AGENDA M/S.

SARACA LABORATORIES LIMITED, BOYAPALEM (V),

ITEM NO : 5 RANASTHALAM (M), SRIKAKULAM DISTRICT
Dt:03.07.2019

M/s. Saraca Laboratories Limited, Boyapalem (V), Ranasthalam (M), Srikakulam District –
Applications for Water and Air Consents & HW Authorization for Change of product mix.

The details of the Bulk Drug manufacturing unit as reported by the RO, Srikakulam is as
follows:

1. Line of Activity:

This is a Bulk Drug manufacturing unit with a project cost of Rs. 53.34 Crores under Red-Haz
category.

2. EC Status:

Environmental Clearance from MoEF vide Order No. j-11011/350/2006-IA II(I), dated
18/05/2007.

3. CFE Status :

CFE (CPM) Order No. APPCB/VSP/VZN/53/HO/CFE/HO/2012, dated 01.05.2019.

4. CFO & HWA Status:

Auto renewal of Consent Order issued on 14/12/2017 which is valid up to 30/11/2022.

5. Details of Present CFO application:

The industry has applied for Water and Air Consents & HW Authorization (Change of
product mix) for a period upto 30.11.2022.

Date of receipt of CFO application at RO 07.06.2019

Date of receipt of additional information at RO
Date of RO inspection 19.06.2019
Date of receipt of consent verification reports at Head Office 22.06.2019
Date of commissioning of industry December, 2007

6. Raw materials:

The industry is using different chemicals & solvents.

7. Products & By Products:

Consented Consented Actual

Consented Applied as
capacity as capacity as Manufact
capacity as per the
per CFE per CFE ured
S. per CFO Order applicatio
Name of The Product order order(CPM) For the
No dated n
dated dated last 6
13/03/15 (CPM)
28/04/12 01.05.2019 TPM
Kg/day (Kg/Day)
Kg/day (Kg/Day (Kg/Day)
Group A (Regular Products):
Ranitidine Base Water
1 Medium (Aqueous 14,700 14,700 14,700 14,700 3,60,000
Solution Tech)

2 Cystophur 4,250 4,250 4,250 4,250 36,000

3 Ranitidine HCL 4,700 4,700 4,700 4,700 5,94,400

4 Losartan Potassium 60 60 60 60 --

63
 Pramipexole
5 5 5 5 5
Intermediate (PRA-10)
Total Production
Capacity from Group- 23,715 23,715 23,715 23,715
A
Group-B (Campaign Products)

1 Levofloxacin 1700 1700 1700 1700

2 Ofloxacin 1700 1700 1700 1700
3 Donepezil
1700 1700 Dropped Dropped
Intermediate (DON-10)
4 Donepezil
1445 1445 Dropped Dropped
Intermediate (DON-20)
5 Irbesartan 850 850 850 850
Ciprofloxacin
6 Hydrochloride 1700 1700 Dropped Dropped
Monohydrate
7 Clopidogrel Bisulphate 650 650 650 650
8 Gabapentin
1700 1700 1700 1700
Hydrochloride
9 Gabapentin 1700 1700 1700 1700
10 Valsatan 1700 1700 1700 1700
11 Pantoproazole sodium - - 1,000 1,000
2-(1-(2-amino-2- 1,700
12 oxoethyl) cyclohexyl) - - 1,700
acetic acid (CAM)
Max. Production capacity from Group-B (Any one product): 1700 Kg/Day

Total production capacity (5 products from Group-A and 1 product from Group-B): 25,415
Kg/Day
By- product
Methane Sulphonic
1 - - 1,700 1700 142075
Acid

8. Water consumption:

1. Source of Water supply as per EC : Borewells

2. Source of Water supply as per CFE :
3. Present Source of Water supply :

Consented Consented
Consented quantity quantity as capacity as per
Applied as per
S. as per CFE order per CFO CFE order(CPM)
Purpose the application
No. dated 24/08/12 dated dated
(CPM) (KLD)
KLD 13.03.2015 01.05.2019
KLD (KLD)
1) Process 38.78 38.78 43.78 43.78
2) Washings 20.0 20.0 20.0 20.0
3) DM Plant 1.0 1.0 1.0
1.0
Regeneration
4) Boiler Feed 100.0 100.0 100.0 100.0
5) Cooling (Makeup)
for process and 250.0 250 250.0 250.0
utilities
6) Scrubbers 5.0 5.0 5.0 5.0
7) Domestic 10.0 10.0 10.0 10.0
8) Gardening /
30.0 30.0 30.0 30.0
Irrigation

64
 Total 454.78 454.78 459.78 459.78*
*The industry shall restrict the water consumption to 454.9 KLD as stipulated in the EC order dt:
18.05.2007.

