View
22
Download
8
Category
Preview:
Citation preview
PRE-FEASIBILITY REPORT
(Proposed Expansion of Active Pharmaceutical Ingredients (APIs) to APIs & API Intermediates with R&D
products manufacturing unit)
Of M/s. Aurore Life Sciences Private Limited
Sry. Plot nos. 180/2, 180/3, IDA Khazipally, Khazipally (Village), Jinnaram (Mandal),
Sangareddy District, Telangana
Submitted to Ministry of Environment, Forests and Climate Change,
New Delhi
March 2019
i
Contents
S. No.
Description Page No.
1.0 Executive Summary 1
1.1 Salient Features of the Project 2
2.0 Introduction 3
2.1 Identification of the Project and project proponent 3
2.2 Brief description of Nature of the Project 5
2.3 Need for the Project and its importance to the country
and or region 5
2.4 Demand and Supply Gap 5
2.5 Imports Vs. Indigenous production, Export Possibility,
Domestic/Export Markets 6
2.6 Employment Generation 6
3.0 Project Description 6
3.1 Type of the project including interlinked and interdependent projects, if any
6
3.2 Location 6
3.3 Alternate sites 7
3.4 Size or magnitude of operation 7
3.5 Project description 10
3.6 Raw materials 11
3.7 Resources optimization / recycling and reuse 11
3.8 Availability of water and Energy 12
3.9 Quantity of Wastes Generation and their Management /
Disposal 12
3.9.1 Water requirement and Wastewater generation and
their Management / Disposal 12
3.9.2 Hazardous / Solid Waste Generation, Handling and
their Disposal 14
3.10 Schematic flow sheet for EIA procedure 16
4.0 Site Analysis 16
4.1 Connectivity 16
4.2 Land Form, Land use and Land ownership 16
4.3 Topography 16
4.4 Existing Land use pattern 16
4.5 Existing & Proposed Infrastructure 17
4.6 Soil Classification 17
ii
S. No.
Description Page No.
4.7 Climate data from Secondary sources 17
4.8 Social Infrastructure 17
5.0 Planning 18
5.1 Planning Concept 18
5.2 Population Projection 18
5.3 Land use planning 18
5.4 Assessment of Infrastructure Demand 18
5.5 Amenities/Facilities 18
6.0 Proposed Infrastructure 19
6.1 Industrial Area 19
6.2 Residential Area 19
6.3 Green Belt 19
6.4 Social Infrastructure 19
6.5 Connectivity 19
6.6 Drinking Water management 19
6.7 Sewerage System 19
6.8 Industrial Waste Management 19
6.8.1 Process Emissions Management 20
6.8.2 Solvent Recovery System 20
6.8.2.1 Fugitive emissions 20
6.8.3 Emissions–Utilities 21
6.8.4 Noise Environment 22
6.9 Hazardous / Solid Waste Management 22
6.10 Power Requirement & Supply / Source 22
7.0 Rehabilitation and Resettlement (R&R) Plan 22
8.0 Project Schedule & Cost Estimates 23
8.1 Time Schedule for the project construction 23
8.2 Estimated project cost 23
9.0 Analysis of proposal (Final Recommendations) 23
9.1 Budgetary allocation for Pollution Control Measures 23
iii
List of Tables
Table Title Page
1 Coordinates of all Corners of the Project Site 7
2 (a) Products and their Capacities (as per EC 2005) 8
2 (b) Products and their Capacities (as per CFO 2018) 8
3 Proposed Products, their Capacity and Therapeutic Use 8
4 Existing Water Requirement, Wastewater Generation and its Treatment
12
5 Proposed Water Requirement and Wastewater Generation with Segregation
13
6 Effluent Treatment Flow as per segregation 14
7 Hazardous Waste Generation from the Existing (CFO) Products
15
8 Hazardous / Solid Waste Generation from the Proposed Products
15
9 Environmental Components Shortest distance from Project Periphery
16
10 Land Break-up details 18
11 Process Emissions from Proposed Products with treatment method
20
12 Stack Emission Details 21
13 Budgetary allocation for pollution Control Measures 24
iv
LIST of Annexures
Annexure
No.
Title
I CFE from APPCB vide order No. 53/PCB/C.Estt/RO/SRC/AEE-
VIII/96-3236 dated August 1996
II CFE - CPM vide order no. 103/PCB/ZO/RCP/CFE/2003-282 dated
31-05-2003
III Post-Facto Environmental Clearance from MoEF vide order no. J-
11011/166/2005-IA-II (I) dated 10-11-2005
IV Public Hearing conducted by APPCB on 12-4-2005
V Sale deed from M/s. Konar Organics Limited to M/s. Eshwar
Pharmaceuticals Private Limited
VI
Latest combined CFO vide order no.
TSPCB/RCP/CFO&HWM/HO/2018-190 dated 21-04-2018 and was
valid till 31-10-2018
VII
Sale deed from M/s. Eshwar Pharmaceuticals Private Limited to M/s.
Aurore Life Sciences Private Limited vide sale deed No. 4992 / 2019
dated 05-02-2019
VIII Extension of Temporary Revocation of Closure Orders up to 31-05-
2019
IX MoEF&CC acknowledgement for submission of Transfer of EC
X CA Certificate
XI G.O.Ms.No.80 dated 27-10-2015 for IDA Khazipally
XII General location of the Proposed Project
XIII Specific Location of the Proposed Project
XIV Google map showing the coordinates
XV Plant Layout
XVI Typical process description & Flowchart for proposed products
XVII Raw Materials of Proposed products
XVIII Hazardous Raw Materials
XIX ETP Flow Scheme
XX Schematic Flow Sheet for EIA Procedure
XXI Topomap of 10km radius
Aurore Life Sciences Private Limited Pre-Feasibility Report
1
Pre-Feasibility Report for Expansion of Active Pharmaceutical ingredients (APIs) to
APIs & API Intermediates Manufacturing Unit and R&D Facility
1.0 Executive Summary
M/s. Aurore Life Sciences Private Limited (Originally M/s. Konar Organics Limited) proposes
to expand its Active Pharmaceutical Ingredients (APIs) to APIs and API Intermediates manufacturing
unit with R&D facility in the existing area of 3.23 Ha (32399 sq m). The Unit is located in Sy. Plot No.
180/2, 180/3, Notified Industrial Area, IDA Khazipally, Khazipally (V), Jinnaram (M), Sangareddy
District, Telangana State.
Background:
Industry was established in the name of Konar Organics Limited in the year 1996 and obtained
Consent for Establishment (CFE) from APPCB vide order No. 53/PCB/C.Estt/RO/SRC/AEE-VIII/96-
3236 dated August 1996 (Annexure-I). Later, industry was granted CFE Change of Product mix
(CPM) without any additional investment and without increase in pollution loads vide order no.
103/PCB/ZO/RCP/CFE/2003-282 dated 31-05-2003 (Annexure-II).
In 2005, industry was granted Post-Facto Environmental Clearance from MoEF vide order no. J-
11011/166/2005-IA-II (I) dated 10-11-2005 (Annexure-III). Public Hearing for the project was
conducted by APPCB on 12-4-2005 (PH minutes are enclosed as Annexure-IV).
M/s. Konar Organics Limited sold its assets to M/s. Eshwar Pharmaceuticals Private Limited dated
22-04-2009 (sale deed enclosed as Annexure-V). Industry regularly renewed the Consent for
Operation (CFO). Consent in the name of M/s. Eshwar Pharmaceuticals Private Limited and Latest
CFO is issued by TSPCB vide order no. TSPCB/RCP/CFO&HWM/HO/2018-190 dated 21-04-2018
and was valid till 31-10-2018 (Annexure-VI).
M/s. Eshwar Pharmaceuticals Private Limited sold its assets to M/s. Aurore Life Sciences Private
Limited vide sale deed No. 4992 / 2019 dated 05-02-2019 (sale deed enclosed as Annexure-VII).
Presently the unit has been issued Extension of Temporary Revocation of Closure Orders up to 31-
05-2019 (Annexure-VIII). Currently Industry is sick and not in operation.
An application is submitted to MoEF&CC through Online on 19-03-2019 for transfer of EC dated 10-
11-2005 from Konar Organics Limited to Aurore Life Sciences Private Limited. MoEF&CC
acknowledgement generated on submission is enclosed as Annexure-IX.
The proposed expansion project is to grant Environmental Clearance by the Ministry of Environment,
Forests and Climate Change (MoEF&CC) to manufacture APIs and API Intermediates with R&D
facility with a production capacity of 2163.6 TPA (including consent permitted 96 TPA capacity) from
any 13 campaign products out of 68 products with R&D products. The total investment of the after
expansion will be Rs. 44.31 Crores (incl. existing Rs. 17 Crores and additional investment Rs. 27.31
Crores) (Annexure-X).
