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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works SMS Envocare Limited 1 PRE - FEASIBILITY REPORT For Expansion Project of PROCESSING OF OPIUM & MANUFACTURING OF ALKALOIDS By GOVT. OPIUM & ALKALOID WORKS Department of Revenue, Ministry of Finance, Government of India NEEMUCH - 458441, MADHYA PRADESH

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Page 1: PRE - FEASIBILITY REPORTenvironmentclearance.nic.in/writereaddata/Online/... · The manufacture of narcotic drugs and psychotropic substances in India is governed through the Narcotic

Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 1

PRE - FEASIBILITY REPORT For Expansion Project

of

PROCESSING OF OPIUM & MANUFACTURING OF ALKALOIDS

By

GOVT. OPIUM & ALKALOID WORKS Department of Revenue, Ministry of Finance,

Government of India NEEMUCH - 458441, MADHYA PRADESH

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 2

CONTENTS

SR. NO. PARTICULARS PAGE NO.

1 INTRODUCTION 4

1.1 TYPE OF PROJECT 4

1.2 CAPITAL INVESTMENT 4

1.3 NEED OF PROJECT 5

1.4 PROJECT JUSTIFICATION 5

1.5 PROCUREMENT OF OPIUM FROM FARMERS & CBN ROLES 5

1.6 EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO PROJECT 6

2 LOCATION OF PROJECT SITE 6

2.1 LOCATION (MAP SHOWING GENERAL LOCATION, SPECIFIC LOCATION AND PROJECT BOUNDARY & PROJECT SITE LAYOUT) WITH COORDINATES 7

2.2 LAND REQUIREMENT DETAILS 9

3 PRODUCT DETAILS 11

3.1 EXISTING & PROPOSED LIST OF PRODUCT 11

3.2 RAW MATERIAL REQUIREMENT 11

3.3 MANUFACTURING PROCESS 12

4 WATER CONSUMPTION & WASTE WATER GENERATION DETAILS 20

4.1 WATER SOURCE 20

4.2 WATER CONSUMPTION AND WASTE WATER GENERATION 20

4.3 EFFLUENT TREATMENT PLANT 22

4.4 DETAILS OF EXISTING ETP 22

5 POWER REQUIREMENT 26

6 FUEL REQUIREMENT 26

7 QUANTITY OF WASTES TO BE GENERATED (SOLID) AND SCHEME FOR THEIR MANAGEMENT DISPOSAL 26

8 AIR POLLUTION MANAGEMENT 27

9 GREEN BELT DEVELOPMENT 27

10 OCCUPATIONAL HEALTH & SAFETY MASURES 27

11 REHABILITATION AND RESETTLEMENT (R & R) PLAN 27

12 SITE ANALYSIS 27

12.1 CONNECTIVITY 27

12.2 LAND FORM, LAND USE AND LAND OWNERSHIP 27

12.3 TOPOGRAPHY 28

12.4 SOIL CLASSIFICATION 28

12.5 CLIMATIC DATA FROM SECONDARY SOURCES 28

13 ANALYSIS OF PROPOSAL (FINAL RECOMMENDATIONS) 28

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SMS Envocare Limited 3

LIST OF TABLES SR. NO. PARTICULARS PAGE NO.

1. Cost Break-up Details 4

2. Employment Details 6

3. Environmental Settling of the Proposed Project 6

4. Land Area breakup details 9

5. Name of Product with its Quantity 9

6. List of Raw Material Requirement 10

7. Water Requirement & Wastewater Generation 20

8. Design Criteria of ETP 22

9. Unit Sizes of Existing ETP 22

10. Solid Non Hazardous & Hazardous Waste Generations 26

LIST OF FIGURES

SR. NO. PARTICULARS PAGE NO. 1. Location Map of project site 8

2. Google Image of Project site 8

3. Detailed Plant Layout 10

4. Manufacturing Process Flow Diagram 13

5. Water Balance Diagram 21

6. ETP Flow Diagram 25

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SMS Envocare Limited 4

1.0 INTRODUCTION

The Government Opium and Alkaloid Factories (GOAF) is an Indian government-owned organisation. Its headquarter is located in New Delhi. There are two factories under this organisation - Government Opium and Alkaloid Works, Ghazipur (U.P.) and Government Opium and Alkaloid Works, Neemuch (M.P.).

Processing of opium in India began with the setting up of the opium factory in 1820 in Ghazipur (U.P.), a town of Eastern U.P. located on the banks of the River Ganga. Later an alkaloid plant was set up a Ghazipur in 1943 during the period of World War II. The Opium and Alkaloid Plants of Ghazipur are spread over an area of about 43 acres.

The second plant for processing opium and manufacture of alkaloids located in Neemuch district of M.P near border of Rajasthan. It also comprises two separate units namely, the Opium Factory and Alkaloid Works. The Neemuch Opium Factory has been in operation since 1st April, 1935. Initially, there was another Opium Factory at Mandsaur but the same was closed down in the year 1969. The Alkaloid works was inaugurated on 6th October, 1976. The campus has an area of 57,000 sq. mtrs.