9. Waste Water Generation:

Consented Consented Consented

quantity as per quantity as capacity as per Applied as
S. CFE order per CFO CFE order(CPM) per CFO CPM
Source
No. dated dated dated application
24/08/12 13/03/15 01.05.2019 KLD
KLD KLD (KLD)
1 Process (High TDS) 49.02 49.02 49.02 49.02
2 Washings(High TDS) 20.0 20.0 20.0 20.0
3 Scrubber Effluent (High
10.0 10.0 10.0 10.0
TDS)
4 DM Plant Regeneration
1.1 1.1 1.1 1.1
(Low TDS)
5 Boiler Blow Down (Low
5.0 5.0 5.0 5.0
TDS)
6 Cooling Tower Blow
15.0 15.0 15.0 15.0
Down (Low TDS)
7 Domestic 8.0 8.0 8.0 8.0
Total: 108.12 108.12 108.12 108.12

10.Out let – as per CFO order dated 13.03.2015

S.
Source of effluent
No
1 High COD & High TDS effluents
(COD / TDS > 15000 mg/lt.
Process – 49.02 KLD +
Washings: 20.0 KLD + Scrubber
Effluent–10.0 KLD
2 Low COD & Low TDS effluents 29.1
(COD / TDS < 15,000 mg/lt
DM Plant Regeneration – 1.1
KLD + Boiler Blow Down: 5.0
KLD + cooling Tower Blow
Down: 15.0 KLD and Domestic:
8.0 KLD
Maximum Daily
Mode of Final disposal
Discharge KLD
79.02  Pretreatment followed by stripping
of effluents in the stripper for
recovery of organics.
 Stripped bottom to evaporate in
MEE.
 MEE condensate to ETP and
recycled into process.
 MEE concentrate to Agitated Nutch
filter.
 Salts to TSDF.

Out let – as per CFE (CPM) order dated-01.05.2019 and CFO (CPM) to be issued for:

S.
Source of effluent
No
1 High COD & High TDS effluents
(COD / TDS > 15000 mg/lt.
Process – 49.02 KLD +
Washings: 20.0 KLD + Scrubber
Effluent–10.0 KLD
Maximum Daily
Mode of Final disposal
Discharge KLD
79.02  Pretreatment followed by stripping
of effluents in the stripper for
recovery of organics.
 Stripped bottom to evaporate in
MEE.
 MEE condensate to ETP and
recycled into process.
 MEE concentrate to Agitated Nutch
filter.
Salts to TSDF.

65
2 Low COD & Low TDS effluents 29.1 Into sea through marine outfall jointly
(COD / TDS < 15,000 mg/lt with M/s. Andhra Organics Ltd.
DM Plant Regeneration – 1.1
KLD + Boiler Blow Down: 5.0
KLD + cooling Tower Blow
Down: 15.0 KLD and Domestic:
8.0 KLD

11. ETP Details & Mode of Disposal

I Outlet No. 1 :
a) Stream Details : High TDS Effluents
b) Treatment unit’s details with : Industry is having ETP consists of
dimensions and treatment Neutralization tank, Holding tank, Stripper
capacity followed by (2x30) MEE followed by forced
evaporation in 4 reactors and MEE
condensate is further treated in biological ETP
.
c) Point of disposal : ETP out let recycled back into the
process/Gas Incineration scrubber.

II Outlet No. 2 Low TDS effluents:

b) Treatment unit’s details with Industry installed 560 KLD biological ETP
dimensions and treatment (Sequential Batch Reactor) consists of 2
capacity Aeration tanks, Clarifier, Oxidation tank
followed by sand Filter and treated effluents
proposed to be stored in storage tanks of 3
Nos. of 50 KL Capacity and subjected to bio-
assay test before marine disposal.
c) Point of disposal The industry has tie up with M/s. Andhra
Organics Limited, Marine Pipe line to
discharge their treated effluents in to marine
out fall. The industry has not connected to
the marine out fall till today. After giving
permission from APPCB, the industry.
proposed to discharge through marine out fall
jointly with M/s. Andhra Organics Limited

