FORM- I & STANDARD TEMPLATE FORenvironmentclearance.nic.in/writereaddata/form-1/2014_5_23_May... ·...

FORM- I & STANDARD TEMPLATE FOR

CAPACITY EXPANSION

APEX DRUGS & INTERMEDIATES LTD SY.NO.10, IDA GADDAPOTHARAM,

JINNARAM (M), MEDAK (D) ANDHRA PRADESH

M/S Pridhvi Enviro Tech pvt. Ltd

Studies & Documentation By

Submitted by M/S APEX DRUGS & INTERMEDIATES LTD, 184/C, Lawn House

(MoE&F O.M – S.NO: 118)

SY.NO 10, GADDAPOTHARAM(V) VengalRao Nagar JINNARAM(M), Hyderabad-500038 MEDAK (D) Ph: 040-40179770 ANDHRA PRADESH Fax: 040-66730926 E-Mail: [email protected]

SUBMITTED TO MINISTRY OF ENVIRONMENT & FORESTS, GOI

PARYAVARAN BHAWAN, CGO COMPLEX, LODHI ROAD, NEW DELHI-110003

PRE-FEASIBILITY REPORT

FOR TERMS OF REFERENCES FOR

CAPACITY EXPANSION October, 2013

APEX DRUGS & INTERMEDIATES LTD SY.NO.10, IDA GADDAPOTHARAM,

JINNARAM (M), MEDAK (D) ANDHRA PRADESH

M/S Pridhvi Enviro Tech pvt. Ltd Studies & Documentation By

Submitted by M/S APEX DRUGS & INTERMEDIATES LTD, 184/C, Lawn House

(MoE&F O.M – S.NO: 118)

SY.NO 10, GADDAPOTHARAM(V) VengalRao Nagar JINNARAM(M), Hyderabad-500038 MEDAK (D) Ph: 040-40179770 ANDHRA PRADESH Fax: 040-66730926 E-Mail: [email protected]

SUBMITTED TO

MINISTRY OF ENVIRONMENT & FORESTS, GOI PARYAVARAN BHAWAN, CGO COMPLEX,

LODHI ROAD, NEW DELHI-110003

CONTENTS

S.No. Description Page No. 1. Introduction 1 2 Introduction of the project 2 About the Group & Promoters 3 3 Project Description 4 3.1 Production Capacity 4 3.1.1 Proposed Expansion 4 3.2 Manufacturing Process 5 3.3 Raw materials 5 3.4 Water Requirement 5 3.5 Waste generation and control systems 6 3.5.1 Liquid effluents 6 3.5.2 Solid waste management 9 4 Site Analysis 10 4.1 Plant location 10 5 Planning in Brief 17 6 Resource requirement 17 6.1 Power requirement and Supply/ Source 17 6.2 Production facilities , Utilities and

effluent handling facilities 17

6.3 Land requirement 18 7 Air pollution 18 8 Bulk chemical storage 19 9 Project financial 20

LIST OF TABLES

LIST OF FIGURES

LIST OF ANNEXURES

Table No. Description Page No. 1.0 Salient Features of the Project 2 2.0 List of Existing Products and Capacity 3 3.0 Proposed Products and Capacity 4 4.0 Water Balance-Current & Proposed 5 5.0 Solid Waste and Disposal 9 6.0 List of Reserve Forests 10 7.0 Utilities and Effluent Handling Facilities

Existing and Proposed 17

8.0 Land Statement 18

9.0 Emission Source – Current & Proposed 18

10.0 Storage facilities of bulk chemicals 19

Fig No Description Page No. 1.1 Schematic treatment scheme of high

TDS effluents 7

1.2 Low TDS Effluent Treatment System 8 1.3 Base Map of the Study Area 12 1.4 Topo Map of the study area 13 1.5 Photographs of Plant & Green Belt 14-15 1.6 Site Plan 16

Annexure Description I CFO copy II List of Raw Material III Technical details of proposed products

ANNEXURE III

TECHNICAL DETAILS OF PROPOSED PRODUCTS

Apex Drugs & Intermediates Limited

Form I Page 1

APPENDIX – I (See Paragraph – 6)

FORM I

I) Basic Information

S.No. Item Details 1 Name of the Project/s APEX DRUGS & INTERMEDIATES LIMITED 2 S. No in the Schedule 5 f – Drug & Drug Intermediates 3 Proposed capacity/area/length/tonnage to

be handled/command area/lease area/number of wells to be drilled

Capacity expansion from 15.0 TPM to 28.5 TPM

4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Recovery of Solvents & Piperazine 15.0 TPM 6

Category of Project i.e 'A' or 'B'

“A”( As the unit is located in 10 Km radius of Bollaram & patancheru cluster which is notified under CEPI )

7 Does it attract the general condition? If yes, please specify

No

8 Does it attract the Specific condition? If yes, please specify.

No

9 Location Plot/Survey/Khasra No. Sy.No- 10, Village IDA Gaddapotharam Tehsil Jinnaram (Mandal) District Medak (District) State Andhra Pradesh

10 Nearest railway station/airport along with distance in kms.

Gaudavalli at distance of 10 Kms from the site Shamshabad is nearly 40 Kms from the site

11 Nearest Town, City, District Headquarters along with distance in kms.

Gaddapotharam – 0.82 Kms from the site Sanga Reddy at about 50 Kms from the site

12 Village Panchayats, Zilla Parishad, Municipal Corporation, Local body (complete postal address with telephone nos. to be given)

Gaddapotharam ( Gram Panchayat) Jinnaram ( Mandal) Medak ( District) Andhra Pradesh

13 Name of the Applicant M/s. Apex Drugs & Intermediates Limited 14 Registered Address 210, Ram’s Enclave,

Erragadda, Hyderabad, Andhra Pradesh. Phone: 040-23706034 Fax: 040-23707368 Mail: vijayreddy @apexdrugs.net


Form I Page 2

15 Address for Correspondence: Name Mr. GHANSHYAM KURMI (ManagingDirector) Designation(Owner/Partner/CEO) Owner Address 210, Ram’s Enclave,

Erragadda, Hyderabad, Andhra Pradesh.

