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Signature Phytochemical Industries
FORM-I
Signature Phytochemical Industries
FORM-1
Signature Phytochemical Industries, Selaqui,
Dehradun
At
Khasra No. 122 MI, Central Hope Town, Selaqui
Dehradun, Uttarakhand.
Signature Phytochemical Industries
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
Signature Phytochemical Industries
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
Signature Phytochemical Industries
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
Signature Phytochemical Industries
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
Signature Phytochemical Industries
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
Signature Phytochemical Industries
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.
Signature Phytochemical Industries
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
quantities/rates, wherever
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.
Signature Phytochemical Industries
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.
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 )
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.
Signature Phytochemical Industries
3.5 Any other causes Not Applicable.
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 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
Signature Phytochemical Industries
5. Release of pollutants or any hazardous ,toxic or noxious substances to air (Kg/hr )
S.No. Information/checklist
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
No Water Sprinkling shall be done to
reduce the dust.
5.5 Dust or odors from handling of
materials including construction
materials, sewage and waste
No Water Sprinkling shall be done to
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.
Signature Phytochemical Industries
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
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
quantities/rates, wherever
Signature Phytochemical Industries
possible)with source of
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.
S.No. Information/checklist confirmation Yes/No Details thereof (with approximate
quantities/rates, wherever
possible)with source of
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.
Signature Phytochemical Industries
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.
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
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
Signature Phytochemical Industries
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.
Signature Phytochemical Industries
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
Signature Phytochemical Industries
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.
Signature Phytochemical Industries
(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
Signature Phytochemical Industries
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
Signature Phytochemical Industries
PRE-FEASIBILITY
REPORT
Signature Phytochemical Industries
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
Environment Management Plan
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.
Environment Management Plan
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.
Environment Management Plan
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
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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.
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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
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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.
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ENVIRONMENT
MANAGEMENT PLAN
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ENVIRONMENTAL MANAGEMENT
PLAN
Signature Phytochemical Industries,
Selaqui, Dehradun
At
Khasra No- 122 Mi, Central Hope Town, Selaqui,
Dehradun.
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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 fire- fighting 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.