Attachment-B Revised EC Compliance Report

M/s. Apothecon Pharmaceuticals Pvt. Ltd., Vadodara, Gujarat 1

Attachment-B_ Revised EC Compliance Report

Six Monthly Compliance Report on the Status of Compliance of The Environmental Clearance Conditions

Name of the company : M/s. Apothecon Pharmaceuticals Pvt. Ltd.

Name of the project and address : Bulk Drug Manufacturing Unit at Plot no. 1134 to 1137,1138 A&B,1143

A&B,1144 A&B,Padra - Jambusar Highway, P.O. Dabhasa, Taluka Padra,

Vadodara, Gujarat.

Environmental Clearance letter : F. No. J-11011/609/2008-IA II (I) dated 23rd December 2010

Period of Monitoring : January 2019 to June 2019

No. Condition Compliance status

A SPECIFIC CONDITIONS:

i Adequate pollution control

measures shall be provided to

control air emissions within

norms prescribed by the CPCB

and Gujarat Pollution Control

Board. At no time, the emission

levels shall go beyond the

stipulated standards. In the

event of failure of pollution

control system(s) adopted by

the unit, the respective unit

shall not be restarted until the

control measures are rectified

to achieve the desired

efficiency.

We have provided adequate APCM, i.e. Brine/chiller condensers, scrubbers,

Dust Collectors at necessary stages. We assure that at no time the emission

level has gone beyond the stipulated standards and or the prescribed limit. In

event of any failure, we will intimate to the board and authority time to time. In

the event of failure of pollution control system(s) adopted by the unit, the

respective unit shall not be restarted until the control measures are rectified to

achieve the desired efficiency.

Flue gas emission stacks monitoring done by approved third party details are as

under:

Name Of Env. Monitoring Agency : Aryan Greens (Vadodara)

NABL Certificate No & Valid Up to: TC-8296 & 17/01/2021.

Stack Height Parameters

APCM Limit

Results

Min. Max. Avg.

Boiler-1,2

& TFH

30 m

PM (mg/Nm3)

SO2 (ppm),

NOx (ppm)

150

100

50

61.0

18.0

23.0

80.0

28.0

38.0

72.0

22.0

33.0

DG (250

kVA)

4 m

58.0

18.0

26.0

86.0

26.0

35.0

75.0

21.0

31.0

DG (750

kVA)

4 m

61.0

17.0

30.0

83.0

26.0

41.0

71.0

23.0

34.0

The details of APCM attached with process gas emission stacks are as under:

Stack Heigh

t Parameters APCM Limit

Results

Min. Max. Avg.

Tablet coater

21 m

PM

(mg/Nm3)

Water scrubber

150 31.0 67.0 20.0

Pilot Plant reactor

vessel

20 m

HCl (mg/Nm3)

Cl2

(mg/Nm3)

Caustic/ water

scrubber (2 stage)

20

09

2.5

1.4

3.9

1.4

1.5

0.1

Reactor vessel (API

plant –III)

20 m

HCl (mg/Nm3)

Cl2

(mg/Nm3)

Caustic/ water

scrubber

(2 stage)

20

09

2.0

0.0

3.3

0.0

1.4

0.0

The analysis reports are enclosed as Annexure-1.



Boiler-1 & TFH

Scrubber with Pilot Plant reactor vessel

Scrubber with Reactor vessel (API plant –III)



Water scrubber with Tablet Coater

Complied.

ii The National Ambient Air

Quality Emission Standards

issued by the Ministry vide G

S.R No. 826(E) dated 16th

November, 2009 shall be

followed.

Regular monitoring is being carried out to ensure quality of ambient air within

prescribed norms of NAAQS as per Valid CC&A. The monitoring done by

approved third party details are as under:

Name of Env. Monitoring Agency : Aryan Greens (Vadodara)


Locations Parameters Limits Results

Min. Max. Avg.

Security Gate

PM10 (µg/m3)

PM2.5 (µg/m3)

SO2 (µg/m3)

NO2 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

80

80

200

100

-

76.0

26.0

14.0

22.0

BDL

BDL

BDL

92.0

43.0

23.0

28.0

BDL

BDL

BDL

86.0

34.0

19.0

25.3

BDL

BDL

BDL

Near ETP

PM10 (µg/m3)

PM2.5 (µg/m3)

SO2 (µg/m3)

NO2 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

80

80

200

100

-

71.0

23.0

15.0

20.0

BDL

BDL

BDL

88.0

32.0

19.0

28.0

BDL

BDL

BDL

81.0

28.0

17.0

24.1

BDL

BDL

BDL

Near R & D

Bldg.

PM10 (µg/m3)

PM2.5 (µg/m3)

SO2 (µg/m3)

NO2 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

80

80

200

100

-

77.0

26.0

13.0

19.0

BDL

BDL

BDL

92.0

45.0

22.0

28.0

BDL

BDL

BDL

85.0

36.0

16.6

25.0

BDL

BDL

BDL

The monitoring reports are enclosed as Annexure-1.

