+ All Categories
Home > Documents > PRE FEASIBILITY REPORT -...

PRE FEASIBILITY REPORT -...

Date post: 06-Feb-2018
Category:
Upload: vophuc
View: 229 times
Download: 3 times
Share this document with a friend
23
PRE FEASIBILITY REPORT OF M/S. VIRUPAKSHA ORGANICS LIMITED. PLOT NO: F-10, I.D.A GANDHI NAGAR, BALANAGAR, HYDERABAD, and TELANGANA 500037 EXPANSION OF INTERMEDIATES MANUFACTURING UNIT AT SY NO: 10, GADDAPOTHARAM VILLAGE, JINNARAMMANDAL, MEDAK (DT), TELANGANA STATE.
Transcript
Page 1: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE FEASIBILITY REPORT OF

M/S. VIRUPAKSHA ORGANICS LIMITED.

PLOT NO: F-10, I.D.A GANDHI NAGAR, BALANAGAR, HYDERABAD, and TELANGANA 500037

EXPANSION OF

INTERMEDIATES MANUFACTURING UNIT

AT

SY NO: 10, GADDAPOTHARAM VILLAGE, JINNARAMMANDAL,

MEDAK (DT), TELANGANA STATE.

Page 2: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

Contents

S. No. Description Page no. 1.0 Executive Summary 1 2.0 Introduction of The Proposed Project 2 2.1 Project Proponent 2 2.2 Brief description of nature of the project. 2

2.3 Need for the project and its importance to the country and or region 2

2.4 Demand-Supply Gap. 3

2.5 Employment Generation(Direct and Indirect) due to the project 5

3.0 Project description 6 3.1 Products and Production Capacity 8 3.2 Raw materials required and Quantities 8 -13 3.3 Manufacturing Process 13 3.4 Resource – Utilize and Recycling 14

3.4.1 Water 14

3.4.2 Power Requirement 15

3.4.3 Fuel Requirement 15 3.5 Quantity of wastes to be generated 15

3.5.1 Waste Water Generation and utilization 15 3.5.2 Solid waste generation and Disposal 16

3.6 Schematic representations of the feasibility drawing which give information of EIA purpose. 16

4.0 Site Analysis 17 4.1 Connectivity 17 4.2 Land Form, Land use and Land ownership. 17 4.3 Existing Infrastructure 17 4.4 Soil classification 17 4.5 Climatic data from secondary sources. 18 4.6 Social Infrastructure available. 18 5.0 Planning brief 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 18 – 19

Page 3: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

6.5 Water management 19 6.6 Sewerage System 19 6.7 Industrial Waste Management 19 7.0 Rehabilitation and Resettlement (R&R) Plan 19 8.0 Project Schedule and Cost estimates 19 9.0 Analysis of project 20

LIST OF TABLES

Table No Description Page no. 3.1 Proposed Products and Quantities 8

3.2 to 3.10 List Of Raw materials 8 - 13 3.2 Water Requirement Details 14 3.3 Wastewater generation and Treatment Method 15 – 16 3.4 Solid waste generation and Disposal 16 8.1 Project Cost 20

LIST OF FIGURES

Figure No Description Page no. 1.1 Location Map 7

LIST OF FLOW CHART

Flow Chart No Description Page no. 3.1 Generalized Flow Chart for Bulk Drug

Manufacturing 14

Page 4: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 1

1.0 EXECUTIVE SUMMARY

M/s. Virupaksha Organics Limited is incorporated to produce bulk drugs and bulk

drug intermediates with registered address at Plot No: F-10, I.D.A Gandhi Nagar,

Balanagar, Hyderabad, Telangana State.

The company proposes to expand its intermediate manufacturing unit – I to bulk

drug manufacturing facility in Sy No.10, Gaddapotharam Village, Jinnaram Mandal,

Medak (Dt), Telangana State.

