PRE – FEASIBILITY REPORT - Welcome to Environment -feasibility report applicant : alchem...

PROJECT : MODERNIZATION WITH PROCESS INTEGRATION OF EXISTING HERBAL EXTRACTS AND THEIR PURIFIED DERIVATIVES

PRE-FEASIBILITY REPORT

APPLICANT : ALCHEM INTERNATIONAL PVT LTD DOCUMENT NO.: EESPL/AIPL/008/399/EC/Ind./2016-17

ENKAY ENVIRO SERVICES PVT. LTD., JAIPUR

February’2017 1

PRE – FEASIBILITY REPORT





February’2017 2

INDEX 1.1 EXECUTIVE SUMMARY .................................................................................................... 5

1.2 SALIENT FEATURES OF THE PROJECT ............................................................................ 6

1.3 PROPOSED PLANNING .................................................................................................... 9

2.0 INTRODUCTION OF THE PROJECT/ BACKGROUND INFORMATION ............................. 10

2.1 IDENTIFICATION OF PROJECT AND PROJECT PROPONENT ......................................... 10

2.2 BRIEF DESCRIPTION OF NATURE OF THE PROJECT ..................................................... 10

2.3 NEED FOR THE PROJECT AND ITS IMPORTANCE TO THE COUNTRY AND OR REGION . 11

2.4 DEMAND - SUPPLY GAP ................................................................................................ 11

2.5 IMPORTS VS. INDIGENOUS PRODUCTION ..................................................................... 11

2.6 EXPORT POSSIBILITY ................................................................................................... 12

2.7 DOMESTIC/ EXPORT MARKETS .................................................................................... 12

2.8 EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO THE PROJECT ........... 12

2.8.1 DIRECT EMPLOYMENT ....................................................................................................................................... 12

2.8.2 INDIRECT EMPLOYMENT ................................................................................................................................. 12

3.0 PROJECT DESCRIPTION ................................................................................................ 12

3.1 TYPE OF PROJECT INCLUDING INTERLINKED AND INTERDEPENDENT PROJECTS, IF

ANY. .............................................................................................................................. 12

3.2 LOCATION (MAP SHOWING GENERAL LOCATION, SPECIFIC LOCATION, AND PROJECT

BOUNDARY AND PROJECT SITE LAYOUT) WITH COORDINATES. ................................. 13

3.3 DETAILS OF ALTERNATE SITES CONSIDERED AND THE BASIS OF SELECTING THE

PROPOSED SITE, PARTICULARLY THE ENVIRONMENTAL CONSIDERATIONS GIVEN

INTO SHOULD BE HIGHLIGHTED. ................................................................................. 14

3.4 SIZE OR MAGNITUDE OF OPERATION ........................................................................... 14

3.5 RAW MATERIAL (Quantity and Source), PRODUCT AND MODE OF TRANSPORT .......... 14

3.9 QUANTITY OF WASTES TO BE GENERATED (LIQUID AND SOLID) AND SCHEME FOR

THEIR MANAGEMENT/ DISPOSAL. ............................................................................... 76

3.9.1 SOLID .......................................................................................................................................................................... 76

3.9.2 WASTE WATER....................................................................................................................................................... 76

3.10 SCHEMATIC REPRESENTATIONS OF THE FEASIBILITY DRAWING WHICH GIVE

INFORMATION OF EIA PURPOSE .................................................................................. 93

4.0 SITE ANALYSIS .............................................................................................................. 94

4.1 CONNECTIVITY ............................................................................................................. 94

4.2 LAND FORM, LAND USE AND LAND OWNERSHIP .......................................................... 94





February’2017 3

4.2.1 LANDFORM .............................................................................................................................................................. 94

4.2.2 LAND USE .................................................................................................................................................................. 94

4.2.3 LAND OWNERSHIP ............................................................................................................................................... 94

4.3 TOPOGRAPHY (ALONG WITH MAP) ........................................................................................................... 95

4.4 EXISTING LAND USE PATTERN .. ................................................................................... 95

4.5 EXISTING INFRASTRUCTURE ........................................................................................ 95

4.5.1 BASIC AMENITIES ................................................................................................................................................ 96

4.6 SOIL CLASSIFICATION ................................................................................................... 96

4.7 CLIMATE ....................................................................................................................... 97

4.8 SOCIAL INFRASTRUCTURE AVAILABLE ........................................................................ 97

5.0 PLANNING BRIEF .......................................................................................................... 97

5.1 PLANNING CONCEPT .. .................................................................................................. 97

5.2 POPULATION PROJECTION ........................................................................................... 97

5.3 LAND USE PLANNING (BREAKUP ALONG WITH GREEN BELT ETC.) ............................. 99

5.4 ASSESSMENT OF INFRASTRUCTURE DEMAND (PHYSICAL AND SOCIAL) ..................... 99

5.5 AMENITIES/ FACILITIES ............................................................................................. 100

6.0 PROPOSED INFRASTRUCTURE ................................................................................... 100

6.1 INDUSTRIAL AREA (PROCESSING AREA) .................................................................... 100

6.2 RESIDENTIAL AREA (NON PROCESSING AREA) ............................................................................... 100

6.3 GREEN BELT................................................................................................................ 100

6.4 SOCIAL INFRASTRUCTURE ......................................................................................... 100

6.5 CONNECTIVITY (TRAFFIC AND TRANSPORTATION ROAD/ RAIL/ METRO/WATER

WAYS ETC.) ................................................................................................................. 100

6.6 DRINKING WATER MANAGEMENT (SOURCE AND SUPPLY OF WATER) ..................... 100

6.7 SEWERAGE SYSTEM .................................................................................................... 101

6.8 INDUSTRIAL WASTE MANAGEMENT .......................................................................... 101

6.9 SOLID WASTE MANAGEMENT ..................................................................................... 101

6.10 POWER REQUIREMENT AND SUPPLY/ SOURCE ......................................................... 101

7.0 REHABILITATION AND RESETTLEMENT (R & R PLAN) .............................................. 101

7.1 POLICY TO BE ADOPTED ............................................................................................ 101

8.0 PROJECT SCHEDULE AND COST ESTIMATES ............................................................... 101

8.1 LIKELY DATE OF START OF CONSTRUCTION AND LIKELY DATE OF COMPLETION . .. 101

8.2 ESTIMATED PROJECT COST ALONG WITH ANALYSIS IN TERMS OF ECONOMIC

VIABILITY OF THE PROJECT. ...................................................................................... 101

9.0 ANALYSIS OF PROPOSAL ............................................................................................ 102





February’2017 4

9.1 FINANCIAL AND SOCIAL BENEFITS WITH SPECIAL EMPHASIS ON THE BENEFITS TO

THE LOCAL PEOPLE INCLUDING TRIBAL POPULATION, IF ANY, IN THE AREA. ......... 103

10.0 CONCLUSION ............................................................................................................... 103

**********************





February’2017 5

1.0 EXECUTIVE SUMMARY

1.1 EXECUTIVE SUMMARY

Alchem International Private Limited was incorporated on 3rd of April 1982 under the

Companies Act 1956 and has been Synonymous to Herbal Extracts and their Purified derivatives

in India. The unit proposes to modernize and integrate the products with no change in land area

and production.

The total land area acquired by the unit is 22 acres. This has been released by HUDA and the

CLU for the same has been taken also (copy enclosed annexure-A).

The total capital investment till 31.12.2016 of AIPL, Ballabgarh plant of Herbal Extract & Its

Purified Products is 137 CR.

As per EIA Notification, published in Gazette of India, Extraordinary Part-II, Section-3, sub-

section (ii) of Ministry of Environment & Forest dated 14.09.2006 & subsequent amendments,

the project falls in Activity 5(f), Category-B of “List of Projects or Activities Requiring Prior

Environmental Clearance”. As per the above notification, project will have to obtain

environmental clearance from State Environmental Impact Assessment Authority (SEIAA) or

State Environmental Appraisal Committee (SEAC) for the proposed changes.





February’2017 6

1.2 SALIENT FEATURES OF THE PROJECT

Particulars Details

Coordinates A B C D

280 17’55.10” N 280 17’57.90” N 280 17’57.48” N 280 17’55.88” N

77 017’54.58” E 770 17’56.38” E 770 17’59.88” E 770 17’59.86” E

E F G H

280 17’55.82” N 280 17’55.02” N 280 17’54.74” N 280 17’52.26” N

770 18’1.04” E 770 18’1.08” E 770 18’04.71” E 770 18’7.10” E

I J K L

280 17’52.58” N 280 17’52.00” N 280 17’50.28” N 280 17’47.28” N

770 18’09.10” E 770 18’10.62” E 770 18’10.08” E 770 18’10.01” E

M N O P

280 17’47.26” N 280 17’48.27” N 280 17’45.48” N 280 17’45.87” N

770 18’08.73” E 770 18’08.35” E 770 18’08.04” E 770 18’02.80” E

Q R S T

280 17’46.85” N 280 17’49.41” N 280 17’49.54” N 280 17’53.91” N

770 17’59.82” E 770 17’59.86” E 770 17’55.03” E 770 17’56.61” E

Toposheet No. 53H3,53H4,53H7,53H8

Production

Capacity

Sr. No

Product Raw Material (Herb)

Annual Quantity of Herb used for Extraction (MT)

Quantity of Final Product (Kg/Annum)

Pure Herbal Product Manufactured in the factory 1 10-Deacetyl Baccatin

(10-DAB) Taxus Baccata 250 150

2 Colchicine

Gloriosa Superba

Seeds 50 150

3 Digoxin

Digitalis Lanata

leaves 100 120

4 Pygeum Extract Prunus Africana 30 150

5 Reserpine Rauwolfia vomitoria 30 100

6 Nicotine Tobacco Dust 1000 75000

7 Nicotine Polacrilex/

Resinate/ Dihydrate

Tobacco Dust

8 Thiocolchicoside

Gloriosa Superba

Seeds 300 2000

9 Hyoscine Butylbromide Duboisia Leaves 300 7000

10

Atropine Sulfate Tropine 1.2 500





February’2017 7

11 Cimetropium Bromide Duboisia Leaves 10 100

12

Enoxolone Acetyl

Glycyrrhetenic acid 10 6000

13 Homatropine

Methylbromide Tropine 0.2 100

14 Hyoscyamine Sulfate Belladona Roots 20 100

15 Methscopolamine

Bromide Duboisia Leaves 10 100

16

Paclitaxel

10-Deacetyl

Baccatin

(10-DAB)

inhouse 100

17 Vinpocetine Vocanga Seeds 400 4000

Estimated

project cost

Project Cost Amount (In Rs.)

Total 137 Crore

Man Power 400 persons

Elevation Highest –204MSL; Lowest 203MSL.

Land use S.NO PARTICULARS Area (SQM) Percentage(%)

1 Buildings / Office / Warehouses

/QC/R&D / Workshop/ DG Room

/Manufacturing plants/ETP/RO

Plant/Boiler

20488.63 23

2 Paved area/

Roads/corridors/parking

21379.44 24

3 Green belt 29396.73 33

4 Open area 17816.2 20

TOTAL PLOT AREA 89081 100

Nearest

Habitation/

Town

Village -Kaili 1.00 km SW

Nearest

Airport

Delhi International Airport – 34.85, Km (NW)

Nearest

Highway

S. No. Particulars Connectivity Distance (m) Direction

(From Project Boundary)

1. National

Highway- 2

Connects Delhi to Agra ̃ 50 W

Source: All distances are taken with respect to Google Earth.

Nearest

railway track

from project

1. Railway Line -1.7 Km towards East direction.

2. Ballabgarh railway station-4.79 Km (NE)





February’2017 8

boundary

Power supply LOAD DETAILS KVA Present total sanctioned load as per HSEB 2500

Total present connected load as per billing 2000

Proposed increase in connected load NIL

• Total present DG set details 500 X 2

4250 X 1

Nearest

Dispensary and

Govt. Hospital

Name Near Village(Km) Distance and Direction (From Project Boundary)

AIIMS, Ballabharh 4.6 N

Sarvodaya Hospital 8.26 NE

Aster Eye Hospital 10.53 NNE

Fortis Hospital, Faridabad 14.7 N

Educational

facility


Presidium School 1.54 S

Govt. School 1.10 NW

Aggarwal PG Colleg 5.60 NE

Meenakshi College of Girls

Education

5.44 NE

Vivekananda educational

institute

5.62 NE

(Source: All distances are taken with respect to Google Earth).

Water demand

,supply and

Waste water

generation

after

modernization

with process

integration

Water consumption & Waste water generation after modernization with process integration

Sr. No Description Water Consumption KLD

Waste Water Generation (KLD)

Effluent Treatment & disposal facility

1 Domestic 20 10 To STP

2 Process 50 45 To ETP followed by

ZLD plant

3 Cooling tower 50 10 To ETP followed by RO

for further use in

process

4 DM Plant 90 0

4.1 Boiler 25 5

5 Gardening 10* -

6 RO reject - 10 To STP after toilet use

7 Floor washing

and equipment

washing

5 5 To ETP followed by RO

for further use in

process. Shown as

process waste water

Fresh Water consumption 130

Recycled water 30

Total water consumption 160

Source: Existing bore well which is already permitted by CGWA, New Delhi

Nearest tourist

places

None within the 10 km radius of the project site





February’2017 9

Defense

installations


Archeological

Features

S. No. Particulars Distance (Km) Direction (From Project Boundary)

1. Kos Minar No.13

Mujessar.

7.52 km N

Ecological

sensitive zones


Nearest

Forests


Nearest

streams/

rivers/ water

bodies (from

project

boundary)


S. No. Particulars Distance (Km) Direction

(From Project Boundary)

1. Agra Canal 4.36 E

2. Gurgaon Canal 4.57 NW

Seismic zone The entire region of Faridabad falls in high risk seismic zone IV.

1.3 PLANNING

Company : Alchem International Private Limited

Project Cost : Rs. 137 Crore.

