DASAMI LAB PVT. LTD.

 
SY.NO. 404, 405, 407, 408, 409 AND 410, VELIMINEDU VILLAGE,  
CHITYAL MANDAL, NALGONDA DISTRICT, TELANGANA 
 

 
 
 
 
 
 
 
 

EXECUTIVE SUMMARY 
 
 
 
 
 
 

 
 
 
 
 
 
 
 

 
 

 
 
 
 
 
 
 
 
 
 
 

 
 
 

SUBMITTED TO 
TELANGANA STATE POLLUTION CONTROL BOARD,  
REGIONAL OFFICE, NALGONDA
Dasami Lab Pvt. Ltd. Executive Summary

CHAPTER 11.0 EXECUTIVE SUMMARY

Introduction
Pharmaceutical Chemicals are used for the benefit of human and animal health. The scale
of manufacturing of active pharma ingredients is less compared to other synthetic organic
chemicals, which are used for the manufacture of consumer products, dyes etc. India is a
major producer of active pharma ingredients contributing to wellbeing of both human and
animal population of the world.

SVAKRM Laboratories Pvt. Ltd., obtained Environmental Clearance vide letter no. F. No.
J-11011/533/2007-IA.II (I), dt. 21.02.2008 and subsequently obtained Consent for
Establishment (CFE) Vide Order no. 256/PCB/CFE/RO-NLG/HO/2011-2272 dated
24.10.2011 subsequently SVAKRM Laboratories Pvt. Ltd., changed the name of industry as
“Medchem Organics Pvt. Ltd. Medchem Organics Pvt. Ltd. has been taken over by Dasmi
Lab Pvt. Ltd., and renewed CFO vide letter no. TSPCB/ RCP/NLG/HO/CFO/HO/2015 -
02 dated 29.03.2016 valid till 30.04.2020.

Dasami Lab Pvt. Ltd., proposed to expand the manufacturing capacity to 15 TPM to 421
TPM by acquiring additional land area of 43.875 acres with a capital cost of Rs. 45 Crores.
Total land area after expansion is 51 acres and the expansion mainly involves construction
and commissioning of additional production blocks, utilities and Zero Liquid Discharge
facility. Prior environmental clearance has to be obtained from Ministry of Environment,
Forest and climate change, vide SO 1533, dated September 14, 2006, for synthetic organic
chemicals manufacturing activity. The terms of reference for the environmental impact
assessment studies was obtained from MoEF&CC vide letter no. F.No. J-11011/57/2016-
IA II (I) dated 08.06.2017 as part of environmental clearance process.

Location of the Project:

The plant site is located at Survey No. 404, 405, 407, 408, 409 & 410, Veliminedu Village,
Chityal Mandal, Nalgonda District, Telangana State. 43.875 acres of site is additionally
acquired for the expansion to the existing 7.125 acres. The total site area for expansion is
51 acres. The site is located at the intersection of 17°13'27" (N) latitude and 79° 2'45" (E)
longitude. The plant site elevation above mean sea level (MSL) is in the range of 329 - 338

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m. The plant site is surrounded by open agricultural land in east and south directions,
proposed site of Actero Pharma Pvt. Ltd., in west direction and Pittampalli village road
connecting national highway in north direction. The nearest habitation from the plant is
Pittampalli village located at a distance of 2.2 km in southwest direction. The main
approach road NH-9 with pittamapalli village is adjacent to site in north direction.
National Highway 9 - Hyderabad - Vijayawada is at a distance of 0.5 km in north
direction. The nearest town Chityal is at a distance of 8.3 km in northeast direction. The
nearest railway station Ramannapet is at a distance of 7.6 km in northeast direction and
nearest airport is Rajiv Gandhi International Airport (Hyderabad) located at a distance of
65 km in northwest direction. Seasonal nala Chinna Vagu is flowing from northwest to
southeast direction at a distance of 6.5 km in southwest direction. There are two reserve
forests in the impact area of 10 km radius of the study area. Chityal RF at a distance of 6.0
km in east direction, Shivanenigudem RF at a distance of 9.0 km in northeast direction.
There is no national park, wildlife sanctuary, ecologically sensitive area, biosphere
reserve, tiger reserve, elephant reserve, critically polluted areas and interstate boundary
within 10 km radius of the site.

