PRE-FEASIBILITY REPORTenvironmentclearance.nic.in/writereaddata/Online/... · M/s. Saiteja Drugs and Intermidiates Pvt. Ltd. Pre-Feasibility Report 2 The industry hence, has submitted

PRE-FEASIBILITY REPORT

(Proposed Expansion of Active Pharmaceuticals Ingredients (APIs) from API Intermediates

Manufacturing Unit)

Of

M/s. Saiteja Drugs & Intermidiates Pvt Ltd Sy. No. 543/A, 544/A,

Seetavani Gudem (V), Bhoodan Pochampally (M), Yadadri District, Telangana State

June 2017

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 4 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

6

2.4 Demand and Supply Gap 6

2.5 Imports Vs. Indigenous production, Export Possibility, Domestic/Export Markets

7

2.6 Employment Generation due to the proposed expansion project 7

3.0 Project Description 8

3.1 Type of the project 8 3.2 Location 8 3.3 Alternate sites 8

3.4 Size or magnitude of operation 9

3.5 Project description with Process Details

10 3.6 Raw materials 10 3.7 Resources optimization / recycling and reuse 10 3.8 Availability of water and Energy 11

3.9 Quantity of Wastes Generation and their Management / Disposal

11

3.9.1 Water requirement and Wastewater generation and their Management / Disposal

11

3.9.2 Hazardous / Solid Waste Generation, Handling and their Disposal

13

3.10 Schematic flow sheet for EIA procedure 15

4.0 Site Analysis 15

4.1 Connectivity 15 4.2 Land Form, Land use and Land ownership 15 4.3 Topography 15 4.4 Existing Land use pattern 15 4.5 Existing Infrastructure 16 4.6 Soil Classification 16

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S. No. Description Page No.

4.7 Climate data from Secondary sources 16 4.8 Social Infrastructure 17

5.0 Planning 17 5.1 Planning Concept 17 5.2 Population Projection 17 5.3 Land use planning 17 5.4 Assessment of Infrastructure Demand 18 5.5 Amenities/Facilities 18

6.0 Proposed Infrastructure 18 6.1 Industrial Area 18 6.2 Residential Area 18 6.3 Green Belt 18 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 6.9 Hazardous/ Solid Waste Management 21 6.10 Power Requirement & Supply / Source 22

7.0 Rehabilitation and Resettlement (R&R) Plan 22 8.0 Project Schedule & Cost Estimates 22

8.1 Time Schedule for the project construction 22 8.2 Estimated project cost 22

9.0 Analysis of proposal (Final Recommendations) 22 9.1 Budgetary allocation for Pollution Control Measures 23

iii

List of Tables

Table Title Page No.

1 Coordinates of all Corners of the Project Site 8

2 Permitted (Existing) as per CFO and their Capacities 9

3 Proposed Products (as per EC 2007) and their Capacities 9

4 Existing Water Requirement, Wastewater Generation and its Treatment 10

5 Proposed Water Balance and segregation and Treatment 12

6 Proposed Water Balance, Segregation and Treatment Method 12

7 Effluent Treatment Flow for as per Segregation 13

8 Permitted Hazardous Waste Generation from the Existing Products

14

9 Proposed Hazardous / Solid Waste Generation from the Proposed Products

14

10 Environmental Components Shortest distance from Project Periphery

15

11 Break up of proposed land use pattern 18

12 Maximum Quantity of Process Emission for Proposed Products 19

13 Stack Emission Details 21

14 Budgetary allocation for Pollution Control Measures 23

iv

LIST of Annexures

Annexure No.

Title Page No.

I CFE in the name of M/s. Saiteja Drugs and Intermediates Pvt Ltd. vide No. 5036/PCB/ZO/RCP/CFE/2000-130 dated 03-11-2000

24

II CFO in the name of M/s. Saiteja Drugs and Intermediates Pvt Ltd. vide order No. APPCB/ PTN/NGL/227/RO/W/2003/ 27-572 dated 09-07-2003

27

III ROC copy 33

IV CFE in the name of M/s. Saiteja Drugs and Intermediates Pvt Ltd for

change of product mix for manufacturing bulk drug (APIs) Intermediates

vide order No. 503/PCB/ZO/RCP/CFE/2005-334 dated 03-08-2005

34

V CFO in the name of M/s. Saiteja Drugs and Intermediates Pvt Ltd vide

order No. APPCB/PTN/NGL/237/RO/W/2003/760-29 dated 31-03-2006 40

VI latest CFO is TSPCB/16642/NLG/110/CFO/2016-2694 dated 24-02-2016

valid upto 31-01-2018 45

VII CFE for Expansion vide order No. NAL-35/PCB/ZO/RCP/CFE/2006-690

dated 18-08-2006 52

VIII Environmental Clearance from MoEF vide F.No. J-1101/4501/2006-IA II

(I) dated 22-08-2007 58

IX Public Hearing by APPCB on 07-06-2006 and its minutes 63

X EC Extension online application Acknowledgment 73

XI General Location Map 74

XII Specific Location (Route Map) 75

XIII Google Map with project site coordiantes 76

XIV Plant layout 77

XV Project description & Flow Chart 78

XVI List of Raw materials 89

XVII List of Hazardous chemicals 94

XVIII Schematic flow Sheet for EIA Procedure 95

XIX ETP Flow Chart 97

XX Topomap 98

M/s. Saiteja Drugs and Intermidiates Pvt. Ltd. Pre-Feasibility Report

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Pre-Feasibility Report for Active Pharmaceutical Ingredients (APIs) Manufacturing Unit with R&D facility

1.0 Executive Summary

M/s. Saiteja Drugs and Intermidiates Pvt Ltd. API & Intermediates manufacturing unit is

located at Sy. No. 543/A, 544/A, Seetavani Gudem (V), Bhoodan Pochampally (M), Yadadri

District, Telangana State. The industry had already obtained Environmental Clearance Vide F.No.

J-1101/4501/2006-IA II (I) dated 22-08-2007 and Consent for Establishment from the then APPCB

(presently TSPCB) but however, has not implemented the Expansion activity owing to various

reasons.

Background of the Industry:

Industry was established in the year 2000 in the name of M/s. SGVS Pharma Pvt. Ltd. and

obtained CFE vide order No. 5036/PCB/ZO/RCP/CFE/2000-130 dated 03-11-2000 (Annexure-I) to manufacture Piperazine and FQ Acid and obtained CFO from APPCB vide order No. APPCB/

PTN/NGL/227/RO/W/2003/ 27-572 dated 09-07-2003 (Annexure-II). Subsequently, the Industry

changed its name to M/s. Saiteja Drugs & Intermidiates Pvt. Ltd. in the year 2003. ROC copy

enclosed as Annexure-III.

Industry obtained CFE for change of product mix for manufacturing bulk drug (APIs) Intermediates

vide order No. 503/PCB/ZO/RCP/CFE/2005-334 dated 03-08-2005 (Annexure-IV) and CFO vide

order No. APPCB/PTN/NGL/237/RO/W/2003/760-29 dated 31-03-2006 (Annexure-V) in the name

M/s. Saiteja Drugs & Intermidiates Pvt. Ltd. and Renewing the Consent for Operation regularly and

the latest CFO is TSPCB/16642/NLG/110/CFO/2016-2694 dated 24-02-2016 valid upto 31-01-

2018 (Annexure-VI).

In 2006 (prior to EIA Notification 14-09-2006) Industry has proposed for expansion to manufacture

the APIs and obtain the CFE from APPCB vide order No. NAL-35/PCB/ZO/RCP/CFE/2006-690

dated 18-08-2006 (Annexure-VII) as per EIA Notification 1994 and also obtained the

Environmental Clearance from MoEF vide F.No. J-1101/4501/2006-IA II (I) dated 22-08-2007

(Annexure-VIII) after completion of the Public Hearing by APPCB on 07-06-2006 and the minutes

are enclosed as Annexure-IX.

However industry could not complete the expansion activity due to various issues as per

Expansion CFE & EC but continuing the CFO of permitted products of manufacturing

intermediates of bulk drugs that were permitted prior to the EC. The management has since

changed in the year 2007, i.e., during the issue of EC, unaware of the availability of EC the new

management could not submit to the Ministry an application for extension of EC.


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The industry hence, has submitted an application on 30-01-2017 (Acknowledgment enclosed as

Annexure-X) for extension of EC and however as the validity of the EC lapsed beyond 10 years,

the Hon’ble EAC committee suggested us to submit a fresh application for the same. Hence, this

application in Form I and PFR is being submitted seeking Environmental Clearance for the same

project for which it was issued in 2007.

Now industry is submitting Form 1 application for ToR & EC for the products as per previous EC

dated 22-08-2007 with a request to exempt the industry from Public Hearing and Baseline studies

as it was completed as per previous EC.

Industry is presently manufacturing only bulk drug intermediates as per the latest consent obtained

from TSPCB.

The proposal is to obtain Environmental Clearance (EC) from the Ministry of Environment, Forests

and Climate Change (MoEF&CC) to manufacture earlier EC permitted 3 campaign products at a

time out of 6 APIs and R&D activity with a production capacity of 108 TPA from current CFO

permitted production capacity of 18 TPA from any 1 products out of 4 API Intermediates at a time

with an additional investment of Rs. 3.5 Crores towards EMP activities. This is including the

existing investment of Rs. 14.8 crores. Hence, total proposed investment is Rs.18.3 Crores.

