated in 2011 with registered address of Plot

No.95, Maruti Maithri Enclave, Yaparal Village, Ranga Reddy District - 500087,

Telangana State.

S. No Parameter Description

1 Project Location Sy.No.168/3, Anthampally Village, Bhiknoor

Mandal, Kamareddy Districtr, Telangana State.

2

Category of Project as

per EIA Notification &

Amendments

5(f) “A”

3 Project cost Existing : 101.00 Lakhs

Proposed: 950.00 Lakhs

4 Plot area 5.00 Acres

5 Proposed Products Existing capacity : 40 MT/M

Proposed to Capacity : 55 MT/M

6 Resources

7

(I)Electricity

Requirement 1200 KVA

Source of electricity

Telangana State Southern Power Distribution

Company Limited (TSSPDCL)

D. G. Sets DG Set (125 KVA & 380 KVA)

8 (II)Water consumption 101.78 KL/day

Source of water Ground Water Through Bore Well

Waste water generation 58.93 KL/ day

9 (III) Boiler 4.0 TPH Coal fired Boiler

10 (IV) Fuel Coal – 20.00 MT /Day

11 Mode of disposal Zero Liquid Discharge System

12 Solid waste generation Mentioned in Para 3.5.2 of report

13 Nearest Highway National Highway 7 – 0.50 KM (E)

14 Nearest Railway Station Talmadla Railway Station - 4.0 Kms (NW)

Bhiknur Railway Station –5.8 KMs (SSE)

15 Nearest Air Port Rajiv Gandhi International Airport - 108.0 KMs (S)

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PRE FEASIBILITY REPORT

Octane Chemicals Pvt Ltd Page 2

2.0 INTRODUCTION OF THE PROJECT

The objective of this pre- feasibility study is to provide information for the Existing

synthetic organic chemical manufacturing unit to proposed Bulk Drug Intermediates

manufacturing unit of M/s. Octane Chemicals Pvt Ltd at Sy No: 168/3, Anthampally

(Village), Bhiknoor (Mandal), Kamareddy (District), Telangana State

2.1 Project Proponent

Mr. Tripuraneni Venkaiah Chowdary is the Director of the company. He has about

25 years’ experience in various industries and he is also director for other three

companies He is overall in-charge of the company.

Mrs. T. Malathi is the Director of the company. She has vast experience in various

industries.

2.2 Brief description of nature of the project.

M/s. Octane Chemicals Pvt Ltd. is Existing synthetic organic chemical manufacturing

unit to proposed Bulk Drug Intermediates manufacturing unit of at Sy No: 168/3,

Anthampally (V), Bhiknoor (M), Kamareddy (Dt), Telangana State.

2.3 Need for the project and its importance to the country and or region

Octane Chemicals Pvt Ltd is expansion project from Existing synthetic organic

chemical manufacturing unit to proposed Bulk Drug Intermediates manufacturing unit

at Survey No: 168/3, Anthampally (Village), Bhiknoor (Mandal), Kamareddy (District),

Telangana State.

• Availability of the well-connected road and railway network for easy

transportation of the construction equipments and materials, Raw materials

and finished products.

• Easy availability of skilled and unskilled labor for construction of Plant and its

operation.

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

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Octane Chemicals Pvt Ltd Page 3

industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 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.

The Indian pharmaceutical sector is highly fragmented with more than 20,000

registered units. It has expanded drastically in the last two decades. The

Pharmaceutical and Chemical industry in India is an extremely fragmented market

with severe price competition and government price control The Pharmaceutical

industry in India meets around 70% of the country's demand for bulk drugs, drug

intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals, and

injectibles. There are approximately 250 large units and about 8000 Small Scale

Units, which form the core of the pharmaceutical industry in India (including 5 Central

Public Sector Units).

The Indian pharma industry, which is expected to grow over 15 per cent per annum

between 2015 and 2020, will outperform the global pharma industry, which is set to

grow at an annual rate of 5 per cent between the same period!. The market is

expected to grow to US$ 55 billion by 2020, thereby emerging as the sixth largest

pharmaceutical market globally by absolute size, as stated by Mr Arun Singh, Indian

Ambassador to the US. Branded generics dominate the pharmaceuticals market,

constituting nearly 80 per cent of the market share (in terms of revenues).

India has also maintained its lead over China in pharmaceutical exports with a year-

on-year growth of 11.44 per cent to US$ 12.91 billion in FY 2015-16, according to

data from the Ministry of Commerce and Industry. Imports of pharmaceutical

products rose marginally by 0.80 per cent year-on-year to US$ 1,641.15 million.