The Alkaloid Works at Ghazipur and Neemuch processes raw opium for manufacture of alkaloid/ drugs, namely narcotine, thebaine, papaverine and codeine phosphate. Morphine salts and Codeine Phosphate are the main products supplied to Indian Pharmaceutical Industries. The Alkaloid Works also has its own process control and quality control laboratories to ensure regular monitoring of process samples and stringent quality control. The organization also has a full-fledged Research and Development wing.

1.1 TYPE OF PROJECT The proposed expansion unit is alkaloids and drugs manufacturing unit covered under the category of 5(f) in schedule “Synthetic organic chemicals industry (dyes & dye intermediates; bulk drugs and intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and chemical intermediates)” of EIA Notification-2006. As the project is located outside the Notified Industrial Area hence as per the said notification this project falls under category ‘A’. 1.2 CAPITAL INVESTMENT The capital investment done in the existing industry is around Rs. 21,03,49,136. Details of the same are given below.

Table No.1 Cost Break-up Details

Sr. No. Cost of Project Amount in Rs.

1. Land for Colony 872,000

2. Buildings 74,152,372

3. Plant & Machineries 113,861,762

4. Furniture & Fixture 3,384,532

5. Office & Misc. Assets 7,393,204

6. Govt. Vehicles 1,770,159

7. Capital W.I.P. 8,915,107

Total 210,349,136

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SMS Envocare Limited 5

1.3 NEED OF PROJECT The manufacture of narcotic drugs and psychotropic substances in India is governed through the Narcotic Drugs and Psychotropic Substances Act, 1985 (NDPS Act). Natural narcotics drugs are currently manufactured solely by the Government Opium and Alkaloids Works (GOAW), an arm of the Ministry of Finance, Department of Revenue. The GOAW are directly responsible for manufacture, sale and export/import of opium and its alkaloids, as well as all commercial transactions in India and abroad. It is headed by the Chief Controller of Factories. The two production units are located at Ghazipur in Uttar Pradesh, 76 kms from Varanasi and at Neemuch in Madhya Pradesh, 120 kms from Udaipur, the nearest airports. The opium factories undertake receipt storage and processing of opium, for domestic sales and export. The Alkaloid Works engage in processing the opium into alkaloids of pharmaceutical grades. Opium alkaloids and their salts are manufactured to meet the internal demands of pharmaceutical chemists, druggists and medical practitioners and the quantity which is found surplus to the home requirements is offered for sale to other countries. 1.4 PROJECT JUSTIFICATION In India opium poppy cultivation is prohibited, under Section 8 of NDPS Act, 1985, except under a license issued by the Central Bureau of Narcotics under Rule 8 of NDPS Rules, 1985. At present, the licit opium poppy cultivation is permitted by the Govt. of India in Selected Tracts in three traditionally opium growing States namely Madhya Pradesh, Uttar Pradesh and Rajasthan. As a signatory to the United Nations Single Convention on Narcotic Drugs, 1961 and as a licit producer of opium, India is required to adhere to the regulations under the said convention. Mandsaur and Neemuch are the leading opium producing districts in the country. This is the main cash crop of Rabi season. The cultivation of opium is done from October to December. The opium is prepared from the fruit extract of opium plant. Manufacture or processing of opium had been an important industry in the district. Opium being a drug, its production is done under the supervision of Narcotics department. Seeds and fruit-shells of opium are used in manufacturing medicines and masalas. Cultivation of opium is prohibited for general mass. As per the “THE NARCOTIC DRUGS AND PSYCHOTROPIC SUBSTANCES RULES, 1985” The manufacture of alkaloids and their respective salts is prohibited except Government Opium Factory (Neemuch & Ghazipur). The Project will create direct & indirect employment opportunities within the surrounding region. The Unit will use good faith efforts to employ local people from the nearby villages depending upon the availability of skilled & un-skilled man-power surrounding the project site. In operation phase, the proposed project would require significant workforce of non-technical and technical persons. Migration of highly education and skilled experience will result in increase of literacy in the surrounding villages. 1.5 PROCUREMENT OF OPIUM FROM FARMERS & CBN ROLE

India is one of the few countries that legally cultivate opium poppy and is the only country on earth that licitly produces opium gum. The Central Bureau of Narcotics, Gwalior, (i) licenses farmers to cultivate opium poppy; (ii) supervises and controls the cultivation; and (iii) procures the opium produced by the licensed cultivators.

The Deputy Narcotics Commissioner is assisted by the Assistant Narcotics Commissioner and District Opium Officers. The District Opium Officer issues licenses for cultivation of opium poppy as per the General Licensing Conditions notified by the Central Government. The Government of India notifies the General Licensing Conditions for every crop year (1st October to 30th September) (these notifications are often referred to as opium policies).

Each farm is individually measured by officers of CBN to ensure that the farmer is not cultivating in excess of his license. Senior officers conduct test checks of the measurements. The farmer is

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SMS Envocare Limited 6

required to tender his entire produce of opium to the CBN who collect it and pay the farmers a price at the rates determined by the Government.