Pin Code 500018 E-mail vijayreddy @apexdrugs.net Telephone Number 040-23706034

Fax No. 040-23707368 16 Details of alternative Sites examined, if any.

Location of these sites should be shown on a topo sheet.

- NA- This is existing unit

17 Interlinked Projects -NA- 18 Whether separate application of interlinked

project has been submitted? -No -

19 If yes, date of submission -NA - 20 If no, reason 21 Whether the proposal involves

approval/clearance under: if yes, details of the same and their status to be given. (a) The Forest (Conservation) Act, 1980? (b) The Wildlife (Protection) Act, 1972? (c) The C.R.Z Notification, 1991?

-NA-

22

Whether there is any Government Order/Policy relevant/relating to the site?

GO MS No 95 of EFES&T Department, Government of AP dated 21.9.2007 on restriction on expansion and establishment of new industries – IDA Gaddapotharam area is identified as one of the restricted area. GO MS No: 64 on lifting of ban on expansion of Drugs and Drug Intermediate units with ZLD facilities

23 Forest land involved (hectares) No 24 Whether there is any legal cases pending

against the project and /or land in which the project is propose to be set up? (a) Name of the Court (b) Case No (c) Orders/directions of the Court, if any and its relevance with the proposed project.

No


Form I Page 3

(II) Activity

1. Construction, operation or decommissioning of the Project involving actions, which will cause physical changes in the locality (topography, land use, changes in water bodies, etc.)

S. No.

Information/Checklist confirmation Yes/No Details thereof (with approximate

quantities /rates, wherever possible) with source of information data

1.1 Permanent or temporary change in land use, land cover or topography including increase in intensity of land use (with respect to local land use plan)

NO The proposal is for expansion of the manufacturing capacity in the existing Solvent & Piperazine Recovery unit.

1.2 Clearance of existing land, vegetation and buildings?

NO No existing buildings or vegetation will be disturbed

1.3 Creation of new land uses? NO Existing land use – Industrial. 1.4 Pre-construction investigations e.g.

bore houses, soil testing? NO Existing unit.

1.5 Construction works?

YES Construction activity involves creation of additional utilities. One production block & 3 clean room are proposed and ZLD facilities

1.6 Demolition works? NO

1.7 Temporary sites used for construction works or housing of construction workers?

NO Labor is employed from nearby villages

1.8 Above ground buildings, structures or earthworks including linear structures, cut and fill or excavations

YES No major cut and fill or excavation is anticipated.

1.9 Underground works including mining or tunneling?

NO

1.10 Reclamation works? NO 1.11 Dredging? NO 1.12 Offshore structures? NO 1.13 Production and manufacturing

processes? YES This is Solvent & Piperazine Recovery unit.

Details given in pre-feasibility report 1.14 Facilities for storage of goods or

materials? YES Existing facilities for storage of chemicals

are used 1.15 Facilities for treatment or disposal of

solid waste or liquid effluents? YES Currently the unit established evaporation

facilities for process and washes. It is now proposed to establish ZLD plant. Details submitted in pre-feasibility report.

1.16 Facilities for long term housing of operational workers?

NO


Form I Page 4

1.17 New road, rail or sea traffic during construction or operation?

NO

1.18 New road, rail, air waterborne or other transport infrastructure including new or altered routes and stations, ports, airports etc?

NO

1.19 Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements?

NO

1.20 New or diverted transmission lines or pipelines?

NO

1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers?

NO

1.22 Stream crossings? NO 1.23 Abstraction or transfers of water

from ground or surface waters? NO Project needs about 81.4 KLD of water

which is proposed to be procured from tankers in which 51.2 KLD is freshwater requirement and 30.2 KLD is recycled water.

1.24 Changes in water bodies or the land surface affecting drainage or run-off?

NO

1.25 Transport of personnel or materials for construction, operation or decommissioning?

YES Transport of material for construction will be there for short period during construction.

1.26 Long-term dismantling or decommissioning or restoration works?

NO Existing plant

1.27 Ongoing activity during decommissioning which could have an impact on the environment?

NO Existing plant

1.28 Influx of people to an area in either temporarily or permanently?

NO All labor is taken from nearby villages or Hyderabad

1.29 Introduction of alien species? NO

1.30 Loss of native species or genetic diversity?

NO There are no losses of tree/shrub species.

1.31 Any other actions? NO


Form I Page 5

2. Use of Natural resources for construction or operation of the Project (such as land, water, materials or energy, especially any resources which are non-renewable or in short supply):

S.No. Information/checklist confirmation Yes/No Details thereof (with approximate quantities /rates, wherever possible) with source of information data

2.1 Land especially undeveloped or agricultural land (ha)

NO Existing Unit. The total area of the plant is 3.0 acres. Out of this green belt area is 0.9 acres. Land already developed is 1.04 acres and the land required for proposed expansion is 0.09 acres

2.2 Water (expected source & competing users) unit: KLD

YES Purchased from tankers (Water Balance submitted in pre-feasibility report)

2.3 Minerals (MT) NA

2.4 Construction material – stone, aggregates, sand / soil (expected source – MT)

YES As it is proposed to add few utilities and ZLD facilities, construction material like steel, sand, cement, aggregate, bricks will be used.