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. The country accounts for around 30 per cent (by volume) and about 10 per cent

(value) in the US$ 70-80 billion US generics market.

2.4 Demand-Supply Gap.

There is a quite considerable gap between supply and demand for, fine chemicals,

bulk drugs and intermediates. Very few players are in the market who can offer

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Octane Chemicals Pvt Ltd Page 4

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 Employment Generation (Direct and Indirect) due to the project

Approximate employment generation due to Existing synthetic organic chemical

manufacturing unit to proposed Bulk Drug Intermediates manufacturing unit is

indirect 35 & Direct 60. Apart from this there will be significant non estimated

employment 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 thereby

contributing to their upliftment.

3.0 Project Description

M/s. Octane Chemicals Pvt Ltd is existing Cetyl chloride with production capacity of

Existing synthetic organic chemical manufacturing unit production capacity 40.00

Tonns /Month to proposed Bulk Drug Intermediates manufacturing unit 55.00

Tonns/Month

The Location map is shown at Figure -3.1 and Google earth map showing Octane

Chemicals Pvt Ltd plant is shown at Figure -3.2 .

The site central coordinates are

Latitude: 18°13'0.72"N

Longitude: 78°23'13.83"E

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

site does not offer any negative impact on the local area, but rather has a positive

impact on socio economic conditions of the habitants around it.

The Octane Chemicals Pvt Ltd is 0.5 Kms away from National Highway No– 7 and

4.0 & 5.8 Kms from Railway Station at Talmadla & Bhiknur Respectively

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Octane Chemicals Pvt Ltd

Sy No: 168/3, Anthampally (V(District),Telangana State

PRE FEASIBILITY REPORT

Chemicals Pvt Ltd

FIGURE 1.1: LOCATION MAP

Sy No: 168/3, Anthampally (Village), Bhiknoor (Mandal),Telangana State

PRE FEASIBILITY REPORT

Page 5

andal), Kamareddy

Octane Chemicals Pvt Ltd

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Octane Chemicals Pvt Ltd

FIGURE 1.2: GOOGLE EARTH MAP SHOWING

PRE FEASIBILITY REPORT

FIGURE 1.2: GOOGLE EARTH MAP SHOWING OCTANE CHEMICALS PVT LTD

PRE FEASIBILITY REPORT

Page 6

CHEMICALS PVT LTD

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3.1 Products, By-Products and their Production Capacities

M/s. Octane Chemicals Pvt Ltd is existing synthetic organic chemical

manufacturing unit production capacity 40.00 Tonns /Month to proposed Bulk Drug

Intermediates manufacturing unit 55.00 Tonns/Month and the list of product is shown

in Table 3.1 & Table 3.2.

Table 3.1: EXISTING PRODUCT AND QUANTITY

S. No Name of

The Product

CAS No’s

Therapeutic Category / Applications

Quantity MT/Month

Quantity MT/Day

1 Cetyl

chloride 4860-03-

1

Used as • solvent • Surfactants • Pharmaceuticals • Antibacterial spray

40.00 1.33

Total 40.00 1.33

Table 3.2: LIST OF PROPOSED PRODUCTS AND QUANTITIES

S. No Product Name Production capacity

MT/ Month

1 Amlodipine Besylate 3.00

2 Atorvastatin calcium 4.00

3 Cetyl chloride 15.00

4 Domperidone 3.00

5 Fluconazole 3.00

6 Itraconazole 2.00

7 Levocetirizine Dihydrochloride 4.00

8 Metformin Hydrochloride 4.00

9 Olmesartan 3.00

10 Rosuvastatin Calcium 3.00

11 Telmisartan 3.00

12 Valsartan 3.00

13 Zidovudine 5.00

Total 55.00

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Octane Chemicals India Ltd

Table 3.3

S. No

Name of the

Product

1 Rosuvastatin Calcium

Triphenyl phosphine oxide

2 Telmisartan Sodium Phosphate

(1dione

3 Zidovudine Trityl methyl

3.2 Raw materials required and Quantities

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

from local market.

3.3 Manufacturing Process

The manufacturing process

synthesis extending to stages of processing involving different type of chemical

reactions. The generalized Flow chart for bulk drug manufacturing is shown in

chart 3.1.