The opium collected by the CBN is transferred to the Govt. Opium Factories at Ghazipur and Neemuch. Part of the opium is dried and exported while some part of the opium is used to extract alkaloids in the Government Opium and Alkaloid Works. The alkaloids so extracted are used in manufacture of pharmaceuticals.

The Chief Controller supervises the Government Opium & Alkaloid Factories (GOAF) which process raw opium procured from the farmers. There are two Government Opium and Alkaloid Works one each at Neemuch (M.P.) and Ghazipur (U.P.). Each of these has an opium factory which dries opium and an alkaloid plant that extracts alkaloids from opium.

Raw opium is a dark viscous substance and contains 62 to 67% solids and 33 to 38% moisture. Farmers are paid reckoning the weight of their produce at 70° consistence, i.e., with 70% solids and 30% moisture. This opium is dried in the Opium Factories to 90° consistence (90% solids plus 10% moisture) for export.

The Alkaloid Plants extract morphine, codeine, thebaine and other alkaloids from opium and sell them to the pharmaceutical industry.

The Chief Controller of Factories also imports alkaloids such as codeine to meet the gap between our production and demand.

1.6 EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO PROJECT Govt. Opium & Alkaloid Works is giving direct employment to local people based on qualification and requirement. In addition to direct employment, indirect employment shall generate ancillary business to some extent for the local population. In operation phase, the proposed expansion project would require significant workforce of non-technical and technical persons. Migration of highly education and skilled experience will result in increase of literacy in the surrounding villages.

Table No. 2 Employment Details

Sr. No. Working Strength Vacant Position Sanction Strength

GOAW Cadre 182 215 397

CBN Cadre 27 53 80

CRCL Cadre 9 20 29

Total 218 288 506

2.0 LOCATION OF PROJECT SITE Opium and manufacture of alkaloids factory located in Neemuch district of M.P., which is approximately 5 kms. from the eastern border of Rajasthan. The plot is located at besides Ashish Bhavan Church & Mission Hospital Compound Neemuch – 458441 Madhya Pradesh, having plot area about 57,000.00 sq.m. Environmental setting of the project site is given below :

Table No. 3 Environmental Settling of the Proposed Project

Sr. No. Particulars Details 1. Latitude 24° 27’29.10” N

2 Longitude 74° 51’37.80” E

3 Elevation above MSL 501 m

4 Toposheet no. 45 L/14 & 45 L/15 of SoI

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4 Climate conditions

Annual Mean Maximum Temperature: 39 °C Annual Mean Minimum Temperature: 9.8 °C Annual Mean Maximum Rainfall: 798 mm

5 Present land use at the location Industrial Use

6 Nearest Village Neemuch within City

7 Nearest Town/City Neemuch within City

8 Nearest Railway Station Neemuch Railway Station (1.0 km, NW)

9 Nearest Hospital Sanjeevani Nursing Home (0.5 km, NE)

10 Nearest Highway MP-SH 31 (5.3 km, NE)

11 Nearest Airport

Nearest Airport: Neemuch Air Strip, 2.0 Km in S Direction. Maharana Pratap Airport, Udapiur 100.0 km in WNW

12 Nearest Water Body

13 Ecological Sensitive Zone within 10 km distance

Not Present

14 Historical/ Archaeological Places Not Present within 10 km radius 15 National Park/ Wild life Sanctuary Not present within 10 km radius

16 Seismic Zone Zone-II

17 Interstate Boundary Madhya Pradesh-Rajasthan Border at 0.180 km towards W

2.1 Location (map showing general location, specific location and project boundary & project site layout) with coordinates.

1. Coordinates of project site Corner Points

Co-ordinates

A 24°27'27.91"N 74°51'32.05"E B 24°27'32.97"N 74°51'39.87"E C 24°27'29.92"N 74°51'46.37"E

D 24°27'22.91"N 74°51'37.22"E

Figure No 1: Location Map of Project site

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 8

Figure No 2: Google Image of Project site

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

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2.2: Land Requirement Details: Land Area breakup details are given in table no. 3 and plant layout is given in figure no. 3

Table No: 4 Land Area breakup details

Sr. No.