2.5 Forests and timber (source – MT) NO 2.6 Energy including electricity and fuels

(source, competing users) Unit: fuel (MT), energy (MW)

YES The total power requirement after expansion would be 950 KVA and the same is drawn from APCPDL. During load shut downs backup DG sets will be used. Coal is procured from local sources. Approximate coal requirement is 20.0 TPD

2.7 Any other natural resources (use appropriate standard units)

NO


Form I Page 6

3. Use, storage, transport, handling or production of substances or materials, which could be harmful to human health or the environment or raise concerns about actual or perceived risks to human health.

S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data

3.1 Use of substances or materials, which are hazardous (as per MSIHC rules) to human health or the environment (flora, fauna, and water supplies)

YES Hazardous chemicals shall be used for manufacturing of Drugs & Drug Intermediates. Safety measures are taken for the storage of hazardous waste.

3.2 Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases).

NO No such diseases are expected

3.3 Affect the welfare of people e.g. by changing living conditions?

YES Shall increase the employment potential for locals and affect the living conditions for betterment

3.4 Vulnerable groups of people who could be affected by the project e.g. hospital patients, children, the elderly etc.,

NO No sensitive receptors are present in the immediate vicinity of the site. The project shall not have any significant impact on vulnerable groups of people.

3.5 Any other causes NO

4. Production of solid wastes during construction or operation or decommissioning (MT/month) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate

quantities/rates, wherever possible) with source of information data

4.1 Spoil, overburden or mine wastes NO 4.2 Municipal waste (domestic and or

commercial wastes) NO Wastes from canteen, other commercial

wastes like paper, empty containers etc. The canteen wastes and commercial wastes shall be in the range of 0.5 TPM

4.3 Hazardous wastes (as per Hazardous Waste Management Rules)

YES Solid waste 47.23 TPM generated sent to TSDF for secured land fill and Incinerable waste to Cement plants for Co- incineration.

4.4 Other industrial process wastes YES Details submitted in pre-feasibility report

4.5 Surplus product NO 4.6 Sewage sludge or other sludge from

effluent treatment YES Details submitted in pre-feasibility report

4.7 Construction or demolition wastes NO

4.8 Redundant machinery or equipment NO


Form I Page 7

4.9 Contaminated soils or other materials NO

4.10 Agricultural wastes NO

4.11 Other solid wastes NO Details given in pre-feasibility report

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)


5.1 Emissions from combustion of fossil fuels from stationary or mobile sources

YES Coal is used as fuel. Particulate matter, CO2, SO2 and NOX are emissions. Bag Filters were installed for existing boilers and for proposed 4 TPH Boiler.

5.2 Emissions from production processes YES Process emissions are primarily CO2, H2 which are safely let into atmosphere and HCl Emissions are scrubbed.

5.3 Emissions from materials handling including storage or transport

YES Material transfer takes place in closed pipeline systems.

5.4 Emissions from construction activities including plant and equipment

Yes Water sprinklers will be used to suppress dust

5.5 Dust or odors from handling of materials including construction materials, sewage and waste

Yes Dust will be suppressed with water sprinkling during construction

5.6 Emissions from incineration of waste NO 5.7 Emissions from burning of waste in

open air (e.g. slash materials, construction debris)

NO

5.8 Emissions from any other sources NO


Form I Page 8

6. Generation of Noise and Vibration, and Emissions of Light and Heat: S.No. Information/Checklist

confirmation Yes/No Details thereof (with approximate

quantities/rates, wherever possible) with source of information data with source of information data

6.1 From operation of equipment e.g. engines, ventilation plant, crushers

YES Material transport and construction equipment shall be source of noise, while transfer pumps, vacuum systems, DG sets are the sources of noise during operation.

6.2 From industrial or similar processes

YES From DG sets, and controlled by providing Acoustic Enclosures.

6.3 From construction or demolition NO No significant impact is anticipated.

6.4 From blasting or piling NO

6.5 From construction or operational traffic

NO The increased vehicle movement shall not have any significant impact.

6.6 From lighting or cooling systems NO

6.7 From any other sources NO

7.Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface waters, groundwater, coastal waters or the sea:

S.No. Information/Checklist confirmation

Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data

7.1 From handling, storage, use or spillage of hazardous materials

Yes All the hazardous materials is stored on elevated plat form and stored in a closed storage tanks/containers (Liner/MS/GI/HDPE) in a covered shed with spill collection and control systems and no contamination of soil is expected.

7.2 From discharge of sewage or other effluents to water or the land (expected mode and place of discharge)

NO All the wastes from domestic operations are sent to effluent treatment plant and the treated water is being used for utilities and gardening

7.3 By deposition of pollutants emitted to air into the land or into water

NO Process emissions are primarily CO2, H2 which are safely let into atmosphere and HCl Emissions are scrubbed.

7.4 From any other sources NO 7.5 Is there a risk of long term build

up of pollutants in environment from these sources?

NO


Form I Page 9

8.Risk of accidents during construction or operation of the Project, which could affect human health or the environment


8.1 From explosions, spillages, fires etc from storage, handling, use or production of hazardous substances

YES All Inbuilt Safety precautions will be adopted and there will not be any damage to environment or human health.

8.2 From any other causes NA

8.3 Could the project be affected by natural disasters causing environmental damage (e.g? Floods, earthquakes, landslides, cloudburst etc)?

