PRE -FEASIBILITY REPORT Introduction of the...

Pre-Feasibility Report of M/s Sunlight Active Drug Ingredients Pvt.Ltd

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PRE-FEASIBILITY REPORT

1. Introduction of the project

M/s Sunlight Active Drug Ingredients Pvt.Ltd is promoted by Sri T.Venkateshwara Rao

and Ms T.Nitya. Industry proposes to establish a bulk drugs, Intermediates and

chemicals manufacturing industry The unit is located on plot Nos.

268,269,270,271,KIADB’s Industrial Area, Kadechur Village, Yadgir Dist, Karnataka.

State. The extent of the industrial plot is 32376 square meters

2. Need of the project

The Indian pharmaceuticals market witnessed growth at a CAGR of 5.64 per cent, during FY11-16, with the market increasing from US$ 20.95 billion in FY11 to US$ 27.57 billion in FY16. The industry’s revenues are estimated to have grown by 7.4 per cent in FY17.

Indian pharmaceutical market grew 5.5 per cent in CY2017 in terms of moving annual turnover. In March 2018, the market grew at 9.5 per cent year-on-year with sales of Rs 10,029 crore (US$ 1.56 billion).

By 2020, India is likely to be among the top three pharmaceutical markets by

incremental growth and 6th largest market globally in absolute size.

Indian pharmaceutical sector industry supplies over 50 per cent of global demand for

various vaccines, 40 per cent of generic demand in the US and 25 per cent of all

medicine in UK. India contributes the second largest share of pharmaceutical and

biotech workforce in the world. In March 2018, the Indian pharmaceutical market grew

at 9.5 per cent year-on-year.

With 71 per cent market share, generic drugs form the largest segment of the Indian

pharmaceutical sector. India has become the third largest global generic API merchant

market by 2016, with a 7.2 per cent market share. The country accounts for the second

largest number of Abbreviated New Drug Applications (ANDAs) and is the world’s

leader in Drug Master Files (DMFs) applications with the US Indian Drugs &

Pharmaceuticals sector has received cumulative FDI worth US$ 15.59 billion between

April 2000 and December 2017.

Indian drugs are exported to more than 200 countries in the world, with the US as the

key market. Generic drugs account for 20 per cent of global exports in terms of volume,

making the country the largest provider of generic medicines globally and expected to

expand even further in coming years. India’s pharmaceutical exports stood at US$ 17.27

billion in 2017-18.


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At a growth rate of 9 percent per year, the pharmaceutical industry in India is well set

for rapid expansion. As a result of the expansion, the Indian pharmaceutical and

healthcare market is undergoing a spurt of growth in its coverage, services, and

spending in the public and private sectors.

Increase in the size of middle class households coupled with the improvement in medical infrastructure and increase in the penetration of health insurance in the country will also influence in the growth of pharmaceuticals sector. Based on the above study .many more pharmaceutical manufacturing industries are required. Source: Indian Pharmaceuticals Industry Analysis

3. Project Description

3.1 Project details

Sl.No Description Details

I Name of the project M/s Sunlight Active Drug Ingredients Pvt.Ltd

II Location

Village Kadechur

Area KIADB Industrial area

District Yadgir

State Karnataka

III Land use pattern

Total Land area in SQM 32376

Built-up area 17159

Production Block 11764

Storage yard 827

Roads 3238

Green Belt 10685

ETP 277

Open Area 738

Others 4847


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3.2 Project site selection

The main reason for selecting this site is industrial area has obtained Environmental

Clearance from MoEF &CC and consent to establish from Karnataka State Pollution

Control Board. Environmental Clearance is obtained for entire area by KIADB.

There are no endangered, threatened or rare plant species at the plant site or within the

10 kms radius of the industrial estate that need to be conserved. No noticeable impacts

on terrestrial life are anticipated. Industrial area is not a migration route to fauna.


