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PRE - FEASIBILITY REPORT
For
EXPANSION OF
EXISTING MANUFACTURING UNIT
at
Plot No: 51 A, C, D, E, F, G & H, IDA Kondapally, Ibrahimpatnam Mandal, Krishna District, Andhra Pradesh.
by
ORCH LABORATORIES INDIA PVT. LTD
Plot No: 44, Palampally Villas, Opp. Karur Vysya Bank
Nizampet Road, Kukatpally 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 - 3
2.4 Demand-Supply Gap. 3
2.5 Employment Generation(Direct and Indirect) due to the project 3
3.0 Project description 4
3.1 Existing Products, Proposed Products and By- Products and Production Capacity
7-8
3.2 Raw materials required and Quantities 8
3.3 Manufacturing Process 9
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 Hazardous Waste, 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 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 12
6.0 Proposed infrastructure 12
6.1 Industrial Area 12
6.2 Residential Area 12
6.3 Green Belt: 13
6.4 Social Infrastructure 13
6.5 Water management 13
6.6 Sewerage System 13
6.7 Industrial Waste Management 13
S. No. Description Page no.
7.0 Rehabilitation and Resettlement (R&R) Plan 13
8.0 Project Schedule and Cost estimates 14
9.0 Analysis of project 14
LIST OF TABLES
Table No Description Page no. 2.1 Proposed Employment for expansion 4 3.1 List of Existing Products 7 3.2 Proposed Products and Quantities 7 - 8 3.3 By-Product and Quantities 8 3.4 Water Requirement Details 10 3.5 Wastewater generation and Treatment Method 10 3.6 Hazardous / Solid Waste Details generation and Disposal 10-11
LIST OF FIGURES
Figure No Description Page no.
1.1 Location Map 5 1.2 Google Earth Map Showing Orch Laboratories India Pvt. Ltd 6
LIST OF FLOW CHART
Flow Chart No Description Page no. 3.1 Generalized Flow Chart for Bulk Drug Manufacturing 9
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 1
1.0 EXECUTIVE SUMMARY
Orch Laboratories India Pvt. Ltd was incorporated as Private sector under
companies Act, 1956 (No.1 of 1956) situated at IDA Kondapally, Vijayawada in the
state of Andhra Pradesh, India during the year 2011-2012. The company is engaged
in the manufacturing of intermediates for supply to the domestic as well as overseas
market.
Orch Laboratories India Pvt. Ltd got Environmental Clearance for manufacturing of
Bulk Drug and Drug Intermediates vide EC letter no SEIAA/AP/SKM - /2011 - 1992
dated: 04.03.2015 and obtained certified compliance report on existing EC Vide F.
No. EP/12.1/2014-15/ SEIAA /126/AP/0726 dated: 11.05.2017
S. No Parameter Description
1 Project Location Plot No: 51 A, C, D, E, F, G & H, IDA Kondapally, Ibrahimpatnam Mandal, Krishna District, Andhra Pradesh.
2 Category of Project as per EIA Notification & Amendments
5(f) “B”
3 Project cost 480 lakhs (proposed expansion)
4 Plot area 5226.52 Sqm
5 Proposed Product Proposed Products List is mentioned in section 3.2
6 Resources
(i)Electricity Requirement
Source of electricity APSPDCL
D. G. Sets
Existing : 125 KVA Proposed : 500 KVA
(ii)Water consumption 100.89 KL/day
Source of water IDA
Waste water generation 38.76 KL/ day
Mode of disposal CETP , Kondapalli
(iii)Boiler Coal Fired Boilers Existing : 2.00 TPH Dropped Proposed : 4.0 TPH Proposed
(iv)Fuel Coal Requirement – 10.0 MT /Day for proposed 4.0 TPH Coal fired boiler
7 Solid waste generation Mentioned in Para 3.6 of report
8 Nearest Highway
National Highway No.30 (Vijayawada – Mylavaram Road)- 0.85 KMs (E)
9 Nearest Railway Station Kondapalli Railway Station – 2.85 KMs (SSW)
10 Nearest Air Port Vijayawada Airport- 28.60 KMs (ESE)
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 2
2.0 INTRODUCTION OF THE PROJECT
M/s. Orch Laboratories India Pvt. Ltd., has its Bulk drug manufacturing plant at
Plot No: 51 A, C, D, E, F, G & H, IDA Kondapally, Ibrahimpatnam Mandal, Krishna
District , Andhra Pradesh.