Production : As given below:-

Sr. No Product Raw Material (Herb) Annual Quantity of Herb used for Extraction (MT)


Pure Herbal Product Manufactured in the factory 1 10-Deacetyl Baccatin (10-

DAB) Taxus Baccata 250 150

2 Colchicine Gloriosa Superba Seeds 50 150

3 Digoxin Digitalis Lanata leaves 100 120


5 Reserpine Rauwolfia vomitoria 30 100



Resinate/ Dihydrate

Tobacco Dust

8 Thiocolchicoside Gloriosa Superba Seeds 300 2000





February’2017 10

9 Hyoscine Butylbromide Duboisia Leaves 300 7000

10



12

Enoxolone Acetyl Glycyrrhetenic

acid 10 6000

13 Homatropine



15 Methscopolamine Bromide Duboisia Leaves 10 100

16

Paclitaxel 10-Deacetyl Baccatin

(10-DAB) inhouse 100


2.0 INTRODUCTION OF THE PROJECT/ BACKGROUND INFORMATION

2.1 IDENTIFICATION OF PROJECT AND PROJECT PROPONENT

Alchem International Private Limited, Ballabgarh is part of the Alchem Group which is run

professionally by highly qualified professionals complying to Good Manufacturing Practices

and all International regulations at the highest levels for international acceptance.

Alchem International Private Limited was set up on 10-01-1985. It is located at 25/2

Mathura Road, Village Kaili, Ballabgarh , Haryana. The total land area acquired by the unit is

22 acres. This has been released by HUDA and the CLU for the same has been taken also.

Name and address of the

Applicant

Sunil Malik

201, Empire Plaza , Mehrauli- Gurgaon Road,

Sultanpur,

New Delhi-110030

2.2 NATURE OF THE PROJECT

Alchem International Private Limited is proposing Modernization with process integration

of existing herbal extracts and their derivatives for manufacturing of herbal extracts and

active pharmaceuticals ingredients.





February’2017 11

The Modernization with process integration is planned in existing plant area of 89081 SQM.

No additional land is required. The total capital investment till 31.12.2016 of AIPL,

Ballabgarh plant of Herbal Extract & Its Purified Products. The total Capital Investment is

137 Cr.

The industry is working in the field of Herbal Extract and their Purified Derivatives to fulfill

the ever increasing international demand of “safe“medicines.

Y6

2.3 NEED FOR THE PROJECT AND ITS IMPORTANCE TO THE COUNTRY AND OR

REGION

India is a developing country with varied geographical locations resulting in climate

change. Changing climate or falling of pollen grains often increases the ratio of patients

suffering from general fever, bacterial infections (like Throat infection), asthma, and

lifestyle diseases like Cholesterol, Heart diseases etc. Few other reasons like stored

water, uncovered litter, dirty places, unhealthy living habits, unhealthy eating habits,

pollution, water contamination and more require Antibiotics. Thus the proposed

production contributes in prevention, cure and recovery of ailments and diseases. Drug

manufacturing units produces life saving drugs which helps the patients recover faster

and result in no medicinal side effects.

2.4 DEMAND - SUPPLY GAP

By 2050, it is expected that India will be the most populous country with an estimated

population of 1.6 billion. By 2025, it is being viewed that 189 million Indians will be 60 or

older up from about 63 million in year 2004. This projection indicates the demand for

pharmaceutical drugs will rise in coming years.

Herbal Extract & their Purified Derivatives, Bulk Drugs & its Intermediates will be

manufactured largely comprising of anticancer, anti-parasitic, anti-inflammatory & pain

reliever drugs. Treatment of various regular and life style diseases like chronic disease,

acute pain, congestive heart failure, type 2 diabetes, constipation, osteoarthritis, and

management of hypertension.

The industry is working in the field of Herbal Extract and their Purified Derivatives to fulfill

the ever increasing international demand of “safe“medicines.

2.5 IMPORTS VS. INDIGENOUS PRODUCTION

There will be Indigenous production in the entire activity. As most of the products are

herbal and majority of all the raw material demand is being met from domestic market only

but few specific herbs is being imported owing to specific geographic locations.





February’2017 12

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 injectibles.

2.6 EXPORT POSSIBILITY

The product is prospecting exports.

2.7 DOMESTIC/ EXPORT MARKETS

Indian drug industry is well developed for the manufacture of many bulk drugs. At present

India is self sufficient and technologically at par with the best in the world. Indian pharma

industry is unit wise small and in fact many units are in small scale sector. Almost 55% of

the domestic production is contributed by small scale units. Production during 1990-91 was

reported to be 750 tons.

2.8 EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO THE PROJECT

2.8.1 DIRECT EMPLOYMENT

Presently the work force of this unit is 225 workers and 175 staff. Highly qualified and

trained manpower is required for running operations in the plant which are already

available. Regular trainings are imparted to personnel to keep them updated with the

requirements of process.

2.8.2 INDIRECT EMPLOYMENT

� Increase in supporting industries such as packaging, printing etc.

� Increase in Supply chain

� Increase in Distribution Channel both- National and International

� Carrier goods

� Government of India Taxes

� Minor increase in telecommunication, couriers etc.

3.0 PROJECT DESCRIPTION

3.1 TYPE OF PROJECT INCLUDING INTERLINKED AND INTERDEPENDENT

PROJECTS, IF ANY.

The Modernization with process integration is planned in existing plant area of 89081 SQM.

No additional land is required. The total capital investment till 31.12.2016 of AIPL,

Ballabgarh plant of Herbal Extract & Its Purified Products is 137 Cr.





February’2017 13

3.2 LOCATION (MAP SHOWING GENERAL LOCATION, SPECIFIC LOCATION, AND

PROJECT BOUNDARY AND PROJECT SITE LAYOUT) WITH COORDINATES.

It is located at 25/2 Mathura Road, Village Kaili, Ballabgarh, Haryana. The project site

falls in Survey of India Toposheet No. 53H3, 53H4, 53H7and 53H 8.

The geographical location with respect to boundary pillars of the project are:-

Table 2: Geographical Position of the Boundary Pillars

A B 280 17’55.10” N 280 17’57.90” N

77017’54.58” E 770 17’56.38” E

C D 280 17’57.48” N 280 17’55.88” N

770 17’59.88” E 770 17’59.86” E

E F 280 17’55.82” N 280 17’55.02” N

770 18’1.04” E 770 18’1.08” E

G H

280 17’34.85” N 280 17’52.26” N

770 18’4.86” E 770 18’7.10” E

I J

280 17’52.58” N 280 17’52.00” N

770 18’09.10” E 770 18’10.62” E

K L

280 17’50.28” N 280 17’47.28” N

770 18’10.08” E 770 18’10.01” E

M N

280 17’47.26” N 280 17’48.27” N

770 18’08.73” E 770 18’08.35” E

O P 280 17’45.48” N 280 17’45.87” N

770 18’08.04” E 770 18’02.80” E

Q R

280 17’46.85” N 280 17’49.41” N

770 17’59.82” E 770 17’59.86” E

S T

280 17’49.54” N 280 17’53.91” N

770 17’55.03” E 770 17’56.61” E





February’2017 14

The map showing location of the project site is enclosed as Annexure – VII.

3.3 DETAILS OF ALTERNATE SITES CONSIDERED AND THE BASIS OF SELECTING

THE PROPOSED SITE, PARTICULARLY THE ENVIRONMENTAL

CONSIDERATIONS GIVEN INTO SHOULD BE HIGHLIGHTED.

No alternative site was examined as the project is modernization of the existing project

3.4 SIZE OR MAGNITUDE OF OPERATION

The size and magnitude of the project area is as given below:-

Table 3: Size or Magnitude

S. No. Particulars Details

1. Area (Ha.) 89081 Sq.m.

2. Production (After

modernization with process

integration)

The production

capacity is 320 kg/day

3. Total Man Power (Nos.)

400 Nos.

3.5 RAW MATERIAL (Quantity and Source), PRODUCT AND MODE OF TRANSPORT

RAW MATERIAL SOURCING AND STORAGE

Alchem`s dependence on agriculture and its produce is complete and total. All the products of

the company which command sustained high demand are produced from agriculture and herbs.

The raw materials /starting herbs used in the extraction and production of the above listed

extracts under reference and report are to be sourced indigenously from various parts of the

country as these harmonize topographically and geographically.

The unit has 2 very large warehouses located on the premises which are used for the storage of

herbs. Being an agricultural produce with specific time of sourcing, the storage gains even more

importance for continuous supply of end product to the market.

WHO- GOOD MANUFACTURING PRACTICES and their standard protocols for WAREHOUSING

are adhered to focused heavily of safety and pest free storage.





February’2017 15

BASIS OF THE MODERNIZATION & PROCESS INTEGRATION

Sr.

No

Existing

product

Modernization Amount Spent

( CR )

1

10-Deacetyl

Baccatin (10-DAB)

New extraction plant for multi product

extraction facility with full concentration

installed as Plant 9. This facility is capable of

extraction of Taxus Baccata – 10 DAB, Gloriosa

Seeds- Thiocolchicoside and Colchicine ,

Vocanga Seeds- Vinpocetine , Tobacco Dust –

Nicotine and all allied products of Nicotine.

The extraction facility also has a Solvent

Recovery Distillation Column with required

storage tanks.

The facility has

been erected at a

cost of 20 cr.

2 Colchicine

As Above

3

Digoxin

New Percolators for the extraction of Digitalis

Lanata with full facility for making upto crude

stage at plant 2.

New clean room of plant E modified with new

reactors, AHU and other ancillary machinery.

Total value of 2 cr.

Plant E modified

at a value of 1 cr.

4 Pygeum Extract

No change

5 Reserpine

No Change

6 Nicotine New extraction plant for multi product

extraction facility with full concentration

installed as Plant 9 . This facility is capable of

extraction of Taxus Baccata – 10 DAB, Gloriosa

Seeds- Thiocolchicoside and Colchicine ,

Vocanga Seeds- Vinpocetine , Tobacco Dust –

Nicotine and all allied products of Nicotine.

The extraction facility also has a Solvent

Recovery Distillation Column with required

The facility of

Plant 9 has been

erected at a cost of

20 cr.

Clean Room as

Plant L for the

final distillation

and packing at a

7 Nicotine

Polacrilex/

Resinate/

Dihydrate





February’2017 16

Sr.

No

Existing

product


( CR )

storage tanks .

The final purification and distillation facility

with 6 dedicated AHUs installed in Plant L FOR

THE PURIFICATION OF Nicotine as one of the

products manufactured in the 3 divided parts

of the clean room.

total cost of 10 cr

8

Thiocolchicoside

The final purification and distillation facility

with 6 dedicated AHUs installed in Plant L FOR

THE PURIFICATION OF Thiocolchicoside ,

Colchicine , Hyoscine Butyl Bromide and

Enoxolone as one of the products

manufactured in the 3 divided parts of the

clean room .

Clean Room as

Plant L for the

final distillation

and packing at a

total cost of 10 cr

9

Hyoscine

Butylbromide

Clean Room as

Plant L for the

final distillation

and packing at a

total cost of 10 cr

10 Atropine Sulfate

New facility of Clean room of Plant F installed

with reactors, AHUs and distillation facility.

Total cost of 2 cr

11 Cimetropium

Bromide

12 Enoxolone

13 Homatropine

Methylbromide

14 Hyoscyamine

Sulfate

15 Methscopolamine

Bromide

16

Paclitaxel

New facility for the purification and isolation

of the final product made as Clean Room Plant

K with dedicated AHUs and equipments

At a total cost of

3.5 cr





February’2017 17

Sr.

No

Existing

product


( CR )

17

Vinpocetine

New facility of Clean room of Plant F installed

with reactors, AHUs and distillation facility.

Total cost of 2 cr

• Water system for supplying water to the 3 clean rooms installed at a total cost of 1 CR.

• Renovation of Grinding Section for all herbs with new Flooring and Ventilation at a total

cost of 50 L.

• Renovation of Raw Material storage Warehouses at a total cost of 1 cr

• Additional storage capacity of Solvents at a cost of 50 L.

• New Semi Purification plant as Plant M installed for all distillation and making upto

crude for multi products at a cost of 2.5 CR.

• New Cemented roads laid out in the factory at a cost of 2 cr.

• New Canteen, conference room, office space added at a cost of 2 cr.

• Testing and Analytical equipments added in the Quality Control Lab at a cost of 3 cr.

• Modification of a new R&D facility for in process development added at a cost of 2 cr.

MANUFACTURING PROCESS AND MATERIAL BALANCE OF THE COMPANYS PRODUCTS

The standardized extraction and purification process is detailed below in a flow chart with

option for minor variations which would be product specific. As it has been specified in the

point No 1.7 where all the products manufactured have been listed. The manufacturing process

and material balance with Raw Material details are appended below in detail.





1. 10-Deacetyl Baccatin

Brief description of the manufacturing process:

10-Deacetyl Baccatin III (10-DAB) is extracted from the leaves of Taxus Baccata and is further

purified through Column Chromatography, Crystallization, Carbon Treatment and Washing.

List of Raw Materials:

Name of Raw Material Source Storage at the site

1. Taxus baccata leaves Kruidendrogen, Netherland Warehouse

2. Acetone Real Chemsys Solvent Storage Tanks

3. Acetonitrile Bharat Jyoti Solvent Storage Tanks

4. Activated Carbon Brilex Chemicals Warehouse

5. Distilled Water In-house Water System

6. Hyflo Supercel Gem Corpochem Warehouse

7. Methanol B. K. Sales Solvent Storage Tanks

8. Methylene chloride B. K. Sales Solvent Storage Tanks

9. Reverse Osmosis Water

(R. O. Water)

In-house Water System

10. Silica Gel (200-400 mesh) Swambe Chemicals,

Maharashtra Chemical

Products,

Warehouse

Taxus baccata Leaves Extraction

10-Deacetyl Baccatin III Molecular Formula: C29H36O10

Molecular Weight: 544.59





February’2017 19

Process Flow Diagram:

Taxus Baccata Leaves

▼

Extraction with Methanol

▼

Concentration

▼

Solubilization in R.O. Water & Filtration

▼

Phase Exchange

▼

Concentration & Crystallization

▼

Filtration & Drying

▼

10-DAB Crude

▼

Purification by Column Chromatography

▼

Concentration of Column Elute

▼

Crystallization & Centrifugation

▼

Carbon treatment

▼

Thermo Vacuum Drying

▼

10- DAB





February’2017 20

MATERIAL BALANCES SHEETS FOR 10 DAB:

STAGE-1 & STAGE-2

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Taxus bacata leaves 3,000

2 Methanol 47,520

3 MDC 2,660

4 Acetonitrile 150

5 Water 7,500

Total: 60,830

Sr. No. Output/Kg of product(Kg) Total Product Liquid

effluent Air Emission

Recovery Solid Waste

1 10-DAB(crude) - - 4 - 4

2 Husk - - - 3000 3000

3 Methanol - 76 45144 - 45220

4 MDC - 10 2470 - 2480

5 Acetonitrile 15 1 130 - 146

6 Water 500 - 7000 - 7500

7 Third party mixed solvent 2300+180 2480

Total: 2995 87 54748 3000 60,830

STAGE-3

Sr. No. Raw Material Input/Kg of Product(Kg) 1 10-DAB(crude) 4

2 MDC 10211

3 Methanol 671

4 Acetonitrile 17

5 Acetone 167

6 Water 42

Total: 11,112 Sr. No. Output/Kg of product(Kg) Total

Product Liquid effluent

Air Emission


1 10-DAB(final) 1 - 3 - 4

2 MDC - 11 9600 - 9611

3 Methanol - 7 604 - 611

4 Acetonitrile 1 0.5 15.5 - 17

5 Acetone 10 07 150 167

6 Water 42 - - - 42

7 Third party mixed

solvent

660 - - - 660

Total: 714 25.5 10372.5 - 11,112





2. Colchicine


Gloriosa Superba Seeds are ground to a powder which is extracted to obtain Colchicine

Syrup. This syrup is further purified by Column Chromatography, Crystallization,

Centrifugation and drying to produce Colchicine API.