12. Air pollution:

Source of Pollution Limiting

Control Stack height
S. Note: Capacity should Flow rate in Standard
equipment in Mts. -
No. be mentioned for each m3/hr. prescribed
provided above GL
unit by Board
Boiler: 10 TPH: Multi Cyclone
1. -- 41m. 115 mg/Nm3
Fuel: Coal: 550 kg/hr and bag filters
Boiler: 8 TPH:
2. Multi Cyclone -- 41 m 115 mg/Nm3
Fuel: Coal: 450 Kg/hr.
Hot Oil Heater:
3 TPH;
3. -- -- 2.5 m 115 mg/Nm3
Fuel: Furnace Oil: 50
Lt/Day;
PIIAN
(Biodegradabl
e Odour
Gas Incinerator: 100
Neutralizer)
4. Kg/Hr.; Fuel: Furnace -- 35 m 30 mg/Nm3
Scrubber
Oil: 250-300 Lt/Day
followed by
Caustic
Scrubber.
DG Set 750 KVA; Silencer
5. Fuel: Diesel (HSD) 200 placed in -- 6m 115 mg/Nm3
Lt/Hr.; closed room
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 DG Set 380 KVA; Silencer 6m
6. Fuel: Diesel (HSD) 100 placed in -- 115 mg/Nm3
Lt/Hr.; closed room
DG Set: 125 KVA (Stand Silencer 6m
7. by): Fuel: Diesel (HSD): placed in -- 115 mg/Nm3
60 Lt/Hr. closed room
DG Set: 1500 KVA Silencer 6m
8. (Stand by): Fuel: Diesel placed in -- 115 mg/Nm3
(HSD): 60 Lt/Hr. closed room

13. Hazardous waste details:

As per CFE Hazardous / as

Applied for
S. order dated defined under Method of
Solid Waste generated CFO
No 01.05.2019 HWM Rules, disposal
Kg/Day Kg/Day 2008
Hazardous waste with disposal option
Process Liquid organic sent to
1 2040.89 34.3 of Sch.–I
residue 2040.89 authorized
2 Process organic Solid 36.2 of Sch.–I Cement units for
Distillation Bottom co-processing or
3 36.2 of Sch.–I TSDF,Parawada,
residue 2281.57 2281.57
Visahapatnam for
4 36.1 of Sch.–I
Spent carbon 45 45.00 Incinerator
5 Process inorganic salts 1054.55 1054.55 34.3 of Sch.–I
6 ETP Sludge 460 460.00 34.3 of Sch.–I
sent to TSDF ,
Forced evaporation 36.4 of
7 parawada for
salts 7004 7004.00 Schedule-I
secured land fill
8 Gas incineration ash 500 500.00 28.1 of Sch.–I
9 Sludge from scrubber 500 500.00 36.4 of Sch.–I
To brick
10 --
Boiler ash 6400 6400 manufactures.
Hazardous Wastes With Recycling Option
to be recovered
63447
1 Spent solvents 63447 Kgs/Day within the
Kgs/Day
premises
Re processers /
recyclers
2 Waste oil 1200 LPA 1200 LPM
authorized by
APPCB.
Containers & Only after
Containers liners of complete
3 HW & Hazardous 1700 Kgs/Day 1700 Kgs/Day detoxification
chemicals will be disposed
a) Drums b) carboys off.
Re processers /
recyclers
4 Mixed spent solvents 40.0 TPM
authorized by
40.0 TPM APPCB
5 Used Glass bottles 0.5 TPM 0.5 TPM Vendors
PCB authorized
6 E Waste - 25 Kg / off-site
month treatment facility

67
 14 CFE Order No. APPCB/VSP/VZN/53/CFE/HO/2012, dated 01.05.2019

Condition Compliance
4 The source of water is bore wells and the : Complied
maximum permitted fresh water
consumption is 459.78 KLD. The industry
shall restrict the water consumption to
454.9 KLD as stipulated in the EC order dt:
18.05.2007.
5 S. No. Purpose Quantity (KLD)
1) Process (High TDS) 49.02
2) Washings(High TDS) 20.0
3) Scrubber Effluent (High TDS) 10.0
4) DM Plant Regeneration (Low TDS) 1.1
5) Boiler Blow Down (Low TDS) 5.0
6) Cooling Tower Blow Down
15.0
(Low TDS)
7) Domestic 8.0
Total 108.12
S.
Effluent Source Treatment Disposal
No
1 High COD & Neutralization stripper,  Pretreatment followed,
High TDS MEE followed by by stripping of effluents in
effluents Agitated Nutch Filter the stripper for recovery
(COD /TDS of organics.
>15,000  Stripped bottom
mg/It) Evaporate in MEE.
 MEE condensate to ETP.
 MEE concentrate
Agitated Nutch filter
•  Salts to TSDF.
2 Low COD & Low ETP consisting of 560 KLD Into sea through marine
. TDS effluents consisting of Aeration tank, outfall.
(COD JTDS clarifier, chemical oxidation
<15,000 mg/It). and sand filter, GAC filter.
Guard pond.

Complied.

6 The Effluent Treatment consists of :
Stripper, MEE,ATFD with condenser and
Biological ETP shall be operated and
maintained properly. All the units of the
ETP shall be impervious to prevent ground
water pollution. The ETP units shall be
constructed above the ground level.
7 The industry shall provide digital flow :
meters with totalisers at the inlet and
outlet of Stripper, MEE and ETP.
The industry has not provided ATFD.
Sludge generated from MEE is being
filtered by using filter press. During this
process handling of leachate and sludge
generated is causing for smell nuisance.
The Board directed the industry for
replacement of this practice with ATFD.
But the industry not complied.
The industry has provided magnetic
flow meter at inlet of stripper only. Not
provided for MEE inlet. Provided at
outlet of MEE before biological
treatment.. Provided at inlet and
outlet of ETP.

