Pre - Feasibility Reportenvironmentclearance.nic.in/writereaddata/Online/TOR/05_May_2016... · Pre...

Pre - Feasibility Report

for

Proposed Expansion of Pharmaceutical Unit

at

Block No. 155/1, 159, Chhatral-Kadi Road, Vill: Dhanot, Tal: Kalol,

Dist: Gandhinagar - 382 729 (Gujarat)

of

M/s. Orbit Pharma Laboratories

Executive Summary

M/s. Orbit laboratories is planning to expand pharmaceutical unit at Block No. 155/1, 159, Chhatral-Kadi Road, Vill: Dhanot, Tal: Kalol, Dist: Gandhinagar – 382 729, Gujarat. Project Cost The total project cost for the proposed expansion pharmaceutical manufacturing unit would be around Rs. 5.45 crores. Total capital cost of pollution control measures will be Rs. 73.25 lacs & recurring cost per annum will be Rs. 10 lacs.

Details of Products Details of existing and proposed products are given in following table. List of Products

No. Name of Products Quantity (MT/Month)

Existing Proposed Total 1. Diclofenac Sodium IP/BP 2.5 22.5 25.0 A. 2:6 Dichloro DIphenyl N-Acetyl Chloride 0 50 50 B. 1-(2;6-Dichloro–Phenyl)–1; 3–Dihydro– Indole–2–one 0 25 25

2. Diclofenac Potassium 0.5 4.5 5.0 3. Diclofenac Diethyl Ammonium 0.25 2.25 2.5 4. Chlorzoxazone 0.0 3.0 3.0 5. Fenbendazole 0.0 10.0 10.0 6. Oxfendazole 0.0 5.0 5.0 7. Triclobendazole 0.0 2.5 2.5 8. Febantel 0.0 2.0 2.0 9. Closantel Base 0.0 5.0 5.0

10. Gabapentine 0.0 1.0 1.0 11. Ondensetronticl Dehydrate 0.0 2.0 2.0

Total 3.25 134.75 138 By Products

1 Hydrochloric Acid 0 100 100 2 Aluminum Chloride Solution 0 70 70 3 Dil. Acetic Acid 0 48 48 4 Liquor Ammonia 0 6 6

Requirements for the Project Land No new land will be acquired for the proposed project. The proposed expansion will come in available open area. The total land area is 7,066 m2. Out of this 2,761.68 m2 land will be developed as green belt. Water Total water requirement for the proposed expansion project would be estimated as 40 KLD, which would be sourced from ground water. Electrical Energy Total power requirement for the proposed expansion project will be 260 KW will be sourced from UGVCL

(Uttar Gujarat Vij Company Limited). During emergency purpose one .D. G. Set of 100 KVA and additional one number of .D. G. Set of 250 KVA will be utilized. Fuel Fuel details are given below for the proposed expansion project:

No. Fuel Existing Proposed Total Remark 1 Wood Waste/ Agro

waste/Coal 300 Kg/Day 2700 Kg/Day 3000 Kg/Day For Boiler & Hot Air

Generator 2 Coal - 1800 Kg/Day 1800 Kg/Day For Thermic Fluid Heater 3 Diesel 8 Lit/Day 20 Lit/Day 28 Lit/Day For DG Sets

Manpower For proposed expansion project additional 81 personnel will be required, total manpower for the project would be 100 personnel. Sources of Air Pollution and Control Measures Emissions From Combustion of Fossil Fuels from Stationary or Mobile Sources

No. Stack Attached to Fuel Used Stack Height APCM Final Concentration Existing Scenario

1. Boiler * (1TPH) Wood Waste/ Agro

waste / 300 kg/Day 30 meter Multi Cyclone SPM 150 mg/nm3

SO2 100 ppm NOX 50 ppm 2. Hot Air Generator 08 meter -

3. D.G Set (Stand By) 100 KVA

Diesel 8 Lit/Hr 03 meter Acoustic

Enclosures

SPM 150 mg/nm3 SO2 100 ppm NOX 50 ppm

Proposed Scenario

1. Boiler * (2TPH)

Coal/ Agro waste / 2700 kg/Day 30 meter Multi Cyclone


2. Thermic Fluid Heater (2 lac Kcal)

Coal 1800 kg/day 30 meter Multi Cyclone




Enclosures


* There will be a common stack for existing and proposed boiler. Emissions from Process

No. Stack Attached to Stack Height APCM Parameter Final Concentration Existing Scenario

1. Reaction vessels (2 Nos.) 09 meter Water scrubber followed

by Alkali Scrubber HCl 20 mg/Nm3

There is no additional process emission in proposed scenario Waste Water Generation and Its Treatment: Total wastewater around 33.6 KLD will be generated from the proposed expansion project, out of total waste water 3.6 KLD sewage waste water shall be generated from domestic use which will be disposed off through septic tank/soak pit system. Around 30 KLD industrial effluent shall be generated which will be

separated into two different steams, concentrated and diluted. Concentrated stream will be sent for common MEE facility and diluted effluent will be treated in ETP after that it will be evaporated through single stage evaporator.