Complied.



iii Process emission fumes shall

be scrubbed in two stage

scrubbers and treated gas shall

be discharged into atmosphere

through adequate stack height.

Regular monitoring shall be

conducted to check efficiency

of the scrubbers.

In-plant control measures for

checking fugitive emissions

from all the vulnerable sources

shall be provided.

Fugitive emissions shall be

controlled by providing closed

storage, closed handling &

conveyance of Chemicals/

materials, multi-cyclone

separator and water sprinkling

system. Dust suppression

system including water

sprinkling system shall be

provided at loading and

unloading areas to control dust

emissions.

Fugitive emissions in the work

zone environment, product, raw

materials storage area etc. shall

be regularly monitored and

records shall be maintained.

The emissions shall conform to

the limits imposed by GPCB

Caustic and water Scrubbers are installed with process stacks. Details of APCM

attached with process gas stacks and monitoring done by NABL approved third

party Monitoring agency, details are as under:

Name Of Env. Monitoring Agency : Aryan Greens (Vadodara)


Stack Height Paramete

rs APCM Limits

Results

Min. Max. Avg.

Tablet coater

21 m PM

(mg/Nm3)

Water scrubber

150 31.0 67.0 20.0

Pilot Plant

reactor vessel

20 m HCl (mg/Nm3)

Cl2

(mg/Nm3)

Caustic/ water

scrubber (2 stage)

20

09

2.5

1.4

3.9

1.4

1.5

0.1

Reactor vessel

(API plant –

III)

20 m HCl (mg/Nm3)

Cl2

(mg/Nm3)

Caustic/ water

scrubber

(2 stage)

20

09

2.0

0.0

3.3

0.0

1.4

0.0


Water scrubber with Tablet Coater

Scrubber with Pilot Plant reactor vessel



Scrubber with Reactor vessel (API plant –III)

Complied.

Fugitive emissions in work zone are being measured as VOC & that due to

transportation or dust are measured as PM10, PM2.5, HCl and Cl2.

Fugitive emissions as PM10, PM2.5, HCl and Cl2 are as under:

Locations Parameters Limit Results

Min. Max. Avg.

Security

Gate

PM10 (µg/m3)

PM2.5 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

200

100

-

76.0

26.0

BDL

BDL

BDL

92.0

43.0

BDL

BDL

BDL

86.0

34.0

BDL

BDL

BDL

Near ETP

PM10 (µg/m3)

PM2.5 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

200

100

-

71.0

23.0

BDL

BDL

BDL

88.0

32.0

BDL

BDL

BDL

81.0

28.0

BDL

BDL

BDL

Near R &

D Bldg.

PM10 (µg/m3)

PM2.5 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

200

100

-

77.0

26.0

BDL

BDL

BDL

92.0

45.0

BDL

BDL

BDL

85.0

36.0

BDL

BDL

BDL

Fugitive emissions in the work zone environment are measured as VOC at

various locations and reported time to time. Raw materials sampling and

charging are done at production material dispensing area. Internal inhouse VOC

monitoring also carried out result attach in Annexure - 1.The results of the VOC

are as below:

Area /

Location Parameter

Permissibl

e limit as

per

Factory

Act Second

Schedule –

41F

Results in ppm

Min. Max. Avg.

SVAPI-

Plant-III Acetone

2375

mg/m3 BDL BDL BDL



R & D

Lab Toluene

560

mg/m3 1.1 1.4 1.25

QC Lab IPA 450

mg/m3 BDL BDL BDL

The analysis reports are enclosed as Annexure-1.

Fume hood provided at necessary locations to control fugitive emissions. Dust

collectors are also provided at necessary locations to control dust emission.

Fume Hood

Dust Collector

Complied.

iv For further control of fugitive

emissions, following steps shall

be followed:

Following steps are taken to control fugitive emissions:



a. Closed handling system shall

be provided for chemicals.

“Close feed” system is used into batch reactor. Pumps and direct pipeline are

connected to batch reactor for material shifting, to ensure the close feed system

in plant.

Photograph of the closed feed system is as under:

Complied.

b. Reflux condenser shall be

provided over reactor.

Reflux condenser is provided over reducer, the photograph of the same is as

under:

Complied.

c. System of leak detection and

repair of pump/pipeline based

on preventive maintenance.

Preventive maintenance (leak test) is carried out at regular interval of all

equipment so as to ensure/ maintain the efficiency of the recovery system. The

records of leak tests performed by the maintenance team as well as the third

party inspection is attached here as Annexure-2.

Complied.



d. The acids shall be taken from

storage tanks to reactors

through closed pipeline.

Storage tanks shall be vented

through trap receiver and

condenser operated on chilled

water Cathodic protection shall

be provided to the underground

solvent storage tanks.

We do not possess the storage tank for acid. For Research and Development

work, Utilization of acid quantum is very small.

Complied.

v The gaseous emissions from

DG set shall be dispersed

through adequate stack height

as per CPCB guidelines.

Acoustic enclosure shall be

provided to the DG sets to

mitigate the noise pollution.