S. No Parameter Description

1 Project Location Sy No.10, Gaddapotharam (V), Jinnaram (M), Medak (Dt), Telangana State

2

Category of Project as per EIA Notification & Amendments 5(f) “A”

3 Project cost 10.00 Crores 4 Plot area 3.36 Acres (13,605.37SQM)

5 Proposed Products 77.0 MT of Bulk Drugs and Intermediate products & the details products and Quantities are mentioned in Section 3.1

6 Resources (I)Electricity Requirement 600 KVA

Source of electricity SPDCL

D. G. Sets Existing -75 KVA (Dropped) Proposed – 500 & 380 KVA

(II)Water consumption Existing :11.00 KLD Proposed : 155.26

Source of water IDA Water supply

Waste water generation Existing : 06.00 KLD Proposed : 90.65

Mode of disposal Zero Liquid Discharge System (III)Boiler Existing -0.5 TPH (Dropped)

Proposed – 2.0 & 4.0 TPH Boilers two numbers (IV)Fuel Coal - 10.0 MT / Day

7 Solid waste generation Mentioned in Para 3.1 of report

8 Nearest Highway

State Highway No.6 - 1.8 KMs (ENE) (Hyderabad to Narsapur Road) National Highway 7: 11.9 KMs (ENE)

9 Nearest Railway Station Medchal Railway Station – 11.3 KMs (WSW)

10 Nearest Air Port Rajiv Gandhi International Airport - 40.10KMs (S)

Page 5: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 2

2.0 INTRODUCTION OF THE PROJECT

The objective of this pre- feasibility study is to provide information for the proposed

expansion of Bulk Drugs and Intermediates manufacturing unit – I at Sy No: 10,

Gaddapotharam (V), Jinnaram (M), Medak (Dt), Telangana State.

2.1 Project Proponent M/s. Virupaksha Organics Pvt. Ltd. is incorporated on 2nd November 1997 for the

purpose of establishing Bulk drugs (APIs) and Intermediates manufacturing unit and

promoted by Mr. G. Chandra Mouliswar Reddy, Managing Director aged 48 years

and he has 20 years of sound exposure in Bulk Drug industry

2.2 Brief description of nature of the project.

M/s. Virupaksha Organics Pvt. Ltd is an existing unit and involved in

manufacturing of Intermediates, now VOL proposes for expansion of existing

intermediate unit to bulk drug industry to manufacture 77.0 TPM of Bulk Drug &

Intermediates

2.3 Need for the project and its importance to the country and or region

The project in general holds significance for an emerging country like India where

health care costs are increasing by the day due to demand supply gap in affordable

medicines. Moreover due to low cost and hi technology the bulk drugs manufactured

in India has immense export potential with consequent possibility of foreign

exchange earnings

Hyderabad has emerged as major drug manufacture city with a presence in global

market. Pharma industry in the state contribute more than one third to the country’s

total production.

Most of the companies have set up their R&D facilities in the state, thus making the

state the pharmaceutical capital of the country.

Hyderabad has developed as a major production center for bulk drugs due to the

location if the many major Pharmaceutical Industries such as Dr. Reddy’s

Laboratories, Aurobindo Pharma, Neuland Laboratories, Siris, Hetaro Drugs, Divis

Page 6: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 3

Labs, Natco Pharma Limited, Matrix Labs, Nicholas Piramal etc., besides a large

number of medium and small industries manufacturing bulk drugs of all kinds.

In support of this growth in Hyderabad and Bangalore, many basic chemical units

and drug intermediate units have also come up to meet the input requirements of

Bulk Drug manufacturing Companies. Large numbers of these units are still

dependent on supply of basic chemicals mainly from Mumbai, Gujarat and other

parts of the country involving heavy expenditure on transport and transit risks.

2.4 Demand-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 and API intermediates 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 cheap 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.

The products envisaged include third generation antibiotics, anticancer,

antipsychotic, etc drugs which address the problems associated with present

day stressful lifestyles and demand for these outstrips their demand and is

increasing by the day.