Noise Pollution and Control Measures: From the proposed manufacturing unit noise pollution will be generated which will be controlled by adopting different types of noise pollution control measures. Main sources of the noise pollution - machineries, electric motors, boiler, D. G. set and boiler, etc. Following noise control measures to be adopted in the proposed manufacturing project, Encasement of noise generating equipment. Greenbelt will be developed all around the plant boundary to act as noise attenuator. In addition personnel, working near high noise level generating sources, will be provided with ear

muffs. Proper and suitable acoustic barrier will also be provided around, areas generating high noise. Effective preventive maintenance and vibration measurement of all rotating equipment will help in

the improvement of plant life and also noise reduction. Solid Waste Generation and its Disposal Method The sources of solid wastes, generation and its management are as given in the following table.

No. Name of the Waste Category No.

Existing (MT/M)

Proposed (MT/M)

Quantity (MT/M) Method of Storage and Disposal

1 ETP Sludge 34.3 2 13 15 Collection, storage and transport to TSDF site.

2 Used Oil 5.1 0.025 0.025 0.05

Collection, storage and reuse as lubricants in the machineries

within the premises only or send to authorized re-processors.

3 Discarded

Containers/Barrels/ plastic

33.3 300 nos/year

300 nos/year

600 nos/year

Collection, storage and send to authorized recycler after

decontamination.

4 Date Expired, discard and off specification

medicines 28.3

What so ever to be generated

1.0 1.0 After giving proper treatment will be disposed at CHWF/TSDF

5 Fly Ash - - 18 18 Collection, storage and send to brick manufacturer or send to

TSDF site. Green Belt Development Company has proposed 39% of total land area for green belt development approx 2,761.68 m2 land area.

Index

Chapter No. Content

1 Introduction of the project

2 Project description

3 Site analysis

4 Planning brief

5 Proposed infrastructure

6 Rehabilitation and resettlement (R & R) plan

7 Project schedule & cost estimates

8 Analysis of proposal

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Chapter-1 Introduction of the Project 1.1 Identification of Project and Project Proponent

M/s. Orbit Pharma Laboratories is planning to expand pharmaceutical unit at Block No. 155/1, 159, Chhatral-Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar – 382 729, Gujarat. 1.2 Promoters Background

Mr. Kunal Kikani-CEO of the company (B.E. Chemical) 06 years of experience business and Mr. N. P. Kikani (M.Sc.) 35 years of experience in business. 1.3 Brief Description of Nature of the Project

M/s. Orbit Pharma Laboratories is planning to expand pharmaceutical unit at Block No. 155/1, 159, Chhatral-Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar – 382 729, Gujarat.

List of Products

No. Name of Products Quantity (MT/Month)

Existing Proposed Total 1. Diclofenac Sodium IP/BP 2.5 22.5 25.0 2:6 Dichloro DIphenyl N-Acetyl Chloride 0 50 50 1-(2;6-Dichloro–Phenyl)–1; 3–Dihydro– Indole–2–one 0 25 25

2. Diclofenac Potassium 0.5 4.5 5.0 3. Diclofenac Diethyl Ammonium 0.25 2.25 2.5 4. Chlorzoxazone 0.0 3.0 3.0 5. Fenbendazole 0.0 10.0 10.0 6. Oxfendazole 0.0 5.0 5.0 7. Triclobendazole 0.0 2.5 2.5 8. Febantel 0.0 2.0 2.0 9. Closantel Base 0.0 5.0 5.0

10. Gabapentine 0.0 1.0 1.0 11. Ondensetronticl Dehydrate 0.0 2.0 2.0

Total 3.25 134.75 138 By Products

1 Hydrochloric Acid 0 100 100 2 Aluminum Chloride Solution 0 70 70 3 Dil. Acetic Acid 0 48 48 4 Liquor Ammonia 0 6 6

1.4 Need for the Project and Its Importance to the Country and or region.

India's pharmaceutical industry is now the third largest in the world in terms of volume and 14th in terms of value. Being a ‘Life Saving Drug’, there is a huge demand and potential of marketing in Gujarat, India and around the world. In fact, bulk drugs/ API’s are normally not used in their basic form, so the demand for basic drugs emanates from formulation industries manufacturing medicines in various forms. As medicines are highly consumed in all seasons, there are thousands of companies in India, which are manufacturing tablets, capsules & syrups of the proposed products. In India, it is highly demanded in the states like Gujrat, Uttarakhand, Punjab, Haryana, Uttar Pradesh, Andhra Pradesh, Tamilnadu, Maharashtra, West Bengal, etc. These states are the hub of the Pharmaceuticals markets. Looking the

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anticipated demand of healthcare sector in domestic as well as global market and growing volume of pharmaceuticals industry, the proposed project to manufacture Pharmaceutical Bulk Drugs and & Drugs Intermediates, have no doubt for the guarantee of the product and its acceptability in the local and international market. There is huge demand for Export in countries like Sri Lanka, Iran, Bangladesh, Pakistan, Bhutan, Vietnam, Africa, Nigeria, Singapore, Malaysia, Jordan etc 1.5 Employment Generation

For proposed expansion project additional 81 personnel will be required, total manpower for the project would be 100 personnel.