68
8 The industry shall properly operate and : Complied. Industry provided one online
maintain online real time monitoring CAAQM station and web cams as per
system along with web camera facilities CPCB directions and connected to
and shall ensure that it is connected to APPCB/ CPCB website.
APPCB / CPCB websites as per CPCB
directions.
9 Floor washing shall be admitted into the : Not complied.
effluent collection system only and shall
not be allowed to find their way in storm
drains or open areas. All pipe valves,
sewers, drains shall be leak proof.
10 Air: : Complied.
The Air pollution Control equipment shall
be installed along with the commissioning
of the activity and shall comply with as
per CFE order for controlling air pollution
11 A sampling port with removable dummy : Complied.
of not less than 15 cm diameter shall be
provided in the stack at a distance of 8
times the diameter of the stack from the
nearest constraint such as bends etc. A
platform with suitable ladder shall be
provided below 1 meter of sampling port
to accommodate three persons with
instruments. A 15 AMP 250 V plug point
shall be provided on the platform.
12 The industry shall comply with monitoring : --
procedure, emission standards for
individual Hazardous Waste Incinerators
as stipulated by MoEF&CC, GoI
Notification dt. 04.03.2009 and
amendments there off.
13 The industry shall properly operate and : Online monitoring system provided for
maintain the monitoring system to all the incinerator is not in operation.
stacks / vents in the plant. Regular
monitoring shall be carried out and report
shall be submitted to the Regional
officer.
14 The industry shall properly operate and : Provided dual stage scrubbers to control
maintain multi-stage scrubbers to the gaseous emission. Still smell nuisance
process vents to control the process observed in the surroundings of the
emissions. The industry shall ensure that unit.
online pH measuring facility with auto
recording system is connected to the
scrubbers.
15 The industry shall properly operate and : The industry has provided VOC analyser
maintain VOC monitoring system with in CAAQMS and also monitoring with
auto recording facility. handy sampler.
16 The industry shall implement adequate : HCL fumes observed from the
measures to control all fugitive emissions production blocks.
from the plant.

69
17 The proponent shall ensure compliance of : Complied.
the National Ambient Air quality
standards notified by MoEF&CC, GoI vide
notification No. GSR. 826 (E), dated.
16.11.2009 during construction and
regular operational phase of the project
at the periphery.
The generator shall be installed in a
closed area with a silencer and suitable
noise absorption systems. The ambient
noise level shall not exceed 75 dB(A)
during day time and 70 dB(A) during night
time
18 The proponent shall not use or generate : Mercaptan smell was observed with in
odour causing substances or Mercaptans the process area.
and cause odour nuisance in the
surroundings.
19 The industry shall send the used / spent : Complied.
solvents to the recyclers (or) process
them at their own solvent recovery
facility within the premises.
20 The evaporation losses in solvents shall be : 1)Industry provided chilled brine
controlled by taking the following circulation system.2)Industry is
measures: i) Chilled brine circulation shall transferring solvents using pumps.
be carried out to effectively reduce the 3)Industry is transferring solvents using
solvent losses into the atmosphere. ii) pumps.4) Industry provided closed
Transfer of solvents shall be done by Centrifuges system to reduce solvent
using pumps instead of manual handling. losses.5) Industry provided primary &
iii) Closed centrifuges shall be used to secondary condensers to catch the
reduce solvent losses. iv) All the solvent solvent vapours.4) Industry provided
storage tanks shall be connected with vent condensers to prevent solvent
vent condensers to prevent solvent vapours
vapours. v) The reactor vents shall be
connected with primary & secondary
condensers to prevent escaping of solvent
vapour emissions into atmosphere.
21 Solid / Hazardous Waste: : Industry provided closed Centrifuges
system to reduce solvent losses.
The industry shall comply with the
disposal of Solid waste as CFE Order
22 The proponent shall place the chemical : Industry provided primary & secondary
drums and / or any drums in a shed condensers to catch the solvent
provided with concrete platform only. vapours.
The Platform shall be provided with
sufficient dyke wall and effluent
collection system. The industry shall
provide containers detoxification facility.
Container & Container liners shall be
detoxified at the specified covered
platform with dyke walls and the wash
wastewater shall be routed to low TDS
collection tank.