The proposed project falls under the Category ‘A’, project or activity 5(f) according to the

EIA Notification 2006.

1.1 Salient Features of the Project:

• Proposing EC permitted expansion project in the existing area of 2.4897 Ha.

• The proposed project is to manufacture any 3 products out of 6 products with a production

capacity of 108 TPA.

• Total Greenbelt area is 0.825 Ha (33.13%).

• This proposed project site is located at an aerial distance of

• 6.5 km (SSW) to National Highway – 65 (previously NH-9) (Hyderabad -Vijayawada)

• Adjacent to the road which connects to BhoodanPochampally.

• 1.1 km to nearest village & 1.4 km (SE) to Jalalpur village

• 1.6 km (W) to Narayanagiri village

• 2 km (NE) to Seetavanigudem village

• 2.3 km (E) to BhoodanPochampally

• 12.2 km (NW) to Hyderabad ORR

• 14.2 km (N) to Bibinagar Railway Station

• 36 km (SW) to Rajiv Gandhi International Airport, Hyderabad


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• Total cost of the expansion is Rs. 18.3 Crores including existing Rs. 14.8 crores. Additional

investment of Rs. 3.5 crores is exclusively for EMP. Total capital cost allocated towards

environmental pollution control measures is Rs. 3.56 crores including existing investment of

Rs. 0.96 Crores. Recurring cost after expansion will be about Rs. 2.71 crores per annum.

• Total water requirement will be about 173.2 KLD of which fresh water requirement will be

142.7 KLD and balance 31 KLD will be recycled water from ETP. Fresh water will be met

from Groundwater from existing Bore wells / private tankers.

• The proposed power requirement (Connected Load) of the plant is 650 HP including existing.

Power will be met from Telangana State Power Distribution Corporation.

• Proposed DG Sets 380 KVA & 2x125 KVA DG sets including existing 62.5 KVA DG Set.

Proposed 2 lakh Kcal/hr Diesel Thermic Fluid Heater including existing 1 lakh Kcal/hr TFH.

DG sets are used as standby during power failure. Diesel of about 170 lit/hr will be used in

the proposed 380, 2x125 & 62.5 KVA DG sets and for proposed 2 lakh Kcal/hr Diesel

Thermic Fluid Heater including existing 1 lakh Kcal/hr TFH.

• Total 65 employees including existing 50 nos. will be benefitted due to the proposed

expansion project. Out of which 25 will be direct and 40 employees will be indirect.

• Coal of about 20 TPD will be used in the proposed 5 TPH coal fired boiler. Another 3 TPH

coal fired boiler is permitted as per CFE & EC will remain as standby. Existing 1 TPH coal

fired boiler will be dismantled. Additional 5 TPH boiler is proposed for solvent recovery and

ETP-ZLD.

• Industry will provide additional dual scrubbers based on the characteristics of process

emissions. Boiler will be provided with multi-cyclone separator & bag filter to reduce the

particulate emissions into atmosphere.

• The wastewater generated from the plant will be about 33 KLD from process, washing,

utilities, DM regeneration, scrubber, Q.C, R&D and domestic wastewater.

• The effluent will be pumped to the above ground level R.C.C lined tanks for storage and

neutralization then sent to proposed upgraded ETP-ZLD of 40 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 to be sent to cement brick manufacturers.


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• 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. Built-in acoustic

enclosures provided for D.G. set unit to minimize the noise levels. However the workers in

this area will be provided with ear muffs.

Industry has uploaded for Form-I along with draft Terms of Reference (ToR) in MoEF&CC

website, in the process of obtaining ToR for preparation of EIA, in line with issue of Environmental

Clearance. Hence, a technical pre-feasibility report highlighting the expansion project and the

various operations including waste generation and mitigation measures are prepared & submitted

to the Environmental Appraisal Committee (EAC) for issuing ToR.

2.0 Project Highlights

2.1 Identification of the Project and Project Proponent

Industry was established in the year 2000 in the name of M/s. SGVS Pharma Pvt. Ltd. to

manufacture Piperazine and FQ Acid.

• First CFE vide order No. 5036/PCB/ZO/RCP/CFE/2000-130 dated 03-11-2000 & CFO vide

order No. APPCB/PTN/NGL/227/RO/W/2003/27-572 dated 09-07-2003 in the name of M/s.

SGVS Pharma Pvt. Ltd.

• Industry changed its name to M/s. Saiteja Drugs & Intermidiates Pvt. Ltd. in the year 2003.

• Industry obtained CFE for change of product mix for manufacturing bulk drug (APIs)

Intermediates vide order No. 503/PCB/ZO/RCP/CFE/2005-334 dated 03-08-2005 and CFO

vide order No. APPCB/PTN/NGL/237/RO/W/2003/760-29 dated 31-03-2006 in the name

M/s. Saiteja Drugs & Intermidiates Pvt. Ltd.

• Latest consent to operate to manufacture API Intermediates obtained from TSPCB vide order

No. TSPCB/16642/NLG/HO/CFO/2016-2694 dated 24-02-2016 valid upto 31-01-2018.

• Industry has proposed for expansion to manufacture the APIs and obtain the CFE from

APPCB vide order No. NAL-35/PCB/ZO/RCP/CFE/2006-690 dated 18-08-2006 as per EIA

Notification 1994 and also obtained the Environmental Clearance from MoEF vide F.No. J-

1101/4501/2006-IA II (I) dated 22-08-2007 after completion of the Public Hearing by APPCB

on 07-06-2006.

• However industry could not complete the expansion activity in time due to various constraints

as per CFE-Expansion & EC.

• Industry is continuing the manufacture bulk drug intermediates only with valid CFO. Total

existing production capacity is 18 TPA, to manufacture one product out of 4 products at any

given point of time.


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• As the industry is in completion stage as per EC dated 22-08-2007 & CFE from APPCB vide

order No.NAL-35/PCB/ZO/RCP/CFE/2006-690 dated 18-08-2006, submitted Form 1

application for EC validity extension to MoEF&CC on 30-01-2017. EAC (Industry-2) has

considered the proposal for EC validity extension in 21st EAC meeting on 27-03-2017 and

directed the industry to submit a Fresh Form 1 application for ToR as the 10 years EC

validity was expired

• Industry proposes its expansion of APIs manufacturing unit from API Intermediates in the

total existing area of 2.4897 Ha located at Sy. No. 543/ A, 544/ A, Seetavani Gudem (V),

Bhoodan Pochampally (M), Yadadri District (formerly Nalgonda District), Telangana State.

The proposal is to obtain Environmental Clearance from the Ministry of Environment, Forests

and Climate Change (MoEF&CC) and Consent for Establishment from TSPCB.

• Total investment for the proposed project is about Rs.18.3 Crores including existing

investment of Rs. 14.8 crores. Industry has already invested as per earlier EC except for

additional EMP. Additional investment is for additional boiler, cooling towers and DG set for

EMP.

Project Proponent: Mr. K Chandrasekhara Reddy is a graduate from Nagarjuna University in Organic Chemistry in the

year 1983. He started his career with “Standard Organics Limited” in the year 1984 as technical

assistant till 1986, from 1986 to 1992 worked with “Dr Reddy’s Laboratories Ltd” and earned vast

experience in Bulk Drugs and API and he is active in Trading of chemicals from 1992 to 1998. He

completed his Post Graduation in the year 1995.

He started his own industry at Jeedimetla in 2000 under the name of “Shree Vinayaka Chemicals”

subsequently it was changed as “Shree Vinayaka Life Sciences Pvt Ltd”. Since then, he had been

successfully managing the company as Managing Director providing the right directions and

leadership in developing the products, upgrading the facilities and expanding the market.

He has purchased another unit of M/S. Saiteja Drugs and Intermidiates Pvt. Ltd., (formerly known

as SGVS Pharma Pvt Ltd) situated at Bhoodhan Pochampally, Nalgonda District in the year 2007”.

He put all his efforts to develop the Industry and succeeded and it is running successfully.

2.2 Brief Description of Nature of the Project

The project proponent proposes for extension of Environmental Clearance (EC) only as per

EIA Notification 2006, the project is 5 (f) Synthetic Organic Chemical Industry (Bulk Drug (API) &

Intermediates). The products manufactured are used in API formulation industry and the

therapeutic category of the products is Anti-ulcerative, Antidiabetic, Anti-thrombotic etc., which are

applicable for human consumption around the world after formulation activity.


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The manufacturing process of APIs consists of chemical synthesis and multiple stage of

processing extending to maximum of ten stages involving different types of chemical reactions.

The entire process operations are operated by various technical, skilled and unskilled persons with

due care to be met various standards prescribed by authorities.

Technology for manufacturing the products listed under proposed expansion is available

from in-house R&D & private consultants and proposes to adopt new technologies and techniques

that are continuously refined in every stage of manufacturing to meet global standards. Industry

will implement the proven technologies in the R&D for the cost effective & environment friendly

practices.

2.3 Need for the Project and its Importance to the Country and or Region

The Indian pharmaceutical industry valued at $16 billion has portrayed tremendous

progress with reference to infrastructure development, technology base creation and a

wide range of production. India has achieved an eminent global position in pharma

sector. The Indian pharmaceuticals market is third largest in terms of volume and thirteen

largest in terms of value, as per a pharmaceuticals sector analysis report by equity master.