2.1 Project Proponent
Mr. P. Butchinayudamma Aged about 49 years, is a Commerce Graduate with over
25 years of experience in Commercial and Financial activities of large industrial
undertakings. Mr. Butchinayudamma is responsible for Commercial and Financial
activities of the company.
Mr. P. Madhusudhan Reddy Aged about 49 years, is a Civil Engineering Graduate,
with over 25 years of experience. He has rich experience in Industrial construction
particular Pharmaceutical industries. He has rich knowledge and expertise in
compliance with schedule M of Drugs and cosmetics Act, which became mandatory
since 2005.
Mrs. K. Usha Rani Aged about 45 years, is a Commerce Graduate with about 15
years of experience in the General Administration and HRD. She is currently on the
Board of M/s. Srimaan Industries Pvt Ltd., a company engaged in construction of
commercial and residential complex.
Mr. Y. Srinivas Rao Aged about 50 years, Mr. Y.Srinivas Rao is a with about
experience in the trading business. He is currently Director in Akhil Drugs Pvt Ltd. &
Eswar Bio Briquette India Pvt Ltd.
2.2 Brief description of nature of the project.
The proposed expansion is to manufacture Bulk Drugs and intermediates, which are
active ingredients with medicinal properties.
2.3 Need for the project and its importance to the country and or region
Active Pharmaceutical Ingredients (API) or bulk drugs are the principal ingredients
for finished pharmaceutical products. Intermediates are the compounds from which
active pharmaceutical ingredients are prepared. APIs cannot be administered
directly to the patient, and other inactive substances called excipients are added to
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 3
stabilise the mixture. This end product, which includes the API and the excipient, is
referred to as a formulation. Formulations are the pharmaceutical products
administered to patients and can take the form of tablets, capsules, syrups,
ointments, creams, injectables, etc.
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 domestic market accounts for 90% of the company’s total revenue and supplies
its products to Leading Pharma industries of domestic and international clients.
2.4 Demands-Supply Gap
There is a quite considerable gap between supply and demand for 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
The Estimated employment generation for this proposed expansion is about Indirect
- 20 and direct operation after expansion – 30 employees. 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.
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 4
Table 2.1: Details of Employment for Proposed expansion
Particulars Employees for
proposed Functional Area
Key managerial staff 4 Finance, Marketing, Production,
Quality control, R&D, Logistics etc.
Administration 3 Office work
Skilled and semi
skilled 23
Production Process, Maintenance,
stores, Safety.& Un skilled workers
Total 30
3.0 Project Description
M/s. Orch Laboratories India Pvt. Ltd proposes for expansion its manufacturing
capacity and products at Plot No: 51 A, C, D, E, F, G & H, IDA Kondapally,
Ibrahimpatnam Mandal, Krishna District, Andhra Pradesh. The Location map is
shown at Figure – 1.
The site coordinates are
Latitude: 16°39'0.53"N
Longitude: 80°33'13.82"E
The site well connected to road and rail way line. No archaeological, historical sites
located nearby. Therefore, the project site does not offer any negative impact on the
local area as because it is an expansion of existing unit in notified industrial area, but
rather has a positive impact on socio economic conditions of the habitants around it.
The plant is well connected both to National Highway No– 30 and Railway line at
Kondapalli Railway Station.
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
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FIGURE 1.1: LOCATION MAP
Plant Site
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
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FIGURE 1.2: GOOGLE EARTH MAP SHOWING ORCH LABORATORIES INDIA PVT LTD
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 7
3.1 Existing Products, Proposed Products and By- Products and Production Capacity
Orch Laboratories India Pvt. Ltd proposes for expansion to produce the below
mentioned shown in Table 3.1, Table 3.2. & Table 3.3
Table 3.1 List of Existing Products and Quantities
S. No. Products Name Quantity in
Kg/Day Quantity in Kg/Month
1 Omeprazole 18.33 550.00 2 Atorvastatin Calcium 23.33 700.00 3 Carvedilol 20.00 600.00 4 Ciprofloxacin 32.33 970.00 5 6-chloro-2-hexanone 32.33 970.00 6 Abacavir sulfate 30.00 900.00 7 Celecoxib 33.00 990.00 8 Clopidogrel bi sulphate 31.67 950.00 9 Di potassium hydrogen phosphate 20.00 600.00
10 2-[4-(4-Chloro-Butyryl)-phenyl ] -2-methyl -propionic acid methyl ester 33.67 1010.00