70
23 The following rules and regulations : Industry provided vent condensers to
notified by the MoEF&CC, GoI shall be prevent solvent vapours.
implemented. a) Hazardous waste and
other wastes (Management and
Transboundary Movement) Rules, 2016. b)
Plastic Waste Management Rules, 2016. c)
Manufacture, Storage and Import of
Hazardous Chemicals Rules, 1989 d) Fly
Ash Notification, 2016. e) Batteries
(Management & Handling) Rules, 2010. f)
E-Waste (Management) Rules, 2016. g)
Construction and Demolition waste
Management Rules, 2016. h) Solid Waste
Management Rules, 2016.
24 Other Conditions: :
1). The industry shall comply with the
following as committed vide lr. dt.
15.04.2019:
a) Elevated Platform with Dyke walls shall Not complied.
be constructed immediately to contain
the Leakages in the drums storage area.
b) Drums used for storage of raw
materials, solvents and waste shall be Not complied.
labeled properly and stored under sheds.
c) Damaged bag filters shall be replaced Complied.
immediately with new bag filters to
control air pollution.
d) The industry shall replace Filter press Not complied.
with ATFD immediately.

e) The used raw material plastic bags Complied.

shall be stored in a rain proof shed in
closed condition.
f) Separate Strippers shall be provided to
Not complied.
the MEEs.
g) Housekeeping shall be improved by
arresting leakages at all the vulnerable
areas. Not complied.

25 Existing green belt shall not be disturbed : Complied.

due to the proposed change of product
mix. Thick green belt shall be maintained
all along the boundary & vacant spaces
with tall growing trees with good canopy
and it shall not be less than 33% of the
total area.
26 The industry shall submit the information : Not submitted.
regarding usage of Ozone Depleting
Substance once in six months to the
Regional Office and Zonal Office of the
Board.
27 Concealing the factual data or submission : --
of fabricated data and failure to comply
with any of the conditions mentioned in
this order attracts action under the
provisions of relevant pollution control
Acts.

71
28 Notwithstanding anything contained in : --
this conditional letter or consent, the
Board hereby reserves its right and power
Under Sec.27(2) of Water (Prevention and
Control of Pollution) Act, 1974 and Under
Sec.21(4) of Air (Prevention and Control
of Pollution) Act, 1981 to revoke the
order, to review any or all the conditions
imposed herein and to make such
modifications as deemed fit and stipulate
any additional conditions by the Board.
29 Any person aggrieved by an order made : --
by the State Board under Section 25,
Section 26, Section 27 of Water Act, 1974
or Section 21 of Air Act, 1981 may within
thirty days from the date on which the
order is communicated to him, prefer an
appeal as per Andhra Pradesh Water
Rules, 1976 and Air Rules,1982, to such
authority (hereinafter referred to as the
Appellate Authority) constituted under
Section 28 of Water (Prevention and
Control of Pollution)Act,1974 and Section
31 of the Air (Prevention and Control of
Pollution) Act, 1981.

15 Compliance status of conditions stipulated in CFO (Schedule-B)

CFO Order No. APPCB/VSP/VZM/53/CFO/HO/2015-2037, dated 13/03/2015

S.
No Condition : Compliance
.
1 The water consumption shall not exceed : Being followed.
the quantities mentioned below:
S.
Purpose Total
No
1 Process 38.78 KLD
2 Washings 20.0 KLD
DM Plant
3 1.0 KLD
generation
4 Boiler Feed 100 KLD
Cooling (Makeup)
5 for process and 250 KLD
utilities
6 Scrubbers 5.0 KLD
7 Domestic 10.0 KLD
Gardening /
8 30.0 KLD
Irrigation
Total 454.78 KL
The industry shall maintain separate meters Complied.
with necessary pipe-line shall be
maintained for assessing the quantity of
water used for each of the purposes.

72
2 The industry shall file the water cess : --
returns in Form-I as required under section
(5) of Water (Prevention & Control of
Pollution) Cess Act, 1977 on or before the
5th of every calendar month, showing the
quantity of water consumed in the previous
month along with water meter readings.
The industry shall remit water cess as per
the assessment orders as and when issued
by Board.
3 The industry shall segregate effluents into : Complied
HTDS & HCOD and LTDS & LCOD system
based on the segregation criteria proposed
i.e., 15,000 mg/lt for COD / TDS
concentration and treat them in
environmentally sound water. Industry shall
maintain zero discharge.
4 The Effluent Treatment Plant (ETP), : Complied.
Stripper, MEE shall be operated regularly.
All the units of the ETP shall be impervious
to prevent ground water pollution. The ETP
units shall be constructed above the ground
level.
5 Regular monitoring of vents of the storage : Not complied.
tanks and work room concentration shall be
carried out using sensors.
6 The industry shall not discharge any waste : Complied.
water outside the factory premises and
shall maintain zero liquid discharge system.
7 Thick greenbelt shall be maintained by the : Complied.
industry covering an area of 33% of total
area.
8 Separate meters with necessary pipeline : Industry provided separate water meters
shall be provided for assessing the quantity for process, Utility & domestic water.
of water used for each of the purposes
mentioned below:
a) Industrial Cooling, Boiler feed.
b) Domestic purposes.
c) Processing, whereby water gets polluted
and pollutants are easily bio-
degradable.
d) Processing, whereby water gets polluted
and the pollutants are not easily
biodegradable.
9 Rain water shall not be allowed to mix with : The industry has isolated the process
either trade or domestic effluents. Industry areas from mixing with storm water.
shall provide storm water drains
immediately.
10 The industry shall maintain magnetic digital : The industry has provided magnetic flow
flow meters with totalisers at following meter for HTDS effluents before going to
points. MEE only.
a) Inlet of Stripper. Complied.
Not complied
b) Inlet of MEE.
Provided at outlet of MEE and not
c) Outlet of MEE, MEE condensate. provided for MEE condensate
d) Inlet and outlet of ETP. Complied.

