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Signature Phytochemical Industries

FORM-I


FORM-1

Signature Phytochemical Industries, Selaqui,

Dehradun

At

Khasra No. 122 MI, Central Hope Town, Selaqui

Dehradun, Uttarakhand.


APPENDIX I

(See paragraph- 6)

FORM 1

(I) Basic Information

S.No Item Details

1. Name of the Project/s Manufacturing of Pharmaceutical

Formulations

2. S. No. in the schedule Doon Valley Notification 1989

3. Proposed Capacity/area/

length/tonnage to be handled/

command area/lease area/ number

of wells to be drilled

The proposed Capacity is as under

1,Tablets &

Capsule

70 Crore Number / annum

2. Ointment 12 Thousand /annum

3. Liquid Oral 15 Lakh Liter / annum

4. Aerosol Spray 800 thousand/ annum

4. New/ Expansion/Modernization New

5. Existing Capacity/ Area etc/ Not Applicable

6. Category of Project i.e. A or B B2 as project site is inside Doon Valley

7. Does it attract the general

condition? if yes, please specify.

No

8. Does it attract the specific

condition? If yes, please specify

Doon Valley Notification 1989

9. Location UPSIDC Industrial Area Selaqui, Dehradun

Plot/Survey/Khasra No. Khasra No. 122 Mi

Village Selaqui


Tehsil Vikas Nagar

District Dehradun

State Uttarakhand

10. Nearest railway station/airport along

with distance in kms.

Dehradun Railway Station, 18km

Jolly Grant Airport, 37.13Km

11. Nearest Town, City, District

Headquarters along with distance in

kms.

Dehradun 17.81 km

12. Village Panchayats, ZillaParishad,

municipal Corporation, Local body (

complete postal Addresses with

telephone nos. to be given)

Village PanchayatSelaqui

ZillaParishad -Dehradun

Tehsil- Vikas Nagar

13. Name of the applicant Mr. C R. Madanan

14. Registered Address Khasra No. 122 Mi, Selaqui Industrial Estate,

Dehradun.

15. Address for correspondence Khasra No. 122 Mi, Selaqui Industrial Estate,

Dehradun.

Name Mr. C R. Madanan

Designation (Owner/Partner/CEO) General Manager

Address Khasra No. 122 Mi, Selaqui Industrial Estate,

Dehradun.

Pin Code 248001

E- mail [email protected]

Telephone No./Mobile No. 9219538308

Fax No.

16. Details of Alternative Site examined,

if any location of these sites should

be shown on a top sheet

No


17. Interlinked Projects No

18. Whether separate application of

interlinked project has been

submitted

Not Applicable

19. If yes, date of submission No

20. If no, reason Not Applicable

21. Whether the proposal involves

approval/clearance under: if yes,

details of the same and their status

to be given.

(a) The Forest (Conservation0 Act,

1980

(b) The Wildlife (Protection0 Act,

1972

(c) The C.R.Z notification, 1991

No

No

No

22. Whether there is any Government

Order/ Policy relevant/relating to the

site

Doon Valley Notification 1989

23. Forest land involved (hectares) No

24. Whether there is any litigation

pending against the project and

/or land in which the project is

proposes to be set up

(a) Name of the Court

(b) Case No.

(c) Orders/direction of the Court, if

any and its relevance with the

proposed project.

No

25. Location/Site under consideration Geographical Location of Project Area is at


Latitude - 30°22'37"N

Longitude -77°51'53.63"E

Altitude -1802 ft.

26. Size of the Project Small

27. Expected Cost of the Project INR 7,94,58,185

28. Contact Information Mr. C R. Madanan, General Manager

Khasra No. 122 Mi, Selaqui Industrial Estate,

Dehradun, Uttarakhand. - 248001

29. Screening Category B2, Orange Category as per criteria of Doon

valley Notification 1989, EIA Notification

2006

Capacity corresponding to sectoral activity (such as production capacity for manufacturing, mining lease area and production capacity for mineral production, area for mineral exploration, length for linear transport infrastructure, generation capacity for power generation etc.,)

(II) Activity

1. Constructions, 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 there of (with

approximate

quantities/rates, wherever

possible)with source of

information data

1.1 Permanent or temporary change is land

use, land cover or topography including

increase in intensity of land use (with

respect to local land use plan)

No

Land use is Industrial


1.2 Clearance of existing land, vegetation

and buildings?

No Not Required.

1.3 Creation of new land uses? No No

1.4 Pre-construction investigations e.g.

bore holes, soil testing?

Yes It will be done before starting

the work.

1.5 Construction works? Yes Existing building shall be

modified as per the project

requirement.

1.6 Demolition works? No Not Required

1.7 Temporary sites used for construction

works or housing of construction

workers?

No No temporary site is required

as part of the building already

exists.

1.8 Above ground buildings, structures or

earthworks including linear structures.

cut and fill or excavations

No NA

1.9 Underground works including mining or

tunneling?

No NA

1.10 Reclamation works? No

1.11 Dredging? No

1.12 Offshore structures? No

1.13 Production and manufacturing

processes?

Yes Enclosed in PFR.

1.14 Facilities for storage of goods or

materials?

Yes Specific area shall be

provided within the premises

for storage of goods or

construction material.

1.15 Facilities for treatment or disposal of

solid waste or liquid effluents?