11 Lamivudine 500.00 15000.00 12 Montelukast Sodium 34.33 1030.00
13 (4-hydrazino-phenyl)-N-methyl-methanesulfonamide hydrochloride
33.33 1000.00
14 Tenofovir disoproxil fumarate 16.67 500.00 Total production at worst combination 666.66 20000.00
Note: The industry will manufacture any Six at a given point of time so that the
Maximum production capacity will not exceed 666.66 Kg/Day
Table 3.2: Proposed Products and Quantities
S. No.
Products Name Quantity
in Kg/Month
CAS Number
Therapeutic category
Group-A 1 6-Chloro-2-Hexanone 2500.00 10226-30-9 Drug Intermediate 2 Abacavir Sulphate 2500.00 136470-78-5 Antiretroviral agent
3 Celecoxib 2500.00 169590-42-5 Anti Inflammatory agent
4 Etoricoxib 2500.00 202409-33-4 Antirheumatics
5 CHE-1 (L-Menthyl glyoxilate)
30000.00 - Drug Intermediate
6
CHE-2 (5-Hydroxy-1,3-oxathiolane-2- carboxylicacid(1R,2S,5R) menthyl ester)
10000.00 - Drug Intermediate
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 8
S. No.
Products Name Quantity
in Kg/Month
CAS Number
Therapeutic category
7 Cyclo propyl thioacetic acid
2500.00 - Drug Intermediate
8 Ritonavir 2500.00 155213-67-5 Antiretroviral agent
Total 55000.00
Group-B
1
CHE-3 (5-(4-Amino-2-oxo-2H-Pyrimidinyl-[1,3]-oxathiolane -2-carboxylic acid-2-isopropyl-5-methyl cyclo hexyl ester)
30000.00 - Drug Intermediate
2
FCE(2R,5S)-5-(4-Amino-5-fluoro-2-oxo-2H- pyrimidin-1-yl)-[1,3]-oxathiolane-2- carboxylic acid,2S-Isoprpyl-5R-Methyl-1R- Cyclohexyl ester
30000.00 - Drug Intermediate
Total (Worst Combination of either one product or combination of two products with a production capacity of 30MT/Month)
30000.00
Grand Total (Group-A + Group-B)
85000.00
Note: Industry proposes to manufacture either final Drug or Drug intermediates with
above mentioned capacities.
Table 3.3 List of By-Products
S. No
Name of the Product
Name of the By-Product
Quantity
In Kg/Day
1
5-(4-Amino-2-oxo-2H-Pyrimidinyl-[1, 3] Oxathiolane-2-carboxylic acid-2-Isopropyl-5-methyl cyclo hexyl Ester (CHE-3)
TriethylamineHydrochloride 372.02
2 Cyclopropylthioaceticacid TriethylamineHydrochloride 185.83
3
2R, 5S)-5-(4-Amino-5-Fluoro-2-Oxo-2H-Pyrimidin -1-Yl)-[1, 3]-Oxathiolane-2-Carboxylic Acid, 2S-Isopropyl-5R-Methyl-1R-Cyclohexyl Ester. (FCE)
Triethylaminehydrochloride 367.42
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 9
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.
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 100.89 KLD. The water requirement will be met through IDA supply.
The detailed water requirement shown in below Table 3.4
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
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Table 3.4: WATER REQUIREMENT DETAILS
S. No Purpose Water Input in KLD
1 Process 16.87
2 Washings 5.00
3 Boiler make up 23.52
4 Cooling towers make up 45.50
5 Scrubbing system 2.00
6 Domestic 4.00
7 Gardening 4.00
Total 100.89
3.4.2 Power Requirement
Power requirement of proposed expansion project will be made available through
APSPDCL. Total power requirement after expansion will be 800 KVA.
In Addition to existing 125 KVA, 500 KVD DG set is being proposed to meet
emergency power requirement of the plant.
3.4.3 Fuel Requirement
Proposed to install 4.0 TPH coal fired Boiler for expansion by dropping existing
2.00 TPH Capacity coal fired Boiler and Total fuel requirement will be around 10.0
TPD coal after Expansion. The Coal will be procured form 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 38.76 KLD which is pre-treated in the plant
and sent to Kondapalli CETP for further treatment of the effluent.