Particulars Area in

m2 Sr. No. Particulars

Area in m2

1 Administrative Block 452 26 Water Fountain 72

2 Fire Station and Dispensary 187 27 Diesel Storage Tank 69

3 Time Office & Search Room 166 28 Temple 24

4 Purchase Sec, General Store, Engineering Section & Boiler House

659 29 C.I.S.F Office 184

5 Under Ground Water Tank 174 30 Opium Store 1172

6 Pump House 96 31 Import Section & Opium Store

238

7 Furnace Oil Storage Tank 414 32 Export Section & Opium Store

547

8 Overhead Water Tank 74 33 Packing Section 673

9 Painting Carpenter Room 104 34 Plastic Room 406

10 Store 184 35 Opium Laboratory 606

11 Alkaloid Canteen 175 36 Mixer cum Dried Room 201

12 Effluent Treatment Plant 75 37 MARC Field 2288

13 Aerobic Lagoon 363 38 Cycle Stand 281

14 C.I.S.F Watch Tower 63 39 Scooter Stand 323

15 Solvent Storage tank 149 40 Open Well 0

16 Production Block 3866 41 Opium Drying Platform 1203

17 Research & Development Block 857 42 H2SO4 – 98% Tank 55

18 Cooling Tower 118 43 Caustic Soda Tank 24

19 Sub Station 169 44 H2SO4 – 98% Tank 29

20 Electrical Equipment Store 41 45 Rest Room 121

21 Acetic Acid 102 46 P.C.L 200

22 C.I.S.F Check Post 36 47 Boiler House 174

23 Pay & Accounts Office 124 48 Hydro conation Unit 55

24 Opium Factory Canteen 463 49 Green Belt 19000

25 Old Administrative Block 788 50 Open & Roads 19157

Total Land 57000

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Figure No. 3 Detailed Plant layout

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3. 0 PRODUCTS DETAILS The Govt. Opium & Alkaloid Works is The Neemuch Opium Factory has been in operation since 1st April, 1935. The Alkaloid works was inaugurated on 6th October, 1976. The campus has an area of 57,000 sq. mtrs. Govt. Opium & Alkaloid Works having valid CCA for Codeine Phosphate & PholcodineIP. Initially Codeine Phosphate and Pholcodine IP were manufactured with total 8.4 MT/Year. Now 21 new products are being proposed in expansion unit having total capacity of 21.6 MT/Year. Total production capability will be 30.0 MT/Year. 3.1 EXISTING & PROPOSED LIST OF PRODUCT The proposed expansion capacity of Govt. Opium & Alkaloid Works is given in below Table No. 5

Table No. 6 Name of Product with its Quantity

Sr. No.

Name of Products EXISTING Proposed Total

Production Capacity

1. Codeine Phosphate 8.4 0.0 8.4

2. Pholcodine IP

3. Morphine BPC

0 21.6 21.6

4. Morphine Sulphate

5. Codeine IP

6. Thebaine IP

7. Narcotine

8. Papavarine

9. Oxycodone Hydrochloride USP 10. Hydrocodone Ditartrate USP 11. Dihydrocodoine Tartrate BP 12. Codeine Sulphate IP

13. Morphine Hydrochloride IP

14. Morphine Acetate 15. Morphine Tartrate 16. Codeine Hydrochloride IP 17. Ethyl Morphine Hydrochloride 18. Narcotine Hydrochloride IP 19. Papavarine Hydrochloride 20. Cotarmine 21. Cotarmine Hydrochloride 22. Papaveratum IP 23. Papaverium Sulphate

TOTAL 8.4 MT/Year 21.6 MT/Year 30.0 MT/Year

3.2 RAW MATERIAL REQUIREMENT Raw materials are purchased from indigenous market by roads way. Details of raw material required for enhancement of Products given in Table No. 6

Table No. 6 List of Raw Material Requirement Sr. No. Raw Material Unit Annual Quantity

1 Acetic Acid Kg 73900 2 Activated Carbon Kg 3400 3 Ammonia Gas Pure Kg 34000 4 Normal Butanol Liter 104000

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5 Caustic Soda Flakes/Lye Kg 256000 6 Filter Aid (dicamol) Kg 52000 7 Filter Cloth Meter 2600 8 Phosphoric Acid Kg 6500 9 Potassium Carbonate Kg 16850

10 Rectified Spirit Liter 77880 11 Sulphuric Acid Kg 127120 12 Tartaric Acid Kg 3090 13 TMPAC (Tri methyl phenol Kg 12600 14 Toluene Liter 622000 15 Absolute alcohol Liter 104780 16 Sodium Hypochloride Liter 5260 17 De-emulsifier Liter 1240 18 Carbon Merck/Qualigenes Kg 1900 19 Sulphuric Acid GR Liter 140 20 Beta morphino Ethyl Chloride HCL Kg 520

