Updated Form I & Prefeasibility Reportenvironmentclearance.nic.in/writereaddata/modification/... · 2016. 2. 26. · Pin Code [email protected] Mob: +91 9448388374 E-mail

Updated Form I & Prefeasibility Report For

the change in products of already obtained TOR for establishment of Active Pharmaceutical

Ingredients and Formulations Manufacturing Unit at Plot 81 A, SIPCOT-I Industrial Area, Hosur,

Krishnagiri District, Tamil Nadu

February 2016

Prepared By:-

Quest Healthcare Pvt. Ltd., Form I

Page 1 FFEEBBRRUUAARRYY 22001166

FORM 1 (I) Basic Information:

S.No

. ITEM DETAILS

1. Name of the Project/s Proposed Bulk Drug, Chemicals such as

mineral salts and Active Pharmaceutical

Ingredients Manufacturing unit by M/s Quest

Healthcare Private Limited

2. S.No. in the Schedule 5 (f)

3. Proposed

capacity/area/length/tonnage to

be handled/command area/lease

area/number of wells to be

drilled

The following Active Pharmaceutical

Ingredients (APIs) and Formulations are

proposed to be manufactured

S.No Products T/

annum

1 Pharmaceutical Bulk

Drugs and chemicals such

as Mineral salts of

Gluconates, Lactates,

Citrates, Lactobionate,

Ascorbate, Aspartate,

Pidolates, Orotates, etc.,

1500

2 API Products such as

Perazin dimaleate,

Glycero Phosphates,

Carbasalate Calcium, etc.,

210

4. New/Expansion/Modernization New

5. Existing capacity/Area etc. -NA-

6. Category of Project i.e., ‘A’ or ‘B’ It is categorized as “A” category, since the

project site is located within 10 km radius of

interstate Boundary of Tamil Nadu and

Karnataka.

7. Does it attract general condition?

If yes, please specify.

Yes. The proposed project site is situated

within 10 Kms from inter-state boundary.

8. Does it attract specific condition?

If yes, please specify.

No



9. Location

Plot No. 81-A, SIPCOT-1 Industrial Complex,

Zuzuvadi

Hosur

Krishnagiri

Tamil Nadu

Plot/Survey/Khatha No.

Village

Tehsil

District

State

10. Nearest railway station/airport

along with distance in Kms.

Railway station: Hosur railway station at a

distance of about 5.7 Km in the SE direction.

Air port: Bengaluru International Airport at

a distance of 49.0 kms towards North

direction

11. Nearest Town, City, District

Headquarters along with distance

in Kms.

The site is located within Hosur

Municipality limit.

Krishnagiri (District HQ) - 51 km (SE)

12. Village Panchayat, Zilla Parishad,

Municipal Corporation, Local

body (complete postal addresses

with Telephone Nos. to be

given).

SIPCOT-1 Industrial Complex,

Hosur Taluk,

Hosur.

Tele: 04344-277188

13. Name of the Applicant Mr. K.K.Somanna

14. Registered Address

M/s. Quest Healthcare Private Limited,

No. 1, 2nd Floor, 100 ft Road, Koramangala,

5th Block, Bangalore 560 095

15. Address for Correspondence M/s. Quest Healthcare Private Limited,

Plot No.81-A,SIPCOT Phase-I Industrial

Complex, Zuzuvadi village, Hosur,

Krishnagiri

Name Mr. K.K.Somanna

Director

M/s. Quest Healthcare Private Limited,

No. 1, 2nd Floor, 100 ft Road, Koramangala,

5th Block, Bangalore 560 095

Designation

(Owner/Partner/CEO)

Address



Pin Code [email protected]

Mob: +91 9448388374

E-mail

Telephone No.

Fax No.

16. Details of Alternative Sites

examined, if any. Location of

these sites should be shown on a

toposheet.

None

17. Interlinked Projects -NA-

18. Whether separate application of

interlinked project has been

submitted?

-NA-

19. If yes, date of submission -NA-

20. If no, reason -NA-

21. Whether the proposal involves

approval/clearance under: if yes,

details of the same and their

status to be given.

(a) The Forest (Conservation)

Act, 1980?

(b) The Wildlife (Protection)

Act, 1972?

(c) The C.R.Z Notification,

1991?

No

22. Whether there is any

Government Order/Policy

relevant/relating to the Site?

Yes, The project site is notified as SIPCOT

Industrial Complex vide GO Ms. No. 553

dated 11-04-1974.

23. Forest land involved (hectares) No

24. Whether there is any litigation

pending against the project

and/or land in which the project

is propose to be setup?

(a) Name of the Court

(b) Case No.

(c) Orders/directions of the

Court, if any and its

relevance with the

proposed project.

No



(I) Activity:

1. Construction, operation or decommissioning of the Project involving actions, which

will cause physical changes in the locality (topography, land use, changes in water

bodies, etc.)

S.

No.

Information/Checklist

confirmation

Yes/

No

Details thereof (with approximate

quantities /rates, wherever possible)

with source of information data

1.1 Permanent or temporary change

in land use, land cover or

topography including increase in

intensity of land use (with respect

to local land use plan)

No

The proposed project is situated in the

SIPCOT-I Industrial Complex. Since it

is the industrial activity, there is no

change in the land use pattern of the

area.

1.2 Clearance of existing land,

vegetation and buildings?

No There is no clearance of existing land

and vegetation. A small shed which is

used for Security cabin is to be

demolished.

1.3 Creation of new land uses?

No There is no change in the land use

pattern of the area

1.4 Pre-construction investigations

e.g. bore houses, soil testing?

No Based on the preliminary soil testing, it

is inferred that strata comprises of 3m

soil overburden, of this, top soil with

nominal vegetal cover is 0.5m thick.

This is followed by Reddish Brown/

Yellowish /greyishwhite medium to

very dense sandy Silt. Further below,

rock formations occur. Rock formations

noticed exhibit evidence of ‘differential’

weathering.

Detailed Soil investigation will be

carried out for the construction of

building. As per the recommendations

of Soil investigation report, the

constructions will be carried out.

1.5 Construction works? Yes Construction of 13368 m2 built-up area

which will include process area, storage

area etc., with adequate road, parking



spaces.

1.6 Demolition works? Yes A small shed which is used for Security

cabin is to be demolished.

1.7 Temporary sites used for

construction works or housing of

construction workers?

No There will not be any temporary sites

for construction.

1.8 Above ground buildings, structures

or Earthworks including linear

structures, cut and fill or

excavations

Yes New buildings/facilities are to be

constructed.

1.9 Underground works including

mining or tunneling?

No Not Applicable

1.10 Reclamation works? No Not Applicable

1.11 Dredging? No Not Applicable

1.12 Offshore structures? No Not Applicable

1.13 Production and manufacturing

processes?

Yes Manufacturing process for all the

products are given in the Section 2.5.1

of Pre-feasibility report.

1.14 Facilities for storage of goods or

materials?

Yes Ware house for raw materials, finished

products.

Underground tanks & drum storage

yard for solvents.

These storage areas are clearly

mentioned in the Site Layout of the

plant (See Figure 4.1 of Pre-feasibility

Report).

1.15 Facilities for treatment or disposal

of solid waste or liquid effluents?

Yes Liquid waste

Construction phase: The sewage

generated from the construction

workers will be around 10 KLD which

will be treated in septic tank and

discharged into soak pit.

Operation phase:

Domestic sewage: The domestic sewage

generated (8.0 KLD) during operation

phase will be treated in Sewage

Treatment Plant (STP) and the treated



water will be used for gardening.

Industrial effluent:

Industrial effluent will be treated in-

house with state of art zero discharge

Effluent Treatment Plant (ETP) and the

treated will be used for gardening,

cooling towers etc.

Solid waste

Construction phase: Solid waste

generated by construction workers will

be disposed to Municipality.

Operation phase:

Domestic solid wastes: The domestic

garbage will be segregated at source,

collected in bins and disposed to nearby

Municipality.

Hazardous wastes: Hazardous waste

generated process will be properly

packed & stored in a designated

impervious structure (under cover roof)

for disposal. The collected hazardous

wastes will be disposed to Tamil Nadu

Waste Management Limited (TNWML)

which is located at Gummidipoondi.

The detail of Hazardous waste is given

in Section 2.8.5 of Pre-feasibility report.

1.16 Facilities for long term housing of

operational workers?

No No long term housing plan for the

operational workers is planned in the

proposed project.

The local population residing in the

surrounding area of the project site is

expected to find employment

opportunities for various maintenance

needs of the Project

1.17 New road, rail or sea traffic during

construction or operation?

No Existing infrastructure is adequate for

the proposed project.



1.18 New road, rail, air waterborne or

other transport infrastructure

including new or altered routes

and stations, ports, airports etc?

No Not Applicable

1.19 Closure or diversion of existing

transport routes or infrastructure

leading to changes in traffic

movements?

No Not Applicable

1.20 New or diverted transmission

lines or pipelines?

No Not Applicable

1.21 Impoundment, damming,

culverting, realignment or other

changes to the hydrology of

watercourses or aquifers?