Page 7: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 4

Pharmaceutical Industry – Domestic Scenario The Indian Pharmaceutical Industry today is in the front rank of India’s Science-

based industries with wide ranging capabilities in the complex field of drug

manufacture and technology. The Indian Pharmaceutical industry is estimated to be

worth US $ 8.0 billions at present, growing at a CAGR of over 15 % annually. If

India‘ s high Economic growth rate holds steady, the pharmaceuticals market will

triple to $ 24 billion by 2015 and become one of the world` s top 10 markets

according to a study by McKinsey and company ,a leading management

consulting firm. At a compounded annual growth rate of 15.0 %, the absolute

growth of $ 24 billion will be next to the growth potential of the US and China, and in

the same league as the growth in Japan and Canada and the UK. Five factors will

drive the growth of the Indian Pharmaceuticals market over the next decade;

Doubling of disposable incomes and the increase in numbers of middle class

households , significant expansion of medical infrastructure, greater penetration of

health insurance, a gradual shift in disease profile and adoption of patented

products, and finally population growth.

It ranks very high in the third world, in terms of technology, quality and range of

medicines manufactured. Playing a key role in promoting and sustaining

development in the vital field of medicines, the Indian Pharmaceutical Industry

boasts of quality producers and many units approved by regulatory authorities in

USA and UK.

The Indian Pharmaceutical sector has more than 20,000 registered units. It has

expanded drastically in the last two decades. The leading 250 pharmaceutical

Companies control 70% of the market. The pharmaceutical industry in India meets

around 70% of the country’s demand for bulk drugs, drugs intermediates,

pharmaceutical formulations, chemicals, tablets, capsules, orals and injectables.

There are about 250 large units and about 8000 small Scale Units, which form the

core of the pharmaceutical industry in India (including 5 Central Public Sector Units).

These units produce the complete range of pharmaceutical formulations, i.e.

medicines ready for consumption by patients and about 350 bulk drugs, i.e.

Page 8: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 5

chemicals having therapeutic value and used for production of pharmaceutical

formulations.

2.5 Employment Generation (Direct and Indirect) due to the project

The project will employ permanent as well as contractual and sub-contractual

employees from surrounding areas. Apart from this there will be significant non

estimated employment generation at the supplier firms and service industry providing

services to the company. Company shall be giving preference to people from

economically weaker sections for employment in various semi-skilled/unskilled jobs

thereby contributing to their upliftment.

.

It is expected to direct or indirect employ about 32people of various skills will be

required during construction as well as operation phase. The Details of employment

shown in below Table.

Particulars No. of employees

Functional Area

Key managerial staff 6 Finance, Marketing, Production,

Quality control, R&D, Logistics etc.

Administration 8 Office work

Skilled and semi

skilled

18 Production Process, Maintenance,

stores, Safety.& Un skilled workers

Total 32

Page 9: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 6

3.0 Project Description

M/s. Virupaksha Organics Limited proposed to expand its existing Intermediate

unit to Bulk drug manufacturing facility from 27.03 TPM to 77.00 TPM at

manufacturing unit- I at Sy No: 10, Gaddapotharam (V), Jinnaram (M), Medak (Dt),

Telangana State. The Location map is shown at Figure – 1.

The site coordinates are Latitude: 17°35'41.24"N

Longitude: 78°22'47.24"E

There are no archaeological, historical sites located nearby. Therefore, the project

site does not offer any negative impact on the local area, but rather has a positive

impact on socio economic conditions of the habitants around it.

The proposed plant is well connected both to State Highway No– 6 and Railway line

at Medchal Railway Station. A total of about 13,605.37 SQMs of land is required for

the project.