Not Complied.

e) Effluent recycling line

73
11 There shall not be any spillages of : Not followed.
chemicals / effluents on ground. The drums
containing chemicals @ wastes shall be
stored on elevated platform under shed
with a provision to collect leachate /
spillages in the collection pit. In no case
the drums shall be stored on the naked
open ground.

12 The emission shall not contain constituents : Being followed.

in excess of the prescribed limits
mentioned below:
Chimney Emission
Parameter
No. Standards
Particulates 30 mg/Nm3
HCl 50 mg/Nm3
SO2 200mg/Nm3
CO 100mg/Nm3
Total Organic
20 mg/Nm3
Carbon
HF 4 mg/Nm3
NOx 400mg/Nm3
Hydrocarbons 10 PPM
Dioxins / 0.1 ng TEQ /
1 Furans Nm3
Metals
Cd + Th (And
0.05 mg/Nm3
its compounds
Hg (And its
0.05 mg/Nm3
Compounds)
Sb + As + Pb +
Cr + Co + Cu +
Mn + Ni + V 0.5 mg/Nm3
(And its
compounds
3,5, & 6 SPM 115 mg/Nm3
4 HCl 35 mg/Nm3

13 The industry shall comply with emission : Being followed

limits for DG Set of capacity upto 800 KW as
per the Notification G.S.R. 520 (E), dated
01/07/2003 under the Environment
(Protection) Amendment Rules, 2003 and
G.S.R. 448 (E), dated 12/07/2004 under the
environment (Protection) Second
Amendment Rules, 2004. In case of DG Sets
of capacity more than 800 KW shall comply
with emission limits as per the Notification
G.S.R. 489 IE), dated 09/07/2002 at serial
No. 96, under the Environment (Protection)
Act, 1986.
14 The industry shall comply with ambient air : Being followed
quality standards of PM10– (Particulate
Matter size less than 10 g /m3)-100 g/m3;
PM2.5 (Particulate Matter size less than 2.5
m)-60 g/m3; SO2-80 g/m3; NOx-90
g/m3, outside the factory premises at the
periphery of the industry. Noise Levels: Day
time (6 AM to 10 PM)-75 dB(A) Night time
(10 PM to 6 AM)-70 dB(A).
15 The industry shall not manufacture any : Being followed
product, other than those mentioned in this