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Chapter-2 Project Description 2.1 Type of Project

M/s. Orbit Pharma Laboratories is planning to expand pharmaceutical unit at Block No. 155/1, 159, Chhatral-Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar – 382 729, Gujarat. The proposed project will be a Bulk Drugs and Drug Intermediates manufacturing activities. This unit is covered under purview of Environment clearance from MoEF, New Delhi as per the Environment Impact Assessment (EIA) notification issued by Ministry of Environment and Forests (MoEF), New Delhi dated 14th September 2006. M/s. Orbit Pharma Laboratories falls under 5(f) of schedule of EIA Notification, 2006 "Synthetic Organic Chemical Industries (Dyes & Dye intermediates; bulk drugs and intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and chemical intermediates)" and categorized under 'A' category. Therefore, unit requires EC for proposed expansion activities.

2.2 Location

M/s. Orbit Pharma Laboratories is planning to expand pharmaceutical unit at Block No. 155/1, 159, Chhatral-Kadi Road, Village Dhanot, Taluka Kalol, District Gandhinagar – 382 729, Gujarat. Total plot area of the project is 7066 m2. A map showing project site is given in following figure-1 & a detailed map of the project site & surrounding is showing in following figure. Latitude - 23°16'.52.50" North Longitude - 72°24'47.72" East Location Map

2.3 Size or Magnitude of Operation M/s. Orbit Pharma Laboratories is planning to expand pharmaceutical unit for 138 MT/M Bulk Drugs and Drug Intermediates products.

4

List of Products

No. Name of Products Quantity (MT/MONTH)

Existing Proposed Total

1. Diclofenac Sodium IP/BP 2.5 22.5 25.0

2:6 Dichloro DIphenyl N-Acetyl Chloride 0 50 50

1-(2;6-Dichloro–Phenyl)–1; 3–Dihydro– Indole–2–one 0 25 25

2. Diclofenac Potassium 0.5 4.5 5.0

3. Diclofenac Diethyl Ammonium 0.25 2.25 2.5

4. Chlorzoxazone 0.0 3.0 3.0

5. Fenbendazole 0.0 10.0 10.0

6. Oxfendazole 0.0 5.0 5.0

7. Triclobendazole 0.0 2.5 2.5

8. Febantel 0.0 2.0 2.0

9. Closantel Base 0.0 5.0 5.0

10. Gabapentine 0.0 1.0 1.0

11. Ondensetronticl Dehydrate 0.0 2.0 2.0

Total 3.25 134.75 138

By Products

1 Hydrochloric Acid 0 100 100

2 Aluminum Chloride Solution 0 70 70

3 Dil. Acetic Acid 0 48 48

4 Liquor Ammonia 0 6 6

2.4 Process Description

Details of Manufacturing Processes

1) Diclofenac Sodium IP/BP: Stage - I: In ss reactor charge Toluene + 2,6 Dichloro Phenol + Potassium Carbonate & reflux for 12hrs & cool to room temperature & add Methyl Mono Chloro Acetate reflux for 5hrs & recover toluene. Ether is reacts with aniline in present of sodium Methoxide forms Dichloro DIphenyl Aniline & Methanol to be recover. Stage - II: In a glass line reactor Dichloro diethyl amine previously drayed reacts with Chloro acetyl chloride toluene as a solvent forms N-Chloro acetyl 2:6 Dichloro DIphenyl amine i.e. one of intermediates to be sale. The HCl gas generated to be scrub in water give Hydrochloric acid i.e. by product.

Stage - III: In a glass line reactor N-Chloro deri. Is reacts with Alluminium Chloride at boiling temperature the HCL gas is generated & scrub in water gives Hydrochloric Acid i.e. by product. After completion of reaction the mass is dumped in 1.5 times water then neutch filter it. The ML is alluminium chloride solution it recycle for three times i.e. by product. The product is Indolenone Intermediate & to be sales it. Stage - IV: In a ss reactor in water Indolenone hydrolyzed by caustic solution & gives Crude Diclofenac Sodium filter it. The ML is west water 750ltrs.

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Stage - V: Final Diclofenac Sodium Crude Diclofenac Sodium is dissolved in DM water, Carbon & charged reflux & filter, cool & centrifuge it. The ML is recycled in stage-IV. The products dry at 80˙c to 85˙c i.e. Diclofenac Sodium 675kgs.

2) Diclofenac Potassium Stage - I: In ss reactor charge Toluene + 2,6 Dichloro Phenol + Potassium Carbonate & reflux for 12hrs & cool to room temperature & add Methyl Mono Chloro Acetate reflux for 5hrs & recover toluene. Ether is reacts with aniline in present of sodium Methoxide forms Dichloro DIphenyl Aniline & Methanol to be recovered. Stage - II: In a glass line reactor Dichloro diethyl amine previously drayed reacts with Chloro acetyl chloride toluene as a solvent forms N-Chloro acetyl 2:6 Dichloro DIphenyl amine i.e. one of intermediates to be sale. The HCl gas generated to be scrub in water give Hydrochloric acid i.e. by product.

