PRE FEASIBILITY REPORT -...

Pre Feasibility Report

FOR

Expansion of Existing Bulk Drug Manufacturing Unit

Of

at

PLOT NO: 118,119,127 & 128, IDA, PHASE - II

PASHAMYLARAM, PATANCHERU MANDAL, SANGAREDDY DISTRICT,

TELANGANA STATE.

By

M/S. SALUBRIOUS LABORATORIES PVT LTD.

Plot No: 118,119,127 & 128, IDA, Phase - II

Pashamylaram, Patancheru Mandal, Sangareddy District,

Telangana State.

Contents

S. No. Description Page no.

1.0 Executive Summary 1

2.0 Introduction of The Project 1

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

4

3.0 Project description 4 - 6

3.1 Product and Production Capacity 7

3.2 Raw materials required and Quantities 7

3.3 Manufacturing Process 7

3.4 Resource – Utilize and Recycling 8

3.4.1 Water 8

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 9 – 10

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

10

4.0 Site Analysis 10

4.1 Connectivity 10

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. 11

5.0 Planning brief 11

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 12

6.6 Sewerage System 12

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

Table No Description Page no.

2.1 Total Employment 4

3.1 Proposed Products and Quantities 7

3.2 Water Requirement Details 8

3.3 Wastewater generation and Treatment Method 9

3.4 Solid and hazardous waste generation and Disposal 9

LIST OF FIGURES

Figure No Description Page no.

1.1 Location Map 5

1.2 Google Earth Map Showing Salubrious Laboratories Pvt Ltd 6

LIST OF FLOW CHART

Flow Chart No Description Page no.

3.1 Generalized Flow Chart for Bulk Drug &

Intermediates Manufacturing 8

PRE FEASIBILITY REPORT

M/s. Salubrious Laboratories Pvt Ltd Page 1

1.0 EXECUTIVE SUMMARY

M/s. Salubrious Laboratories Pvt Ltd. is a Private limited company incorporated on

November 15, 2000 with the main objective to manufacture Bulk Drug. Company

located at Hyderabad.

S. No

Parameter Description

1 Project Location Plot No:118,119,127, & 128 ,IDA, Phase - II

Pashamylaram, Patancheru Mandal, Sangareddy

District, Telangana State.

2 Category of Project as per

EIA Notification &

Amendments

5(f) “B”

3 Project cost 2 Crores

4 Plot area 1.13 Acres (4588.0 SQM)

5 Proposed Products List of products are Enclosed in Section 3.1 & Page

No:7

6 Resources

(I)Electricity Requirement Existing - 300 H.P

Proposed – 300 H.P

Source of electricity TSSPDCL

D. G. Sets DG Sets Existing - 125 KVA & 250 KVA Continued

DG Sets Proposed - 180 KVA

(II) Water consumption 130.00 KL/day(for Proposed Expansion)

Source of water IDA Supply

Waste water generation 52 KLD (from Proposed Expansion)

Mode of disposal Effluent will be collected in tanks, after neutralization

effluent Sent to RO System

7 (III) Boiler 4.0 TPH Coal Fired Boiler is Proposed and existing 0.5TPH boiler is dropped

8 (IV) Fuel Coal - 16.0 MT /Day for boilers Requirement

9 Solid waste generation Mentioned in Section 3.5.2 of report

10 Nearest Highway National Highway 65 – 2.0 KM ( Hyderabad –

Mumbai)

11 Nearest Railway Station Lingampally Railway Station - 15.0 Kms

12 Nearest Air Port Rajiv Gandhi International Airport - 42.0 KMs



2.0 INTRODUCTION OF THE PROJECT

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

manufacturing unit of M/s. Salubrious Laboratories Pvt Ltd at Plot No:

118,119,127, & 128, IDA, Phase – II, Pashamylaram, Patancheru Mandal,

Sangareddy District, Telangana State.

2.1 Project Proponent

Mr. K. Ekambernath Reddy, is the Managing Director, is a Graduate in Chemistry

and well experienced in production/Processes engineering and process development

in pharmaceutical units. Having more than 28 years of Experience.

Sri M.V. Prasad Reddy is Whole time Director of the Company, he is a Post

Graduate in Chemistry and well experienced in establishing and operating

pharmaceutical units, having vast experience in R&D, Quality Control & Commercial

matters.

The management is adequately supported by qualified and skilled executives. The

promoters have wide experience in the pharmaceutical industry.

2.2 Brief description of nature of the project.

SALUBRIOUS Laboratories Private Limited (SLPL) is a private limited company

incorporated on November 15, 2000 with the main objective of manufacture of Bulk

Drug at Plot No: 118,119,127, & 128, IDA, Phase – II, Pashamylaram, Patancheru

Mandal, Sangareddy District, Telangana State.

