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PRE - FEASIBILITY REPORT
For
PROPOSED TO ESTABLISH BULK DRUGS AND DRUG
INTERMEDIATES MANUFACTURING UNIT
at
Sy No. 290 & Parts, Dondapadu Village,
Chinthalapalem Mandal , Suryapet District,
Telangana State
By
SRR LABORATORIES
Plot No.l05, Lakshmi Nivas, Czech colony, Opp: FCI Godown,
Sanath Nagar, Hyderabad
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 - 4
2.5 Employment Generation(Direct and Indirect) due to the project
4
3.0 Project description 4
3.1 Product and Production Capacity 7
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 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.
11
4.0 Site Analysis 12
4.1 Connectivity 12
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 13
6.0 Proposed infrastructure 13
6.1 Industrial Area 13
6.2 Residential Area 13
6.3 Green Belt: 13
6.4 Social Infrastructure 13
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
S. No. Description Page no.
8.0 Project Schedule and Cost estimates 14
9.0 Analysis of project 14
LIST OF TABLES
Table No Description Page no.
2.1 Details of Proposed Employment for Proposed Project. 4
3.1 Proposed Products and Quantities 7 - 8
3.2 Water Requirement Details 9
3.3 Wastewater generation and Treatment Method 10
3.4 Solid and hazardous waste generation and Disposal 11
LIST OF FIGURES
Figure No Description Page no.
1.1 Location Map 5
1.2 Google Earth Map Showing SRR Laboratories 6
LIST OF FLOW CHART
Flow Chart No
Description Page no.
3.1 Generalized Flow Chart for Bulk Drug Manufacturing 9
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1.0 EXECUTIVE SUMMARY
SRR Laboratories is proposing to establish Bulk drug and intermediates
manufacturing unit at Dondapadu Village.
S. No Parameter Description
1 Project Location
SRR Laboratories
Sy No. 290 & Parts, Dondapadu Village
Chinthalapalem Mandal, Suryapet District,
Telangana State
2 Category of Project as per EIA Notification & Amendments
5(f) “A”
3 Project cost 15 Crores
4 Plot area 8.00 Acres (32368 Sq.m)
5 Proposed Products Proposed Products List is mentioned in section
3.1
6 Resources
7 (I)Electricity
Requirement 2100 KVA
Source of electricity Telangana State Power Distribution Company
Limited (TSPDCL)
D. G. Sets 750 KVA
8 (II)Water consumption 194 KLD
Source of water Ground Water through Bore Well
Waste water generation 82.8 KLD
9 (III)Boiler 3.0 TPH Coal fired Boiler & 4.0 TPH Coal fired Boiler
10 (IV)Fuel Coal Requirement – 28 MT /Day for proposed boilers
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 9 – 16 kms (ENE) (Hyderabad – Vijayawada Road ) Dondapadu –Muktyala Road – 410 mtrs (ENE)
14 Nearest Railway Station Motumari Railway Station – 33.00 kms (ENE)
15 Nearest Airport Vijayawada Airport – 87.0 kms (ESE)
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2.0 INTRODUCTION OF THE PROJECT
The objective of this pre- feasibility study is to provide information for the proposed
Bulk Drugs and Drug Intermediates Manufacturing unit of SRR Laboratories located
at Sy No. 290 & Parts, Dondapadu Village, Chinthalapalem Mandal, Suryapet
District, Telangana State.
2.1 Project Proponents
A. Koti Reddy Partner, studied B.Sc and having 30 years experience in Chemical Industry.
R. Venkata Manikanta, Partner, studied B.Tech Mechanical Engineering and having experience in Maintenance Department.
Dr. A. Kavitha Partner, studied MBBS and having 10 years of experience.
K. Rameshbabu Partner, studied B.Sc and having 35 years experience in various Industries.
R. Raghavendra Partner, studied B.Tech Electrical Engineering and having 9 years experience in Software Company.
2.2 Brief description of nature of the project.
SRR Laboratories is proposing to manufacture Bulk Drugs and Drug Intermediates
manufacturing unit located at Sy No. 290 & Parts, Dondapadu Village,
Chinthalapalem Mandal, Suryapet District, Telangana State .
2.3 Need for the project and its importance to the country and or region
SRR Laboratories is a Greenfield project intended to start a manufacturing unit of
Bulk Drugs and Drug Intermediates at Sy No. 290 & Parts, Dondapadu Village,
Chinthalapalem Mandal, Suryapet 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
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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 16 per cent per annum
between 2017 and 2020, will outperform the global pharma industry, which is set to
grow at an annual rate of 5 per cent between the same periods. 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 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 2016-17, 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 2016-17 from 109 in FY 2015-
16. 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.
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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 90. 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.
Table 2.1: Details of Proposed Employment for Project
Sl. No. Manpower Total No.
1 Un-Skilled 60
2 Skilled 20
3 Managerial &Supervisory 10
3.0 Project Description
SRR Laboratories is proposing to Manufacture Bulk Drugs and Drug Intermediates
with production capacity of 129 TPM
The Location map is shown at Figure - 3.1 and Google earth map showing SRR
Laboratories plant is shown at Figure - 3.2.
The site central coordinates are
Latitude: 16°49'31.74"N
Longitude: 80° 2'56.67"E
The project site does not offer any negative impact on the local area, but rather has
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a positive impact on socio economic conditions of the habitants around it because of
employment to locals.
The SRR Laboratories is 16.0 kms away from National Highway No - 9 and 33 kms
from Motumari Railway Station.