The market is dominated majorly by branded generics which constitute nearly 70% to 80%

of the market. The Indian pharmaceutical industry is estimated to grow at 20% compound

annual growth rate (CAGR) over the next five years, as per India Ratings. The domestic

pharma growth rate was 11.9% in October 2015.

It is estimated that by the year 2015, the Indian pharmaceutical industry has the potential to

achieve over Rs.2,00,000 Crore in formulations and bulk drug production. The industry now

produces bulk drugs belonging to all major therapeutic groups requiring complicated

manufacturing process and has also developed Good Manufacturing Practices (GMP)

facilities for the production of different dosage forms.

The pharma industry exports APIs and pharmaceuticals worth over $ 14.9 billion in 2013-

14. It ranks 17th in terms of export value of bulk activities and dosage. Indian exports cover

more than 200 countries including the highly regulated markets of USA, Europe, Japan and

Australia.

At a growth rate of 12% per year, the pharmaceutical industry in India is well set for rapid

expansion. As a result of the expansion, the Indian pharmaceutical and healthcare market

is undergoing a spurt of growth in its coverage, services, and spending in the public and

private sectors.

2.4 Demand and Supply Gap

The products manufacture by the proponent has demand from China, Japan, Middle East,

Latin American countries and other Asian countries etc. In addition, the products are consumed in


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domestic market by Dr. Reddy labs, Mylan etc. It is reported that there is increase in the

consumption of these products by about 5-6% every year. As Indian industries are importing from

neighbouring countries and western countries, indicates the gap in the demand and supply of the

products in the domestic markets.

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 lifesaving drugs i.e., Anti-

Cancer Drugs, Anti ulcerative, etc. We are importing from China – the Third generation Antibiotics

mainly Cephalosporin intermediates that are of very high value. Most of our imports are from

Chinese companies and thus we are losing our valuable foreign reserves to China. As mentioned

above the imports have gone up from $ 2.9 billion in 2011 to about $ 4.6 billion in 2012 on account

of APIs, Pharmaceuticals and fine chemicals. During the same period the imports of formulations

has also doubled. The Chinese, American and European markets play a very vital role in the

supply of these products to our country. This clearly indicates that there is tremendous scope for

developing the indigenous products by reducing the imports and thus saving the foreign exchange

reserves of the country. 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 from Rs.8007 in 2005 to

Rs.16565 Crores in 2009. This shows the acceptability of the products produced in India. The

formulations market has shown a tremendous increase in the exports from about Rs.9500 to

Rs.23700 Crores during the same period. 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. The figures mentioned above are

sourced from BDMA.

2.6 Employment Generation due to the Proposed Project

The following table shows the manpower requirement after expansion of the proposed

project:

Type Existing (No. of persons)

Proposed (No. of persons)

Total after Expansion

Direct 20 5 25 Indirect 30 10 40 Total 50 15 65


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3.0 Project Description

3.1 Type of the project

Proposed expansion project falls under category ‘A’ as per EIA Notification 2006 under the

item No. 5 (f). There are no interlinked projects.

3.2 Location

The unit is located at Sy. No. 543/ A , 544/ A, Seetavani Gudem (V), Bhoodan Pochampally

(M), Yadadri District (formerly Nalgonda district), Telangana state. The proposed project site has

coordinates of all corners is presented in Table 1. The study area represents Rural Environment.

Table 1: Coordinates of all corners of the Project site

Sl. No. Latitude Longitude

1. 17°20'37.76"N 78°47'30.76"E 2. 17°20'37.82"N 78°47'34.07"E 3. 17°20'29.23"N 78°47'33.90"E 4. 17°20'29.19"N 78°47'30.95"E

The map showing general location, specific location, Google map showing the Coordinates

and plant layout of the total Project and existing project is enclosed at Annexures XI, XII, XIII & XIV respectively.

3.3 Alternate sites

This proposed expansion project is as per the permitted EC products in the existing plant

area at Seetavanigudem village. Hence no alternate sites were considered.

Environmental considerations of this project site.

This proposed project is in existing industry land.

Human habitation is more than 1.1 km in ENE & Jalalpur village is at 1.4 km (SE)

Musi River – 6 km (NW) & Chinna Musi River – 2.3 km (SE) Pond near Maddivanigudem – 1.3 km (N) Pond near Seetavanigudem – 1.5 km (NE) Pond near BhoodanPochampally – 2.8 km (NE) Pond near Revanpalli – 4.7 km (NE) Pond near Mukthapuram – 2.5 km (NNE) Pond near Alingar – 4.1 km (NNW) Pond near Jolur – 4.4 km (NNW) Pond near Peddagudem – 4.5 km (NW) Pond near Yenkirala & Madaram – 7 km (NW) Pond near Yenkirala – 8.3 km (NNW) Pond near Raghavapuram – 9 km (N) Ponds near Khapraipalli – 5.7 km (N), 6.5 km (NNE) & 5.5 km (NNE) Pond near Ravulapalli Kalan – 8.5 km (NE)


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Pond near Ghauskonda – 5.7 km (NE) Pond near Ramalingampalli – 7.3 km (NE)

There are 4 reserve forests.

• Jalapur RF – 0.75 Km (SW) • Meharnagar RF – 2.8 Km (SSW) • Malkapuram RF – 6.5 (SSE) & 8.6 (SSE) • Lakkaram RF – 9.5 Km (SE)

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: 2.4897 Ha. Production Capacity: 108 TPA from 3 out of 6 products at any

given point of time.

Products: The permitted and proposed products along with its production capacities are presented

in Tables 2 & 3.

Table 2: Permitted (Existing) as per CFO and their Capacities

SI. No. Product

Quantity (kg/day) (TPA)

1. 1-Acetyl-4-(4-Hydroxy Phenyl) Piperzine (manufactured in two stages and used as raw material in the 7th stage of Ketaconazole)

50 18

2. 5-Cyano Phthalide (manufactured in three stages and used as raw material in the 4th stage of Citalopram Hydro bromide)

50 18

3. Cis-Bromo Benzoate (manufactured in three stages and used as raw material in the 4th stage of Ketaconazole)

50 18

4. Cis-Tosylate manufactured in two stages and used as raw material in the 6th stage of Ketaconazole)

50 18

Any 1 product on campaign basis out of 4 products at a time 50 18 Source: M/s. Saiteja Drugs and Intermediates Pvt Ltd.

Table 3: Proposed Products (as per EC 2007) and their Capacities

SI. No. Product

Quantity Therapeutic Category (kg/day) (TPA)

1. Sidenafil Citrate 100 36 Anti-erectile dysfunction

agent 2. Omeprazole 100 36 Anti-ulcerative 3. Lansoprazole 100 36 Anti-ulcerative 4. Pantoprazole 100 36 Anti-ulcerative 5. Glimepiride 100 36 Antidiabetic 6. Clopidogrel Hydrogen Bisulfate 100 36 Anti-thrombotic

Any 3 products on campaign basis out of 6 products at a time 300 108

Source: M/s. Saiteja Drugs and Intermidiates Pvt Ltd.


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3.5 Project Description with Process Details The manufacturing process of APIs consists of chemical synthesis extending to maximum

of 10 stages of processing involving different types of chemical reactions. Typical process

description with process details is enclosed at Annexure-XV. These drugs are mainly used for

human medication after formulation activity for various diseases. Industry will implement the

proven technologies in the R&D for the cost effective & environment friendly practices. The plant

layout showing existing and proposed components of the project is enclosed at Annexure-XIV.

3.6 Raw Materials

The raw materials required for the manufacture of proposed products are the chemicals

and the fuel.

• The 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.

• Coal consumption will be 20 TPD for the proposed 5 TPH. Another proposed 3 TPH boiler

will be standby. Existing 1 TPH coal fired boiler will be dismantled.

• Diesel of about 170 lit/hr will be used in the proposed 380 KVA & 2x125 KVA DG sets

along with existing 62.5 KVA DG set and proposed 2 lakh Kcal/hr Diesel Thermic Fluid

Heater including existing 1 lakh Kcal/hr TFH.

• The total power requirement of the proposed plant is 650 HP KVA including existing.

• Mode of transportation of all raw materials and finished products from the project site is by

road to local markets and by road / rail / sea if exported.

The chemicals (raw materials) required for the manufacture of proposed products is

presented at Annexure – XVI and Hazardous chemicals list is presented at Annexure – XVII.

3.7 Resources Optimization / Recycling and Reuse

R&D facility in the unit is taking 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 industry.

Industry is proposing for up gradation of 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 and spent carbon will continue to be sent to Authorized Cement industries to

burn in Cement Kiln as an alternate fuel.

Boiler ash will continue to be sent to Cement Brick manufacturing units.

Waste / Used oil will be sent to Authorized Waste / Used oil Reprocessing units.


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Container & container liners of hazardous chemicals, Polythene / HDPE Bags, broken plastic

drums shall be disposed of to outside agencies after complete detoxification.

Spent catalyst will be sent back to supplies

Waste Lead acid batteries will be sent back to suppliers on buy back basis.

Optimum utilization of solar energy.

Recycling and reuse of by-products, solvents generated during the process will also be

planned properly thereby implementing the clean manufacturing techniques.

3.8 Availability of Water and Energy

The total fresh water requirement is about 142.7 KLD which will be met from Groundwater

from existing bore well/ through 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 total power requirement will be met from Telangana State Power Distribution

Corporation Limited (TSPDCL). 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 permitted, proposed water requirement and wastewater generation with its proposed

treatment is presented in Tables 5 & 6 respectively. The sources of wastewater generation are

from the process, floor & reactor washes, utilities, Q.C, R&D, scrubber and plant domestic waste.