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

At present the global Pharma market is estimated at US$ 500 billion. The market is

expected to continue to grow at the rate of 5 to 6% per year. During the last decade

India has built up strong position as a bulk drug (Active Pharmaceutical Ingredients –

API) supplier to the international market and expects to further consolidate the

position. For this reasons many existing bulk drug units are proposing for expansion

their existing manufacturing capacities.

Currently, the Indian pharmaceutical industry is one of the world’s largest and most

developed. Hyderabad cluster has come to be recognized as the bulk drugs capital



of India. Currently the Bulk Drug Manufacturers Association, Andhra Pradesh has

around 450 members, of these 300 are situated around Hyderabad.

Bulk Drug Industry is the backbone of the self-reliant Pharmaceutical industry in

India, playing a significant role in improving the health standards of the people.

Pharmaceutical manufacturers consisting of Formulations and Bulk Drugs and drug

intermediates in large, medium and small scale sectors in the country employ man

power of 24.

The capital investment in the pharma industry is about Rs.35,000 cores. Present

90% of the domestic bulk drugs requirement is met by the Indian industry, itself. The

Bulk Drug industry contributed about Rs. 48,000 Crores worth of exports, during the

year 2010-2011 which is growing by over 15%-20% every year. Over 45% of the

world's bulk drug requirement is met by India.

There are approximately 300 large companies and over 10,000 medium and small-

scale companies in the sector, of which 77% manufacture formulations and 23% of

units manufacture APIs.

The pharma sector has a significant presence of small and medium companies with

revenues of around Rs 60,000 crore which contribute 40% of the volume and value

and the rest is contributed by large companies with revenue more than Rs 90,000

crore. These API manufacturers not only export 50% of the production to various

countries, but also meet majority requirement of the domestic formulations units.

The growth and achievement of the Indian Drug Industry during the last five decades

has been phenomenal and has been rated as one of the highest among the

developing countries. From a mere processing industry to begin with, India's bulk

drug and pharmaceutical industry today has grown into a highly sophisticated one,

meeting the International standards of Production, Technology and Quality Control.

The progress of the Drug industry has not only rendered the country self-sufficient in

National Health Care, but also played a role in reversing the trend of Indian foreign

trade profile from a predominantly importing country to a highly visible exporter to

global marketing.



2.4 Demands-Supply Gap.

There is a quite considerable gap between supply and demand for bulk drugs &

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.

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

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. The details of total

employment due to proposed expansion shown in below Table2.1.

TABLE 2.1: TOTAL EMPLOYMENT GENERATION DUE TO PROPOSED

EXPANSION

Particulars No. of employees

Functional Area

Key managerial staff 2 Finance, Marketing, Production,

Quality control, R&D, Logistics etc.

Administration 2 Office work

Skilled and semi

skilled 20

Production Process, Maintenance,

stores, Safety.& Un skilled workers

Total 24



3.0 Project Description

M/s. Salubrious Laboratories Private Limited is were established in IDA

Pashamylaram, Phase – II of Telangana State in the year 2000 to produce drug and

now proposing for expansion of Existing Bulk Drug Manufacturing.

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

Salubrious Laboratories Private Limited plant is shown at Figure -3.2.

The site central coordinates are

Latitude: 17°32'14.70"N

Longitude: 78°11'10.73"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 Salubrious unit is 2.0 Kms away from National Highway No– 65 and 15.0 Kms

from Lingampally Railway Station.



FIGURE 1.1: LOCATION MAP

Salubrious Laboratories Private Limited

Plot No: 118,119,127, & 128, IDA, Phase – II, Pashamylaram, Patancheru Mandal, Sangareddy District, Telangana State



FIGURE 1.2: GOOGLE EARTH MAP SHOWING



3.1 Product and Production Capacity

M/s. Salubrious Laboratories Private Limited is proposing to produce below

mention products with Manufacturing Capacity 30 MT/Month and the list of product

are shown in Table3.1.

Table3.1: Proposed Products and Quantity

S. No.

Product Name Quantity In Kg/Month

Quantity In Kg/Day

1 Amlodipine Besylate 2500.00 83.33

2 Atorvastatin Calcium 2500.00 83.33

3 Domperidon 2500.00 83.33

4 Duloxetine Hydrochloride 1500.00 50.00

5 Fluconazole 2000.00 66.67

6 Lansoprazole 2000.00 66.67

7 Losartan potassium 2000.00 66.67

8 Pantoprazole sodium 5000.00 166.67

9 Rabeprazole Sodium 2500.00 83.33

10 Simvastatin 2500.00 83.33

11 Zidovudin 5000.00 166.67

Total 30000.00 1000.00

3.2 Raw materials required and Quantities

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

from local market. The required raw materials and quantities are enclosed as

Annexure.

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.



FLOW CHART 3.1: GENERALIZED FLOW CHART FOR BULK DRUG &

INTERMEDIATES 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 130.00 KLD. The water requirement will be met through IDA supply.

The detailed water requirement shown in below Table3.2.

