PRE - FEASIBILITY REPORT

For

PROPOSED BULK DRUGS AND

INTERMEDIATES MANUFACTURING UNIT (MANUFACTURING CAPACITY 75 TONNES/MONTH)

at

SY NO: 11/2B , POCHAMPALLY VILLAGE ,

JAGGAIAHPET MANDAL,

KRISHNA DISTRICT, ANDHRA PRADESH By

AJAY LABS PRIVATE LIMITED Plot No No: 90, Vivekananda Nagar, Kukatpally,

Hyderabad-500072

January, 2019

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 -3

2.4 Demand-Supply Gap. 3

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

3 -4

3.0 Project description 4

3.1 Product and Production Capacity 7

3.2 Raw materials required and Quantities 7

3.3 Manufacturing Process 7 - 8

3.4 Resource – Utilize and Recycling 8

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

3.5.2 Solid waste generation and Disposal 10

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

10

4.0 Site Analysis 11

4.1 Connectivity 11

4.2 Land Form, Land use and Land ownership. 11

4.3 Existing Infrastructure 11

4.4 Soil classification 11

4.5 Climatic data from secondary sources. 11

4.6 Social Infrastructure available. 12

5.0 Planning brief 12

6.0 Proposed infrastructure 12

6.1 Industrial Area 12

6.2 Residential Area 12

6.3 Green Belt: 12

6.4 Social Infrastructure 12

6.5 Water management 13

6.6 Sewerage System 13

6.7 Industrial Waste Management 13

7.0 Rehabilitation and Resettlement (R&R) Plan 13

8.0 Project Schedule and Cost estimates 13

9.0 Analysis of project 13

LIST OF TABLES

LIST OF FIGURES

Figure No Description Page no.

1.1 Location Map 5

1.2 Google Earth Map Showing Ajay Labs Private Limited 6

LIST OF FLOW CHART

Table No Description Page no.

2.1 Details of Proposed Employment for Proposed Project. 4

3.1 Proposed Products and Quantities & By Products Details

7

3.2 Water Requirement Details 8

3.3 Wastewater generation and Treatment Method 9

3.4 Solid and hazardous waste generation and Disposal 10

8.1 Project Cost 13

Flow Chart No

Description Page no.

3.1 Generalized Flow Chart for Bulk Drug Manufacturing 8

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1.0 EXECUTIVE SUMMARY

Ajay Labs Private Limited is proposing to establish Bulk Drugs and Intermediates

Manufacturing unit at Sy No: 11/2B , Pochampally Village , Jaggaiahpet Mandal,

Krishna District, Andhra Pradesh. The proposed production quantity is 60

Tonns/Month.

S. No Parameter Description

1 Project Location Sy No: 11/2B , Pochampally Village , Jaggaiahpet

Mandal, Krishna District, Andhra Pradesh

2 Category of Project as per EIA

Notification & Amendments 5(f) “A”

3 Project cost 6.4 Crores

4 Area Acres 2. 62 Cents / 10602.76 Sq meters

5 Proposed Products Proposed Products List is mentioned in section

3.1

6 Resources

7 (I)Electricity Requirement 900 KVA

Source of electricity

Andhra Pradesh Southern Power Distribution

Company Limited (APSPDCL)

D. G. Sets 320 KVA X 2 no’s

8 (II)Water consumption 119 KLD

Source of water Ground Water

Waste water generation 39.26 KLD

9 (III)Boiler 4.0 TPH Coal Fired Boiler

10 (IV)Fuel Coal – 12 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 Hyderabad – Vijayawada National Highway –

1.0 Km (NE)

14 Nearest Railway Station Motumari Railway Station – 19 Kms (ENE)

15 Nearest Airport Vijayawada International Airport - 78 Kms

(ESE)

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2.0 INTRODUCTION OF THE PROPOSED PROJECT

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

Bulk Drugs and Intermediates Manufacturing unit by Ajay Labs Private Limited at Sy

No: 11/2B, Pochampally Village, Jaggaiahpet Mandal, Krishna District, Andhra

Pradesh.

Ravi Ajay Chand is the Director of the company. He did B. Pharmacy and having 6

years experience in Bulk Drug and Intermediates manufacturing company and wants

to become an entrepreneur.

R Venu is the Director of the company. She did B.Sc and having 32 years

experience in various Pharma companies in the Production and Administrative

Departments.

2.1 Brief description of nature of the project.

Ajay Labs Private Limited is proposing to manufacture Bulk Drugs and intermediates

at Sy No: 11/2B, Pochampally Village, Jaggaiahpet Mandal, Krishna District, Andhra

Pradesh.