NO

9.Factors which should be considered (such as consequential development) which could lead to environmental effects or the potential for cumulative impacts with other existing or planned activities in the locality

S. No.

Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data

9.1 Lead to development of supporting. facilities, ancillary development or

development stimulated by the project which could have impact on the environment e.g.:

• Supporting infrastructure (roads, power supply, waste or waste water treatment, etc.) • housing development • extractive industries • supply industries • other

YES The project shall enhance the socio economic status of the area by increasing the demand for housing, improving the employment. There are no major support industries required for this plant.

9.2 Lead to after-use of the site, which could haven impact on the environment

NO

9.3 Set a precedent for later developments NO

9.4 Have cumulative effects due to proximity to other existing or planned projects with similar effects

Yes There is possibility of cumulative impacts as other units in industrial area can go for expansion


Form I Page 10

(III) Environmental Sensitivity S.No. Areas Name/

Identity Aerial distance (within 15 km.) Proposed project location boundary

1 Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value

NA

2 Areas which are important or sensitive for ecological reasons - Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests

NO

3 Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration

NO

4 Inland, coastal, marine or underground waters NO 5 State, National boundaries NO 6 Routes or facilities used by the public for access

to recreation or other tourist, pilgrim areas NO

7 Defense installations YES 6.5 Kms – Hakimpet Air Force Station

8 Densely populated or built-up area No

9 Areas occupied by sensitive man-made land uses (hospitals, schools, places of worship, community facilities)

NA

10 Areas containing important, high quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals)

NO

11 Areas already subjected to pollution or environmental damage. (those where existing legal environmental standards are exceeded)

NO

12 Areas susceptible to natural hazard which could cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions)

NO


Form I Page 11

(IV) Proposed Terms of Reference for EIA studies Scope of Work of EIA

“...The EIA shall cover the following: Description of the proposed project: The first task:” Description of the proposed project” forms a vital component of the Environmental Impact Assessment (EIA) as it provides the basis for evaluating the likely causes of Environmental Impacts.

Existing Environment and Baseline Conditions: The baseline assessment will be carried out to identify potentially sensitive and critical areas that may be affected by the project in an area of 10 km surrounding the project location. The critical and sensitive targets shall be plotted on land use map of project impact area. The existing environment and baseline conditions should be established from:- Analysis of existing information published and secondary data. -Consultation with relevant statutory authorities, and Field visits for supplementation of missing gaps.

The key subject areas which the EIA shall address include Ecology and Nature conservation, Air quality, surface and water quality in project impact area, soil quality, cultural heritage, landscape, land use, noise quality, etc. Natural habitats like national parks, wildlife reserves, sanctuaries, sacred grove, protected areas, forests, wetlands, major rivers and waterways if any, shall also be identified and marked.

Assessment of Environmental Impacts: Based upon the results from the review of existing information, field visits, site data collection and consultation, for each component of environment (physical, biological and socio economic) the positive, negative, direct and indirect, temporary and permanent impacts will be evaluated along with an indication of the degree of impact, i.e., whether the impact is significant, moderate, minor or negligible. The degree of impact shall also be quantified by using state of the art air quality impact prediction models based on ISCST3 algorithms.

Environment Management Plan And Mitigation Plan: For each significant negative impact identified, specialist shall work closely with the engineering team/technical consultants to suggest practicable measures to avoid or mitigate the impact. The mitigation of environmental impacts will be by three mechanisms. =>Introduction of mitigation features through the engineering practices. =>Implementation of environmental controls during construction and operation. =>Legislative control involving compliance with Indian environmental laws. The Environmental management plan shall include an estimate of capital and recurring costs of mitigation measures and will identify the institutional framework for implementation.

Monitoring Plan: Having identified the significant environmental impact that is likely to arise as a result of the project, the project team shall specify what monitoring is required during the various phases of the project cycle. The monitoring plan will identify parameters and frequency of monitoring and responsible organization.


Form I Page 12

BASIC INFORMATION FOR TOR PROPOSAL OF M/S APEX DRUGS & INTERMEDIATES LIMITED, Sy. NO.10, IDA

GADDAPOTHARARAM, JINNARAM (M), MEDAK DISTRICT, ANDHRA PRADESH

Agenda Item No. Name of Project:

M/S Apex Drugs & Intermediates Limited Capacity Expansion of (5 f) organic chemicals and Intermediates manufacturing unit

If expansion, state status of implementation of project for which EC has been accorded : NO previous EC’s

Name of Project Proponent:

Ghanshyam Kurmi (Managing Director) M/S APEX DRUGS & INTERMEDIATES LIMITED, IDA GADDAPOTHARARAM JINNARAM (M), MEDAK DISTRICT, ANDHRA PRADESH.

Name of Consultant & QCI No.:

M/s Pridhvi Envirotech Pvt.Ltd S.No 118 in list of accredited consultants ( rev 13 October, 2013)

Sl. No. Salient Features 1.

Location of project Village : Taluk : District : State : Co-ordinates :

Sy. NO 10, Gaddapotharam (V) Jinnaram Mandal Medak District Andhra Pradesh N 170

E 7927’.01” Latitude &

010’.01” Longitude 2. Capacity & Unit Configurations: Capacity Expansion from 15 TPM to 28.5

TPM Number of Days operation in a year Full year Products to be manufactured (TPD/MTPA)

Details given in prefeasibility report

3. Land requirement: Total land area is 3.0 acres

4. Status of Land acquisition: Land is in possession of the company 5.

Break-Up of Land-Use of project site:

Forests land (Type and density) : None Detailed land use shall be provided with EIA Double Crop agricultural land : Single crop agricultural land : Waste land :

Grazing land : Others (specify) : Land is in possession of the company which is converted to industrial use

