PRE-FEASIBILITY REPORT (Proposed Expansion of Active Pharmaceutical Ingredients (APIs) to APIs & API Intermediates with R&D products manufacturing unit) Of M/s. Aurore Life Sciences Private Limited Sry. Plot nos. 180/2, 180/3, IDA Khazipally, Khazipally (Village), Jinnaram (Mandal), Sangareddy District, Telangana Submitted to Ministry of Environment, Forests and Climate Change, New Delhi March 2019
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PRE-FEASIBILITY REPORT
(Proposed Expansion of Active Pharmaceutical Ingredients (APIs) to APIs & API Intermediates with R&D
State. Hence, Alternate sites are not considered for the present expansion project.
Environmental considerations of this expansion project site.
> 1.5 km away from nearest human habitation Kishtaipalli
Water Bodies
• Pond near Gaddapotharam – 1.4 km (N) • Pond near Gaggilapur – 3.5 km (NE) • Pond near Dundigal – 5 km (NE) • Pashib Cheruvu – 4.3 km (NNW) • Bapanna Cheruvu – 5.6 km (W) • Gandigudem chruvu – 4 km (WSW) • Pond near Sultanpur – 7.7 km (WSW)
Stripper condensate ~10 KLD; Moisture in salt and ETP sludge is ~ 6 KLD, Water loss in ETP ~33 KLD (Total water loss is ~49 KLD = 12.6 %) Reuse: 340 KLD 723 723
Note: *267 Tons consists of ~250 KL liquid and ~19.4 Tons of salt
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Table 6: Effluent Treatment Flow as per Segregation
Effluent Characteristics
Quantity (KLD) Treatment Flow
Stream -1 (Process & scrubber)
TDS > 5000 mg/l COD > 5000 mg/l
255
Collection Equalization cum Neutralization Settling Holding Steam stripper MEE along with HTDS effluent Condensate to ETP (biological treatment) Concentrate to ATFD
MEE & ATFD Condensate to ETP (Biological Treatment) along with domestic wastewater holding tank Pressure Sand Filter Activated Carbon Filter ETP RO system RO permeate water reuse in Cooling towers.
ETP RO rejects to MEE.
ATFD Salts to TSDF and stripped solvents to SPCB authorized cement industries
Stream- 2 (Washings, QC, R&D
and Domestic) TDS / COD < 5000 mg/l
113.5 Collection Equalization cum Neutralization ETP (Biological Treatment) along with MEE & ATFD Condensate
Stream 3 (Fresh water RO rejects) 20 Collection Tank ETP RO system
Existing treatment system will be enhanced to meet the proposed effluent quantities. All the
proposed additional tanks in the ETP will be constructed / installed above the ground with water proof
lining. These individual effluents will be pumped to the RCC lined tanks for storage and neutralization
and then sent to upgraded ETP-ZLD of 400 KLD capacity within the plant premises. Effluent
Treatment Plant flow chart is enclosed as Annexure-XIX.
ETP – ZLD facility consists of primary treatment (equalization and neutralization), thermal
treatment (stripper with MEE, ATFD), secondary treatment (biological) and tertiary treatment
(Pressure sand filter, Activated carbon filter & Reverse Osmosis) will be provided. Domestic
wastewater will be sent to septic tank and the overflow to ETP (biological treatment). Concentrate
from MEE system will be sent to ATFD and the salts from the evaporation system will be collected
and sent to TSDF / Authorized Cement industries for safe disposal based on calorific value of the
waste.
3.9.2 Hazardous / Solid Waste Generation, Handling and their Disposal
Hazardous / Solid waste will be segregated, detoxified and collected in the HDPE drums /
bags and will be stored in the covered and raised platform with Leachate collection system. The
existing and proposed solid waste and other waste generated, handling and disposal method from
the various stages of APIs manufacturing plant is presented in the Tables 7 & 8 respectively.
Spillages such as wastewater / solid wastes / raw materials are possible and the risk of this would be
limited to within the premises of the manufacturing facility. A precautionary measure like spillage
control management is practiced in the industry.