Aurore Life Sciences Private Limited Pre-Feasibility Report
2
The proposed project falls under the Category ‘B’ project or activity 5(f) according to the EIA
Notification 2006 as the project location is in Notified Industrial Area, Khazipally (Annexure-XI). As
the SEIAA, Telangana is not constituted, Form 1 application is being submitted to Ministry of
Environment, Forest and Climate Change, Govt. of India, New Delhi.
1.1 Salient Features of the Project
• Proposed expansion is in the existing plant premises 3.23 Ha and is located in the Notified
Industrial Area, IDA Khazipally.
• Total Greenbelt area is 1.07 Ha (33 %) of 3.23 Ha.
• This proposed project site is located at an aerial distance of:
i. State Highway (SH) no.6 – 2.8 Km (NE)
ii. Hyderabad ORR – 1.5 Km (SE).
iii. Nearest habitation Kishtaipalli is 1.7 km (WNW)
iv. Kazipally village – 2.7 km (WSW)
v. Jinnaram – 6.5 km (NW)
vi. Gowdavally Railway Station – 10.2 Km (ENE)
vii. Rajiv Gandhi International Airport - 38 km (S)
• Total cost after expansion will be Rs. 44.31 Crores (existing investment of Rs. 17 Crores &
additional investment Rs. 27.31 crores). Total capital cost allocated towards environmental
pollution control measures is Rs. 18.35 Crores. Recurring cost after expansion will be about Rs.
25 Crores per annum.
• Proposed power requirement of the plant is 5000 KVA (CMD) including existing. Power will be
met from Telangana State Power Distribution Corporation Limited.
• Total water requirement will be about 723 KLD of which fresh water requirement will be
383 KLD. Treated effluent of 340 KLD from ETP will be reused in cooling tower makeup. Fresh
water will be met from private tankers supply.
• Diesel of about 1260 lit/hr will be used in the proposed DG sets of 4x500 KVA, 2x1010 KVA &
1500 KVA and proposed 3 nos. of 4 lakhs Kcal/hr & 2 nos. of 2 lakh Kcal/hr Diesel/ Furnace oil
fired Thermic Fluid Heaters (TFH). Existing 2 x 125 KVA DG sets will be removed after
expansion. DG sets are used as standby during power failure.
• About 80 TPD of coal will be used in the proposed 3 TPH, 7 TPH and 10 TPH coal fired boilers.
Another proposed 10 TPH coal fired boiler will be standby and existing 0.5 TPH coal fired boiler
will be dismantled.
• About 990 employees including existing 140 employees will be benefitted due to the proposed
project. Out of which direct 580 and indirect 410 employees.
Aurore Life Sciences Private Limited Pre-Feasibility Report
3
• Industry will provide dual scrubbers based on the characteristics of process emissions. Multi-
cyclone separator & bag filter will be provided to boilers to reduce the particulate emissions into
atmosphere.
• Wastewater generated from the plant will be about 388.5 KLD from process, washing, utilities,
fresh water RO rejects, scrubber, Q.C, R&D and domestic wastewater.
• Effluent will be pumped to the above ground level RCC lined tanks for storage and
neutralization then sent to upgraded ETP-ZLD of 400 KLD capacity within the premises.
• Domestic wastewater will be sent to ETP - ZLD.
• Hazardous waste will be segregated and collected in the HDPE drums / bags as appropriate
and will be stored in the covered and raised platform with provision of leachate collection
system.
• Solid waste like boiler ash will be sent to cement brick manufacturers.
• Industry will provide the solvent recovery system for recovery of solvents from the process.
Primary and secondary condensers will continue to be provided with cooling water and chilled
brine circulation for effective recovery of solvents thereby reducing the solvent emissions.
• Compressors, Boilers and DG sets will be the major noise generating units in the plant. Out of
these, the generator will be functioning at the time of power failure only. Built-in acoustic
enclosures provided for DG sets unit to minimize the noise levels. However, the workers in this
area will be provided with ear muffs.
Industry is submitting Form-1,Pre-feasibility report (PFR) along with draft Terms of Reference
(ToR) in the process of seeking ToR for preparation of EIA, in line with issue of Environmental
Clearance. Hence, pre-feasibility report highlighting the expansion project and the various operations
including waste generation and mitigation measures are prepared & submitted to the Ministry of
Environment, Forest and Climate Change (MoEF&CC) for granting ToR.
2.0 Introduction
2.1 Identification of the Project and Project Proponent
The present unit was established in 1996 in the name of Konar Organics Limited and in 2005,
EC was granted under Post-Facto Environmental Clearance from MoEF vide order no. J-
11011/166/2005-IA-II (I) dated 10-11-2005 (Annexure-III). Public Hearing for the project was
conducted by APPCB on 12-4-2005. Industry proposes for expansion of APIs to APIs and API
Intermediates manufacturing unit with R&D facility in the existing area of 3.23 Ha (37373.79 sq m)
located at Sy. Plot No. 180/2, 180/3, Notified Industrial Area, IDA Khazipally, Khazipally (V), Jinnaram
(M), Sangareddy District, Telangana State.
Aurore Life Sciences Private Limited Pre-Feasibility Report
4
• CFE was issued by APPCB vide order No. 53/PCB/C.Estt/RO/SRC/AEE-VIII/96-3236 dated
August1996 and CFE-CPM without any additional investment and without increase in pollution
loads vide order no. 103/PCB/ZO/RCP/CFE/2003-282 dated 31-05-2003.
• M/s. Konar Organics Limited sold its assets to M/s. Eshwar Pharmaceuticals Private Limited
dated 22-04-2009.
• Latest CFO is issued by TSPCB vide order no. TSPCB/RCP/CFO&HWM/HO/2018-190 dated
21-04-2018 and was valid till 31-10-2018 (Annexure-VI). Currently Industry is sick and not in
operation.
• M/s. Eshwar Pharmaceuticals Private Limited sold its assets to M/s. Aurore Life Sciences
Private Limited vide sale deed No. 4992 / 2019 dated 05-02-2019.
• M/s. Aurore Life Sciences Private Limited submitted letter to TSPCB on dated 07-03-2019
intimating the revamping of facilities in dilapidated condition to comply the consent and EC
conditions. TSPCB acknowledged the letter on dated 12 -03-2019 (Annexure-IX).
• An application is submitted to MoEF&CC through Online on 19-03-2019 for transfer of EC
dated 10-11-2005 from Konar Organics Limited to Aurore Life Sciences Private Limited.
MoEF&CC acknowledgement generated on submission is enclosed as Annexure-X.
The proposed expansion project is located in IDA Khazipally and falls under the Category ‘B’,
project or activity under 5(f) according to the EIA notification 2006 and will be appraised by SEIAA
Telangana. However, as SEIAA, Telangana is not constituted, Form 1 application is being submitted
to Ministry of Environment, Forest and Climate Change, Govt. of India, New Delhi.
Project Proponent
Aurore Life Sciences is an API manufacturer with a diverse portfolio of capabilities in delivering
efficiencies to generic players globally. Founded in 2017 by a team with vast experience across the
pharmaceutical value chain, the company is on a mission to become the most preferred partner for
pharmaceuticals
Rajender Rao Juvvadi, Managing Director is a Mechanical Engineer from Osmania University, Post
Graduate from Indian Institute of Foreign Trade (IIFT) New Delhi 1992. Commenced Professional
career with Reliance Industries Ltd handling exports of Liquids. From 1996-1998 Nicholas Piramal
Ltd: Joined as the first person on behalf of Nicholas Piramal into the acquisition of an API unit and
bestowed with multi-functional responsibilities that laid the foundation for a learning and
understanding of all facets of business. Initiated Pharma trading business in the year 1998 and later
graduated into manufacturing from contracted facilities until 2003. Started Ra Chem Pharma, when
the first manufacturing facility was acquired and the journey of Ra Chem Pharma Ltd commenced.
The three divisions put together have around 1000 employees. The product identification and
selection, developing niche products under API and FDF and bringing in vertical integration into
certain products have been the key strengths that Raj has brought to fore in driving Ra Chem into the
Aurore Life Sciences Private Limited Pre-Feasibility Report
5
entity that it has evolved into. Started with the new entity Aurore Life Sciences Pvt Ltd with an
aggressive growth plan.
P.R. Kannan –Director, Tenshi Group, Mr. P R Kannan, is the Executive Director at Tenshi Life
Sciences Private Limited, India. In addition to managing the operations of Tenshi Life Sciences, Mr.
Kannan, overseas a number of investments within Tenshi and Agnus Group (Promoter Group) and
serves as a director on the board of several companies under these groups in India and abroad. Prior
to joining Tenshi, Mr. Kannan was a Joint Chief Financial Officer at the Himalaya Drug Company. He
then moved on to the role of Chief Financial officer at SeQuent Scientific Limited, a Listed Company.