6 Whether project located in the notified Industrial area

Yes in IDA Gaddapotharam

7. Fuel to be used: Coal is used for boiler 8.

Quantity of Fuel Required per Annum: Coal 20.0 TPD

9 Source of Water: Purchased from private parties through tankers

10 Water Quantity:

Water requirement after Expansion-81.4 KLD Fresh water requirement – 51.2 KLD

11 Quantity of industrial effluent generation and domestic wastewater generation.

35.8 KLD – Industrial waste water 3.0 KLD - Domestic

12 Effluent treatment process proposed Industrial Effluents are proposed to be evaporated in MEE followed by ATFD Domestic effluents along with MEE condensate proposed to be treated in biological treatment system followed by RO. RO Permeat proposed to be re-used and RO rejects goes back to MEE

13

Disposal of treated effluent Zero Liquid discharge

14 Membership of CETP society (if existing)

--

15 Details of process emissions HCl, H2 and CO2 emissions 16 Proposed air pollution control device

alongwith stack height Process emissions are scrubbed Fugitive Emissions – vent condensers and chillers Stack heights are provided as per the guidelines of CPCB for effective dispersion of emissions

17 Details hazardous waste generation Details given in prefeasibility report 18

Management of hazardous waste (Treatment & Disposal)

TSDF and authorized recyclers

19 Membership of TSDF (if existing) Yes 20 Quantity of Fly Ash to be Generated: 7.6 Tons/day. Will be sold to brick

manufacturers 21. Greenbelt area proposed 3700.0 Sqm 22.

CRZ Clearance Status, if any

Not applicable as this does not comes under CRZ clearance

23. Names & distance of National parks, Wildlife sanctuaries, Biosphere reserves, Heritage sites Rivers, Tanks, Reserve Forests etc. Located within 10 Km from the plant boundary:

There are no National parks, wildlife sanctuaries, bio sphere reserves etc. within 10 KM from the site.

24.

Any litigation/Court case pertaining to the project:

None

25 Cost of the Project: Rs (in Crores) Current Rs. 7.75 Crores Proposed-22.005 Crores

Pre-Feasibility Report Apex Drugs & Intermediates Ltd- Unit II

1

1. Introduction

M/s. Apex Drugs & Intermediates Limited is located at Survey No: 10,

IDA, Gaddapotharam (V), Jinnaram (M), Medak (D) in Andhra Pradesh.

The unit was established in 2003. Subsequently obtained CFO of the

Board vide Consent Order No: APPCB/PTN/BLM/361/CFO/HO/2011 for

Recovery of Solvents & Piperzine with a capacity of 15.0 TPM.

As Recovery units were not covered under EIA Notification of 1994 prior

EC requirements were not there. As now the industry proposed to

manufacture drugs & drug intermediates with a capacity of 28.5 TPM this

application was made for getting Environmental Clearance. As 2006

notification covers both Drugs and Drug intermediates, It is now applied

for EC for expanding the capacity.

A copy of CFO of the Board are enclosed at Annexure- I


2

2. Introduction of the Project

The salient features of the project are described in table below

TABLE 1.0

Salient Features of the Project

Location Survey No: 10, IDA, Gaddapotharam (V), Jinnaram (M), Medak (D), Andhra Pradesh.

Longitude and latitude 17°27'.01"N Latitude and 79°10'01"ELongitude.

Year of establishment 2003 Product category 5(f), Drugs &Drug Intermediates Project category as per EIA notification

Category A (As the unit is located in 10Km radius of Bollaram and Patancheru clusted which is notified under CEPI)

Proposed Activity Capacity expansion from 15 TPM to 28.5 TPM

Total investment on the plant Current - Rs. 7.75Crores& Proposed – Rs.22.005 Crores

Total Investment on Environmental Infrastructure

Rs. 3.0 Crores (Current) Rs. 4.0Crore ( Proposed)– Total 7.0 Crores

Total area of the plant 3.0Acres Total area of green belt 0.9 Acres Water requirement Total Water requirement-81.4 KLD

Fresh water requirement-51.2 KLD Recycled water-30.2 KLD

Source of water Purchased from outside through tankers

Nearest habitation and distance from the site

Gaddapotharam(V) at a distance of 0.82 Km from the site

Nearest surface water bodies Rainfed tank at Gaddapotharam is located 0.7 Kms from the site

Nearest reserve forest Kistaipalli reserve forest at a distance of 0.32Kms in West direction

Environmentally sensitive areas within 10 km radius

None

Any national parks, wild life sanctuaries within 10 km radius

None

Nearest air port and distance Rajiv Gandhi International Airport,Shamshabad is Nearly 40 Kms from the plant site

Nearest railway station and distance

Gaudavalli at distance of 10 Kms from the site


3

i) About the Group &Promoters

Apex Drugs & Intermediates Limited was established by M/S SAS

Technologies in the year 2003. M/S Apex Drugs & Intermediates Limited

represented by its Managing Director Mr. GHANSHYAM KURMI took over

the facility in the year 2006.

Apex Drugs & Intermediates Limited is well known manufacturing

company in therapeutic segments such as Anti-histamine, Anti-

Thrombotic, Anti- Inflammatory and Anti- Ulcerative.

Apex Drugs & Intermediates Limited is manufacturing and marketing APIs

& Intermediates from its unit-I located in Sy. No. 14, which is established

in 1988. Over 20 years manufactures and supplies APIs to most of Top 20

Pharma companies in INDIA and also to some reputed MNCs abroad.

The Apex is adopting cleaner environment technologies and complying to

the directions issued by APPCB from time to time. The industry made and

continuously making all efforts to treat liquid solid & Air to achieve

standards prescribed. Upgrading the facilities time to time as per the

technologies available.