No Not Applicable

1.22 Stream crossings? No Not Applicable

1.23 Abstraction or transfers of water

from ground or surface waters?

No Company proposes to source the

required water from SIPCOT.

1.24 Changes in water bodies or the

land surface affecting drainage or

run-off?

No Not Applicable

1.25 Transport of personnel or materials

for construction, operation or

decommissioning?

Yes There will be minor increase in traffic

due to the movement of vehicles

carrying construction materials during

the construction phase & due to the

movement of employees to & from the

industry during the operation phase

which will not have any major impact

on the existing traffic in the region.

1.26 Long-term dismantling or

decommissioning or restoration

works?

No Not Applicable

1.27 Ongoing activity during

decommissioning which could

have an impact on the

environment?

No -NA-

1.28 Influx of people to an area in

either temporarily or

permanently?

Yes There will be influx of people during

the construction and operational phase.

Construction phase - Temporarily –

about 300 people during peak

construction period. Operational phase

– about 220 people

1.29 Introduction of alien species?

No Local native plants are planted in and

around the plant premises.



1.30 Loss of native species or genetic

diversity?

No There will not be any loss of native

species.

1.31 Any other actions? No NA

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


quantities /rates, wherever possible) with

source of information data

2.1 Land especially undeveloped

or agricultural land (ha)

No The land is developed SIPCOT industrial

land. Total site area is 16023.32 m2

2.2 Water (expected source &

competing users) unit : KLD

Yes Company proposes to source the required

water from SIPCOT.

Fresh water requirement is about 205

KLD. The break-up details are given in

Section 2.6 of Pre-feasibility report.

2.3 Minerals (MT) No -NA-

2.4 Construction material – stone,

aggregates, sand / soil (expected

source – MT)

Yes Sand, coarse and fine aggregates etc.

available locally. Material Requirement Cement 2,518 Tons

Sand 172,670 Cu. ft Aggregates 100,724 Cu. ft

Steel 576 Tons Bricks 2,590,055 No.

2.5 Forests and timber (source –

MT)

No NA

2.6 Energy including electricity

and fuels (source, competing

users) Unit: fuel (MT), energy

(MW)

Yes Power requirement

The total power requirement for the

industry is about 1.2 MW is to be obtained

from Tamil Nadu Generation and

Distribution Corporation Limited

(TANGEDCO).

DG sets of 4X380 KVA and 2X180 KVA

capacities are proposed to be used during

occupancy phase which will serve as

back-up power supply during power

failure.

Fuel requirement: 330 L/hr



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 or raise concerns about actual or

perceived risks to human health.

S.No

.


confirmation

Yes/

No


quantities/rates, wherever possible)

with source of information data

3.1 Use of substances or materials,

which are hazardous (as per MSIHC

rules) to human health or the

environment (flora, fauna, and

water supplies)

Yes Chemicals like Methanol, etc., are

being used in the process, which are

hazardous. The details of hazardous

substance are given in Table 2.16 of

Pre-feasibility report.

However, in-built safety features of the

plant would be made adequate in order

to avoid hazardous events causing

damage.

3.2 Changes in occurrence of disease or

affect disease vectors (e.g. insect or

water borne diseases)

No -NA-

3.3 Affect the welfare of people e.g. by

changing living conditions?

Yes Socio-economic status of the

surrounding area will improve.

3.4 Vulnerable groups of people who

could be affected by the project e.g.

hospital patients, children, the

elderly etc.,

No Since there is no vulnerable group in

the vicinity of the project site, it is not

applicable.

3.5 Any other causes No Not Applicable

4. Production of solid wastes during construction or operation or decommissioning

(MT/month)

S.No.


confirmation

Yes/

No


quantities/rates, wherever possible) with


4.1 Spoil, overburden or mine wastes Yes The excavated soil during construction

phase will be reused within the site

premises.

4.2 Municipal waste (domestic and or

commercial wastes)

Yes Entire garbage generated from the

industry premises will be disposed to

Municipality.



4.3 Hazardous wastes (as per

Hazardous Waste Management

Rules)

Yes Hazardous waste generation, treatment

and disposal details are given in the

Section 2.8.5 of prefeasibility report.

4.4 Other industrial process wastes No -

4.5 Surplus product No Not Applicable

4.6 Sewage sludge or other sludge from

effluent treatment

Yes Sludge generated from sewage treatment

plant will be used as manure for green

belt development and residue generated

from effluent treatment will be disposed

to TNWML, Gummidipoondi for

treatment and safe disposal.

4.7 Construction or demolition wastes Yes The excavated soil during construction

phase will be reused within the site

premises.

4.8 Redundant machinery or

equipment

No Not Applicable

4.9 Contaminated soils or other

materials

No The following measures are adopted to

control soil contamination.

Prevention of spillage & leakage of oils,

providing curb stones, lined gutter & oil

traps.

4.10 Agricultural wastes No Not Applicable

4.11 Other solid wastes

No None.

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

S.No.


confirmation

Yes/

No




5.1 Emissions from combustion of fossil

fuels from stationary or mobile

sources

Yes Air emissions comprising particulate

matter, NO2, unburnt hydrocarbon and

SO2 will be from the operating D.G. set

and Boiler. Adequate height of Stack will

be provided to disperse the flue gases to

conform NAAQS in atmospheric air

environment.

Besides, air emissions will also be from



the raw material carrying vehicles.

Hence, expected air emissions in the

vicinity of the project will be particulate

matter, NO2, SO2. Proper maintenance of

vehicles will mitigate the pollution.

5.2 Emissions from production

processes

Yes Gaseous emissions during manufacturing

process are treated using packed column

scrubbers before letting out into the

atmosphere. The details of Scrubbers are

given in Section 2.8.3 of Pre-feasibility

report.

5.3 Emissions from materials handling

including storage or transport

Yes Dust collectors will be provided to

mitigate fugitive emissions during

handling of raw materials and scrubbers

will be provided to mitigate emissions

during solvent charging to reactors. The

details are given in Section 2.8.2 of Pre-

feasibility report.

5.4 Emissions from construction

activities including plant and

equipment

Yes Particulate Matter would be the

predominant pollutant generated from

construction activities. The gaseous

emissions such as SO2, NO2 and unburnt

hydrocarbons would be generated from

the construction equipments and

vehicles.

The other sources of emission during the

construction period are the movement of

construction equipments at site and dust

emitted during the leveling, grading,

earthworks, foundation works and other

construction related activities.

The impact is likely to be insignificant

for short duration and confined locally to

the construction site itself.

5.5 Dust or odours from handling of

materials including construction

materials, sewage and waste

Yes Dust emission during unloading of

construction materials is possible and it

will be suppressed by Water sprinkling.

Sewage during construction stage will be

treated in the septic tank and soak pit.

Domestic solid waste generated will be



handed over to municipal authority.

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

Not Applicable

5.8 Emissions from any other sources No

Not Applicable

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

S.No. Information/Checklist

confirmation

Yes/

No



source of information data with source of

information data

6.1 From operation of equipment e.g.

engines, ventilation plant, crushers

Yes During the operational phase, noise will

be generated from the DG sets (standby),

and general noise characteristic of a

proposed industry. The DG sets are

provided with inbuilt acoustic

enclosures. The noise levels in and

around the proposed industry will be

maintained within the stipulated norms

both during the day and night time as per

TNPCB norms.

6.2 From industrial or similar

processes

Yes Noise generation will be maintained

within the stipulated norms both during

the day and night time as per TNPCB

norms.

6.3 From construction or demolition Yes To minimize noise level impacts during

construction phase, major construction

activities would be scheduled during

normal daylight working hours and

would be implemented consistent with

the applicable standards. The

construction contractor will use

equipments that are adapted to operate

with appropriate noise muffling devices

resulting in the least possible noise. Every

effort would be taken to minimize the



noise levels including the mandatory use

of construction equipment with operable

mufflers.

Overall, the impact of noise generated

during construction phase of the project

on the environment is likely to be

insignificant, reversible and localized in

nature and mainly confined to daytime

and reduces gradually as the project

progresses.

6.4 From blasting or piling

No Not Applicable

6.5 From construction or operational

traffic

Yes

Construction traffic for loading and

unloading, fabrication and handling of

equipment and construction materials

are likely to cause an increase in the

ambient noise levels. The areas affected

are those close to the site. At the peak

period of the construction, marginal

increase in noise levels is expected to

occur locally at the construction site. The

proper maintenance of vehicles would

mitigate the noise levels.

6.6 From lighting or cooling systems No

Not Applicable

6.7

From any other sources No

Not Applicable

7. Risks of contamination of land or water from releases of pollutants into the ground or

into sewers, surface waters, groundwater, coastal waters or the sea:

S.No.


confirmation

Yes/

No






7.1 From handling, storage, use or

spillage of hazardous materials Yes

The safety features such as dedicated storage

tank, overfill protection, flow meters and

periodic maintenance will be followed to

avoid spillage/contamination to environment.