Page 10: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 7

FIGURE 1.1: LOCATION MAP

M/s. Virupaksha Organics Pvt Ltd Sy No: 10, Gaddapotharam (V), Jinnaram (M), Medak (Dt), Telangana State

Page 11: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 8

3.1 Products and Production Capacity

M/s. Virupaksha Organics Limited Unit- I is proposes to produce the below

mentioned shown in Table3.1.

Table3.1: Proposed Products and Quantities

S. No

Product Name Therapeutic Category

Quantity in Kg/Month

Quantity in Kg/Day

1 Cinnarizine Antihistamine 3000.00 100.00 2 Cyano diol base Antidepressant 3000.00 100.00 3 Dextromethorphan Hydrobromide Antitussive 5000.00 166.67 4 Escitalopram Oxalate Antidepressant 1000.00 33.33

5 Fexofenadine hydrochloride(BCN)

Antihistamine 5000.00 166.67

6 Fexofenadine hydrochloride(MAC)

Antihistamine 5000.00 166.67

7 Fluconazole Antifungal 5000.00 166.67 8 Tramadol Hydrochloride (MBA) Analgesic 25000.00 833.33 9 Tramadol Hydrochloride (MCA) Analgesic 25000.00 833.33

Total 77000.00 2566.67

3.2 Raw materials required and Quantities All the raw materials required for manufacturing of above products will be sourced

from local market. The products wise required raw materials and quantities are

shown in below Tables 3.2-3.14.

TABLE 3.2: RAW MATERIALS FOR CINNARIZINE

S. No.

Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 1-Benzhydryl piperazine 106.00 106.00 2 Cinnamyl chloride 93.00 93.00 3 Potassium carbonate 63.50 63.50 4 Ethyl acetate 915.00 915.00 5 Methanol 190.00 190.00 6 Activated carbon 8.40 8.40 7 Hyflow 5.30 5.30

Page 12: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 9

TABLE 3.3: RAW MATERIALS FOR CYANO DIOL BASE

S. No.

Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Para Bromo fluoro benzene 27.00 13.50 2 Magnesium turnings 65.05 32.53 3 Ethylene dibromide 4.40 2.20 4 THF 573.00 286.50 5 Dimethl amino propyl chloride 934.00 467.00 6 Potassium hydroxide 140.00 70.00 7 Sodium hydroxide 234.00 117.00 8 Hydrochloric acid 140.00 70.00 9 Dimethyl amino propyl chloride 280.00 140.00

10 Iodine 16.75 8.38 11 5-Cyano phthalide 67.00 33.50 12 THF + Toluene 1460.00 730.00 13 Toluene 2975.00 1487.50 14 Acetic acid 340.00 170.00

TABLE 3.4: RAW MATERIALS FOR DEXTROMETHORPHAN HYDROBROMIDE

S. No.

Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 2-(Cyclohex-1-en-1-yl) ethanamine

230.00 383.33

2 (4-Methoxy phenyl)acetic acid 206.00 343.33 3 Phosphorus oxychloride 189.00 315.00 4 Caustic soda flakes 329.04 548.40 5 Sodium borohydride 19.50 32.50 6 D(-)Mandelic acid 127.00 211.67 7 Toluene 7229.90 12049.83 8 Liquor ammonia 40.80 68.00 9 Hydrochloric acid 26.88 44.80 10 Sodium chloride 22.80 38.00 11 Phosphoric acid 703.50 1172.50 12 Nitrogen gas 3.00 5.00 13 Methanol 581.50 969.17 14 Formaldehyde 59.40 99.00 15 Formic acid 123.26 205.43 16 Sodium hydroxide flakes 13.75 22.92 17 Activated carbon 8.75 14.58 18 Hyflow 6.60 11.00 19 Acetone 995.70 1659.50 20 Hydrobromic acid 67.00 111.67

Page 13: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 10

TABLE 3.5: RAW MATERIALS FOR ESCITALOPRAM OXALATE

S. No.

Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 4-[4-Dimethyl amino-1-(4-Fluoro phenyl)-1-hydroxy butyl]-3-hydroxy methyl benzonitrile