Prior to that he also worked in the role of Consultant - SAP -FICO at Tata Consultancy Limited and
Deputy Manager Finance at Delphi Automotive Systems Pvt Ltd. Mr. Kannan is a member of Institute
of Chartered Accountant of India (ICAI), and holds a degree from The American College, Madurai.
2.2 Brief Description of the Nature of the Project
Proposed project is to manufacture APIs and API Intermediates. The manufacturing process
of API and API Intermediates consists of chemical synthesis and multiple stage of processing
extending to maximum of 10 stages involving different types of chemical reactions
2.3 Need for the Project and its Importance to the Country and or Region
According to RNCOS’ (Business Consultancy Services) analysis, the Indian API domestic
consumption market will grow at a CAGR of around 10% from FY 2016 to FY 2022. The Indian
Government made the announcement of 2015 being the ‘Year of APIs.’ This has helped to increase
awareness among people. The products manufactured are used in API formulation industry and the
therapeutic category of the products Anticonvulsant, Antifungal, etc., which are applicable for human
consumption around the world after formulation activity.
Source: Indian API market outlook 2022 by Assocham India.
2.4 Demand and Supply Gap
The demand for APIs and API intermediates is a derived demand. It gets derived from the
demand for various medicinal formulations (final administrable drugs) for the formulation industry. The
APIs being manufactured by basic drug manufacturers are exported as such or used by domestic
formulators in their production processes. The formulation firms further produce final medicines and
export these as well as sell these in the domestic market.
There is a wide gap in the demand and availability of low cost and quality medicines in India
and the world over. Generic medicines and off patent drugs have significant potential to increase
access to cheap and effective medicines to poor people and in general to bridge the demand supply
gap. Indian basic drug manufacturers are playing a significant role in increasing access to affordable
off patent drugs.
Aurore Life Sciences Private Limited Pre-Feasibility Report
6
2.5 Imports vs. Indigenous production, Export Possibility, Domestic/Export Markets
Presently China is dominating in the API (bulk drug) market the world over. India is importing
all major intermediate chemicals required for manufacturing life-saving drugs. Most of imports are
from Chinese companies and thus India losing valuable foreign reserves to China. India imported
APIs worth Rs. 13,853 Cr from China in 2015-16, or 65.29 % of the total API Imports of Rs. 21,216
Cr. This potential can be utilized to the fullest extent possible by increasing the production capacity of
the existing industries or by establishing new industries to meet the market demand of the products.
As it is a well-known fact that Indian products are well accepted abroad for its quality and marketing
flexibility. The exports from the Indian companies to other foreign countries such as Europe, America,
Japan and other African countries has been increasing every year. The formulations market has
shown a tremendous increase in the exports every year. However, the basic raw material for
formulations is APIs. Hence, this sector has a tremendous potential of indigenous market as well as
export market and the promotion of such projects will not only help by way of generation of
employment but also by generation of foreign currency reserves for the country.
2.6 Employment Generation
The expansion facility will generate direct and indirect employment. About 990 employees
including existing 140 employees will be benefitted due to the proposed project, in that 580 nos.
direct employment and 410 nos. of indirect employment.
3.0 Project Description
3.1 Type of the project including interlinked and interdependent projects, if any:
Proposed Expansion of APIs to API and API Intermediates manufacturing industry (Synthetic
Organic Chemical industry) falls under Category-B project under 5 (f) of EIA Notification 2006 and its
subsequent amendments. As the SEIAA, Telangana is not constituted, Form 1 application is being
submitted to Ministry of Environment, Forest and Climate Change, Govt. of India, New Delhi. The
proposed unit is located in IDA Khazipally, Sangareddy District, Telangana State. There is no interlink
and interdependent project for this expansion project.
3.2 Location
The Unit is located in Sry Plot No. 180/2, 180/3, Notified Industrial Area, IDA Khazipally,
Khazipally (V), Jinnaram (M), Sangareddy District, Telangana State. Project site co-ordinates of all
corners are presented in Table 1. The project site is well connected by the State High Way 6. Its
Latitude: 17°35'4.96"N, Longitude: 78°22'29.13"E (msl: 600 m)
Aurore Life Sciences Private Limited Pre-Feasibility Report
7
Table 1: Co-ordinates of all corners of the Project site
Sl. No. Latitude Longitude
1 17°35'8.23"N 78°22'31.71"E 2 17°35'2.47"N 78°22'32.84"E 3 17°35'1.23"N 78°22'26.86"E 4 17°35'7.08"N 78°22'25.56"E
The map showing general location, specific location, Google map showing the Co-ordinates
and Plant layout of the project showing existing and proposed facilities are presented at Annexures- XII, XIII, XIV and XV respectively.
3.3 Alternate Sites
This proposed expansion project is in the existing plant premises Sry. Plot No. 180/2, 180/3,
Notified Industrial Area, IDA Khazipally, Khazipally (V), Jinnaram (M), Sangareddy District, Telangana
State. Hence, Alternate sites are not considered for the present expansion project.
Environmental considerations of this expansion project site.
> 1.5 km away from nearest human habitation Kishtaipalli
Water Bodies
• Pond near Gaddapotharam – 1.4 km (N) • Pond near Gaggilapur – 3.5 km (NE) • Pond near Dundigal – 5 km (NE) • Pashib Cheruvu – 4.3 km (NNW) • Bapanna Cheruvu – 5.6 km (W) • Gandigudem chruvu – 4 km (WSW) • Pond near Sultanpur – 7.7 km (WSW)
Reserved forests :
Narsapur Reserved Forest Block (Gottimukkula RF, Nallagutta RF, Naguvaram RF, Royyapalli RF, Mangapet RF, Bonthapalli RF, Jinnaram RF, Mambapur RF, Nalavalli RF) – 6.07 km (NNW)
Kazipalli RF (Open Scrub) – 0.38 km (W)
Dundigal RF (Dense Scrub) – 0.65 km (E)
Wailal RF (Dense Mixed Jungle) – 2.2 km (NW)
Pottaguda RF (Dense Mixed Jungle) – 6 km (WNW)
Gaudavalli RF (Open Scrub) / Pochampally Khurd RF – 6.28 km (E)
Gajularamaram RF (Dense Mixed Jungle) – 4.46 km (ESE)
Dulapalle RF (Rocy Knob) – 7.65 km (ESE)
Exist Transportation and Communication network There are no rare or endangered or endemic or threatened (REET) species of animals or birds.
3.4 Size or Magnitude of Operation
Project Area: 3.23 Ha.
Aurore Life Sciences Private Limited Pre-Feasibility Report
8
Production Capacity: 2163.6 TPA from total 13 campaign products out of 68 products with
R&D products. The permitted in EC & CFO and proposed products with its production capacities are
presented in Tables 2 (a) & (b) and 3 respectively.
