PRE-FEASIBILITY REPORTenvironmentclearance.nic.in/writereaddata/Online/TOR/30... · 2019-03-30 ·...

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).


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.


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.


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


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.


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)


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.


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

https://www.medindia.net/drugs/therapeutic-classification/antirheumatics.htm

https://www.medindia.net/drugs/therapeutic-classification/antiulcers.htm


9


kg/day Quantity


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,

http://reference.medscape.com/drugs/antimalarials

http://reference.medscape.com/drugs/antihistamines-ophthalmic


10


kg/day Quantity


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.


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


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


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


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.


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


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)


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.


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


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


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.


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


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.


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.


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

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From: [email protected] <[email protected]> Sent: Friday, March 29, 2019 11:00:46 AM

To: [email protected]; Ravisankar Reddy Cc: [email protected]; [email protected]

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

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mailto:[email protected]





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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)

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::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

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Jinnaram Mandal , Sangareddy District

India

General Location Map

Project Site

90

Jinnaram Mandal , Sangareddy District

India

General Location Map

Project Site

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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

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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

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