78.50 26.17

2 Di-Paratoluoyl-D Tartaric acid 88.50 29.50 3 IPA 800.00 266.67 4 Oxalic acid 44.00 14.67 5 Liquor ammonia 6.00 2.00 6 Sodium sulphate 25.00 8.33 7 Paratoluene sulphonyl chloride 5.00 1.67 8 Sodium chloride 77.00 25.67 9 MDC 3160.00 1053.33 10 Triethylamine 85.00 28.33 11 Toluene 2930.00 976.67 12 Acetone 1385.00 461.67 13 Activated carbon 5.00 1.67 14 Hyflow 5.00 1.67

TABLE 3.6: RAW MATERIALS FOR FEXOFENADINE HYDROCHLORIDE (BCN)

S.No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Benzyl cyanide 85.00 141.67 2 Dimethyl sulphate 117.00 195.00 3 Dimethyl sulphoxide 15.00 25.00 4 Potassium hydroxide flakes 50.00 83.33 5 Hydrochloric acid 408.03 680.05 6 Sodium hydroxide 244.30 407.17 7 Mono ethylene Glycol 202.00 336.67 8 Methanol 2554.00 4256.67 9 Sodium bicarbonate 49.90 83.17 10 Toluene 1794.00 2990.00 11 Sodium borohydride 29.90 49.83 12 Dimethyl ether 167.00 278.33 13 Aluminium chloride 205.45 342.42 14 Acetic anhydride 77.00 128.33 15 n-Hexane 300.00 500.00 16 4-Chloro butyl chloride 90.00 150.00 17 Methylene dichloride 1148.00 1913.33 18 Potassium permanganate 76.92 128.20 19 Sodium meta bisulphate 12.40 20.67 20 Azacyclonol 99.40 165.67 21 MIBK 496.80 828.00

Page 14: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 11

22 Potassium bicarbonate 68.30 113.83 23 Potassium iodide 0.70 1.17 24 Ethylacetate 74.00 123.33 25 Activated carbon 6.00 10.00 26 Hyflow 18.50 30.83 27 Acetone 618.00 1030.00

TABLE 3.7: RAW MATERIALS FOR FEXOFENADINE HYDROCHLORIDE (MAC)

S. No.

Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Methallyl chloride 254.00 211.67 2 Sodium acetate 257.18 214.32 3 Dimethyl formamide 161.88 134.90 4 Calcium chloride anhydrous 28.40 23.67 5 Benzene 1060.00 883.33 6 AlCl3 861.24 717.70 7 FeCl3 23.64 19.70 8 NaHCO3 30.94 25.78 9 MDC 2242.80 1869.00 10 4-Chlorobutanoyl chloride 238.14 198.45 11 Hydrochloric acid(scrubber) 625.34 521.12 12 Methanol 2952.54 2460.45 13 Sodium hydroxide 259.52 216.27 14 Toluene 2718.40 2265.33 15 Potassium permanganate 288.00 240.00 16 Sodium meta bisulphate 24.00 20.00 17 MIBK 993.60 828.00 18 Azacyclonol 108.72 90.60 19 Potassium bicarbonate 136.62 113.85 20 Potassium iodide 1.38 1.15 21 Ethyl Acetate 147.40 122.83 22 Hyflow 43.00 35.83 23 Sodium borohydride 17.48 14.57 24 Acetone 1234.38 1028.65 25 Carbon 16.00 13.33