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

Ajay Labs Private Limited intended to start a Bulk Drugs and Intermediates

manufacturing unit at Sy No: 11/2B, Pochampally Village, Jaggaiahpet Mandal,

Krishna District, Andhra Pradesh.

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.

Increase in population rate and continuous change in lifestyle and physical

environment is increasing the demand of drugs, medicines to address the wellbeing

of human kind. The sustainable development of Indian Pharmaceutical Industry is

important in order to make India one of the largest global providers of quality

medicines at reasonable prices.

The market of Pharmaceutical Drugs has fast progressing growth and there is ample

opportunity in indigenous as well as export market. With the ever increasing world

market demand for Pharmaceutical Drugs, the management having expertise in the

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same field and has decided to enhance its manufacturing capacity. The project is

proposed with all required infrastructural facilities.

It is well known that Pharma industry in India as at a developing phase. The industry

is not tapped its fullest growth level. India has got great resources for drug

manufacturing. Drugs and medicine manufacturing Industry is going to grow with a

very high pace in the country. Globalization has opened doors and in future medicine

industry is seems to be having very bright in India.

Recognizing the scope of the potentials the Govt. of telangana has put more

emphasis on the development of Pharma industry and announced series of

incentives and subsidies. This scenario is helping to setup new manufacturing units.

It is pertinent to notice that, various industrial authorities of India that there is evenly

increase in knowhow about pharmaceutical products manufacturing in India, it is

seen that there is demand for pharmaceutical products in India as the substantial

population of globe resides in Asia itself.

2.3 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.

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

Approximate employment generation due to proposed proposal is 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.

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Table 2.1: Details of Proposed Employment for Project

Sl. No. Manpower Total No.

1 Un-Skilled 20

2 Skilled 35

3 Managerial &Supervisory 5

3.0 Project Description

Ajay Labs Private Limited is proposing to Manufacture Bulk Drugs and

Intermediates with production capacity of 75 TPM

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

Labs Private Limited plant is shown at Figure - 3.2.

The site coordinates are

Latitude: 16°51'47.57"N

Longitude: 80°10'13.01"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 Ajay Labs Private Limited is 1.0 Kms away from away from Hyderabad –

Vijayawada National Highway and 18 Kms from Motumari Railway Station.

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FIGURE 1.1: LOCATION MAP

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FIGURE 1.2: GOOGLE EARTH MAP SHOWING AJAY LABS PRIVATE LIMITED

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3.1 Product and Production Capacity

Ajay Labs Private Limited proposing to produce below mention products with

Manufacturing Capacity of 75 TPM and the list of products and by-products are

shown in Table 3.1.

Table 3.1: Proposed Product and Quantity

S. No

Name of the Product CAS No Thereputic Categeory

Quantity in

Kg/Month

1 Atorvastatin Calcium Trihydrate 344423-98-9

Lipid-Lowering Agent

5000

2 Darunavir 206361-99-1 Antiretroviral 5000

3 Levetiracetam 102767-28-2 Anticonvulsant 10000

4 Montelukast Sodium 151767-02-1 Antasthmatic 10000

5 Tri Ethyl Ortho Formate 122-51-0 Drug Intermediate

20000

6 Di Cyclohexyl Carbo Di Imide

538-75-0 Drug Intermediate

20000

7 Curcumin 458-37-7

Anti-Inflammatory And Anti-Oxidant

5000

Total 75000.00

Table 3.1: List of By-products

S. No Name of the

Product Name of the By-Product

Quantity in

Kg/Batch

Quantity in Kg/Day

1 Darunavir Isobutene 60.36 20.12

1-Hydroxy-pyrrodiline-2,5-dione 107.60 35.86

3.2 Raw materials required and Quantities

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

from local market. The products wise required raw materials and quantities are

enclosed in additional information.

3.3 Manufacturing Process

The manufacturing process of bulk drugs 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 chart 3.1.