Name of Raw

Material

Source Storage at the site

1. Gloriosa Superba

Seeds

Twin Multiflora Warehouse

2. Absolute Alcohol

(Ethanol)

Daurala Sugar Solvent Storage

Tanks

3. Alumina Oxide

(Neutral)

Real Chemsys Warehouse

4. Ethyl Acetate Amba

Associates

Solvent Storage

Tanks

5. Methanol B. K. Sales Solvent Storage

Tanks

6. Methylene Chloride B. K. Sales Solvent Storage

Tanks

7. Reverse Osmosis

Water


Gloriosa Superba Seeds Extraction

Colchicine

Molecular Formula: C22

H25

NO6






February’2017 22

Process Flow Diagram:

MATERIAL BALANCES SHEETS FOR COLCHICINE: STAGE-1 & STAGE-2

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Gloriosa Superba Seeds 2,000

2 Methanol 20000

3 Methylene Di Chloride 5000

4 Ethanol 1000

5 Water 3000

6 Ethyl Acetate 350

7 Alumina Oxide Neutral 600

Total: 31950 Sr. No. Output/Kg of product(Kg) Total

Product Liquid effluent Air Emission Recovery Solid Waste 1 Colchicine - - 10 - 10

2 Gloriosa Seeds - - - 1990 1990

2 Methanol - 20 19500 19520

3 Methylene Di Chloride - 20 4850 - 4870

4 Ethanol 20 10 900 - 930

5 Water 2000 15 870 - 2885

6 Ethyl Acetate 20 5 300 - 325

Gloriosa Superba Whole seed (Starting material)

▼

Extraction in Methanol

▼

Concentration

▼

Centrifugation & washing with R.O. water

▼

Phase Exchange of Aqueous Layer

▼

Enriched organic layer containing Colchicine

▼

▼

Concentration

▼

Colchicine Syrup

▼

Column Chromatography

▼

Concentration of Column Elute, Crystallization &

Centrifugation

▼


▼

Colchicine





7 Alumina Oxide Neutral - - - 600 600

7 Third party mixed

solvent

480+130+70+11

5+25

820

Total: 2860 70 26430 2590 31950

3. Digoxin


Digitalis lanata leaves contain Lantoside C which is hydrolyzed into Digoxin by aqueous

alkaline hydrolysis. The Digoxin formed is extracted in water and is further transferred

to chloroform layer by phase exchange. The chloroform layer is purified to produce

Digoxin API.



1. Digitalis lanata leaves Kruidendrogen, Netherland Warehouse

2. Acetone Real Chemsys Solvent Storage Tanks



5. Alumina oxide neutral Real Chemsys Warehouse

6. Ammonia Solution Fluorides Warehouse

7. n-Butanol Radiant Warehouse

8. Chloroform B. K. Sales Solvent Storage Tanks

9. Hyflo Supercel Gem Corpochem Warehouse

10. Isopropyl ether Bharat Jyoti Solvent Storage Tanks



Digitalis Lanata leaves

(Lanatoside C)

Glucose

Digoxin

Molecular Formula: C41

H64

O14

Molecular Weight: 781





13. Resorcinol Shilpa Chemicals Warehouse


(R. O. Water)


15. Sodium Carbonate (Soda

Ash)

Aristo Chemicals Warehouse

16. Sodium bisulphite Haryana Scientific Warehouse

This is the general description of manufacturing of Digoxin. The process include following steps.

Product: Digoxin

1. The product is manufacturing through different stages.

2. The stage-1 is extraction from raw material to making concentrated syrups.

3. Stage-2, concentrated syrup is then converted in to Digoxin(crude) after treating with

various solvents through various unit operations .

4. Stage-3, Digoxin (crude) is converted into Digoxin (API) after purification process.

Stage-1

Extraction

washing

Layer separation

Organic layer

Concentration

Washing

Concentration

Leached water

Aqueous layer

Water

Chloroform

Inactive lanata leaves with husk (solid garbage)

Water

Syrup

Digitalis Lanata leaves Rice Husk Water Sodium bi-caronate





Stage-2

Stage-3

pH maintenance

Dissolution

Cooling & Filtration ML

Drying

Mixing

ML

Dissolution

Cooling & filtration ML

Washing

Concentration

Ammonia solution

Acetonitrile+Aceton

Sodium bi-sulfite Digoxin (crude) Resorcinol Water

Isopropyl ether

Filtration

Wet cake

Water

Wet cake Methanol MDC

ML





Stage-4

Dissolution(maintaining pH)

Cooling & filtration

Drying

Carbon treatment with hyflo

Filtration through Alumina

Concentration

Stripping

Cooling & filtration

Drying

Ammonia

Solution

MDC Dry Powder

Methanol

Methanol

Digoxin (API)

Dry Powder Butanol Water

Drying

MDC

ML





February’2017 27

MATERIAL BALANCE SHEETS FOR DIGOXIN: STAGE-01 Sr. No. Raw Material Input/Kg of Product(Kg)

1 Lanata leaves 450

2 Rice husk 90

3 Sodium bi-carbonate 40

4 Chloroform 20115

5 Water 13230

Total: 33925

Sr. No. Output/MT of product Total

Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Syrup - - 70 70

2 Husk + Booty - - - 537 537

3 Chloroform - 1006 19052 - 20058

4 water 12693+40 527 - - 13260

Total: 12733 1543 19122 537 33925

STAGE-02(P-2) & STAGE-03 Sr. No. Raw Material Input/Kg of Product(Kg)

1 Syrup 70

2 Acetonitrile 6.29

3 Acetone 6.33

4 Sodium bi-sulfite 0.20

5 Resorcinol 9.80

6 Isopropyl ether 78.18

7 Methanol 23.45

8 MDC 33.38

9 Water 110

Total: 337.63


Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Dry powder digoxin (crude) - - 3.5 - 3.5

2 Isopropyl ether - 1.4 58.6 - 60

3 Water 110 - - - 110

5 Third party mixed solvent 164.13 - - - 164.13

Total: 174.13 1.4 62.1 - 337.63





February’2017 28

STAGE-04(P-E)

• 12.5 kg used Silica with impurities is sent to GAPIL

Sr. No. Raw Material Input/Kg of Product(Kg)

1 Dry powder digoxine(crude) 3.5

2 Butanol 11.7

3 Methanol 109.3

4 MDC 103.7

5 Water 2.4

6 Carbon 1.5

7 Alumina powder 6

Total: 238.1


Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Digoxin(API) - - 1.2 - 1.2

2 Methanol - 3 77 - 80

3 MDC - 4 83 - 87

4 Carbon(wet) - - - 1.5 1.5

5 Alumina (wet) - - - 6.0 6.0

6 Third party mixed

solvent

62.4 - - - 62.4

Total: 62.4 7 161.2 7.5 238.1





February’2017 29

4. Pygeum Extract


Pygeum Extract is manufactured by extraction of Pygeum bark using Methylene Chloride.



1. Pygeum Bark World Botanical Warehouse


MATERIAL BALANCES SHEETS FOR PYGEUM EXTRACT:

Sr.

No.

Raw Material Input/Kg of Product(Kg)

1 Pygeum Africana Bark 2,000

2 Methylene Di Chloride 20000

Total: 22000

Sr.

No.

Output/Kg of product(Kg) Total

Product Liquid effluent Air

Emission

Recovery Solid

Waste

1 Pygeum Extract - - 10 - 10

2 Pygeum Africana Bark - - - 1990 1990

3 Methylene Di Chloride 40 50 19910 - 20000

Total: 40 50 19920 1990 22000

Process Flow Chart:

Pygeum Bark ▼

Extraction in Methylene Chloride

▼

Concentration

▼

Filtration & Distillation

▼

Thermo- Vacuum Drying

▼

Mixing & Heating

▼

Pygeum Extract





5. Reserpine


Reserpine is extracted through Rauwolfia Vomitoria roots through Methanolic

Extraction. The extract is further purified via Phase Exchange, Crystallization and

Column Chromatography to produce Reserpine API.



Rauwolfia Vomitoria World Botanical Warehouse

1. Absolute Alcohol (Ethanol) Daurala Sugar Solvent Storage Tanks

2. Alumina oxide neutral Real Chemsys Warehouse


4. n-Butanol Radiant Warehouse




8. (R. O. Water)


9. Silica Gel (60-120 Mesh) Real Chemsys Warehouse

10. Toluene V. S. Interchem Private Limited Solvent Storage Tanks

Process Flow Chart:

● The product is manufacturing though different stages.

● Stage-01 includes extraction from Rauwolfia powder to making syrup.

● Stage-02, thick syrup is converting through different unit operation to Reserpine(crude).

● Stage-03, Reserpine (crude) is finally converted to Reserpine(API) after purification process.

Rauwolfia

Vomitoria roots

Extraction &

Purification

Reserpine

Molecular Formula: C33H40N2O9






Process flow Diagram:

Stage-01

Extraction

Concentration

Stage-02

Leached methanol

KF & pH adjustment

Phase exchange

Non-polar layer(toluene)

Concentration

Concentration to thick syrup

Stripping

Dissolution

Cooling & crystallization

Filtration

Rauwolfia powder Methanol Husk

Inactive rauwolfia with

Ammonia Solution

Toluene Polar Layer

(methanol)

Syrup

Toluene Out Ethanol

Ethanol

ML





Stage-03

Luxivation with pH

maintenance


Washing

Drying

Dissolution

Washing

Column chromatography

Concentration

Stripping


along with pH maintenance

Filtration

Dissolution

Ethanol

MDC Proserpine (Crude)

Ethanol

Ethanol

ML

MDC





l

Concentration



Stripping

Filtration

Dissolution



Filtration

Drying

RESERPINE (API)

Butanol

ML

ML

Ethanol

Ethanol





February’2017 34

MATERIAL BALANCE SHEETS FOR RESERPINE:

STAGE-01


1 Rauwolfia powder 4000

2 Husk 400

3 Methanol 31680

4 Toluene 6069

Total: 42149


Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Syrup - - 350 - 350

2 Exhausted powder with husk - - - 4400 4400

3 Methanol 1580 1600 28500 - 31680

4 Toluene 309 260 5150 - 5719

Total: 1889 1860 34000 4400 42149

STAGE-02


1 Syrup 350

2 Ethanol 572

Total: 922


Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Reserpine(crude) - - 35 - 31

2 Ethanol 50 52 470 - 572

3 Toluene 39 280 - 319

Total 50 91 781 - 922





February’2017 35

STAGE-03


1 Reserpine(crude) 35

2 MDC 2190

3 Ethanol 280

4 Butanol 195

5 Water 210

Total: 2910


Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Reserpine 8 - 27 - 35

2 MDC - 220 1970 - 2190

3 Ethanol 60 20 200 - 280

4 Butanol 60 15 120 - 195

5 Water 210 - - - 210

Total: 338 255 2317 - 2910





6. Nicotine


Nicotine is extracted from Tobacco Powder and further purified by Phase Exchange, Distillation

to form Nicotine API.


Name of Raw Material Source Storage at the site Quantity

1. Tobacco Powder Various Vendors in

Gujrat

Warehouse





(R. O. Water)


6. Sodium Hydroxide

(Caustic Soda)


7. Sulphuric Acid

Chaudhary Chemical

Industries, Sonepat

Super Acid & Chemicals,

Delhi

Warehouse

MATERIAL BALANCES SHEETS FOR NICOTINE:

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Tobacco Dust 2,500

2 Methanol 800

3 Chloroform 16000

4 RO Water 2000

5 Sodium Hydroxide 250

6 Sulfuric Acid 130

7 Ammonia Solution 270

Total: 21950

Tobacco Dust Extraction

Nicotine

Molecular Formula: C10H14N2






February’2017 37

Sr. No. Output/Kg of product(Kg) Total Product Liquid



1 Nicotine Final - - 20 - 20

2 Tobacco Dust - - - 2480 2480

3 Methanol 30 30 740 - 800

4 Chloroform 20 30 15950 - 16000

5 RO Water 2000 - - - 2000

6 Sodium Hydroxide 250 - - - 250

7 Sulfuric Acid 130 - - - 130

8 Ammonia Solution 270 - - - 270

Total: 2700 60 16710 2480 21950

Process Flow Chart:

Tobacco Powder

▼

Extraction of Tobacco Powder

▼

Concentration of Extracted Wash

▼

Phase Exchange in Sulphuric Acid & R.O. Water

solution

▼

▼

Basification of Aqueous Layer

▼

Phase Exchange in Chloroform

▼

Concentration

▼

Nicotine crude

▼

Distillation and collection of good fraction

▼

Refluxing

▼

Nicotine API





7(A). Nicotine Polacrilex/Resinate


Nicotine API which is manufactured in-house as described in the earlier section is treated with

Amberlite IRP-64 Resin. This nicotine-resin complex is further washed with acetone and treated

with ethanol & glycerol to form Nicotine Polacrilex, also known as Nicotine Resinate.