7.2 From discharge of sewage or

other effluents to water or the

land (expected mode and place of

discharge)

Yes

Domestic sewage: Construction phase: The sewage generated

from the construction workers will be

treated in septic tank and discharged into

soak pit as per provisions given in CPHEEO.

Operation phase: Domestic sewage: The domestic sewage

generated during operation phase will be

treated in Sewage Treatment Plant (STP)

and the treated water will be used for

gardening as per norms stipulated by

TNPCB.

Industrial effluent: Industrial effluent will be treated in-house

with state of art zero discharge Effluent

Treatment Plant (ETP) and the treated

effluent shall be used for gardening, cooling

towers etc. as per norms stipulated by

TNPCB.

7.3 By deposition of pollutants

emitted to air into the land or

into water

No

Not Applicable

7.4 From any other sources No

Not Applicable.

7.5 Is there a risk of long term build

up of pollutants in the

environment from these

sources? No

Adequate environmental protection

measures will be provided to mitigate the

impacts as per standards. There is no risk

anticipated for long term build up of

pollutants in the environment from any of

the source.

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

human health or the environment

S.No.


confirmation

Yes/

No




8.1 From explosions, spillages, fires Yes Construction labourers will be provided



etc from storage, handling, use

or production of hazardous

substances

with necessary PPE depending upon their

nature of activity.

During the operational place also, PPE

will be provided for the employees. Risk

Assessment and Disaster Management

Plan will be prepared. Environment

Health and Safety will be the Industry’s

top priority.

8.2 From any other causes No Not Applicable

8.3 Could the project be affected by

natural disasters causing

environmental damage (e.g.

floods, earthquakes, landslides,

cloudburst etc)?

No

The plant area falls in Zone-II of Seismic

Zone and is referred to as least active.

The seismic factors will be appropriately

incorporated in the civil designs for the

project.

9. Factors which should be considered (such as consequential development) which

could lead to environmental effects or the potential for cumulative impacts with

other existing or planned activities in the locality

S.

No.


confirmation

Yes/

No




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

Yes

Yes

NA

No

Yes

No

Net positive impact in terms of overall

development of the area is expected from

the proposed project.

Direct & indirect employment

opportunities are created due to proposed

development of this project.

9.2 Lead to after-use of the site,

which could have an impact on

the environment

No Not Applicable



9.3 Set a precedent for later

developments No

The project is proposed in SIPCOT

Industrial Area, Phase-1, Hosur and

therefore no major impacts are expected.

9.4 Have cumulative effects due to

proximity to other existing or

planned projects with similar

effects

No Not Applicable

(III) Environmental Sensitivity

S.No.

Areas

Name/

Identity

Aerial distance (within 15 km.)

Proposed project location boundary

1 Areas protected under

international conventions,

national or local legislation for

their ecological, landscape,

cultural or other related value

No

None within 15 km radius

2 Areas which are important or

sensitive for ecological reasons -

Wetlands, watercourses or other

water bodies, coastal zone,

biospheres, mountains, forests

No


3 Areas used by protected,

important or sensitive species of

flora or fauna for breeding,

nesting, foraging, resting, over

wintering, migration

No


4 Inland, coastal, marine or

underground waters

Yes SIPCOT Pond – 0.75 km (SE)

Santhapuram Lake – 1.66 km (S)

Kalavarapalli Reservoir – 7.0 km (E)

Ponnaiyar River (Dakshina Pinakini) –

7.82 km (E)

5 State, National boundaries Yes Karnataka state boundary is at a

distance of about 1.7 kms towards SW.

6 Routes or facilities used by the

public for access to recreation or

other tourist, pilgrim areas

No NA

7 Defence installations No NA

8 Densely populated or built-up

area

Yes Hosur (The site is within the Municipal

Limit of Hosur)

Quest Healthcare Pvt. Ltd., Pre-feasibility Report


PRE-FEASIBILITY REPORT

1. INTRODUCTION

M/s. Quest Healthcare Private Limited has proposed to establish the Bulk Drugs and

Active Pharmaceutical Ingredients manufacturing unit at Plot No. 81A, SIPCOT-I

Industrial Complex, Hosur, Krishnagiri District. Since proposed project is to establish a

manufacturing facility related to pharmaceuticals and the site is located within the 10km

radius of Interstate boundary of Tamil Nadu & Karnataka, it requires Environmental

Clearance from Ministry of Environment Forest and Climate Change (MoEFCC) under

Category ‘A’ in the Schedule 5 (f) of EIA Notification 2006 and its subsequent

amendments.

In this regard, earlier we applied for environmental clearance and received ToR vide

letter F. No. J-11011/36/2013-IA II(I), Dated 25.04.13 in this regard we conducted the

EIA studies and draft EIA report was made. But due to the poor market demand of the

proposed products, we were unable to proceed with the proposed products, so we are

withdrawing the products proposed earlier and proposing the new products as per present

market demand.

1.1 Need for the project

Bulk drugs have become a part of our life for sustaining many of our day-to-day activities,

preventing and controlling diseases. Bulk drugs manufacturing sector in India is well

established and has recorded a steady growth in the overall Indian industrial scenario.

The bulk drugs and allied industries have been amongst the fastest growing segments of

the Indian industry.

The Indian Pharmaceutical Industry today is in the front rank of India’s science-based

industries with wide ranging capabilities in the complex field of drug manufacture and

technology. It ranks very high third in the world, in terms of technology, quality and

range of medicines manufactured. From simple headache pills to sophisticated antibiotics

and complex cardiac compounds, almost every type of medicine is now made

indigenously.

Playing a key role in promoting and sustaining development in the vital field of

medicines, Indian Pharma Industry boasts of quality producers and many units approved

by regulatory authorities in USA and UK. International companies associated with this

sector have stimulated, assisted and spearheaded this dynamic development in the past

years and helped to put India on the pharmaceutical map of the world.



India's pharmaceutical industry is the third largest in the world in terms of volume. Its

rank is 14th in terms of value. India is also one of the top five active pharmaceutical

ingredients (API) producers (with a share of about 6.5 per cent).

The pharmaceutical industry in India meets around 70% of the country's demand for bulk

drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals

and injectables. Between September 2008 and September 2009, the total turnover of

India's pharmaceuticals industry was US $21.04 billion. The domestic market was worth

US $12.26 billion. This was reported by the Department of Pharmaceuticals, Ministry of

Chemicals and Fertilizers. As per a report by IMS Health India, the Indian pharmaceutical

market reached US $10.04 billion in size in July 2010. A highly organized sector, the

Indian Pharma Industry is estimated to be worth $4.5 billion, growing at about 8 to 9

percent annually.

International pharma majors have preferred many companies from the State. When large

companies offer their services on contractual basis to global MNCs, they want to

outsource drug production for the domestic market from quality small-medium

manufacturers in State. Here the small-medium units ideally fit into slot as third party

manufacturers and serve as major hubs for pharmaceutical outsourcing. The units have

been recognized for stringent regulatory enforcement and known to manufacture quality

products. Another added advantage favoring the State is that it is emerging as an

investment destination.

1.2 Demand Supply Gap, Imports Vs Indigenous production

Indian pharmaceutical companies supply almost all the country's demand for

formulations and nearly 70 per cent of demand for bulk drugs. The imports of

pharmaceuticals are estimated at 10 to 12 percent of the total market. The major suppliers

are Switzerland, China, USA, Germany, Italy, Denmark, France, and UK. Imports include

raw materials and finished products. Some major pharmaceuticals which are imported

include Provitamins and Vitamins, Cortisones, Hydrocortisone, Insulin, Penicillin,

Osetrogen, Progesterone and other hormones, Erythromycin and other ANTIBIOTICS,

Antisera & other blood fraction, and Glycosides. The imports are from Switzerland, US

and Germany primarily consist of finished medicament in dosage forms for retail sales.

1.3 Export Possibility

The size of the domestic pharmaceutical market is larger than export market. However,

owing to the growth of global generics market, stringent price controls in the domestic



market, and better margins, the export market is growing much faster than the domestic

market.

India exports pharmaceuticals to numerous countries around the world, including to the

U.S., Germany, France, Russia and UK. The Indian pharmaceutical industry ranks 17th

with respect to exports value of bulk actives and dosage. Exports constitute nearly 40 per

cent of the production, with formulations contributing 55 per cent and bulk drugs 45 per

cent.

According to the Pharmaceutical Export Promotion Council (Pharmexcil), the

pharmaceutical exports in 2007-08 stood at US$6.68 billion against US$5.73 billion in

2006-07, recording a growth rate of 16 per cent. The industry has been clocking export

growth rate, recording 18 per cent, 23 per cent and 17 per cent growth rates during 2006-

07, 2005-06, and 2004-05, respectively. The overall pharmaceutical exports are estimated

to increase at a CAGR of 30-32 percent.

1.4 Employment Generation due to the project

The total direct employment potential of the proposed industry is about 220 people.

However, there are indirect employment generations due to the project during the

transportations, marketing & distribution etc.



