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PRE FEASIBILITY REPORTON

PROPOSED MANUFACTURING OF BULK DRUGS & PHARMACEUTICALS UNIT

By

Adroit Pharmaceuticals Pvt.LtdAmadi (V)-441105.Nagpur (D)

( Maharashtra )

Adroit Pharmaceuticals Pvt.Ltd Pre-feasibility ReportAmadi (V), Nagpur (D).

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SUMMARY

Title : Pre-feasibility Report

Purpose : Environmental Clearance

Project : Manufacturing of Bulk Drugs and Pharmaceuticals

Project Sector : Industry – 2

Type : New project

No.of States : 1 (Maharashtra)

Category : A

Schedule S.No : 5 ( f ) Synthetic Organic Chemical Industry

Project Proponent : Adroit Pharmaceuticals Pvt.Ltd.

Address : Administrative Office :No:46, Garoba Maidan, Basti Precinct,Nagpur – 440 008.Maharashtra.

Tel: 0712-2766731, 2769832E-Mail : [email protected]

Location of Project : Survey (309),Amadi (V)-441105.Parseoni (T),Nagpur (D).( Maharashtra )


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INDEX

S.No CONTENTS Page1 Executive Summary of Project 32 Introduction of the project / Background informationA. Identification of project and project proponent 5B. Brief description of nature of the project 5C. Need for the project 5D. Demand supply gap 6E. Imports vs indigenous production 6F. Export possibilities 6G. Employment generation 63 Project DescriptionA. Type of project 7B. Location of project 7C. Details of alternate sites considered. 10D. Size or magnitude of operation 11E. Project description with process details 12F. Details of Raw materials 16G. Resource optimization/ Recycling and Reuse envisaged in the project 16H. Resource requirement: Power and water 17I. Effluent generation, management and disposal. 184 Site AnalysisA. Connectivity 20B. Land Form,Land use and Land ownership 20C. Topography 20D. Existing Land use pattern 20E. Existing infrastructure 21F. Soil Classification 21G. Climatic data from secondary sources. 21H. Social infrastructure available 215 Planning Brief 216 Proposed InfrastructureA. Land use 22B. Residential Area 22C. Green Belt 22D. Social Infrastructure 22E. Connectivity 22F. Industrial Waste & Solid Waste Management 22G. Power Requirement & Supply 237 Rehabilitation & Resettlement (R&R) Plan 238 Project Schedule & Cost Estimates 239 Analysis of proposal ( Final Recommendations) 24


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1.EXECUTIVE SUMMARY OF PROJECTName of Company Adroit Pharmaceuticals Pvt.Ltd.

Address for Correspondence Administrative Office :No:46, Garoba Maidan, Basti Precinct,Nagpur – 440 008.Maharashtra.Tel.FaxE-mail 0712-2766731, [email protected] person Mr.Sanjay Kukreja, DirectorMob-9373107400Promoters Mr.Sanjay Cheturam Kukreja, DirectorMr.Bhupesh Kukreja, Director.Type of Project Manufacturing of Bulk Drug & Pharmaceuticals.Schedule S.No : 5(f)Category ALocation of Project

Survey No:309,Village:Amadi;Pincode:441105.Taluka: Parseoni.District: Nagpur.State: Maharashtra.Nearest Railway Station AmadiNearest Town Parseoni.Nearest Airport Nagpur International Airport.Geographical Location The proposed project site is located

@ 21.3718737,79.2456293 ( Vil.-Amri, Maharashtra.)In Toposheet No: F-44-N-3.Proposed Investment 180 Lacs

Location Selection Proposed location is a pollution free environment, which isessential requirement as per the cGMP guidelines of FDA-Indiaand US-FDA.


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About Proposed Project Company proposed to start new facility for Manufacture of BulkDrugs & Pharmaceuticals as below.1.Bulk Drug –Paracetamol,Ferrous Ascorbate,Metformin Hcl.2.Pharmaceutical-Granules, Tablets, Capsules,Liquid orals,etc.In the proposed plant all the process shall be fully automatedwithout human touch.All the Raw materials & chemicals shall behandled/processed in a close system from starting point up tofinal product, without exposing to atmosphere. This system willhelp in avoiding pollution and reducing handling loss ofmaterial/chemicals.All the Mother liquids in the process shall be recycled.All the effluents generated shall be segregated as per nature ofeffluent and shall be treated in an ETP, so as to recover productas well as By-product from effluent. The recovered product andBy product shall be sold in the market.The solid residue generated after recovery shall be disposed offto CHWTSDF located in Butibori-MIDC. Ultimately there shall beZero discharge from our unit.All efforts shall be taken to keep the premises as well assurroundings a POLLUTION FREE and ENVIRONMENTFRIENDLY.