Name of Raw Material Source Storage at the

site Quantity

1. Nicotine In-house Warehouse

2. Acetone Pon Pure Chemical Solvent Storage

Tanks

3. Amberlite IRP-64

Resin

Virmani Brothers Warehouse

4. Absolute Alcohol

(Ethanol)


Tanks

5. Glycerol Real Chemsys Warehouse

6. Reverse Osmosis

Water


MATERIAL BALANCES SHEETS FOR NICOTINE POLACRILEX:

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Nicotine Final 10

2 Acetone 600

3 Amberlite Resin 50

4 Ethanol 500

5 Water 2000

6 Glycerol 30

Total: 3190

Nicotine Polacrilex/Resinate

Molecular Formula: C10H14N2 x (C10H10C4H6O2)Y





February’2017 39

Sr. No. Output/Kg of product(Kg) Total


Air Emission


1 Nicotine Polacrilex - - 60 - 60

2 Acetone 15 10 575 - 600

3 Amberlite Resin - - - - -

4 Ethanol 10 10 480 - 500

5 Glycerol - - - 20 20

6 RO Water 1950 50 - - 2000

7 Mixed solvent - - 10 - 10

Total: 1975 70 1125 20 3190

Process Flow Chart:

Nicotine

▼

Chemical synthesis with Resin

▼

Centrifugation

▼

Slurry washing & Centrifugation

▼

Ethanol + Glycerol Treatment

▼

Concentration

▼

Thermo vacuum Drying

▼

Nicotine Polacrilex/Resinate





7(B). Nicotine Ditartrate Dihydrate


Nicotine API which is manufactured in-house as described earlier is treated with L(+)- Tartaric

Acid & Tartaric Acid. This resulting reaction mass is filtered, and then concentrated. The

concentrated syrup is dissolved in R.O. water and crystallized in Ethanol. The crystallized

material is centrifuged and dried to form Nicotine Ditartrate Dihydrate.


Name of Raw Material Source Storage at the site Quantity

1. Nicotine In-house Warehouse

2. Absolute Alcohol

(Ethanol)


Tanks


Tanks

4. Reverse Osmosis

Water


5. Tartaric Acid Aristo Chemicals Warehouse

Nicotine Ditartrate Dihydrate

Molecular Formula: C180H26N2O12.2H2O






February’2017 41

Process Flow Chart:

Nicotine

▼

Reaction with Tartaric Acid

▼

Microfiltration, Concentration & Dissolution of

Concentrated Mass

▼

Crystallization & Filtration

▼

Thermo vacuum Drying

▼

Sieving

▼

Nicotine Ditartrate Dihydrate

MATERIAL BALANCES SHEETS FOR NICOTINE DITARTRATE DIHYDRATE:


1 Nicotine Final 7

2 Methanol 70

3 Tartaric Acid 12

4 Ethanol 60

5 Water 15

Total: 164


Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Nicotine Ditartrate

Dihydrate

- - 18 - 18

2 Methanol 20 5 45 - 70

3 Tartaric Acid - - - - -

4 Ethanol 10 10 - - 20

5 RO Water 15 - - - 15

6 Mixed Solvent - - 41 - 41

Total: 45 15 104 164





8. Thiocolchicoside


a) The starting material Gloriosa Superba Whole seed is extracted to obtain Colchicoside

which is reacted with sodium methylmercaptan to produce Thiocolchicoside.

Gloriosa Superba Seeds

Thiocolchicoside

Molecular Formula: C27H33NO10S


Colchicoside

Molecular Formula: C27H33NO11


Reaction with Sodium Methylmercaptan

Extraction





February’2017 43



1. Gloriosa Superba Seeds Twin Multiflora Warehouse

2. Absolute Alcohol (Ethanol) Daurala Sugar Solvent Storage Tanks

3. Acetic acid Syndic India Warehouse

4. Alumina Oxide (Neutral) Real Chemsys Warehouse





(R. O. Water)


9. Sodium Methylmercaptan Karvy Therapeutics Private

Limited

Warehouse





Process Flow Chart:

Colchicoside

Chemical Synthesis ( reaction with Sodium Methyl Mercaptan)

Concentration of reaction mass & washing

Phase Exchange

Concentration of Extracted Phase

Further steps are identical in both the processes

Stirring in Methanol & Concentration

Phase Exchange & Concentration

Mixing with alumina & drying

Column Chromatography

Concentration of pure fraction

Aqua Solubilization & Concentration

Crystallization in Ethanol & Centrifugation

Drying

Thiocolchicoside

MATERIALS BALANCE SHEETS FOR THIOCOLCHICOSIDE:

Stage-1


1 Gloriosa Seed 2000

2 Chloroform 5364

3 Methanol 6217

4 MDC 19950

5 Water 1650

Total: 35181





February’2017 45


Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Aqueous layer(colchicoside) - - 500 - 500

2 Organic layer(colchicine) - - 500 - 500

3 Inactive gloriosa seed - - - 2000 2000

4 Chloroform 14 250 5100 - 5364

5 Methanol 100 300 5600 - 6000

6 MDC - 950 18500 - 19450

7 Water 1367 - - - 1367

Total: 1481 1500 30200 2000 35181

Stage-2

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Aqueous layer( colchicoside) 500

2 Perchloric acid 20

3 Sodium methylmarcaptan 17

4 Caustic soda 5

5 Alumina 120

6 Methanol 2660

7 Ethanol 146

8 Chloroform 9797

9 Water 200



Air Emission


1 Thio-colchicoside(crude) 1 - 9 - 10

2 Alumina - - - 75 75

3 Methanol - 150 2250 - 2400

5 Chloroform - 400 9000 - 9400

6 Water 200 - - - 200

7 Third party mixed solvent 930 - - - 930

Total: 1131 550 11259 75 13015 • 75kg used Alumina with impurities is sent to GAPIL

Stage-3

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Thio-colchicoside (crude) 9

2 Methanol 71

3 Ethanol 87

4 Water 10

Total: 177







Air Emission


1 Thio-colchicoside(API) 0.5 - 8.5 - 9

2 Methanol 4 2 65 - 71

3 Ethanol 2 5 80 - 87

4 Water 10 - - - 10

Total: 16.5 7 153.5 - 177

9. Hyoscine Butylbromide

Duboisia Leaves

Hyoscine



Hyoscine Hydrobromide

Molecular Formula: C17H21NO4. HBr


Hyoscine Butylbromide

Molecular Formula: C21H30BrNO4


Extraction

Hydrobromic Acid

Reaction

n-Butylbromide

reaction

Hyoscine



Basification





February’2017 47


Duboisia leaves are extracted with Methanol to produce Hyoscine Syrup which is reacted with

Hydrobromic Acid to produce Hyoscine Hydrobromide. Hyoscine Hydrobromide is basified to

form pure Hyoscine syrup, which is treated with n-butylbromide to make Hyoscine

butylbromide. It is further purified by crystallization and washing to produce Hyoscine

Butylbromide API.



1. Duboisia Leaves Twin Multiflora Warehouse




5. n-Butylbromide Neogen Chemicals Limited Warehouse

6. Hydrobromic Acid Neogen Chemicals Limited Warehouse

7. Hyflo Supercel (Filter aid) Gem Corporation Warehouse


9. Methylene Chloride B. K. Sales Solvent Storage Tanks

10. Purified Water in bulk In-house Water System


(R. O. Water)


MATERIAL BALANCE SHEETS FOR HYOSCINE BUTYLBROMIDE:

Stage-1


1 Dubosia Seed 1000

2 Methanol 8316

3 MDC 41895

4 Acetonitrile 55

5 Water 3200

Total: 5,4466


Product Liquid effluent Air

Emission

Recovery Solid

Waste

1 Concentrated Syrup - - 113 - 113





February’2017 48

2 Husk - - - 1000 1000

3 Methanol - 83 7817 - 7900

4 MDC - 200 39800 - 40000

5 Water 3200 - - - 3200

6 Third party mixed

solvent

2253 - - - 2253

Total: 5453 283 47730 1000 54,466

Stage-2


1 Concentrated Syrup 113

2 Hydrobromic acid 45

3 Acetonitrile 14

4 Methanol 145

5 MDC 638

6 Water 240

Total: 1195


Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Hyoscine syrup - - 62 - 62

2 MDC - 8 500 - 508

3 Methanol - 5 120 - 125

4 Water 240 - - - 240


Total: 500 13 682 - 1195





February’2017 49

Stage-3


1 Hyoscine Syrup 62

2 Acetonitrile 50

3 Butyl bromide 93

4 Methanol 150

Total: 355


Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Hyoscine butyl

bromide(crude)

- - 62 - 62


Total: 293 - 62 - 355

Stage-4


1 Hyoscine butyl bromide(crude) 62

2 Methanol 248

3 Carbon 4

Total: 314


Product Liquid

effluent

Air

Emission

Recovery Solid

Waste

1 Hyoscine Butyl bromide(API) 7 - 51+4 - 62

2 Methanol 58 - 190 - 248

3 Carbon - - - 4 4

Total: 65 - 245 4 314





February’2017 50

Process Flow Chart:

Duboisia Leaves (Starting material)

▼

Extraction

▼

Hyoscine Syrup (Intermediate)

▼

Reaction of Hyoscine with Hydrobromic Acid

▼


▼

Hyoscine Hydrobromide (Intermediate)

▼

Basification & Phase Exchange

▼

Concentration

▼

Concentrated Syrup (Hyoscine)

▼

Reaction of concentrated syrup (Hyoscine) with

n-Butylbromide & Concentration

▼


▼

Hyoscine Butylbromide Crude (Intermediate)

▼

Carbon treatment & Filtration

▼

Concentration

▼

Crystallization & Filtration

▼

Thermo – Vacuum Drying

▼

Hyoscine Butylbromide API





10. Atropine Sulfate


Tropine is esterified with α- formyl phenylacetic acid methyl ester in Toluene medium in the

presence of Sodium Methoxide as base under refluxing conditions to produce the corresponding

Tropine Ester. The aldehyde group of the Tropine ester is reduced using sodium borohydride in

methanol-chloroform medium to synthesize Atropine. The Atropine formed is treated with

dilute sulfuric acid to form Atropine Sulfate API.

a) Esterification of Tropine with α-

formyl phenylacetic acid

methyl ester

b) Reduction of Tropine Ester

c) Sulfate Salt Formation

Atropine Sulfate

Molecular Formula: C34H46N2O6.H2SO4. H2O

Molecular Weight: 695

Atropine



Tropine Ester







February’2017 52



1. Tropine In-house Warehouse

2. α- formyl phenylacetic

acid methyl ester

Unisynaxis Laboratories

Private Limited,

Warehouse

3. Acetone V.S. Interchem Private Limited Solvent Storage

Tanks


5. Chloroform B. K. Sales Solvent Storage

Tanks


7. Hyflo SuperCel Gem Corporation Warehouse


Tanks

9. Reverse Osmosis Water In-house Water System

10. Sodium Borohydride Shandong Guobang

Pharmaceutical, China

Warehouse

11. Sodium Methoxide Triveni Interchem Private

Limited

Warehouse

12. Sulphuric Acid Super Acid Warehouse

13. Toluene Radiant Polychem Private

Limited

Solvent Storage

Tanks

Process Flow Chart:

Tropine (Starting Material)

▼

Esterification of Tropine with

α- formyl phenylacetic acid methyl ester

▼

Tropine Ester (Intermediate)

▼

Reduction of Tropine Ester

▼

Phase Exchange, Crystallization & Drying

▼

Atropine

▼

Dissolution of Atropine Crude in Acetone, Carbon

treatment & Filtration

▼

Sulfate formation

▼

Filtration & Thermo vacuum Drying

▼

Atropine Sulfate





February’2017 53

MATERIAL BALANCE FOR ATROPINE SULPHATE:


1 Atropine Crude(Lepro) 10

2 Sulfuric acid 2.2

3 water 8.8

4 Acetone 245

Total: 266


Product Liquid

effluent

Air

Emission


1 Atropine Sulfate 1.0 0.2 10 0.8 12

2 Acetone 7.0 8.0 230 - 245

3 Sulfuric acid 0.5 - - - 0.5

4 water 8.5 - - - 8.5

Total: 17 8.2 249 0.8 266

11.Cimetropium Bromide

Hyoscine Cimetropium Bromide

(Natural origin) Quarternary salt formation on nitrogen. Minor change

Product: Cimetropium Bromide

1. The raw material is first made into purified syrup.

2. The purified syrup is charged into the reaction vessel as per the stoichiometry.

3. The reaction is taken place at required temperature & atmospheric pressure converting

the raw material into the product Cinetropium bromide.

4. Product is washed with Acetonitrile then filtered.





5. Wet cake (1) of product is dissolved in methyl alcohol, after cooling it is then filtered.

6. Wet cake (2) of product is washed with ethyl alcohol then filtered.

7. After drying of the wet cake (3) of product, we get Cimetropium Bromide as a final

product.

The schematic diagram /flow chart is given below.

Hyoscine syrup MDC

Acetonitrile

Pure Hyoscine Syrup

Cyclopropyle Methyl bromide

Wet cake (1)

Methyl alcohol

Wet cake (2)

Ethyl Alcohol

Cimetropium Bromide

Disolution

Impurities absorption by

Al2O3

Concentration

Reaction

Cooling then Filtration

Washing & Filtration


Recovery

ML

ML

ML

Drying

Al2O3 with impurities





February’2017 55


Name of Raw Material Source Storage at the

site

Quantity

1. Hyoscine Syrup In-house Warehouse

2. Cyclo propyle

methyl bromide

Unisynaxis Laboratories

Private Limited,

Warehouse

3. Acetonitrile V.S. Interchem Private

Limited

Solvent Storage

Tanks

4. Methylene Di

Chloride

V.S. Interchem Private

Limited

Solvent Storage

Tanks

5. Ethyl Alcohol DCM, Daurala Solvent Storage

Tanks



Tanks

MATERIALS BALANCE FOR CIMETROPIUM BROMIDE:

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Hyoscine syrup 021

2 Cyclo propyle methyl bromide 046

3 MDC 452

4 Acetonitrile 110

5 Methyl alcohol 115

6 Ethyl alcohol 032

776

Total: Sr. No. Output/MT of product Remark

Product Liquid effluent Air Emission


1 Cimetropium Methyl

Bromide

15 - 16 - 31

2 MDC 02+6 20 430 - 458

3 Acetonitrile 5+10 5 100 - 120

4 Ethanol - 5 - - 5

5 Third party mixed

solvent

- - - - 162

Total: 38+162 30 546 776

• Used Al2O3 is sent to GAPIL.