2. PROJECT DESCRIPTION

2.1 Type of Project

M/s. Quest Healthcare Pvt. Ltd. proposes manufacture of Bulk Drug, Chemicals such as

mineral salts and Active Pharmaceutical Ingredients. The main APIs proposed to be

manufactured are antibiotics & anti-bacterial agents. The formulation product is produced

as per the market demand.

An active ingredient (AI) is the substance of a pharmaceutical drug that is biologically

active. Terms in similar use include: active pharmaceutical ingredient (API) and bulk

active in medicine. Some medications may contain more than one active ingredient. The

traditional word for the API is pharmacon or pharmakon which originally denoted a

magical substance or drug.

A dosage form of a drug is traditionally composed of two things: The API, which is the

drug itself; and an excipient, which is the substance of the tablet, or the liquid the API is

suspended in, or other material that is pharmaceutically inert. Drugs are chosen primarily

for their active ingredients.

The main activity of the proposed industry is manufacturing of Bulk Drug products and

Active Pharmaceutical Ingredients (APIs) and formulations.

The total production capacity per annum is 1500 MT of Bulk Drugs and Chemicals such

as Mineral Salts and 210 MT of API Products.

2.2 Project Location Details

The industry is proposed to be established at Plot No. 81-A, SIPCOT Phase-I Industrial

Complex, Hosur- 635 126. The Environmental setting of the project site is presented in

the Table 2.1. The general location of the project area is represented in Figure 2.1. The

google image showing the project site is given in Figure 2.2.



TABLE 2.1 - Environmental Settings of the Project Site

S.

No. Particulars Details

1 Latitude 12°45'59.97"N

2 Longitude 77°48'14.66"E

3 Site Elevation above MSL 885 m

4 Topography Plain

5 Present land use at the site Industrial

6 Nearest highway National Highway (NH-7) – 1.0 km (SW)

7 Nearest railway station Hosur – 5.7 km, SE

8 Nearest airport Bengaluru International Airport – 49 km (N)

9 Nearest town / city Hosur

10 Water body SIPCOT Pond – 0.75 km (SE)

Santhapuram Lake – 1.66 km (SE)

Kalavarapalli Reservoir – 7.0 km (E)

Ponnaiyar River (Dakshina Pinakini) – 7.82 km (E)

11 Nearest Port Chennai Fort – 270 km (NE)

12 Hills / Valleys/Forests Perandapalli Forest – 12.0 km (SE)

13 Archaeologically important

places


14 National parks / Wildlife

Sanctuaries


15 Seismicity Zone II

16 Defense Installations None within 15 km radius



FIGURE 2.1 - Location Map of the Project Site



FIGURE 2.2 – Google Image of the project site



2.3 Basis of selecting the project site

The efficient functioning of any industry mainly depends on the availability of its basic

requirements viz. raw materials, fuel, power, water, manpower etc. The industry is

proposed to be established in SIPCOT Industrial Complex, Hosur. The choice of the land

confers several advantages, which are summarized below.

1. The land use of the site is Industrial

2. The site is well connected by roadways.

3. Water supply facility is available with SIPCOT.

4. Power will be supplied by TANGEDCO.

5. Housing colonies, educational facilities, hospitals and other amenities are available

in the vicinity.

No incidence of cyclones, earthquake, floods or landslides in the region.

2.4 Size or magnitude of operation

The industry “M/s. Quest Healthcare Pvt. Ltd.” is a large scale industrial unit with a total

capital investment of Rs. 25.07 Crores. The total production capacity proposed is 1500

MT/Annum of Bulk Drugs and Chemicals such as Mineral salts and 210 MT/Annum of

API Products.

2.4.1. Products Manufactured

The following Bulk drugs and APIs, are proposed to be manufactured.

TABLE 2.2 – Bulk Drug Products proposed to be manufactured

S. No Products T/ annum

1 Pharmaceutical Bulk Drugs and chemicals such as Mineral

salts of Gluconates, Lactates, Citrates, Lactobionate,

Ascorbate, Aspartate, Pidolates, Orotates, etc.,

1500



TABLE 2.3 – APIs proposed to be manufactured

S. No API product T/ annum

1 Perazin dimaleate 9

2 Glycero Phosphate 30

3 Carbasalate Calcium 9

4 Iron sucrose 36

5 TMS (Tiemmonium Methyl Sulphate) 18

6 Alendronate sodium 15

7 Beta Glycero phosphate 11.9

8 Phenprocoumon 3

9 Strontium ranelate 6

10 Calcium D sacharate 18

11 Calcium dobesylate 15

12 Ethamsylate 6

13 Benfotiamine 18

14 Tolperisone HCl 9

15 Dobutamine HCl 6

16 Calcium Folinate 0.1

Total 210

2.5 Project Description

2.5.1 Manufacturing process

The manufacturing process for each product proposed to be produced is described with

process description and flow charts as under.

2.5.1.1. Bulk Drug products

Combined manufacturing process for all other Bulk Drug products

Calculated Quantities of required Raw materials are dissolved / Reacted in water, filtered,

Crystallized, Centrifuged, Milled, dried, Sieved, Blended, Packed and dispatched.



FIGURE 2.3 – Generic Process Flowchart - Bulk Drug Products

Calcium Gluconate

Calculated quantity of Dextrose Mono Hydrate, Sodium Bromide, are dissolved in DM

water and electrolysed to produce Gluconic acid and neutralized with Calcium carbonate,

the neutralized salt is then filtered, Crystallised, Centrifuged, dried, milled and packed.

FIGURE 2.4 –Process Flowchart - Calcium Gluconate

Spray Drying process

Calculated Quantities of required Raw materials are dissolved / Reacted in water filtered,

Spray dried, Sieved, Blended, Packed and dispatched.

FIGURE 2.5 –Process Flowchart – Spray Drying Process

Filtration Crystallization Neutralization/

Reaction

Filtration Crystallization

Sieving Blending Packing

Centrifuging Drying Milling

Electrolysis Neutralisation Filteration Crystallisation

Packing Milling Drying Centrifuging

Neutralization/

Reaction Filtration Spray Drying

Packing Blending Sieving



API Products

1. IRON SUCROSE

Ferric Chloride is dissolved in water then sodium bicarbonate solution is added to

precipitate ferric hydroxide which is then filtered. Above ferric hydroxide is mixed with

sucrose and heated to get iron sucrose in solution. Which is concentrated to get thick

mass, which is added with vigorous stirring to De Natured Spirit(DNS) and then methanol

to precipitate iron sucrose solid. This is centrifuged and slurried with DNS and acetone

again to remove the impurities. The wet material is dried under vacuum, pulverized,

redried, milled, blended as needed and packed.

FIGURE – 2.6: PROCESS FLOW CHART – IRON SUCROSE

Filter Mass

Filtration

Vacuum Drying

Milling, Blending & Packing

Water + Ferric Chloride

Filtration of Ferric hydroxide

Ferric hydroxide Cake + Sugar

Concentrated

Filtration

Sodium carbonate

solution

MLR Collection

DNS

MLR Collection

MethanolDNS

MLR CollectionAcetone



2. TIEMMONIUM METHYL SULPFATE (TMS)

Morpholine is reacted with 2-acetyl thiophene and p-formaldehyde in the presence of

hydrochloric acid in denatured spirit (DNS) to get the corresponding mannich base as

HCl salt. The above HCl salt is basified in toluene to get the corresponding mannich

ketone base. This is reacted with phenyl magnesium bromide in tetrahydrofuran to get

tiemmonium hydrochloride which is purified using methanol slurry. The pure

hydrochloride is converted to base and treated with dimethyl sulfate in acetone to get

the tiemmonium methyl sulfate. This is dried in a vacuum oven, milled, blended and

packed.

FIGURE 2.7 –Process Flowchart – Tiemmonium Methyl Sulpfate

MLR Collection

MLR Collection

Dimethyl Sulphate

Methanol

Con. HCL

Phenyl Magnesium bromide

MLR Collection

Con. HCL Morpholine + 2- Acetyl thiophene +

P-Formaldehyde +DNS

Cool, Centrifugation, Basification

Ketone Base

Quenching ice water

Centrifugation

Basification with Ammonia

Centrifugation

Vacuum Drying




3. PERAZINE DIMALEATE

Stage – I: N-methyl piperazine is reacted with Bromochloro propane in presence of

sodium hydroxide.

Stage – II: condensation of phenothiazine with stage –I product in DMF (Dimethyl

formamide) to form Perazine base.

Stage – III: Perazine base reacted with Maleic acid in acetone to form Perazine Dimaleate.

FIGURE 2.8 –Process Flowchart – Perazine Dimaleate

Stage-II

Phenothiazine

Stage-I

N-methyl piperazine + Sodium Hydroxide +

Sodium Carbonate + Toluene

Filtration &Evaporation of Toluene

Stage – I + DMF + base

Quenching & Centrifugation

Perazine base + Acetone + Maleic acid

Basification with Ammonia

Centrifugation

Vacuum Drying




4. CALCIUM D-SACHARIDE (CADS)

Nitric acid reacted with Dextrose monohydrate (DMH) at hot condition. The reacted

mass is basified with Potassium hydroxide. Again the mass is acidified to get mono

potassium salt of D-sacharic acid. This salt is reacted with Sodium hydroxide. The mass is

reacted with Calcium chloride to form Calcium D-sacharide.