3.3 MANUFACTURING PROCESS

Opium containers from the Opium factory having consistency 60-70'% of Opium is carried to the SR Morphine Section of the Alkaloid Plant along with the detailed challan sheets. Opium mainly contains mainly five alkaloids, namely morphine, codeine, thebaine, narcotine (noscapine) and papaverine accounting 16 to 17% of alkaloids in opium and rest being marc, gums & resins, meconic acid, undissoilved inorganic salts etc.. Gums & Resins are organic Polymers of different composition separated at different Units of Operations at different pH- values and at cooling conditions, left as a residual waste on the nutches of the concerned unit. One batch is about 120 Kg of opium. 350 liters of 2% Acetic acid solution(v/v) maintained at pH 3.5, Temperature 60-65 0C for one and half hours under constant stirring with four counter current extraction, leaving marc as the residual Waste. marc contains gums & resins, silicates and dissolved inorganic salts etc silicates are from the used filter aid in the nutches to get rid of sticky gums & resins from the free flow of the filtrate containing the main alkaloids. marc is discarded at the discarded site within the GOAW Neemuch after getting tested in the Process Control Laboratory (PLC) and when < 0.2% Other alkaloids or we can say Alkaloid free. Dried marc is shilled to cement factory where it is used as source of heat and also marc is burned completely at high temperatures to end the solid-pollutants (if any). The aqueous phase filtrate withabove said alkaloids is sequentially treated with caustic lye ( alkali solution increasing the pH from 4.0-4.5 to 12.0 and meanwhile passing through Chilling unit at pH-50 and temperature14OC, where the residual gums & resins leftover on it's nutch . By giving three consecutive counter current toluene phase extraction at pH-5 maintaining temperature at 50 oC with constant stirring followed by 1 hour settling and separation of organic phase containing and Narcotine and Papaverine of 1st toluene phase at pH 5, which separated afterword’s in NCT section. Toluene is added in aqueous phase pH adjusted to 11.5 to 12.0, at 50 0C with constant stirring followed by 1 hr settling time and separation. Organic/Toluene phase contains the Codeine and Thebaine unit at pH-12 which separated afterword’s in NCT section by acid base tuning, using toluene and alcohol as solvents. The leftover aqueous phase now contains MORPHINE in sodium-morphinate form. Three batches of such aqueous phases collectively taken into the Extractor Ex11 treated with 40%- sulphuric acid till pH is 5,0 and filtered for further removal of residual gums & resins on its neutch. the acidic-phase –filtrate is taken back into the E-ll(Vessel) and treated with ammonia –gas below

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the room temp. Morphine precipitates in the settler and then Filtered. Morphine in the nutch is given two water washings at 60- 65 oC in the washer unit filtered dried packed as semi-refined morphine (morphine strength is 70-75% with 90% recoveries Brown in Colour.) Purified Morphine of higher purities obtained by treating S. R. Morphine with two to three times decolorization with industrial carbon in acetic acid soIution at Dc unit and followed with Ammonia gas treatment at EX.17 leaving Purified Morphine ( white in color) on its neutch. Morphine is converted in to synthetic codeine and further to codeine phosphate hemi-hydrate as- a major bulk drug of I P. Specification (codeine phosphate used in cough syrup and analgesic in nature). Morphine Sulphate used as pain killer concern patients and in military/security force. Pholcodine is used as cough suppressant for children.

Figure No. 4 Manufacturing Process Flow Charts

Noscopine & Papaverine

SR Noscopine SR Papaverine

Pure Noscopine Pure Papaverine

Alkaloids from opium

Opium

Opium Broth Process Waste (Marc,

Gums & Resins)

Organic Phase

Aqueous Phase

Organic Phase

Aqueous Phase

Toluene Extraction pH 5.0 – 5.5

Toluene Extraction pH 11.5 – 12.0

Codeine & Thebaine

Natural SR Codeine Crude Thebaine

Pure Thebaine

SR Morphine

Synthetic Codeine

Crude Codeine

SR Codeine

Codeine Phosphate

Pure Morphine Pure Morphine

Pholcodine Morphine Sulphate

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s

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4. WATER CONSUMPTIONS AND WASTE WATER GENERATION DETAILS

4.1 WATER SOURCE The water required for the factory is fulfilled by the Neemuch Nagar Palika and tankers. Total water requirement after expansion will be 271.0 KLD. Industrial waste water is treated in 70 KLD ETP is also capable of handling 58 KLD effluents. Currently domestic sewage is treated existing ETP. Now domestic sewage will be treated in proposed STP of 20 KLD Capacity. ETP treated water is being reused for make up water for cooling water and chilling plant, as well as additional remaining treated water will be used for washing purpose in process. STP treated water will be used for the gardening. Effluent is not flow to outside premises as well as in future. Zero Liquid Discharge (ZLD) is adopted. 4.2 WATER REQUIREMENT AND WASTE WATER GENERATION

Table No. 7A Details of Daily Water Consumptions

Sr. No.

Category Existing

Proposed Total

1. Domestic (A) 5.0 17.0 22.0 2. Green Belt (B) -- 57.0 57.0 3. Industrial (C) Process & Washing 52.0 100.0 152.0 Makeup water for

Cooling tower & Chilling unit

5.0 5.0 10.0

Boiler 20.0 10.0 30.0 Total (C) 77.0 115.0 192.0 Total (A+B+C) 82.0 189.0 271.0

Table No. 7B Details of Daily Waste Water Generation

Sr. No.