Stack height of DG set (04 Meter) has been calculated as per GPCB guideline

and installed.

Acoustic enclosure has been provided to the DG sets to mitigate the noise

pollution.

Complied.

vi The company shall upload the

status of compliance of the

stipulated environmental

clearance conditions, including

results of monitored data on its

website and shall update the

same periodically.

It shall simultaneously be sent

to the Regional office of

MOEF, the respective Zonal

office of CPCB and the Gujarat

Pollution Control Board.

The levels of PM10, PM2.5, NOx,

SO2, HCI and Cl2 in ambient air

shall be monitored and

displayed at a convenient

Compliance reports will be upload from time to time on website.

Noted & Agreed with

We have already submitted the 6 monthly compliance report to the authority for

all six monthly periods between 2015 to 2019. The submission details are as

below:

Sr. No. EC Compliance Report Period Submission Date

1 January-June’ 2019 To be submit

2 July-December’ 2018 03/06/2019

3 January-June’ 2018 24/01/2019

4 July-December’ 2017 18/09/2018

5 January-June’ 2017 13/10/2017

6 July-December’ 2016 28/9/2017

7 January-June’ 2016 19/09/2017

8 July-December’ 2015 10/04/2017



location near the main gate of

the company and at important

public places.

VOCs monitoring in ambient

air shall also be ensured.

9 January-June’ 2015 10/04/2017

Complied.

The levels of PM10, PM2.5, NOx, SO2, are being monitored in ambient air and

the same is been displayed on a board near our gate.

Complied.

Regular VOC monitoring is being carried out at various locations in the

industry the details of locations and VOC concentration are as under:

Locations Parameters Limit Results

Min. Max. Avg.

Security

Gate

PM10 (µg/m3)

PM2.5 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

200

100

-

76.0

26.0

BDL

BDL

BDL

92.0

43.0

BDL

BDL

BDL

86.0

34.0

BDL

BDL

BDL

Near ETP

PM10 (µg/m3)

PM2.5 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

200

100

-

71.0

23.0

BDL

BDL

BDL

88.0

32.0

BDL

BDL

BDL

81.0

28.0

BDL

BDL

BDL

Near R &

D Bldg.

PM10 (µg/m3)

PM2.5 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

200

100

-

77.0

26.0

BDL

BDL

BDL

92.0

45.0

BDL

BDL

BDL

85.0

36.0

BDL

BDL

BDL

Complied.



vii

Solvent management shall be

carried out as follows:

a. Chiller shall be provided

for chilled brine circulation

to condensate the solvent

vapors and reduce solvent

losses Solvent distillation

assembly shall be provided

for ethanol as by product.

Necessary brine chilling plant is in place to circulate the brine to necessary

equipment’s and condensers to prevent the vapour losses and optimum

recovery.

Complied.

b. Reactor shall be connected

to chilled brine condenser

system.

Reactors & Condensers are being provided with chilled brine as a cooling

media circulation system to prevent the vapor losses. Photograph of the same

are as under:

Preventive maintenance is being carried out at regular interval of equipment’s

to ensure the efficiency of the solvent recovery system.

Complied.



c. Reactor and solvent

handling pump shall have

mechanical seals to prevent

leakages.

Reactors are being provided with mechanical seals to prevent leakages and also

provided vacuum systems instead of using transfer pumps.

Mechanical Seal on Reactor

Vaccum Charging

Vaccum Receiver

Complied.

d. The condensers shall be

provided with sufficient

HTA and residence time so

as to achieve more than

95% recovery.

The condensers are provided with sufficient HTA and residence time and

achieved more than 95% recovery. Photograph of the same is as under:

Complied.

e. Solvents shall be stored in

a separate space specified

with all safety measures.

Solvents are properly stored in separate and isolated place complying to the

requirements of PESO or as per Explosives license with all safety measures.

The Drum solvent storage area is provided with Automatic Ceiling mounted fire

extinguisher system. The area is provided with flame proof electrical fittings.

Also the proper ventilation of the area is ensured.

The photographs of the solvent storage area are as under:



Complied.

f. Proper earthing shall be

provided in all the

electrical equipment

wherever solvent handling

is done.

Proper earthing provided in all the electrical equipment in the areas where

solvent is handled and stored.

Preventive maintenance is carried out at regular interval of all equipment so as

to ensure/ maintain the efficiency of the recovery system.

Complied.

g. Entire plant shall be flame

proof. The solvent storage

tanks shall be provided

with breather valve to

prevent losses.

We have only Solvent drum storage area with valid license from PESO.

Peso Licence is obtained for storage of solvent vide letter no. P/WC/GJ/16/337

(P252140) dated 26/12/2014. Peso Licence is enclosed as Annexure-3.

Complied.

viii Total ground water requirement

shall not exceed 78 m3/day and

prior permission shall be

obtained from CGWB/SGWB

and a copy be submitted to the

Ministry's Regional Office at

Bhopal within 3 months of

issue of environment clearance.

Permission of CGWA obtained vide letter no. 21-4(725)/WCR/CGWA/2010-

2260 dated 17 Sep, 2010. Permission letter is enclosed as Annexure -4.