FIGURE 2.8 –Process Flowchart – Calcium D-Sacharide

Nitric acid

Conc. Nitric acid

Reaction with potassium hydroxide

Filtration

Centrifugation

Reaction with NaOH

Filtration

Reaction with Calcium chloride

Centrifugation

Drying, Milling, Blending & Packing

DMH

Hot condition

NaOH

DNS



5. ALENDRONATE SODIUM

4-aminobutyric acid is treated with a mixture of phosphorous trichloride in presence of

methane sulphonic acid at 70 deg.C Then hydrolysed by refluxing with water and then

treated with sodium hydroxide to get the required product.

FIGURE 2.8 –Process Flowchart – Alendronate Sodium

6. PHENPROCOUMON

Mixture of 1-phenyl-1-propanol and 4-hydroxy coumarin heated to reflux in ethylene

chloride. The reaction mass is extracted with sodium hydroxide. Then acidified with HCl

to get the product. The crude product is purified with DNS.

DNS

Reflux

Sodium Hydroxide

4-amino butyric acid + Phosphorous trichloride +

Phosphorous acid + Methane sulphonic acid

Quenching

Basification

Centrifugation

Vacuum Drying


Water



FIGURE 2.9 –Process Flowchart – Phenprocoumon

7. STRONTIUM RANELATE

Stage-I: Ethyl acetone dicarboxilate is made by reacting citric acid with chlorosulfonic

acid in methylene chloride

Stage – II: Ethyl acetone dicarboxilate is condensed with , Malano nitrile and Sulphur in

presence of triethylamine to get stage-II

Stage –III: Stage –II is reacted with Methyl bromoacetate and Potassium carbonate in

Acetone, and to get alkylated Stage –II.

Stage –IV; Stage –III reacted with strontium hydroxide in water under reflux condition

to get the final product which is washed with water, dried, milled and packed.

DNS

Reflux

HCl

Ethylene Dichloride + 1-phenyl-1-propanol + 4-

hydroxy coumarin

Extract with Sodium hydroxide

Acidify

Centrifugation

Purification

Drying

DNS




FIGURE 2.10 –Process Flowchart – Strontium Ranelate


Water

Methylene dichloride + Chlorosulphonic acid

Quenching

Morpholine + methanol + Malano nitrile +

Suphur

Quenching

Filtration

Acetone + Potassium carbonate + Methyl

bromoacetate

Filtration & Concentration

Reaction with Strontium hydroxide

Citric Acid

Stage-I

Stage-II

Water

Hot Condition

Stage-III

Stage-IV

Water

Filtration

Drying



8. CALCIUM GLYCEROPHOSPHATE

Stage – I: Epichlorohydrin is hydrolyzed with dilute acid, and reacted with Tri sodium

phosphate, to get Crude sodium Glycerophosphate.

Stage –II : To the Above crude Sodium Glycerophosphate solution , Calcium chloride is

added to get Crude Calcium Glycerophosphate

Stage – III : crude Calcium Glycerophosphate is washed with DNS: Water mixture to get

Pure Calcium Glycerophosphate, which is centrifuged and dried

FIGURE 2.11 –Process Flowchart – Calcium Glycerophosphate


Epichlorohydrin + water

Reaction with Trisodium phosphate

Charcoal treatment & Filtration

Reaction with calcium chloride

Centrifugation & Slurry wash

Drying

Stage-I

Stage-II

Calcium Chloride

Hot Condition

Stage-III

Reflux

DNS: Water



9. MAGNESIUM GLYCEROPHOSPHATE

Stage – I: Epichlorohydrin is hydrolised with dilute acid, and reacted with Tri sodium

phosphate, to get Crude sodium Glycerophosphate.

Stage –II : To the Above crude Sodium Glycerophosphate solution ,Magnesium chloride

is added to get Crude Magnesium Glycerophosphate

Stage – III : crude Magnesium Glycerophosphate is washed with DNS: Water mixture to

get Pure Magnesium Glycerophosphate, which is centrifuged and dried.

FIGURE 2.12 –Process Flowchart – Magnesium Glycerophosphate





Reaction with Magnesium chloride


Drying

Stage-I

Stage-II

Magnesium Chloride

Hot Condition

Stage-III

Reflux

DNS: Water

Concentration



10. SODIUM GLYCEROPHOSPHATE

Stage – I: Epichlorohydrin is hydrolised with dilute acid, and reacted with Tri sodium

phosphate, to get Crude sodium Glycerophosphate solution which is concentrated and

filtered to get Crude sodium Glycerophosphate

Stage – II : crude Sodium Glycerophosphate is washed with DNS: Water mixture to get

Pure Sodium Glycerophosphate, which is entrifuged and dried.

FIGURE 2.13 –Process Flowchart – Sodium Glycerophosphate

11. SODIUM BETA GLYCEROPHOSPHATE

Stage – I : Glycerol is reacted reaction with pivaloyl chloride in presence pyridine in

Methyl tertiary butyl ether to get dipivaloyl glycerol, which is reacted with phosphorous

oxychloride in presence of Triethylamine.

Stage – II : stage I is quenched with water. And extracted with hexane and

methanol:water.

DNS





Crystallization


Drying

Stage-I

Stage-II

Hot Condition

Stage-III

Reflux

DNS: Water

Concentration



Stage – III: methanol –water mixture is basified with sodium hydroxide to the beta

sodium salt which is Centrifuged and dried.

FIGURE 2.14 –Process Flowchart – Sodium Beta Glycerophosphate

12. CARBASALATE CALCIUM

Aspirin is dissolved in water using sodium bicarbonate. This clear solution is reacted

with urea and calcium chloride solution to get carbasalate calcium precipitated which is

Centrifuged, washed with DNS and dried.

Methanol: water

Glycerol + MTBE +Pyridine +

pivaloyl chloride

Extraction with HCl & Water

Quenching

Basification

Centrifugation

Drying, Milling, Blending & Packing

Stage-I

Stage-II

NaO

Extraction

Phosphorous oxychloride

Triethyl Amine

Hexanes

Water



FIGURE 2.15 –Process Flowchart – Carbasalate Calcium

13. ETHAMSYLATE

Stage-I: Sulphuric acid is added to a suspention of hydroquinone in ethylene di chloride.

After the sulfonation, water is added and aqueous layer separated.

Stage-II: aqueous layer is neutralized with diethylamine, concentrated, chilled, the

product filtered and washed with isopropanol and dried.

DNS


Aspirin + Sodium Bicarbonate

Filtration

Reaction with Urea

Crystallization

Centrifugation

Drying

DNS

Reaction with calcium chloride



FIGURE 2.16 –Process Flowchart – Ethamsylate

14. CALCIUM DOBESYLATE

Stage-I: Sulphuric acid is added to a suspention of hydroquinone in ethylene di chloride.

After the sulfonation, water is added and aqueous layer separated.

Stage-II: aqueous layer is neutralized with a slurry of calcium carbonate in water,

centrifuged to separate calcium sulfate.

Liquid from centrifuge is concentrated, chilled, the product filtered and washed with

isopropanol and dried.

Stage-I

Aqueous layer

Crystallisation

Centrifugation

Drying

Stage-II

Chill, residue

diethylamine

Concentration


isopropanol

Hydroquinone + ethylene di chloride

Sulphonated mass

Sulphuric acid

Water

Layer separation



FIGURE 2.17 –Process Flowchart – Calcium Dobesylate

15. BENFOTIAMINE

Mixture of thiamine HCl and orthophosphoric acid is heated and phosphorous pentoxide

is added slowly over a period. Diluted by adding water and Hydrolysed by heating to

reflux.

The above solution is basified with sodium hydroxide and treated with benzoyl chloride

in methylene di chloride at low temperature. After the reaction, centrifuged to remove

Stage-I

Liquid from centrifuge

Crystallisation

Centrifugation

Drying

Stage-II

Residue

Centrifuge


isopropanol

Hydroquinone + ethylene di chloride

Aqueous layer

Sulphuric acid

Calcium carbonate

Layer separation

Concentrated

chilled



inorganics, the MLR is concentrated and filtered. The filtrate is acidified to get the crude

benfotiamine which is centrifuged and washed with water.

crude product is dissolved in dilute sodium hydroxide, charcolised, filtered, acidified to

get the pure product which is centrifuged, washed with water, methanol and spin dried.

The wet material is dried under vacuum, pulverized, milled, blended as needed and

packed.