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2.INTRODUCTION OF THE PROJECT.

A. Identification of project and project proponent.The objective of this pre- feasibility report is to provide information for the proposed Bulk drug &Pharmaceuticals manufacturing unit of Adroit Pharmaceuticals Pvt.Ltd proposed at Survey No:309,Amadi(V)-441105.Parseoni(T).Nagpur(D).Maharashtra.Project Proponent.

1. Mr.Sanjay Kukreja, Director2. Mr.Bhupesh Kukreja, Director

B. Brief description of nature of the project.The proposed unit will be a small scale unit to manufacture various Bulk Drugs andPharmaceuticals with total production capacity of 2684 MT/Month.The proposed site is located at :Survey No :309,Village :AmadiPin code :441105.Taluk :ParseoniDistrict :NagpurState :Maharashtra.The proposed project will be set up in a land located in village-Amadi, 40 km from Nagpur inNH-7 Nagpur-Jabalpur road, Project site is well connected by road ,rail and air to rest of India.Proposed location is a pollution free environment, which is essential requirement as per the cGMPguidelines of FDA (Food and Drugs Administration)-India and US-FDA.The proposed project is covered under Category-: A, S.No-5(f) Synthetic organic chemicalsindustry as per EIA Notification of Ministry of Environment, Forest and Climate change(MoEF),Therefore, unit requires to obtain Environmental Clearance from Ministry ofEnvironment,Forest and Climate change(MoEF),New Delhi.C.Need for the project.The Indian pharmaceutical industry is highly organized sector currently tops the chart amongstIndia's science based industries with wide ranging capabilities in the complex field of drugmanufacture and technology. It ranks very high amongst all the third world countries, in terms oftechnology, quality and the vast range of medicines that are manufactured.The Indian pharmaceutical industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9percent annually.


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It ranges from simple headache pills to sophisticated antibiotics and complex cardiac compounds,almost every type of medicine is now made in the Indian pharmaceutical industry.The domestic market accounts for 90% of the company’s total revenue and supplies its products toLeading Pharma industries of domestic and international clients. These Products are used as anAuxiliary product for Organic Synthesis, used as a raw material for the manufacture of RetroviralDrugs.Government recognizes Chemical and Bulk drug industries are key growth element of Indianeconomy. In these Sector, 100% FDI is permissible. Manufacture of most of chemical products isdelicenced. Sales are expected to grow rapidly in the next three years of operation and to acceleratebeyond that as anticipated new enzyme and inhibitor sales materialize. Positive income and cashflows should be achieved within next four years of operation. Before that time, additional fundingor capitalization issues will be addressed to support future growth alternatives.Promoters of Adroit Pharmaceuticals Pvt.Ltd intends to respond to this challenge by setting up newunit so that we are able to put more teams in the field, by moving to a larger facility, and bylaunching several innovative marketing.D.Demand supply gap.There is a quite considerable gap between supply and demand for, bulk drugs and pharmaceuticals.The company wants to bridge this gap between demand and supply by setting up new productioncapacity and thereby, making good business. Company's marketing edge comes from its direct andclose contact with the customers. Their products shall be a major strength of their customers. Eachstage of their product shall be monitored /checked for their quality to ensure quality productreaches their customer. They plan to launch new products also in future to satisfy the need of theircustomers as per the market demand.E.Imports vs indigenous production.This product-Paracetamol is one of the generic drug used commonly for Fever and Head ache.It isone of the largest consuming drug in the market.Apart from domestic manufacturing facilities,there is also large volume of imports from othercountries mainly from china.This project can be a part of “Make in India” ,”Make in Maharashtra” initiative made both by centralas well as state government respectively.F.Export possibilitiesThere is huge scope in Domestic as well as Export Markets for this products.G. Employment generationThe unit shall have around 12 permanent and contractual employees. Apart from this there will besignificant non estimated employment generation at the supplier firms and service industryproviding services to the company. Company shall be giving preference to people fromeconomically weaker sections for employment in various semi-skilled/unskilled jobs therebycontributing to their upliftment.