Table 3.2: WATER REQUIREMENT DETAILS

S.No Purpose Water Requirement In KLD

1 Process 22.00

2 Washings 2.00

3 Boiler make up 23.00

4 Cooling towers make up 70.00

5 Scrubbing system 1.00

6 Domestic 5.00

7 Gardening 4.00

8 DM Plant 3.00

Total 130.00



3.4.2 Power Requirement

Power requirement of proposed expansion project will be made available through

TSSPDCL. The total power requirement for the unit after expansion is 600 HP

respectively

In addition to the existing 125 KVA DG Set, 250 KVA DG set and another 180 KVA

D.G. set is proposed installed to meet the emergency power requirement of the

plant for the proposed Expansion.

3.4.3 Fuel Requirement

The company proposed to install 4.0 TPH coal fired Boiler and an existing 0.5 TPH

coal fired boiler is dropped and total fuel requirement will be around 16.0 TPD of

coal 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 52 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.

Table3.4: WASTEWATER GENERATION

Unit HTDS In

KLD

LTDS In

KLD

Effluent Generation

In KLD

Treatment Method

Process 22.00 3.00 25.00 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

Washings 0.00 2.00 2.00

Boiler blow down 0.00 3.00 3.00

Cooling towers blow down 0.00 14.00 14.00

Scrubbing system 1.00 0.00 1.00



DM Plant 3.00 0.00 3.00 salts for disposal to TSDF.

Domestic 0.00 4.00 4.00

Total 26.00 26.00 52.00

3.5.2Solid waste generation and Disposal

The types of Hazardous and non Hazardous wastes generated from them proposed

expansion, method of disposal is shown in below table3.5.

Table 3.5: Solid & Hazardous waste generation and Disposal

S. No Name of the

Hazardous Waste Quantity Kg/Day

Disposal Method

1 Organic waste 1422.00 Sent to Cement Industries

2 Spent Carbon 91.00 Sent to Cement Industries

3 Solvent Distillation Residue 321.00 Sent to Cement Industries

4 Inorganic Waste 132.00 Sent to TSDF

5 MEE Salts 2210.00 Sent to TSDF

6 ETP Sludge 150.00 Sent to TSDF

7 Used Oils 700Ltrs/Annum

TSPCB Authorized Agencies for Reprocessing/Recycling

8 Container liners 500 No’s/Month

After Detoxification sent to outside agencies

9 Used Lead Acid Batteries 4 No’s/ Annum

Send back to suppliers for buyback of New Batteries

Solid Waste Details

10 Coal ash from boiler 4000.00 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) “B” 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 SEAC/SEIAA along with the Environmental Impacts Assessment

Study Report for the proposed expansion 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) “B” of schedule –I of the notification.

4.0Site Analysis

4.1 Connectivity

Salubrious Laboratories Private Limited is located at Plot No: 118,119,127, &

128, IDA, Phase – II, Pashamylaram, Patancheru Mandal, Sangareddy District,

Telangana State

The nearest habitation from the site is Pashamylaram (Village) at a distance

of 0.9 Km (SSE).

The nearest railway station is Lingampally Railway Station at a distance of

15.0 KMs from the site (SE).

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

42.00 KMs

The Nearest road ways

National Highway No.65 – 2.0 Kms

4.2 Land Form, Land use and Land ownership.

Salubrious Laboratories Private Limited is an existing unit. There would be no

any change in Land Use, Land Cover or Topography of plot. Dense green belt is

already developed in the plant premises.

4.3 Existing Infrastructure.

Project is a located very nearer to National Highway (NH 65 - 2.0 Km) and the city is

located (i. e Hyderabad -16.0 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: 42.20o C

Minimum: 10.0 o C

Normal annual rainfall 811.9mm

4.6 Social Infrastructure available.

Well developed social infrastructure facilities are available at nearby Habitations.

5.0 Planning Brief

Proposed expansion activities will be started after getting statutory clearance form

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

Further 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

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 living in nearby town or

Hyderabad & no proposal for residential area for employees.

6.3 Green Belt:

Approximately 34 % of Green Belt (i.e1684.74 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.65, Southern railways.

6.5 Water management

Water requirement will be met through IDA Supply.

6.6 Sewerage System:

There will be no discharge of industrial effluent. The treated effluent will be reused.

Domestic waste water will be disposed off through soak pit system.

6.7 Industrial Waste Management:

The effluent from cooling tower and boiler will be sent to Neutralization Tank, after

neutralization effluent sent to RO System for water recovery and reuse.

7.0 Rehabilitation and Resettlement (R & R) Plan

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

project.

8.0 Project Schedule & Cost Estimates

Expansion activities will be started after getting statutory clearance form related

authorities. The project will be completed within two years.

This Expansion will provide benefits to the local people in terms of financial and

social welfare.

The project cost for proposed Expansion is 2.00 Crores will be used for constructing

additional building, Equipments, Machinery, MEE 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

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