FIGURE 2.18 –Process Flowchart – Benfotiamine

Reaction mixture+ sodium hydroxide

Centrifugation

Centrifugation

Vacuum Drying

Centrifuge, MLR concentrate

cool


Hydrochloric Acid

Thiamine HCl + orthophosphoric acid

Reaction mixture

Phosphorous pentoxide

Heat

Reflux

Water

Benzoyl chloride in DCM

Hydrochloric Acid

Above solid + aq. sodium hydroxide

Charcoalise, filter



16.TOLPERISONE HCl

Mixture of 4-methyl propiophenone, piperidine, and hydrochloric acid heated to reflux

in 1,3-dioxalone. After the reaction is over, diluted with ethyl acetate and chilled with

stirring. Product formed is centrifuged, washed with ethyl acetate. The crude product is

purified with methanol and ethyl acetate using charcoal.

FIGURE 2.19–Process Flowchart – Tolperisone HCl

17. DOBUTAMINE HCl

Anisyl acetone is condensed with homoveratrylamine in toluene. The product is

precipitated adding conc. HCl and centrifuged. The hydrochloride salt is hydrogenated

using hydrogen and Palladium on carbon catalyst in DNS. This is demethylated by

refluxing with aqueous hydrobromic acid and acetic acid. The product is centrifuged. The

hydrobromide salt is converted into the hydrochloride via basification and precipitation

Centrifugation

Filtrate, concentrate, add ethyl

acetate, chill

Centrifugation

Vacuum Drying

Dissolve stage-1 in methanol


4-methyl propiophenone + piperidine

+ HCl + 1,3-dioxolane

Dilute with ethyl actate

Stage-1

Charcoal

Filter



with conc. HCl. The final product is centrifuged, The wet product is dried under vacuum,

milled and sieved and packed

FIGURE 2.20–Process Flowchart – Dobutamine HCl

Stage-1 + Palladium charcoal catalyst

+DNS + HCl

Stage-2 + Aq.HBr + acetic acid

Centrifugation

Vacuum Drying

Centrifugation


Ethyl Acetate

Anisyl acetone + toluene

Centrifugation

Homovertylamine

Heat

Filtration, concentration

Stage-1

Hydrogen Gas

Cool, concentrate, basify

Conc. HCl

Stage-2

Reflux

Conc. HCl



18. CALCIUM FOLINATE

Folic acid dissolved in water and treated with sodium borohydride under cooling. The

mixture is quenched into hydrochloric acid and then formylated using formic acid. The

reaction solution is concentrated under vacuum and centrifuged to get stage-1(formyl

folic acid). Stage-1 is reacted with triethylamine in water and then converted to the

corresponding calcium salt using calcium chloride. The product is precipitated by adding

DNS. The crude product is purified using water and DNS. Washed with acetone and

dried. The wet product is dried under vacuum, milled, sieved and packed.

FIGURE 2.21–Process Flowchart – Calcium Folinate

Centrifugation

Recrystallization

Centrifugation

DNS Reaction mixture

Vacuum Drying


Triethylamine

Calcium Chloride

Filtration,concentration

Stage‐1 in water

Centrifugation

Folic acid in water

Quench into HCl

Sodium Boro Hydride

Heat

Formic acid

Stage‐1



2.5.2 Raw Material Requirement

The raw materials required for the manufacture of Bulk drugs, APIs and formulations are

appended in the table below. Raw materials as listed will be procured as per the

production requirement.

TABLE 2.4 –RAW MATERIAL REQUIREMENT FOR MANUFACTURE OF BULK

DRUG PRODUCTS

S. No. Raw Material Avg. Qty (T/Year)

1 DMH/ GDL 700.0

2 Lactose 144.0

3 Lactic acid 315.0

4 Citric acid 78.0

5 Malic acid 30.0

6 Ascorbic acid 48.0

7 Pyro Glutomic Acid 48.0

8 Aspartic acid 12.0

9 Orotic acid 96.0

10 Glycine 12.0

11 Calcium Carbonate/ Oxide 400.0

12 Magnesium Oxide/Carbonate/ metal 96.0

13 Zinc Carbonate/ Oxide 24.0

14 Iron Powder 62.0

15 Ferrous Sulphate 56.0

16 Sodium Bromide 7.0

17 DNS 360.0

TABLE 2.15 –RAW MATERIAL REQUIREMENT FOR MANUFACTURE OF API

PRODUCTS

S. No. Raw Material Avg. Qty (T/Year)

1. Phenothiazine 4.5

2. Piperazine 4.5

3. Epichorohydrin 45.0

4. Trisodium phosphate 180.0

5. Aspirin 13.5

6. Urea 9.0

7. Calcium chloride 16.5

8. Ferric chloride 7.2

9. Sucrose 72.0

10. Morpholine 28.8



11. 2-acetylthiophene 27.0

12. 4-aminobutyric acid 7.5

13. Phosphorous trichloride 6.0

14. Glycerol 12.0

15. Phosphorous oxy chloride 10.8

16. 4-hydroxy coumarin 30.0

17. Malononitrile 3.6

18. Ethyl bromo acetate 7.8

19. Dextrose mono hydrate 36.0

20. Nitric acid 54.0

21. Hydroquinone 24.0

22. Sulphuric acid 39.0

23. Hydrochloric acid 270.0

24. Thiamine HCl 45.0

25. Phosphorous pentaoxide 45.0

26. Orthophosphoric Acid 63.0

27. Benzoyl chloride 27.0

28. 4- Methyl propiophenone 9.0

29. 1,3- Dioxalone 13.5

30. Homoveratrylamine 7.5

31. Anisyl Acetone 7.5

32. Potassium carbonate 18.0

33. Palladium on Carbon 1.5

34. Hydro Bromic acid 36.0

35. Folic Acid 0.8

36. Sodium Borohrdride 1.5

37. Triethyl amine. 0.5

38. Citric acid 12.0

39. 1, Phenyl 1, propanol 15.0

40. Phenyl MagBromide 84.0

41. Tetra Hydrofuran 75.0

42. P- Formaldehyde 25.5

43. Potassium Hydroxide 28.8

44. Sodium Hydroxide 105.0

45. Dimethyl formamide (DMF) 9.0

46. Methane sulphonic acid 37.5

47. Calcium carbonate 24.0

48. Strontium hydroxide 9.0



TABLE 2.55 – List of Solvent with requirement

S.No. Solvents KL/Year Storage

1 Toluene 135.0 U/G

2 DMF 18.0 Barrel

3 Acetone 138.0 U/G

4 Hexane 36.0 Barrel

5 DNS 663.0 U/G

6 Methanol 360.0 U/G

7 THF 36.0 Barrel

8 Pyridine 24.0 Barrel

9 MTBE 48.0 Barrel

10 EDC 93.0 U/G/ Barrel

11 MDC 102.0 Barrel

12 Isopropanol 48.0 Barrel

13 Ethyl Acetate 63.0 U/G

Total 1764.0

TABLE 2.6 - List of hazardous materials used in the premises

Sl. No. as

per

MSIHC

Name of the raw material Quantity of

Major RM in

T/Year or

KL/Year

451 Orotic acid 96.0

239 Epichorohydrin 45.0

408 Morpholine 18.0

506 Phosphorous trichloride 6.0

504 Phosphorous oxy chloride 10.8

353 Malononitrile 3.6

423 Nitric acid 54.0

319 Hydroquinone 24.0

591 Sulphuric acid 39.0

313 Hydrochloric acid (gas) 270.0

505 Phosphorous pentaoxide 45.0

497 Orthophosphoric Acid 63.0

65 Benzoyl chloride 27.0

59 Tetra Hydrofuran 75.0

522 Potassium Hydroxide 28.8



571 Sodium Hydroxide 105.0

285 Formaldehyde 25.5

628 Toluene 135.0

4 Acetone 138.0

106 Hexane 36.0

602 THF 36.0

547 Pyridine 24.0

271 EDC 93.0

247 Ethyl Acetate 63.0

2.5.3 Fuel Requirement

TABLE 2.7 – Details of Fuel requirement

Type of fuel Source of use Quantity

High Speed Diesel DG sets 330 L/Hr

Briquettes Boiler 15 MT/Day

2.5.4 Recovery and recycling

2.5.4.1 Solvent Recovery and recycling

Various solvents are proposed to be used during the process of manufacture of Bulk drugs,

APIs and formulations. The solvent lost during the process of solvent distillation is mainly

due to organic thermal disintegration and in form of residue left behind from the bottom

un-distilled product. Evaporation loss is minimized by the passage of chilled water

through the condenser. The average recovery of solvent is estimated as 90%.

SOLVENT RECOVERY SYSTEM

After the reaction is complete the solvents are recovered in a distillation unit.

The distillation unit has two condensers in series (shell and tube type).

The first condenser is passed with chilled cooling tower water at 7-12 oC, while

the second condenser will be passed with chilled brine solution at -10 - 200 C as

coolants.

After the vapors are condensed, the condensate along with un-condensed vapors is

passed through a trap which is cooled externally with chilled water.

The vents of condenser and receiver are connected to scrubber system.



All the reaction vessels and centrifuges are connected to a common line. These

fumes and exhausts are sucked by ID fan and scrubbed by alkali solution.

The air after scrubbing is let out into the atmosphere and the scrubbed water is

sent to ETP for further treatment.