Yes During construction temporary

toilets shall be provided.

Municipal waste shall be

disposed as per the norms.

1.16 Facilities for long term housing of

operational workers?

No The plant site is located at a

distance of 17.81Kms from

Dehradun city Adequate

residential facilities are

available for the operational


workers.

1.17 New road, rail or sea traffic during

construction or operation?

No Not required

1.18 New road, rail, air waterborne or other

transport infrastructure including new or

altered routes and stations, ports,

airports etc?

1.19 Closure or diversion of existing transport

routes or infrastructure leading to

changes in traffic movements?

1.20 New or diverted transmission lines or

pipelines?

No Not required

1.21 Impoundment, damming, culverting,

realignment or other changes to the

hydrology of watercourses or aquifers?

1.22 Stream crossings?

1.23 Abstraction or transfers of water form

ground or surface waters?

Yes Proposed water requirement

is 15KL/day and shall be met

out from Borewell.

1.24 Changes in water bodies or the land

surface affecting drainage or run-off?

No Not Applicable, as the

proposed activity will be

undertaken within existing

industrial estate.

1.25 Transport of personnel or materials for

construction, operation or

decommissioning

Yes Mainly local persons will be

employed. Construction

material shall be purchased

from the vendors available in

Selaqui.


1.26 Long-term dismantling or

decommissioning or restoration works?

No Long-term dismantling or

decommissioning or

restoration works are not

involved.

1.27 Ongoing activity during decommissioning

which could have an impact on the

environment?

No Not Applicable.

1.28 Influx of people to an area in either

temporarily or permanently?

Yes There will be influx of 50

skilled workers including the

supervisory staff; this influx

will not have any significant

impact on the socio-economic

pattern of the area as

Dehradun is a well-developed

commercial center. Rather it

will improve the per capita

income and living standards of

the local people.

1.29 Introduction of alien species? NA

1.30 Loss of native species or genetic

diversity?

1.31 Any other actions?

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


possible)with source of information

data

2.1 Land especially undeveloped or

agricultural land (ha)

No Developed Industrial Land

2.2 Water (expected source &

competing users) unit: KLD

Yes 12KLD

Source is Bore Well.


2.3 Minerals (MT) No -

2.4 Construction material - Stone,

aggregates, sand/soil (expected

source-MT)

Yes From local vendors.

2.5 Forests and timber (source-MT) No No

2.6 Energy including electricity and

fuels (source, competing users

)unit: fuel (MT), energy (MW)

Yes Proposed power consumption is

expected to be400 KVASupplied by

Uttarakhand Power Corporation.

An additional DG Set220 KVAis

proposed for power backup.

2.7 Any other natural resources (use

appropriate standard units)

No NA

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


confirmation



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 )

No No except diesel which will be stored

as per the norms of MSIHC rules.

3.2 Changes in occurrence of disease

or affect disease vectors (e.g.

insect or water borne diseases)

No No effect envisaged.

3.3 Affect the welfare of people e.g. by

changing living conditions?

Yes Generation of employment will provide

better living conditions to local people.

3.4 Vulnerable like groups of people

who could be affected by the

project e.g. hospital patients,

children, the elderly etc.

No No effect envisaged.


3.5 Any other causes Not Applicable.

4. Production of solid wastes during construction or operation or decommissioning (MT/ month)


confirmation

Yes/No Details thereof (with

approximate quantities/rates,

wherever possible)with source

of information data

4.1 Spoil, overburden on mine wastes No No Applicable.

4.2 Municipal waste (domestic and or

commercial wastes )

Yes Municipal waste will be separated

as Biodegradable and Non-

Biodegradable waste, which will be

disposed as per MSW rules.

4.3 Hazardous wastes (as per

hazardous waste Management

Rules)

Yes No hazardous waste shall be

generated in constructionphase.

4.4 Other industrial process wastes Yes No industrial process waste.

4.5 Surplus product No Entire production will be based on

order.

4.6 Sewage sludge or other sludge

from effluent treatment

Yes No sludge generation for the

proposed expansion.

4.7 Construction or demolition wastes Yes Construction waste shall be used

for the leveling of uneven plot area.

4.8 Redundant machinery or

equipment

No NA

4.9 Contaminated soils or other

materials

No

4.10 Agricultural wastes No

4.11 other solid wastes No


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


confirmation

Yes/No Details thereof (with

approximate quantities/rates,

wherever possible)with source

of information data

5.1 Emissions from combustion of

fossil fuels from stationary or

mobile sources

Yes The emissions would be only due

to HSD burning in the DG set.

Stack height of D.G. set shall be

provided as per the norms of State

Pollution Control Board.

5.2 Emissions from production

processes

No The entire operation will be under

closed chambers, None of the

process during manufacturing

results in emissions.

5.3 Emissions from materials

handling including storage or

transport

No Water Sprinkling shall be done to

reduce the dust.

5.4 Emissions from construction

activities including plant and

equipment


reduce the dust.

5.5 Dust or odors from handling of

materials including construction

materials, sewage and waste


reduce the dust.

5.6 Emissions from incineration of

waste

No Not Applicable

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 Unit is proposing one DG setof 220

KVA .Stacks will be provided as per

the norms of SPCB.