Product Profile
The manufacturing capacity of proposed products after expansion and by-products are
presented in following tables;
Manufacturing Capacity – After Expansion
S.No Name of Product CAS No. Capacity
TPM Kg/day
1 Amlodipine Besylate 111470-99-6 20 666.7
2 Aprimilast 608141-41-9 3 100
3 Bocepravir 394730-60-0 6 200
4 Bupropion HCl 31677-93-7 20 666.7
5 Carvedilol 72956-09-3 30 1000
6 Clopidogrel Hydrogen Bisulfate 135046-48-9 10 333.33
7 Colisevelam 182815-44-7 6 200
8 Dalfampridine 45498-20-2 17 566.7
9 Dex lansoprazole 138530-94-6 5 166.67
10 Divalproex Sodium 76584-70-8 15 500
11 Drotaverine HCl 985-12-6 3 100
12 Duloxetine HCl 136434-34-9 15 500
13 Esli Carbazapine 236395-14-5 2 66.7
14 Fexofenadine HCl 153439-40-8 10 333.3
15 Glimepride 93479-97-1 3 100
16 Lansoprazole 103577-45-3 8 266.67

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17 Lomitapide 202914-84-9 2 66.7

18 Mesalamine 89-57-6 7 233.33
19 Nebumitone 42924-53-8 10 333.33
20 Omeprazole 73590-58-6 5 166.7
21 Piperquine Phosphate 4085-31-8 5 166.7
22 posacanazole 171228-49-2 7 233.3
23 Ramipril 87333-19-5 7 233.3
24 Ranolazine 95635-55-5 10 333.3
25 Sevelamir HCl 152751-57-0 29 966.67
26 Sparfloxacin 110871-86-8 20 666.7
27 Telapravir 402957-28-2 5 166.7
28 Ticagrelor 274693-27-5 1 33.3
29 Tramadol HCl 27203-92-5 12 400
30 Valacyclovir 124832-27-5 6 200
31 Valagancyclovir HCl 175865-59-5 2 66.7
32 Abiraterone Acetate 154229-18-2 1 33.3
33 Anastrozole 120511-73-1 2 66.7
34 Bendamustine Hydochloride 3543-75-7 2.5 83.3
35 Bexarotene 153559-49-0 3 100
36 Bicalutamide 90357-06-5 5 166.7
37 Bortezomib 179324-69-7 0.5 16.7
38 Carboplatin 41575-94-4 5 166.7
39 Capecitabine 154361-50-9 2 66.7
40 Cisplatin 15663-27-1 2 66.7
41 Cyclophosphamide 50-18-0 2 66.7
42 Dasatinib 302962-49-8 2 66.7
43 Emtricitabine 143491-57-0 30 1000
44 Erlotinib HCl 183319-69-9 4 133.3
45 Gefitinib 184475-35-2 2 66.7
46 Gemcitabine HCl 122111-03-9 1 33.3
47 Imatinib Mesylate 220127-57-1 16 533.3
48 Irinotecan HCl 136572-09-3 14 466.7
49 Lapatinib Ditosylate Monohydrate 388082-78-8 2 66.7
50 Letrozole 112809-51-5 2.5 83.3
51 Nilotinib HCl 923288-90-8 2 66.7
52 Oxaliplatin 63121-00-6 4 133.3
53 Pazopanib Hydrchloride 635702-64-6 2 66.7
54 Pemetrexed Disodium 150399-23-8 0.5 16.7
55 Sorafenib Tosylate 475207-59-1 6 200
56 Temozolomide 85622-93-1 1 33.3
57 Sunitinib Malate 341031-54-7 6 200
Total 421
Total - Worst Case 27 Products on campaign basis 11566.7