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Table 7: Hazardous Waste Generation from the Existing (CFO) Products Sl. No Description Stream Quantity Disposal
Hazardous Wastes with Recycling Option
1 Waste Oils 5.1 of Schedule - I
50 Ltrs/ Annum
Authorised re-processors / recyclers
Table 8: Hazardous / Solid Waste Generation from the Proposed Products
Sl. No. Description
Proposed Quantity
(TPD) HW Stream Handling
Method Disposal
1. Organic residue from Process 13 28.1 of Schedule -I
HDPE Drums
Sent to SPCB Authorized Cement
industries or to TSDF for Incineration
2. Distillation Bottom Residue (1% of spent solvents) 3 36.1 of
Schedule -I
3. Spent carbon 1.1 28.3 of Schedule -I
4. Inorganic & Evaporation salt (Process) (10% moisture) 24.6 28.1 of
Schedule -I HDPE Bags
Sent to SPCB Authorized Cement
industries or to TSDF for Incineration
(based on Calorific value)
5. Evaporation salt with moisture (Non-Process & scrubber) 2 35.3 of
Schedule -I
6. ETP Sludge with moisture 1.0 35.3 of Schedule -I
7. Boiler ash 32 -- HDPE Bags
Sent to Brick Manufacturers
Other Hazardous Waste generation from the Plant
8.
a) Detoxified Container / Liners drums, HDPE Carboys, Fiber Drums,
Recovered Solvents from Spent solvents (80% recovery from spent solvents)
145 KLD 28.6 of
Schedule -I
Tanks / Drums
Reuse or sold to Recyclers
11. Spent Mixed solvents (unrecovered solvents) 40 KLD 28.6 of
Schedule -I Tanks/ Drums
Sent to SPCB Authorized agencies
12. Waste oils & Grease 6 KL/ Annum
5.1 of Schedule -I MS Drums
Sent to SPCB Authorized agencies for
reprocessing
13. Used Lead acid Batteries 100 nos. / annum
A1160 of Schedule-III
Stored in Covered
shed
Sent to suppliers on buy-back basis.
14. Misc. Waste (spill control waste) L.S. -- Stored in
Drums TSDF 15. Rejects L.S. --
16. E- waste L.S. -- Designated covered
area
Authorized reprocessor or
TSDF
17. Waste papers & other types of packing scrap L.S. -- Sold to scrap venders
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Sl. No. Description
Proposed Quantity
(TPD) HW Stream Handling
Method Disposal
18. Canteen waste L.S. -- HDPE bags
Composted on site and reused for green belt
19 Bio Medical Waste LS. -- Color coded
containers
Sent to SPCB authorized Biomedical
waste incinerator
20 Spent Catalyst LS -- Drums Sold to suppliers on buy
back basis / Auth. Reprocessor
21 Segregated Construction waste LS -- Covered
area
Filling the low lying areas./ sent to Auth. Agencies for recycle
Note: * Max. Hazardous / Solid waste quantities from 13 campaign products out of total 68 products and R&D products
3.10 Schematic Flow Sheet for EIA Procedure
The schematic flow sheet for EIA procedure is depicted as Annexure -XX.
4.0 Site Analysis 4.1 Connectivity
This proposed expansion project site is located at a distance (aerial) of 2.8 km (NE) from
State Highway No. 6: about 1.7 km (WNW) from nearest habitation Kishtaipalli, 10.2 km (ENE) to
Gowdavally railway station; 38 km (S) to Rajiv Gandhi International Airport, Shamshabad, Hyderabad.
4.2 Land Form, Land use and Land Ownership
The proposed expansion is in the plain land of existing manufacturing unit. Total land is 3.23
Ha. Land is in possession of Project Proponent.
4.3 Topography
The Topography map with a 10 km radius is enclosed as Annexure-XXI.
4.4 Existing Land Use Pattern
The existing and proposed land use pattern of project area (core area) of 3.23 Ha is Industrial
land and shortest aerial distance environmental components in buffer area from the project periphery
are given in Table 9.