Around average 37.3 KL/d water is consumed in last 6 months. The details are

as under:

Month (2019) Quantity of Water Withdrawal (KL/d)

Min Max Average

January 11 51 32.0

February 24 41 34.5

March 18 47 34.9

April 16 45 35.7

May 24 57 41.9

June 31 60 44.8

Complied.

ix Total waste water generation

shall not exceed 45 m3/day and

treated in ETP comprising of

primary, secondary treatment

facility. Treated wastewater

shall be sent to CETP operated

by M/s EICL, Umaraya after

meeting CETP inlet water

quality norms prescribed by

GPCB for further treatment.

Around 20.23 KL/d (Avg.) wastewater is generated in last 6 months. The details

are as under:

Month (2019) Quantity of Wastewater Generation (KL/d)

Min Max Average

January 2.8 27.9 15.8

February 11.3 29.2 19.4

March 8.2 26.6 18.7

April 6.0 31.1 20.2

May 10.8 30.4 20.2

June 13.0 38.3 27.1

The company has its own effluent treatment plant of 75 KL/day capacity to treat

the waste water.

Size of ETP units are mentioned below:

Sr. No. Name of The Unit Dimension (m) Capacity

Primary Treatment

01 Equalization Tank/Neutralization Tank

5 x 5 x (2 + 0.5) 100 m3

02 Flash Mixer 1 x 1 x (1 + 0.5) 1.98 m3

03 Flocculater 1.5 x 1.1 x (1.2+0.5) 1.98 m3



04 Primary Settling Tank 3.2 x 3.2 x (2.5 x 1 x 0.5) 25.6 m3

Secondary Treatment

01 Aeration Tank-1 15.6 x 7.5 x (4.5+0.5) 526.5 m3

02 Secondary Settling Tank-1 2.7 x 2.7 x (2.5+1 + 0.5) 18.3 m3

03 Aeration Tank-2 7.5 x 6.1 x (4.5+0.5) 206.6 m3

04 Secondary Settling Tank-2 2.7 x 2.7 x (2.5+1 + 0.5) 18.3 m3

05 Intermediate Sump 15 m3

06 Dual Media Filter 5 m3

07 Treated Effluent sump 3.6 x 2.85 x (2 + 0.5) 20.5 m3

08 Sludge Sump 3.6 x 2.85 x (2 + 0.5) 20.5 m3

09 Final Effluent storage tank FRP tank 50 m3

Unit has obtained membership certificate from M/s EICL, Umaraya.

Membership certificate is enclosed as Annexure-5.

Paramete

r Unit

Result Inlet Norms

of CETP Min Max Avg.

pH °C 6.52 7.8 7.39 5 to 9

Temperature

Pt.co. Units 25 34 28.3 45

Colour (Pt.

unit) mg/lit 30 70 47.1 -

TSS mg/lit 40 70 48.8 600

Oil and

Grease mg/lit BDL BDL - 20

Phenolic

compounds mg/lit 0.4 0.8 0.6 5

Arsenic mg/lit BDL BDL - 0.2

Total Chromium

mg/lit BDL BDL - 2

Hexavalent Chromium

mg/lit BDL BDL - 1

Copper mg/lit BDL BDL - 2

Lead mg/lit BDL BDL - 0.2

Mercury mg/lit BDL BDL - 0.01

Nickel mg/lit BDL BDL - 5

Zinc mg/lit BDL BDL - 5

Cadmium mg/lit BDL BDL - 2

Pesticides mg/lit Absent Absent - -

Bio-assay

test %

100% survival

of fish

after 96 hrs in

effluent

100% survival of fish after 96

hrs in effluent

- -

TDS mg/lit 2438 4303 3324.5 -

BOD mg/lit 30 44 34.3 500

COD mg/lit 81 180 130.1 2000

Cyanides mg/lit BDL BDL - 0.2

Chloride (as Cl)

mg/lit 1020 1460 1223.17 -

Sulphate (as SO4)

mg/lit 67 155 111.38 -

Sulphides mg/lit 0.4 0.96 0.65 2

Fluoride (as F)

mg/lit 0.5 1.5 0.97 2

Ammonical Nitrogen

mg/lit 8.2 10 9.07 50



Sodium

Absorption

Ratio

(SAR)

% 11 22 14.5 -

Free

Ammonia mg/lit BDL BDL - 5

Analysis report is attached as Annexure-1.

Complied.

x NaCl shall be supplied to

caustic soda plants.

Total spent solvent shall be

treated and reused.

Distillation residue shall be

incinerated at CHWI.

Spent oil shall be sold to

registered re-processors.

ETP sludge shall be disposed

off at TSDF.

Manufacturing of API during the period Jan-Jun -2019, No by-product NaCL is

being generated from the process.

Complied.

Unit has obtained membership of CHWIF facility of

RSPL vide letter dated 30/01/2017. Membership certificate is enclosed as

Annexure-6.