Stage - III: In a glass line reactor N-Chloro deri. Is reacts with Alluminium Chloride at boiling temperature the HCL gas is generated & scrub in water gives Hydrochloric Acid i.e. by product. After completion of reaction the mass is dumped in 1.5 times water then neutch filter it. The ML is alluminium chloridesolution it recycles for three times i.e. by product. The product is Indolenone Intermediate & to be sales it.

Stage - IV: In a ss reactor in water Indolenone hydrolyzed by Potassium Hydroxide solution & gives Crude Diclofenac Potassium filter it. The ML is west water 750ltrs. STAGE-V Final Diclofenac Potassium, Crude Diclofenac Potassium is dissolved in DM water, charge carbon & reflux & filter, cool & centrifuge it. The ML is recycled in stage-IV. The products dry at 80˙c to 85˙c i.e. Diclofenac Potassium 600kgs.

3) Diclofenac Diethyl Ammonium Stage - I: In a ss reactor charge water + Diclofenac sodium stirr for half an hour slowly add acetic acid & after completion of addition stirr for a hour & filter it. Dry it. The ML is west water neutral 700lits.

Stage - II : In ss reactor charge water 750lits + Diclofenac acid stirr well slowly add diethyl amine stirr for two hours. Cool to room temperature. Filter through centrifuge ML is neutral water 700lits. Dry the product i.e. Diclofenac Diethyl Amine dry weight 525kgs. PRODUCT: Diclofenac Diethyl Amine INTERMEIDATE: Diclofenac Free Acid ETP: West water neutral 1400lits

4) Chlorzoxazone Stage - I: In a glass line reactor charge hydrochloric acid + 4-cap heat to reflux maintain for 4 hours. Then charge catalyst reflux for one hour. Cool to 100˙c charge water stirr for half an hour filter & ML west water 800lits. Collect cake i.e. crude chlorzoxazone.

Stage - II: In ss reactor charge methanol & crude reflux for one hour. Filter in next ss reactor adjust ph-6. Stirr for one hour & recheck it. Centrifuge it ML is west water for ETP 500lits. Collect cake of semi final product.

Stage - III: PURIFICATION In ss reactor charge methanol + semi final cake & charcoal. Heat to reflux for two hrs. Filter is at 80˙c collect ML in ss reactor cool it to room temperature centrifuge it. Collect methanol dry the cake. Pulverize & pack it i.e. CHLORZOXAZONE USP. 5) Fenbendazole Stage - I: (A) In a ss reactor charge Methanol & 5Chlorophenylthio- 2 -Nitro Aniline heat to reflux i.e.65˙C to 70˙C. cool to room temperature filter it. Collect crude Methanol & recover methanol from M.L. residue is approx 5kgs. The product it Nitro Thiophenyl Aniline charge Toluene & Nitrothiophenyl aniline heat to 70˙ - 80˙C start addition of Hydrazine Hydrate after completion of Hydrazine Hydrate check reduction completion test if ok cool to room temperature wash with 100lits water collect upper organic layer convert it in Hydro Chloride by adding con. HCl & water.

6

Stage - II (B): In glass line reactor charge water & hydrogen cynamide heat it to 50˙C. Then start addition of Methyl Chloro Formate & Caustic Flakes. After completion of addition check Ph neutral. Stirr for one hour. The product is Methyl Carbono hydrogen cynamide 270kgs. (B)

Stage – III: Coupling (A) + (B) In a glass line reactor charge Acetone + Stage I(A) & Stage II(B) couple the both stages at room temperature stirr for 5 hours below room temperature filter it. Collect cake i.e. crude Fenbendazole west water is approx 200 lits product quantity 150kgs wet. Charge wet cake in ss reactor + methanol 2times heat to reflux for one hour. Cool it filter it. Collect methanol & distilled out. Residue is approx 10kgs dry the wet cake. Product is approx 100kgs. Final FENBENDAZOLE.

6) Oxfendazole In a dry clean glass line reactor charge acetic acid, Dimethyl Sulfoxide & Fenbendazole cool to 5˙C & add hydrogen peroxide slowly maintain 3 hours. Check TLC for reaction completion. Filter it & wash with acetone. The collect cake & dry it i.e. OXFENDAZOLE 7) Triclobendazole Stage - I: In glass line reactor charge 80kgs DMF + 100kgs Dinitro phenoxy Acetamide & stirr for a hour. Charge 50kgs Dichloro Phenol & 60kgs Potassium Carbonate. Reflux for 8 hours. Check TLC for completion of reaction. Then charge Methanol 150lits & slowly add caustic lye solution. Maintain temperature 70˙C to 75˙C for 4 hours. Check TLC for absence of Dichloro nitro phenoxy Acetamide of reaction completed add water 250lits. Stirr for half an hour. Filter it & collect cake & dry it. Dry wet 120kgs