12. Enoxolone


Enoxolone is synthesized by the alkaline hydrolysis of the starting material Acetyl

Glycyrrhetenic Acid and is purified via Carbon Treatment, Crystallization and Filtration.



1. Acetyl Glycyrrhetinic

acid

Parling International Warehouse


3. Hydrochloric Acid Choudhary Chemical

Industries

Warehouse

4. Hyflo Supercel Gem Corpochem Private

Limited

Warehouse


Tanks

6. Potassium Hydroxide

(Caustic Potash)



8. Toluene V.S. Interchem Private

Ltd.

Solvent Storage

Tanks

Acetyl Glycyrrhetinic Acid

Molecular Formula: C32H48O5


Alkaline

Hydrolysis





February’2017 57

Process Flow Chart:

Acetyl Glycyrrhetinic Acid (Starting material)

▼

Hydrolysis in alkaline media & pH adjustment

▼

Filtration & Drying

▼

Dissolution in a mixture of methanol and toluene &

Filtration through Hyflo Supercel Bed

▼

Concentration, Crystallization & Filtration

▼

Enoxolone Crude

▼ ▼

Dissolution in methanol, Carbon treatment & Filtration

▼

Concentration, Crystallization & Filtration

▼


▼

Enoxolone API

MATERIALS BALANCE FOR ENOXOLONE (API):

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Acetyl Glycyrrhetinic Acid 460

2 Potassium Hydroxide 165

3 Methyl Alcohol 8950

4 Hydrochloric Acid 0.5

5 water 850

6 Toluene 1734

Total: 12159.5 Sr. No. Output/Kg of product(Kg) Total



1 Enoxolone(API) 22 - 400 422

2 Methyl Alcohol - 50 8000 - 8050

3 Hydrochloric Acid 0.5 - - - 0.5

4 Water 850+150=1000 - - - 1000

5 Toluene - 20 1600 - 1620

6 Third party mixed

solvent

940+127 - - - 1067

Total: 2089.5 70 10000 - 12159.5





February’2017 58

13. Homatropine Methylbromide

Homatropine Homatropine Methylbromide


Product: Homatropine methyl bromide

1. The final product Homatropine Methyl Bromide is manufactured in 3 stages.

2. Stage 1 involves reaction using raw material convert to Homatropine as per

stoichiometry.

3. Stage 2 involves the reaction using Homatropine with Methyl Bromide as a raw material

convert to Homatropine methyl bromide as per stoichiometry.

4. Stage 3 involves purification of Homatropine methyl bromide with the help of Ethanol to

Homatropine methyl bromide (pure).

5. After filtration and then drying we get desired product Homatropine methyl bromide

(pure).






Hyoscine syrup MDC

Acetonitrile

Pure Hyoscine Syrup

Cyclopropyle Methyl bromide

Wet cake (1)

Methyl alcohol

Wet cake (2)

Ethyl Alcohol

Cimetropium Bromide

Disolution

Impurities absorption by

Al2O3

Concentration

Reaction

Cooling then Filtration



Recovery

ML

ML

ML

Drying

Al2O3 with impurities





February’2017 60



1. Mandelic Acid Warehouse

2. Acetyl Chloride Warehouse

3. Acetone V.S. Interchem Private Limited Solvent Storage Tanks

4. Thionyl Chloride Warehouse

5. Tropine In House Warehouse


7. Ethanol DCM, Daurala Solvent Storage Tanks

8. Ethyl Alcohol B. K. Sales Solvent Storage Tanks


MATERIALS BALANCE FOR HOMATROPINE METHYL BROMIDE:

Sr. No.

Raw Material Input/Kg of Product(Kg)

1 Mandelic acid 5

2 Acetyl chloride 7.7

3 Thionyl chloride 11.5

4 Tropine 4.2

5 MDC 320

6 Water 56

7 Acetone 88.6

8 Methyl Bromide 26

9 Ethanol 23.7

- - -

Total: 542.7 Sr. No.

Output/MT of product Remark Product Liquid effluent Air

Emission Recovery Solid

Waste 1 Homatropine Methyl

Bromide (Pure)

3.2+1.8 - 6 - 11

2 MDC - 15 300 - 315

3 Water 56+15 - - - 71

4 Acetone - 3.6 80 - 83.6

5 Third party mixed

solvent

62.1 - 62.1

Total: 138.1 18.6 386 - 542.7





February’2017 61

14. Hyoscyamine Sulfate

Hyoscyamine Hyoscyamine sulphate

(Natural origin) Salt formation on nitrogen. Minor change

Product: Hyoscamine Sulfate

1. The raw material is charged into the reaction vessel as per the stoichiometry.

2. The reaction is taken place in standard temperature & pressure converting the raw

material into the product.

3. The product is separated from sulphuric acid and acetone by filtration process.

4. After drying this product, it is send back to reaction vessel for washing with acetone.

5. It is filtration then drying to get product.






Hyoscamine crude Sulfuric acid (Aqueous) Acetone

Acetone

Hyoscamine Sulfat



Hyoscamine Crude In-house Warehouse

1. Sulfuric Acid Choudhary Chemicals Warehouse 2. Acetone V.S. Interchem Private Limited Solvent Storage Tanks 3. Distilled Water In-house Water System


MATERIAL BALANCE FOR HYOSCAMINE SULPHATE:

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Hyoscamine Crude 6

2 Sulfuric acid 1.3

3 Water 11.7

3 Acetone 142

Total: 161

Sr. No. Output/MT of product Total Product Liquid



Reaction Vessel

ML

filtration

Drying

Washing

Drying





February’2017 63

1 Hyoscamine

Sulfate

1.2 0.2 6 - 7.4

2 Sulfuric acid 0.3 - - - 0.3

3 Water 11.3 - - - 11.3

4 Acetone 20 2.0 120 - 142

Total: 34.8 0.2 126 - 161

15. Methscopolamine Bromide

Hyoscine Hydrobromide Methscopolamine Bromide


Product: Methescoplamine Bromide

1. The raw material is charged into the reaction vessel as per the stoichiometry.

2. The reaction is taken place in standard temperature & pressure converting the raw

material into the product.

3. The product is separated from Acetonitrile and excess methyl bromide by filtration

process.

4. After drying this product, it is send back to reaction vessel for washing with water then

ethyl alcohol.

5. Process is repeated through filtration then drying.






Hyosine Hydro Bromide (crude) Acetonitrile (ACN) Methyl bromide

MDC

Water+ Ethanol

Ethanol

Methescoplamine Bromide

Reaction Vessel

Filtration

ML

Washing

MDC

Washing

Water+

ethanol


Filtration

Drying

ML





February’2017 65

LIST OF RAW MATERIALS:


1. Hyoscine Hydrobromide

Crude

In-house Warehouse

2. Methyl Bromide Unisynaxis Laboratories Private

Limited, Warehouse

3. Acetonitrile V.S. Interchem Private Limited Solvent Storage Tanks 4. Ethanol DCM, Daurala Warehouse 5. Methylene Chloride B. K. Sales Solvent Storage Tanks 6. Distilled Water In-house Water System

MATERIAL BALANCE FOR METHESCOPLAMINE BROMIDE :

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Hyosine Hydro Bromide (crude) 12

2 Methyl Bromide 30

3 Acetonitrile (ACN) 23.6

4 Ethanol 65.1

5 Water 107.5

6 MDC 399

Total: 637.2 Sr. No. Output/ Kg of product(Kg) Total


Air Emission


1 Methescoplamine

Bromide

3.7 - 7.2 - 10.9

2 Ethanol - 5 - - 5

3 Water 107.5+2.5 - - - 110

4 MDC - 19 380 - 399

5 Third party mixed solvent - - - - 112.3

Total: 113.7 14 387.2 - 637.2





February’2017 66

16. Paclitaxel





February’2017 67

▼

Thermo vacuum drying

▼

7-O-Troc-13-O-Oxazonyl Baccatin III

▼

Ring Opening Reaction

▼

Liquid- Liquid Extraction

▼

Concentration

▼

Dissolution, Crystallization & Centrifugation (1 & 2)

▼


▼

7-O-Troc Paclitaxel

▼

Troc - Deprotection Reaction

▼

Filtration & Concentration

▼

Liquid- Liquid Extraction

▼

Concentration

▼

Dissolution, Crystallization & Filtration

▼


▼

Paclitaxel USP (6848)





February’2017 68

List of Raw Materials


1. 10 DAB In-house Warehouse

2. Tetrahydrofuran VS Interchem Warehouse

3. Acetic Anhydride Jubiliant Chemicals Solvent Storage Tanks

4. Acid Side Chain Imported from China Warehouse

5. Cerium III Imported from China Warehouse

6. Pyridin Imported from China Warehouse

7. TROC Spectrochem Pvt Ltd Warehouse

8. Methylene Chloride B. K. Sales Solvent Storage Tanks

9. Reverse Osmosis

Water


10. Sodium Bi Carbonate VS Interchem Warehouse

11. Ethyl Acetate VS Interchem Solvent Storage Tanks

12. Hydrochloric Acid Super Acid Warehouse

13. Acetic Acid Jubiliant Chemicals Ware House

14. 4- DMAP Multi Chem Warehouse

15. NN DCC Globe Chemi Warehouse

16. Ammonium Chloride VS Interchem Warehouse

17. Acetone VS Interchem Solvent Storage tanks

18. Toluene VS Interchem Solvent Storage tanks

19. Petroleum Ether VS Interchem Solvent Storage tanks

20. Sodium Chloride Syndeic India Warehouse

21. EDTA Amba Associates Warehouse

22. Zinc Amba Associates Warehouse

17.Vinpocetine

Product: Vinpocetine

1. The product is manufacturing through making two intermediate products in few different stages.

2. The stage-1 is extraction from raw material to making concentrated syrup.

3. In stage-2, syrup is charged into the reaction vessel as per the stoichiometry.

4. The reaction is taken place at required temperature & atmospheric pressure converting the raw

material into Intermediate-1.

5. In stage-3, intermediate-1(Tabersonine) is reacted with the required reactants at required

operating conditions to produce intermediate-2.





6. In stage-4, intermediate-2(Vincadifformine) is reacted with the required reactants at required

operating condition to produce Vinpocetine (Crude). Wet cake (1) of product is dissolved in

methyl alcohol, after cooling it is then filtered.

7. In stage-5, Vinpocetine (crude) is converting to Vinpocetine (Pure) after purification process.


Vocanga Seed Ricers Ammonia solution Stage-1

Chloroform +methanol

Inactive vocanga seed (solid garbage)

Syrup Stage-2

Citric Acid +RO water

Ammonia solution

MDC

Methanol

Methanol

Intermidiate-1(Tabersonine)

Extraction

washing

Concentration

Layer separation-1

Aqueous layer

(pH maintenance)

Layer separation-2

Concentration(Organic layer)

Stripping of MDC

Filtration ML

Drying

Leached chloroform+

methanol

Oil layer

Aqueous layer

MeOH+_MDC

Dissolution & cooling





Stage-3

Ethyl acetate Hydrogen

MDC

Intermediate-2 (Vincadifformine)

Stage-4

N-chlorosuccinimide MDC Formic acid

MDC

Dissolved Sodium in Ethyl alcohol Wet cake dissolved wet cake in MDC+Ethylacetate

Reaction in presence of

Raney-Ni

Filtration

Concentration to thick mass

Dissolution

Drying

Reaction

Concentration & cooling MDC+ Formic acid

Layer separation-3 Aqueous layer

Concentration

(Thick syrup)& cooling

Filtration ML

Reaction





Hydrochloric acid (aqueous)

MDC

Vinpocetine (Crude)

Stage-5

MDC

Ethyl alcohol

VINPOCETINE (PURE)

Concentration& cooling

Dissolution &

pH maintenance

Layer separation-4 Aqueous layer

Concentration& cooling

(Organic layer)

Filtration

Drying

Dissolution

Concentration

Dissolution

Cooling & Crystallization

Filtration ML

Drying





February’2017 72

LIST OF RAW MATERIALS:


1. Vocanga Seeds World Botanicals Warehouse

2. Ammonia Fluorides and Chemicals Warehouse

3. Acetone V.S. Interchem Private Limited Solvent Storage Tanks




7. Ethyl Acetate Gem Corporation Solvent Storage tanks



10. Citric Acid V.S. Interchem Private Limited Warehouse

11. Methylene Di Chloride V.S. Interchem Solvent Storage Tanks


13. N-chlorosuccinimide Spectrochem Warehouse

14. Formic Acid Leo Chem Plast Warehouse

15. Ethanol DCM, Daurala Solvent Storage Tanks

MATERIAL BALANCE SHEETS FOR VINPOCETINE :Stage-1

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Vocanga Seed 2000

2 Ricers 200

3 Chloroform 28310

4 Methanol 792

5 Ammonia (liq.) 17

6 Water 176

Total: 31495 Sr. No. Output/MT of product Total



1 Syrup - - 1020 1020

2 Husk - - - 2200 2200

3 Chloroform - 9 26000 - 26009

4 Methanol - 3 730 - 733

5 Third party mixed

solvent

83+1450 1533

Total: 1533 12 27750 2200 31495

Stage-2

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Syrup 1020

2 Citric acid 420

3 Water 3950

4 Ammonia (liq.) 35

5 MDC 2000

6 Methanol 33





February’2017 73



Air Emission


1 Tabersonine - - 30 - 30

2 Chloroform - 6 560 - 566

3 Methanol - 4 - - 4

4 Water 985+850 - 3000 - 4835

5 MDC - 10 1950 - 1960

6 Third party mixed solvent 9+54 63

Total: 1898 14 5576 - 7458

Stage-3

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Tabersonine 30

2 Hydrogen gas 2

3 Ethyl acetate 278

4 Water 720

5 MDC 20

6 Methanol 38



Air Emission


1 Vincadifformine 2 - 30 - 32

2 Ethyl acetate - 8 200 - 208

3 Water 720 - - - 720

4 MDC - 3 17 - 20

5 Third party mixed solvent 32+70 - - - 102

Total: 824 11 247 - 1082 • 10 Kg used raney-Ni is sent to R&D to re-activate.