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3.PROJECT DESCRIPTION

A. Type of project.The type of proposed project is “Manufacture of Bulk Drugs and Pharmaceuticals”The proposed project comes under the heading “ Industry-2”The proposed project is covered under Category-: A, Schedule S.No-5(f) “Synthetic organicchemicals industry” as per EIA Notification 2006 of Ministry of Environment,Forest andClimate change,Govt.of India.B. Location of projectThe proposed site is located at :Survey No :309,Village :AmadiPin code :441105.Taluk :ParseoniDistrict :NagpurState :Maharashtra.The coordinates of proposed site are @ 21.3718737,79.2456293 ( Vil.-Amri, Maharashtra.)as shown in the Google map.The site is identified in Survey of India Toposheet No: F-44-N-3.


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Location Map of Maharashtra.

Location Map of Nagpur


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Location Map of Nagpur District

Location Map of Amadi (V) in Google Map

Amadi (V)

Nagpur (D)

Amadi (V)

Nagpur (D)


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Location Map of Adroit Pharmaceuticals,Amadi in Google Earth

C.Details of alternate sites considered.Alternate site not considered for this project.


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D. Size or magnitude of operationThe unit proposes to manufacture following Bulk Drugs & PharmaceuticalsTable-1:LIST OF PRODUCTS

S.No PRODUCT TYPE CAPACITYPER MONTH1 PARACETAMOL Bulk Drug 1000 MT2 FERROUS ASCORBATE Bulk Drug 100 MT3 METFORMIN Hcl Bulk Drug 500 MT4 PARACETAMOL- D.C.GRANULES Pharmaceuticals 200 MT5 PARACETAMOL- TABLETS Pharmaceuticals 50 MT6 ACETIC ACID – 33 % (By product) Inorganic chemicals 800 MT7 SODIUM SULPHATE (By product) Inorganic chemicals 34 MTTOTAL 2684 MT


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E. Project description with process details.The manufacturing process of Bulk drugs and Pharmaceuticals has been schematically described inthe form of flow chart as below.Flow Chart -1: Paracetamol -Manufacturing Process Flow chart


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Flow Chart -2: Metformin Hcl -Manufacturing Process Flow chart


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Flow Chart -3: Ferrous Ascorbate -Manufacturing Process Flow chart


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Flow Chart -4: Granules /Tablets -Manufacturing Process Flow chart


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F. Details of Raw materials

The following is the list of Raw materials

Table-2:LIST OF RAW MATERIALS

S.No Raw Materials QtyMT /Annum1 Para aminophenol 96002 Acetic Anhydride 91003 Ascorbic Acid 10004 Ferrous Sulphate 5005 Dicyandiamide 30006 Dimethylamine 17007 Maize Starch Powder 5008 Activated Carbon 159 Sodium Hydrosulphite 1510 Soda ash 611 Sodium Hydroxide 12012 Hydrochloric acid 30013 Toluene 5014 Potassium Sorbate 315 Magnesium stearate 616 Aerosil 3

All the raw materials required for manufacturing of above products will be sourced from Importedas well as local market.G.Resource optimization/ Recycling and Reuse envisaged in the project

All the mother liquids shall be Recycled to avoid fresh water consumption. There by load onETP shall reduce very drastically. All the condensate from the process equipments shall be collected and reused in boiler feedwater. There by wastage of hot water is avoided. Since hot water is recycled in boiler feedwater, fuel consumption in the boiler is reduced, there by reduction in stack emission isachieved. All the acids are collected and distilled in ETP to get pure acid as By-product, which can besold in the market. The product, which escaped along with the effluent shall be recovered in ETP. Our ETP isdesigned as a Process specific design according to the nature of effluent. Our liquid effluent will no longer come in contact with any land/soil, there by avoidingland/soil pollution.