Stage - II: In a ss auto clear reactor charge 400lits methanol + stage-I + Raney Nickel pass first Nitrogen Gas & than hydrogen gas rise pressure up to 3kgs & temperature 50˙C maintain for 4 hours. Check sample ok. Filter it. Charge ML in another reactor charge potassium hydroxide & carbon sulphide at low temperature. Raise the temperature & reflux for one hour. Check completion of reaction. Distilled out methanol & add water 300lits dil. HCl to Ph 6.5. filter it dry it at 90-95˙C Product Quantity 80kgs. ETP west water 280lits

Stage - III: In glass line reactor charge TBZ Thiol + Methanol at room temperature add slowly DMS. Raise temperature 70˙C to 75˙C & maintain 2-3 hours check reaction completion cool it. Filter it. Wet cake 100kgs. Charge wet cake in glass line reactor + methanol + carbon. Heats to reflux for 2hours cool to room temperature filter it wash with acetone. Dry it. Dry wet 90kgs.

8) Febantel : Stage - I: In glass line reactor charge 2-Nitro-5-(Phenylthio)- aniline, Methoxyacetyl chloride & 200lits Methylene dichloride. Stirr the reaction mass at room temperature. Then start addition of Methoxy acetyl chloride during half an hour. Maintain for 8 hours. Check TLC for reaction completion. Then recover MDC charge water 250lits stirr for 2 hours filter it wash with 25% soda ash solution & dry it. Dry wt 80kgs. Stage - II: In a ss autoclave previously provided nitrogen blanketing charge Methanol 400lits FBT-Amide 80kgs & raney nickel 5.6kgs. Then start processing hydrogen gas. Heat the reaction mass upto 70-80˙C. check the hydrogen pressure constant. Check TLC for completion reaction. Cool to room temperature drain out the material along with washing by methanol. Filter the catalyst. Heat the ML for recovery of methanol & cool to 10˙C filter it. Give the suspension wash of cake by Xylene. Then again filter it & recover Xylene from ML 70%. Dry the cake. Dry wet is 56kgs i.e. FBT Amine.

Stage - III: In a dry & clean glass line vessel add methanol 160lits+Thiourea 40kgs+1decyl bromide 80kgs. Heat to reflux. Check for reaction completion fro TLC. Distilled out methanol cool to room temperature add MDC 400lits + K2co3soln + Methyl Chloro Formate slowly as the exothermic reaction maintain for 5hrs. Check for completion of reaction. Add water & separate layer. Bottom organic layer heats to reflux & recover MDC 70% in residue add methanol & stirr for one hour & filter it. Collect ML for recovery of methanol 80% dry it. Dry wt 80kgs

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9) Closantel Base: Stage - I: In a dry glass line charge toluene 500lits. Add 3:5 Dilodosalicylic acid 325 kgs + Closantel amine 250kgs heat to reflux & then add slowly phosphorus Trichloride. Maintain for 8 hrs check the completion of reaction. Cool to room temperature. Filter it wash with toluene & followed by 550lits water. Collect cake & dry wt is 450kgs Closantel Base. Stage - II: Charge Closantel Base in ss reactor add caustic solution 600lits. Heat to reflux & maintain for 2 hrs. Cool to room temperature check Ph should be alkaline. Filter it wash with 200lits water. Collect cake & dry it. Dry wt 510kgs.

10) Gabapentine Stage - I: Take 350 water and 98.5 NaOH in reactor to got clear solution. And cool -5 to -10 ˚c and charge 1.1 Cyclohaxane di acitic acid monoamide. Cool -5 to -10 ˚c and charge bromine liquid in 1 hour than temp. Rice 35 to 40 ˚c For 3 hours. Charge mdc at 15 ˚c stirrer for 30 min. than charge HCl bring reaction mass PH 2.0 Stirrer for 30 min. than filter the mass. Take crude. Charge methanol and wet cake stirrer 30 min. and filter the reaction mass. Take the stage 1 (84) Stage - II: Take acetone 336 + water 84 in reactor charge stage - 1 (84) Than charge TEA and bring reaction mass PH 7.2 stirrer 30 min. than filter the reaction mass and take crude Take acetone 240 + water 5 add crude stirrer for 1 hours cool 0 to 5 ˚C for hours filter the reaction mass take wet cake and dry at 70 ˚C finish gabapentin 50

11) Ondensetronticl Dehydrate Stage - I: Take water charge 1, 3, Cyclohaxane done in reactor charge phenyl hydrazine in 2 hours. Than temp. Rice 40˚C maintain for 3 hours and cool at RT. than filter reaction mass. Wet cake dry. Finish stage I.

Stage - II: Charge acetic acid charge zinc chloride heat at 85˚C for 1 hour. Than charge stage I maintain 100˚C for 3 hours and cool at RT add water than filter the reaction mass. Take crud wet cake charge MeOH stirrer for 1 hours cool & filter stage II dry.

Stage - III: Take acetone in reactor charge stage II NaOH and stirrer 30 min. add DMS stirrer for 3 hours cool and filter and dry.