Table 9: Environmental Components shortest distance from Project periphery
Sl. No. Description Distance & Direction w.r.t. site 1. Water bodies • Pond near Gaddapotharam – 1.4 km (N)
• Pond Near Gaggilapur – 3.5 km (NE) • Pond near Dundigal – 5 km (NE) • Pashib Cheruvu – 4.3 km (NNW) • Bapanna cheruvu – 5.6 km (W) • Gandigudem cheruvu – 4 km (WSW) • Pond near Sultanpur – 7.7 km (WSW)
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Sl. No. Description Distance & Direction w.r.t. site 2. Reserved Forests • Narsapur Reserved Forest Block (Gottimukkula RF, Nallagutta
• Kazipally RF (Open scrub) – 0.38 km (W) • Dundigal RF (Dense Scrub) – 0.65 km (E) • Wailal RF (Dense mixed Jungle) – 2.2 km (NW) • Pottaguda RF (Dense Mixed Jungle) – 6 km (WNW) • Gaudavalli RF (Open Scrub) / Pochampally Khurd RF– 6.28 km
(E) • Gajularamaram RF (Dense Mixed Jungle) – 4.46 km (ESE) • Dulapalle RF (Rocy Knob) – 7.65 km (ESE)
3. National Parks/ Wild Life Sanctuaries/ Eco sensitive areas
Nil
4. Industries Located in Notified Industrial Area of IDA, Khazipally 5. Defence Installation Dundigal Airforce station – 4.8 km (NNE) 5. Habitation Nearest habitation is 1.7 km (NNE) away from the project site.
4.5 Existing & Proposed Infrastructure
Internal Cement Concrete roads, water supply, Upgraded to In-house ETP-ZLD facility, Power
supply, Production block, Utilities, Conference halls, Fire hydrant system, Telecommunication facility
etc., are available.
4.6 Soil Classification
The soil in the study area is reddish brown in colour containing 38.19 % silt, Clay 19.65 %,
and sand 42.16% (Sandy loam).
4.7 Climate Data from Secondary Sources
The area enjoys pleasant, warm and dry climate. The coldest season is during December and
January, where the temperature touch a minimum of 13.6-15.8°C and warmest period is during the
month of April to May when the Mercury shoots up to 43 – 44.2°C.
The area experiences the maximum rainfall during the months of July to October and a little
rainfall during November and December due to North-East monsoon. Apart from these, occasional
rainfall is obtained from cyclonic storms and depression originating in the Bay of Bengal. The normal
annual rainfall of the area is around 951.7 mm. The rainfall is erratic and long period of dry spells
leading to drought conditions are frequent and periodic.
4.8 Social Infrastructure
IDA, Khazipally is in notified industrial area having power supply, communication system, well
maintained internal roads, operating various industries in the Industrial area and IDA is well
connected by Road, Rail and Airways.
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5.0 Planning 5.1 Planning Concept Type of Industry: APIs & API Intermedaites manufacturing industry with R&D products.
Facilities: Industry proposed for expansion at existing land and facilities required for the project will
be provided as per requirement.
Transportation: Transportation of raw materials and final products is done via roads as the proposed
expansion project is well connected to Road.
Town and Country Planning Classification: This is Notified Industrial land of IDA, Khazipalli, and is
in possession of project proponent
5.2 Population Projection
Proposed project is in the existing industry of Notified industrial area and there is a scope for
increase in the population in the vicinity as most of the skilled workers prefers to stay in the nearby
locations to avoid travelling from long distances. However, semi-skilled and indirect employment
potential is from local villages. Hence, there is a possibility of increase in population of the skilled and
semi-skilled. The local unskilled villagers will be preferred for the unskilled jobs such as gardening,
movement of materials, etc. Educated youth will be employed as semi-skilled workers and training will
be provided. However, on the whole there is a possibility of marginal increase in population of the
area.
5.3 Land use Planning
The expansion unit has been proposed in existing area of about 3.23 Ha i.e., 32373.79 sq.m.
The Land use pattern of the proposed expansion is presented in Table 10.