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H.Resource requirement:i. Land: For the proposed project, land required for factory building, ETP and Boiler house is@ 3000 SqM. The total land available for the proposed project is 8000 SqM (2.0 acres) .ii. Power: The total Power requirement for the unit is 300 kVA. Power shall be drawnfrom MSEDCL. D.G. set of 100 KVA capacities is proposed to be installed to meet theemergency power requirement of the plant.iii. Water: Water requirement of the project for domestic and industrial activity duringoperation phase will be 68 M3. The water requirement will be met by borewell within thepremises. The detailed water requirement is shown Table as below . The total fresh waterrequirement for the unit is 68 M3/ Day.Table-3: DETAILS OF WATER CONSUMPTION

Purpose Quantitya) Industrial cooling :21.0 M3/dayb) Domestic Purpose : 1.0 M3/dayc) Process :14.0 M3/dayd) DM Plant /Softener :28.0 M3/daye) Gardening : 4.0 M3/dayTotal :68.0 M3/dayiv. Fuel:It is proposed to install Steam Boiler (3 TPH), which will use coal or Bio mass asfuel. The daily consumption l shall be 3 MT/Day. (in case of coa) or 4 MT/Day (in case ofBiomass.v. Manpower: Total 11 personnel are planned to employ,which comprises : Management -2, Supervisory-2 and Workers-7.


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I. Effluent generation, management and disposal.a) All the mother liquids shall be Recycled to avoid fresh water consumption. There by load onETP shall reduce very drastically.b) All the condensate from the process equipments shall be collected and reused in boiler feedwater. There by wastage of hot water is avoided. Since hot water is recycled in boiler feedwater, fuel consumption in the boiler is reduced, there by reduction in stack emission isachieved.c) All the acids are collected and distilled in ETP to get pure acid as By-product, which can besold in the market.d) The product, which escaped along with the effluent shall be recovered in ETP. Our ETP isdesigned as a Process specific design according to the nature of effluent.e) Our liquid effluent will no longer come in contact with any land/soil, there by avoidingland/soil pollution.f) The total water consumption for different use shall be 68 m3/day as detailed in the Table-3.g) Break up for 68 m3/day is as follows: 29 m3 will mix with 9 MT of acid generated during process.This acid mixture is distilledin ETP to get 35 MT of pure dilute acid (BY product),which are sold in the market. The remaining 3 m3 waste water is neutralized and evaporated in Forced Evaporator inETP. 18 m3 shall be of evaporation loss in cooling tower. 7 m3 of water is carried along with the product and gets dried off during drying processin final stage of drying. 5 m3 generated during mfg of Ferrous ascorbate is subjected to natural evaporationprocess in open pond, where by water gets evaporated and remaining solid by-productis recovered an sold in the market. 4 m3 water is directly used for gardening as fresh water.h) All the condensate water from process will be recovered & reused in Boiler.i) Waste water generated in Domestic,Boiler blow down,Cooling tower blow down,DM plantand Softening plant shall neutralized and used for gardeningand plantation within the premises.j) For the proposed steam boiler, the unit shall install stack of adequate height withsuitable Cyclone Separator for dust control and maintain emission parameters withinprescribed limitk) The main sources of hazardous waste generation from proposed manufacturing activity willbe Process Waste viz.Distillation Residue and Spent Carbon. The Dried sludge will begenerated from effluent treatment plant.l) The ancillary source of hazardous waste generation will be discarded bags/ liners/drums/ Carboys/Containers from storage and handling of raw materials.m) The unit will provide an adequate designated storage area for the hazardouswaste storage and shall obtained membership of MPCB approved CHWTSDF in Butibori.Details of effluent generation,management and disposal is given in the following table.


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Table-4:DETAILS OF EFFLUENT TREATMENT AND DISPOSAL

S.No Descriptionof Effluent

Nature ofTreatment

Nature of Waste Qty./Day

Method of Disposal1 ProcessInfluent .(Paracetamol) Distillation ACETIC ACID -33 %:-

SOLID PRODUCT:-*TRADE INFLUENT

35 MT4 MT3 M3

Sold as By-ProductRecycled in Stage-2Treated as below.2 *TradeInfluent –(AfterDistillation)(Paracetamol)

Neutralizationfollowed byForcedEvaporationin Evaporator.LIQUID EFFLUENT

SOLID WASTE:

3 M320 Kg Forced EvaporationSend to CHWTSDF atButibori.3 ProcessInfluent(FerrousAscorbate)Evaporation inopen ponds. LIQUID EFFLUENT:

SOLID:-Sodium Sulphate :98 %5 M31 MT

Natural Evaporationin Open PondSold as By-Product4 ProcessInfluent(Metformin) Low VacuumDistillation LIQUID EFFLUENT:Recovered Solvent :99 %SOLID RESIDUE:

2 MT2 Kgs

Recycled in Processafter DistillationDisposal toCHWTSDF.5 DomesticEffluent Collected in SoakPit. LIQUID EFFLUENT 1 M3 Overflow used forGardening.6 Boiler &Cooling TowerBlowdownWater

Neutralizationfollowed byGardening LIQUID EFFLUENT 3 M3 For Coal Ash Cooling&Excess water usedfor Gardening7 DM Plant &SoftenerRegenerationWaterNeutralizationfollowed byGardening LIQUID EFFLUENT 1 M3 Used for Gardening

8 Coal Ash Nil Coal Ash 1 MT Used for Land Filling.


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4.SITE ANALYSIS

A.Connectivity.The proposed project will be set up in land located in village-Amadi, 40 km from Nagpur inNH-7 Nagpur-Jabalpur road.Project site is well connected by road ,rail and air to rest of India. The nearest railway station is Amadi Railway Station at a distance of 3 KMs(SE). The nearest airport is Nagpur International Airport at a distance of 52 KMs. (SW). The Nearest road ways State Highway No. 249 Touch, NH-7 – 0.1 KMs.(E)

B. Land Form,Land use and Land ownership.The current land use is Agriculture land which shall be converted into NA land. The proposedproject is coming in that land of 2 acre. The said land is owned by project proponent.C.Topography.The proposed project site is located @ 21.3718737,79.2456293 ( Vil.-Amri, Maharashtra.)The altitude of the site is 310 m above sea level.In Survey of India OSM,it is loacated in Toposheet No: F-44-N-3.D. Existing Land use pattern.The current land use is Agriculture land which shall be converted into NA land. The proposedproject is coming in that land of 2 acre. The said land is owned by project proponent.


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Following is the shortest distance from the periphery of project.Table-5: AERIAL DISTANCE OF DIFFERENT PLACES

AROUND 15 KMS RADIUS OF PROPOSED SITE.

S.No Name of Places Direction Approx Aerial Distance1 Ramdham NE 2.2 Km2 Forest NE 3.0 km3 Ramtek NE 8.5 km4 Ambala Lake NE 10.0 km5 Ramtek Dham NE 11.0 km6 Amadi Rly Station SE 3.0 km7 Amadi Village SE 2.5 km8 Pench River SW 6.0 km9 Coal mines SW 14.0 km10 Bhagimahari Dam SW 13.0 kmE.Existing Infrastructure.The proposed project site is well connected with road way. State Highway No. 249– Road touch.Power transmission infrastructure is easily accessible to the project site.Water is abundantly available within the site.F.Soil classificationThe area is largely covered by Black soil.G.Climatic data from secondary source.The climatic condition of the project site is extreme climate.The Maximum Temperature is 28.8 oC to 42.7 oCThe Minimum Temperature is 5.7 oC to 21.0 oCThe Rainfall is in the range 8 mm to 304 mmH.Social infrastructure available.Well developed social infrastructure facilities are available at nearby Habitations.5.PLANNING BRIEF.

Proposed plant activities will be started after getting statutory clearance form relatedauthorities. The project will be completed within 18 Months. Further proposed project activities will take care of all the rules and regulation of statutoryauthority and provide the control measure and devices to achieve the standard norms. The existing infrastructure facilities are adequate for the proposed project. The existing amenities/ facilities are adequate for the proposed project.


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6.PROPOSED INFRASTRUCTURE

A.Land use:The current land use is agriculture land. It shall be converted into NA land after gettingEC node.The proposed project is coming in that land of 2 acre. The said land is owned by projectproponent.B.Residential Area:The employees who will work in the industry will be live in nearby town /area& no proposal for residential area for employees.C.Green Belt:For the proposed project, land required for factory building, ETP and Boiler house is@ 3000 SqM. The total land available for the proposed project is 8000 SqM (2.0acres) .Presently the total area is of green belt. After the project is commissioned the remainingarea shall remain as green belt.D.Social Infrastructure: Facilities like road and communication are good..Banks, ATM's, andmedical facilities are also adequate.

