SY. NO: PARTS OF 318, 319 AND 321 LOCATED AT –...

PRE - FEASIBILITY REPORT

For

PROPOSED BULK DRUGS INTERMEDIATES

MANUFACTURING UNIT

at

SY. NO: PARTS OF 318, 319 AND 321 LOCATED AT –

PALLEPAHAD VILLAGE, THURKAPALLY MANDAL,

YADADRI - BHONGIR DISTRICT, TELANGANA STATE

By

VEDGIR LIFE SCIENCES

HOUSE NO: 8-3-228/662/A, RAHAMATH NAGAR, YOUSUFGUDA, HYDERABAD

TELANGANA STATE

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. 4

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

4

3.0 Project description 5

3.1 Product and Production Capacity 8

3.2 Raw materials required and Quantities 9

3.3 Manufacturing Process 9

3.4 Resource – Utilize and Recycling 10

3.4.1 Water 10

3.4.2 Power Requirement 10

3.4.3 Fuel Requirement 10

3.5 Quantity of wastes to be generated 10

3.5.1 Waste Water Generation and utilization 10

3.5.2 Solid waste generation and Disposal 11

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

12

4.0 Site Analysis 12

4.1 Connectivity 12

4.2 Land Form, Land use and Land ownership. 12

4.3 Existing Infrastructure 13

4.4 Soil classification 13

4.5 Climatic data from secondary sources. 13

4.6 Social Infrastructure available. 13

5.0 Planning brief 13

6.0 Proposed infrastructure 13

6.1 Industrial Area 13

6.2 Residential Area 13

6.3 Green Belt: 14

6.4 Social Infrastructure 14

6.5 Water management 14

6.6 Sewerage System 14

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 15

LIST OF TABLES

Table No Description Page no. 3.1 Proposed Products and Quantities 8 3.2 List of By-Products 9 3.3 Water Requirement Details 10 3.4 Wastewater generation and Treatment Method 11 3.5 Solid and hazardous waste generation and Disposal 11 & 12

LIST OF FIGURES

Figure No Description Page no. 1.1 Location Map 6 1.2 Google Earth Map Showing Clarus Chem Pvt. Ltd. 7

LIST OF FLOW CHART

Flow Chart No

Description Page no.

3.1 Generalized Flow Chart for Bulk Drug Manufacturing 9

Pre Feasibility Report

Vedgir Life Sciences Page 1

1.0 EXECUTIVE SUMMARY

Vedgir Life Sciences is a partnership firm and it is registered office at H.No.8-3-

228/662/A, Rahamath Nagar, Yousufguda, Hyderabad Telangana Sate.

S. No Parameter Description

1 Project Location

Sy No: Parts of 318,319 & 321, Pallepahad(V),

Thurkapally(M) Yadadri - Bhongiri District,

Telangana State

2 Category of Project as per EIA Notification & Amendments

5(f) “A”

3 Project cost 18 Crores

4 Plot area 9.77 Acres (39537.79 Sq.m)

5 Proposed Products Proposed Products List is mentioned in section

3.1

6 Resources

7 (I)Electricity

Requirement 800 KVA

Source of electricity Telangana State Southern Power Distribution

Company Limited (TSSPDCL)

D. G. Sets 250 KVA & 380 KVA

8 (II)Water consumption 164.15 KLD

Source of water Ground Water

Waste water generation 76.59 KLD

9 (III)Boiler 2 TPH & 5 TPH Coal Fired Boiler is Proposed

10 (IV)Fuel Coal – 28.00 MT /Day for proposed boiler Requirement

11 Mode of disposal Zero Liquid Discharge System

12 Solid waste generation Mentioned in Para 3.5.2 of report

13 Nearest Highway State Highway - 17 - (Pragnapur - Bhongir Road) – 1.90 kms (E)

14 Nearest Railway Station Bhongir Railway Station – 11.50 kms (SSE)

15 Nearest Airport Rajiv Gandhi International Airport – 58 kms

(SW)



2.0 INTRODUCTION OF THE PROJECT

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

Bulk Drug Intermediates manufacturing unit of Vedgir Life Sciences located at Sy.

No: Parts of 318, 319 and 321 Pallepahad Village, Thurkapally Mandal, Yadadri -

Bhongir district, Telangana State.