• 25 kg used Silica with impurities is sent to GAPIL

Stage-4

Sr. No. Raw Material Input/Kg of Product(Kg) 1 Vincadifformine 30

2 N-chlorosuccinimide 11.8

3 Formic acid 73.2

4 Sodium 0.8

5 Ethanol 197.3

6 MDC 692

7 Ethyl acetate 09

8 Hydrochloric acid 0.1

9 water 720

10 Sodium carbonate 20

Total: 1754.2 Sr. No. Output/Kg of product(Kg) Total





February’2017 74


Air Emission


1 Vinpocitine 11 - 20 - 31

2 Formic acid - - 40 - 40

3 MDC - 22 630 - 652

4 Ethanol - 7.2 120 - 127.2

5 Water 720 - - - 720

6 Third party mixed

solvent

- - - - 184

Total: 731+184 9.2 810 - 1754.2

Stage-5 Sr. No. Raw Material Input/Kg of Product(Kg) 1 Vinpocetine( crude) 020

2 MDC 240

3 Ethanol 158



Air Emission


1 Vinpocetine (pure) - - 020 - 020

2 MDC - 2 230 - 232

3 Ethanol - - 150 - 150

4 Third party mixed

solvent

- - - - 16

Total: 16 2 400 - 418





February’2017 75

PLANT CAPACITY

Sr. No

Product Raw Material (Herb)

Annual Quantity of Herb used for Extraction (MT)


Pure Herbal Product Manufactured in the factory 1 10-Deacetyl Baccatin

(10-DAB) Taxus Baccata 250 150

2 Colchicine

Gloriosa Superba

Seeds 50 150

3 Digoxin

Digitalis Lanata

leaves 100 120


5 Reserpine

Rauwolfia

vomitoria 30 100



Resinate/ Dihydrate

Tobacco Dust

8 Thiocolchicoside

Gloriosa Superba

Seeds 300 2000

9 Hyoscine

Butylbromide Duboisia Leaves 300 7000

10



12

Enoxolone Acetyl

Glycyrrhetenic acid 10 6000

13 Homatropine



15 Methscopolamine

Bromide Duboisia Leaves 10 100

16

Paclitaxel

10-Deacetyl

Baccatin

(10-DAB)

inhouse 100






February’2017 76

3.9 QUANTITY OF WASTES TO BE GENERATED (LIQUID AND SOLID) AND SCHEME

FOR THEIR MANAGEMENT/ DISPOSAL.

3.9.1 SOLID

S NO Hazardous

waste

description

Category as

per HWMR

Rules

Quantity

generated

per annum

Unit Method of Disposal

1 ETP Sludge 34.3 2400 Kg It will be sent to GEPIL site

at Faridabad for treatment

and disposal

2 Used Oils and

Spent Oil

5.1 & 5.2 1000 Lit It will be disposed through

authorized handlers

3 Process residue

and waste

process oil

28.1 33000 Kg It will be sent to GEPIL site


and disposal

4 Off

Specification

product



and disposal

5 Expiry Drugs/

Medicines



and disposal

3.9.2 WATER REQUIREMENT AND WASTE WATER GENERATION

The present water requirements for the existing facility are 160 KLD. As there is no increase in

the production capacity post this modernization the total water requirement as detailed earlier

also remains same.

After modernization with process integration one time water requirement is 160 KLD. Daily

fresh water requirement is 130 KLD and 30 KLD water will be recycled.

Water consumption & Waste water generation details (existing)

Description Water Consumption

KLD

Waste Water Generation

(KLD)

Effluent

Treatment

& disposal

facility

Domestic 20 10 To STP

Process 50 45 To ETP





February’2017 77

Cooling tower 50 10 To ETP

Boiler/RO 25 5

Floor washing and

equipment washing

5 5

Fresh water

consumption

160 65

Water consumption & Waste water generation after modernization

Sr. No Description Water Consumption

KLD

Waste Water

Generation (KLD)

Effluent

Treatment

& disposal

facility

1 Domestic 20 10 To STP

2 Process 50 45 To ETP followed by ZLD

plant

3 Cooling tower 50 10 To ETP followed by RO

for further use in process

4 DM Plant 90 0

4.1 Boiler 25 5

5 Gardening 10* - -

6 RO reject - 10 To STP after toilet use

7 Floor washing and

equipment washing

5 5 To ETP followed by RO

for further use in process.

Shown as process waste

water

Fresh Water consumption 130

Recycled water 30

Total water consumption 160

Source: existing bore well which is already permitted by CGWA, New Delhi





February’2017 78





February’2017 79

A. ETP

The discharge design of the effluent is based on a capacity of 80 KLPD.

Influent characteristics

S NO PARAMETERS VALUE UNIT

1 COD 5000- 8000 Mg/L

2 BOD 300- 350 Mg/L

3 TSS 125- 180 Mg/L

4 Ph 6.0- 9.0

5 OIL & GREASE 5- 10 Mg/L

Treated Effluent Characteristics

S NO PARAMETERS VALUE UNIT

1 COD <250 Mg/L

2 BOD <100 Mg/L

3 TSS <100 Mg/L

4 Ph 5.5 to 9.0

The detailed design of the ETP is as under

ETP DESIGN

Effluent Treatment Capacity Per Day in Metric Cube

S. No. Tank Name Dimension[M] Volume [Capacity] M³

Hydraulic Retention Time [in Days] based on flowrate 80 KLPD

1 Bar & Screen Chamber 1 1.0*4.5*1.1 4.95 0.06

2 Bar & Screen Chamber 2 4.20*1.75*0.98 7.37 0.09

3 Collection Tank 8.5D*5.0 283.5 3.54

4 Flash Mixing Tank-1 1.5*1.5*1.2 2.7 0.03

5 Tube Settler 2.4*2.4*1.85 10.66 0.13

6 Bio-Tower-1 5.75*5.75*0.6 19.84 0.24

7 pH correction Tank 2.6*2.43*1.9 12 0.15





February’2017 80

8 Anaerobic Filter-1 3.8*6.6*4.0 100.32 1.25

9 Anaerobic Filter-2 3.8*6.6*4.0 100.32 1.25

10 Clarifier 5.75*5.75*0.6 19.84 0.25

11 Aeration Tank-1 7.45*5.05*4.6 173.06 2.16

12 Clarifier-1 3.4D*2.5 22.68 0.28

13 Aeration Tank-2 7*7*3 147 1.84

14 Clarifier-2 3.4D*2.5 22.68 0.28


16 Settling Tank-1 7.20*5.65*1.73 70.37 0.88

17 Settling Tank-2 7.20*5.65*1.73 70.37 0.88


19 Sludge Beds1,2,3 2.70*1.98*0.63 (3) 10.08 0.13

20 Maturation Pond 7.30*5.50*1.80 72.27 0.9

21 Sand Filter 0.7D*2.10 0.8 0.01

22 Carbon Filter 1 0.8D*1.50 0.75 0.01

23 Discharge Tank 7.30*5.58*1.80 73.32 0.92

24 Carbon Filter- 2 0.83D*3 1.62 0.02

Distances between systems

Bar Screen to collection Tank: 1 m

Collection Tank to Flash Mixer: 13.2 m

Flash Mixer to Tube Settler: 1.9 m

Tube Settler to pH correction tank: 1 m

pH correction Tank to AF-1: 1.0 m

AF-1 to AF-2: 1.4 m

AF-2 to Clarifier: 1.65 m

Clarifier to BT-1: :0.9 m

BT-1 to BT-2: 0.55 m

BT-2 to CF-1: 6 m

AT-1 to CF-1: 1.05m

CF-1 to AT-2: 1.8 m

AT-2 to CF-2: 1.1 m

CF-2 to ST-2: 7.45 m

Total Area of ETP: 2775 sq.m inclusive of greenery (111 m length & 25 m in width)





February’2017 81

ETP UNIT OPERATIONS

1. Collection Tank (CT)

a. Receive the various liquid effluents generated by the process into CT via bar screen chamber and

oil & grease trap.

b. Operate the blower to purge the air through Spurger grid in effluent continuously.

c. Pump the collected and equalized effluent to the next stage of Flash Mixing Tank No-1. (FMT-1) in

regulated fashion.

d. Draw a sample of effluent each day.

e. Ensure that water level indication mark above the four walls is always visible. Adjust the outflow

from tank accordingly.

f. When level goes below four walls from top stop pumping. Resume when the level touches the four-

wall level mark from top.

g. Allow boiler blow down water in collection tank to keep the water warm.





February’2017 82

2.Flash Mixing Tank No-1 (FMT-1) :-

a. Agitate continuously.

b. Intermittently add quick lime powder to the tank so that the pH at tube settler outlet is

between10.00 to11.00. Ensure by periodic sampling for pH at the tube settler outlet and monitored

by pH paper strip. Randomly check by pH meter.

c. Add 50-200 PPM Microflock-90 solution to FMT-1 (1.0-liter Micro flock added to 200-liter water)

continuously as a trickle over 12 Hrs. Maintain continuous additions round the clock.

d. Add 10-30 PPM ferric chloride to FMT-1 (0.5 Kg ferric chloride in 200-liter water) continuously as a

trickle over 12 Hrs. Maintain continuous additions around the clock.

e. Let the tank over flow by gravity to the next stage of Tube Settler (TS).

3 Tube Settler (TS)

a. Allow the tube settler to overflow to the next state of Bio-oxidation Tower No-1. Periodically

discharge the settled lime and other solids into the discharge pit below TS. The discharge to be

taken up every 4 hrs with about 1.0 kl discharge each time (A drop of 30 cm in liquid level

corresponds to a discharge of 1.2kl)

b. Periodically skim and remove the floating oil and grease layer.

c. Draw a sample from outlet launder each day.

d. Note the flow rate of effluent pumping from CT by noting the time taken to fill a known volume

bucket (12 ltrs.) placed beneath effluent reception point in inlet launder.

e. Draw a sample from outlet launder each hour to check pH.

3 A Filter Press No-1 (FP-1)

a. Mix the contents inside the tube settler discharge sump with the aid of air purging and re-

circulation via pump.

b. Pump the homogenized slurry to filter press to filter out the solids. Allow the filtrate to flow back

into the CT. Note the drop-in slurry level in the pit to ascertain the slurry volume so filtered.

c. After filtration is over pressurize the filter press with compressed air from air compressor to drive

out the retained fluid as much as possible.

d. When squeezing is over, open the press and discharge the cake. Fill in trolley and drop in the yard

for final disposal.

e. Wash the filter cloth, if needed, and assemble the press for reuse.

f. Carry out filtration at least once a day, more it required.





February’2017 83

4 Bio oxidation Tower No-1 (BT-1)

a. Receive the effluent into the sump. Monitor the clarity regularly.

b. Allow the regulated flow to be pumped to pH correction tank (pH CT).

c. Continuously re-circulate and spray the balance effluent flow over packed fills.

d. Collect sample from pump outflow daily.

5. pH Correction Tank:

a. Receive effluent from BT-1 via pump.

b. Dissolve 2.5 kg of diammonium phosphate in about 200 liters of water inside a container. Allow to

trickle down into the pH correction tank outflow. Regulate trickle so that the quantity get added in

12 hrs. Maintain continuous additions around the clock.

c. Purge the air in pH correction tank continuously to ensure the proper mixing of nutrient in effluent.

d. Continuously maintain pH in the range of 7.5 to 8.5 by addition of sulfuric acid.

e. Allow the effluent to overflow and go to Anaerobic Filter No-1 (AF-1) and Anaerobic Filter No-2

(AF-2) by gravity flow.

f. Periodically monitor the pH in pH CT and take corrective action.

6. Anaerobic Filter No-1,2 (AF-1, AF-2)

a. Receive the effluent in all the above anaerobic filters in parallel.

b. Supply the steam in jacket to heat the effluent in pipe line extended from pH correction tank to AF-

1 & AF-2 to maintain the temperature at 40-50 0C.

c. Allow the overflow to go to Bio-oxidation Tower No-2 (BT-2) through clarifier by gravity.

d. Monitor the temperature in the outflow effluent. It should not exceed 37 0C. Preferably 33-370C.

e. Collect sample at anaerobic filter outlets daily.

7. Bio-oxidation Tower No-2 (BT-2)

a. Receive the effluent into the sump.

b. Allow a regulated flow to go to Aeration Tank No-1 (AT-1).

c. Continuously re-circulate the balance effluent and spray it over packed fills.

d. Collect sample at pump outlet daily.





February’2017 84

8. Aeration Tank No-1 (AT-1)

a. Receive effluent on a continuous basis.

b. Run the air blower to continuously purge air in the effluent.

c. Dose Micro flock-90 (1-liter micro flock-90 in 100 liter water) at a trickle over 12 hours at the AT-1

over flow line Maintain continuous additions round the clock if required.

d. Draw a sample of slurry periodically.

e. Add 500 gms gud in the tank as & when required to maintain MLSS

f. Modify sludge wasting frequency so as to have mixed liquor suspended solids (MLSS) at 2500 to

5000 PPM.

9 Clarifier No-1 (CF-1)

a. Receive the effluent in the drum located in the center of CF-1.

b. Run the scrapper on a continuous basis. The sludge is pumped for recirculation from CF-1 to AT-1

continuously.

c. Allow the clarified effluent to overflow into outlet launder for onward flow to Aeration Tank No-2

(AT-2).

d. Periodically clean the outlet launder for foam and floating mass.

e. At every 6 hrs interval waste 0.55 kl of settled sludge from the clarifier bottom is pumped to the

sludge sump below TS. Before wasting stop recirculation from CF-1 to AT-1 for about 15 minutes.

f. Draw a sample of clarified over flowing effluent daily.

10. Aeration Tank No-2 (AT-2)

a. Receive effluent on a continuous basis.

b. Run the air blower to continuously purge air into the effluent through fine bubble air diffusers.

c. If required, spray the effluent over the liquid surface to arrest foaming.

d. Dose Micro flock (1 liter in 100-liter water) as a trickle over 12 hours at the AT-2 overflow

launders. Maintain continuous additions around the clock.

e. Draw sample of the effluent slurry periodically.

f. Modify sludge wasting frequency so as to maintain mixed liquor suspended solids (MLSS) at 2500

to 5000 PPM.