Generation of Noise and Vibration, and Emissions of Light and Heat:


confirmation




information data

6.1 From operation of equipment e.g.

engines, ventilation plant,

crushers

No Very nominal increase in noise

levels will be observed, However all

the operations shall be done in

closed chambers. Noise levels shall

be monitored and shall be kept

within the norms specified by State

Pollutions Control Board.

6.2 From industrial or similar

processes

Yes Timely maintenance of machines

and proper housekeeping will be

done.

6.3 From construction or demolition

No NA

6.4 from blasting or piling

No NA

6.5 From construction or operational

traffic

No

6.6 From lighting or cooling systems

No

6.7 From any other sources

6. 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




information data

7.1 From handling, storage, use or

spillage of hazardous materials

No Chemical solvents used in the

process shall be stored in safe and

specified places. Necessary

precautions for the same shall be

taken. Fuel used for D.G. set shall

be stored in separate storage.

7.2 From discharge of sewage or other

effluents to water or the land

(expected mode and place of

discharge)

Yes Sewage and industrial effluent will

be treated in Septic tank/soak pit

and ETP respectively. Capacity of

the proposed ETP is 10 KLD.

Treated water will be used in

gardening and flush in washroom of

plant premises only.

7.3 By deposition of pollutants emitted to

air into the land or into water

No No

7.4 From any other sources No No

7.5 Is there a risk of long term buildup of

pollutants in the environment form

these sources?

No No

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




information data

8.1 From explosions. spillages, fires etc

from storage, handling, use or

production of hazardous substances

No Necessary arrangements for

firefighting are proposed. i.e. fire

hydrant system and Fire

extinguishers.


8.2 From any other causes. No -

8.3 Could the project be affected by natural

disasters causing environmental

damage (e.g. floods, earthquakes,

landslides, cloudburst etc)?

Yes

There are least possibilities of the

proposed project site getting

flooded. However, building base has

been taken 600 mm above the

ground level.

Buildings have been designed as

per the norms for seismic zone-IV

.

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




information data

9.1 Lead to development of supporting

utilities, 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

No Selqui, Rampur, Harbatpur,

Vikasnagar are well developed area

city and influx of 50 skilled workers

will not have significant impacts on

the socio-economic pattern of the

area. Rather jobs shall be created for

50local people which will improve

their per capital income and living

standards.

The project site is on State Highway

and entire infrastructure has been

developed and maintained by

UPSIDC Industrial area Selaqui. 9.2 Lead to after-use of the site, which

could have an impact on the

environment


9.3 Set a precedent for later developments A better after use scenario, which is

likely to increase aesthetic beauty of

the area and greenery, should set

precedence for subsequent

entrepreneurs who venture such

projects.

9.4 Have cumulative effects due to

proximity to other existing or planned

projects with similar effects

The project is in Industrial Area of

Government of Uttarakhand.

(III) Environmental Sensitivity

S.

No.

Areas Name/Identity Aerial distance (within 15Km.)

Proposed project location

boundary.

1 Areas protected under international

conventions, national or local

legislation for their ecological,

landscape, cultural or other related

value

Reserve

Forest

3 km

2 Areas which are important or

sensitive for ecological reasons -

Wetlands watercourses or other

water bodies, coastal zone,

biospheres, mountains, forests

Suvarna

River

Seasonal River Suvarna at a

distance of 0.10 Km.


3 Areas used by protected, important or

sensitive species of flora of fauna for

breeding, nesting, foraging, resting,

over wintering, migration

No Raja Ji National Park -32.61 km

4 Inland, coastal, marine or

underground waters

No No

5 State, National boundaries

No No state boundary within 15 Km.

6 Routes or Facilities used by the

public for access to recreation or

other tourist pilgrim areas

No No

7 Defence installations IMA,

Dehradun

IMA is located at a distance of 12.80

Kms

8 Densely populated or built-up area Selaqui,

Vikasnagar,

Sahaspur,

Premnagar

Selaqui, Vikasnagar, Sahaspur,

Premnagar are located within the

distance of 15 Km from the Project

site.

9 Areas occupied by sensitive man

made land uses (hospitals schools

places of worship, community

facilities)

Yes School Mayadevi Institute of

Technology, Shivalik College of

Engineering ,

Hospitals-ESI Hospital & Private

Dispensaries


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 Not Applicable.

12 Areas susceptible to natural hazard

which could cause the project or

present environmental problems

(earthquakes, subsidence,

landslides, erosion, flooding or

extreme or adverse climatic

conditions)

There are least possibilities of the

proposed project site getting

flooded. However, building base has

been raised sufficiently above the

ground level.

Buildings have been designed as

per the norms for seismic zone-IV.


(IV) Proposed Terms of Reference for EIA studies (a) ToR is not required being a Category „B2‟ project. (b) UNDERTAKING I hereby given undertaking that the data and information given in the application and

enclosures are true to best of my knowledge and belief and I am aware that if any part of the

data and information submitted is found to be false or misleading at any stage, the project will

be rejected and clearance give, if any to the project will be revoked at our risk and cost.

Date: 06-09-2015 For- Signature Phytochemical Industries

Place: Dehradun

C.R. Madanan

(Authorized Signatory


NOTE:

1. The Project involving clearance under Coastal Regulation Zone Notification 1991 shall submit with

the application a C.R.Z map duly demarcated by one of the authorized agencies, showing the

project activities, w. r.t C.R.Z(at the stage of TOR) and the recommendation of the state coastal

Zone management Authority (at the stage of EC).Simultaneous shall also be taken to obtain the

requisite clearance under the provisions of the C.R.Z Notification, 1991 for the activities to be

located in the CRZ.