Table 2 (a): Products and their Capacities (as per EC 2005)
Sl. No. Name of the product Quantity
(TPA) 1 Ampicillin Trihydrate 20 2 Amoxiycillin Trihydrate 20 3 Cloxacillin Sodium 20 Total 60
Table 2 (b): Products and their Capacities (as per CFO 2018)
Sl. No. Name of the product Quantity
(TPA) 1 Ampicillin Trihydrate 20 2 Cloxacillin Sodium 20 3 D-Glucosamine HCl 96
Industry is permitted to manufacture only D-Glucosamine HCl 96
Table 3: Proposed Products, their Capacity, CAS No. and Therapeutic Category
Sl. No. List of Products Quantity
kg/day Quantity
(TPA) CAS No. Therapeutic Category
1. Gabapentin 333.3 120 60142-96-3 Anticonvulsant 2. Verapamil Hydrochloride
233.3 84 152-11-4 Antianginal,
Antihypertensive, Antiarrhythmic
3. Amlodipine Besylate 600.0 216 88150-42-9 Antianginal, Antihypertensive
4. Amlodipine Base 333.3 120 88150-47-4 Antihypertensive 5. Etoricoxib
333.3 120 202409-33-4 Antirheumatics
Anti-Inflammatory
6. Pinaverium Bromide 200.0 72 53251-94-8 Antispasmodic 7. Pantoprazole Sodium
Sesquihydrate 200.0 72 164579-32 Antiulcer agent
Gastric acid suppressant
8. Clopidogrel Hydrogen sulfate 266.7 96 135046-48-9
Platelet Aggregation
Inhibitor 9. Rebamipide 1466.7 528 90098-04-7 Antiulcers 10. Nizatidine 333.3 120 76963-41-2 Antiulcerative 11. Erdosteine 233.3 84 84611-23-4 Mucolytic agent 12. Citicoline Sodium 666.7 240 33818-15-4 Central stimulant
Nootropic agent 13. Rifaximin 166.7 60 80621-81-4 Antibiotic
Antibacterial 14. Myrtecaine 33.3 12 7712-50-7 Anesthetic, local 15. Marbofloxacin 33.3 12 115550-35-1 Antibacterial 16. Levetiracetam 500.0 180 102767-28-2 Anticonvulsant
Aurore Life Sciences Private Limited Pre-Feasibility Report
9
Sl. No. List of Products Quantity
kg/day Quantity
(TPA) CAS No. Therapeutic Category
17. Desvenlafaxine 166.7 60 93413-62-8 Anti-Depressant 18. Febuxostat 66.7 24 144060-53 Antigout
preparations 19. Mesalamine 33.3 12 89-57-6 Anti-inflammatory 20. Rupatadine Fumarate 33.3 12 182349-12-8 Antiallergic agent 21. Loratadine 33.3 12 79794-75-5 Antihistaminic 22. Risperidone 100.0 36 106266-06-2 Antipsychotic 23. Sodium Cromoglycate 100.0 36 15826-37-6 Anti-allergic agent 24. Omeprazole 100.0 36 73590-58-6 Gastric acid
suppressant 25. Tolvaptan
200.0 72 150683-30-0
Endocrine-Metabolic Agent Cardiovascular
agent 26. Mefloquine Hydrochloride 66.7 24 51773-92-3 Antimalarials 27. Alphalipoic acid 100.0 36 1077-28-7 Anti-aging 28. Bepotastine Besilate 33.3 12 190786-44-8 Anti-allergic agent
Antihistamines 29. Valganciclovir Hydrochloride 33.3 12 175865-59-5 Antiviral 30. Darunavir 66.7 24 206361-99-1 Anti-Viral 31. Lisinopril 66.7 24 83915-83-7 Antihypertensive 32. Famciclovir 33.3 12 104227-87-4 Antiviral 33. Tofacitinib Citrate 33.3 12 540737-29-9 Anti-rheumatic 34. Celecoxib 166.7 60 169590-42-5 Analgesic
Anti-inflammatory 35. Chlorthalidone 100.0 36 77-36-1 Diuretic,
Dntihypertensive 36. Prazosin Hydrochloride 100.0 36 19237-84-4 Antihypertensive 37. Raloxifene Hydrochloride 100.0 36 82640-04 Antiosteoporotic 38. Ramelteon 66.7 24 196597-26-9 Neuropsychiatric
agent 39. Oxcarbazepine 33.3 12 28721-07-5 Antiepileptic 40. Flecainide Acetate 66.7 24 54143-55-5 Antiarrhythmic 41. Pelubiprofen 100.0 36 69956-77-0 Anti-inflammatory
drug 42. Cloperastine Fendizoate 100.0 36 85187-37-7 Antitussive 43. Salsalate 100.0 36 552-94-3 Analgesic,
Anti-inflammatory 44. Propranolol Hydrochloride
133.3 48 318-98-9 Antihypertensive,
Antianginal, Antiarrhythmic
45. Pirfenidone 100.0 36 53179-13 Anti-inflammatory agent
46. Pentoxyverine 66.7 24 77-23-6
Antitussive Cough
suppressant 47. Eperisone Hydrochloride 133.3 48 56838-43-1 Antispasmodic 48. Ozagrel Hydrochloride
133.3 48 74003-18-2 Cardiovascular
agent Antiasthmatic
49. Fenoprofen Calcium 66.7 24 71720-56-4
Nonnarcotic Analgesic, Antipyretic,
Aurore Life Sciences Private Limited Pre-Feasibility Report
10
Sl. No. List of Products Quantity
kg/day Quantity
(TPA) CAS No. Therapeutic Category
Anti-inflammatory 50. Amisulpride 100.0 36 53583-79-2 Antipsychotic
drug 51. Carprofen 66.7 24 53716-49-7 Anti-inflammatory
drug 52. Benfotiamine 66.7 24 22457-89-2 Vitamin B1 53. 4-Aminosalicylic acid 100.0 36 65-49-6 Antitubercular
agent 54. Lopinavir 200.0 72 192725-17-0 Antiviral 55. Ritonavir 200.0 72 155213-67-5 Antiviral 56. Sofosbuvir 66.7 24 1190307-88 Antiviral 57. Ledipasvir Copovidone 133.3 48 1256388-51-8 Antiviral 58. Tenofovir Alafenamide
Hemifumarate 66.7 24 1392275-56-7 379270-37-8
Antiviral
59. Abacavir Sulfate 166.7 60 188062-50-2 Antiviral 60. Dolutegravir 100.0 36 1051375-16 Antiviral
Anti-Retroviral 61. Sotalal Hydrochloride 133.3 48 959-24-0 Cardiovascular
agent 62. Phthalimido Amlodipine 500.0 180 88150-62-3 63. 5-(1-Carboxyethyl)-2-
(phenylthio)phenylacetic acid 133.3 48 83237-49-4 Zaltoprofen Intermediate
64. 1-(6-Methyl-3-pyridinyl)-2-[4-(methylsulfonyl) pheny] ethanone (Ketosulfone)
133.3 48 221615-75-4 Ketosulfone Intermediate
65. 3,4-Dimethoxy-6-Bromo-Benzyl Bromide 66.7 24 Loranitrile
Intermediate 66. 2,6-Dihydroxy Acetophenone 66.7 24 699-83-2 67. 3-(2-Chloroethyl)-2-methyl-
6,7,8,9-tetrahydro-4H-pyrido [1,2-a] pyrimidine-4-one Hydrochloride
133.3 48 63234-80-0
Risperidone Intermediate -1
68. 6-Fluoro-3-(4-piperidinyl)-1,2-benzisoxazole 133.3 48 84163-77-9 Risperidone
Intermediate -2 13 Campaign products at any time out of 68 Products 6000 2160
1 R&D 10 3.6 13 Campaign products at any
time out of 68 Products and R&D products
6010 2163.6
Source: Aurore Life Sciences Pvt. Ltd.
3.5 Project Description
The manufacturing process of APIs and API intermediates consists of chemical synthesis and
multiple stages of processing extending to maximum of 10 stages involving different types of
chemical reactions. Typical process description with process details for all 68 products is at
Annexure-XVI. The plant layout showing existing and proposed units of the project is enclosed at
Annexure-XV.
Aurore Life Sciences Private Limited Pre-Feasibility Report
11
3.6 Raw Materials
The raw materials required for the manufacture of proposed products are the
chemicals/solvents and the fuel. The chemicals required for the process are secured from the local
(indigenous) markets. Mode of transportation of all raw materials is from local markets by road.
Finished products from the project site are also by road to markets.
• APIs manufacturing involve the use of various chemicals and organic solvents either directly
as reactant or for extraction of a product of interest from the reaction mixture.
• About 80 TPD of coal will be used in the proposed 3, 7 and 10 TPH coal fired boilers. Another
10 TPH coal fired boiler will be standby after expansion and existing 0.5 TPH coal fired boiler
will be removed after expansion.
• Diesel of about 1260 lit/hr will be used in the proposed DG sets of 4x500 KVA, 2x1010 KVA &
1500 KVA and proposed 3 x 4 lakhs Kcal/hr & 2 x 2 lakh Kcal/hr Diesel/ Furnace oil fired
Thermic Fluid Heaters (TFH). Existing 2 x 125 KVA DG sets will be removed after expansion.
DG sets are used as standby during power failure.
• Proposed power requirement of the plant is 5000 KVA (CMD) including existing. Power will be
met from Telangana State Power Distribution Corporation Limited.
• Chemicals (raw materials) required for the manufacture of proposed products is presented at
Annexure -XVII and Hazardous chemicals list is presented at Annexure-XVIII.
3.7 Resources Optimization / Recycling and Reuse
R&D facility in the unit is making all efforts to recycle the wastes / reuse wherever possible.
However, R&D is a continuous process, where improvements in the processes adopted by the
industry, waste minimization etc. will be worked out as the project progresses. Following are some of
the recycle options proposed by the Proponent.
Improvement of yield of the products so as to reduce the waste generation during
manufacturing.
Industry upgrading the zero liquid discharge plant to reuse all treated effluents as makeup
water for utilities like Cooling Tower. This will reduce the fresh water consumption.
All solvents are recovered to the extent possible and reused in the process.
Organic residue, spent carbon, distillation residue will be sent to Authorized Cement Industries
to burn in Cement Kiln as an alternate fuel or TSDF.
Boiler ash will be sent to Brick manufacturing units.
ETP sludge / Evaporation salts will be sent to TSDF / Authorized Cement Industries based on
the calorific value of the waste.
Container & container liners of hazardous chemicals, Polythene / HDPE Bags, broken plastic
drums will be disposed-off to outside agencies after complete detoxification.
Spent catalyst will be sent back to suppliers
Aurore Life Sciences Private Limited Pre-Feasibility Report
12
Waste Lead acid batteries will be sent back to suppliers on buy back basis.
Optimum utilization of solar energy.