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List of By-products – After Expansion

S. No Name of Product Stage Name of By Product Quantity
(Kg/day)
1 Amlodipine Besylate I Phthalic acid 195.2
2 Clopidogrel Hydrogen Sulphate I p-Toluene sulfonic acid 170.8
Tarataric acid 149
3 Duloxetine HCl I Sodium Phenyl Carbonate 239.9
Ethyl Acetate 131.9
4 Emtricitabine I Triethyl amine HCl 409.7

Manufacturing Process
Chemical synthesis produces majority of API’s currently in the market. Chemical
synthesis consists of four process steps - reaction, separation, purification, and drying.
Large volumes of solvents are used during chemical syntheses as medium, extractions,
and solvent interchanges. The manufacturing process of the above mentioned molecules
involve various types of reactions like acetylyzation, protection, deprotection, hydrolysis
etc. The manufacturing process of all the compounds, reactions involved, material
balance are presented in chapter 2 of EIA report.

Utilities
The proposed expansion requires additional steam for both process and effluent treatment
system. It is proposed to establish 2 x 10 TPH coal fired boilers in addition to the existing 5
TPH coal fired boiler. The DG sets required for emergency power during load shut down
is estimated at 3380 kVA and accordingly 3 nos. of 1000 kVA DG sets are proposed for
expansion in addition to existing 380 kVA DG set. The list of utilities is presented in
following table;
List of Utilities
S.No Utility Permitted Proposed After Expansion
1 Coal Fired Boiler 1 x 5 TPH 2 x 10 TPH 1 x 5 TPH
2 x 10 TPH
2 DG Sets* 1 x 380 kVA 3 x 1000 kVA 1 x 380 kVA
3 x 1000 kVA
*DG sets will be used during load shut down by TRANSCO.

Water Requirement
Water is required for process, scrubbers, washing, cooling tower makeup, steam
generation and domestic purposes. The total water requirement after expansion increased
from 107.06 to 487.73 KLD consisting of 272.73 KLD of fresh water and 215 KLD of
recycled water. The required water shall be drawn from ground water in addition to reuse

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of treated wastewater. The water balance for daily consumption after expansion is
presented below;
Water Balance after Expansion
Purpose INPUT (KLD) OUTPUT (KLD)
Fresh Water Recycled Water Loss Effluent
Process 113.73 127.07*
Washings 10 10
Scrubber 10 10
Boiler Feed 75 20 85 10
Cooling Tower 10 185 159 36
RO/DM Plant 24 24
Domestic 25 5 20
Gardening 15 15
Gross Total 272.73 215 264 237.07
Total 487.73 501.07
* Process Effluents contains unreacted raw materials, water formed during reaction, soluble solvents, by-products etc

Baseline Environmental Data

The baseline data was collected in the study area during the months of March to June 2017
for 3 co located units i.e., Dasami Lab Pvt. Ltd., Hindys Lab Pvt. Ltd., and Actero Pharma
Pvt. Ltd. The baseline data includes collection of Samples of ground water, surface water
and soil, monitoring of ambient air quality, noise levels, ecological status and
meteorological parameters. The analytical results show that the values are within the
prescribed limits for air quality. The ground water quality is observed to be above the
limits for potable purpose when compared to the prescribed standards of IS: 10500 – 2012
at few locations.

Identification and Quantification of Impacts

The impact assessment report has identified various sources of pollution and quantified
the pollution loads due to proposed expansion. It has also identified the technologies to be
adopted for the mitigation and control of the same. The sources of pollution are air
emissions from utilities and process; liquid effluents from process, utilities and domestic
usage; solid wastes from process, treatment systems and utilities; and noise pollution from
utilities, and process equipment.