2. The project to be located within 10 km of the national parks, sanctuaries, Biosphere Reserves,

Migratory Corridors of wild Animals, the project proponent shall submit the map duly authenticated

by chief Wildlife warden showing these features vis-a –vis the project location and the

recommendations or comments of the Chief Wildlife Warden thereon (at the stage of EC)

3. All correspondence with the Ministry of Environment & Forests including submission of application

for TOR/Environmental Clearance, subsequent clarifications, as may be required from time to time,

participation in the EAC meeting on behalf of the project proponent shall be made by the authorized

signatory only. The authorized signatory should also submit a document in support of his claim of

being an authorized signatory for the specific project.”

Date: 06-09-2015 For- Signature Phytochemical Industries

Place: Dehradun

C.R. Madanan

(Authorized Signatory


PRE-FEASIBILITY

REPORT


Pre- Feasibility Report

For

Manufacturing of Pharmaceutical Formulations in Signature

Phytochemical Industries, Selaqui, Dehradun

At

Khasra No- 122 Mi, Central Hope Town Selaqui, Dehradun, Uttarakhand

Environment Management Plan

1

EXECUTIVE SUMMARY

1.0 M/s Signature Phytochemical Industries proposes to manufacture a variety of products

ranging from Anti – Bacterial, Anti- Malarial, Anti-biotic and Anti- inflammatory etc. in the form of Tablets, Capsules and Liquids in various forms of Packing and different filling capacities. It is also intended to expand the range of products by adding branded and widely accepted medicines at competitive costs taking into consideration the vagaries of the market and its locational advantages and after careful study of details, economic viability and financial requirements of the project. The Manufacturing facility for Formulation drug products is situated at Khasra No- 122 Mi, Selaqui, Dehradun Uttarakhand, India.

1.1 INTRODUCTION

A) History of the Company:

Mr. Krishna Kumar R. Agarwal, Mr. Sanjiv Garg, Mr. Saurabh K. Agarwal & Miss. Shristi Garg mutually agreed to enter into a Partnership agreement with each other in the year 2009- 2010 for the purpose of setting up a plant for the purpose of manufacturing, producing, exporting, importing and dealing in all kinds of Pharmaceutical Products/Chemicals and allied activities. The unit was established in the year 2009-2010by acquiring land and constructing the plant on the land situated at 122Mi, Selaqui, (District) Dehradun for the purpose of manufacturing Pharmaceutical Products/Chemicals and allied activities. Till date manufacturing of pharmaceutical products could not be carried out due to unforeseen circumstances. The partners of the firm now propose to enter into manufacture of Pharmaceutical Formulations such as Tablets, Capsules, Liquids etc. in the same name and style of Messrs. Signature Phytochemical Industries. The Partners have now proposed and mutually agreed to set up a manufacturing unit at the existing unit for the purpose of manufacturing Tablets and Capsules for which purpose alternations, modifications of the plant and purchase of machinery have become essential to the existing unit.

B) History of the product:

The Firm proposes to manufacture a variety of products ranging from Anti-Bacterial, Anti- Malarial, Anti-Biotic and Anti- inflammatory etc. in the form of Tablets, Capsules and Liquids in various forms of Packing and different filling capacities. It is also intended to further the products by adding new ranges of branded and widely accepted medicines at competitive costs taking into consideration the vagaries of the market and its locational advantages and after careful study of details, economic viability and financial requirements of the project Pharmaceutical Formulation is the process in which different chemical substances, including then active drug, are combined to produce a final medicinal product. Formulation studies involve developing and preparation of the drug which is both stable and acceptable to the patient. For orally taken drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to appreciate that a tablet contains a variety of other substances apart from the drug itself, and the studies have to be carried out to ensure that the drug is compatible with these other substances in the process of manufacturing

1.2 Salient Features of The Project


2

Proponent Name Signature Phytochemical Industries

Location Khasra No- 122 Mi, Central Hope town Selaqui, Dehradun, Uttarakhand.

Latitude 30° 22' 37" N

Longitude 77° 51' 53.63" E

Land use Industrial

Nearest Habitate/ Town Selaqui

Nearest Railways Station Dehradun –18 km

Nearest Airport Jolly grant – 37.13 Km

Nearest Highway NH-72

Water Demand and Supply source 15 KLD Supply of Bore well

Nearest Tourism Place Mussoorie22 Km

Seismic Zone Zone – IV

Altitude 1802 ft. (549 meters)

Proposed Production process Tablets, Capsules, Ointment, Liquid Oral and Aerosol Spray

Estimated Project Cost INR 7,94,58,185

Working Days 26

Man Power 50

2. INTRODUCTION OF THE PROJECT /BACKGROUND INFORMATION

A. Identification of the project and project proponent.

Category of Project: Category B2 (Doon Valley)

The project proponent is M/s Signature Phytochemical Industries is a limited company. B. Brief Description of Nature of Project.

M/s Signature Phytochemical Industries proposes to manufacture Pharmaceutical formulations such as Tablets, Capsules, and Liquids etc.