4

3. Project Description 3.1 Production Capacity

TABLE 2.0

LIST OF EXISTING PRODUCTS

S.No Name of the Product Quantities in TPM

1. Spent solvent distillation 10 2 Recovery of Piperazine 5.0 Total 15.0

3.1.1 Proposed expansion:

It is now proposed to expand the existing production capacity by adding 5

New products. Below Table provides list of products and proposed

capacities.

TABLE 3.0

PROPOSED PRODUCTS & CAPACITY

S.No Product Name Production Capacity

TPM

Product Description

Drug/Intermediate/Multipurpos

e chemicals

1 Clopidogrel Hydrogen Sulfate 10.00 Bulk Drugs

2 Nimesulide 10.00 Bulk Drugs

3 Cetirizine Dihydrochloride 3.00 Bulk Drugs

4 LevocetirizineDihydrochloride 0.50 Bulk Drugs

5 Pantoprazole Sodium Sesquihydrate 5.00 Bulk Drugs

Total 28.50

Bi Products

1 Ammonium Tartrate 5.5 TPM


5

2 PiperizineDi-hydrochloride 1.15 TPM

3.2 Manufacturing Process

The detailed manufacturing process and process flow sheets are enclosed

at Annexure III

3.3 Raw Materials

List of raw material product wise is given at Annexure II

3.4 Water Requirement The water requirement is met from private suppliers through tankers. The

requirement for water in this unit is for process and domestic purposes.

The water balance for daily consumption is presented below.

TABLE 4.0

Water Balance– Current & Proposed

S. No Stream

Water requirement in KLD

Waste Water discharge in KLD

Method of Treatment and

Disposal Curre

nt After Expansion

Current

After Expansi

on 1 Process 0.5 19.6 0.5

22.1 Stripper, MEE and

ATFD (condensate to RO)

2 Washings 3.0 3.0 Stripper, MEE and ATFD (condensate to RO)

3 Boiler Feed 12.0 36.0 0.3 7.2 ETP Followed by RO (RO Reject to MEE)

4 Cooling tower

8.0 12.0 0.2 1.2 ETP Followed by RO (RO Reject to MEE)

5 DM/Softener back washes

-- 2.3 -- 2.3 ETP Followed by RO (RO Reject to MEE)

6 Domestic 1.5 3.5 1.0 3.0 ETP Followed by RO 7 Gardening 2.0 5.0 ---- ----

Total 24.0 81.4 2.0 38.8


6

3.5 Wastes generation and control systems

3.5.1 Liquid Effluents As detailed in table 4.0 waste water generation after expansion would be

38.8 KLD. It is proposed to segregate effluents into high COD and High

TDS stream and Low COD and Low TDS streams.

High TDS and High COD stream would be treated in stripper followed by

MEE and ATFD. The resultant sludge would be disposed to TSDF,

Hyderabad. The Low TDS stream would be treated along with MEE/ATFD

condensates in biological ETP followed by RO. The RO rejects would be fed

back to MEE. The Permeate from RO would be used for cooling tower

make up. Thus the treatment system proposed is based on “Zero Liquid

Discharge” (ZLD) Concept

The schematic diagrams of ETP proposed are given in Figure 1.1 and

Figure 1.2 below


7

Fig 1.1

Schematic treatment scheme of high TDS effluents

Effluent from

Process and Aq. Distillate to cement plant/ Authorized recyclers

washings , Scrubber R&D

RO Reject To TSDF Condensate to Biological Treatment Condensate to Biological Treatment

Sludge to TSDF

Stripper Setting

Tank Neutralization

Tank Equalization

Tank

MEE

ATFD


8

Fig 1.2 Low TDS Effluent Treatment System

Domestic effluent

Effluents from utilities & MEE condensate

Sludge to TSDF

Permeate for re-use

Rejects to MEE

Screen Chamber

Sludge Holding Tank

Aeration Tank2

Equalization Tank

Neutralization Tank

Clarifier2

Holding

Tank

Filter Press Sludge Cake

Aeration Tank1

Clarifier1

Sand filter

Carbon Filter

Ultra filtration RO

Screen Chamber


9

3.5.2 Solid wastes management

Hazardous and non - hazardous wastes generated from the proposed

expansion project are detailed below. Mode of disposal are also identified

and listed. Adequate storage of hazardous waste is ensured at the site

TABLE 5.0 Solid Wastes and Disposal

S.No Description

Quantity

Remarks Current After Expansion

TPM

1

Forced Evaporation salts & ETP sludge/MEE Salts

200 Kgs/ Day 35.0 TPM Sent to TSDF

2 Process in-organic waste

600 Kgs/ Month

0.23 TPM

Sent to TSDF, Dundigal

3 Spent caustic lye 18 KLM --

4 Spent carbon 500 Kgs/Month 0.89 TPM

5 Distillation bottom residue/ Organic resiude

4 TPM 11.11 TPM

6 Ash from boiler - 7.6 TPD Sold to brick manufacturers

7 Waste oil 3.0 Lts/ Month

10Lts/ Month

Authorized reprocessors/

recyclers

8

Container and container liners of hazardous waste & chemicals

20 Nos/ Month

100 Nos/ Month

After detoxification should be disposed to outside agencies

9 Spent solvents 13 TPM ---

10

*Piperazine MLs from unit 1 for their sister concern unit

15 TPM ----


10

TSDF facility is 1.14 KM from the site in Medak District which is created

for catering the industries in this area. Transport of Hazardous wastes to

TSDF is done by the facility. In case other hazardous wastes, authorized

recyclers will transport the wastes.

4. Site Analysis 4.1 Plant Location M/s Apex Drugs & Intermediates Limited (Unit-II) is located at Sy. No

10, IDA Gaddapotharam(V), Jinnaram(M), Medak District, Andhra

Pradesh. The site is situated at 17035’30.3”N Latitude and 780

The site is surrounded by other industries of IDA Gaddapotaram.