Total proposed wastewater will be 33 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 R.C.C lined tanks for storage and neutralization then sent to

ETP-ZLD. The effluents segregated quantity, characteristics and treatment flow is briefly

presented in Table 7.


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Table 5: Existing Water Requirement, Wastewater Generation and its Treatment

Description Water

Requirement (KLD)

Wastewater Generation

(KLD) Treatment Method

Process & Washings 1.1 0.95

• Effluent stripped for recovery of organics

• Stripper condensate to distillate for organics recovery.

• Stripped effluents to forced evaporation in the MEE followed by Nutch filter.

• Condensate from MEE to the LTDS treatment system.

• Salts from Nutch filter to TSDF. Boiler feed & Cooling make up 16 1.55 • RO permeate water to boiler / cooling

tower makeup • RO rejects to HTDS effluents system

i.e., MEE & ATFD. Domestic 0.5 0.25 Gardening 3 -

Total 20.6 2.75

Table 6: Proposed Water Balance, Segregation and Treatment Method

Description Input (KLD) Output (KLD)

Fresh Water

Recycled Water

Evaporation / Handling Loss

Total Wastewater

Segregation type of Wastewater

Process (3 products at a time)

5.7 -- - 5.7 (6.5 Tons) HTDS/HCOD

Washings (reactor,centrifuges, containers, floor mopping, etc.,)

5 - -- 5 LTDS/LCOD

Boiler (5 TPH)

24 (20 %

Makeup) - 20 4

(Blow down) Utilities (LTDS/LCOD)

Cooling Tower 2000 TR 89 31 110 10

(Bleed)

DM Regeneration 1 -- - 1 HTDS / LCOD

Scrubber 3.5 - - 3.5 HTDS / LCOD Q.C and R&D 1 -- - 1 LTDS/LCOD Domestic (65 nos @50 lpcd) 3.5 -- 0.7 2.8 LTDS/LCOD

Greenbelt (2 acres @ 5 KL/acre)

10 -- 10 - --

Total 142.7 31 140.7 33

Reuse: 27 KLD (Total water loss is 3.5 KLD = 12 %) 173.7 173.7


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Note: 5.7 KLD is 6.5 Tons consists of 5.7 KLD liquid effluent and 0.8 Tons of salts (Max. on various combinations) as per material balance.

Table 7: Effluent Treatment Flow for as per Segregation

Effluent Characteristics

Quantity (KLD) Treatment Flow

Process, DM & Scrubber

HTDS/HCOD & (HTDS)

HTDS > 5000 mg/l HCOD > 5000 mg/l

10.2

Collection Equalization Neutralization Settling Holding Steam stripper MEE along with HTDS effluent Condensate to ETP (biological treatment) Concentrate to ATFD ATFD Condensate to ETP (Biological Treatment) along with domestic wastewater (septic tank overflow) Pressure Sand Filter Activated Carbon Filter R.O R.O rejects to MEE. R.O Permeate & MEE Condensate to cooling tower ATFD Salts to TSDF and stripped solvents to SPCB authorized cement industries

Washings, Boiler, Cooling Tower, QC &

R&D LTDS / LCOD

LTDS < 5000 mg/l LCOD < 5000 mg/l

20 Collection Equalization Neutralization ETP (Biological Treatment) along with MEE Condensate

Domestic 2.8 Collection Tank sent to ETP (Biological Treatment) along with LTDS / LCOD Effluent

Proposing to upgrade the (Effluent Treatment Plant system) ETP capacity to 40 KLD and

flow chart is enclosed as Annexure-XVIII. All the treatment tanks etc., will be constructed /

installed above the ground with water proof lining. This individual effluent will be pumped to the

above ground level R.C.C lined tanks for storage and neutralization then sent to ETP-ZLD.

ETP-ZLD facility consists of primary (equalization and neutralization), secondary (stripper

with MEE, ATFD & biological) and tertiary treatment (PSF, ACF & R.O) will be provided. Domestic

wastewater will be sent to collection tank and then to ETP (biological treatment) along with

LTDS/LCOD. Concentrate from MEE system will be sent to ATFD and the salts from the

evaporation system will be collected and sent to TSDF for safe disposal.

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 manufacturing plant is presented in the Tables 8 & 9 respectively. Spillages

such as wastewater / solid wastes / raw material are possible and the risk of this would be limited


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to within the premises of the manufacturing facility. A precautionary measure like spillage control

management is practiced in the industry.

Table 8: Permitted Hazardous Waste Generation from the Existing Products

Sl. No. Source Stream Quantity

(kg/day) Disposal Option

1. Process residues 28.1 of Schedule-I 236.6 Should be sent to TSDF, Dundigal for incineration 2. Spent carbon 28.2 of Schedule- I 5

3. Forced evaporation salts 34.3 of Schedule-I 100 Should be sent to TSDF,

Dundigal for land filling. 4. ETP Sludge 34.3 of Schedule-I 12

Table 9: Proposed Hazardous / Solid Waste Generation from the Proposed Products

Sl. No. Source

*Proposed Quantity

(TPD) Handling Method Disposal

1. Organic residue 0.45

HDPE Drums

Sent to SPCB Authorized Cement industries / TSDF

2. Spent Carbon 0.03

3. Distillation Bottom Residue (1% of spent solvents)

0.2

4. Inorganic & Evaporation salt (Process) (10% moisture)

0.95

HDPE Bags 5. Evaporation salt (Non-Process)(10% moisture)

0.7

6. ETP Sludge with 50% moisture 0.1

7. Boiler Ash 9.6 Stored in covered area

Sold to Cement Brick Manufacturers

Other Hazardous Waste generation from the Plant

8.

a) Detoxified Container / Liners drums b) HDPE Carboys c) Fiber Drums

200 Nos./ month

Designated covered area

Disposed to SPCB Authorized agencies after

complete detoxification

d) PP Bags 100 Kg/month

9. Spent solvents (with moisture) (solvents 12.9+water 0.5)

13.4 KLD Stored in Drums / Tanks

Recovery within the premises duly sending the residue to

Authorized agencies

10. Recovered Solvents from spent solvents 11.0 KLD

Stored in Drums / Tanks

Reuse in process / Send to authorized recyclers

11. Spent Mixed solvents (3.4 from SRS + 0.2 from ETP)

3.6 KLD Stored in Drums / Tanks

Sent to SPCB Authorized agencies

12. Waste oils & Grease 1 KL/A Stored in Drums

Sent to SPCB Authorized agencies for reprocessing /

recycling.


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13. Used Lead acid Batteries

30 Nos. / annum

Designated covered area

Sent to suppliers on buy-back basis.

14. Misc. Waste (spill control waste) LS Stored in

Drums TSDF

15. Spent Catalyst (Raney Nickel, Potassium carbonate, Camphor Sulfuric Acid)

75.2 TPA Stored in Drums

Sold to suppliers on buy-back basis / auth. reprocessers.

* Solid waste quantities maximum on 3 products at a point of time

3.10 Schematic Flow Sheet for EIA Procedure

The schematic flow sheet for EIA procedure is depicted as Annexure -.XIX.

4.0 Site Analysis

4.1 Connectivity

The proposed project site is at 6.5 km (SSW) to National Highway–65 (previously NH-9)

(Hyderabad -Vijayawada) and adjacent to the road which connects to Bhoodan Pochampally, 1.1

km to nearest village, 1.4 km (SE) to Jalalpur village, 1.6 km (W) to Narayanagiri village, 2 km

(NE) to Seetavanigudem village, 2.3 km (E) to Bhoodan Pochampally, 12.2 km (NW) to Hyderabad

ORR, 14.2 km (N) to Bibinagar Railway Station and 36 km (SW) to Rajiv Gandhi International

Airport, Hyderabad.

4.2 Land Form, Land use and Land Ownership

Total land is 2.4897 Ha. is in possession of Project Proponent.

4.3 Topography

The Topography map with a 10 km radius is enclosed as Annexure-XX.

4.4 Existing Land Use Pattern

The existing and proposed land use pattern of project area (core area) 2.4897 Ha.

Industrial land and shortest distance of environmental components in buffer area from the project

periphery is given in Table 10.