C. Need for the Project & Importance to the Country

The Proponent has expertise in the manufacture of above dosage. There is a growing demand for the pharmaceutical products internationally as well as in the domestic market. A need has therefore been felt to establish the unit for manufacturing.


3

D. Demand and supply gap

These products are having National market and still demand is more than supply so manufacturing of these items are feasible. The Proposed Company does not see any difficulty in marketing their products as the two essential points in marketing a product i.e. product quality & packing and experience are reasonable in favour of the Promoters.

E. Export Possibility Yes .Entire product shall be of export quality and possibilities of export will be explored. F. Domestic/Export Markets There is domestic market of this product but export shall also be done. G. Employment Generation (Direct & Indirect) due to the project

With this proposed project direct employment generation of50persons will be there in worker/supervisor/ managerial category. Indirect generation of employment will also be there in way of contractors, transportation, suppliers, other service providers with continues chain of employment.

3. PROJECT DESCRIPTION

A. Type of Project including Interlinked and Interdependent Projects, if any There is no interlinked and/or interdependent project linked with it. No other allied activities and/ or services will be carried out with this project. B. Location (map showing general location, specific location, and project boundary & project site layout) with coordinates. The unit situated at Khasra No- 122 Mi, Central Hope Town Selaqui, Dehradun, Uttarakhand is a well-defined and developed industrial area in Tehsil of Vikas Nagar and District of Dehradun at a distance of 18Km west of Dehradun on National Highway No 72 to Chandigarh. C. Details of alternate sites considered and the basis of selecting the proposed site,particularly the environmental consideration gone into should be highlighted. No alternate site.


4

D. Size and Magnitude of the operation. S.No. Items of Manufacture/ Type of Service Quantity per annum

1. TABLETS & CAPSULE 70 Crore

2. OINTMENT 12 Thousand

3. LIQUID ORAL 15 Lakh Litre

4. AEROSOL SPRAY 800 Thousand

E. Project description with process details (a schematic diagram/flow chart showing theproject layout, components of the project etc. should be given) The process involves following steps for various pharmaceuticals product.

1. TABLETS:

A) GRANULATION: The raw material (various ingredients), viz the powder is sieved through a

“sifter” so as to have the powder of equal mesh sizes after which, it is finely grind (through

a Multi Mill) and mixed homogenously in a Mass- Mixer. This mass is then kept for drying

(in a fluid bed dryer) for varying time and temperatures depending upon the quality of the

product. The dried powder is ready to be converted in tablet form in the compression

department.

B) COMPRESSION: The dried powder from the granulation department is fed through a

hopper to a Rotary Tableting machine where it is compressed into tablets, which can be of

different sizes depending upon the requirements. The process is carried out under

controlled temperature, which is done by Air- conditioning.

C) COATING: This is an optional process depending on the customer‟s requirement. At the

same time it is also essential in order to maintain highest quality standards. In this process,

the compressed tablets are coated (in a Tableting machine) with the help of a compressor.

The tablets may be coated by sugar, material cellulose or any other material. Again the

work area shall be Air-conditioned. The tablets are ready for packing which is done in a

“Blister Pack Machine”. The general pack size is of ten tablets.

2. CAPSULES: In order to maintain “Good Manufacturing Practices” (GMP) standards, it is

necessary to have two capsule sections. One is for general capsules and the other is for

sensitive penicillin or ampicillin group capsules. Both the sections are separate with proper Air-

conditioning and controlled relative humidity with the help of de- humidifier. In both the cases,

the process is the same. The powder of various pharmaceutical raw materials is thoroughly

mixed in a double cone blender for a fixed length of time. After mixing is complete, the powder

is filled in empty capsules on a capsule filling machine which after fillings are closed and

sealed. The capsules are then ready for packing on the Blister Packing Machine. Again the

pack sizes if generally of ten capsules.

3. LIQUIDS: In preparing Liquid, utmost care is taken in purifying the water. The water s purified

with the help of de-mineralizer plant. Only then it is used for manufacturing purposes. From the

demineralizer the water is collected in a stainless steel tank. The necessary ingredients are


5

added into it and mixed with the help of an electric stirrer. If suspensions are to be

manufactured, then it is churned with the help of homogenizer. Further, they are also churned

by a Colloid Mill, which mixes the fine particles of water insoluble compound into an emulsion.

After sometime, the stirred/churned liquid is passed through a volumetric filling machine into

bottles/jar as required. The Bottle is then sealed with the help of a sealing machine. It is then

visually checked under light for any foreign particles in the syrup. After labeling the bottle is

ready for dispatching. The bottles used in filling the liquids are thoroughly washed with the help

of Bottle Washing machine and then dried in Bottle Dryer for sterilization. This is a very

important process for the product to be of best quality.