Stage - IV: Take DM water in reactor charge stage III charge formaldehyde heat 100 - 105 ˚C maintain for 6 hours. Than cool RT & filter wet cake dry.

Stage - V: Take DM water in reactor add stage IV cool at 15˚C and add Cons. HCL then add limidazole heat at 100 - 105˚C for 24 hours and cool 5˚C neutralise with liquor Ammonia solution filter & wash with chilled water take wet cake charge MeOH add charcoal 2 heat and reflux hot filter mother liquor cool 5˚C and stirrer 1 hours and filter dry 65˚C stage IV wt methanol recover from mother liquor.

Stage - VI: Take DM water charge kg stage - V add MeOH add HCL 70 stirrer for 24 hours at RT than cool 5˚C filter dry. The product is ONDANSETRON HCL DIHYDRATE IP / BP.

2.5 Raw Materials Requirement with Their Source and Transportation Details of Raw material consumption and Mode of Transportation are given in following table.

List of Raw Materials

No Raw Material Type of Storage Mode of Transport 1. 2,6 Dichloro Phenol Drum By Road 2. Potassium Carbonate Bags By Road 3. Methyl Mono Chloro Acetate Drum By Road 4. Toluene MS Tank By Road 5. Aniline Oil MS Tank By Road

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No Raw Material Type of Storage Mode of Transport 6. Sodium Metal (Sodium Methoxide) Drum By Road 7. Methanol MS Tank By Road 8. Chloro Acetyl Chloride Drum By Road 9. Aluminum Chloride Bags By Road 10. Caustic Flakes Bags By Road 11. Carbon Bags By Road 12. Catalyst Bags By Road 13. Caustic Potash Bags By Road 14. Diclofenac Sodium Bags By Road 15. Acetic Acid SS Tank By Road 16. Diclofenac Acid Drum By Road 17. Diethyl Amine Drum By Road 18. 4-chloro 2-amino phenol Bags By Road 19. T. Urea Bags By Road 20. Hydrochloric acid HDPE TANK By Road 21. Carbon Bags By Road 22. 5 Nitro, 2 Chloro Aniline Bags By Road 23. Thiophenol Drum By Road 24. Hydrazine Hydride Drum By Road 25. Methyl Chloro Formate Drum By Road 26. Hydrogen Cyanamide Drum By Road 27. Acetone SS Tank By Road 28. Fenbendazole Drum By Road 29. Hydrogen Peroxide Drum By Road 30. Dimethyl Sulfoxide Drum By Road 31. Sodium Hydroxide Bags By Road 32. 4,5 Dichloro-2-Nitro Phenyl Acetamide Bags By Road 33. Dimethyl Formamide Drum By Road 34. 2,3 Dichlorophenol Bags By Road 35. Potassium Carbonate Bags By Road 36. Raney Nickel MS Tank By Road 37. Carbon Disulfide Drum By Road 38. Potassium Hydroxide Bags By Road 39. Hydrous Bags By Road 40. 2-Nitro-5-(Phenylthio) Aniline Bags By Road 41. Methoxy Acetyl Chloride Drum By Road 42. Methylene Dichloride Drum By Road 43. Hydrogen Gas cylinders By Road 44. Xylene Drum By Road 45. Decyl Bromide Drum By Road 46. Thiourea Drum By Road 47. Sodium Carbonate Bags By Road

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No Raw Material Type of Storage Mode of Transport 48. Sodium Dithionite Bags By Road 49. 1-decyl Bromide Drum By Road 50. 1,3-cyclohexadione Drum By Road 51. Phenyl hydrazine Drum By Road 52. Zinc chloride Bags By Road 53. Dimethyl sulfate Drum By Road 54. Para formaldehyde Drum By Road 55. Ammonia soln Drum By Road 56. 2-Methylimidazole Bags By Road 57. 1,1-Cyclohexane diacetic acid mono amide Bags By Road 58. Tri ethylamine Drum By Road 59. 3:5 DiIodosalicylic Acid Drum By Road 60. Closantel Amine Bags By Road 61. Phosphorus Trichloride Drum By Road

2.6 Resource Optimization / Recycling and Reuse in the Project Treated effluent will be reused in utilities, washing and gardening purpose which will reduce in fresh water intake quantity. 2.7 Availability of water It’s Source, Energy/Power Requirement and Source

Water Total water requirement for the proposed expansion project would be estimated as 40 KLD, which would be sourced from ground water. Power Total power requirement for the proposed expansion project will be 260 KW will be sourced from UGVCL (Uttar Gujarat Vij Company Limited). During emergency purpose one .D. G. Set of 100 KVA and additional one number of .D. G. Set of 250 KVA will be utilized. 2.7.1 Water Requirement and Waste Water Generation Total wastewater around 33.6 KLD will be generated from the proposed expansion project, out of total waste water 3.6 KLD sewage waste water shall be generated from domestic use which will be disposed off through septic tank/soak pit system. Around 30 KLD industrial effluent shall be generated which will be separated into two different steams, concentrated and diluted. Concentrated stream will be sent for common MEE facility and diluted effluent will be treated in ETP after that it will be evaporated through single stage evaporator. 2.7.2 Fuel Requirement For the proposed expansion project fuel details are given below:

No. Fuel Existing Proposed Total Remark 1 Wood Waste/

Agro waste/Coal 300 Kg/Day 2700 Kg/Day 3000 Kg/Day For Boiler & Hot Air

Generator 2 Coal - 1800 Kg/Day 1800 Kg/Day For Thermic Fluid Heater 3 Diesel 8 Lit/Day 20 Lit/Day 28 Lit/Day For DG Sets

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2.7.3 Air Pollution

Emissions from Combustion of Fossil Fuels from Stationary or Mobile Sources

No. Stack Attached to Fuel Used Stack Height APCM Final Concentration Existing Scenario

1. Boiler * (1TPH) Wood Waste/ Agro

waste / 300 kg/Day 30 meter Multi Cyclone SPM 150 mg/nm3

SO2 100 ppm NOX 50 ppm 2. Hot Air Generator 08 meter -



Enclosures


Proposed Scenario

1. Boiler * (2TPH)

Coal/ Agro waste / 2700 kg/Day 30 meter Multi Cyclone


2. Thermic Fluid Heater (2 lac Kcal)

Coal 1800 kg/day 30 meter Multi Cyclone




Enclosures


* There will be a common stack for existing and proposed boiler. Emissions from Process

No. Stack Attached to Stack Height APCM Parameter Final Concentration Existing Scenario

1. Reaction vessels (2 Nos.) 09 meter

Water scrubber followed by Alkali Scrubber

HCl 20 mg/Nm3

There is no additional process emission in proposed scenario 2.7.5 Solid Waste Generation and Their Disposal The sources of solid wastes, generation and its management are as given in the following table.


Existing (MT/M)

Proposed (MT/M)

Quantity (MT/M)

Method of Storage and Disposal


2 Used Oil 5.1 0.025 0.025 0.05

Collection, storage and reuse as lubricants in the machineries within the

premises only or send to authorized re-processors.

3 Discarded


33.3 300 nos/year

300 nos/year

600 nos/year

Collection, storage and send to authorized recycler

after decontamination.


medicines 28.3


1.0 1.0 After giving proper

treatment will be disposed at CHWF/TSDF

5 Fly Ash - - 18 18 Collection, storage and

send to brick manufacturer or send to TSDF site.

11

Chapter-3 Site Analysis 3.1 Connectivity 3.1.1 Rail

The nearest railway station is Kalol Railway station, which is around 10 km in south east direction from the project site. 3.1.2 Road

The site is well connected by road network to all the key places. The major highway passing near the project site is NH-8 C which is around 20 km south east direction from the project site, SH-133 around 2.8 km in east direction and SH-135 around 7.4 km in north direction. 3.1.3 Air

The nearest airport from the project site is Ahmedabad Airport. The distance of airport from project site is around 30 km in south east direction. 3.1.4 Communication

Project site is within existing company premises which is already well connected with telephone, telefax etc. all the communications facilities are well developed in the area. 3.2 Topography

Topography of the land is plane. 3.3 Existing Land use pattern

There is no Forest, National park; Wild life sanctuary within a radius of 10 km. Details of existing land use is given in the following table: Details of Existing Land use

No. Particular Name & its Distance

1. Nearest State Highway Nearest State Highway

SH-133 at around 2.8 km in east SH-135 at around 7.4 km in north

2. Nearest National Highway NH-8 C at around 20 km in south east

3. Nearest city Chhatral city 2.8 km in east

4. Nearest River Narmada at around 3.3 km in south west

5. Nearest Railway station Kalol Railway Station 10.0 km in south east east direction

6. National park/Reserve Forest, Biosphere, etc. None within 10 km 3.4 Existing Social Structure

Project site is located at a distance of around 10 km from Kalol city. All the infrastructures are available within city like Schools, Hospitals & community facilities.

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Chapter – 4 Planning Brief 4.1 Planning Concept

Type of industries: The proposed project will be a Bulk Drugs and Drug Intermediates manufacturing activities. This unit is covered under purview of Environment clearance from MoEF, New Delhi as per the Environment Impact Assessment (EIA) notification issued by Ministry of Environment and Forests (MoEF), New Delhi dated 14th September 2006. M/s. Orbit Pharma Laboratories falls under 5(f) of schedule of EIA Notification, 2006 "Synthetic Organic Chemical Industries (Dyes & Dye intermediates; bulk drugs and intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and chemical intermediates)" and categorized under 'A' category. Therefore, unit requires EC for proposed expansion activities.

4.2 Land use Planning

The Plant General Layout has been planned considering production facilities, auxiliary and ancillary facilities and plant utilities & services. The total plot area is 7066 sq. m. Land use shall be as build up area of buildings, Storage facility, Roads, Greenbelt, open land etc., these kinds of land use will be there.