There is tremendous potential for implementation of clean technologies, recovery and reuse
techniques in this proposed APIs unit which will be explored and implemented after successful R&D
study.
3.8 Availability of Water and Energy
Total water requirement will be about 723 KLD of which fresh water requirement is about 383
KLD which will be met from private tankers. The proposal is to minimize the effect on the level of
water table by practicing reuse / recycling of the treated water wherever possible thereby reducing
the fresh water requirement.
The proposed power requirement (Contract Power Demand) of the plant is 5000 KVA
including existing and it is sourced from the Telangana State Power Distribution Corporation Limited.
Coal and Diesel will be procured from the distribution sources closer to the project site.
3.9 Quantity of Wastes Generation and their Management /Disposal
3.9.1 Water requirement and Wastewater Generation and their Management / Disposal
The existing water requirement and waste water generation with treatment is presented in
Table 4. The proposed gross water requirement after expansion will be 723 KLD of which total fresh
water requirement will be 383 KLD. Treated effluent from ETP-ZLD of about 340 KLD will be reused
in utilities. Fresh water will be met from private tankers. Proposed Water Requirement and Waste
water Generation with Segregation is presented in Table 5. The sources of wastewater generation
are from the process, floor & reactor washings, utilities, Q.C, R&D, scrubber and plant domestic
wastewater. Total proposed wastewater will be 400 KLD, which will be segregated into HTDS/HCOD
& LTDS/LCOD and collected by gravity into a collection tank separately. This individual effluent will
be pumped to the above ground level RCC lined tanks for storage and neutralization then sent to
ETP-ZLD. The effluents segregated quantity, characteristics and treatment flow is briefly presented in
Table 6.
Table 4: Existing Water Requirement, Wastewater Generation and its Treatment
Description Water
Requirement (KLD)
Wastewater Generation
in KLD Treatment
High TDS effluents Process & washings 9 7.45 • MEE system of M/s JETL Jeedimetla
LTDS effluent Boiler Feed & Cooling Tower
makeup 25 0.75 • CETP, PETL, Patancheru, duly
confirming to the influent standards of CETP DM Plant 2
Aurore Life Sciences Private Limited Pre-Feasibility Report
13
Description Water
Requirement (KLD)
Wastewater Generation
in KLD Treatment
Domestic 5 4.5
(Septic tank over flow)
Total 41 12.7
Table 5: Proposed Water Requirement and Wastewater Generation with Segregation
Description
Input (KLD) Output (KLD)
Fresh Water
Recycled Water
Evaporation / Handling
Loss Total
Wastewater Segregation type of
Wastewater
Process (13 campaign products from total682 products)
234 - (-16) 250 (267)* HTDS/HCOD
Washings (reactor, centrifuges, nutch filters, dryers, floor, etc.)
30 - - 30 LTDS/LCOD
Boiler (Proposed 3, 7 & 10 TPH boilers)
26 70 80 16 Utilities (LTDS/LCOD) Cooling Tower
4500 TR 0 270 247.5 22.5
Fresh water RO rejects 20 - - 20 LTDS / LCOD
Scrubber 5 - - 5 HTDS / LCOD Q.C and R&D 5 - - 5 LTDS/LCOD Domestic (990 nos @50 lpcd) 50 - 10 40 LTDS/LCOD
Greenbelt (2.6 acres @ 5KL/acre) 13 - 13 - --
Total 383 340 334.5 388.5
Stripper condensate ~10 KLD; Moisture in salt and ETP sludge is ~ 6 KLD, Water loss in ETP ~33 KLD (Total water loss is ~49 KLD = 12.6 %) Reuse: 340 KLD 723 723
Note: *267 Tons consists of ~250 KL liquid and ~19.4 Tons of salt
Aurore Life Sciences Private Limited Pre-Feasibility Report
14
Table 6: Effluent Treatment Flow as per Segregation
Effluent Characteristics
Quantity (KLD) Treatment Flow
Stream -1 (Process & scrubber)
TDS > 5000 mg/l COD > 5000 mg/l
255
Collection Equalization cum Neutralization Settling Holding Steam stripper MEE along with HTDS effluent Condensate to ETP (biological treatment) Concentrate to ATFD
MEE & ATFD Condensate to ETP (Biological Treatment) along with domestic wastewater holding tank Pressure Sand Filter Activated Carbon Filter ETP RO system RO permeate water reuse in Cooling towers.
ETP RO rejects to MEE.
ATFD Salts to TSDF and stripped solvents to SPCB authorized cement industries
Stream- 2 (Washings, QC, R&D
and Domestic) TDS / COD < 5000 mg/l
113.5 Collection Equalization cum Neutralization ETP (Biological Treatment) along with MEE & ATFD Condensate
Stream 3 (Fresh water RO rejects) 20 Collection Tank ETP RO system
Existing treatment system will be enhanced to meet the proposed effluent quantities. All the
proposed additional tanks in the ETP will be constructed / installed above the ground with water proof
lining. These individual effluents will be pumped to the RCC lined tanks for storage and neutralization
and then sent to upgraded ETP-ZLD of 400 KLD capacity within the plant premises. Effluent
Treatment Plant flow chart is enclosed as Annexure-XIX.
ETP – ZLD facility consists of primary treatment (equalization and neutralization), thermal
treatment (stripper with MEE, ATFD), secondary treatment (biological) and tertiary treatment
(Pressure sand filter, Activated carbon filter & Reverse Osmosis) will be provided. Domestic
wastewater will be sent to septic tank and the overflow to ETP (biological treatment). Concentrate
from MEE system will be sent to ATFD and the salts from the evaporation system will be collected
and sent to TSDF / Authorized Cement industries for safe disposal based on calorific value of the
waste.
3.9.2 Hazardous / Solid Waste Generation, Handling and their Disposal
Hazardous / Solid waste will be segregated, detoxified and collected in the HDPE drums /
bags and will be stored in the covered and raised platform with Leachate collection system. The
existing and proposed solid waste and other waste generated, handling and disposal method from
the various stages of APIs manufacturing plant is presented in the Tables 7 & 8 respectively.
Spillages such as wastewater / solid wastes / raw materials are possible and the risk of this would be
limited to within the premises of the manufacturing facility. A precautionary measure like spillage
control management is practiced in the industry.
Aurore Life Sciences Private Limited Pre-Feasibility Report
15
Table 7: Hazardous Waste Generation from the Existing (CFO) Products Sl. No Description Stream Quantity Disposal
Hazardous Wastes with Recycling Option
1 Waste Oils 5.1 of Schedule - I
50 Ltrs/ Annum
Authorised re-processors / recyclers
Table 8: Hazardous / Solid Waste Generation from the Proposed Products
Sl. No. Description
Proposed Quantity
(TPD) HW Stream Handling
Method Disposal
1. Organic residue from Process 13 28.1 of Schedule -I
HDPE Drums
Sent to SPCB Authorized Cement
industries or to TSDF for Incineration
2. Distillation Bottom Residue (1% of spent solvents) 3 36.1 of
Schedule -I
3. Spent carbon 1.1 28.3 of Schedule -I
4. Inorganic & Evaporation salt (Process) (10% moisture) 24.6 28.1 of
Schedule -I HDPE Bags
Sent to SPCB Authorized Cement
industries or to TSDF for Incineration
(based on Calorific value)
5. Evaporation salt with moisture (Non-Process & scrubber) 2 35.3 of
Schedule -I
6. ETP Sludge with moisture 1.0 35.3 of Schedule -I
7. Boiler ash 32 -- HDPE Bags
Sent to Brick Manufacturers
Other Hazardous Waste generation from the Plant
8.
a) Detoxified Container / Liners drums, HDPE Carboys, Fiber Drums,
10000 nos./month
33.1 of Schedule-I Designated
covered area
Disposed to SPCB Authorized agencies
after complete detoxification b) PP Bags 1000
Kg/month --
9. Spent solvents (180 KLD + 10KLD water) 190 KLD 28.6 of
Schedule -I Tanks / Drums
Recovered within the premises
10.
Recovered Solvents from Spent solvents (80% recovery from spent solvents)
145 KLD 28.6 of
Schedule -I
Tanks / Drums
Reuse or sold to Recyclers
11. Spent Mixed solvents (unrecovered solvents) 40 KLD 28.6 of
Schedule -I Tanks/ Drums
Sent to SPCB Authorized agencies
12. Waste oils & Grease 6 KL/ Annum
5.1 of Schedule -I MS Drums
Sent to SPCB Authorized agencies for
reprocessing
13. Used Lead acid Batteries 100 nos. / annum
A1160 of Schedule-III
Stored in Covered
shed
Sent to suppliers on buy-back basis.