Table 10: Environmental Components Shortest distance from Project Periphery

S. No. Particulars Details (Distance & Direction w.r.t. site)

1. Water bodies • Musi River-6 km (NW) & Chinna Musi River-2.3 km (SE) • Pond near Maddivanigudem – 1.3 km (N) • Pond near Seetavanigudem – 1.5 km (NE) • Pond near BhoodanPochampally – 2.8 km (NE) • Pond near Mukthapuram – 2.5 km (NNE) • Pond near Alingar – 4.1 km (NNW) • Pond near Jolur – 4.4 km (NNW) • Pond near Peddagudem – 4.5 km (NW)


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• Pond near Yenkirala & Madaram – 7 km (NW) • Pond near Yenkirala – 8.3 km (NNW) • Pond near Raghavapuram – 9 km (N) • Ponds near Khapraipalli – 5.7 km (N), 6.5 km (NNE) &

5.5 km (NNE) • Pond near Ravulapalli Kalan – 8.5 km (NE) • Pond near Ghauskonda – 5.7 km (NE) • Pond near Ramalingampalli – 7.3 km (NE) • Pond near Revanpalli – 4.7 km (NE)

2. Reserve Forests Following Reserved forest are present such as • Jalapur RF – 0.75 Km (SW) • Meharnagar RF – 2.8 Km (SSW) • Malkapuram RF – 6.5 (SSE) & 8.6 (SSE) • Lakkaram RF – 9.5 Km (SE)

3. National Parks/ Wild Life Sanctuaries/ Eco sensitive areas

Nil

4. Habitation • 1.1 km to nearest village & 1.4 km (SE) to Jalalpur village

• 1.6 km (W) to Narayanagiri village • 2 km (NE) to Seetavanigudem village • 2.3 km (E) to BhoodanPochampally

4.5 Existing Infrastructure Internal CC roads, 6.5 Km (SSW) to National Highway – 65 (previously NH-9) (Hyderabad

–Vijayawada and adjacent to the road which connects to Bhoodan Pochampally. Transportation

facilities, water supply, Power supply, Conference hall, Telecommunication facility etc., are

available.

4.6 Soil Classification

The soil in the project site is Red with Silty clay texture..

4.7 Climate Data from Secondary Sources

The project area comes under the Deccan Plateau of vast triangular platform of peninsular

shield, which is the most distinctive physiographic unit of India. The area is represented by

undulating topography marked by scattered hillocks, domes, ridges, Irregularities of land are also

operations to assess the environmental quality frequently observed.

The area enjoys pleasant, warm and dry climate. The coldest season is during December

and January, where the temperature touch a minimum of 12-16°C and warmest period is during

the month of April to May when the Mercury shoots up to 43 - 46 °C.

The area experiences the maximum rainfall during the months of June to September and a

little rainfall during October and November due to North-East monsoon. Apart from these,


17

occasional rainfall is obtained from cyclonic storms and depression originating in the Bay of

Bengal. The average annual rainfall of the area is 786 mm. The rainfall is erratic and long period

of dry spells leading to drought conditions are frequent and periodic. The relative humidity ranges

between 75-95% during monsoon and 35-40% in summer afternoon.

4.8 Social Infrastructure

National Highway no. 9 (Hyderabad -Vijayawada) is at 6.5 km (SSW), road network,

transportation facilities, power supply, fire station and other basic amenities such as

telecommunication facility, education centre, hospitals, community halls are available at

BhoodanPochampally at 2.3 km (E).

5.0 Planning

5.1 Planning Concept

Type of Industry: The proposed project is within the existing premises to expand the production

from API intermediates to APIs Manufacturing Unit with R&D facility.

Facilities: Industry proposed its API manufacturing unit at existing land and facilities required for

the project will be provided as per requirement.

Transportation: Transportation of raw material and final products is done via roads as the

proposed project is well connected with roads, rail and airways.

Town and Country Planning Classification: This is existing industry land and private land

converted to industrial use and is in possession of project proponent.

5.2 Population Projection

There is a scope for increase in the population from the proposed expansion project.

Skilled workers prefer to stay in the nearby locations to avoid travelling from long distances. Local

non-technical villagers will be preferred for the unskilled jobs such as gardening, movement of

materials, etc. Local / Non local educated youth will be employed as semi-skilled workers and

training will be provided. Hence, there is a possibility of increase in population of the skilled and

semi-skilled. However, on the whole there is a possibility of little increase in population of the area.

5.3 Land use Planning

The unit has been proposed in the existing land. Land use pattern of the project area is

given in Table 11.


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Table 11: Break up of proposed land use pattern

S. No.

Purpose

Area after expansion

% Sq.m 1. Built up area 3597.28 14.45 2. Green belt 8250 33.13 3. Roads 13050.32 52.42 4. Open area

Total 24897.6 100

5.4 Assessment of Infrastructure Demand

On assessment of infrastructure demand near the project area Hospital with Ambulance

facility and Fire station is requirement for the nearby villages of project area.

5.5 Amenities/Facilities

Industry will continue to provide and upgrade the following amenities / facilities in the

proposed expansion project.

• Canteen • Potable drinking water • Training block • Laying of Black top / Concrete internal roads • Fire hydrant facility • Eye/body wash showers • First Aid kits at all prominent places. • Head nurse for emergency medication. • Rest Room for employees • Seating facilities for those employees who do their work standing and ergonomically

designed sitting facilities for those who do their work sitting • 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 block, administration facilities, utility area, ETP area are been

proposed in the area.

6.2 Residential Area :

There will be no residential area within the project site.

6.3 Greenbelt

The unit has been proposed in existing area about 2.4897 Ha i.e., 24897.6 sq.m. Out of

which about 0.8259 Ha i.e. 8250 sq.m is allocated for greenbelt area which is equivalent to


19

33.13% of the total area.

6.4 Social Infrastructure

As a Corporate / Entrepreneur Social Responsibility (ESR), Industry will contribute for

development of village social infrastructure.

6.5 Connectivity

There is no change in connectivity compare to existing facility.

6.6 Drinking Water Management

Potable drinking water will continue to be provided to all employees. The source of drinking

water is Groundwater/ private tankers.

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 ETP – ZLD system which needs to be

upgraded to meet the project demand.

6.8 Industrial Waste Management

Existing storage system needs to enhance to meet the project demand. The management

of these wastes is to be handled very sensitively and by adopting proper segregation techniques.

Liquid Waste Management: The liquid wastes from the various industrial activities will continue to

be segregated and send to ETP-ZLD.

Process Emissions Management:

Manufacturing of APIs will result in gaseous emissions. Maximum Process emissions from

proposed products are given in Table 12 respectively. Proposed gaseous emissions will be

scrubbed in two stage scrubbers with water or other liquid based on the characteristics of gases.

Table 12: Maximum Quantity of Process Emission for Proposed Products

Sl. No.

Process Emission

Maximum Quantity on various combinations

(kg/day) Treatment Method

1. HCl 121 Scrubber with water / caustic sol. 2. H2 10 Diffused with flame arrestor 3. SO2 133 Scrubber using caustic sol. 4. CO2 42 Dispersed into atmosphere

Fugitive emissions Management:

Solvents used in the APIs manufacturing process will be stored in drums and bulk

quantities will be stored in underground/ above ground storage tanks.


20

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.

The 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 connected to vent condensers.

The height of the solvent receiver tank vent is above production block roof level and the

diameter is 20 mm.

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.

Solvent Input Solvent Loss in Effluent

Solvent Loss in Org. residue

Solvent Loss (Evaporation)

Solvent Recovery

Solvent Recovery

(KLD) (KLD) (KLD) (KLD) (KLD) (%) 13.75 0.087 0.163 0.586 12.93 94.04

Emissions from Utilities Management:

Boilers and DG sets are the two main sources contributing to emissions from the plant.

Proposed coal fired boiler will be 5TPH in addition to the existing 1 TPH coal fired boiler. Another

proposed 3 TPH coal fired boiler will be standby. Diesel will be used for proposed 2 lakh Kcal./hr

TFH in addition to the existing 1 lakh Kcal./hr TFH and Proposed 380 KVA & 2 x125 KVA DG Sets

including existing 62.5KVA DG Set. DG Sets will be used as standby power during power failures.

The emissions from the boiler are given in Table 13.


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Table 13: 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 Boiler 5 TPH 30 0.6 150 13308 13.1 0.675 7.08 4.05 3 TPH

(Standby) 30 0.5 150 7985 11.3 0.41 4.25 2.43

Existing Boiler 1 TPH 30 0.3 150 2662 10.4 0.135 1.42 0.81

Proposed Diesel fired thermic fuel heater 2 lakh Kcal/hr 30 0.2 150 868 7.68 0.004 0.088 0.094

Existing Diesel fired thermic fuel heater 1 lakh Kcal/hr 30 0.1 150 434 15.4 0.002 0.044 0.047

DG Sets 380 KVA 8 0.2 150 2146 18.9 0.02 0.48 0.51 125 KVA 7 0.1 150 706 24.9 0.008 0.16 0.17 62.5 KVA 6 0.1 150 353 12.5 0.004 0.08 0.084

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,

30m height stack each will be installed.

The 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. The NOx

emissions will be restricted to below 500 mg/Nm3.

Stacks will be provided to proposed D.G 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.

Noise Management:

• Compressors, Boilers and DG sets will be the major noise generating units in the plant.

• The 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, boiler ash


22

spent mixed unrecoverable solvents and spent carbon.

• The organic residues, Spent carbon & Spent mixed unrecoverable solvents 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

Power supply 650 HP will be drawn from the nearby sub-station of TSPDC. D.G. set will be

used as alternate arrangement in case of failure in power supply. Proposed 380 KVA & 2 x 125

KVA D.G. sets in addition to the existing 62.5 KVA DG set.

7.0 Rehabilitation and Resettlement (R&R) Plan

The proposed project is in the existing land and is in possession of project proponent.

Therefore Rehabilitation and Resettlement plan is not applicable to this expansion project. The

nearest habitation is away from 1 km away from the project site.

8.0 Project Schedule & Cost Estimates

8.1 Time Schedule for the project construction

The timelines for commencement of proposed operation will be from April 2018 as it is

expected that the expansion project will be in a position to obtain Environmental Clearance &

Consent for Operation for the project. In December 2018 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. 18.3 Crores including existing Rs.14.8 Crores. Total capital cost

allocated towards environmental pollution control measures is Rs. 3.56 Crores (incl. existing Rs.