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Topographical map of the Area

Toposheet Nos:

E43X2 E43X6

E43X3 E43X7


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General Location

KIADB Industrial area


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Site Layout


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3.3.1 List of proposed Products

The proposed industry intends to produce the products given below. The proposed

installation capacity is 180 TPM

Bulk Drugs

Intermediates

Sl No Name of the product Proposed production in TPM

1 Dabigatran 4.50 2 Trityl-Olmesartan 4.50

Sl No Name of the product Proposed production in TPM

1. Atorvastatin Calcium 1.00 2. Ciprofloxacin.HCl.H2O 10.0

3. Clopidogrel bisulphate 2.00

4. Domperidone 3.00 5. Drotaverine 4.00

6. Esomeprazole Mg Trihydarete 1.00 7. Fexofinadine HCl 3.00 8. Fluconzole 2.00

9. Lamotrizine 1.60 10. Lansoprazole 2.00 11. Levo Citirizine HCl 3.00

12. Mebeverine 3.00 13. Montelukast sodium 0.50 14. Olmesartan 0.50

15. Omeprazole 3.00 16. Oxalamine Phosphate 1.50 17. Pantoprazole Sodium 3.00

18. Rabiprazole Sodium 0.50 19. Ractopomine 1.00 20. Sildnafil citrate 5.00

21. Telmisatran 4.50 22. Triclabendazole 10.00 23. Valsartan 3.00


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Chemicals

Sl No

Name of the Intermediate Proposed production in TPD

1. Indole Derivatives 25.00 2. N-Butyl Lithium 8.40 3. Lithium Carbonate 10.00

4. Lithium Chloride 10.00 5. Sodium HMDS 5.00 6. Lithium HMDS 5.00

7. Lithium Tert Butoxide 0.50 8. N-Butyl Mg Chloride 20.0 9. Iso propyl Mg Chloride 8.40

10. Methyl Magnesium Chloride 1.00 11. Ethyl Magnesium Bromide 1.00 12. Tert Butyl Mg Chloride 1.00

13. Phenyl Mg Bromide 1.00 14. Phenyl Mg Chloride 2.00 15. Mg Tert Butoxide 0.50

Solvent Distillation

Sl No Name of the Intermediate Proposed production in TPD

1. All Solvents 25.00


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Chemicals


16. Indole Derivatives 25.00

17. N-Butyl Lithium 8.40 18. Lithium Carbonate 10.00 19. Lithium Chloride 10.00

20. Sodium HMDS 5.00 21. Lithium HMDS 5.00 22. Lithium Tert Butoxide 0.50

23. N-Butyl Mg Chloride 20.0

24. Iso propyl Mg Chloride 8.40 25. Methyl Magnesium Chloride 1.00

26. Ethyl Magnesium Bromide 1.00 27. Tert Butyl Mg Chloride 1.00 28. Phenyl Mg Bromide 1.00

29. Phenyl Mg Chloride 2.00 30. Mg Tert Butoxide 0.50

Solvent Distillation


2. All Solvents 25.00


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By-Products

Sl.No Name of the By-Product Quantity in TPM

1. 1-Bromo-5,5-dimethyl imidazolidine-2,4-dione 1.80

2. 2-Methylpentane 0.60 3. Acetaldehyde 0.39

4. Acetic acid 2.24 5. Ammonium Acetate 3.80 6. Copper Iodide 1.20 7. Dilute Bromo acetate 1.49

8. Dimethyl Sulfoxonium 0.50 9. Ethyl Benzene 1.20 10. Ethyl di isopropyl amine chloride 1.07

11. Ethyl Magnesium Bromide 0.12 12. Hydrobromic acid 0.63 13. Hydrogen Iodide 0.10

14. Hydroxy.Mg.Bromide 0.20 15. Iron(II) hydrate 0.64

16. Liq. Ammonia 1.57 17. Lithium Chloride 0.74 18. Methanesulfonic acid 0.08

19. Phosporic Acid 0.95 20. Piperazine HCl 2.90 21. Pot. Chloride 0.65

22. Pot. Acetate 0.86 23. Pot. Bromide solution 1.00 24. Pot. Iodide 1.09

25. Pot. Sulphate 2.95 26. Pot.Chloride 0.47 27. p-toluene sulfonic acid 0.10

28. Sod.Ethanoate 0.10 29. Sodium acetate 159

30. Sodium Bromide 0.73 31. Sodium Phosphate 1.30

32. Sodium Sulphate 1.06 33. Sodiumbicarbonate 0.1 34. Tributyl-methyl stanne 2.10

35. Triethylamine HCl 1.90 36. Triphenyl propionic acid 0.26


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3.4 Brief Manufacturing process