Impacts on Air quality: The impacts on air quality shall be due to the emissions from,
Coal Fired Boilers and standby DG sets. The incremental concentrations are quantified
using ISC-AERMOD model based on ISCST3 Algorithm. The results indicate marginal

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increase in ambient air quality concentration. The predicted values for SPM, PM10, PM2.5,
SO2 and NOx are 6.05, 1.74, 1.17, 8.38 and 9.26 μg/m3 respectively and he maximum values
are observed at a distance of 1.8 km from the center of plant site in northwest direction,
and the cumulative values of baseline air quality combined with predicted values are
found to be within the prescribed limits of National Ambient Air Quality Standards. The
mitigative and control measures of air pollution shall ensure that the impact on air quality
is local – within the site area and its surroundings. The fugitive and diffuse emissions
were quantified and a box model was used to predict air borne concentrations, and the
results indicate the work room concentrations less than threshold limit values (TLV) for
various solvents.

Impacts on Water: Water is essentially used for process and utilities and domestic
purposes. The required water is drawn from ground water in the order of 272.73 KLD in
addition to reuse of treated wastewater in the order of 215 KLD. No impact on water
quality is expected due to discharge of effluents as zero liquid discharge is envisaged,
which ensures reuse of treated wastewater for cooling towers, boiler makeup and
scrubbers. There is no usage of treated wastewater for on land irrigation.

Impacts on Noise quality: The noise levels may increase due to motors, compressors, DG
set and other activities. The major source of noise generation is DG sets which emit noise
levels of above 90 dB (A) at a reference distance of 1m from the source. The predicted
cumulative noise levels (as calculated by the logarithmic model without noise attenuation)
ranged between 55 and 75 dB (A) at distances of 70 to 135 m. The increase in noise levels
shall have neutral impact, restricted to within site area.

Impacts on Soil: The solid wastes generated from process, utilities and effluent treatment
plant may have significant negative impacts if disposed indiscriminately. The total solid
waste will be stored separately in Hazardous waste storage area. Solid waste will be sent
to cements plants for co-incineration based on calorific value or sent to TSDF. The
operational phase impacts shall be neutral due to effective implementation of mitigative
measures in handling, storing and transferring of solid wastes, effluents and chemicals,
and development of green belt.

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Impacts on Ecology: There are no endangered species of flora and fauna in the impact
area. The impact on biological environment is neutral with the effect confined mainly to
the site area.

Environmental Monitoring Programme

It is proposed to monitor Ambient Air Quality (AAQ) for PM10, PM2.5, SO2 and NOX, work
room for VOC concentrations, stack emissions for boiler and DG sets, noise levels on
quarterly basis. Water, treated wastewater are monitored on daily basis, while Soil
analysis is done once in a year.

Additional Studies
Risk assessment was conducted and the heat radiation damage distances of pool fire in
the tank farm was limited to 12m for a heat radiation of 4 KW/m2, and the same was
within the plant premises.

Project Benefits
The proposed expansion will provide employment to 400 people. The proposed project
will also generate indirect employment to the locals during construction phase in the
order of 200 people for a period of 18-24 months. The project shall have positive impact on
socioeconomic environment due to provision of employment both direct and indirect and
proposed CSR activities.

Environment Management Plan

The management plan is drawn in consultation with project proponents and technical
consultants after evaluating various mitigation and control measures to address the
impacts identified, predicted and monitored. The impacts during construction stage are
temporary and less significant, the management plan for impacts identified during
operation stage is described as follows;

Liquid Effluents
The effluent generated from the proposed expansion is mainly from process, washings,
scrubbers, cooling towers and boiler blow downs, RO/DM rejects from pre-treatment of
water and domestic wastewater. The effluents from process, washings, scrubber and
RO/DM rejects are considered as HTDS stream, while utility blow downs and domestic