Flow Chart 3.1: Generalized Flow Chart for Bulk Drug Manufacturing

PRE FEASIBILITY REPORT

Chemicals India Ltd

Table 3.3: LIST OF BY-PRODUCTS

Name of the By-Product

Triphenyl phosphine oxide-

Sodium Phosphate

(1-Bromo-5,5-dimethyl imidazoline-2,4-dione-52.13)

Trityl methyl Ether

3.2 Raw materials required and Quantities

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

Manufacturing Process

The manufacturing process of bulk drugs and Intermediates consists of

synthesis extending to stages of processing involving different type of chemical

reactions. The generalized Flow chart for bulk drug manufacturing is shown in

Generalized Flow Chart for Bulk Drug Manufacturing

PRE FEASIBILITY REPORT

Page 8

Quantity

In Kg/Day

75.22

150.56

52.13

93.50

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

of bulk drugs and Intermediates consists of chemical

synthesis extending to stages of processing involving different type of chemical

reactions. The generalized Flow chart for bulk drug manufacturing is shown in Flow

Generalized Flow Chart for Bulk Drug Manufacturing

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3.4 Resource – Utilize & Recycling

3.4.1 Water

Water requirement of the project for domestic and industrial activity during operation

phase will be 101.78 KL/day. The water requirement will be met through bore well.

The detailed water requirement shown in below Table 3.3

Table 3.4: WATER REQUIREMENT DETAILS

3.4.2 Power Requirement

Power requirement of proposed project will be made available through TSSPDCL.

The total power requirement for the unit is 1200 KVA respectively

D.G. sets of (125 KVA & 380 KVA) are proposed installed to meet the emergency

power requirement of the plant.

3.4.3. Fuel Requirement

The company proposed to install 4.0 TPH Coal fired Boiler Coal Fired Boiler and

total fuel requirement of coal will be around 20.00 MT /Day and it will be procured

from local sources.

3.5 Quantity of wastes to be generated

3.5.1 Waste Water Generation and utilization

Total effluent generated in the project is 58.93 KL/ day. The treated water will be

reused for plant operations.

S. No Purpose Water Input KLD

1 Process 40.38

2 Washings 5.00

3 Boiler make up 23.00

4 Cooling towers make up 24.40

5 Scrubbing system 3.00

6 Domestic 3.00

7 Gardening 3.00

Total 101.78

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The HTDS waste water from Process after neutralization taken for treatment in

stripper followed by MEE and ATFD, vapor condensate collected and transferred to

Biological Treatment. LTDS waste water including domestic sewage, floor Washes,

Utilities waste water taken along with Vapour Condensate from MEE & ATFD for

Biological Treatment. Treated effluent from ETP sent to RO, RO permeate collected

and RO rejects are sent to MEE followed by ATFD for evaporation and separation of

salts. Evaporation salts collected and sent to TSDF. MEE & ATFD vapour

condensates collected & reused along with RO permeate in plant operations.

Table 3.5: Wastewater generation and Treatment Method

Unit HTDS KLD

LTDS KLD

Effluent Generation

in KLD

Treatment Method

Process 34.72 8.01 42.73 HTDS Effluent sent to stripper

followed by MEE system. LTDS

effluents treated in ETP along with

MEE condensate. Treated effluent

is sent to RO, RO permeate water

is recycled and RO rejects taken

for evaporation in MEE followed by

ATFD to collect evaporation salts

for disposal to TSDF.

Washings 5.00 0.00 5.00 Boiler Blow down 0.00 3.00 3.00 Cooling towers Blow down

0.00 2.70 2.70

Scrubbing system 0.00 3.00 3.00

Domestic 0.00 2.50 2.50

Total 39.72 19.21 58.93

3.5.2 Solid waste generation and Disposal

The types of Hazardous and non Hazardous wastes generated from the project,

method of disposal is shown in below table 3.5.

Table 3.6: Solid & Hazardous waste generation and Disposal

S. No Name of the

Hazardous Waste Quantity Kg/Day

Disposal Method

1 Organic waste (Process Residue) 1066.45 Sent to Cement Industries 2 Spent Carbon 81.43 Sent to Cement Industries 3 Solvent Distillation Residue 746.72 Sent to Cement Industries 4 Inorganic Waste 38.50 Sent to TSDF 5 MEE Salts 1841.77 Sent to TSDF 6 Organic Evaporative Liquid ( from

MEE Stripper) 790.00 Sent to Cement Industry

7 ETP Sludge 300.00 Sent to TSDF 8

Used Oils 200

Ltrs/Annum SPCB Authorized Agencies for Reprocessing/Recycling

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9 Detoxified Containers

400 No’s / Month

After Detoxification sent back to suppliers/SPCB Authorized Parties

10 Used Lead Acid Batteries

4 No’s/ Annum

Send back to suppliers for buyback of New Batteries

Solid Waste Details

11 Coal ash from boiler 5600.00 Sent to Brick Manufacturers

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 noticed that

the proposed project falls under Category 5 (f) “A” of the Schedule-I of EIA

Notification S.O.1533.