Page 15: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 12

TABLE 3.8: RAW MATERIALS FOR FLUCONAZOLE

S. No.

Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 1,3 Di fluoro benzene 206.00 114.47 2 Chloro acetyl chloride 252.00 140.03 3 Aluminum chloride 307.50 170.87 4 Hydrochloric acid 1495.80 831.17 5 4-Amino Triazole 206.70 114.86 6 Dichloro methane 22421.70 12458.99 7 Isopropyl alcohol 1120.20 622.46 8 Sodium nitrite 145.53 80.87 9 Sodium hydrogen Sulphate 4.41 2.45 10 Liquor ammonia 347.10 192.87 11 TMSI 408.00 226.71 12 1H-1, 2, 4-Triazole 166.80 92.69 13 Sodium hydroxide flakes 166.80 92.69 14 Ethyl acetate 877.50 487.60 15 Citric acid 11.10 6.17 16 Activated carbon 65.00 36.12 17 Hyflow 11.10 6.17

TABLE 3.9: RAW MATERIALS FOR TRAMADOL HYDROCHLORIDE (MBA)

S. No.

Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Dimethylamine Hydrochloride 698.50 582.08 2 Cyclohexanone 1220.00 1016.67 3 Paraformaldehyde 277.00 230.83 4 Hydrochloric acid 6.90 5.75 5 Acetic acid 22.00 18.33 6 Methylene Dichloride 2378.00 1981.67 7 n-Hexane 1957.00 1630.83 8 Sodium hydroxide 804.00 670.00 9 Sodium Sulphate 38.80 32.33

10 Metabromo anisole 1080.00 900.00 11 Tetrahydrofuran 2278.00 1898.33 12 Magnesium turnings 179.00 149.17 13 Iodine 0.10 0.08 14 Ethylene Di bromide 10.00 8.33

Page 16: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 13

15 Sulphuric acid 397.00 330.83 16 Methanol 1301.00 1084.17 17 Nitric acid 500.00 416.67 18 Toluene 3821.00 3184.17 19 Isopropyl alcohol 1137.00 947.50 20 IPA HCl 666.00 555.00 21 Activated carbon 27.00 22.50 22 Hyflow 20.00 16.67

TABLE 3.10: RAW MATERIALS FOR TRAMADOL HYDROCHLORIDE (MCA)

S. No.

Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Dimethylamine Hydrochloride 210.00 175.00 2 Cyclohexanone 977.00 814.17 3 Paraformaldehyde 224.50 187.08 4 Acetic acid 18.00 15.00 5 Hydrochloric acid 3.50 2.92 6 Sodium hydroxide 606.00 505.00 7 Metachloroanisole 777.00 647.50 8 Magnesium turnings 312.50 260.42 9 Iodine 0.10 0.08

10 Ethylene dibromide 2.30 1.92 11 Sulphuric acid 364.00 303.33 12 Tetrahydrofuran 1400.00 1166.67 13 Methanol 1230.00 1025.00 14 Nitric acid 413.00 344.17 15 Toluene 4299.10 3582.58 16 IPA 1075.20 896.00 17 N-Hexane 119.10 99.25 18 IPA HCl 688.70 573.92 19 Activated Carbon 20.20 16.83 20 Hyflow 7.40 6.17

3.3 Manufacturing Process

The manufacturing process of bulk drugs consists of chemical synthesis extending

to stages of processing involving different type of chemical reactions. The

generalized Flow chart for bulk drug manufacturing is shown in Flow chart 3.1.

Page 17: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 14

Flow Chart 3.1: Generalized Flow Chart for Bulk Drug Manufacturing

3.4 Resource – Utilize & Recycling 3.4.1 Water Water requirement of the project for domestic and industrial activity during operation

phase will be 155.26 KLD. The water requirement will be met through IDA Supply.

The detailed water requirement shown in below Table3.11. Table 3.11: WATER REQUIREMENT DETAILS

S. No Purpose Water Requirement In KLD 1 Process 56.26 2 Washings 2.00 3 Boiler make up 35.00 4 Cooling towers make up 51.00 5 DM Plant 2.00 6 Scrubbing system 2.00 7 Domestic 3.00 8 Gardening 4.00 Total 155.26

Page 18: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 15

3.4.2 Power Requirement

Power requirement of proposed project will be made available through SPDCL. Total

power requirement of proposed plant shall be 600 KVA.