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wastewater are considered LTDS stream. It is proposed to treat HTDS effluents from
process and washing in stripper followed by MEE and ATFD, and MEE and ATFD in the
case of effluents from RO/DM backwash and scrubber. All LTDS effluent along with
condensate from MEE and ATFD shall be treated in Biological treatment followed by RO
system. RO Rejects are sent to MEE and permeate is used for cooling towers, boilers as
make up and scrubbers as medium. Total Effluent generated and mode of treatment
before and after expansion is presented in following table;
Total Effluent Generated and Mode of Treatment
Description Quantity (KLD) Mode of Treatment
Permitted After
Expansion
HTDS Effluents
Process 20.8 127.07 Sent to Stripper. Stripper condensate
Washings 3 10 shall be disposed to cement industries for
Scrubber Effluent   10 co-processing/TSDF. Stripper bottom is
RO/DM Plant Rejects   24 sent to MEE followed by AFTD.
Condensate from MEE is sent to
biological treatment plant followed by
RO. RO rejects are sent to MEE and
permeate is reused in cooling towers,
boiler make-up and scrubbers.
Total I 23.8 171.07
LTDS Effluents
QC and R&D 1 -- Sent to Biological Treatment System
Boiler Blow downs 3 10 followed by RO. RO permeate is reused
Cooling Tower Blow 36 for cooling towers, boiler make-up and
downs scrubbers. RO rejects are sent to MEE.
Domestic 3 20
Total II 7 66
Grand Total (I+II) 30.8 237.07

Effluent Treatment System

The Effluent management system is developed to ensure `Zero Liquid Discharge’.
Segregation of effluents is an integral part that facilitates effective treatment of various
effluent streams. The effluents are segregated into two streams; High COD/ TDS and
Low COD/ TDS streams.

The High TDS/ COD Effluents

The treatment system for treating High TDS/ COD effluents consists of Equalization,
Neutralization, Settling tank, Stripper, Multiple Effect Evaporator (MEE) followed by
Agitated Thin Film Dryer (ATFD). The organic distillate from the stripper is sent to cement

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plants for co-incineration and aqueous bottom from stripper is sent to MEE followed by
ATFD for evaporation. The condensate from the MEE and ATFD are sent to ETP
(Biological). Salts from ATFD are disposed to TSDF.

The Low TDS/ COD Effluents:

These effluents along with the condensate from MEE and ATFD are treated in primary
treatment consisting of equalization, neutralization, and primary sedimentation followed
by secondary biological treatment consisting of aeration tank and clarifier.

The treated effluents after biological treatment are subjected to tertiary treatment in a
reverse osmosis (RO) system. Permeate from RO is reused for cooling tower and boiler
make-up and rejects are sent to MEE followed by ATFD. Sludge from various units of
Biological treatment are thickened in sludge handling system and sent to TSDF.

Air Pollution
The sources of air pollution are proposed 2 x 10 TPH Coal fired boilers, existing 1 x 5 TPH
coal fired boiler, proposed DG set of 3 x 1000 kVA and existing DG set of 380 kVA. The
proposed air pollution control equipment for 2 x 10 TPH coal fired boilers is Bag filters.
DG sets shall be provided with effective stack height based on the CPCB formula.

The process emissions contain Ammonia, Carbondioxide, Hydrogen, Nitrogen, Oxygen,

Hydrogen chloride, Hydrogen fluoride, Hydrogen sulfide and Sulfur dioxide. Hydrogen
chloride, Hydrogen fluoride, Hydrogen sulfide and Sulphur dioxide are sent to scrubber
in series. The resultant solutions after scrubbing i.e., Sodium chloride from Hydrogen
chloride, ammonium chloride from ammonia, sodium fluoride from hydrogen fluoride,
sodium sulfide from hydrogen sulfide scrubbing are sent to ETP. Carbon dioxide, oxygen
and nitrogen gases are let out into atmosphere following a standard operating procedure,
while Hydrogen gas is let out into atmosphere through a water column.

Emissions are also released from various operations of manufacturing like centrifuge,
drying, distillation, extraction etc. These emissions mainly contain volatile contents of the
material used for processing. It is proposed to provide vent condensers in series to
reactors, distillation columns, driers and centrifuge etc. to mitigate VOC emissions release.
Other vents are connected to common headers and scrubbers.