As per the provision of the SO 1533, it is necessary to get Environmental Clearance

by applying to MoEF&CC along with the Environmental Impacts Assessment Study

Report for the proposed project prior to commissioning of the project activities.

Therefore the EIA is required to conduct to comply with provisions of SO 1533 made

for Category 5(f) “A” of schedule –I of the notification.

4.0Site Analysis

4.1 Connectivity

Octane Chemicals Pvt Ltd is located at Sy.No.168/3, Anthampally Village,

Bhiknoor Mandal, Kamareddy Districtr, Telangana State.

• The nearest habitation from the site is Anthampally (Village) at a distance of

1.7 Km(E).

• The nearest railway station is Talmadla Railway Station at a distance of 4.0

KMs from the site (NW).

• The nearest airport is Rajiv Gandhi International Airport at a distance of 108

KMs

• The Nearest road ways National Highway No.7 – 0.5 Kms

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4.2 Land Form, Land use and Land ownership.

The Current land use of the site is rain fed agricultural land and it is converted to

Industrial purpose. The land use of the 5.00 Acres will be permanently changed to

industrial purpose

4.3 Existing Infrastructure.

Proposed project is a located very nearer to National Highway (NH-0.5 Km) and

Mandal Head Quarters (i.e Bhiknoor - 2.8 Kms) and the basic infrastructure is

already there. The plant well connected with Road and Railway facilities

4.4 Soil classification

The district is mainly covered by two types of soils i.e black and chalka (Sandy

looms) covering 55% and 45% respectively of the total area.

4.5 Climatic data from secondary sources.

Temperature Maximum: 44.40o C

Minimum: 8.90 o C

Normal annual rainfall 1078.7mm

4.6 Social Infrastructure available.

Well developed social infrastructure facilities are available at nearby Habitations.

5.0 Planning Brief

Proposed plant activities will be started after getting statutory clearance form related

authorities. The project will be completed within two years.

Further proposed project activities 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

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6.1 Industrial Area

The infrastructure and other facilities are already well developed in nearby Mandal

head quarter and other villages .

6.2 Residential Area

The employees who will work in the industry will be live in nearby villages or

Bhiknoor mandal & no proposal for residential area for employees.

6.3 Green Belt:

Approximately 47.58 % of Green Belt (i.e 9629.00 M2.) will develop and it will be

maintained.

6.4 Social Infrastructure:

Facilities like road and communication are good. Banks, ATM's and medical facilities

are also adequate.

Amenities:

Education- schools including middle, secondary and higher secondary schools,

social welfare hostels.

Medical and Health- Community Health Centre, & Primary Health center Are

available near villages

Power and water- All the villages are electrified and drinking water facilities are

extended to all villages.

Rail and Road- The project site is very well connected by road through National

Highway no. 7, Southern railways.

6.5 Water management

Water requirement will be met through ground water.

6.6 Sewerage System:

There will be no discharge of industrial effluent as company proposing Zero Liquid

Discharge (ZLD) system. The treated effluent will be reused.

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6.7 Industrial Waste Management:

Due to proposed project, the effluent from cooling and Plant/Equipment washing will

be generated and treated in the well designed Effluent Treatment Plant. The treated

effluent will be reused.

7.0 Rehabilitation and Resettlement (R & R) Plan

Rehabilitation & Resettlement (R&R) plan is not applicable to proposed project.

8.0 Project Schedule & Cost Estimates

Proposed project activities will be started after getting statutory clearance form

related authorities. The project will be completed within two years.

Proposed activity will provide benefits to the local people in terms of financial and

social welfare.

The project cost for Existing Project is 1.01 Crores and Proposed bulk drugs and

intermediates manufacturing unit Project cost is 9.50.00 Crores will be used for

constructing additional building, Equipments, Machinery and RO system.

9.0 Analysis of proposal (Final Recommendations)

� 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