Table 3.5: Wastewater generation and Treatment Method
S. No.
Purpose HTDS in KLD
LTDS in KLD
Effluent in KLD
Disposal Method
1 Process 16.23 3.61 19.85 After preliminary treatment of Effluent (HTDS & LTDS) in the plant, sent to CETP Kondapally IDA.
2 Washings 5.00 0.00 5.00 3 Boiler blow down 0.00 3.36 3.36 4 Cooling towers blow down 0.00 5.05 5.05 5 Scrubbing system 2.00 0.00 2.00 6 Domestic 0.00 3.50 3.50
Total 23.23 15.52 38.76
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
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3.5.2 Hazardous Waste, Solid waste generation and Disposal
The types of Solid and Hazardous wastes generated from the project, method of
disposal is shown in below table 3.6.
Table 3.6: Solid & Hazardous Waste generation and Disposal
S. No. Description Quantity In Kg/Day
Method Of Disposal
1 Organic Solid Waste 312 Sent to Cement Industries 2 Inorganic Solid Waste 1313 Sent to TSDF 3 Spent Carbon 59 Sent to Cement Industries 4 ETP Sludge 50 Sent to TSDF 5 Fly ash from Boiler 3500 Sent to Brick Manufacturers
6 Solvent Distillation Residue
574 Sent to Cement Industries
7 Waste Oils & Grease 300
Ltrs/Annum SPPCB Authorized Agencies for Reprocessing/Recycling
8 Container liners 500
No’s/Month After Detoxification sent to outside agencies.
9 Used Lead Acid Batteries 2 No’s/Annum Send back to suppliers for buyback of New Batteries
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 MoEF 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) “B” of schedule –I of the notification.
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 12
4.0Site Analysis
4.1 Connectivity
Orch Laboratories India Pvt. Ltd is having well developed road and Rail way line
Connections for transportation of raw materials and finished products.
• The nearest habitation from the site is Kattubadipalem at a distance of 0.85 Km -
NE.
• The nearest railway station is Kondapalli Railway station at a distance of 2.85
KMs – SSW from the site.
• The nearest airport is Vijayawada Airport at a distance of 28.60 KMs - SE at
Gannavaram.
• The Nearest road ways National Highway No.30 (Vijayawada - Mylavaram Road)
– 0.85 KMs - E
4.2 Land Form, Land use and Land ownership
The proposed expansion is in existing area only and located in Notified Industrial
Area. There would be no any change in Land Use, Land Cover or Topography of
plot.
4.3 Existing Infrastructure
Proposed project is an expansion within existing facility and the basic infrastructure
is already there.
4.4 Soil classification
The district is mainly covered by three types of Red loamy soils, Sandy soils, Black
soils.
4.5 Climatic data from secondary sources
Annual Temperature Maximum : 38o C
Minimum : 20o C
Normal annual rainfall 1011 mm
4.6 Social Infrastructure available
Well developed social infrastructure facilities are available at nearby Habitations.
5.0 Planning Brief
Proposed plant expansion activities will be started after getting statutory clearance
form related authorities. The project will be completed within two years.
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
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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
Basic infrastructure developed already and the required plant and machineries will
be installed after getting statutory clearance.
6.2 Residential Area
No residential area is involved in the proposed project. The employs are
accommodated in nearby Residential areas
6.3 Green Belt:
Area of 313.59 SQM (6 %) green area developed within the plant site, In addition to
the above Orch Laboratories Pvt Ltd got permission from Kondapalli Notified Gram
Panchayath Industrial Area Service Society to develop Green belt in an area of 4487
Sq.mts in the industrial Development Park.
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 plant site is very well connected by road through National
Highway No. 30, Kondapalli railway station.
6.5 Water management
Water requirement will be fulfilled through Industrial Development Authority.
Pre-Feasibility Report Orch Laboratories India Pvt. Ltd
Prepared By Rightsource Industrial Solutions Pvt. Ltd Page 14
6.6 Effluent Treatment System
An industrial effluent of 38.76 KL/ day is generated and will be sent to Kondapalli
CETP. Domestic waste water will be sent to septic tank followed by soak pit .
6.7 Industrial Waste Management:
Due to proposed expansion, the effluent from cooling and Plant/Equipment washing
will be sent to CETP Kondapalli.
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 Expansion activities will be started after getting statutory clearance form
related authorities. The cost of the proposed expansion will be approximately 4.80
Crores the project will be completed within two years.
9.0 Analysis of proposal (Final Recommendations)
Proposed expansion activity will provide benefits to the local people in terms of
financial and social welfare.
� 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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