Following are the surroundings of the site

22’30.0”E

Longitude. The total land area of the plant is 3.0 acres. The nearest

habitation from the site is Gaddapotharam (V) at a distance of 0.82 km.

The nearest railway station is located at Gaudavalli at a distance of 10

Kms from the site. There are no ecologically sensitive areas like national

parks, sanctuaries within 10 km radius of the site.

North –12m wide road and Mylan Laboratories

South – open land

East – Virchow Chemicals

West - open land

Following 19 reserve Forests are there within 10 KM radius of the site

Table 6.0

Reserve Forests in the study area

S.No Reserve Forest Direction from the site

Distance from the site

1 Dundigal E 0.8 2 Kistaipalli W 0.32 3 Kazipalli SW 0.7 4 Wailal W 1.6 5 Pottaguda W 6.2


11

6 Kodakanchi W 8.4 7 Pochampalli E 6.5 8 Gudavalli E 8.3 9 Borampet E 5.14 10 Suraram E 5.9 11 Gajularamaram E 6.15 12 Dulapalle E 8.1 13 Palem NW 7.5 14 Jinnawaram NW 5.9 15 Mangampet NW 7.5 16 Royyapalli NW 9.4 17 Bontapalli NW 6.3 18 Mamdapur NW 9.6 19 Dabilpur NE 9.0

Topo graphic features of the site and 10 KM study area and base map are

given at Fig 1.3 & 1.4.

Plant & Green Belt Photographs are given at Fig. 1.5

Site Plan is given at Fig 1.6


12

Fig 1.3 Base Map of the Study Area


13

Fig 1.4 Topo Map of the Study Area


14

Fig 1.5. Photographs of Plant & Green Belt


15


16

Fig 1.6 Site Plan


17

5.0 Planning in Brief

The project is envisaged to be completed by August 2014, and the

production shall be initiated thereon. Consultants are identified for

preparing the detailed project report.

6. Resource requirements

6.1 Power Requirement and Supply/Source

The total power requirement is 950 KVA and meet through APCPDL With

100%power backup by DG sets.

6.2 Production facilities, Utilities and effluent handling facilities

Apart from the existing facilities it is proposed to add additional production facilities, utilities and effluents treatment infrastructure with an additional investment of Rs. 22.005 Cores. The details are outlined in the below table

TABLE 7.0 Production facilities/Utilities/ETP – Existing & Proposed

S.NO Details Capacity/

No Current Additions After

expansion

Production facilities

1 Production Blocks- - 2 1 3 2 Clean rooms - - 3 3 Utilities 3 Boiler ( coal Fired) TPH 2X2 4 8 4 DG sets KVA 480

1 x 160, 1 x 320

1 X500 980

5 Cooling tower TR 2X 200 2X200 800 6 Softner/DM plant M3/day 2X25 2X25 100 Effluent handling & treatment facilities 7 collection tanks-

Storage KL 40 - 40

8 Neutralisation tanks KL 40 -- 40 9 Stripper ,MEE,ATFD KLD 50 - 50 10 RO & Biological

treatment KLD - 50 50


18

6.3 Land Requirement

The unit currently has 3 acres of land and out of which 0.9 acres of green

belt is developed. The land requirement for proposed expansion activities

will be 0.09 acres which can be met from existing open area. Below table

provides the land statement. Detailed site lay out plan outlining current

and proposed expansion activities is given at Figure 1.5

Table 8.0 Land Statement

S.NO Purpose Units Extent 1 Built up area Sq.M 4225 2 Green belt Sq.M 3700 3 Open area Sq.M 4228 Total Sq.M 12153 4 Area required for Proposed expansion Sq M 350

7.0 Air Pollution

The Sources of air emissions from the plant are 2 TPH & 4 TPH coal fired

boiler, DG sets and from process. Following table provides information

about the air pollution sources and proposed control measures

The process emissions from the second phase contain HCl, H2 and CO2

Table 9.0

.

HCl fumes are scrubbed with water or with caustic soda scrubbed waste

send to MEE. The other gases expected in the process are Carbon dioxide

& H2 which are let out into atmosphere. Below Table gives current &

proposed emission sources from the plant.

Emission Source – Current & Proposed

S.NO Source Capacity

Fuel Anticipated emissions

Control system

Current

1 Boiler 2X2 TPH Coal SPM,SO2 & NOx

Bag filter

2 DG sets 1 x 160 KVA, 1 x 320 KVA

Deisel SPM, SO2, NOX

Acoustic enclosure

3 Process emissions -- -- -- --


19

Proposed additions 5 Boiler ( coal Fired) 4 TPH Coal SPM,SO2

&NOx Bag filter

6 DG sets 1 x 160 KVA, 1 x 320 KVA,

1 X500

Diesel SPM, SO2 &NOx

Acoustic Enclosure

7 Process emissions -- -- HCl,H2and CO2

Scrubber

8.0 Bulk Chemical Storages:

Following bulk chemical storage facilities are proposed for expansion activity

Table No 10.0

Storage facilities of bulk chemicals

Sr No

Capacity (KL) Name of the solvent MOC

1 30 Methanol MS 2 30 Toluene MS 3 30 Acetone MS 4 20 IPA MS 5 20 Di chloromethane MS

Total maximum storage capacity: 130 KL


20

9. Project Financial

The estimated cost of the expansion project is approximately 22.005

Crores. Out of this Rs. 4 Crores will be for environmental infrastructure

and rest for other process equipment and safety equipment

Project cost Rs. In lakhs Plant& machinery 1700 Civil buildings 213 Steel Structures 20