Table 10: Land Breakup Details
Sl. No. Description
Existing Area
Proposed Area
Total Area after expansion
(SQ.M) (SQ.M) (SQ.M) Percent (%)
1. Built-up area 7470 7094 14564 44.9 2. Roads 24929
17835 6550 20.2
3. Open Area 570 1.8 4. Greenbelt 10715 33.1
Total 32399 32399 32399 100
5.4 Assessment of Infrastructure Demand
On assessment of infrastructure demand near the project area; Ambulance facility
requirement for the nearby villages of project area. Project site located in IDA Khazipalli, Sangareddy
district, Telangana.
5.5 Amenities/Facilities
Industry will continue to provide and upgrade the following amenities / facilities in the
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proposed expansion project.
• Canteen • Potable drinking water • Training block • Laying of Concrete internal roads • Fire hydrant facility • Eye/body wash showers • First Aid kits at all prominent places. • Rest Room for employees • Seating facilities for those employees who do their work standing and ergonomically designed
seating facilities for those who do their work seating • Pre-employment and routine medical examinations and the necessary follow up actions • Communication systems like Phone, Internet with safety measures, etc. • Security system at the entrance etc.
6.0 Proposed Infrastructure
6.1 Industrial Area
Additional Production Blocks, Utilities area, ETP up-gradation has been proposed in the
existing area with extended land of 3.23 Ha.
6.2 Residential Area
There will be no residential area within the project site.
6.3 Greenbelt
The existing Greenbelt of 1.07 Ha (33%) out of 3.23 Ha total area of the project.
6.4 Social Infrastructure
As Corporate Environment Responsibility (CER), Industry will contribute for development of
village social infrastructure in association with other industries of IDA Khazipalli.
6.5 Connectivity
There is no change in connectivity compare to existing facility.
6.6 Drinking Water Management
Potable drinking water will be provided to additional employees. The source of drinking water
is packaged drinking water.
6.7 Sewerage System
Sewage will be generated from the Canteen and Toilets, which will be collected into sewage
collection tank through pipelines and will be sent to proposed ETP – ZLD system.
6.8 Industrial Waste Management
Existing storage system needs to be enhanced to meet the project requirement. The
management of these wastes is to be handled very sensitively and by adopting proper segregation
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techniques.
6.8.1 Process Emissions Management
Manufacturing of APIs will result in gaseous emissions. Maximum process emissions for
proposed products are given in Tables 11. Proposed gaseous emissions will be scrubbed in two
stages with water and caustic solution based on the characteristics of gases.
Table 11: Process Emissions from Proposed Products with treatment method
Sl. No.
Process Emission Treatment
1. HCl • Scrubbed by using water & CS lye solution
2. NH3 • Scrubbed by using Chilled water / dilute H2SO4
solution. 3. H2 • Diffused with Flame Arrestor 4. n-Butane • Diffused with Flame Arrestor 5. N2 • Dispersed into atmosphere 6. SO2 • Scrubbed by using CS lye solution 7. Bromine • Scrubbed by using CS lye solution
8. Hydrogen Bromide • Scrubbed by using CS lye solution
9. CO2 • Dispersed into atmosphere
6.8.2 Solvent Recovery System:
Industry proposed to install 4 nos. of 1 KL/hr solvent distillation system for solvent recovery in the
expansion proposal with double condensers to recover > 95% solvent. Following will implement to
reduce the solvent losses.
6.8.2.1 Fugitive emissions
Solvents used in the APIs manufacturing process will be stored in drums and bulk quantities
will be stored in above ground storage tanks.
Solvents are handled in closed conditions thereby reducing the losses in the form of
evaporation.
Proper earthing will be provided to all the electrical equipment and the joints / connections
wherever solvent handling is done.
Reactor and solvent handling pump will have mechanical seals to prevent leakage.
Industry will take measures for reduction of fugitive emissions and for further reduction
industry will provide vent condensers to the tanks.
Chilled brine circulation will be carried out to condensate the solvent vapour and to the
receivers of the solvent vapors which ensures the maximum recovery.
Solvent vapours from the Centrifuge and Catch pots will be connect to vent condensers.
The height of the solvent receiver tank vent is above production block roof level and the
diameter is 20 mm.
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Flame proof fitting / equipments / pumps / lighting will be used wherever solvents are used.