8.01 MT distillation residues has been disposed to CHWIF in last 6 months.

Month (2019) Generation (Mt/Month) Disposal

(Mt/Month)

January 3.69 -

February 1.69 3.88

March 2.12 4.13

April 1.44 -

May 1.62 -

June 1.63 -

Around 36.58 MT spent solvent /oil & disc.Container has been sent to

registered re-processor in last 6 months. The details are as under:


(Mt/Month)

January 22.28 8.08

February 61.25 8.77

March 36.17 0

April 50.09 8.53

May 79.47 11.19

June 6.32 8.08

Unit has obtained membership of TSDF facility of

NECL. Membership certificate is enclosed as Annexure-6.

Around 3.69 MT ETP sludge has been disposed to TSDF in last 6 months. The

details are as under:


(Mt/Month)

January 2.83 -

February 0.27 3.69

March 0.33 -

April 0.32 -

May 0.40 -

June 0.48 -



Manifest copies and Financial year disposal details are enclosed as Annexure-6.

Complied.

xi The Company should obtain

Authorization for collection,

storage and disposal of

hazardous waste under the

Hazardous Waste

(Management, Handling and

Trans boundary Movement)

Rules, 2008 and 'Authorization'

should be obtained from GPCB

for the disposal of solid/

hazardous waste in the TSDF.

The concerned company shall

undertake measures for

firefighting facilities in case of

emergency.

'Membership' for the disposal

of solid/hazardous waste to

TSDF shall be obtained.

The Company has obtained Consolidated Consent for Authorization (CCA)

vide letter no. AWH-73492 dated 22/10/2015 valid till 21/10/2020 for collection, storage and disposal of hazardous waste under the Hazardous Waste

(Management, Handling and Trans boundary Movement) Rules, 2008. CCA is

enclosed as Annexure-7.

Complied.

Following firefighting facilities have been installed in plant:

1 Fire Hydrant Reservoir: 314 m3

2 Main Hydrant Pump

Make: Mather & Platt Pumps Ltd

Model : ET ISO No:12 (CAT-B1)

Head: 70 m

Flow: 137 m3/h

Motor : 2955 RPM

3 Jockey Pump



Head: 70 m

Flow: 11 m3/h

Motor : 2850 RPM

4 Diesel Engine Pump

Make: Graves Cotton Ltd

Model : 4G IIT

Head: 70 m

Flow: 137 m3/h

5 Fire Hydrant Details

Type of Hydrant Total Nos. Installed

Single Hydrant 15

fixed Monitor 1

6 Fire Extinguisher Details

Fire Extinguisher Type Fire Extinguisher

Capacity Quantity

DCP 5 kg, 10 kg 40

ABC 2 kg, 5 kg, 25 kg 61

Foam 9 kg, 50 kg 18

CO2 2 kg, 4.8 kg, 6.8 kg, 9 kg 54



Fire Hydrant layout attached as Annexure- 7-A.


NECL. Membership certificate is enclosed as Annexure-6.

Complied.

xii The Company shall strictly

comply with the rules and

guidelines under Manufacture,

Storage and Import of

Hazardous Chemicals Rules,

1989 as amended time to time.

Transportation of hazardous

chemicals including phenol

shall be as per the Motor

Vehicle Act (MVA), 1989.

All the hazardous chemicals such as solvents are handled with proper care. The

areas where these chemicals are being stored or consumed warnings are

displayed.

Proper PPE’s are mandatory for workers handling these chemicals.



All vents of solvent storage units are connected with vent condensers supplied

with chilled brine.

Brine Plant

Chilling Plant

Close feed systems are provided to avoid direct contact, leakages and spillages

of chemicals. Regular work zone monitoring is conducted to check efficiency of

the system adopted.

The unit is strictly complying with all the rules and regulation under

manufacture, storage and import of Hazardous chemicals rules, 1989 as

amended in October, 1994 and January, 2000. Peso Licence is obtained for

storage of solvent vide letter no. P/WC/GJ/16/337 (P252140) dated 26/12/2014.

Peso Licence is enclosed as Annexure-3.

All transportation of Hazardous Chemicals is as per the MVA, 1989 and its

subsequent amendments.

Complied.

xiii Hazardous chemicals shall be

stored in tanks, drums, carboys

etc. Flame arresters shall be

provided on tank farm. Solvent

transfer shall be done by

pumps.

Hazardous chemical such as HCL, Acetic Acid, Formic Acid are stored in

Carboys in a separate Hazardous chemical storage area equipped with Fire

Extinguishers. Solvent transfer is done manually from drum with proper

earthing.

Complied.



xiv The company shall undertake

following waste minimization

measures :-

a. Metering and control of

quantities of active

ingredients to minimize

waste.

Ingredients/inputs are being properly weighted and charged to the vessel

through hoppers & flow metering control systems.

Complied.

b. Reuse of by-products from

the process as raw materials

or as raw material substitutes

in other processes.

Manufacturing of API during the period Jan to Jun-2019, No by-product NaCL

is being generated from the process.

Complied.

c. Use of automated filling to

minimize spillage.