14. Misc. Waste (spill control waste) L.S. -- Stored in
Drums TSDF 15. Rejects L.S. --
16. E- waste L.S. -- Designated covered
area
Authorized reprocessor or
TSDF
17. Waste papers & other types of packing scrap L.S. -- Sold to scrap venders
Aurore Life Sciences Private Limited Pre-Feasibility Report
16
Sl. No. Description
Proposed Quantity
(TPD) HW Stream Handling
Method Disposal
18. Canteen waste L.S. -- HDPE bags
Composted on site and reused for green belt
19 Bio Medical Waste LS. -- Color coded
containers
Sent to SPCB authorized Biomedical
waste incinerator
20 Spent Catalyst LS -- Drums Sold to suppliers on buy
back basis / Auth. Reprocessor
21 Segregated Construction waste LS -- Covered
area
Filling the low lying areas./ sent to Auth. Agencies for recycle
Note: * Max. Hazardous / Solid waste quantities from 13 campaign products out of total 68 products and R&D products
3.10 Schematic Flow Sheet for EIA Procedure
The schematic flow sheet for EIA procedure is depicted as Annexure -XX.
4.0 Site Analysis 4.1 Connectivity
This proposed expansion project site is located at a distance (aerial) of 2.8 km (NE) from
State Highway No. 6: about 1.7 km (WNW) from nearest habitation Kishtaipalli, 10.2 km (ENE) to
Gowdavally railway station; 38 km (S) to Rajiv Gandhi International Airport, Shamshabad, Hyderabad.
4.2 Land Form, Land use and Land Ownership
The proposed expansion is in the plain land of existing manufacturing unit. Total land is 3.23
Ha. Land is in possession of Project Proponent.
4.3 Topography
The Topography map with a 10 km radius is enclosed as Annexure-XXI.
4.4 Existing Land Use Pattern
The existing and proposed land use pattern of project area (core area) of 3.23 Ha is Industrial
land and shortest aerial distance environmental components in buffer area from the project periphery
are given in Table 9.
Table 9: Environmental Components shortest distance from Project periphery
Sl. No. Description Distance & Direction w.r.t. site 1. Water bodies • Pond near Gaddapotharam – 1.4 km (N)
• Pond Near Gaggilapur – 3.5 km (NE) • Pond near Dundigal – 5 km (NE) • Pashib Cheruvu – 4.3 km (NNW) • Bapanna cheruvu – 5.6 km (W) • Gandigudem cheruvu – 4 km (WSW) • Pond near Sultanpur – 7.7 km (WSW)
Aurore Life Sciences Private Limited Pre-Feasibility Report
17
Sl. No. Description Distance & Direction w.r.t. site 2. Reserved Forests • Narsapur Reserved Forest Block (Gottimukkula RF, Nallagutta
RF, Naguvaram RF, Royyapalli RF, Mangapet RF, Bonthapalli RF, Jinnaram RF, Mambapur RF, Nalavalli RF) – 6.07 km (NNW)
• Kazipally RF (Open scrub) – 0.38 km (W) • Dundigal RF (Dense Scrub) – 0.65 km (E) • Wailal RF (Dense mixed Jungle) – 2.2 km (NW) • Pottaguda RF (Dense Mixed Jungle) – 6 km (WNW) • Gaudavalli RF (Open Scrub) / Pochampally Khurd RF– 6.28 km
(E) • Gajularamaram RF (Dense Mixed Jungle) – 4.46 km (ESE) • Dulapalle RF (Rocy Knob) – 7.65 km (ESE)
3. National Parks/ Wild Life Sanctuaries/ Eco sensitive areas
Nil
4. Industries Located in Notified Industrial Area of IDA, Khazipally 5. Defence Installation Dundigal Airforce station – 4.8 km (NNE) 5. Habitation Nearest habitation is 1.7 km (NNE) away from the project site.
4.5 Existing & Proposed Infrastructure
Internal Cement Concrete roads, water supply, Upgraded to In-house ETP-ZLD facility, Power
supply, Production block, Utilities, Conference halls, Fire hydrant system, Telecommunication facility
etc., are available.
4.6 Soil Classification
The soil in the study area is reddish brown in colour containing 38.19 % silt, Clay 19.65 %,
and sand 42.16% (Sandy loam).
4.7 Climate Data from Secondary Sources
The area enjoys pleasant, warm and dry climate. The coldest season is during December and
January, where the temperature touch a minimum of 13.6-15.8°C and warmest period is during the
month of April to May when the Mercury shoots up to 43 – 44.2°C.
The area experiences the maximum rainfall during the months of July to October and a little
rainfall during November and December due to North-East monsoon. Apart from these, occasional
rainfall is obtained from cyclonic storms and depression originating in the Bay of Bengal. The normal
annual rainfall of the area is around 951.7 mm. The rainfall is erratic and long period of dry spells
leading to drought conditions are frequent and periodic.
4.8 Social Infrastructure
IDA, Khazipally is in notified industrial area having power supply, communication system, well
maintained internal roads, operating various industries in the Industrial area and IDA is well
connected by Road, Rail and Airways.
Aurore Life Sciences Private Limited Pre-Feasibility Report
18
5.0 Planning 5.1 Planning Concept Type of Industry: APIs & API Intermedaites manufacturing industry with R&D products.
Facilities: Industry proposed for expansion at existing land and facilities required for the project will
be provided as per requirement.
Transportation: Transportation of raw materials and final products is done via roads as the proposed
expansion project is well connected to Road.
Town and Country Planning Classification: This is Notified Industrial land of IDA, Khazipalli, and is
in possession of project proponent
5.2 Population Projection
Proposed project is in the existing industry of Notified industrial area and there is a scope for
increase in the population in the vicinity as most of the skilled workers prefers to stay in the nearby
locations to avoid travelling from long distances. However, semi-skilled and indirect employment
potential is from local villages. Hence, there is a possibility of increase in population of the skilled and
semi-skilled. The local unskilled villagers will be preferred for the unskilled jobs such as gardening,
movement of materials, etc. Educated youth will be employed as semi-skilled workers and training will
be provided. However, on the whole there is a possibility of marginal increase in population of the
area.
5.3 Land use Planning
The expansion unit has been proposed in existing area of about 3.23 Ha i.e., 32373.79 sq.m.
The Land use pattern of the proposed expansion is presented in Table 10.
Table 10: Land Breakup Details
Sl. No. Description
Existing Area
Proposed Area
Total Area after expansion
(SQ.M) (SQ.M) (SQ.M) Percent (%)
1. Built-up area 7470 7094 14564 44.9 2. Roads 24929
17835 6550 20.2
3. Open Area 570 1.8 4. Greenbelt 10715 33.1
Total 32399 32399 32399 100
5.4 Assessment of Infrastructure Demand
On assessment of infrastructure demand near the project area; Ambulance facility
requirement for the nearby villages of project area. Project site located in IDA Khazipalli, Sangareddy
district, Telangana.
5.5 Amenities/Facilities
Industry will continue to provide and upgrade the following amenities / facilities in the
Aurore Life Sciences Private Limited Pre-Feasibility Report
19
proposed expansion project.
• Canteen • Potable drinking water • Training block • Laying of Concrete internal roads • Fire hydrant facility • Eye/body wash showers • First Aid kits at all prominent places. • Rest Room for employees • Seating facilities for those employees who do their work standing and ergonomically designed
seating facilities for those who do their work seating • Pre-employment and routine medical examinations and the necessary follow up actions • Communication systems like Phone, Internet with safety measures, etc. • Security system at the entrance etc.
6.0 Proposed Infrastructure
6.1 Industrial Area
Additional Production Blocks, Utilities area, ETP up-gradation has been proposed in the
existing area with extended land of 3.23 Ha.
6.2 Residential Area
There will be no residential area within the project site.
6.3 Greenbelt
The existing Greenbelt of 1.07 Ha (33%) out of 3.23 Ha total area of the project.
6.4 Social Infrastructure
As Corporate Environment Responsibility (CER), Industry will contribute for development of
village social infrastructure in association with other industries of IDA Khazipalli.
6.5 Connectivity
There is no change in connectivity compare to existing facility.
6.6 Drinking Water Management
Potable drinking water will be provided to additional employees. The source of drinking water
is packaged drinking water.
6.7 Sewerage System
Sewage will be generated from the Canteen and Toilets, which will be collected into sewage
collection tank through pipelines and will be sent to proposed ETP – ZLD system.
6.8 Industrial Waste Management
Existing storage system needs to be enhanced to meet the project requirement. The
management of these wastes is to be handled very sensitively and by adopting proper segregation
Aurore Life Sciences Private Limited Pre-Feasibility Report
20
techniques.
6.8.1 Process Emissions Management
Manufacturing of APIs will result in gaseous emissions. Maximum process emissions for
proposed products are given in Tables 11. Proposed gaseous emissions will be scrubbed in two
stages with water and caustic solution based on the characteristics of gases.
Table 11: Process Emissions from Proposed Products with treatment method
Sl. No.