This wet scrubber absorbs acidic vapors, traces of solvents etc. and purified gas

stream is let out into the atmosphere.

FIGURE 2.22–Typical solvent recovery system

2.6 Water Requirement

The water demand is met from SIPCOT water supply. The requirement of water for the

unit is for domestic, industrial purposes etc.



TABLE 2.18 – Details of Water requirement

S. No. Description Requirement in KLD

1. Domestic 10

2. Process / Boiler / Equipment 105.5

3. Cooling/Floor 64.5

4 Green Belt Development 25.0

Total 205

2.7 Wastes Generated and Scheme for their management/disposal

2.8.1. Wastewater Generation, treatment & disposal

2.8.1.1. Domestic Waste water generation, treatment & disposal

The quantity of wastewater generated from domestic activities during operation phase

will be treated in the Wastewater treatment plant. The treated wastewater will be reused

for green belt development. The treatment scheme shall be designed to treat the

wastewater and reuse the treated water for green belt development. The treatment

scheme shall be designed to deliver the treated water quality norms stipulated by the

Tamil Nadu Pollution State Pollution Control Board (TNPCB), in order to conserve the

water.

Table 2.8 Sewage Characteristics

Parameter Inlet Outlet

pH 7.0 – 8.0 7.0 – 8.0

TSS 150 - 200 mg/l < 30 mg/l

B.O.D5 250 – 300 mg/l < 20 mg/l

2.8.1.2. Trade Effluent generation, treatment & disposal

The trade effluents are generated from process, washing and cleaning of

vessels/equipments, boiler blow down, cooling tower bleed off, pretreatment regeneration

& rejects and scrubbed water from Scrubbers. The industrial effluent thus generated is

proposed to be treated in the proposed ETP.



TABLE 2.20 – Details of Wastewater Generation

S. No. Description Requirement in KLD

1. Domestic 8

2. Process / Boiler / Equipment 105.5

3. Cooling/Floor 64.5

Total 178

TABLE–2.21 CHARACTERISTICS OF RAW EFFLUENT AND TREATED EFFLUENT

S. No. Parameters Unit Value

Untreated Treated

1. PH mg/l 4.43 7.5 - 8.0

2. BOD - 3 day at 270C mg/l 6250 <30

3. COD mg/l 10483 <200

4. Total Suspended

Solids

mg/l 290 <40

5. Total Dissolved

Solids

mg/l 18500 <2100

6. Chlorides mg/l 1290 <800

7. Sulphates mg/l 156 <100

8. Oil & Grease mg/l 4.0 <1.0 2.8.2. Wastewater Management

At the plant, trade effluent will be generated from the process, floor washings and

equipment cleaning.

The trade effluent generated from process, floor washings/equipment cleanings

will be collected in a collection tank.

At the inlet of the tank, hydrated lime slurry will be added to effect neutralization.

The neutralized waste will be then pumped to flow control tank, from where the

waste is allowed to discharge into a settling tank.

The overflow from the settling tank will be allowed to pass through a three stage

anaerobic contact filter.

After anaerobic treatment, the waste will be aerobically treated in an aerated

lagoon.

The treated wastewater from the tank will be allowed to settle in a settling tank

and pumped to aerated tank, wherein polyelectrolyte will be added for better floc

formation and to enable easy settling of suspended particles.

The aerated water will be then taken to settling tank II, from where the clear

supernatant is pumped into the collection tank.



The treated water will be then passed through the RO plant. Treated water from

RO will be reused and the RO rejects will be subjected to Mechanical evaporation.

Condensed water from Mechanical evaporator will also be reused.



FIGURE 2.23-ETP Process Flow Chart

Floor washing &

Equipment cleaning

wastewater

DM Regenerant Waste

Cooling Tower and

Boiler Blow Down

Neutralization Pit Collection Settling Tank 3 Stage Anerobic

Contact filter

Aerated Lagoon 1

Settling Tank

Filter Press

Aerated Tank

Settling Tank

Collection Tank

RO Plant

MEE

Dry Solids Treated water for

Reuse



2.8.3. Air Pollution Management

The major air pollution sources from the industry are DG set and boiler apart from the

process sections. These sources are provided with stacks of adequate height so as to

disperse the emanating flue gases containing SPM, oxides of sulfur and nitrogen without

affecting the ground level concentrations are proposed to the process section with

adequate stack height as per the regulatory requirements.

The sources of air pollution, type of fuel used, fuel consumption and chimney heights for

each of the air pollution sources of the proposed project are indicated in the table below.

TABLE 2.9 – Air Pollution Sources, Fuel consumption and Chimney Height Details

Stack

Number

Description of Chimney

Stack Attached to

Dimension Point of discharge in

metres (Above ground

level)

1 Spray Drier I 500 mm 22 m

2 Spray Drier II 500 mm 22 m

3 Hot air generator 400 mm 22 m

4 Drying and Milling x 5 Nos 300 x200 mm 12 m

5 Boiler - 4 Tons 700 mm 30 m

6 Electrolytic cells 400 mm 12m

7 Scrubber x 3 Nos 400 mm 12 m each

8 DG set 380 KVA x 4 Nos 150 mm 10 m each

9 DG set 180 KVA x 2 no's 125 mm 9 m each 2.8.4. Noise Generation and its management

The major source of noise pollution in the industry is the DG set for which acoustic

enclosure is proposed. Also ambient noise levels will be ensured within the ambient

standards by inbuilt design of mechanical equipment and building apart from vegetation

(tree plantations) along the periphery and at various locations within the industry

premises.

2.8.5. Solid waste Generation & Management

The solid wastes generated during the process of manufacture of different APIs are stored

at hazardous waste storage area and sent to TSDF for further treatment. The quantities of

hazardous waste generated from various processes are shown in the following tables. The

industry proposes to provide adequate storage facilities for the hazardous wastes.



TABLE 2.10 - Details of Solid waste generation & management

Sl.

No.

Particulars Category No. Quantity Management

Hazardous

1. Process Waste 28.1 405.0 TPA Disposed to TSDF

2. ETP Sludge 34.0 6.0 TPA Disposed to TSDF

3. Used / Spent Oil 5.1 15 KL/A Disposed to waste oil

recyclers

4. Residue from

Solvent Recovery

20.3 45 TPA Disposed to TSDF

Non-Hazardous

5. Boiler Ash 1.2 TPD Disposed to TSDF

Power Requirement

The total power requirement of the industry is 1.2 MW. Further diesel generators of 4 ×

380 KVA and 2 × 180 KVA capacity is proposed to be installed to serve as an alternative

source of power supply to this unit.

Manpower Requirement

The total manpower requirement of the industry is 220 Nos.

3. SITE ANALYSIS

The site of the proposed site is located at Plot 81 A, SIPCOT Industrial Complex, Hosur,

Krishnagiri District.

3.1. Connectivity

The project site has well connectivity. The details are given in below Table and

represented in the Figure 3.1.

TABLE 3.1 – CONNECTIVITY DETAILS FROM THE PROJECT SITE

Sl.

No.

Road Distance from

the project site

(km)

Direction

w.r.t. project

site

1 NH- 7 1.0 South West

2 SH 35 (Sarjapura-Attibele Rd) 3.6 West

3 NH 207 5.9 North East

4 Hosur Railway station 5.7 South East

5 Bengaluru International Airport 49 North Note: All distances mentioned are aerial.



FIGURE 3.1 – Map represents the connectivity details from the project site

3.2. Land Form, Land Use & Ownership

M/s. Quest Healthcare Pvt. Ltd. is an Active Pharmaceutical Ingredients (APIs),

intermediates and formulations manufacturing industry is proposed to be established at

Plot No. 81-A, SIPCOT Industrial Complex, Phase I, Hosur-635 126. The plot where the

industry is being set-up is a designated SIPCOT industrial area. M/s. Quest Healthcare

Pvt. Ltd. has entered into a lease agreement with SIPCOT& a copy of the lease deed is

attached as Annexure I.

3.3. Topography

M/s. Quest Healthcare Pvt. Ltd. is located at latitude of 12°45'59.97"N & Longitude

77°48'14.66"E at an elevation of 885 m above MSL. The topo map showing the location of

the project site is appended as Figure 3.2.

Project SiteNH 7 NH 207

SH 35

SH 85



FIGURE 3.2 – Topo Map of the project site covering 10 km radius



3.4. EXISTING INFRASTRUCTURE

The list of existing infrastructure at the project site is

1. Water supply from SIPCOT

2. Power supply from TANGEDCO

3. Existing storm water drainage system

3.4.1. SITE CONNECTIVITY

Table 3.1-Connectivity details

Connectivity

Nearest Railway Station Hosur Railway Station- 5.70 km, SE

Nearest Airport Bengaluru International Airport – 49 km, N

Nearest Highway National Highway (NH-7) – 1.0 km, SW

3.4.2. Industries

The site is located in the SIPCOT Industrial Complex (Phase -I)which is an industrial hub

for several industries.