Ingredients/inputs are being properly measured and transfer to the vessel

through hoppers, transferring pumps & vacuum systems.

Vaccum Charging

Vaccum Receiver

Solvent Transfer Pumps

Charging Hopper

Complied.

d. Use of Close Feed system

into batch reactors.

Batch rectors having close feed systems (Nozzles) for hoppers, transferring

liquids as well as vacuum systems.



Vacuum Charging

Vacuum Receiver

Complied.

e. Venting equipment through

vapour recovery system.

Batch reactors having two stage condensers and are connected with scrubbers.

Complied.

f. Use of high pressure hoses

for equipment clearing to

reduce wastewater

generation

Water jet hose are being used for cleaning of equipment’s.

Complied.



xv The unit shall make the

arrangement for protection of

possible fire hazards during

manufacturing process in

material handling. Firefighting

system shall be as per the OISD

117 norms.

The detail of firefighting system is given as under:

Following firefighting facilities have been installed in plant:

1 Fire Hydrant Reservoir: 314 m3

2 Main Hydrant Pump



Head: 70 m

Flow: 137 m3/h

Motor : 2955 RPM

3 Jockey Pump



Head: 70 m

Flow: 11 m3/h

Motor : 2850 RPM

4 Diesel Engine Pump

Make: Graves Cotton Ltd

Model : 4G IIT

Head: 70 m

Flow: 137 m3/h

5 Fire Hydrant Details

Type of Hydrant Total Nos. Installed

Single Hydrant 15

fixed Monitor 1

6 Fire Extinguisher Details

Fire Extinguisher Type Fire Extinguisher Capacity Quantity

DCP 5 kg, 10 kg 40

ABC 2 kg, 5 kg, 25 kg 61

Foam 9 kg, 50 kg 18

CO2 2 kg, 4.8 kg, 6.8 kg, 9 kg 54

Complied.

xvi As proposed, green belt shall be

developed in 19,025 sq. m out

of 38,077 sq m. Green belt

design shall be as per CPCB

guidelines.

Total 12925 m2 area is covered with greenbelt which is more than 33 % of total

plot area (38077 sq. m.) consisting of air and noise pollution capturing trees on

periphery; shrubs and lawn. The photographs of greenbelt developed within

plant premises are as under: Plant layout with green belt area marking is

attached as Annexure- 7-B.



Complied.

xvii Provision shall be made for the

housing for the construction

labour within the site with all

necessary infrastructure and

facilities such as fuel for

cooking mobile toilets mobile

sewage treatment plant, safe

drinking water, medical health

care, creche etc. The housing

may be in the form of

temporary structure to be

removed after the completion

of the project All construction

wastes shall be managed so that

there is no impact on the

surrounding environment.

All necessary housing and other required facilities are provided to construction

labour, construction waste is managed within the construction site to avoid

impact on surrounding environment.

Complied.

B. GENERAL CONDITIONS:

i The project authorities shall

strictly adhere to the

stipulations made by the

Gujarat Pollution Control

Board.

We are periodically submitting the Monthly Patraks, Annual Returns such as

Water Cess, Form-4 Hazardous Waste Returns, Form-V Environment

Statement, etc. as a part of informing the authorities for the environmental

status / conditions during the financial years. The proof of submission is

enclosed as Annexure-8.

Complied.



ii No further expansion or

modifications in the plant shall

be carried out without prior

approval of the Ministry of

Environment and Forests. In

case of deviations or alterations

in the project proposal from

those submitted to this Ministry

for clearance, a fresh reference

shall be made to the Ministry to

assess the adequacy of

conditions imposed and to add

additional environmental

protection measures required, if

any.

No additional expansion/modification is carried our other than approved from

Ministry of Environment and forests,

Construction work is going on at site is as per the project proposal submitted to

the MoEF, and we have also received the valid extension vide F. No: J-

11011/186/2009-IA-II (I), dated 5th March 2018, up to 23rd December 2020.

The extension letter is enclosed as Annexure-9.

We will provide sufficient environment protection measures for constructed

API plant facility.

Complied.

iii The locations of ambient air

quality monitoring stations

shall be decided In consultation

With the State Pollution

Control Board (SPCB) and it

shall be ensured that at least

one stations is installed in the

upwind and downwind

direction as well as where

maximum ground level

concentrations are anticipated.

Regular monitoring is being carried out to ensure quality of ambient air within

prescribed norms of NAAQS within premises. The details of monitoring are as

under:

Locations Parameters Limits Results

Min. Min. Avg.

Security Gate

PM10 (µg/m3)

PM2.5(µg/m3)

SO2 (µg/m3)

NO2 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

80

80

200

100

-

76.0

26.0

14.0

22.0

BDL

BDL

BDL

92.0

43.0

23.0

28.0

BDL

BDL

BDL

86.0

34.0

19.0

25.3

BDL

BDL

BDL

Near ETP

PM10 (µg/m3)

PM2.5(µg/m3)

SO2 (µg/m3)

NO2 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

80

80

200

100

-

71.0

23.0

15.0

20.0

BDL

BDL

BDL

88.0

32.0

19.0

28.0

BDL

BDL

BDL

81.0

28.0

17.0

24.1

BDL

BDL

BDL

Near R & D

Bldg.