February’2017 85

11. Clarifier No-2 (CF-2)

a. Receive the effluent slurry into the drum located in the center of CF-2.

b. Run the scrapper on a continuous basis. Run recirculation from CF-2 to AT-2 on a continuous basis.

c. Allow the clarified effluent to overflow into outlet launder for going to Flash Mixing Tank No-3

(FMT-3).

d. Periodically clean the outlet launder of CF-2.

e. At every 6hr. interval waste 0.55 kl of settled sludge from the clarifier bottom with the aid of pump

and transfer it to the sludge sump below TS. Before wasting stop recirculation from CF-1 to AT-1

for about 15 minutes.

f. Draw a sample of clarified liquid overflow daily.

12 Flash Mixing Tank No-3 FMT-3

a. Receive the effluent continuously.

b. Add 25-75kg of activated carbon daily @ 1-3 kg at the interval of one hour around the clock.

c. Dose micro flock-90 (1 liter in 100-liter water) as a trickle over 12 hours at the AT-2 overflow

launders. Maintain continuous additions around the clock.

d. Dose ferric chloride (0.3 kg in 200-liter water) as a trickle over 12 hours in FMT-3. Maintain

continuous additions around the clock.

a. Run the agitator continuously.

b. Dose quick lime powder intermittently so as to maintain the slurry pH at 11.50 to 12.00

monitored with pH paper/pH meter.

c. Let the tank overflow into settling Tank No-1 and No-2 (ST-1 & ST-2).

13. Settling Tank No-1 and 2 (ST-1, ST-2)

a. Let the lime + effluent slurry flow into the tank.

b. Simultaneously from the other end let the slurry is pumped to sludge beds & sludge sump

below TS.

c. Draw a sample of supernatant daily.

14. Filter Press No-2 (FP-2)

a. Mix the contents inside the tube settler discharge sump with the aid of air purging and re-

circulation via pump.

b. Pump the homogenized slurry to filter press to filter out the solids. Allow the filtrate to flow

back into the CT. Note the drop-in slurry level in the pit to ascertain the slurry volume so





February’2017 86

filtered.

c. After filtration is over pressurize the filter press with compressed air from air compressor to

drive out the retained fluid as much as possible

d. When squeezing is over, open the press and discharge the cake. Fill in trolley and drop in the

yard for final disposal.

e. Wash the filter cloth, if needed, and assemble the press for reuse.

f. Carry out filtration at least once a day, more it required.

15. Flash Mixing Tank No-4 (FMT-4)

a. Receive the effluent continuously.

b. Run the agitator continuously.

c. Dose concentrated sulfuric acid in a trickle to maintain pH between 6.5 to 8.5.

d. Allow FMT-4 to overflow to Maturation Pond (MP).

16. Maturation Pond (MP)

a. Receive clarified effluent continuously.

b. Let the clear effluent pumped to FD via sand & carbon filter.

c. Monitor pH of the pumped effluent to Final Discharge Tank (FD). Correct if necessary by

adjusting acid/ alkali addition.

d. Draw a sample daily from the tank.

17 Final Discharge Tank (FD)

a. Receive treated effluent from MP.

b. Draw a sample daily.

c. Pump out for discharge after fine air bubble diffused aeration via carbon filter over land for

gardening purpose.

PRECAUTIONS:

a. Whenever effluent pumping from CT has to be stopped the following should also be stopped.

- Dosing of lime and Micro flock-90 in FMT-1.

- Dosing of diammonium phosphate in pH correction tank.

Whenever forward effluent pumping from BT-1 (or BT-3) is stopped the following should

also be stopped.

- Dosing of acid in pH correction tank.





February’2017 87

- Supply of steam to the jacket of effluent feed pipe line extended from pH correction tank to AF-

1 & AF-2.

b. Whenever forward effluent pumping from BT-2 is stopped the following should also be

stopped.

- Dosing of Micro flock-90 at outlet of AT-1.

- Dosing of Micro flock-90 at outlet launder of AT-2.

- Dosing of lime in FMT-3.

c. Recirculation of sludge in AT-1 and AT-2 should never be stopped, except when sludge wasting

is required to be done, in which case it should be stopped for 15 minutes before wasting is

started.

d. Air purging in AT-1 and AT-2 should never be stopped when sludge wasting is required to be

done at CF-1 and CF-2.

e. Recirculation from CF-1 to AT-1 and CF-2 to AT-2 at excessive flow rates should be avoided.

Regulate, if possible to approximately equal the inflow or even less.

Take care the scrapped mechanism in CF-1 and CF-2 works all the time.

DOMESTIC WASTE WATER

The total domestic waste water generated is 14 KL. This quantity of waste water is treated in

properly designed Sewage treatment plant. The details and the schematic flow is appended

below.

SEWAGE TREATMENT PLANT

Process Scheme of Sewage Treatment Plant

Equalization Tank

The raw sewage collected in worker toilet sump thru bar and screen chamber for removal of

coarse and floating matters by trapping them in mesh. The screened sewage is passed through

the equalization tank to homogenize the characteristics by means of air agitation which help in

avoiding shock loading to the downstream process.

Aeration Tank

This homogenized sewage is pumped to aeration tank with the help of sewage transfer pump.

The aeration tank is designed on extended aeration activated sludge process to degrade the

organic matters by means of biological activity. The aeration tank is equipped with membrane





February’2017 88

diffusers and blower assembly to provide atmospheric oxygen in to the sewage. The air blowers

are common for aeration process and equalization process.

Clarifier

The treated sewage from the aeration tank is taken in to the clarifier where the biomass is

settled with the help of polymer. The sludge settled in the clarifier is recycled back to the

aeration tank to maintain the desired level of mixed liquor suspended solids in with the help of

the pump.

Sludge Drying Beds

Excess sludge is disposed of in the sludge drying bed for dewatering of sludge.

Chlorination Tank

The clear supernatant from clarifier is then transferred in to the chlorination tank for

disinfection by sodium hypochlorite added in tank by dosing pump.

Sand Filter

From Chlorination tank the treated effluent is pumped for filtration to the multi-grade filter.

Activated Carbon Filter

The effluent is further passed through the activated carbon polishing unit.

Treated Water Storage Tank

The finally treated water is stored in collection tank and pumped directly to the garden for

irrigation purposes.





February’2017 89

SOLVENT RECOVERY SYSTEM





February’2017 90

The unit uses a large quantity of solvent both for Extraction of the main Ingredient from the

herb and also in purification and the final manufacture of API. The standard system followed for

all distillations and Solvent recovery are appended below in detail. However, it is pertinent to

mention that specific methods are followed dependent on the solvent used and the Product

Stability with heat application.

1. During distillation, the solvent vapors should be taken to the primary condenser, which

should always be provided with cooling tower water. (Maximum of heat load will be in

the primary condenser, hence cooling tower water should only be used as a utility in-

order to reduce load on chiller, moreover, proper HTA of condenser and cooling water

line size should be used for effective condensation)

a. Note: Except for few condition, such as: when distilling MDC solvent during peak

summer time when cooling tower water temp is >35C, it is recommended to

provide the primary condenser with chilling water.

b. If any solvent is distilled under high vacuum, during which solvent vapor

temperature is below <38C then it is recommended to use chilling water in the

primary condenser.

2. The secondary condenser should always be placed above the primary condenser, where

the uncondensed vapor from primary condenser should be sent to secondary condenser,

this condenser should always be provided with chilling water only.

3. The product cooler should be placed in common to both the primary and secondary

condenser, the condensed solvent from both primary and secondary condenser should

be taken to this product cooler where chilling water only should be used before storing

it into tank.

4. Preheated is recommended in all possible area where we can recover heat from the

concentrated syrup before storing it into tank, the heat from concentrated syrup can be

used for pre-heating the solvent feed before feeding it into the distillation setup to

reduce the heat load on utility.

5. When performing vacuum distillation, always the main vacuum line should be given to

the secondary condenser, whereas small balancing/equalizing line should be given to

the condensed solvent collection tanks.





February’2017 91

6. It is recommended to place a small condenser followed by storage tank in the vacuum

line i.e. before vacuum pump with chilling water utility in the condenser for preventing

solvent vapor loss during vacuum distillation.





February’2017 92





3.10 SCHEMATIC REPRESENTATIONS OF THE FEASIBILITY DRAWING WHICH GIVE

INFORMATION OF EIA PURPOSE

Project Concept

Form 1, Pre-feasibility Project Report with Proposed TOR to SEAC

Scoping by EAC

(Site visit by sub group of EAC, if necessary)

TOR approved by SEAC EC - rejected by SEIAA on recommendation of SEAC

Draft EIA Report to SPCB

by Project Proponent

Public Consultation process by SPCB

Summary EIA and Form 1 – display

on the Website by SPCB

Proceedings of Public Consultation

Appraisal and Recommendation by SEAC

Display on MoEF&CCWebsite

Display at Panchayat, ZP, DM/DC/

Dy. Com & on the SPCB website

To Proponent for Submission of Final EIA

Report/Supplementary Report to Draft EIA

Approval by SEIAA

Rejected Approved Display on SEIAA Website& Project Proponent Website

Post EC

Monitoring

Submission of half yearly Compliance

Report to MoEF&CC/ RO-MoEF&CC

Display of Compliance Report

on MoEF&CCWebsite





February’2017 94

4.0 SITE ANALYSIS

4.1 CONNECTIVITY

The site is located in the HUDA Industrial sector 59 part 2. All the amenities that are required

for a stable industry are available there.

Table 4: Connectivity

Particulars Name Distance, Direction (From Project Boundary)

NH NH-2 50 m, W

Railway Station Ballabgarh 4.79 Km NE

Airport Delhi International

Airport

34.85 Km NW

4.2 LAND FORM, LAND USE AND LAND OWNERSHIP

4.2.1 LANDFORM

The unit is situated in the notified Industrial sector of HUDA. No additional land is required

for the modernization with process integration. Existing land of 89081 sqm will be used

4.2.2 LAND USE

The proposed land use of the project is as under.

S.NO PARTICULARS Area (SQM) Percentage(%)

1 Buildings / Office / Warehouses /QC/R&D /

Workshop/ DG Room /Manufacturing

plants/ETP/RO Plant/Boiler

20488.63 23

2 Paved area/ Roads/corridors/parking 21379.44 24

3 Green belt 29396.73 33

4 Open area 17816.2 20


4.2.3 LAND OWNERSHIP

The project is situated in well-established HUDA industrial Sector 59 part2.





February’2017 95

4.3 TOPOGRAPHY (ALONG WITH MAP)

The physical features of the region are quite astounding. The Aravali mountain range is the only

mountain range in the near vicinity. There is no desert. In totality, it can be concluded that the

township of Ballabgarh which is a satellite town of the industrial hub of Faridabad is ideally

suited to industrial activity. There is no National park or Sanctuary within the radius of 10 KM.

The nearest River is Yamuna which is more than 10 km radius area.

4.4 EXISTING LAND USE PATTERN (AGRICULTURE, NON-AGRICULTURE, FOREST, WATER

BODIES (INCLUDING AREA UNDER CRZ)), SHORTEST DISTANCES FROM THE

PERIPHERY OF THE PROJECT TO PERIPHERY OF THE FORESTS, NATIONAL PARK,

WILD LIFE SANCTUARY, ECO SENSITIVE AREAS, WATER BODIES (DISTANCE FROM

THE HFL OF THE RIVER), CRZ. IN CASE OF NOTIFIED INDUSTRIAL AREA, A COPY OF

THE GAZETTE NOTIFICATION SHOULD BE GIVEN.

The existing land use pattern is given in point no. 1.2.

4.5 EXISTING INFRASTRUCTURE

The project is a Bulk Drug Manufacturing Unit – Alchem International Private Limited,

situated at 25/2, Min Mathura Road, Village Kaili, Ballabgarh, Distt Faridabad, Haryana.

• Sector 59 part 2 has a well-established Industrial Base comprising of many leading

industries.

• Power is supplied almost uninterrupted from HSEB through an independent feeder.

• There is availability of semi- skilled/skilled work force from the vicinity.

A. Physical Infrastructure

Physical Infrastructure is an important aspect of a city. It determines the quality of life to

a large extent. Physical Infrastructure deals with.

• Water Supply

• Electricity

• Solid Waste disposal

B. Water supply

The water requirement is being met from existing bore well





February’2017 96

C. Solid Waste & Sanitation

All solid waste will be disposed of to the HSPCB approved site at Pali, Faridabad being

managed by GEPIL.

D. Electricity

The Unit is being fed through an independent feeder from the nearest Sub Station of

HSEB at Orient Steel, Jharsaintly. The unit has a sanctioned load of 2500 KVA with a

connected load of 2000 KVA. There is no increase of electricity load envisaged post this

modernization with process integration

4.5.1 BASIC AMENITIES

The details of basic amenities like schools, hospitals and community center located nearby

the project site are mention below:-

Table 5: Basic Amenities


Medical Facility AIIMS, Ballabharh 4.6 N

Sarvodaya Hospital 8.26 NE

Aster Eye Hospital 10.53 NNE

Fortis Hospital, Faridabad 14.7 N

Schools

Presidium School 1.54 S

Govt. School 1.10 NW

Aggarwal PG Colleg 5.60 NE

Meenakshi College of Girls

Education

5.44 NE

Vivekananda educational

institute

5.62 NE

Places of Worship

local mosque 3.68 NE

Peer Baba 7.08 SE

Hanuman Mandir 1.35 NW


4.6 SOIL CLASSIFICATION

The Soil of Faridabad can be broadly being divided into 2 classes. Older Alluvial Soil and

Red/Brown Sandy Soil. As Faridabad is located in the Gangetic plains of major rivers of

Ganga and Yamuna the soil is very fertile. However, with close vicinity to Rajasthan

there is a strong presence of Sandy soil as well.





February’2017 97

4.7 CLIMATE

Faridabad weather is moderate. It experiences a generally dry climate, which is hot

during summers, a cold winter and a monsoon season which is generally very short. The

summer season spans between months of April to July. May is the hottest month of the

year when the temperature rises to in excess of 45 deg Celsius. Faridabad comes across

a cold winter as well. The winter month span between November to March with January

being the coldest month. The temperature in the winter month spans between 25 deg

(max) to 5 deg (min). Faridabad experiences a very short monsoon. The average annual

rainfall is around 542 mm. The average humidity is around 60 %. The ideal time to visit

the city is between November to March.