Two No’s of D. G. sets of capacity 380 KVA & 500KVA are available to meet

emergency power requirement of the plant.

3.4.3 Fuel Requirement

M/s. Virupaksha Organics Limited Unit- I is proposes to install 4 TPH & 2 TPH

coal fired boilers and the existing 0.5 TPH coal fired Boiler will be dismantled. Total

fuel requirement will be around 15.0 TPD. Coal is procured form local sources. 3.5 Quantity of wastes to be generated

3.5.1 Waste Water Generation and utilization

Total effluent generated in the project is 90.65 KLD. The treated water will be reused

for plant operations.

The process waste water from Process, floor Washes, scrubbers, QC and R&D are

evaporated in MEE with stripper and ATFD after neutralization. The condensate from

MEE and ATFD will be collected and treated in effluents treatment plant along with

effluents from utilities followed by RO. RO rejects will be send back to MEE and RO

Permeate will be re-used back.

To treat the sewage generated due to domestic activities will be disposed through

septic tank following by soak pit.

Table3.18: Wastewater generation and Treatment Method

S. No

Unit HTDS KLD

LTDS KLD

Effluent Generation

in KLD

Treatment Method

1 Process

64.32 2.83 67.15 HTDS effluent sent to ETP with MEE System LTDS effluents treated in ETP – RO Plant / RO Rejects to MEE System and RO permeate to reuse, Condensate from MEE to reuse and

2 Washings 0.00 2.00 2.00 3 Boiler Blow Down 5.00 0.00 5.00 4 Cooling towers Blow

Down 0.00 10.00 10.00

5 DM Plant 2.00 0.00 2.00 6 Scrubbing System 2.00 0.00 2.00

Page 19: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 16

MEE residue to ATFD. 7 Domestic

0.00 2.50 2.50 Septic tank followed

by soak pit Total 73.32 17.33 90.65

3.5.2Solid waste generation and Disposal

The types of Hazardous and non Hazardous wastes generated from the project,

method of disposal is shown in below table3.19. Table 3.19: Solid waste generation and Disposal

S. No

Name of the Solid Waste Quantity Kg/Day

Disposal Method

1 Organic Residue 1666.50 Sent to Cement Industries 2 Inorganic solid waste 511.50 Sent to TSDF 3 MEE salts 9076.00 Sent to TSDF 3 Spent carbon 223.50 Sent to Cement Industries 4 Coal ash from Boiler 7050.00 Sent to Brick manufacturers 5 ETP Sludge 30.00 Sent to TSDF 6 Solvent Distillation bottom

Residue 2150.00 Sent to Cement Industries

7 Waste Oils & Grease 250 Ltrs/Annum

TSPCB Authorized Agencies for Reprocessing/Recycling

8 Detoxified Containers 150 No’s/Month

After Detoxification sent back to suppliers/TSPCB Authorized Parties

9 Used Lead Acid Batteries 4 No’s/Annum Send back to suppliers for buyback of New Batteries

3.6 Schematic representations of the feasibility drawing which give

information of EIA purpose.

The applicability of the S.O 1533 for the proposed project was explored by

considering different possibilities & provision made in the said notification.

Considering the products & project location of the proposed project it is noticed that

the proposed project falls under Category 5 (f) “A” of the Schedule-I of EIA

Notification SO 1533.

As per the provision of the SO 1533, it is necessary to get Environmental Clearance

by applying to MoEF along with the Environmental Impacts Assessment Study

Page 20: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 17

Report for the proposed project prior to commissioning of the project activities.

Therefore the EIA is required to conduct to comply with provisions of SO 1533 made

for Category 5(f) “A” of schedule –I of the notification.

4.0Site Analysis

4.1 Connectivity M/s. Virupaksha Organics Limited. is located at Sy No: 10, Gaddapotharam (V),

Jinnaram (M), Medak (Dt), Telangana State

The nearest habitation from the site is Chetlapotharam (Village) at a distance

of 1.0Km(NW).