The solvent storage tanks will be provided with breather valve to prevent losses.
Considering the above precautions, Solvent recovery will be ~98% and losses will be
restricted to ~ 2%
6.8.3 Emissions–Utilities
Boilers and DG sets are the main sources contributing to emissions from the plant. Proposed
3, 7 & 10 TPH coal fired boilers. Another proposed 10 TPH coal fired boiler will be standby after
expansion and existing 0.5 TPH coal fired boiler will be removed after expansion. Coal of about 80
TPD will be used in the boilers.
Diesel about 1260 lit / hr will be used at full operation load in the DG sets. 4 x 500 KVA, 2 x
1010 KVA & 1500 KVA and proposed 3 x 4 lakhs Kcal/hr & 2 x 2 lakh Kcal/hr Diesel/ Furnace oil fired
Thermic Fluid Heaters (TFH). Existing 2 x 125 KVA DG sets will be removed after expansion. DG
sets are used as standby during power failure. The stack emissions from the boiler and DG sets are
given in Table 12. Table 12: Stack Emission Details
*Existing 0.5 TPH coal fired boiler and 2 x 125 KVA DG set will be removed after expansion
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The various measures proposed to minimize the pollution from the boiler are as follows:
Multi-cyclone separator followed by Bag filter will be installed to control the particulate (PM)
emissions within statutory limit of 115 mg/Nm3. To facilitate wider dispersion of pollutants, 32 /
30 m height stack each will be installed as per CPCB guidelines based on sulphur content.
[Stack height formula H = 14 Q0.3 (Q is emission rate of SO2 in kg/hr)]
NOx emissions from the boilers will be controlled by controlling combustion measures, which
will be approached by way of low NOx burners or by air stagging in boiler.
Stack height will be based on Sulphur content in fuel as per CPCB guidelines
Stacks will be provided to proposed DG sets as per CPCB / SPCB Guidelines.
Fugitive dust will be controlled by adopting dust extraction and dust suppression measures
and development of greenbelt along the periphery of the proposed Boiler area.
6.8.4 Noise Environment
• Compressors, Boilers, TFH and DG sets will be the major noise generating units in the plant.
• Noise levels of the DG sets will be well within the limits as these will be installed with acoustic enclosures. Workers will always be provided with ear muffs.
• All the equipment in the plant would be designed to have a total noise level not exceeding 85-
90 dB(A) as per the requirement of OSHA (Occupational Safety and Health Administration)
standards.
6.9 Hazardous / Solid Waste Management
• Solid waste mainly segregated into process organic residues, inorganic salts, distillation
residue, boiler ash, spent mixed unrecoverable solvents and spent carbon.
Subject: Acknowledgement Slip for Transfer of EC applica�on
Acknowledgement Slip for Transfer of EC application
This is to acknowledge that the proposal has been successfullyuploaded on the portal of the Ministry. The proposal shall beexamined in the Ministry to ensure that required information has beensubmitted. An email will be sent seeking additional information , ifany, within 20 working days. Once verified, an acceptance letter shallbe issued to the project proponent .
Following should be mentioned in further correspondence
1. Proposal No. : IA/TG/IND2/99833/20052. Category of theProposal : IND2
3. Name of the Proposal : Aurore Life Sciences Private Limited4. Date of Submissionfor EC : 19 Mar 2019
5. Name of the Project Proponent along with Contact Details
a) Name of theproponent : AURORE LIFE SCIENCES
PRIVATE LIMITEDb) State : Telanganac) District : Sangareddyd) Pincode : 502319
Industrial Promotion - Notified Industrial Areas – Gaddapotharam (Kazipally), Bonthapally & Gundlamachanoor areas of Jinnaram Mandal, Medak District declared as Notified Industrial Areas in G.O. Ms. No. 120, Industries & Commerce (IP) Department, Dated : 22-10-2013 – Further Orders – Issued. -----------------------------------------------------------------------------------------------------------------------------
INDUSTRIES & COMMERCE (IP & INF) DEPARTMENT
G.O.Ms.No.80 Dated: 27/10/2015 Read the following :
1. G.O. Ms. No.120, Industries & Commerce (IP) Department, Dated: 22-10-2013 2. From the Commissioner of Industries, Hyderabad single file No.29/1/2012/13884
/15679/UP, Dated :04.09.2015 3. Orders of the Hon’ble High Court of Judicature, Hyderabad dt:28-09-2015. 4. From the Commissioner of Industries Letter No.29/1/2012 /13884/15679/UP,
Dated : 01-10-2015 5. G.O.Ms.No.309, Industries & Commerce (IP) Department, Dated: 03-10-2015. 6. From the Commissioner of Industries Letter No.29/1/2012 /13884/15679/UP,
Dated :09-10-2015 & 19.10.2015.