74
 order.
16 The industry shall complete stabilization of : Being followed
ETP within one month and report the
compliance to RO-Vizianagaram.
17 The industry shall linkup CAAQM station to : Industry provided online CAAQM station
the APPCB website with TVOC monitoring and connected to APPCB website.
system within one month.
The industry has provided handy sampler
for monitoring the VOC’s for the
incinerator stack.
18 The industry shall maintain one AAQM : Industry provided online CAAQM station
station, VOC analyzer, online analyzer for and connected to APPCB website. On
incinerator and submit the report the stack analyzer provided for incinerator is
compliance to RO-Vizianagaram. not working.
19 The industry shall provide double stage : Being followed.
scrubbing system to Bromine gas emissions
and provide online pH monitoring system
within one month and submit the report the
compliance to RO-Vizianagaram. The vent
of the caustic scrubber shall be dipped into
dilute caustic soda, lye for effective
removal of Bromine in the emissions.
20 The industry shall maintain multi-stage : Provided dual stage scrubbers to control
scrubbers for control of NH3, SO2, HCl and gaseous emission.
other gaseous emissions. The scrubbed
solutions shall be reused to the possible
extent. The industry shall keep the record
of disposal of all such waste quantities and
shall submit the record to concerned
Regional Officer.
21 The industry shall submit bank guarantee of : Bank guarantee not renewed.
Rs. 1.3 Lakhs for a period up to 30/11/2017
for green belt development of 2.6 Acres.
Bank guarantee will be forfeited if the
green belt was not developed within one
year.
22 Industry shall convert Methyl mercaptan : The industry informed that they are
emissions into useful product and inform converting the mercaptans into methyl
the status to the Regional Office – sulphonic acid.
Vizianagaram. Characteristic smell of Mercaptans was
observed with in the process area.
23 The evaporation losses in solvents shall be :
controlled by taking the following
measures:
i Chilled brine circulation shall be carried : Industry provided chilled brine circulation
out to effectively reduce the solvent losses system
into the atmosphere.
ii Transfer of solvents shall be done by using : Industry is transferring solvents using
pumps instead of manual handling. pumps.
iii Closed centrifuges shall be used due to : Industry provided closed Centrifuges
which solvent losses will be reduced system to reduce solvent losses.
drastically.
iv The reactor vents shall be connected with : Industry provided primary & secondary
primary & secondary condensers to catch condensers to catch the solvent vapours.
the solvent vapours.
v All the solvent storage tanks shall be : Industry provided vent condensers to
connected with vent condensers to prevent prevent solvent vapours.
solvent vapours.
24 Solvents shall be taken from underground : Being followed.
storage tanks to reactors through closed
pipeline. Storage tanks shall be vented
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 through trap receiver and condenser
operated on chilled water.
25 Proper earthling shall be provided in all the : Being followed.
electrical equipment wherever solvent
handling is done.
26 The industry shall isolate the storage of : Being followed.
highly inflammable chemicals solvents and
other raw materials from the rest of the
facilities in the plant premises.
27 The industry shall ensure implementation of : Provided the vacuum gauges wherever
requisite measures to prevent air pollution necessary to control the leakages in the
& odour nuisance in the surrounding area. system to reduce the odour nuisance in
the surrounding area.
28 The industry shall submit mock drill report : Not submitted.
carried out at least once in six months, as
required under the Manufacturing, storage
and import of Hazardous Chemical Rules,
1989.
29 Industry shall submit the inventory of : Not submitted.
solvents (i.e., both fresh and spent) to the
RO on monthly basis.
30 The industry shall not use any raw material : Being followed.
other than those permitted as mentioned in
the application.
31 The industry shall maintain record on : Not submitted
source of intermediates for each product-
wise and the consolidated records shall be
submitted to RO, Visakhapatnam every
month along with invoice copies of the
intermediates outsourced.
32 The industry shall not send the used / : Being followed.
spend solvents to the recyclers and shall
process them at their own solvent recovery
plant within the plant premises. Solvents
shall be recovered to the maximum extent
possible and shall be reused. The residues
shall be sent to incinerator in the
Pharmacity.
33 System of leak detection and repair of : --
pump / pipeline shall be installed in the
plant and immediate response team shall
be identified for preventive maintenance.
34 The industry shall comply with the : ----
directions issued by the Board from time to
time.
35 The industry shall comply with the : --
conditions stipulated in the CFE order No.
APPCB/VSP/VAN/53/CFE/HO/2012-2212,
dated 24.08.2012 and EC order dated
18/05/2007.
36 The applicant should submit Environment : Being followed.
Statement in Form-V before 30th September
every year as per Rule No. 14 of E (P) rules,
1986 & Amendments.
37 The conditions stipulated are without : ----
prejudice to the rights and contentions of
this Board in any Hon’ble Court of Law.

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16. Inspecting Officer’s Remarks & Recommendations:

1) M/s. Saraca Laboratories Limited is Bulk Drugs / Intermediates manufacturing unit