Education: Schools including middle, secondary and higher secondary schools, socialwelfare hostels. Medical and Health: Community Health Centre, & Primary Health center are available nearvillages Power and water- All the villages are electrified and drinking water facilities are extendedto all villages. Rail and Road- The project site is very well connected by road through State Highway andrailways.

E.Connectivity:The proposed project will be set up in land located in village-Amadi, 40 km from Nagpur inNH-7 Nagpur-Jabalpur road.Project site is well connected by road ,rail and air to rest of India. The nearest railway station is Amadi Railway Station at a distance of 3 KMs(SE). The nearest airport is Nagpur International Airport at a distance of 52 KMs. (SW). The Nearest road ways State Highway No. 249 Touch, NH-7 – 0.1 KMs.(E)

F.Industrial Waste & Solid Waste ManagementLiquid effluent shall be treated & (a) Recovered product will be recycled, (b) Recovered by-productwill be sold to end user,.Domestic effluent shall be treated and used for gardening.Solid waste shall be disposed to CHWTSDF, Butibori,Nagpur.( About 75 km from proposed site)The details has been described in point 3 (I).


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G.Power Requirement & Supply

Power: The total Power requirement for the unit is 300 kVA. Power shall be drawn fromMSEDCL.D. G. set of 100 KVA capacities is proposed to be installed to meet the emergency powerrequirement of the plant.7.REHABILITATION & RESETTLEMENT (R & R ) PLAN.Rehabilitation & Resettlement (R&R) plan is not applicable to proposed project.8.PROJECT SCHEDULE & COST ESTIMATES.Proposed project activities will be started after getting statutory clearance form related authorities.The project will be completed within 18 months. The project cost for proposed Product is 225 lacsincluding plant & machinery,ETP equipments.

Table-5: DETAILS OF PROJECT COST:S.No Description Capital Cost

Rs.Lacs1 Land 0.002 Building 35.003 Plant & Machinery 180.004 Electricals 15.00

Total 230.00


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9.ANALYSIS OF PROPOSAL.(FINAL RECOMMENDATION)

Our proposed industry shall take following control and mitigation measures to combatpollution in air,land,noise and water. All the mother liquids shall be Recycled to avoid fresh water consumption. There byload on ETP shall reduce very drastically. All the condensate from the process equipments shall be collected and reused inboiler feed water. All the acids are collected and distilled in ETP to get pure acid as By-product, whichcan be sold in the market. The product, which escaped along with the effluent shall be recovered in ETP. OurETP is designed as a Process specific design according to the nature of effluent. Our liquid effluent will no longer come in contact with any land/soil, there byavoiding land/soil pollution. Industrial wastewater will be treated by ETP within the premises.The industry shallhave zero discharge ETP. The domestic wastewater generated will be treated separately and treated waterwill be used for gardening. The noise generation will be reduced due to the measure provided in EnvironmentalManagement plan. No air pollution, the fluegas emission from boiler will be left out through stack. Thestack with adequate height as per MPCB norms will be provided.

The industry will manufacture Bulk Drug & Pharmaceuticals which is in good demand forgrowing Medical facilities in India. The proposed project would provide a quality drugs product at lower cost to the users. There would be considerable saving in energy resources on account of transportationProject activity will not disturb the environmental setting because we have proposed allpreventive and mitigation measures required for pollution prevention. No Rehabilitation issue is involved. There will not be problematic waste materials as all willbe safely disposed. Socio-economic benefits due to creation of direct/indirect employment. Country will save valuable foreign exchange as import of these drugs will reduce bycorresponding amount. These drugs also have export potential. Hence, possibility of earning foreign exchange. It can be concluded on a positive note that proposed project activity of AdroitPharmaceuticals Pvt. Ltd. may be considered for Environmental Clearance in the interest ofcommon man, the society, the state and as the country as a whole. This project can be a part of “Make in India” ,”Make in Maharashtra” initiative made both bycentral as well as state government respectively.

* End of Document *

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