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Flow Chart 3.1: Generalized Flow Chart for 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 119 KLD. The water requirement will be met through Ground water

Supply. The detailed water requirement shown in below Table 3.2

Table 3.2: WATER REQUIREMENT DETAILS

S. No. Purpose Water Requirement

in KLD

1 Process 16

2 Floor & Reactor Washings 6

3 Boiler make up 23

4 Cooling towers make up 63

5 Domestic 4

6 Scrubber 4

7 Gardening 3

Total 119

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3.4.2 Power Requirement

Power requirement of proposed project will be made available through Andhra

Pradesh Southern Power Distribution Company Limited (APSPDCL) .The total power

requirement for the unit is 900 KVA respectively

Two numbers of D.G. set with 320 KVA will be proposed to install 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. The total Coal

requirement will be around 12 TPD 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 39.26 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. LTDS waste water including domestic sewage,

floor Washes, Utilities waste water taken along with Vapour Condensate from MEE &

ATFD for Biological Effluent Treatment plant. Treated effluent from ETP sent to RO

and RO permeate water is recycled and RO rejects are sent to MEE followed by

ATFD for evaporation. Evaporation salts collected and sent to TSDF. MEE & ATFD

vapour condensate reused along with RO permeate.

Table 3.3: Wastewater generation and Treatment Method

S. No. Purpose Water Requirement

in KLD

1 Process 16

2 Floor & Reactor Washings 6

3 Boiler make up 23

4 Cooling towers make up 63

5 Domestic 4

6 Scrubber 4

7 Gardening 3

Total 119

3.5.2 Solid / Hazardous waste generation and Disposal

The types of Solid and Hazardous wastes generated from the project, method of

disposal is shown in below table 3.4.

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Table 3.4: Solid / Hazardous waste generation and Disposal

S. No Name of the

Hazardous Waste Quantity Kg/Day

Disposal Method

1 Organic Solid Waste 1086

Sent to Cement Industries

2 Spent Carbon 12

3 Solvent distillation residue 148

4 Organic distillate from Stripper

166

5 ETP Sludge 100 Sent to TSDF

6 MEE Salts 1306

7 Inorganic solid waste 2305

8 Used Oils 300

Ltrs/Annum

SPCB Authorized Agencies for Reprocessing/Recycling

9 Detoxified Container/liners 600

No's/Month

After Detoxification sent back to suppliers/sent to outside Parties

10 Used Lead Acid Batteries 4 No's /Annum Sent back to suppliers on buyback basis

11 Fly ash from boiler 5600 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 SO 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.

4.0. Site Analysis

4.1 Connectivity

The nearest habitation from the site is Gauravaram at a distance of 2.5 Kms

(E).

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The nearest railway station is at Motumari Railway Station at a distance of 19

Kms (ENE) from the site.

The nearest airport is Vijayawada International Airport at a distance of 78 Km

(ESE)

The Nearest road ways is Hyderabad – Vijayawada National Highway – 1.0 Km (NE)

4.2 Land Form, Land use and Land ownership.

The land use of the Acres 2. 62 Cents / 10602.76 Sq meters will be permanently

changed to industrial purpose.

4.3 Existing Infrastructure.

The proposed project is a Greenfield project which Hyderabad – Vijayawada

National Highway – 1.0 Km (NE) and Mandal head quarters Jaggaiahpet is 7.0 Km

(NW) from the site.

4.4 Soil classification

The predominant soils in the district are

Red soils Black soils Alkaline soils Alluvium

4.5 Climatic data from secondary sources.

Temperature Maximum: 47.1 oC

Minimum: 9.3 oC

Average Annual Rainfall:982 mm

(Source: IMD- Nandigama)

4.6 Social Infrastructure available.

Well developed social infrastructure facilities are available at nearby Habitations.

5.0 Brief Planning

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 regulations of

statutory authorities and provide the control measure and devices to achieve the

standard norms

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6.0 Proposed Infrastructure

6.1 Industrial Area

The infrastructure and other facilities are already well developed in Jaggaiahpet

which is a Mandal head quarters.

6.2 Residential Area

The employees who will work in the industry are from nearby habitations and hence

no proposal for residential area for employees.

6.3 Green Belt:

Proposed to develop green belt in an area of 4449 Sq. mtrs, i.e 42 % out of the total

area 10602.76 Sq. mtrs

6.4 Social Infrastructure:

Facilities like roads, communication: Banks, ATM's and medical facilities are

adequate.

Amenities:

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

social welfare hostels.

Medical and Health- Community Health Centre & Primary Health center and all

multispecialty Medical facilities are available at Jaggaiahpet which is 7.0 Kms (NW)

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 at 1.0 kms away from

Hyderabad –Vijayawada National Highway and nearest railway station is Motumari

at a distance of 26 Km

6.5 Water management

Water requirement will be met from ground water supply.

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:

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 activity is 6.4Crores will be used for constructing

additional building, Equipments & misc.

TABLE 8.1: PROJECT COST

S. No Particulars Rs. Crores

1 Land 0.4

2 Civil Works 1.0

3 Plant & Machinery 5.0

Total 6.4

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.