4.8 SOCIAL INFRASTRUCTURE AVAILABLE

The well-established social infrastructure like hospitals, temple, community centre, roads,

bridges, telecommunication and others similar are available/ existing within 15 km radius

which is tabulated in point no. III of Form – 1.

5.0 PLANNING BRIEF

5.1 PLANNING CONCEPT (TYPE OF INDUSTRIES, FACILITIES, AND

TRANSPORTATIONETC.) TOWN AND COUNTRY PLANNING/ DEVELOPMENT

AUTHORITY CLASSIFICATION.

The Bulk Drugs and Chemical industry is aptly described as the “Life Saving Industry”

signifying the crucial role its products play in alleviating human suffering from diseases and

controlling the various epidemics with pose and endemic danger to human civilization.

Keeping in view the apparent consumption for pharmaceutical formulations and existing

production capacities in the state and adjoining areas.

5.2 POPULATION PROJECTION

There will be recruitment of few workers as per requirement in operational phase.

Operation phase will require recruitment of skilled workers. Hence, there will be no change

in the population projection of the most nearest & farther most villages of the project. There

are approximately 44 villages in the study area as follows:-

Population Profile of the study area (10.0 Km):-





February’2017 98

Table 6: Population Projection

S.no. Name of the villages TRU Households Population Males Females

1 Badraula(93) Rural 508 2970 1551 1419

2 Ballabgarh Rural 36677 210603 111843 98760

3 Ballabgarh Urban 786 4291 2350 1941

4 Bhanakpur(45) Rural 531 3080 1663 1417

5 Bijopur(35) Rural 678 4358 2174 2184

6 Bukharpur(85) Rural 437 2331 1199 1132

7 Chandaoli(82) Rural 972 5312 2810 2502

8 Dayalpur(86) Rural 1368 7350 3903 3447

9 Digh(56) Rural 770 4291 2317 1974

10 Fatehpur Biloch(58) Rural 1790 10156 5446 4710

11 Fatehpur Taga(29) Rural 1150 7592 4016 3576

12 Firozpur Kalan(41) Rural 346 2253 1217 1036

13 Harphola (47) Rural 176 945 505 440

14 Jajru(52) Rural 468 2677 1424 1253

15 Kabulpur Bangar(39) Rural 215 1099 603 496

16 Kadhaoli(50) Rural 615 4181 2145 2036

17 Kail Gaon(51) Rural 202 1085 583 502

18 Karnera(42) Rural 387 2091 1110 981

19 Kheri Gujran(22) Rural 123 731 377 354

20 Kureshipur(24) Rural 356 2166 1116 1050

21 Ladhauli(70) Rural 387 2225 1199 1026

22 Ladhia Pur(38) Rural 245 1781 899 882

23 Machhgar(83) Rural 889 5214 2802 2412

24 Madalpur(28) Rural 288 1944 1039 905

25 Mahola(46) Rural 279 1625 872 753

26 Malerna(75) Rural 359 2035 1085 950

27 Mortzapur(97) Rural 461 2630 1431 1199

28 Mujeri(81) Rural 532 2994 1619 1375

29 Nagla Jogian(49) Rural 357 1956 1049 907

30 Nawada Tigaon(84) Rural 502 2812 1524 1288

31 Nekpur(23) Rural 209 1290 693 597

32 Pahladpur Majra Badrola(94) Rural 181 1101 587 514

33 Pahladpur Majra Digh (57) Rural 415 2450 1307 1143

34 Piala (54) (CT) Urban 786 4291 2350 1941

35 Sagarpur(55) Rural 513 2918 1554 1364

36 Sahrawak(166) Rural 66 537 273 264

37 Samaipur(43) Rural 556 2945 1585 1360

38 Sarurpur(27) Rural 335 2001 1070 931

39 Shahpur Kalan(71) Rural 423 2393 1316 1077

40 Shahupura(74) Rural 475 2567 1380 1187

41 Sikri(48) Rural 1035 5320 2816 2504

42 Sikrona(40) Rural 241 1390 748 642





February’2017 99

43 Sunper(72) Rural 400 2353 1225 1128

44 Tikri Khera(31) Rural 319 2541 1346 1195

Total

58808 338875 180121 158754

*Source: Census of India, 2011

5.3 LAND USE PLANNING (BREAKUP ALONG WITH GREEN BELT ETC.)

S.NO PARTICULARS Area (SQM) Percentage(%)

1 Buildings / Office / Warehouses /QC/R&D /

Workshop/ DG Room /Manufacturing

plants/ETP/RO Plant/Boiler

20488.63 23

2 Paved area/ Roads/corridors/parking 21379.44 24

3 Green belt 29396.73 33

4 Open area 17816.2 20


The existing unit has approximately 33% total land area in green belt and plantation. The

main aim of the green belt development is to improve the ecosystem to a maximum possible

extent by designing the green cover with the same native species.

However, in order to compensate the loss of vegetation, it is suggested to carry out

extensive afforestation program mainly in and around the project area. Appropriate plant

species of different life forms have been suggested in the following table to grow and to re-

establish the vegetation cover and thereby provide habitat for the faunal species. The list of

plant species suggested includes the following criteria:-

� Tree species which are well adapted to local environmental setting, tall, bearing

larger canopy cover and leaf area.

� Tree species of different size classes (small, medium and larger) were suggested to

maintain the different canopy levels at vertical profile.

� Fruit trees in the selection list would help to attract birds and fruit eating bats which

are locally available.

� Wild species were suggested to provide habitat for faunal species, increase the faunal

species diversity and maintain the naturalness.

5.4 ASSESSMENT OF INFRASTRUCTURE DEMAND (PHYSICAL AND SOCIAL)

On the basis of the preliminary site visit, the infrastructure demand in the villages assessed

on the basis of need and priority.

The health infrastructure of the study area requires improvement.





February’2017 100

The assessment will be identified in the socio economic survey, after the grant of TOR and

will be submitted at the time of final presentation regarding EC.

5.5 AMENITIES/ FACILITIES

As there is no major construction activities to be proposed. However necessary amenities

will be provided if required.

6.0 PROPOSED INFRASTRUCTURE

6.1 INDUSTRIAL AREA (PROCESSING AREA)

The area is very well connected by road network to the site, district headquarter etc. The

area is self sufficient to cater the needs of the project. Hence, no infrastructure is proposed.

6.2 RESIDENTIAL AREA (NON PROCESSING AREA)

No housing facility has been proposed .

6.3 GREEN BELT

The same has been given in point 5.2.

6.4 SOCIAL INFRASTRUCTURE

The existing project is situated at Tehsil –Ballabhgarh, District – Faridabad (Haryana). Local

population is employed by the company in the project. Further, indirect means of earnings

have been created in the area of contractual jobs, vehicle driving, shops, construction etc.

Therefore, this project brought a positive impact on the adjoining society. The proponent is

being spent 1% of profit for the development of the area i.e. medical facilities, schools,

temples and other social work. There is well developed social infrastructure in the area;

detail has been tabulated in section – III of Form – 1.

6.5 CONNECTIVITY (TRAFFIC AND TRANSPORTATION ROAD/ RAIL/

METRO/WATER WAYS ETC.)

Given in point no. 4.0.

6.6 DRINKING WATER MANAGEMENT (SOURCE AND SUPPLY OF WATER)

Given in point no. 3.8.1.





February’2017 101

6.7 SEWERAGE SYSTEM

For the treatment of domestic sewage, STP (15 KLD) has already provided with adequate

capacity in existing plant.

6.8 INDUSTRIAL WASTE MANAGEMENT

The company has already provided ETP for treatment of industrial waste water. The up

gradation of the ETP and the scheme for ZLD is proposed in order to comply the norms .

6.9 SOLID WASTE MANAGEMENT

The same has been given in point no. 3.9.

6.10 POWER REQUIREMENT AND SUPPLY/ SOURCE

The same has been given in point no. 3.8.2.

7.0 REHABILITATION AND RESETTLEMENT (R & R PLAN) : Not applicable

7.1 POLICY TO BE ADOPTED (CENTRAL/STATE) IN RESPECT OF THE PROJECT

AFFECTED PERSONS INCLUDING HOME OUSTEES, LAND OUSTEES AND

LANDLESS LABOUR (A BRIEF OUTLINE TO BE GIVEN)

Since, it is an existing project and there is no habitation in the unit area, therefore

rehabilitation & resettlement plan is not required/ applicable.

8.0 PROJECT SCHEDULE AND COST ESTIMATES: Rs. 137 Cr

8.1 LIKELY DATE OF START OF CONSTRUCTION AND LIKELY DATE OF

COMPLETION (TIME SCHEDULE FOR THE PROJECT WILL BE GIVEN).

It is an existing project hence no major construction activities are involved. The

proposal is for Modernization with process integration

8.2 ESTIMATED PROJECT COST ALONG WITH ANALYSIS IN TERMS OF ECONOMIC

VIABILITY OF THE PROJECT.

The expected capital investment for the project is Rs137 Cr.

Table 9: Expenditure Proposed for Environmental Protection Activities

S. No. Description of Item Capital Cost

(In Lacs)

Recurring Cost

(In Lacs)





February’2017 102

1 Bag filtration system and multi cyclone

in 1 boiler in order to reduce particulate

matters

40 3

2 Installation of Zero Liquid Discharge

followed by RO. Multiple Effect

Evaporator and Agitated Thin Film Drier

in the final discharge of Effluent

Treatment plant. This installation will

recycle the entire 55 KL of ETP treated

water and be reused in the Cooling

towers thus reducing the water by up to

50 KL

150 20

3 All new installation of Condensers will

be done by Corrugated shell and tube

type instead of Plain shell and tube type

to minimize solvent evaporation losses.

50 10

4 Installation of vent condensers to

condensate the solvent vapors going to

the atmosphere.

10 2

5 Replacement of Water Ring Vacuum

pumps with Dry Vacuum pumps in order

to recover solvent vapor going in the

discharge of vacuum pump and this

leads to also reduction in effluent load

with high solvent content.

40 10

6 Installation of scrubbers in order to

reduce the effluent generation

20 5

7 Environmental Monitoring and Management 5

8 Green Belt Development 4.0 0.5

9 Occupational Health 20 5

Total 339 55.5

9.0 ANALYSIS OF PROPOSAL





February’2017 103

9.1 FINANCIAL AND SOCIAL BENEFITS WITH SPECIAL EMPHASIS ON THE

BENEFITS TO THE LOCAL PEOPLE INCLUDING TRIBAL POPULATION, IF ANY, IN

THE AREA.

There have been many social benefits from the existing manufacturing operations. The

underlying financial and social benefits envisaged through the existing plant have been

listed as follows:-

Table 10: Financial & Social Benefits

S. No. Activities

1. It aims to provide few additional employments to the local population of the proposed study area.

Existing Direct employment provided: - 400 Approx.

Indirect Employment to locals :- 25 + 25 Approx.

2. The PP proposes for sustainable development as per the Companies Act 2013 and its subsequent

notifications regarding activities enlisted under the CSR. The PP has been undertaking need based

CSR activities annually and the same shall be given in the EIA / EMP report for the year 2017-18.

The proposed modernization with process integration project aims to continue the

sustainable social development. The Project authorities are committed towards fulfilling its

corporate social responsibility.

As per the preliminary site visit, the CSR activities were identified on the need based

requirement of the study area. However after the analysis of the baseline data generation

and socio – economic survey, and the public hearing, the appropriate sustainable

development plan will be contributed on the basis of need based analysis and projected by

the corporation.

The appropriate amount of CSR will be proposed by the Alchem International Private

Limited as per the Companies Act, 2013 with an appropriate 2% of the next three years

average annual net profits of the coming years.

Corporate Social Responsibility undertaken by Alchem International Pvt. Ltd.

Period

Year

Paid Via Amount

Contribution

As per the Schedule VII of the

Notification dated 27/02/14 of the

Companies Act, 2013

2017-

18

SBI Cheque No. 029855

dated 19.01.2017

9,00,000 Rotary and Blood Bank

Society for Facilitation

of

• Blood bags

• ELISA Testing

Kits

For screening donated

2017-18





February’2017 104

blood to ensure it is

safe.

2017-

18

January 2017

• Water Cooler (Stainless Steel)

• 10 Black Boards

• 120 seating Mats

55,000 Approx.

Rajkiya Prathmik

Pathshalla, Bapu Nagar

approx. 1.0 km N

2017-18

2016-

17

CitiBank Cheque no.

035891 dated

19.07.2016

8,00,000 BLOOD BANK

SOCIETY, PGI

CHANDIGARH

• Ambulance Car

2016-17

2015-

16

IDBI NET

BANKING Confirmation

No 85846304,

13,90,000 PRIME MINISTER

NATIONAL RELIEF

FUND

2015-16

2014-

15

IDBI, NET BANKING

Confirmation No

60883875

15,50,000

PRIME MINISTER

NATIONAL RELIEF

FUND

2014-15

Total 46,95,000

Pictorial Representation of the CSR Activities Undertaken :

Rajkiya Prathmik

Pathshalla, Bapu Nagar

approx. 1.0 km N January

2017

Water Cooler (Stainless

Steel)worth INR 35,000/-

For Making available safe

drinking water.





February’2017 105

Rajkiya Prathmik Pathshalla,

Bapu Nagar approx. 1.0 km

N January 2017contribution

of 10 Black Boards

120 seating Mats for

Promoting education.





February’2017 106





February’2017 107

Contribution of Ambulance Car to Blood Bank Society, Chandigarh by Alchem

International in the Year 2016.





February’2017 108





February’2017 109

10.0 CONCLUSION

The Modernization with process integration is planned in existing plant area of 89081 SQM. No

additional land is required. The total capital investment till 31.12.2016 of AIPL, Ballabgarh plant of

Herbal Extract & Its Purified Products is 137 CR.. The project is not only contribute to the growth of

Indian economy but also strengthen the socio-economic values/ status in the area. All the latest and

environment friendly technology is adopted. The unit is already adopt all measures like; pollution

control equipments, effective EMP & DMP to prevent harm/ damage to the environment. Green belt

development in & around the area is increase aesthetic value, as tool for effective pollution mitigate

measure, and are also serve as biological indicators for that particular site.

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