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Solvent Use and Recycle

Solvents are used for extraction of products and as reaction medium. Used solvents are
recovered by distillationfor reuse. Residues from distillation columns and mixed solvents
shall be sent to TSDF for incineration or cement plants for co-incineration. If any of the
distilled spent solvents are not reused due to statutory reasons the same shall be sold to
end users.

Solid Waste
Solid wastes are generated from process, solvent distillation, effluent treatment system,
DG sets and boilers. Stripper distillate, process residue and solvent residue are sent to
cement plants for co-incineration based on acceptability as the same contain significant
calorific value and are predominantly organic in nature. If these wastes are not suitable
for co-incineration, the same are sent to TSDF facility. The evaporation salts from ATFD ,
and sludge from ETP are sent to TSDF for landfill. Waste oil and used batteries from the
DG sets are sent to authorized recyclers. Other solid wastes expected from the unit are
containers, empty drums which are returned to the product seller or sold to authorized
buyers after detoxification. Coal ash from boiler is sold to brick manufacturers.

Noise Pollution
Noise is anticipated from motors, compressors, centrifuges and DG sets. DG sets shall be
provided with acoustic enclosure. Engineering controls like acoustic enclosures, barriers,
shields, and anti vibrating pads are provided to ensure reduction of noise levels and
vibration. Employees working in noise generating areas shall be provided with
appropriate personnel protective equipment.

Occupational Safety and Health

Direct exposure to chemicals or its raw materials may affect health of employees. Direct
exposure to hazardous materials is eliminated by providing closed handling facilities.
Personal Protective Equipment (PPE) i.e., hand gloves, safety goggles, safety shoes, safety
helmets, respiratory masks etc. are provided to all the employees working in the plant.
Company has a policy of providing PPEs to all personnel including contract workers.
Periodic medical checkup in addition to checkup during recruitment is adopted to
monitor health status of employees.

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Prevention, maintenance and operation of Environment Control Systems

The pollution control equipment, and the effluent treatment system is monitored
periodically to estimate their efficiency and performance potential as part of adoptive
management. Proactive maintenance and monitoring program for all equipment and
machinery is adopted to identify the problems/under performance of the equipment.
Necessary measures will be adopted to rectify the identified problems/defects. The
management agrees that the results of monitoring will be reviewed periodically to adopt
new measures if necessary, for efficient pollution control.

Transport systems
All the raw materials and finished products are transported by road. Dedicated parking
facility is provided for transport vehicles. There will be 40-50 truck trip per day to the
factory for transporting raw materials and products. Traffic signs will be placed in the
battery limit. The drivers of vehicles will be provided with TREM cards of chemicals and
materials to be transported, and will be explained the measure to be adopted during
various emergencies

Reduce, Recycle and Reuse

A number of measures are proposed to achieve high yields and reduce generation of
wastes. It shall be endeavor of the R&D team to improve yields through constant research
and development activities. The solvents shall be recycled for reuse in the process after
distillation. Mother liquors from the first crop shall be reused for process. The steam
condensate shall be reused for boiler feed. Treated wastewater from sewage treatment
plant is reused for greenbelt development. It is also proposed to explore recovery of
various salts from MEE salts, and from process effluents to reduce effluent loads, and
quantity of solid waste.

Green Belt Development

The management developed green belt in a total area of 2.4 acres and proposed to enhance
the greenbelt area to 18 acres covering the boundary of the site as part of environment
management plan to enhance environmental quality through mitigation of fugitive
emissions, attenuation of noise levels, balancing eco-environment, prevention of soil
erosion, and creation of aesthetic environment

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Post Project Monitoring

Environmental monitoring for water, air, noise and solid waste quality will be conducted
periodically either by proponent or third party. The frequency of monitoring and the
quality parameters shall be as suggested by the Ministry of Environment and Forests and
Climate Change, Government of India.

Environment Management Department

The Environment Management Cell of the project shall be headed by the AGM operations,
followed by Dy. Manager (EH&S), Junior executives, Managers, Chemists and fitters.

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