Total 1933

Pipe lines & insulation 10% on plant & machinery 17

Electricals & instrumentation 10% on plant & machinery 17

Erection & commissioning & painting

5% on plant & machinery and structures 8.5

Environment & Safety infrastructure 50 Furniture, fixtures, computers, lighting etc 25

Total 117.5 Contingencies & pre-operative expenses 150

Total Project cost 2200.5


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Annexure I


22


23


24


25


26

Annexure II

List of Raw Materials


27


Clopidogrel Hydrogen Sulfate

S.No. Raw Material Quantity (Kgs/Day)

1 2-(Thiophen-2-yl)ethyl Acetate 182.4 2 Acetone 653.6 3 Ammonia (10%)solution 380 4 Ammonia (23%)solution 68.4 5 Carbon 6.08 6 Couple Amine Hydrochloride 304.0 7 Formaldehyde (45%) 91.2 8 Hydrochloride acid (35%) 6.08 9 Hydrogen Chloride 7.6

10 Hyflow 3.8 11 Isopropyl Alcohol Hydrochloride (20%) 190.0 12 Methanol 767.6 13 o-Chloro Phenyl Glycine 199.12 14 Sodium Hydroxide 48.64 15 Sulfuric acid 86.64 16 Tartaric acid 164.16 17 Tartrate Salt 2.28 18 TEBAC 1.52 19 Toluene 1335.92


28


LevocetirizineDihydrochloride


1 2-Chloroetahnol 4.608 2 Ammonium Formate 4.608 3 Dimethylformamide 51.2 4 Hydrochloride acid (30% in Acetic acid) 15.36 5 Hydrochloric acid (35%) 28.928 6 Hydrogen Chloride 3.84 7 Methylene Dichloride 128.0 8 N,N-(bis) Chloroethyl-4-methyl benzene

sulfonamide 16.64

9 p-ChloroBenzophenone 15.36 10 Phenol 3.84 11 Potassium Hydroxide 2.816 12 Sodium Hydroxide 26.112 13 Sodium Monochloro Acetate 7.68 14 Tartaric Acid 8.96 15 Toluene 550.4 16 Triethylamine 21.248


Pantoprazole Sodium Sesquihydrate


1 Acetonitrile 433.29 2 Carbon 16.66 3 Ethyl Acetate 183.31 4 Hyflow 3.33 5 Methylene Dichloride 1583.17 6 Pantoprazole Sulfide 183.15 7 Sodium Hydroxide 23.33 8 Sodium Hypochlorite (15%) 249.97


29


Nimesulide


1 2-Phenoxy aniline 333.45 2 O-nitro chloro benzene 292.5 3 Phenol 175.5 4 Potassium hydroxide 104.13 5 Iron power 6 Ammonium chloride 7 Carbon 5.85 8 Hydrochloric acid (35%) 23.4 9 Hyflow 1.17

10 Methanesulfonyl Chloride 210.6 11 Nitric acid 128.7 12 Sodium Hydroxide 81.9 13 Toluene 2983.5


Cetirizine Dihydrochloride


1 2-Chloroethanol 37.05 2 Dimethylformamide 148.2 3 Hydrochloride acid (35%) 88.92 4 Hydrochloride Chloride 37.05 5 Methanol 370.5 6 p-ChloroBenzophenone 85.21 7 Piperazine 54.093 8 Potassium Hydroxide 55.57 9 Sodium Borohydride 8.892

10 Sodium Monochloro Acetate 54.09 11 Toluene 1259.7 12 Triethylamine 59.58


30


31

Annexure III

Technical Details of Proposed Products


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33


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35


36


37


38


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40


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43


44

Product : Nimesulide

Description: Stage-I o-chloro nitro benzene react with phenol in presence of potassium hydroxide ,toluene to form stage-I Stage-II stage-I reduction with iron powder in presence of ammonium chloride,toluene,water,HCl to form a stage-II Stage-III Stage-II react with methanesulfony chloride in presence of sodium hydroxide and HCl in toluene solvent and gets purified with carbon and hyflow to form stage-III compound Stage-IV Stage-III reaction with niric acid in toluene solvent to get nimesulidepharma


45

Product: Nimesulide Flow chart Sol .Recovery o-chloro nitro benzene Evoporation loss phenol Efflent Toluene organic Residue potassium hydroxide water

Iron power Sol .Recovery Ammonium chloride Evoporation loss Water Efflent Con. Hydrochloric acid organic Residue Toluene

Methanesulfonyl chloride Sol .Recovery Sodium hydroxide Evoporation loss Con. Hydrochloric acid Efflent toluene organic Residue carbon spent carbon hyflow water

Sol .Recovery Nitric acid Evoporation loss Toluene Efflent Water organic Residue

STAGE-I

STAGE-II

STAGE-III

STAGE-IV


46

NIMESULIDE Nimesulide reaction scheme

OH

+

N+ O

-O

Cl

+ OHK

O

N+ O

-O

+ OH2 + ClK

phenol 1-chloro-2-nitrobenzene

Molecular Formula = C12H9NO3

Formula Weight = 215.20476

O

N+ O

-O

+ +


Molecular Formula = C12H9NO3

6H2ONH4Cl

O

NH2

1-nitro-2-phenoxybenzene

1-nitro-2-phenoxybenzene

2Fe+2 + 2Fe(OH)3+ 2H2O

2-phenoxyanilineMolecular Formula = C12H11NO


Stage-I

Stage-II

Molecular Formula = C6H6OFormula Weight = 94.11124

Molecular Formula = C6H4ClNO2Formula Weight = 157.55446

STAGE-III


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STAGE-IV


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