Process Emission Treatment
1. HCl • Scrubbed by using water & CS lye solution
2. NH3 • Scrubbed by using Chilled water / dilute H2SO4
solution. 3. H2 • Diffused with Flame Arrestor 4. n-Butane • Diffused with Flame Arrestor 5. N2 • Dispersed into atmosphere 6. SO2 • Scrubbed by using CS lye solution 7. Bromine • Scrubbed by using CS lye solution
8. Hydrogen Bromide • Scrubbed by using CS lye solution
9. CO2 • Dispersed into atmosphere
6.8.2 Solvent Recovery System:
Industry proposed to install 4 nos. of 1 KL/hr solvent distillation system for solvent recovery in the
expansion proposal with double condensers to recover > 95% solvent. Following will implement to
reduce the solvent losses.
6.8.2.1 Fugitive emissions
Solvents used in the APIs manufacturing process will be stored in drums and bulk quantities
will be stored in above ground storage tanks.
Solvents are handled in closed conditions thereby reducing the losses in the form of
evaporation.
Proper earthing will be provided to all the electrical equipment and the joints / connections
wherever solvent handling is done.
Reactor and solvent handling pump will have mechanical seals to prevent leakage.
Industry will take measures for reduction of fugitive emissions and for further reduction
industry will provide vent condensers to the tanks.
Chilled brine circulation will be carried out to condensate the solvent vapour and to the
receivers of the solvent vapors which ensures the maximum recovery.
Solvent vapours from the Centrifuge and Catch pots will be connect to vent condensers.
The height of the solvent receiver tank vent is above production block roof level and the
diameter is 20 mm.
Aurore Life Sciences Private Limited Pre-Feasibility Report
21
Flame proof fitting / equipments / pumps / lighting will be used wherever solvents are used.
The solvent storage tanks will be provided with breather valve to prevent losses.
Considering the above precautions, Solvent recovery will be ~98% and losses will be
restricted to ~ 2%
6.8.3 Emissions–Utilities
Boilers and DG sets are the main sources contributing to emissions from the plant. Proposed
3, 7 & 10 TPH coal fired boilers. Another proposed 10 TPH coal fired boiler will be standby after
expansion and existing 0.5 TPH coal fired boiler will be removed after expansion. Coal of about 80
TPD will be used in the boilers.
Diesel about 1260 lit / hr will be used at full operation load in the DG sets. 4 x 500 KVA, 2 x
1010 KVA & 1500 KVA and proposed 3 x 4 lakhs Kcal/hr & 2 x 2 lakh Kcal/hr Diesel/ Furnace oil fired
Thermic Fluid Heaters (TFH). Existing 2 x 125 KVA DG sets will be removed after expansion. DG
sets are used as standby during power failure. The stack emissions from the boiler and DG sets are
given in Table 12. Table 12: Stack Emission Details
Source Stack Height
(m)
Diameter (m)
Temperature (oC)
Flue Gas Flow rate
(m3/hr)
Exit Gas
Velocity (m/sec)
PM SO2 NOx
kg/hr
Proposed Coal Fired Boilers 10 TPH 32 0.8 150 26615 14.7 1.35 14.17 8.1 3 TPH 30 0.5 150 7985 11.3 0.405 4.25 2.43 7 TPH 30 0.7 150 18631 13.5 0.945 9.92 5.67
10 TPH (Stand by) 32 0.8 150 26615 14.7 1.35 14.17 8.1
Proposed Diesel Fired Thermic Fluid Heater 4 lakhs Kcal/hr 30 0.3 150 1735 6.8 0.009 0.176 0.188
4 lakhs Kcal/hr 30 0.3 150 1735 6.8 0.009 0.176 0.188
4 lakhs Kcal/hr 30 0.3 150 1735 6.8 0.009 0.176 0.188
2 lakhs Kcal/hr 30 0.2 150 878 7.8 0.004 0.088 0.094
2 lakhs Kcal/hr 30 0.2 150 878 7.8 0.004 0.088 0.094
Proposed Diesel Generator (DG) sets 1500 KVA 12 0.5 150 8467 11.9 0.095 1.88 2.01 1010 KVA 11 0.4 150 5702 12.6 0.064 1.26 1.36 1010 KVA 11 0.4 150 5702 12.6 0.064 1.26 1.36 500 KVA 9 0.3 150 2822 11.1 0.032 0.63 0.67 500 KVA 9 0.3 150 2822 11.1 0.032 0.63 0.67 500 KVA 9 0.3 150 2822 11.1 0.032 0.63 0.67 500 KVA 9 0.3 150 2822 11.1 0.032 0.63 0.67
*Existing 0.5 TPH coal fired boiler and 2 x 125 KVA DG set will be removed after expansion
Aurore Life Sciences Private Limited Pre-Feasibility Report
22
The various measures proposed to minimize the pollution from the boiler are as follows:
Multi-cyclone separator followed by Bag filter will be installed to control the particulate (PM)
emissions within statutory limit of 115 mg/Nm3. To facilitate wider dispersion of pollutants, 32 /
30 m height stack each will be installed as per CPCB guidelines based on sulphur content.
[Stack height formula H = 14 Q0.3 (Q is emission rate of SO2 in kg/hr)]
NOx emissions from the boilers will be controlled by controlling combustion measures, which
will be approached by way of low NOx burners or by air stagging in boiler.
Stack height will be based on Sulphur content in fuel as per CPCB guidelines
Stacks will be provided to proposed DG sets as per CPCB / SPCB Guidelines.
Fugitive dust will be controlled by adopting dust extraction and dust suppression measures
and development of greenbelt along the periphery of the proposed Boiler area.
6.8.4 Noise Environment
• Compressors, Boilers, TFH and DG sets will be the major noise generating units in the plant.
• Noise levels of the DG sets will be well within the limits as these will be installed with acoustic enclosures. Workers will always be provided with ear muffs.
• All the equipment in the plant would be designed to have a total noise level not exceeding 85-
90 dB(A) as per the requirement of OSHA (Occupational Safety and Health Administration)
standards.
6.9 Hazardous / Solid Waste Management
• Solid waste mainly segregated into process organic residues, inorganic salts, distillation
residue, boiler ash, spent mixed unrecoverable solvents and spent carbon.
• Organic residues, Spent carbon & Spent mixed unrecoverable solvents, distillation residue
can be disposed-off to Cement plants as recommended by CPCB for use as alternate fuels
either in the solid or liquid form.
• Boiler ash will be sold to brick manufacturers.
• Inorganic salts are to be sent for landfill at TSDF.
Solid waste will be segregated, stored and disposed as mentioned in the Table 8.
6.10 Power Requirement & Supply / Source
The proposed power requirement (Contract Power Demand) of the plant is 5000 KVA
including existing. Proposed DG sets are of 4x500 KVA, 2x1010 KVA & 1500 KVA. DG set which will
be used as standby during power failure.
7.0 Rehabilitation and Resettlement (R&R) Plan
The proposed project is in the existing plant area and is in possession of project proponent.
Therefore Rehabilitation and Resettlement plan is not applicable to this expansion project.
Aurore Life Sciences Private Limited Pre-Feasibility Report
23
8.0 Project Schedule & Cost Estimates
8.1 Time Schedule for the project construction
The timelines for commencement of proposed construction activity will be from June 2020 as
it is expected that the expansion project will be in a position to obtain Environmental Clearance for
the project and Consent to Establish from the State Pollution Control Board. In 2020 the commercial
production is expected to be commenced.
8.2 Estimated Project Cost
Overall estimated cost involved in the total project (existing and proposed) like land, building,
plant & machinery is Rs. 44.31 Crores (including existing Rs. 17 Crores). Total capital cost allocated
towards environmental pollution control measures is Rs. 18.35 Crores and the Recurring cost will be
about Rs. 25 Crores per annum.
9.0 Analysis of proposal (Final Recommendations)
• Proposed expansion project will result in growth of surrounding area by generating direct and
indirect employment to local people. Around 990 members will be benefitted due to the
expansion project (including existing).
• Under the Corporate Environment Responsibility, Industry will continue to develop a policy of
developing the surrounding villages in the vicinity by identifying the requirements in association
with other member industries of IDA, Khazipalli.
• No adverse effect on environment is envisaged as proper mitigation measures will be
implemented.
• Industry will strengthen the existing Safety, Health & Environment Department and also
continue to engage recognized laboratories to carry out all necessary monitoring parameters for
its activities.
• Segregated (HTDS / LTDS) wastewater will regularly analyzed before and after treatment in
ETP-ZLD.
• Qualified staff will be appointed for the purpose of Operation and Maintenance of the pollution
control facilities.
• Stand-by facilities will be provided to all the pumps so as to ensure fail proof treatment, handling
and disposal.