0.96 Cr) and the Recurring cost will be about Rs. 2.71 crores per annum.

9.0 Analysis of proposal (Final Recommendations)

• The proposed expansion project will result in growth of surrounding area by generating direct

and indirect employment to local people. Around 65 members will be benefitted due to the

expansion project (incl. existing 50 nos.).

• Under the Corporate Social Responsibility the Industry will continue to develop a policy of

developing the villages in the vicinity by identifying the requirements.


23

• No adverse effect on environment is envisaged as proper mitigation measures will be taken

up.

• 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.

• The 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 existing and proposed capital equipment for

environmental management include effluent treatment plants, pipelines and channels for

wastewater discharge, greenbelt development, environment laboratory, fire, occupational health

etc., The break-up of budgetary allocation for various control measures is presented in Table 14.

Table 14: Budgetary allocation for Pollution Control Measures

S. No. Description

Existing cost (in lakhs)

Proposed cost (in lakhs)

Capital Capital *Recurring Air Pollution Control 1. Multicyclone& Bag filter with Stacks 5 15 5 2. Scrubbers 5 15 Water Pollution Control

3. ETP Civil works, Steam stripper, MEE, ATFD, R.O. and mechanical equipment 50 150 120

Noise Pollution Control 4. Silencers / acoustic enclosures 1 6 1 Solid Waste Management

5. Covered Platform with leachate collection system 2 3 85**

6. Greenbelt Development 5 5 5 7. Occupation Health and Safety 3 6 5 8. Fire Management 10 20 5 9. Dyke walls and Storm water drains 5 10 5

10. Environmental Laboratory 5 10 10 11. Misc. 5 20 30

Total 96 260 271 *Recurring cost includes manpower, consumables, maintenance, energy charges per annum

** includes transportation and handling charges

ANNEXURES

ANNEXURE - I

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ANNEXURE - I

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ANNEXURE - I

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ANNEXURE - II

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ANNEXURE - II

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ANNEXURE - II

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ANNEXURE - II

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ANNEXURE - II

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ANNEXURE - III

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ANNEXURE - IV

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ANNEXURE - IV

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ANNEXURE - IV

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ANNEXURE - IV

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ANNEXURE - IV

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ANNEXURE - IV

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ANNEXURE - V

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ANNEXURE - V

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ANNEXURE - V

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ANNEXURE - V

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ANNEXURE - VI

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ANNEXURE - VI

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ANNEXURE - VI

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ANNEXURE - VI

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ANNEXURE - VI

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ANNEXURE - VI

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ANNEXURE - VI

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ANNEXURE - VII

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ANNEXURE - VII

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ANNEXURE - VII

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ANNEXURE - VII

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ANNEXURE - VII

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ANNEXURE - VII

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ANNEXURE - VIII

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ANNEXURE - VIII

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ANNEXURE - VIII

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ANNEXURE - VIII

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ANNEXURE - VIII

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ANNEXURE - IX

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ANNEXURE - IX

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ANNEXURE - IX

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ANNEXURE - IX

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ANNEXURE - IX

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ANNEXURE - IX

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ANNEXURE - IX

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ANNEXURE - IX

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ANNEXURE - IX

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ANNEXURE - IX

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1/30/2017 Gmail Acknowledgement Slip for EC application

https://mail.google.com/mail/?ui=2&ik=6bbe8b6e6d&view=pt&search=inbox&th=159efb764c396f2e&siml=159efb764c396f2e 1/1

saitejadrugsintermediates <[email protected]>

Acknowledgement Slip for EC application 1 message

monitoring[email protected] <monitoring[email protected]> Mon, Jan 30, 2017 at 7:40 PMTo: [email protected], [email protected]: monitoring[email protected], [email protected]

Acknowledgement Slip for extension of validity of EC

This is to acknowledge that the proposal for extension of validity of EC has beensuccessfully uploaded on the portal of the Ministry. The proposal shall be examinedin the Ministry to ensure that required information has been submitted. An email willbe sent for seeking additional information , if any, within 20 working days. Onceverified, an acceptance letter shall be issued to the project proponent.

Following should be mentioned in further correspondence

1. Proposal No. : IA/TG/IND2/62138/20072. Category of the Proposal : Industrial Projects 23. Name of the proposal : M/s. Saiteja Drugs and Intermediates Pvt. Ltd.4. Date of submission : 30 Jan 20175. Name of the Project proponent along with contact details

a) Name of the proponent : SAITEJA DRUGS AND INTERMEDIATESPRIVATE LIMITEDb) Mobile No. : 9949169990c) State : Telanganad) District : Nalgondae) Pincode : 508284

GmailANNEXURE - X

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Project Site Location Map

Project Site

Telangana state

Seetavanigudem (V), BhoodanPochampally (M), Yadadri District

ANNEXURE - XI

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Saiteja Drugs and Intermediates Pvt. Ltd.

Bhoodan Pochampally

Pochampally Cheruvu

Juloor

Specific Location (Route map)

Saiteja Drugs and Intermediates Pvt. Ltd.

Village

ANNEXURE - XII

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Sl. No. Latitude Longitude

1. 17°20'37.76"N 78°47'30.76"E 2. 17°20'37.82"N 78°47'34.07"E 3. 17°20'29.23"N 78°47'33.90"E 4. 17°20'29.19"N 78°47'30.95"E

Google Image of the Proposed Project with Site Coordinates

ANNEXURE - XIII

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ANNEXURE - XIV

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2-Pentanone is reacted with Diethyl Oxalate, Dimethyl Sulfate , Hydrazine Hydrate and Sodium Hydroxide inpresence of Toluene to get Stage-1 Compound.

Sildenfil Base is reacted with Citric Acid in presence of Acetone to get Sildenafil Citrate.

Stage-2 Compound is reacted with Thionyl Chloride and Ammonium Hydroxide in presence of Toluene to get Stage-3 compound.

2-Ethoxy Benzoic Acid is reacted with Thionyl Chloride in presecnce of Methylene Dichloride and Toluene to get Stage-5 Compound.

Stage-5 is reacted with Stage-4 and Potassium Hydroxide in presence of Methylene Dichloride to get Stage-6 compound.

Stage-6 is reacted with Chloro Sulfonic acid and N-Methyl Piperazine in presence of Methylene Dichloride to get Sildenafil Base.

Stage-3 Compound is reacted with Hydrogen in presence of Methanol to get Stage-4 Compound.

PRODUCT : Sildenafil CitrateAnnexure - IV

Stage-1 Compound is reacted with Sodium Nitrate and Sulfuric Acid to get Stage-2 Compound.

Description :

ANNEXURE - XV

78

Flow Chart2-PentanoneDiethyl Oxalate Sol.RecoveryDimethyl Sulfate Evaporation LossHydrazine Hydrate EffluentSodium Hydroxide Organic ResidueHydrochloric Acid (35%)TolueneWater

Stage-1Sodium Nitrate EffluentSulfuric Acid Organic ResidueWater

Stage-2Thionyl Chloride Sol.RecoveryAmmonium Hydroxide (25%) Evaporation LossToluene EffluentWater Organic Residue

Process Emissions

Stage-3Methanol Sol.RecoveryHydrogen Evaporation LossRaney Nickel EffluentWater Organic Residue

2-Ethoxy Benzoic AcidThionyl Chloride Sol.RecoveryMethylene Dichloride Evaporation LossToluene Organic Residue

Process Emissions

Stage-5Stage-4 Sol.RecoveryMethylene Dichloirde Evaporation LossPotassium Hydroxide EffluentHydrochloric Acid (35%) Organic ResidueWater

Stage-6Chloro Sulfonic Acid Sol.RecoveryMethylene Dichloride Evaporation LossN-Methyl Piperazine EffluentDM Water Organic Residue

Process Emissions

Sildenafil BaseAcetone Sol.RecoveryCitric acid Evaporation LossActivated Carbon Organic Residue

Spent Carbon

Sildenafil Citrate

PRODUCT : Sildenafil Citrate

Stage I

Stage II

Stage III

Stage IV

Stage V

Stage VI

Stage VII

Stage VIII

ANNEXURE - XV

79

Description:

Stag-5 Compound is reacted with Hydrogen Peroxide in presence of Methanol and Acetone to getOmeprazole.

PRODUCT : OMEPRAZOLE

4-Nitro-3,5-Dimethyl Pyridine -N-Oxide is reacts with Methanol, Sodium Hydroxide and DMS in presence ofMethanol and Toluene to get Stage-2 Compound.

State-2 Compound is reacted with Methanol and Sodium Hydroxide in presence of Methanol, Pet etherand Methylene Dichloride to get Stage-3 Compound.

Stage-3 Compound is reacted with Thionyl Chloride in presence of Methylene Dichloride and Toluene toget Stage-4 Compound.

3,5-Lutidine is reacted with Hydrogen Peroxide and Nitric Acid in presence of Acetic Acid to give 4-Nitro-3,5-Dimethyl Pyridine-N-Oxide.

Stage-4 Compound is reacted with 2-Mercapto-5-Methoxy Benzimidazole and Sodium Hydroxide inpresence of Methylene Dichloride to get Stage-5 Compound.