PM10 (µg/m3)

PM2.5(µg/m3)

SO2 (µg/m3)

NO2 (µg/m3)

HCl (µg/m3)

Cl2 (µg/m3)

VOC(µg/m3)

100

60

80

80

200

100

-

77.0

26.0

13.0

19.0

BDL

BDL

BDL

92.0

45.0

22.0

28.0

BDL

BDL

BDL

85.0

36.0

16.6

25.0

BDL

BDL

BDL


Complied.

iv The overall noise levels in and

around the plant area shall be

kept well within the standards

by providing noise control

measures including acoustic

hoods, silencers, enclosures etc.

on all sources of noise

generation. The ambient noise

levels shall conform to the

standards prescribed under

Environment (Protection) Act,

1986 Rules, 1989 viz. 75 dBA

(day time) and 70 dBA (night

time).

The overall noise levels in and around the plant area is kept well within the

standards by providing noise control measures including acoustic hoods,

silencers, encloses etc. on all sources of noise generation. Ambient noise levels

are being monitored regularly. It is mandatory for workers to use PPE’s such as

ear plugs/ear muffs in high noise area.

The ambient noise levels is under the standards prescribed under Environment

Protection act, 1986 Rules, 1989 viz. 75 dB(A) (day time) & 70 dB(A) (night

time).

Equipment generating high noise are equipped with Acoustic enclosures;

regular maintenance, lubrication and vibration pads are assured for such

sources. The results are stated as under;



Location

Permissible limit (dB(A)) Day - Night time results (dB(A))

Day Night Min. Max. Avg.

Day Night Day Night Day Night

ETP area

75 70

61 52 68 60 65.67 57

Boiler House 65 54 73 67 68.5 60.83

D.G. Set area 61 54 71 62 67.70 58.33

Security main Gate 48 45 68 56 57.33 50.33

Administrat

ion area 46 46 57 58 52.33 49.83

Q. C.

Laboratory 49 45 65 56 57 50

R & D

Laboratory 48 46 67 54 55.5 50

Utility Ground

Floor 61 53 72 58 65.83 56.70

Utility First

Floor 55 50 72 62 64.5 55.33

ADL Area 52 47 62 58 55.5 52.33

The analysis reports for noise level monitoring are attached as Annexure-1.

Complied.

v During transfer of materials,

spillages shall be avoided and

garland drains be constructed to

avoid mixing of accidental

spillages with domestic

wastewater and storm water

drains.

“Close feed” system is used into batch reactor. Pumps and direct pipeline are

connected to batch reactor for material shifting, to ensure the close feed system

in plant.

Photograph of the closed feed system is as under:

Complied.

vi The Company shall harvest

rainwater from the roof-tops of

the buildings and storm water

drains to recharge the ground

water and use the same water

for the process activities of the

project to conserve fresh water.

Rainwater harvesting is carried out through collecting the runoff from rooftops

of the buildings to Percolating wells. Drawing of percolation well is attached

here as Annexure-10.

Effective area- 4660.65 m2

Rain water available- 4324.097 KL

Capacity of rain water Harvesting wells – 250 lit/Min

Nos. of Recharge Bore wells- 02

Complied.

vii Usage of Personnel Protection

Equipments (PPEs) by all

PPE’s are mandatory for all workers and employees as per possible hazard type.

Type and quantity of PPE’s available at unit are as under:



employees/ workers shall be

ensured. Type Quantity

Purple nitrile Gloves 270 Packet

Surgical Gloves (Powder free) 260 Packet

Sterile Surgical Gloves 15 Packet

Nitrile Gloves 55 Pairs

Rubber Gloves 70 Pairs

Grey nitrile gloves 480 Nos

Plastic Full length hand gloves 10500 Nos

Face Shield 7 Nos

Dust mask 750 Nos

Safety Googles 80 Nos

Full face mask 13 Nos

Half Face mask 08 Nos

Ear Plug/Ear Muff 100 Nos

Complied.

viii Occupational health

surveillance of the workers

shall be done on a regular basis

and records maintained as per

the Factories Act.

Total 85 nos of Pre-employment and 65 nos of annual medical check-up is

carried out in last last 6 months as per Factories Act. Agreement copy of doctor

and health report is attached here as Annexure-11.

Complied.

ix Training shall be imparted to

all employees on safety and

health aspects of chemicals

handling. Pre-employment and

routine periodical medical

examinations for all employees

shall be undertaken on regular

basis. Training to all employees

on handling of chemicals shall

be imparted.

Training of safety and health aspects of chemicals handling is being arranged

periodically. Pre-Employment and periodical check-up is being carried out.

Medical reports are enclosed as Annexure-11.

Complied.

x The company shall also comply

with all the environmental

protection measures and

safeguards proposed in the

project report submitted to the

Ministry.