Active raw materials of the respective products are charged into reactor using a solvent

as per the process batch sheet. After maintenance solvent is recovered by distillation for

next batch. Thus final product is isolated and purified with water wash and sometimes

with crystallsation with a suitable solvent.

3.5 Typical flow chart

Active inputSolventCatalyst

Reactor Solvent recovery

CentrifugeWater Waste water

Product

3.6 Raw materials requirement

Bulk drugs, Intermediates & Chemicals manufacturing involves the use of chemicals

and organic solvents either directly as reactant or for extraction of a product of interest

from the reaction mixture.

These materials required for the process is mostly bought from the local (indigenous)

market. Coal is used in the proposed boiler of 3 MT/hour. The coal consumption is

about 6.0 Tons per day. Diesel used for DG set of capacity 250KVA will be about 40

liters/hr at full operation load.

3.7 Resource Re-Cycling Optimizing /Re-cycling

All efforts will be made by the industry to carry out R& D on the isolated by-products /

wastes to minimize wherever possible. However R& D is a continuous process, where

improvement in the process adopted by the industry, waste minimization etc can be

worked out as the project progresses.


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3.8 Utilities

Sl.No Name of the utility Units 1 Coal Fired Boiler -3 TPH 1 2 Thermic Fluid Heater 2 KCal 1

3 GG Set -225KVA 1 4 Cooling Towers-400TR 2 5 Air Compressor-5 CFM/1 Kg

pressure 1

3.9 Water requirement

The total water requirement of the plant is 82M3/day. The water needs for the industry

will be met from KIADB supply.

3.10 Power requirement

The total power requirement of the plant is 350HP and is met from public supply. DG

set of 250KVA will be used only as stand by.

3.11 Wastewater generation & Proposed Treatment method

The wastewater generated from the production block will be subjected to primary

treatment and treated effluent will be pumped in to the R.C.C. tanks constructed above

ground level and will be lined with Acid proof tiles for storage and it will be sent to

Multiple Effect Evaporators for re-cycling till CETP is established. Condensate will be

reused appropriately. Salts from the MEE evaporation system will be collected and sent

to TSDF. Domestic waste water will be sent to septic tank.

3.12 Hazardous waste generation & Proposed Treatment method

Hazardous wastes generated from the plant are divided into Inorganic waste and

Organic waste. Inorganic wastes will be sent to TSDF for secured land fill. Organic

wastes will be sent to nearby cement plants for incineration along with spent Carbon.

Coal ash from boiler will be sold to suitable buyers.


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4. Site Analysis

Industrial area is well connected by Road and rail. It is beside to KA SH 15 connecting

between Yadgir and Bengaluru. Project area is a notified industrial area. Industrial area

has obtained Environmental Clearance from MoEF & CC in 2016

The area is well away from sensitive sites such as National parks, Wild life sanctuaries,

biosphere reserves, defense installations and religious places.

Temperatures in summer during day time is 400C and 250C during night times. During

monsoon it will be between 290C and 200C and in winter it will varies between 290C

during day time and 160C in the night. Relative humidity is between 60% and 65% .The

rainfall generally is spread over 49 days. Nearly 69% annual rainfall is between June

and September. A few showers will be received during the October. Maximum average

rainfall is 700mm in the area during monsoon period.

Secondary source

5. Brief Planning

Industry proposes to operate round the clock in shifts. Transportation of workers is a not

a concern as proposed industry provides transportation. Industry will engage private

operators for the purpose.