2.1 Project Proponent

Mr. S. Mohan Reddy is Managing Partner of the company having more than 30

years experience in Pharma Industry.

2.2 Brief description of nature of the project.

Vedgir Life Sciences is proposing to manufacture Bulk Drug intermediates at Sy.

No: Parts of 318, 319 and 321 Pallepahad Village, Thurkapally Mandal, Yadadri -

Bhongir district, Telangana State.

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

Vedgir Life Sciences is a Greenfield project intended to start a manufacturing unit of

Bulk Drug Intermediates at Survey No: Parts of 318, 319 and 321 Pallepahad

Village, Thurkapally Mandal, Yadadri – Bhongir.

• 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

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

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 proposed unit is 70. 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

Vedgir Life Sciences is proposing to Manufacture Bulk Drug Intermediates with

production capacity of 75.00 TPM

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

Life Sciences plant is shown at Figure - 3.2.

The site central GPS - coordinates are

Latitude: 17°35'49.28"N

Longitude: 78°49'7.98"E

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 because of

employment to locals.

The Vedgir Life Science is 1.90 kms away from State Highway No– 17 and 11.50

kms from Bhongir Railway Station.



FIGURE 1.1: LOCATION MAP

Vedgir Life Sciences


FIGURE 1.2: GOOGLE EARTH MAP SHOWING

FIGURE 1.2: GOOGLE EARTH MAP SHOWING VEDGIR LIFE SCIENCES


Page 7

VEDGIR LIFE SCIENCES.

PRE FEASIBILITY REPORT


3.1 Products, By-Products and their Production Capacities

Vedgir Life Sciences to produce below mention products with Manufacturing

Capacity of 75 TPM and the list of products are shown in Table 3.1 & 3.2.

Table 3.1: Proposed Product and Quantity

S. No Product Name Production capacity MT/

Month

1 Aceclofenac 10.00

2 Certrizine Hydrochloride 10.00

3 Domperidone 4.50

4 Drotraverine Hydrochloride 4.00

5 Emiticitabine Hydrochloride 5.00

6 Esomeprazole 3.00

7 Fexofenadine Hydrochloride 4.50

8 Fluconazole 5.00

9 Glycazide 5.00

10 Ketoconazole 5.00

11 Levetiracetam 3.00

12 Loratidine 4.00

13 Losartan Potassium 4.50

14 Lansoprazole 10.00

15 Montelukast Sodium 3.00

16 Omeprazole 10.00

17 Pantoprazole sodium 4.50

18 Sertaline Hydrochloride 5.00

19 Telmisartan 4.50

20 Tramadol Hydrochloride 10.00

Total (Worst combination of any 10 products at any given point of time)

75.00


Table 3.

S.No Name of the Product

1 Aceclofenac 2 Emtricitabine 3 Fluconazole 3 Montelukast Sodium

4 Losartan Potassium

5 Omeprazole 6 Tramadol Hydrochloride

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 fo


Table 3.2: List of By-Products

Name of the Product Name of the By-Product

t- Butanol TEA Hcl DMSO

Montelukast Sodium Diisopropyl amine HCl

Losartan Potassium Succinimide Trityl chloride Sodium Sulphate

Tramadol Hydrochloride Magnesium Sulphate

3.2 Raw materials required and Quantities


3.3 Manufacturing Process

The manufacturing process of bulk drugs and Intermediates consists of chemical


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

Flow Chart 3.1: Generalized Flow Chart for Bulk Drug Manufacturing


Page 9

Quantity In Kg/Day

69.85 106.55

44.08 30.40 41.54

105.84 152.04 218.55


consists of chemical


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

r Bulk Drug Manufacturing



3.4 Resource – Utilize & Recycling

3.4.1 Water

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

phase will be 164.15 KLD. The water requirement will be met through ground water

sources. The detailed water requirement shown in below Table 3.3.

Table 3.3: WATER REQUIREMENT DETAILS

S.No Purpose Water Input In KLD

1 Process 47.90

2 Washings 5.00

3 Boiler make up 42.00

4 Cooling towers make up 57.25

5 Scrubbing system 4.00

6 Domestic 3.00

7 Gardening 5.00

Total 164.15

3.4.2 Power Requirement

Power requirement of proposed project will be made available through Telangana

State Southern Power Distribution Company Limited (TSSPDCL). The total power

requirement for the unit is 800 KVA respectively

D.G. sets of 250 KVA & 380 KVA is proposed installed to meet the emergency

power requirement of the plant.