The nearest railway station is Medchal Railway Stationat a distance of 11.3

KMs (WSW)from the site.

The nearest airport is Rajiv Gandhi International Airport at a distance of

40.10 KMs (S) a.

The Nearest road ways

State Highway No.6 – 1.8 KMs

4.2 Land Form, Land use and Land ownership. The unit is already an existing unit. There would be no any change in Land Use,

Land Cover or Topography of plot. Green belt is already developed at plant.

4.3 Existing Infrastructure. Proposed expansion project is a located in industrial Estate and the basic

infrastructure is already there. The plant well connected with Road and Railway

facilities

4.4 Soil classification The district is mainly covered by three types of soils Sandy Loan, Black clay Loam,

Laterate types of soil.

Page 21: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 18

4.5 Climatic data from secondary sources. Temperature Maximum: 44.4o C Minimum: 6.9 o C

Normal annual rainfall 873 mm

4.6 Social Infrastructure available.

Well developed social infrastructure facilities are available at nearby Habitations.

5.0 Planning Brief

Proposed plant activities will be started after getting statutory clearance form related

authorities. The project will be completed within two years.

Further proposed project activities will take care of all the rules and regulation of

statutory authority and provide the control measure and devices to achieve the

standard norms

6.0 Proposed Infrastructure 6.1 Industrial Area

Basic infrastructure developed already and the required plant and machineries will

be installed after getting statutory clearance.

6.2 Residential Area

No residential area is involved in the proposed project. The employs are

accommodated in nearby Residential areas

6.3 Green Belt: Approximately 33 % of Green Belt will be provided and maintained. 6.4 Social Infrastructure: Facilities like road and communication are good..Banks, ATM's and medical facilities are also adequate.

Page 22: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 19

Amenities: Education- schools including middle, secondary and higher secondary schools, social welfare hostels. Medical and Health- Community Health Centre, & Primary Health center Are available near villages Power and water- All the villages are electrified and drinking water facilities are extended to all villages. Rail and Road- The project site is very well connected by road through State

Highway no. 6, Southern railways.

6.5 Water management

Water requirement will be fulfilled through Water tankers. 6.6 Sewerage System:

There will be no discharge of industrial effluent (Zero Liquid Discharge). The treated

effluent will be reused. Domestic waste water will be disposed off through soak pit

system.

6.7 Industrial Waste Management:

Due to proposed Expansion of unit, the effluent from cooling and Plant/Equipment

washing will be generated and treated in the well designed Effluent Treatment Plant.

The treated effluent will be reused.

7.0 Rehabilitation and Resettlement (R & R) Plan

Rehabilitation & Resettlement (R&R) plan is not applicable to proposed project.

8.0 Project Schedule & Cost Estimates

Proposed expansion activities will be started after getting statutory clearance form

related authorities. The project will be completed within two years.

Page 23: PRE FEASIBILITY REPORT - environmentclearance.nic.inenvironmentclearance.nic.in/writereaddata/Online/TOR/0_0_15_Nov... · PRE FEASIBILITY REPORT OF ... Matrix Labs, Nicholas Piramal

PRE- FEASIBILITY REPORT

M/s. Virupaksha Organics Limited, Unit-I Page 20

Table 8.1: Project Cost

S.NO Particulars Amount Rs in lakhs

1 Building, Civil works& site development 200 2 Plant and Machinery 500 3 Furniture, Fixtures and other assets 50 4 Preliminary Pre operative 50 5 Liasoning work 50 6 Marginal money for working capital 150

Total 1000

9.0 Analysis of proposal (Final Recommendations)

Proposed activity will provide benefits to the local people in terms of financial and

social welfare.

Local people will get direct financial benefit by way of employment.

Local people will get some contracts of supply and services to get indirect

income.

Company will contribute in improving education and health facilities in nearby

area.


Recommended