6


7

PLANT AND MACHINERY

Sr. No. PARTICULARS Quantity

TABLET SECTION

GRANULATION SECTION

1. Multi Mill (Granulator) GMP Model with accessories and Motor One

2. Vibro Sifter 20” Model with screen size 550 mm dia. One

3. Mixer Granulator- 220 ltrs with accessories and motor One

4. Fluid bed dryer 60 kg with 225 ltrs capacity of trolley &

accessories

One

5. Hexagonal Blender Mixer – GMP Model 1000 ltrs capacity One

COMPRESSION SECTION

6. 27- Stn Rotary Machine, D- tooling with A.C. drive and upper

punch

One

7. Dust Extractor 150 CFM Model GMP with 1 HP motor One

COATING SECTION


8

8. Coating Pan 48” with Hot Air Blower, 3 HP motor, 1440 RPM

& 600 FM Blower

One

PACKING SECTION

9. Alu- Alu mach1, Blister pack machine along with change parts One

10. Blister Pack machine, type Model 2200 Ch along with change

parts

One

CAPSULES SECTION

1 Double Cone Blender-75 Kgs capacity One

2 Automatic Capsule Loading machine with interchangeable

section with loading trays

One

3 Manually operated capsule filling machine with

interchangeable section with loading trays.

One

F. Raw Material Required Along Estimated Quantity, Likely Source, and Marketing Area Of Final Product/s Mode Of Transport Of Raw Material And Finished Product.

LIST OF RAW MATERIALS

Sr. No. Name of the Raw Material Quantity per month

1. Paracetamol 20 Tonnes

2. Ibubrofen 10 Tonnes

3. C.P.M. 150 kg

4. Ceferoxin 300 kg

5. Cetrasine 200 kg

6. Befamethaxine 5 kg

7. Dexamethaxine 10 kg

8. PVRK - 30 200 kg

9. Cetobtyl alcohol 2100 ltr

10. Prochlorparasine molecule 200 kg

Availability of Raw materials: The raw materials such as basic salts and excipients are freely available in the open market in almost all commercial cities. There are no price controls or distribution controls on the same. They can be manufactured indigenously and can be procured directly from the manufacturers in case of bulk purchases. As regards the cost of raw materials, the rates of different basic salts and excipients are different and fluctuating.

Availability of Packing Materials: The presentation of any product is an important factor. However, this factor assumes special attention in Pharmaceutical Industry due to various reasons such as shelf-life, hygiene, quality, stability, durability, easy to use etc., as also steady flow of finished product as per the requirement of market. Keeping these factors in mind there are many methods of packing too viz glass bottles, strips & blisters (in foils & PVC‟s), plastic pouches, tubes etc. Because of the variety and different types of methods used in packing pharmaceutical products, it is difficult to ascertain the exact cost of packing per unit.


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G. Power Requirement:

Total Power requirement is 400 KVA and will be met from Uttarakhand electricity board, also DG set of

220 KVA is proposed. DG set shall be used at the time of power failure only.

H. Water Requirement:

Proposed water requirement is12KLD and shall be met from bore well.

4. SITE ANALYSIS

A. Connectivity Well connected with Road, Rail and air service Dehradun Chandigarh highway – 2 km Dehradun Railway Station – 18 km Dehradun Airport – 37.13 km B. Land form, Land use and Land owner ship Plain and flat land having Industrial use falling UPSIDC Industrial Estate Selaqui, Dehradun. C. Topography – Land is plane and flat with inclination towards South

D. Existing land use pattern The existing land use is Industrial. E. Existing Infrastructure All infrastructures have been developed by UPSIDC Industrial Estate Selaqui, Dehradun. . F. Climatic data from secondary sources


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Monthly mean maximum & minimum temperature and total rainfall based upon 1961-1990 data:

Month Mean Temperature oC Mean Rainfall in

mm

Maximum Minimum

January 19.3 6.0 55.0

February 25.1 7.8 58.8

March 26.4 12.0 49.0

April 32.1 16.7 22.5

May 35.6 20.7 41.7

June 34.8 23.0 201.8

July 30.5 22.8 672.6

August 29.4 22.4 728.2

September 29.7 20.8 296.5

October 28.5 15.7 49.8

November 25.0 10.4 8.6

December 21.1 6.8 24.4

Source- http://www.imd.gov.in/doc/climateimp.pdf

G. Social Infrastructure The area is under Selaqui and Vikas Nagar Tehsil,Entire social infrastructure has been developed by State Govt.

I. Drinking Water Management ( Source & Supply of water) The source of the drinking water is Borewell

J. Sewage System. Soak pit and septic tank arrangement shall be provided for the waste generated from toilets and domestic use.

K. Industrial Waste Management. Effluent Treatment Plant is proposed for industrial waste. Capacity of ETP shall be 10 KLD

L. Solid Waste Management


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1. Solid waste generated from sludge drying beds of ETP shall be disposed to TSDF as per the

norms of State Pollution Control Board. 2. Used oil shall be disposed to authorized recycler. 3. Expired drugs shall be disposed as per the norms of State Pollution Control Board.

M. Power Requirements & Supply/ source. Total Power requirement is 400 KVA and will be met from Uttarakhand electricity board, capacity DG

set of 220 KVA is proposed. DG set shall be used at the time of power failure only.

5.0 PLANNING BRIEF

A. Planning concept (type of industries, facilities, transportation etc) town and country planning/Development authority Classification.

The proposed industry is small scale and established in a developed UPSIDC Industrial Estate Selaqui, Dehradun.

6.0 PROPOSED INFRASTRUCTURE

A. Industrial Area (Processing Area) No additional infrastructure is proposed

B. Resident Area (Non Processing Area) as only local person will be given employment, no residential area/ housing is proposed.

C. Green Belt - 33% area has been reserved for green belt Company has been developed dense

green belt around the plant premises with plant species.