Annexure - IV

ANNEXURE - XV

80

Flow Chart:

3,5-LutidineAcetic Acid Sol.RecoveryHydrogen Peroxide (50%) Evaporation LossSulfuric Acid Spent AcidNitric Acid Organic ResidueWater

Nitro CompoundSodium Hydroxide Sol.RecoveryMethanol Evaporation LossToluene EffluentDimethyl Sulfate Organic ResidueWater

Sol.RecoveryMethanol Evaporation LossAmmonium Persulfate EffluentSodium Hydroxide Organic ResidueMethylene Dichloride Spent CarbonPet EtherActivated CarbonWater

Hydroxy Methyl Base Sol.RecoveryThionyl chloride Evaporation LossMethylene Dichloride Organic ResidueToluene Process Emissions

Chloro compound Sol.RecoveryEvaporation Loss

EffluentMethylene Dichloride Organic ResidueSodium HydroxideWater

Omeprazole Sulphide Sol.RecoveryMethanol Evaporation LossHydrogen peroxide (50%) EffluentCatalyst I Organic ResidueCatalyst II Spent CarbonMethylene DichlorideAcetoneEDTAHydroseTriethyl AmineSodium HydroxideAcetic AcidActivated CarbonWater

2-Mercapto-5-Methoxy Benzimidazole

OMEPRAZOLE

Methoxy DMS salt + Toluene (1.2+0.15)

Stage IV

Stage I

Stage II

Stage III

Stage V

Stage IV

ANNEXURE - XV

81

Description:

2,3-Lutidine is reacted with Hydrogen Peroxide and Nitric Acid in presence of Acetic Acid to get Stage-1Compound.

Stage-1 Compound is reacted with Trifluoro Ethanol, Potassium Carbonate, Acetic Anhydride. SodiumHydroxide and Hydrochloric Acid in presence of MIBK and Toluene to get Stage-2 Compound.

Stage-2 Compound is reacted with Thionyl Chloride in presence of Toluene and Methylene Dichloride to get Stage-3 Compound.

Stage-3 Compound is reacted with 2-Mercapto Benzimidazole and Sodium Hydroxide to get Stage-4 Compound.

Annexure - IV

Stage-4 Compound is reacted with Hydrogen Peroxide in presence of Isopropyl Alcohol, Chloroforma nd Acetone to get Lansoprazole.

PRODUCT : LANSOPRAZOLE

ANNEXURE - XV

82

Flow Chart:

2,3-LutidineAcetic acid Sol.RecoveryHydrogen peroxide(50%) Evaporation LossSulfuric Acid Send to Auth. PartyNitric Acid Organic ResidueWater

Lansoprazole NitroSodium Hydroxide Sol.RecoveryPotassium Carbonate Evaporation LossTri Fluoro Ethanol EffluentMIBK Organic ResidueAcetic Anhydride Spent CarbonTEBACTolueneHydrochloric Acid gasActivated CarbonWater

Hydroxy Methyl HydrochlorideMethylene Dichloride Sol.RecoveryToluene Evaporation LossThionyl Chloride Organic residue

Process Emissions

Lansoprazole Chloro2-Mercapto Benzimidazole EffluentSodium Hydroxide Organic residueWater

Lansoprazole sulphideIsopropyl Alcohol Sol.RecoveryHydrogen Peroxide (50%) Evaporation LossCatalyst EffluentChloroform Organic ResidueAcetoneSodium HydroxideAcetic AcidWater

PRODUCT : LANSOPRAZOLE

LANSOPRAZOLE

Stage II

Stage III

Stage IV

Stage V

Stage I

ANNEXURE - XV

83

Annexure - IVPRODUCT : Pantoprazole

Stage-8 compound is reacted with 5-Difluoromethoxy-2-mercapto Benzimidazole and Sodium Hydroxide in presence of Acetone and Toluene to get Stage-9 Compound.

Stage-9 Compound is reacted with Sodium Hypochlorite in presence of Tolune to get Pantoprazole.

Stage 1 compound is reacted with Ammonium Carbonate in presence of Toluene to get Stage-2 Compound.

Stage 2 compound is reacted with Phosphorus Oxychloride in presence of Ethylene Dichloride to get (Stage-3) compound

Description :

Maltol is reacted with Diemthyl Sulfate and Potassium Carbonate in presence of Acetone to get (Stage-1) Compound.

Stage-3 compound is reacted with Hydrogen Peroxide in presence of Methylene Dichloride and n-Hexane to get Stage-4 Compound.

Stage-4 compound is reacted with Sodium Methoxide in presence of Methanol to get Stage-5 Compound.

Stage-5 compound is reacted with Acetic Anhydride to get Stage-6 Compound.

Stage-6 compound is reacted with Sodium Hydroxide in presence of Acetic Acid to get Stage-7 Compound.

Stage-7 compound is reacted with Thionyl Chloride in presence of Methylene Dichloride to get Stage-8 Compound.

ANNEXURE - XV

84

Flow ChartMaltolDimethyl Sulfate Sol.RecoveryPotassium carbonate Evaporation LossAcetone Organic Residue

Inorganic Solid WasteProcess Emissions

Stage-1 Sol.RecoveryAmmonium carbonate Evaporation LossWater EffluentToluene Organic Residue

Process Emissions

Stage-2Phosphorus oxychloride Sol.RecoveryWater Evaporation LossSodium hydroxide EffluentEthylene dichloride Organic Residue

Stage-3Hydrogen peroxide (50%) Sol.RecoveryAcetic acid Evaporation LossSodium hydroxide EffluentWater Organic ResidueMethylene dichloriden-Hexane

Stage-4Sodium Methoxide Sol.RecoveryMethanol Evaporation Loss

Organic ResidueInorganic Solid Waste

Stage-5 Sol.RecoveryAcetic anhydride Evaporation Loss

Organic Residue

Stage-6 Sol.RecoverySodium Hydroxide Evaporation LossMethylene dichloride EffluentWater Organic Residue

Stage-7Thionyl chloride Sol.RecoveryToluene Evaporation LossAcetone Organic Residue

Process Emissions

Stage-8Sol.Recovery

Evaporation LossSodium Hydroxide EffluentWater Organic ResidueToluene

Stage-9Sodium Hypochlorite EffluentWater Organic ResidueCarbon Spent Carbon

PRODUCT : Pantoprazole

5-Difluoromethoxy-2-mercapto benzimidazole

Pantoprazole

Stage I

Stage II

Stage III

Stage IV

Stage V

Stage VI

Stage VII

Stage VIII

Stage XI

Stage X

ANNEXURE - XV

85

Glimepiride (Crude) is Purified in Dimethyl Formamide and MIBK to get Glimepiride (Pure).

Flow Chart

Sol.Recovery2-Phenyl Ethyl Isocyanate Evaporation Lossn-Hexane Organic ResidueMethanol

Stage-1Chlorosulfonic Acid EffluentLiq.Ammonia (25%) Organic ResidueWater Process Emissions

Stage-2Acetone Sol.RecoveryPotassium Carbonate Evaporation Loss

Organic Residue

Acetic acid

Glimepiride (Crude)Dimethyl Formamide Sol.RecoveryActivated Carbon Evaporation LossD.M.Water EffluentMIBK (10%) Organic ResidueDiisopropyl Ether Spent CarbonMethanol

PRODUCT :Glimepiride

Trans-4-Methyl Cyclohexyl Iso Cyanate

Description :3-Ethyl-4-Methyl-3-Pyrroline-2-one is reacted with 2-Phenyl Ethyl Isocyanate in presence of n-Hexane and Methanol to get (Stage-1) Compound.

Glimepiride

Stage 1 compound is reacted with Chlorosulfonic Acid and Ammonia to get (Stage-2) Compound.

Stage 2 compound is reacted with Trans-4-Methyl Cyclohexyl Iso Cyanate in presence of Acetone andAcetic acid to get Glimepiride Crude.

3-Ethyl-4-Methyl-3-Pyrroline-2-one

Annexure - IV

Stage I

Stage II

Stage III

Stage IV

ANNEXURE - XV

86

Annexure - IV

DL-Clopidogrel Base is isomerised with Camphor Sulfonic Acid in presence of Methanol to get S(+) Clopidogrel.

S(+) Clopidogrel is reacted with Sulfuric acid in presence of Acetone to get Clopidogrel Hydrogen Bisulfate.

Stage 1 compound is reacted with Methyl-2-Bromo-O-Chloro Phenyl Acetate and Sodoium Hydroxide inpresence of Methanol to get (Stage-2) Compound.

Stage 2 compound is reacted with Formaldehyde in presence of Methanol to get DL-Clopidogrel Base.

Description :

Thiophene Ethanol is reacted with Thionyl Chloride and Ammonia in presence of Toluene to get Stage-1 Compound.