9.1 Budgetary allocation for Pollution Control Measures
The management will set aside adequate funds in its budget to fully meet the stated objectives
of the environmental policy. The proposed and existing capital equipment for environmental
management include up-gradation of effluent treatment plant, pipelines and channels for wastewater
discharge, greenbelt development, air pollution control equipments and the environment laboratory.
Aurore Life Sciences Private Limited Pre-Feasibility Report
24
The estimated break-up of budgetary allocation for various control measures is presented in Table 13.
Table 13: Budgetary allocation for Pollution Control Measures
Sl. No. Description
Proposed cost (in lakhs)
Capital *Recurring 1. Air Pollution Control
10 a. Multi-cyclone / Bag filter with Stacks 20 b. Scrubbers 2. Water Pollution Control
1500 1050 a.
ETP Civil works, Steam stripper, MEE, ATFD, RO and mechanical equipment
3. Noise Pollution Control 10 10 a. Silencers / acoustic enclosures 4. Solid Waste Management
15 1220**
(disposal cost)
Covered Platform with leachate collection system
5. Greenbelt Development 10 10 6. Occupation Health and Safety 60 60 7. Fire Management 50 30 8. Dyke walls and Storm water drains 20 10 9. Environmental Laboratory 50 50 10 Miscellaneous 100 50
Total 1835 2500 *Recurring cost includes manpower, consumables, maintenance, energy charges per annum
** includes transportation, stabilization and handling charges to Cement industries / TSDF
ANNEXURE - I
25
ANNEXURE - I
26
ANNEXURE - I
27
ANNEXURE - II
28
ANNEXURE - II
29
ANNEXURE - III
33
ANNEXURE - III
34
ANNEXURE - III
35
ANNEXURE - III
36
ANNEXURE - IV
37
ANNEXURE - IV
38
ANNEXURE - IV
39
ANNEXURE - IV
40
ANNEXURE - IV
41
ANNEXURE - IV
42
ANNEXURE - IV
43
ANNEXURE - IV
44
ANNEXURE - IV
45
ANNEXURE - IV
46
ANNEXURE - IV
47
ANNEXURE - IV
48
ANNEXURE - IV
49
ANNEXURE - IV
50
ANNEXURE - V
53
ANNEXURE - V
54
ANNEXURE - V
56
ANNEXURE - V
57
ANNEXURE - V
58
ANNEXURE - V
59
ANNEXURE - VI
63
ANNEXURE - VI
64
ANNEXURE - VII
70
ANNEXURE - VII
71
ANNEXURE - VII
72
ANNEXURE - VII
75
ANNEXURE - VII
76
ANNEXURE - VIII
81
ANNEXURE - VIII
82
ANNEXURE - VIII
83
ANNEXURE - VIII
84
ANNEXURE - VIII
85
From: monitoring-ec@nic.in <monitoring-ec@nic.in> Sent: Friday, March 29, 2019 11:00:46 AM
To: sk.smree66@nic.in; Ravisankar Reddy Cc: monitoring-ec@nic.in; rupesh.pal@nic.in
Subject: Acknowledgement Slip for Transfer of EC applica�on
Acknowledgement Slip for Transfer of EC application
This is to acknowledge that the proposal has been successfullyuploaded on the portal of the Ministry. The proposal shall beexamined in the Ministry to ensure that required information has beensubmitted. An email will be sent seeking additional information , ifany, within 20 working days. Once verified, an acceptance letter shallbe issued to the project proponent .
Following should be mentioned in further correspondence
1. Proposal No. : IA/TG/IND2/99833/20052. Category of theProposal : IND2
3. Name of the Proposal : Aurore Life Sciences Private Limited4. Date of Submissionfor EC : 19 Mar 2019
5. Name of the Project Proponent along with Contact Details
a) Name of theproponent : AURORE LIFE SCIENCES
PRIVATE LIMITEDb) State : Telanganac) District : Sangareddyd) Pincode : 502319
Reply Reply all Forward
ANNEXURE - IX
86
ANNEXURE - X
87
GOVERNMENT OF TELANGANA ABSTRACT
Industrial Promotion - Notified Industrial Areas – Gaddapotharam (Kazipally), Bonthapally & Gundlamachanoor areas of Jinnaram Mandal, Medak District declared as Notified Industrial Areas in G.O. Ms. No. 120, Industries & Commerce (IP) Department, Dated : 22-10-2013 – Further Orders – Issued. -----------------------------------------------------------------------------------------------------------------------------
INDUSTRIES & COMMERCE (IP & INF) DEPARTMENT
G.O.Ms.No.80 Dated: 27/10/2015 Read the following :
1. G.O. Ms. No.120, Industries & Commerce (IP) Department, Dated: 22-10-2013 2. From the Commissioner of Industries, Hyderabad single file No.29/1/2012/13884
/15679/UP, Dated :04.09.2015 3. Orders of the Hon’ble High Court of Judicature, Hyderabad dt:28-09-2015. 4. From the Commissioner of Industries Letter No.29/1/2012 /13884/15679/UP,
Dated : 01-10-2015 5. G.O.Ms.No.309, Industries & Commerce (IP) Department, Dated: 03-10-2015. 6. From the Commissioner of Industries Letter No.29/1/2012 /13884/15679/UP,
Dated :09-10-2015 & 19.10.2015.
***** ORDER:
In the reference 1st read above, Government have notified Gaddapotharam (Kazipally), Bonthapally & Gundlamachanoor areas of Jinnaram Mandal, Medak District declared as Notified Industrial Areas, as those areas were already located within Manufacturing Zones as notified in the master plan of Hyderabad Metropolitan Development Authority and more than 140 industries are operating in these areas with all the required clearances including Consent for operations (CFO) with certain conditions as proposed therein.
2. In the references 2nd & 4th read above, the Commissioner of Industries, Hyderabad has stated that M/s. Bulk Drugs Manufacturers Association has informed that the State Pollution Control Board insisting to get amended the G.O. 1st read above mentioning that the units specified in the notified industrial areas were in operation since 1990’s, as the same was not included in the said G.O. He has therefore, requested the Government to constitute a Committee for verification and getting the information on number of such units together with evidence of being in operation from 1990s. 3. In the G.O. 5th read above, the Government have constituted a committee under the Chairmanship of the Additional Director of Industries with the members mentioned therein for verification and getting the information of the Bulk Drugs Units established during 1990’s and after that decade and to suggest amendments required to G.O.Ms.No.120, Industries & Commerce (IP) Department, Dated:22-10-2013.
4. In the reference 6th read above, the Commissioner of Industries has submitted a report of the Committee which, after visiting the Bulk Drugs Units and after studying the status of the units with specific reference to their operations since inception including change of Management if any, duly verifying the documentary evidence has confirmed that the following notified Industrial Areas are existing since 1990’s: 1. Bonthapally, Jinnaram Mandal, Medak District. 2. Khazipally/Gaddapotharam, Jinnaram Mandal, Medak District.
(PTO)
ANNEXURE - XI
88
::2::
5. Government, after careful examination of the proposal, hereby accept the recommendations of the committee and orders that the period of establishment of the above said notified Industries Areas shall be read as mentioned in para-4 above, in implementation of the orders issued in the G.O. 1st read above.
6. The Commissioner of Industries, Hyderabad shall take necessary further action in the matter accordingly.
[ BY ORDER AND IN THE NAME OF THE GOVERNOR OF TELANGANA ]
JAYESH RANJAN SECRETARY TO GOVERNMENT & CIP (I/c)
To The Commissioner of Industries, Hyderabad. Copy to: The Member Secretary, T.S.Pollution Control Board, Hyderabad. The President, Bulk Drug Manufacturers Association, Hyderabad. The Additional Principal Secretary to Hon’ble Chief Minister The P.S. to Hon’ble Minister for Industries. The P.S to Chief Secretary to Government. The P.S to Secretary to Government & CIP, Ind. & Com. Dept., Sf/Sc.
//FORWARDED::BY ORDER//
SECTION OFFICER
ANNEXURE - XI
89
Jinnaram Mandal , Sangareddy District
India
General Location Map
Project Site
90
Jinnaram Mandal , Sangareddy District
India
General Location Map
Project Site
ANNEXURE - XII
91
Specific Location (Route Map)
Project Site Village
Dundigal Air Force Academy
M/s. Aurore Life Sciences Private Limited
Kazipalli Industrial Area
Ali Nagar
Dundigal
Gandi Maisamma
Dommara Pochampalli
Chetla Potaram
SambhupurKistaipalli
ANNEXURE - XII
92
Google Image of the Proposed Project with Project Site Coordinates
Sl. No. Latitude Longitude
1 17°35'8.23"N 78°22'31.71"E
2 17°35'2.47"N 78°22'32.84"E
3 17°35'1.23"N 78°22'26.86"E
4 17°35'7.08"N 78°22'25.56"E
ANNEXURE - XIV
93
ANNEXURE - XV
94
Recommended