D Hazardous waste Management: Company shall get the Authorization under “Rule-5” of the

Hazardous Waste (Management, Handling & Trans-boundary Movement) Rule, 2008, and

maintain proper storage & safety management for Hazardous material. All Hazardous waste shall

be disposed through authorized vendor .Quantities of various hazardous wastes are given below:

1. 5.1 400LTR/annum Waste oil. 2. 34.3 1.2 MTA Dried ETP sludge.

3. 28.4 3.0 MTA Expired finished product and raw materials.

7.0 REHABILITATION AND RESETTLEMENT (R & R) PLAN

The unit is in developed industrial estate, so R & R plan is not required.

8.0 PROJECT SCHEDULE AND COST ESTIMATES

Project is expected to be complete in next 3 - 4 months

Funds requirement shall be Rs 7, 94, 58,185/- including the machinery and plant.


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9.0 ANALYSIS OF PROPOSAL (FINAL RECOMMENDATIONS) The Indian pharmaceutical industry is a success story providing employment for millions and ensuring

that essential drugs at affordable prices are available to the vast population of this subcontinent. Also

Improvement of infrastructure as well up-liftment of social structure in the area. The people residing in

the nearby areas have been benefited directly & indirectly.


13

ENVIRONMENT

MANAGEMENT PLAN


14

ENVIRONMENTAL MANAGEMENT

PLAN

Signature Phytochemical Industries,

Selaqui, Dehradun

At

Khasra No- 122 Mi, Central Hope Town, Selaqui,

Dehradun.


15

WATER POLLUTION

FROM PROCESS

Items Water consumption Waste water

generation

Treatment

Method

From Process 10 KLD 9 KLD ETP

Domestic 2 KLD 1.6 KLD Septic Tank and

Soak pit.

Generation of wastewater

The waste water is generated because of the following factors:-

Accidental and unintentional spillages.

Dripping allowed escaping into the water.

Washings from equipment and bottle cleaning.

The small quantity of waste generated will be treated in existing ETP having following details.

TABLE 3.1: QUANTITY & CHARACTERISTICS OF EFFLUENT

Raw Effluent Characteristics:

Sr. No. Details Concentration Units

1. pH 6.0- 8.0 --

2 Total Suspended solids 300 Mg/lt

3 Chemical Oxygen Demand 450-600 Mg/lt

4 Biochemical Oxygen Demand, 3 day, 270C

250 - 350 Mg/lt

5 Oil & Grease ~60 Mg/lt


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Outlet Characteristics:

Sr. No. Details Concentration Units

1. pH 6.0- 8.0 --

2. Total Suspended solids Less than 5 Mg/lt

3. Chemical Oxygen Demand Less than 30 Mg/lt

4. Biochemical Oxygen Demand, 3 day, 270C Less than 10 Mg/lt

5. Oil & Grease Less than 1 Mg/lt

TREATMENT SCHEME Primary Treatment: Raw Effluent generated shall be passed through Screen Chamber. Bar screens shall be provided for removing any type of floatable matter in the raw Effluent which shall be scrapped out and collected in drums. Clear Effluent shall be collected in Equalization/ Collection Tank for equalizing the Effluent. Aeration grids shall be provided for mixing purpose. Equalized Effluent shall be pumped to MBBR tank for further treatment. Flash Mixer and Primary Tube Settler: Equalization ensures that the effluents have uniform characteristics in terms of pollution load, pH and temperature. The equalization tank shall be equipped with diffused aeration system. Aeration system helps in the homogenization of waste water and at the same time it also helps in preventing odorous condition. The aeration also reduces BOD and COD load. The homogenized aerated effluent from equalization tank shall be pumped for physic-chemical treatment plant. The physic-chemical treatment system consists of lime dosing, coagulant dosing in flash mixer tank and flocculation in flocculate followed by settling in settling tank. The chemical treatment helps in reduction of color and suspended solids. Further reduction in BOD and COD values can be achieved. Secondary Treatment: The Moving Bed Bio-film Reactor shall be filled with the specified quantity of bio media made of light weight plastic material to enhance the surface area for bio-growth. Oxygen required for the bacterial growth shall be supplied through Fine Bubble Diffuser systems. The system envisages better oxygen transfer because of fine bubbles and increased contact with the Effluent. The overflow from MBBR tank shall be gravitating to Secondary Tube Settler. To increase the retention time of settling tank, PVC tube settler shall be provided. This unit I provided to arrest the sludge from leaving the system. The arrested sludge shall be pumped backed to the MBBR tank to maintain the growth of biomass in system and excess sludge shall be taken to the Sludge Holding Tank. Collected sludge shall be pumped to the Filter Press for de-watering. The filtrate from filter press shall be taken to the equalization cum collection tank. Clear overflow from tube settler shall be gravitated to further tertiary treatment. Dried sludge from filter press can be used as manure or can be disposed off as per statutory norms.


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Tertiary Treatment: Overflow from the tube settler shall be gravitated to Chlorine Contact Tank where provision shall be made for hypochlorite dosing as required for disinfection. Dosing shall be done by pumping. Treated Effluent shall be pumped to Pressure Sand Filter followed by Activated Carbon Filter. Treated Effluent from carbon filter shall be used for gardening and flushing.


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PROCESS FLOW DIAGRAM OF EFFLUENT TREATMENT PLANT

EQUIPMENT SIZING

TABLE 3.2: CIVIL UNITS OF THE EQUIPMENTS

Sr. No.