PRODUCT : Clopidogrel Hydrogen Bisulfate

ANNEXURE - XV

87

Flow Chart

Thiophene EthanolThionyl Chloride Sol.RecoveryToluene Evaporation LossLiq.Ammonia (25%) EffluentWater Organic Residue

Process Emissions

Thiophene EthylamineSol.Recovery

Evaporation LossSodium Hydroxide EffluentMethanol Organic ResidueWater

Stage-2Formaldehyde (37%) Sol.RecoveryHydrochloric Acid (35%) Evaporation LossMethanol EffluentSodium Hydroxide Organic ResidueWater

DL-Clopidogrel BaseCamphor Sulfonic Acid Sol.RecoverySodium Hydroxide Evaporation LossMethanol EffluentHydrochloric Acid (35%) Organic ResidueWater

S(+) ClopidogrelAcetone Sol.RecoverySulfuric Acid Evaporation Loss

Organic Residue

Methyl-2-Bromo-O-Chloro Phenyl Acetate

Clopidogrel Hydrogen Bisulfate


Stage I

Stage II

Stage III

Stage IV

Stage V

ANNEXURE - XV

88

Raw Material Consumption/ Kg

Consumption/ Day

Kg Kg2-Ethoxy Benzoic Acid = 0.4 40.02-Pentanone = 0.3 30.0Acetone = 6.25 625.0Activated Carbon = 0.07 7.0Ammonium Hydroxide (25%) = 2 200.0Chloro Sulfonic Acid = 0.25 25.0Citric acid = 0.32 32.0Diethyl Oxalate = 0.51 51.0Dimethyl Sulfate = 0.44 44.0Hydrazine Hydrate = 0.2 20.0Hydrochloric Acid (35%) = 0.4 40.0Hydrogen = 0.01 1.0Methanol = 4.5 450.0Methylene Dichloirde = 12.5 1250.0N-Methyl Piperazine = 0.25 25.0Potassium Hydroxide = 0.15 15.0Raney Nickel = 0.04 4.0Sodium Hydroxide = 0.35 35.0Sodium Nitrate = 0.25 25.0Sulfuric Acid = 0.2 20.0Thionyl Chloride = 0.59 59.0Toluene = 6.55 655.0

PRODUCT : Sildenafil CitrateLIST OF RAW MATERIALS

ANNEXURE - XVI

89


Consumption/ Day

Kg Kg2-Mercapto-5-Methoxy Benzimidazole = 0.7 0.003,5-Lutidine = 0.6 0.00Acetic Acid = 1.62 0.00Acetone = 2.6 0.00Activated Carbon = 0.07 0.00Ammonium Persulfate = 1 0.00Catalyst I = 0.01 0.00Catalyst II = 0.01 0.00Dimethyl Sulfate = 0.6 0.00EDTA = 0.01 0.00Hydrogen Peroxide (50%) = 0.66 0.00Hydrose = 0.01 0.00Methanol = 10.65 0.00Methylene Dichloride = 14.9 0.00Nitric Acid = 0.35 0.00Pet Ether = 3.7 0.00Sodium Hydroxide = 1.03 0.00Sulfuric Acid = 1.4 0.00Thionyl chloride = 0.46 0.00Toluene = 6.95 0.00Triethyl Amine = 0.01 0.00

PRODUCT : OmeprazoleLIST OF RAW MATERIALS

ANNEXURE - XVI

90

Raw MaterialConsumption/

KgConsumption/

DayKg Kg

2,3-Lutidine = 0.45 1350.02-Mercapto Benzimidazole = 0.49 1470.0Acetic acid = 1.33 3990.0Acetic Anhydride = 1.30 3900.0Acetone = 1.25 3750.0Activated Carbon = 0.03 90.0Catalyst = 0.01 30.0Chloroform = 4.65 13950.0Hydrochloric Acid gas = 0.14 420.0Hydrogen Peroxide (50%) = 0.54 1620.0Isopropyl Alcohol = 2.5 7500.0Methylene Dichloride = 1.75 5250.0MIBK = 1.30 3900.0Nitric Acid = 0.26 780.0Potassium Carbonate = 0.53 1590.0Sodium Hydroxide = 0.60 1800.0Sulfuric Acid = 1.05 3150.0TBAB = 0.01 30.0Thionyl Chloride = 0.41 1230.0Toluene = 4.60 13800.0Tri Fluoro Ethanol = 0.39 1170.0

PRODUCT : Lansoprazole

LIST OF RAW MATERIALS

ANNEXURE - XVI

91


Consumption/ Day

Kg Kg5-Difluoromethoxy-2-mercapto benzimidazole = 0.700 173.6

Acetic acid = 0.400 99.2Acetic anhydride = 0.400 99.2Acetone = 10.000 2480.0Ammonium carbonate = 0.650 161.2Carbon = 0.100 24.8Dimethyl sulphate = 0.450 111.6Ethylene dichloride = 3.600 892.8Hydrogen peroxide (50%) = 0.400 99.2Maltol = 0.850 210.8Methanol = 4.150 1029.2Methylene dichloride = 7.150 1773.2n-Hexane = 4.000 992.0Phosphorus oxychloride = 0.350 86.8Potassium carbonate = 0.550 136.4Sodium hydroxide = 0.720 178.6Sodium Hypochlorite = 0.200 49.6Sodium Methoxide = 0.230 57.0Thionyl chloride = 0.390 96.7Toluene = 11.050 2740.4

PRODUCT : PantoprazoleLIST OF RAW MATERIALS

ANNEXURE - XVI

92


KgConsumption/

DayKg Kg

3-Ethyl-4-Methyl-3-Pyrroline-2-one = 0.43 43.02-Phenyl Ethyl Isocyanate = 0.51 51.0Acetic acid = 7.95 795.0Acetone = 19 1900.0Activated Carbon = 0.1 10.0Chlorosulfonic Acid = 1.1 110.0Diisopropyl Ether = 0.43 43.0Dimethyl Formamide = 13.15 1315.0Liq.Ammonia (25%) = 11 1100.0Methanol = 7.95 795.0MIBK (10%) = 4.3 430.0n-Hexane = 4.3 430.0Potassium Carbonate = 0.75 75.0Trans-4-Methyl Cyclohexy Iso Cyanate = 0.36 36.0


KgConsumption/

DayKg Kg

Acetone = 4.6 0.0Camphor Sulfonic Acid = 1.3 0.0Formaldehyde (37%) = 0.7 0.0Hydrochloric Acid (35%) = 1.27 0.0Liq.Ammonia (25%) = 1 0.0Methanol 15.9 0.0Methyl-2-Bromo-O-Chloro Phenyl Acetate = 1.87 0.0Sodium Hydroxide 0.79 0.0Sulfuric Acid = 0.26 0.0Thionyl Chloride = 0.93 0.0Thiophene Ethanol = 1 0.0Thiophene Ethylamine = 0.9 0.0Toluene = 5 0.0



PRODUCT :Glimepiride


ANNEXURE - XVI

93

List of Hazardous ChemicalsAcetic AcidAcetic AnhydrideAcetoneActivated CarbonAmmonia (20%)Ammonia gasAmmonium carbonateAmmonium Hydroxide (25%)Ammonium PersulfateBenzoyl ChlorideBromineCalcium HydroxideChloro Sulfonic AcidChloroacetyle ChlorideChloroformDiethanol AmineDiisopropyl EtherDimethyl FormamideDimethyl SulfateEDTAEthyl AcetateEthylene DichlorideFormaldehyde (37%)Formic AcidHydrochloric AcidHydrogenHydrogen Peroxide (50%)Isopropyl AlcoholMethanolMethylene Dichloirden-HexaneNitric AcidPara FormaldehydePhosphorus oxychloridePotassium Hydroxidep -Toluene Sulfonyl ChlorideSodium HydroxideSodium HypochloriteSulfuric AcidTerephthalic acidThionyl ChlorideTolueneTriethyl Amine

ANNEXURE - XVII

94

Schematic flow Sheet for EIA Procedure

Time schedule for obtaining the EC from MOEF

Submission of application by proponent (Form 1, Pre-feasilibility report and Draft Terms of Reference)

Scrutiny by EAC

Scoping an communication of Terms of Reference for EIA Studies to the Proponent for EIA preparation

Submission of proceedings of the public hearing by the SPCB / PCC to EAC

Conducting public hearing by SPCB / PCC or any other public Agency / authority engaged by regulatory authority

Submission of Draft EIA / Summary EIA / Application for Public consultation

Appraisal by EAC

Submission of final EIA by the proponent after improving EIA / EMP

Decision of MoEF

Decision of MoEF

Specific Concerns

Yes NO Rejection

Issuing clearance to project proponent

60 days

45 days

60 days

Scop

ing

Publ

ic C

onsu

ltanc

y De

cisio

n M

akin

g Ap

prai

sal

Reservation on the proposal conveyed to EAC

EAC views on reservations sent to MoEF

45 days

60 days

30 days

Category A Project

Preparation of FORM I Application & Prefeasibility report

30 days on obtaining information from industry

as per check list

Preparation of Draft EIA report 120 days minimum other than monsoon period of 120 days

30 days for preparation of Final REIA Maximum

ANNEXURE - XVIII

95

Environmental Baseline Monitoring (To Establish quality of the

Environment)

Application of Impact Prediction Tools (Quantitative Significance Analysis)

Identification of Likely Impacts (Quantitative Significance Analysis

(Ref: Impact Matrix)

EIA Team

Social Impact Assessment

Risk Assessment

Project Features (Pre-feasibility Report,

Form1)

Valued Environment Components

Mitigation Measures

Environmental Management Plan

Reporting

Approach of EIA Study – 4 months other than monsoon period after obtaining TOR copy from MOEF

ANNEXURE - XVIII

96

Schematic Effluent Treatment Scheme - HTDS/HCOD & LTDS/LCOD

ANNEXURE - XIX

97

ANNEXURE - XX

98

Documents

PRE-FEASIBILITY REPORTenvironmentclearance.nic.in/writereaddata/Online/... · M/s. Saiteja Drugs and Intermidiates Pvt. Ltd. Pre-Feasibility Report 2 The industry hence, has submitted