existing in Boyapalem (V), Ranasthalam (M), Srikakulam District in the extent of 23.52
Acres.
2) The industry was accorded with EC vide F No. j-11011/350/2006-IA II (I), dated
18/05/2007 for enhancement in production capacities to the tune of 25.42 TPD.
3) The industry obtained CFO of the Board vide order No. APPCB/VSP/VZN/53/HO/
CFO/2015-2037, dated 13/03/2015 for production capacity (5 products from Group-A 1
Product from Group-B): 25,415 Kg/Day at any given time with a validity upto
30/11/2017 with condition that industry produce all the regular products (5 Nos.)
mention above in Group-A and only one product will be manufactured at any point of
time out of the 10 Campaign Products in Group-B.
4) The industry also obtained CFO Auto Renewal of the Board vide order dated 14/12/2017
with validity upto 30/11/2022. Subsequently the industry has obtained CFE Change of
Product Mix of the board vide order dated 01/05/2019.
5) Now the industry applied for CFO Change of Product Mix through OCMMS i.e Total
production capacity shall not exceed 25415 kg/day ( five products from group A) & one
product from group B Max production capacity from group 1700 Kg/Day.
6) The industry provided 3 Nos of MEEs with two effect to treat the HTDS effluents, The
industry has provided individual stripper one MEE and common stripper to the other
two MEEs.
7) The industry shall take necessary measures for complete usage of Methyl Mercaptan gas
into Methane Sulphonic Acid, so as to avoid odour nuisance in the industry premises. The
industry also collecting process hot water from production blocks in open RCC tanks,
which is also one of the source for odour nusience.
8) The industry has constructed elevated platform with dyke walls for storage of drums
however the industry is storing huge quantity of drums openly in the industry premises.
9) The industry has to replace Filter press with ATFD immediately for treatment of MEE
concentrate.
10) During inspection it was observed that the handling of sludge, storage of filtrate at the
filter press area was very poor, which is causing is odour nuisance. The leachate
generated from filter press is also not handling properly..
11) The industry is using a reactor for process residue to avoid pipeline clogging before
loading into drums by injecting steam, the vapors generated from the reactor is
causing odour nuisance.
12) The industry is mixing the Hazardous waste by using husk/ash un-scientifically in a
partially closed shed, which also causing odour nuisance.
13) During the inspection it was observed the incinerator Primary chamber temperature as
906 0C and secondary chamber temperature as 906 0C and black plume was observed
from the stack and odour pertaining to methyl mercaptance is prevailing around the
incinerator area.
14) The industry is operating 10 TPH boiler for which multi cyclone followed by bagfilters
provided as APCE, thick black smoke was observed from the stack and the industry is
operating only multi cyclones, the representative of the unit informed that bags have
been damaged for which orders placed for procurement.
15) The industry submitted Bank Guarantee of Rs. 10 Lakhs to the Board towards compliance
of the directions issued vide order dated 30/09/2011 and it is extended up to
05/11/2015, after that it is not renewed.
17. RO Recommendations:

1. The Board is receiving frequent complaints against the unit regarding the smell nuisance,
the industry has to take all necessary measures for evaluation of existing treatment
systems, scrubbers, MEE, Strippers etc.
2. Individual strippers shall be provided for each MEE.
3. The industry has to replace Filter press with ATFD immediately for treatment of MEE
concentrate

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4. The industry shall take necessary measures for complete usage of Methyl Mercaptan gas in
to Methane Sulphonic Acid So as to avoid Odour nuisance in the industry premises.

Issue of CFO renewal may be considered upto 30/11/2022 duly stipulating necessary
conditions after payment of balance consent fee of Rs. 20,000/-.

18. HEAD OFFICE Remarks:

a) The industry obtained CFO of the Board vide order dated 13/03/2015 for production
capacity (5 products from Group-A 1 Product from Group-B): 25,415 Kg/Day at any given
time with a validity upto 30/11/2017 and further auto renewed upto 30.11.2022.
b) Further, the industry has obtained CFE Change of Product Mix of the board vide order
dated 01/05/2019 i.e Total production capacity shall not exceed 25415 kg/day ( five
products from group A) & one product from group B Max production capacity from group
1700 Kg/Day.
c) Now the industry applied for CFO Change of Product Mix through OCMMS.
d) The Board is receiving frequent complaints against the unit regarding the smell nuisance
and the following violations / problems were observed by the Board officials during
inspection:
a. The industry has not provided ATFD. Sludge generated from MEE is being filtered
by using filter press. During this process handling of leachate and sludge generated
is causing for smell nuisance.
b. The industry has provided magnetic flow meter at inlet of stripper only. Not
provided for MEE inlet, MEE condensate, effluent recycling line.
c. Online monitoring system provided for gas incinerator is not in operation from past
2 years.
d. HCL fumes observed from the production blocks.
e. Mercaptan smell was observed with in the process area and surroundings of the
unit.
f. Not provided Elevated Platform with Dyke walls shall be constructed immediately
to contain the Leakages in the drums storage area. Not properly stored the drums
used for storage of raw materials, solvents and waste. The industry stocked huge
quantity of drums openly.
g. Not provided separate strippers to the MEEs.
h. Housekeeping was not improved by arresting leakages at all the vulnerable areas.
i. The industry is mixing the Hazardous waste by using husk/ash un-scientifically in a
partially closed shed, which also causing odour nuisance.
j. The industry is maintaining 9060C temperature in the primary chamber and
secondary chamber. The industry is supposed to maintain 10500C + or - 500C. the
incinerator is emitting thick black smoke and also causing Methyl Mercaptane
odour.
k. Hot water from the production block is being discharged into open RCC tanks and
causing odour nuisance.
l. Bag filters provided to the 10 TPH boiler were damaged and emitting thick black
smoke.
m. Not provided proper drainage system for floor washings.
n. The industry not submitted the information regarding usage of Ozone depleting
substances; mock drill reports; inventory of solvents; source of intermediates &
consolidated production records.
o. The industry not carried out regular monitoring of vents of the storage tanks and
work room concentrations.
The issue is placed before the CFO committee for review and recommendations.

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