5.1. Rehabilitation and Resettlement

Since the industry is proposed on a notified industrial area, R& R is not required. By

providing direct and indirect employment to the locals and also by facilitating the

villages by conducting various developmental programs in a phased manner in

association with local bodies, Yadgir district will develop socio-economically.

5.2 Post project monitoring

The industry has definite environmental monitoring program to monitor the Ambient

Air Quality as well as Stack Emissions. The industry will install online monitoring

system as per the CPCB guidelines. Qualified staff appointed for the purpose will take

care of Operation and maintenance of the pollution control facilities. Stand-by facilities

will be provided to all the pumps so as to ensure fail proof treatment.


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5.3 Greenbelt development

5.3.1 Objective

The purpose of a green belt around the plant site is to capture the fugitive emission,

attenuate the noise generated and improve the aesthetics.

The green belt at the project site will form an effective barrier between the plant and the

surroundings. Open spaces, where tree plantation may not be possible, will be covered

with shrubs and grass to prevent erosion of topsoil. Adequate attention will be paid to

plantation of trees, their maintenance and protection. Green belt is being developed

around the periphery of the plant. Open spaces within the factory will be converted to

green areas in the form of lawns or flowering plants.

5.3.2 Plant species for green belt.

A wide range of plant species will be planted in and around the premises to help capture

the fugitive emission and noise levels form the plant premises. This wide range covers

plants of

Fast growing type.

With thick canopy cover

Perennial green nature

Native origin

A specialist in horticulture may be appointed to identify any other native species and

also supervise greenbelt development.

5.3.3 Design of Green Belt

As far possible the following guidelines will be considered in proposed green belt

development. Shrub and trees will be planted in encircling rows around the outer three

rows (away from planted side)

The short trees (<10 m height) will be planted in the first two rows (towards plant side)

of the green belt. The tall trees (>10 m height) will be planted in the outer three rows

(away from plant side).

Planting of trees in each row will be in staggered orientation.

In the front row, shrubs consisting of Callistemon, Prosodies etc. Will be grown.


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Since the trunks of the tall trees are generally devoid of foliage, it will be useful

to have shrubs in the fronts of the trees so as give coverage to this portion.

The spacing between the trees will be maintained slightly less than the normal spaces,

so that the trees may grow vertically and slightly increase the effective height of the

green belt.

5.4. Recycle of wastes

All efforts will be made by the industry to carryout R&D on the isolated by-products /

wastes to recycle / reuse wherever possible. However, R&D is a continuous process,

where improvement in the processes adopted by the industry, waste minimization etc

can be worked out as the project progresses.

6 Environment management cell

The unit will provide upgraded Environment Management cell as below:

6.1 Environment Management Cell

The Environment Management Cell shall include:

1. Manager 2. Process in charge from production 3. In charge Maintenance Department 4. In charge Operation ETP, Air Pollution Control Division, Solid waste

management with Chemist

7. Handling of raw materials and finished materials

The industry proposes to store the raw materials sufficient for one month of operations.

These raw materials and finished goods will be stored in the ware house as per safety

norms.

8. Hazardous Chemical, waste and Risk Assessment

Bulk Drugs, intermediate and Chemicals manufacturing industry has to handle many

such a chemicals that are hazardous in nature. The industry will provide special training

to the workers handling Hazardous chemical / wastes. The industry will engage safety

consultants to prepare a risk assessment and suggest safe handling and safe storage of

Hazardous wastes for the proposed project. Only highly trained personal with personal

projective Equipments (PPE’s) will be allowed to handle such chemicals or under strict

supervision.


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9. Project schedule and cost estimates

Industry proposes to commence the production activity as soon as Environmental

Clearance and Consent to operate are granted by respective authorities.

The Total Gross proposed investment on Land, Buildings and Plant & Machinery is

about ₹.18.80 crore and the Unit has been registered under Small Scale Industry.

Industry has allocated an amount of about ₹.18.00 Lacs for Environmental Protection

measures including for green belt development.

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