Category Existing

Proposed Total

1. Domestic (A) 2.0 14.0 16.0 2. Green Belt (B) -- 0.0 0.0 3. Industrial (C) Process & Washing 17.0 40.0 57.0 Makeup water for

Cooling tower & Chilling unit

0.0 0.0 0.0

Boiler 0.0 1.0 1.0 Total (C) 17.0 45.0 58.0 Total (A+B+C) 19.0 59.0 74.0

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 21

Figure No. 4 Water Balance Diagram

10.0* 42.0*

58.0 52.0*

57.0 1.0

16.0 15.0#

Water Requirement 271.0 KLD (BASIS: KLD)

(204.0 Fresh water + 67.0 Recycled Water)

Process & Washing (110.0+42.0*)

Boiler (30.0)

Domestic Water (22.0)

Green Belt (42.0+15.0# )

Cooling Tower & Chilling Plant (10.0*)

Sewage Treatment Plant (20.0 KLD Capacity)

Effluent Treatment Plant (70.0 KLD Capacity)

Note: * ETP treated Recycle Water # STP treated Recycle Water

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 22

4.3 EFFLUENT TREATMENT PLANT The effluent generated from the process, washing cooling and boiler blow down will be treated in in-house 70 KLD ETP. The sludge generated from the ETP is being disposed off to ACC Limited (Kymore Cements Works) P.O. Kymore, Dist. Katni, Madhya Pradesh 483880 for co-processing. This is an activated sludge type effluent treatment plant based on UASB technology. Effluent flow is nearly 100 metric cube per 16 hour two shift working of the plant. Treatment process: The water will be screened in a screen chamber to eliminate the possibility of any floating matter entering into further treatment process. Semi-solids will be trapped in solvent trap unit where under & over baffles provided. Screened semi-solid waste & floating objects will be collected in to collection tank where pH will be raised with help of alkali solution for removal of ammonia condition by using a twin lobe blower an additional collection tanks is proposed for condition will be pumped from collection tank to UASB for anaerobic treatment. Collection tanks will be used as buffer tank alternatively to trigger of the acidogenious phase of the anaerobic treatment and also accepted the re-circulation flow of 1:05 ratio. Due to destruction of COD under anaerobic condition, methane gas will be generated and collected in gas holder where gas vent will be provided for flare or use of collected gas. After reduction of high pollution load effluent will be taken in to aeration tank where oxygen is transferred by diffusion with the help of membrane tube diffusers & air purging grid from air blower which will continuously pass to support living micro-organism under aerobic conditions. The sludge generated as a result of biological process will be allowed to settle in the settling tank. This tank will also be provided with tube settlers for increasing effective area for settlement and reducing the land area requirement . nutrient and defoaming solution dosing arrangement will also be provided in the aeration tank. Part of the sludge will be drained in to aeration tank for maintaining proper MLSS level. If required and or excess sludge will be drained over the sludge during beds provided for dewatering & solar evaporation. The overflow of settling tank will be sent to filter feed sump and from here it will be pumped through a pressure and activated carbon filters provided as a polishing treatment. Before filtration effluent will also be disinfected /chlorinated with help of bleaching powder solution for oxidation of residual organic matter. V-notch chamber will also be used for flow measurement to maintain records. Filtered water can be disposed off safely on land for irrigation/gardening hazardous waste collected in semi dried condition from SDB will be stored in specially designed storage pit with HDPE liner & leachate collection pit.

Table No. 8 : Design Criteria for ETP Sr. No. Parameters Inlet Outlet 2 BOD 15000 to 17000 mg/lit <30 mg/lit 3 Suspended Solid 2200 to 2650 mg/lit <100 mg/lit 4 COD 30000 to 35000 mg/lit <250 mg/lit Design criteria has been considered for renovation is based on three shift operations with peak discharge, with approx. 50% extra capacity of percept discharge to care of additional effluent load due to any type of expansion activities in future or changes due to seasonal variations.

Table No. 9 : Unit Sizes of Existing ETP Sr. No. Modifications/ Additions Dimension/specifications Qty. 1. Bar Screen MS, Float bars with

spacing of mm c/c to suit existing inlet chamber size

201 Nos

2. Solvent trap unit 1.25x5x1.25 m3, RCC UG 1 No 3. Additional collection tank 40 KL capacity RCC UG 1 No 4. Air blower for effluent collection

tank 73 m3/hr, 4MWC, twin lobe complete with

1 No

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 23

motor, base plate etc. 5. Air distribution grid for effluent

collections tank Complete distribution network with lateral in HDPE pipes to suit tank size.

2 set

6. Chemical solutions dosing tank for alkali, acid bleaching powder, nutrients/anti foaming

500 lit capacity in HDPE/PP tank with dosing nipple & valve

4 Nos.

7. Agitators of chemical solutions tank SS-304, 960 RPM, shafts, Impeller, propeller type design

4 Nos.

8. UASB Reactor 6.0 m dia x 6 m ht in MS with anti corrosive with safety valve, temperature & pressure gauge, flushing and sampling provision etc.

1 No

9. Gas holder 3m dia x 2 m ht in ms dome type with anticorrosive painted, complete weight, safety valve, pressure gauge, vent pipe for flare/use etc

1 No

10. Modification in existing Aeration Tank

Repairing of damaged structure, removal of existing aerator & raise the height of wall up to 1.55 m of aeration tank.