***** ORDER:
In the reference 1st read above, Government have notified Gaddapotharam (Kazipally), Bonthapally & Gundlamachanoor areas of Jinnaram Mandal, Medak District declared as Notified Industrial Areas, as those areas were already located within Manufacturing Zones as notified in the master plan of Hyderabad Metropolitan Development Authority and more than 140 industries are operating in these areas with all the required clearances including Consent for operations (CFO) with certain conditions as proposed therein.
2. In the references 2nd & 4th read above, the Commissioner of Industries, Hyderabad has stated that M/s. Bulk Drugs Manufacturers Association has informed that the State Pollution Control Board insisting to get amended the G.O. 1st read above mentioning that the units specified in the notified industrial areas were in operation since 1990’s, as the same was not included in the said G.O. He has therefore, requested the Government to constitute a Committee for verification and getting the information on number of such units together with evidence of being in operation from 1990s. 3. In the G.O. 5th read above, the Government have constituted a committee under the Chairmanship of the Additional Director of Industries with the members mentioned therein for verification and getting the information of the Bulk Drugs Units established during 1990’s and after that decade and to suggest amendments required to G.O.Ms.No.120, Industries & Commerce (IP) Department, Dated:22-10-2013.
4. In the reference 6th read above, the Commissioner of Industries has submitted a report of the Committee which, after visiting the Bulk Drugs Units and after studying the status of the units with specific reference to their operations since inception including change of Management if any, duly verifying the documentary evidence has confirmed that the following notified Industrial Areas are existing since 1990’s: 1. Bonthapally, Jinnaram Mandal, Medak District. 2. Khazipally/Gaddapotharam, Jinnaram Mandal, Medak District.
(PTO)
ANNEXURE - XI
88
::2::
5. Government, after careful examination of the proposal, hereby accept the recommendations of the committee and orders that the period of establishment of the above said notified Industries Areas shall be read as mentioned in para-4 above, in implementation of the orders issued in the G.O. 1st read above.
6. The Commissioner of Industries, Hyderabad shall take necessary further action in the matter accordingly.
[ BY ORDER AND IN THE NAME OF THE GOVERNOR OF TELANGANA ]
JAYESH RANJAN SECRETARY TO GOVERNMENT & CIP (I/c)
To The Commissioner of Industries, Hyderabad. Copy to: The Member Secretary, T.S.Pollution Control Board, Hyderabad. The President, Bulk Drug Manufacturers Association, Hyderabad. The Additional Principal Secretary to Hon’ble Chief Minister The P.S. to Hon’ble Minister for Industries. The P.S to Chief Secretary to Government. The P.S to Secretary to Government & CIP, Ind. & Com. Dept., Sf/Sc.
//FORWARDED::BY ORDER//
SECTION OFFICER
ANNEXURE - XI
89
Jinnaram Mandal , Sangareddy District
India
General Location Map
Project Site
90
Jinnaram Mandal , Sangareddy District
India
General Location Map
Project Site
ANNEXURE - XII
91
Specific Location (Route Map)
Project Site Village
Dundigal Air Force Academy
M/s. Aurore Life Sciences Private Limited
Kazipalli Industrial Area
Ali Nagar
Dundigal
Gandi Maisamma
Dommara Pochampalli
Chetla Potaram
SambhupurKistaipalli
ANNEXURE - XII
92
Google Image of the Proposed Project with Project Site Coordinates