4.3 Amenities / Facilities

Adequate storage facility for Chemicals, machinery spares and consumables shall be provided. A small mechanical and electrical/ instrument workshop facilities for repairs and maintenance shall be provided. Time and security offices shall be provided in the plant. To avoid fire hazard, internal fire hydrants system in all major plant unit will be provided.

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CHAPTER – 5 Proposed Infrastructure 5.1 Industrial Area

The company has already acquired land area of 7,066 m2 in which company will expand their production capacity. 5.2 Green Belt

The main objective of the green belt is to provide a barrier between the source of pollution and the surrounding areas. The green belt helps to capture the fugitive emission and to attenuate the noise generated apart from improving the aesthetics. Development of green belt and other forms of greenery shall also prevent soil erosion and washing away of topsoil besides helping in stabilizing the functional ecosystem and further to make the climate more conducive and to restore water balance. The company has green belt area with Lawn, plants and flowers spread across about 33% of the total area. Green belt shall be developed at plant boundary, road side, around offices & buildings and Stretch of open land. The selection of tree species suitable for plantation at the industry are governed by guiding factors as stated below: The trees should be tolerant to air pollutants present in the area The trees should be able to grow and thrive on soil of the area, be evergreen, inhabitant, having

minimum of leaf fall. The trees should be tall in peripheral curtain plantation and with large and spreading canopy in

primary and secondary attenuation zone. The trees should posses extensive foliar area to provide maximum impinging surface for continued

efficient adsorption and absorption of pollutants. The trees should be fast growing and indigenous and should maintain ecological, land and hydrological

balance of the region. It is also recommended to plant few trees, which are sensitive to air pollution, as air pollution

indicator. It is also recommended to carry out extensive plantation within premises. Keeping in view the climatic conditions, status of soils and vegetation types in and around the project area the species shall be selected for proposed green belt development. 5.3 Social Infrastructure

Drinking water facility, Canteen, proper sanitation, etc. will be provided to the workers working in plant. 5.4 Connectivity

As discussed earlier, proposed expansion project location of the plant is already well connected with the network of road & rail. So there is no need to construct any new road or rail for the transportation.

5.5 Waste Water Management

Total wastewater around 33.6 KLD will be generated from the proposed expansion project, out of total waste water 3.6 KLD sewage waste water shall be generated from domestic use which will be disposed off through septic tank/soak pit system. Around 30 KLD industrial effluent shall be generated which will be

14

separated into two different steams, concentrated and diluted. Concentrated stream will be sent for common MEE facility and diluted effluent will be treated in ETP after that it will be evaporated through single stage evaporator.

5.7 Industrial Solid Waste Management

From the proposed expansion project activity there shall be mainly Spent/Used Oil, ETP Sludge and Discarded containers. Details of Solid & Hazardous Waste Generation during Operation


Existing (MT/M)

Proposed (MT/M)

Quantity (MT/M)

Method of Storage and Disposal


2 Used Oil 5.1 0.025 0.025 0.05

Collection, storage and reuse as lubricants in the machineries within the

premises only or send to authorized re-processors.

3 Discarded


33.3 300 nos/year

300 nos/year

600 nos/year

Collection, storage and send to authorized recycler

after decontamination.


medicines 28.3


1.0 1.0 After giving proper

treatment will be disposed at CHWF/TSDF

5 Fly Ash - - 18 18 Collection, storage and

send to brick manufacturer or send to TSDF site.

15

Chapter – 6 Rehabilitation and Resettlement (R & R) Plan The proposed project is an expansion project within existing premises. So the project proposal does not involve any Rehabilitation & Resettlement.

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Chapter – 7 Project Schedule & Cost Estimates 7.1 Time Schedule for the Project

The implementation of the project will involve major activities like preparation of specification / drawings, issue of tenders, receipt of quotations, scrutiny of tenders, placing of orders, civil & structural construction, delivery & erection of equipment, test trial runs of various items of equipment and commissioning of the plant & equipment and completion of the project will take about 6 months after the necessary clearances are available, and the funding for the project has been tied up. 7.2 Estimated Project Cost

The total cost of the proposed expansion project would be around Rs. 5.45 crores. Total capital cost of pollution control measures will be Rs. 73.25 lacs. 7.3 Budgetary Provisions for EMP

Adequate budgetary provisions have been made by the management for execution of environmental management plans. The details of capital and recurring (per annum) budget earmarked for pollution control / monitoring equipment; operation and maintenance of pollution control facilities, for greenbelt development and maintenance. Cost of Environmental Protection Measures

NO. Particulates Rs. In Lacs 1. Capital Expenditure 73.25 2. Recurring expenditure on environmental management cell

and on pollution control systems per annum. 10.00

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Chapter – 8 Analysis of Proposal 8.1 Financial and Social Benefits

The capital cost of the proposed expansion project is estimated at about Rs. 5.45 crores for the installation of plants & machinery along with required auxiliary.

For the coming of this project surrounding area will get developed due to this project and through the Corporate Social Responsibility (CSR) activities, socio-economic status of the region will also get developed.

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