1 No

11. Air Blower for aeration tank 300 m3/hr, 5m wc twin lobe complete with motor, base plate etc.

2 Nos.

12. Air Diffusers 65 mm x 1000 mm long tabular, membrane type with complete no. app. Assembly.

30 Nos.

13. Sludge Drying Beds 16 m2 each with graded media in brick work with RCC slab base plate etc.

4 Nos.

14. Tube Setter 2x2.3x1.75 m SWD, MS painted with epoxy filled with PVC tube media with sludge withdrawal arrangements

1 No

15. Minor modifications required in civil foundation for UASB, gas Holder, filters etc/electrical/interconnection piping works including sewage line connection from sewage pump to aeration tank directly

To suit recommended modifications/additions in equipment’s

LS

16. Pressure sand filter 5 m3/hr, MS shell with 1 No

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 24

anticorrosive painted, with aggregates & sand with complete frontal piping pressure gauge sampling port backwash drain pipe etc.

17. Activated carbon filter 3 m3/hr, MS shell with anticorrosive painted, with aggregates & activates carbon with complete frontal piping pressure gauge sampling port backwash drain pipe etc.

1 No

18. Filter feeds pumps 5 m3/hr Cl centrifugal 30 m head

2 Nos

19. Hazardous waste storage facility 4.5x2.3x1.2 m3LD + 0.3 FB storage pit & leachate collection pit of 1x1x2 m3 with HDPE liner of 1.5 mm thick sheet

1 No

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 25

Figure No. 6 ETP Flow Diagram

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 26

5 POWER REQUIREMENT

The total power requirement for this project will be 450 KVA. The Source of Electricity will be MP Paschim Khetra Vidhyut Vitran Co. Ltd. for emergency DG set is provided having capacity of 435.5 KVA. 6 FUEL REQUIREMENT

The fuel requirement for the project is for IBR Packaged Boiler having capacity 1.5 TPH and 1.5 TPH Boiler stand by. For the proposed expansion 2.5 TPH Boiler will be installed. 1.5 TPH boiler will be dismantled. Currently furnace oil is being used for 1.5 TPH boiler is 100 lit/hour. For 2.5 TPH Boiler furnace oil requirement will be 170 lit/hour. Furnace oil is being sourced from Indian oil/Hindustan Petroleum/Bharat Petroleum.

7 SOLID & HAZARDOUS WASTE MANAGEMENT

Solid wastes generated from the plant are process waste (Marc, Gums & Resins), ETP Sludge, Used Oil, empty barrels/drums/containers. The hazardous waste generated from different process waste (Marc, Gums & Resins) along with ETP Sludge is disposed to the M/s. ACC Limited (Kymore Cements Works) P.O. Kymore, Dist. Katni, Madhya Pradesh 483880 for co-processing. Waste oil is reused in plant and empty barrels/drums are send to authorize recyclers. The other solid wastes expected from the unit are containers, empty drums which is used for packing product, and or returned to the product seller or sold to authorized recyclers.

Table No. 9 Quantity of Hazardous Waste Generation

Type of Waste

Source of Waste

Category Quantity per Year Method

of storage

Method of Disposal Existing Proposed Total

Empty Barrels

From Raw Material

Consumption 33.1

Not mentione

d

12000 Nos/year

12000 Nos/year

Stored in covered

area

Reuse/ send to vendor/

sell to approved

MPPCB approved

scrap dealer

Process Waste

(Marc, Gums & Resins)

From Manufacturing

Process 28.1

45 MT/Year

105 MT/Year

150 MT/year

Stored separately

in dry & covered

place with platform

Sold to cement plant

for co-processing (M/s. ACC

Ltd.)

ETP Sludge From effluent

treatment plant

35.3 0.6 MT/

year 1.4

MT/year 2.0

MT/year

Stored in covered

area

Sold to cement plant

for co-processing (M/s. ACC

Ltd.)

Used Oil Lubrication 5.1 0.06 MT/

year 0.14 MT/

year 0.2 MT/

year

Stored in covered

area

Reused in industry/

sold authorized

oil processor Spent

carbon and filter

Purification of intermediate

product 28.3

Not mentione

d

57.3 MT/ year

57.3 MT/ year

Stored in covered

area

Sold to cement plant

for co-

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 27

Type of Waste

Source of Waste

Category Quantity per Year Method

of storage

Method of Disposal Existing Proposed Total

medium processing (M/s. ACC

Ltd.) 8 AIR POLLUTION MANAGEMENT The main source of air pollution is from boiler. 30 meter stack is attached to boiler. Presently there is two IBR Packaged Boiler having capacity of 1.5 TPH of which one is always stand by. For proposed expansion 2.5 TPH boilers is proposed. After commissioning of 2.5 TPH boiler one 1.5 TPH boiler will be dismantled. As per the MPPCB concept, emission of Particulate matter shall not exceed the limit of 150 mg/Nm3.