MS UNIT 10 cum / day

QTY SIZE RETENTION TIME (hrs)

MOC

1. Screen Chamber 1 1.0m x 1.0m x 1.0m SWD

-- MS angles with PVC mesh

2. Equalization cum Collection Tank

1 3.0m x2.0m x 2.0m

SWD

-- RCC

3. MBBR Tank 1 - -- MS

4. Secondary Tube Settler

1 - -- MS

5. Chlorine Contact Tank

1 - -- MS

6. Final Water Tank 1 4.0m x 3.0m x 2.0m

SWD

RCC

7. Operating & Control Panel Room

1 - -- -

TABLE 3.3: MECHANICAL UNITS OF THE EQUIPMENTS:

Sr. No.

EQUIPMENT 10 cum / day

QTY CAPACITY MOC

1. Bar Screen 1 Suitable SS 304

2. Raw Effluent Transfer Pumps

1 1m3/hr @ 8m WC

CI

3. Air Blower 1 40 m3/hr CI

4. Membrane Diffusers Lot Dia 63 mm x 950 mm Long

EPDM

5. MBBR biomedia Lot Suitable PVC

6. Final Water Tank Lot Suitable PVC

7. Sludge Return Pumps 1 0.75 m3/hr CI

8. Filter Feed Pumps 1 1m3/hr @ 35m WC

CI

9. Pressure Sand Filter 1 600 mm dia x 1200mm HOS

FRP

10. Activated Carbon Filter

1 600 mm dia x 1200mm HOS

FRP

11 Electrical Control Panel

1

AIR POLLUTION

Table 3.4: Sources of air pollution and control measures.

Source of Air Pollution Preventive/ Control Measures

1. Vehicular Emissions. Entry of Vehicles inside the industrial premises will be restricted.

Inspections at regular intervals of all operational Vehicles making them strictly undergo regular maintenance and pollution checkup.

2. Emissions from the DG Set. There will be one DG set of 220 KVA capacities for the standby power backup.

DG set will operate only when UPCL power will not be available

Stack of appropriate height as per the CPCB norms will be installed on the DG set to clear the exhaust and acoustic insulation will be done by supplier of the DG Set.

SOLID WASTE MANAGEMENT

Table 3.5: Sources and Prevention/ Control of SWM.

Sources of Solid Waste Preventive/ Control Measures

Packing Material (approx. quantity will be100 Kg/month)

Packing material will be sold to a Recycler.

HAZARDOUS WASTE MANAGEMENT

Table 3.6: Sources and Management of Hazardous waste

Hazardous

waste QTY

Management Plan

Schedule I -5.1 Lube oil

400Ltr/annum Recyclable. Will be sold to authorized recycler

Schedule I -34.3 ETP Sludge.

1.2 MTA Will be send to authorized secured land fill site.

Schedule I-28.4 Expired finished products and raw

3.0 MTA As per rules.

materials

GREEN BELT DEVELOPMENT

33% of the total plot area is proposed to be developed as green beltfor further attenuation of the noise.

.

Green Belt will also add aesthetic Beauty to the Plant and also help in maintaining the Ecological Balance.

Table 3.7: Cost of proposed Environmental Measures

S.No.

Particulars Qty Size Price (INR)

1.

Cost of ETP 1 set 10 KLD 7.0 Lakh

2.

Green Belt development LS As required 3.0 Lakh

3.

Cost of Rainwater Harvesting System

LS As required 3.0 Lakh

4.

Annual operation cost of Environmental measures

5.00 Lakh

Total 18 Lakhs

NOISE ENVIRONMENT Pollution Sources The significant noise generating sources identified for the project are as following: During operation of the project the sources of noise will be: i Vehicular traffic ii Standby DG Set Control Measures: The following control and mitigation measures are proposed to keep the noise levels within the permissible limits.

Proper maintenance and greasing of noise generating equipment‟s and vehicles.

There will be restriction in speed of vehicles in factory.

The proposed DG set will be attached with Acoustic Enclosure.

FIRE SAFETY AND FIRE FIGHTING DEVICES

A comprehensive firefighting system is proposed containing fire hydrant system, fire water tank, fire water pump, jockey pump. Fire extinguishers are also proposed as approved by fire department. Sand Buckets for fighting shall be provided in sufficient numbers in whole of the plant. Proper use of Personal Protective Equipment (PPE) like helmet, goggles, safety shoe, ear plugs, musk, etc. is being assured.

All electrical equipment and machinery have been properly grounded. Control

switches have been properly located at the point of operations best suited to

control the equipment.

Informatory hoarding have been displayed to handle the by chance situations.

Information for good housekeeping will be displayed.

Supervisors and employees are properly trained to operate power Equipment or

machinery and also in their safe operation.

An Effective communication system is being practiced in case of any un

favorable conditions

RAIN WATER HARVESTING

Rain Water Harvesting is collection and storage of rain water for suitable uses. For rain water

harvesting, water is captured and stored either above the ground or used as to recharge the

ground water to be used later on.

The Rain Water Harvesting System shall consist of seepage/percolation pits.

The Rainwater shall be diverted from the rooftop using rain water pipes to the rainwater

harvesting system.

Proper precautions will be taken to ensure that rain water collected is free of any pollutants.

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