3.4.3 Fuel Requirement

The company proposed to install 2 TPH & 5 TPH Coal Fired Boiler and total fuel

requirement of coal will be around 28.00 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 76.59 KLD. The treated water will be reused

for plant operations.

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 3.4: Wastewater generation and Treatment Method

Unit HTDS KLD

LTDS KLD

Effluent Generation

in KLD

Treatment Method

Process 35.43 17.15 52.59 HTDS Effluent sent to stripper

followed by MEE/ATFD system.

LTDS effluents treated in ETP along

with MEE/ATFD vapour 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, MEE Condensate collected

and reused along with RO permeate.

Washings 5.00 0.00 5.00 Boiler Blow down 0.00 6.00 6.00 Cooling towers Blow down

0.00 6.50 6.50

Scrubbing system 4.00 0.00 4.00

Domestic 0.00 2.50 2.50

Total 44.43 32.15 76.59

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 3.5: Solid / Hazardous waste generation and Disposal

S. No Name of the Solid/ Hazardous Wastes

Quantity

Disposal Method

1 Organic waste (Process Residue)

456.06 Kgs/Day Sent to Cement Industries

2 Spent Carbon 138.17 Kgs/Day Sent to Cement Industries 3 Solvent Distillation Residue 1247.86 Kgs/Day Sent to Cement Industries 4 Inorganic Waste 462.73 Kgs/Day Sent to TSDF 5 MEE Salts 1666.01 Kgs/Day Sent to TSDF 6 Organic Evaporative Liquid (

from MEE Stripper) 890 Kgs/Day Sent to Cement Industry

7 ETP Sludge 200 Kgs/Day Sent to TSDF



8 Used Oils 500 Ltrs/Annum

SPCB Authorized Agencies for Reprocessing/Recycling

9 Containers liners 300 No’s / Month

After Detoxification sent to outside agencies

10 Used Lead Acid Batteries 4 No’s/ Annum

Send back to suppliers for buyback of New Batteries

11 Ash from boiler 9800.00 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

Vedgir Life Sciences located at Sy. No: Parts of 318, 319 and 321 Pallepahad

Village, Thurkapally Mandal, Yadadri - Bhongir district, Telangana State.

• The nearest habitation from the site is Pallepahad Village at a distance of 0.50

kms (NNW).

• The nearest railway station is Bhongir Railway Station at a distance of 11.50

kms (SSE) from the site.

• The nearest airport is Rajiv Gandhi International Airport at a distance of 58

kms

• The Nearest road ways State Highway No.17 – 1.90 kms



4.2 Land Form, Land use and Land ownership.

The land use of the Area of 9.77 Acres (39537.79 Sq.m) will be permanently

changed to industrial purpose.

4.3 Existing Infrastructure.

The Proposed project is a Greenfield project which is 1.90 kms away from SH-17

and Mandal head quarter Turkapally is 6.00 kms (NNE) from the project site.

4.4 Soil classification

The predominant soils in the district are Red sandy soil, Sandy Loam Soil and black

soil.

4.5 Climatic data from secondary sources.

Temperature Maximum: 44.5 oC

Minimum: 10.6 oC

Normal annual rainfall : 651.5 mm

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 project management 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 Industrial Area

The infrastructure and other facilities are already well developed in Turkapally, which

is a Mandal head quarter.

6.2 Residential Area

The employees who will work in the industry are from nearby villages and hence no

proposal for residential area for employees.



6.3 Green Belt:

48.78 % of Green Belt will be developed and 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 in Turkapally which is 6.50 kms NNE of proposed project site.

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 State

Highway No. 17 and nearest railway station is Bhongir.

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.

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 this 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 proposed Project is 18.00 Crores will be used for constructing

additional building, Equipments & misc.

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.

SY. NO: PARTS OF 318, 319 AND 321 LOCATED AT –...

Documents

Transcript of SY. NO: PARTS OF 318, 319 AND 321 LOCATED AT –...