9 GREEN BELT Total plot area of factory is 57000 sq. m. Out of total area, 19000.00 (33.33 % of total land) has been developed as green belt development which helps to control the air pollution and also noise pollution in the premises. 10 OCCUPATIONAL HEALTH & SAFETY MEASURES The Project design and development has been planned with utmost care and all provisions have been considered for the safety and security of the plant and personnel. For protection of the facility against fire, explosion or gas leak, all the blocks and yards are well equipped with required firefighting arrangement including Fire hydrants, DCP and CO2 Fire extinguishers. Following safety measures shall be implemented for expansion unit also:

Fire Hydrant System Fire Detection and Alarm System Different types of Fire Extinguishers (CO2 & DCP) Onsite & Offsite Emergency Plan

11 REHABILITATION AND RESETTLEMENT (R & R) PLAN R & R Plan has not been found relevant for the proposed project as there would not be any land acquisition of local people, property of other assets and liability. The project site is within on the Govt. Opium & Alkaloid Works, Neemuch, established in 1935. Hence, no R & R action plan has been found relevant. 12 SITE ANALYSIS 12.1 CONNECTIVITY Govt. Opium & Alkaloid Works is located in Neemuch, District Neemuch, MP. Neemuch Railway station is located at 1.0 km in NW direct ion from Project site. Udaipur Airport is located at 100 km in WNW direction from Project site. Neemuch Air strip is also located 2.0 km in S direction. District headquarters of Neemuch district is located at 1.9 km from the project site. This factory is located within Neemuch town. There is no Eco-sensitive Zone i.e. National Park/ Wildlife Sanctuary/ Reserve Forests/ Biosphere reserve or Archaeological/ Religious site are present within the 10 Km radius study area. Rajasthan-Madhya Pradesh State Border is lies at about 0.180 km towards W direction. 12.2 LAND FORM, LAND USE AND LAND OWNERSHIP The land was initially under the Govt. of India. The factory established in 1935. The Alkaloid works was inaugurated on 6th October, 1976. The campus has an area of 57,000 sq. mtrs.

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Project: Manufacturing of Life Saving Drugs Pre-Feasibility Report Project Proponent: Govt. Opium & Alkaloid Works

SMS Envocare Limited 28

12.3 TOPOGRAPHY Neemuch district forms the part of Malwa plateau. It can broadly be divided into two physical divisions; northern plateau consists of Vindhyan rocks and southern Malwa plateau, under trap with gentle sloping topography. The highest elevation of 573 m msl in the district is recorded at north-western corner of the district in Jawad tehsil, comprising of upper Vindhyan rocks. The lowest elevation in the district is recorded about 410 m amsl located near village Latwas (24º 20’ – 75º 25’) in Neemuch block occupied by basaltic rocks. Almost entire district is falling under Chambal sub-basins area of the Ganga Basin. A very small area to the south west of Jiran in Neemuch block flows into Jakam a tributary of Mahi and drains into Arabian Sea. The river Chambal is flowing in eastern part of the district in northeast direction. The Retam, Idar, Erda, Rupa, Bamm, Gangali & Rajori are main tributaries of the Chambal River and all are flowing either east or northeast direction. Gambhir River flowing north of Jawad town in northwest part of the district is only westerly flowing river. 12.4 SOIL CLASSIFICATION The district is generally covered with black cotton soil covering almost three fourths of the area. This part is occupied by Deccan Basalts. The rest part has red-yellow mixed soils derived from sandstone, shale, and gneiss. The alluvial soils are found along the river courses. The higher elevations i.e. the hilly regions have a cover of murum, which is made up of small rounded pieces of weathered basalts. The Vindhyans and Bijawars have a thin cover of sandy loams. The alluvium is derived from hill slopes by numerous streams and watercourses. 12. 5 CLIMATIC DATA FROM SECONDARY SOURCES The climate of Neemuch district is generally dry except the southwest monsoon season. The year can be divided in to four seasons. The winter commences from middle of November and lasts till the end of February. The period from March to about first week of June is the summer season. May is the hottest month of the year. The southwest monsoon starts from middle of June and lasts till end of September. October and middle of November constitute the post monsoon or retreating monsoon season. The normal maximum temperature received during the month of May is 39.80 C and minimum during the month of January is 9.80 C. The normal daily mean monthly maximum temperature is 31.60 C and daily mean minimum temperature is 19.00 C. The summer season is the driest period of the year. The relative humidity generally exceeds 87% in the month of August. The average normal annual wind velocity of the district is 9.2 km./hr. The normal annual rainfall of Neemuch district is 797.96mm. District received maximum rainfall during south west monsoon period i.e. June to September. About 90.5 % of the annual rainfall received during monsoon season. Only 9.5 % of the annual rainfall takes place between October to May period. Thus surplus water for ground water recharge is available only during the southwest monsoon period. 13. ANALYSIS OF PROPOSAL (FINAL RECOMMENDATIONS) Project shall create direct & indirect employment opportunities to the people residing at surrounding region. Different types of people will be recruited for proposed unit based on the basic qualification as skilled, unskilled or semiskilled. As the project needs good amount of workforce of non-technical and technical nature, they are being maSde available from the nearby villages. Migration of highly education and skilled experience people will result in increase of literacy in the surrounding villages. Project will also enhance the prospects of employment to the nearby people. Additional government revenues are generated from taxes, duties and other fees. Additional benefit of the project also includes considerable growth of the industrial and commercial activities in the region and the state.