The major industries are like

APL Apollo Tubes Ltd,

TVS Motor Company Ltd,

Ashok Leyland Limited,

Hindustan Motors,

Titan Industries,

Global calcium

Calcium India

Micro Labs

Reckitt Benckiser

Faiveley Transport India Ltd,

Kamaz Vectra Motors Ltd,

LuK India Pvt Ltd,

AVTEC Limited,

Carborundum Universal Limited,

Taneja aerospace and aviation Limited,

Caterpillar India Pvt Ltd,

Exide Industries Ltd,



Hindustan Unilever,

Premier Mills,

INEL-India Nippon Electricals Ltd,

Asia Tobacco Pvt Ltd (I.T.C),

Base Corporation Ltd,

Luk India,

TTK Prestige Limited,

Bata India Ltd,

Kansai Nerolac Paints,

GRB Dairy Foods Pvt Ltd,

Granite companies like Aro Granite Industries Ltd,

Madhucon Granites Ltd,

Tab India Granite Pvt Ltd

3.4.3. Regional Geology & Soil Classification

Hosur is a part of Krishnagiri District, Tamil Nadu. Red loamy and sandy soils are

predominant in Hosur taluk. Krishnagiri district is underlain by Archaean crystalline

formations with recent alluvial deposits of limited areal extent and thickness along the

courses of major rivers. The district forms part of upland region with many hill ranges

and undulating plains. Denudational landforms like buried pediments in the plains and

inselbergs and plateaus represented by conical hills aligned with major lineaments, recent

Alluvium, weathered and fractured rocks which are mostly crystalline rocks comprising

charnockites granites and unclassified gneisses.

Based on data available, it is inferred that strata comprises of 3m soil overburden, of this,

top soil with nominal vegetal cover is 0.5m thick. This is followed by Reddish Brown/

Yellowish /grayish white medium to very dense sandy Silt. Further below, rock

formations occur. Rock formations noticed exhibit evidence of ‘differential’ weathering.

3.4.4. Rainfall & Climate

The district receives the rain under the influence of both southwest and northeast

monsoons. The normal annual rainfall over the district varies from about 750 to about 900

mm. It is the minimum around Hosur (767.7 mm) and Rayakottai (768.0 mm) in the

northern and central parts of the district. It gradually increases towards west and east and

is the maximum around Denkanikotai (910.7 mm) in the western part. The climate of

Krishnagiri district is comparatively more pleasant than that of the surrounding districts

due to general dryness of atmosphere and appreciable drop in temperature in the

monsoon season. The year may be divided into four seasons namely dry season from



January to March, summer season April and May, southwest monsoon season from June

to Sept. and northeast monsoon season from October to December. During summer

season (April to May) the maximum temperature is about 37°C, and the mean daily

minimum temperature of about 25°C in the plains. There is a gradual decrease of both day

and night temperatures from June onwards till December, when the mean daily

maximum temperature is about 30°C and the mean daily min. is about 19°C in plains. The

day temperature increases gradually from January onwards. The lowest temperature is

reached in January when the mean daily minimum is about 19°C. However, in higher

areas i.e., Hosur, Thally and Krishnagiri taluks day and night temperature is lower by

about 2 to 3°C. In these areas weather is comparatively pleasant round the year.

3.4.5. Hydrogeology

Ground water generally occurs under phreatic conditions in the weathered mantle and

under semi-confined conditions in the fractured zones at deeper levels. The thickness of

weathered zones in the district ranges from less than a meter to more than 15 m. The

yield of large diameter dug wells in the district, tapping the weathered mantle of

crystalline rocks ranges from 100 to 500 lpm. These wells normally sustain pumping for 2

to 6 hours per day, depending upon the local topography and characteristics of the

weathered mantle.

The depth to water level (DTW) during pre monsoon (May 2006) ranged between 0.5 and

9.9 m bgl in the district. In major part of the district the DTW is more than 5 mbgl.

Whereas it ranged between 2 and 9.9 m bgl during post monsoon, in the district and the

DTW is in the range of 5 – 10 m bgl in the entire district except a few isolated pockets.

The yield of successful exploratory wells drilled in the district ranged from 0.78 lps to 26

lps. As per the studies the wells drilled in granitic gneiss have higher yields than the

wellsdrilled in charnockites. The specific capacity of the wells ranged from 1.2 to 118.0

lpm/m/dd. The piezometric head of fracture zones varied between 0.50 and 18.45 m bgl.

3.4.6. Social Infrastructure Available

Infrastructure is the basic physical and organizational structures needed for the operation

of a society or enterprise or the services and facilities necessary for an economy to

function. The term typically refers to the technical structures that support a society, such

as roads, water supply, sewers, electrical grids, telecommunications and so forth and can

be defined as "the physical components of interrelated systems providing commodities

and services essential to enable, sustain, or enhance societal living conditions.

Viewed functionally, infrastructure facilitates the production of goods and services, and

also the distribution of finished products to markets, as well as basic social services such as



schools and hospitals; for example, roads enable the transport of raw materials to a

factory.

The list of hospitals & other infrastructural facilities available in the vicinity of the

proposed industry is tabulated below.

Sl.

No.

Infrastructure Distance from the

industry

Direction

w.r.t. the

industry

1 SIPCOT ESI hospital 1.2 km South

2 Government Hospital 4.8 km SE

3 Govt. Primary School 1.5 km W

4. PLANNING BRIEF AND PROPOSED INFRASTRUCTURE FOR THE

PROPOSED PROJECT

4.1. PLANNING BRIEF

The proposed project will be facilitated in the 3.95 acres of land in the SIPCOT

Industrial Complex (Phase - I). The land use of the site is industrial. The land use break-

up showing the proposed activities is given in Table 4.1. All required amenities and

facilities are available in the plant itself. The site layout showing plant and other

amenities is given Figure 4.1.

TABLE 4.1 - Land Use Break-Up

Sl. No Particulars Area in Sq.m % of occupancy

1 Process and utility buildings 6861 42.82

2 Roads, pathways 2654.16 16.56

3 Vacant Land 900 5.62

4 Green-belt area 5608.16 35

Total plot area 16023.32 100.0



FIGURE 4.1 – Site Layout showing plant and utilities

Quest Healthcare Pvt. Ltd., Pre-feasibility Repor


4.2. Industrial Area – Processing Area

M/s. Quest Healthcare Pvt. Ltd. is an Active Pharmaceutical Ingredients (APIs), and

formulations manufacturing industry. The site will be facilitated only for the production

of APIs and formulations in the eco-friendly manner.

4.3. Residential Area – Non Processing Area

No residential area is proposed under this project.

4.4. Green Belt

An area of about 5608.16 sq.m of land will be developed with green belt which

constitutes about 35 % of the total project area.

4.5. Drinking water Management – Source & Supply

Drinking water requirement will be met by supply from SIPCOT water supply scheme

after required treatment.

4.6. Sewage Treatment System

Adequate capacity of sewerage systems was provided taking in to consideration the total

no of people that will be employed and the expected floating population on any day at

site. Sewage Treatment Plant will be provided to treat the sewage water and treated water

will be used for green belt development.

4.7. Effluent Treatment System

The generated trade effluents will be treated in Effluent Treatment Plant.

4.8. Solid waste Management

The generated solid wastes will be properly collected and managed as given in the

Section 2.8.4.

4.9. Power requirement, Supply & Source

The total power requirement of the proposed plant will be about 1.2 MW which will be

being sourced from Tamil Nadu Generation and Distribution Corporation Limited



(TANGEDCO). As a back-up power supply, DG sets having capacity 4 × 380 KVA and 2 ×

180 KVA capacity is proposed to be installed to serve as an alternative source of power

supply to this unit.

4.10. Rain Water Harvesting System & Storm water management system

M/s Quest Healthcare Pvt. Ltd., has proposed to provide adequate rain water harvesting

and storm water drainage system after consultation with professionals.

5. REHABILITATION AND RESETTLEMENT PLAN

M/s. Quest Healthcare Pvt. Ltd. is coming up in a designated industrial area. No home

outstees/land outstees are expected & hence no rehabilitation plan is envisaged.

6. PROJECT SCHEDULE AND COST ESTIMATES

4.11. Time Schedule

The time schedule for completion of the proposed project is given in the following table

Particulars Time schedule

Start of construction activity After getting necessary approvals

from Authorities

Completion 7-9 months After getting

necessary approvals from

Authorities

4.12. Estimated Project Cost

Total capital investment on the proposed Project is detailed as under

S. No. Item Cost (Rs. in Lakhs)

1 Land Development & Buildings 505

2 Plant and machinery 1816

3 Environmental Protection Measures 186

Total 2507



7. CONCLUSION

The proposed project will increase the employment potential by creating direct and in-

direct employment opportunities and thus be beneficial for the local population. The

management of the industry proposes to give preference to local people with both

direct and indirect employment.

Documents

Updated Form I & Prefeasibility Reportenvironmentclearance.nic.in/writereaddata/modification/... · 2016. 2. 26. · Pin Code [email protected] Mob: +91 9448388374 E-mail