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FIGURE 1.1: LOCATION MAP
SRR Laboratories
Sy No. 290 & Parts, Dondapadu Village
Chinthalapalem Mandal, Suryapet
District, Telangana State
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FIGURE 1.2: GOOGLE EARTH MAP SHOWING SRR LABORATORIES
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3.1 Product and Production Capacity
SRR Laboratories to produce below mention products with Manufacturing Capacity
of 129 TPM and the list of products are shown in Table 3.1.
Table 3.1: Proposed Product and Quantity
S No
Product name
Quantity
in
Tonne
/Month
CAS no Therapeutic
category
1 Carvedilol 10 72956-09-3 Antihypertensive
2 Cyano diol hydrochloride 5 717133-25-0 Drug intermediate
3 Dabigatran 5 211915-06-9 Anticoagulant
4 Fexofenadine hydrochloride 10 153439-40-8 Anti allergic
5 Fluconazole 10 88386-73-4 Antifungal
6 Folic acid 20 59-50-3 Hematinic (Vit-B)
7 Itraconazole 10 84625-61-6 Antifungal
8 Ketoconazole 10 65277-42-1 Antifungal
9 Levocetirizine dihydrochloride 5 130018-77-8 Antihistamine
10 Linagliptin 5 668270-12-0 Anti diabetic
11 Meropenem 5 119478-56-7 Antibacterial
12 Montelukast sodium 2 151767-02-1 Anti asthmatic
13 Rosuvastatin calcium 2 147098-20-2 Anti lipemic agent
14 Sitagliptin Phosphate Monohydrate 5 654671-77-9 Anti Diabetic
15 Teneligliptin 5 760937-92-6 Anti Diabetic
16 Tri butyl tin chloride 5 1461-22-9 Organic Reagent
17 Valacyclovir Hydrochloride Monohydrate
10 124832-27-5 Anti Viral
18 Vildagliptin 5 274901-16-5 Anti diabetic
Total 129
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.
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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 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 194 KLD. The water requirement will be met through bore well. The
detailed water requirement shown in below Table 3.2
Table 3.2: WATER REQUIREMENT DETAILS
S.No Purpose Water input KLD
1 Process 52
2 Washings 5
3 Boiler make up 42
4 Cooling towers make up 79
5 Scrubbing system 7
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S.No Purpose Water input KLD
6 Domestic 4
7 Gardening 5
Total 194
3.4.2 Power Requirement
Power requirement of proposed project will be made available through Telangana
State Power Distribution Company Limited (TSPDCL). The total power requirement
for the unit is 2100 KVA respectively
D.G. sets of 750 KVA is proposed to install to meet the emergency power
requirement of the plant.
3.4.3 Fuel Requirement
The company proposed to install 3.0 TPH Coal fired Boiler & 4.0 TPH Coal fired
Boiler and total Coal requirement will be around 28 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 54.50 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 HTDS KLD
LTDS KLD
Total Effluent in
KLD
Disposal Method
1 Process 30 25 55
ZLD System 2 Washings 0 5 5
3 Boiler Blow down 0 6 6
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S. No
Purpose HTDS KLD
LTDS KLD
Total Effluent in
KLD
Disposal Method
4 Cooling towers blow down
0 11 11
5 Scrubbing system 2 0 2
6 Domestic 0 3.8 3.8
Total 32 50.8 82.8
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.
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 1657
Sent to Cement Industries
2 Spent Carbon 145
3 Solvent distillation residue
1091
4 Organic Evaporate liquid from MEE stripper
640
5 Mixed Solvents 3945 Sent to paint industries
6 ETP Sludge 1000 Sent to TSDF
7 Inorganic solid waste 359
8 MEE Salts 3151
9 Used Oils
500 Ltrs/Annum
SPCB Authorized Agencies for Reprocessing /Recycling
10 Detoxified Containers
500 No’s/Month
After Detoxification sent back to suppliers/sent to outside Parties
11 Used Lead Acid Batteries 2 No’s/Year
Send back to suppliers for buyback of New Batteries
Solid Waste Details
12 Fly ash from boiler
7700 Kg/Day
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
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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
SRR Laboratories located at Sy No. 290 & Parts, Dondapadu Village
Chinthalapalem Mandal, Suryapet District, Telangana State
The nearest habitation from the site is Dondapadu Village at a distance of 1.30
kms (W).
The nearest railway station is Motumuri Railway Station at a distance of 33 kms
(ENE) from the site.
The nearest airport is Vijayawada Airport at a distance of 87 kms
The Nearest National Highway is NH 9 – 16 kms
4.2 Land form, Land use and Land ownership.
The land use of the 8.00 Acres (32368 Sq.m) will be permanently changed to
industrial purpose.
4.3 Existing Infrastructure.
The Proposed project is a Greenfield project which is 16 kms away from NH-9 and
Mandal head quarter Chinthalapalem is 10 kms (SW) from the project site.
4.4 Soil classification
The predominant soils in the district are Red soils, Black soils, Alkaline soils and
Alluvium.
4.5 Climatic data from secondary sources.
Temperature Maximum: 46.5 oC
Minimum: 12 oC
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Normal annual rainfall : 750.7 mm
(Source: IMD Climatological Normals 1981-2010)
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
6.1 Industrial Area
The infrastructure and other facilities are already well developed in Chinthalapalem
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:
Approximately 34.27 % of Green Belt 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 in Chinthalapalem which is 10 kms SW of proposed project site.
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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. 9 and nearest railway station is Motumari.
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 Proposal, 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 15 Crores will be used for constructing
additional building, Equipments & misc.
TABLE 8.1: PROJECT COST
S. No Particulars Rs. Crores
1 Land 0.65
2 Civil Works 4.0
3 Plant & Machinery 9.0
4 Miscellaneous 1.35
Total 15
9.0 Analysis of proposal (Final Recommendations)
Local people will get direct financial benefit by way of employment.
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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.