All the recommendations made

in the EIA/EMP in respect of

environmental management,

risk mitigation measures and

public hearing relating to the

project shall be implemented.

Following are the environmental protection measures and safeguards have been

installed as proposed in the project report submitted to the Ministry &

recommendations made in the EIA/EMP in respect of environmental

management, risk mitigation measures and public hearing:

Point as per EMP of

EIA Report &

Public Hearing

Implementation Details



Proper collection,

handling & storage

shall be provided for

hazardous waste.

Unit has provided hazardous waste storage area with

pucca flooring, leachate collection system & roof.

Unit shall obtain

necessary

membership

certificate from

approved TSDF,

CHWIF.

Unit has obtained membership of CHWIF facility of

RSPL vide letter dated 30/01/2017. Membership

certificate is enclosed as Annexure-6.


NECL. Membership certificate is enclosed as

Annexure-6.

Company shall install

ETP consisting of

primary and

secondary facility.

Fully Functional ETP having 75 m3/Day capacity is

installed.



Distillation unit is provided for high COD effluent.

Online Effluent monitoring analyser and data logging

is installed at ETP

Unit shall obtain

necessary

membership

certificate from

CETP of EICL,

Umaraya.

Unit has obtained membership certificate from M/s

EICL, Umaraya. Membership certificate is enclosed as

Annexure-5.



Adequate pollution

control system shall

be provided with

stacks.

Online stack monitoring Analyser and data logging is

installed.

As fuel used in boiler-1 & TFH is diesel APCM is not

required.

Water scrubber is attached with stack of Tablet coater.



Caustic/ water scrubber is attached with Pilot Plant

reactor vessel.

Caustic/ water scrubber is attached with Reactor vessel

(API plant –III).

Plantation shall be

done in & around

plant

Total 12,925 m2 area is covered with greenbelt which is

more than 33 % of total plot area consisting of air and

noise pollution capturing trees on periphery; shrubs and

lawn. The photographs of greenbelt developed within

plant premises are as under:



Rain water

harvesting system

shall be provided to

conserve ground

water level.

Rainwater harvesting is carried out through collecting

the runoff from rooftops of the buildings to Percolating

wells.

Effective area- 4660.45 m2

Rain water available- 4324.097 KL

Capacity of rain water Harvesting wells – 250

lit/Min

Nos. of Recharge Bore wells- 02

Drawing of percolation well is attached here as

Annexure-10.

Separate solvent

storage area shall be

provided.

Necessary

permissions shall be

obtained from PESO

if applicable.

Hazardous chemical such as HCL, Acetic Acid, Formic

Acid are stored in Carboys in a separate Hazardous

chemical storage area equipped with Fire

Extinguishers. Solvent transfer is done manually from

drum with proper earthing.

Peso Licence is obtained for storage of solvent vide

letter no. P/WC/GJ/16/337 (P252140) dated

26/12/2014. Peso Licence is enclosed as Annexure-3.



PPE’s shall be

provided to workers.

Following PPE’s are provided:

Type Quantity

Purple nitrile Gloves 270 Packet

Surgical Gloves (Powder free) 260 Packet

Sterile Surgical Gloves 15 Packet

Nitrile Gloves 55 Pairs

Rubber Gloves 70 Pairs

Grey nitrile gloves 480 Nos

Plastic Full length hand gloves 10500 Nos

Face Shield 7 Nos

Dust mask 750 Nos

Safety Googles 80 Nos

Full face mask 13 Nos

Half Face mask 08 Nos

Ear Plug/Ear Muff 100 Nos



Onsite offsite

emergency plan shall

be prepared &

rehearsed.

Onsite offsite emergency plan is prepared and

rehearsed at regular interval of time.

Safety audit is carried out by safety auditor once in a 2

years. The recommendation of audit report are enclosed

as Annexure-12.

Regular monitoring

of various

environmental

parameters shall be

carried out to check

effectiveness of

control system.

Regular monitoring of various environmental

parameters is carried out. Analysis reports are enclosed

as Annexure-1.

Complied.

xi The company will undertake all

relevant measures for

improving the socio-economic

conditions of the surrounding

area. CSR activities will be

undertaken by involving local

villages and administration.

The company undertake all relevant measures and CSR activities for improving

the socioeconomic conditions in the surrounding area, Drinking water RO

system and Educational kit provided to nearby village school, photographs are

attached herewith;

xii The company shall undertake

eco-developmental measures

including community welfare

measures in the project area for

the overall improvement of the

environment.



xiii A separate Environmental

Management Cell equipped

with full-fledged laboratory

facilities shall be set up to carry

out the Environmental

Management and Monitoring

functions.

Company has formed a separate cell involving cross functional departments i.e.

R&D, Production, QC, QA, EHS, Maintenance and security persons.

Following is the structure of an Environmental Cell;

Designation Name of Person Qualification

Associate Vice President& Executive Director (Operation & R&D.)

Mr. Raja Jeyakumar M Sc.Applied Chemistry

Executive director & CFO Mr. Nirmal parikh C.A

GM (Prod.) Mr. Jignesh Chopra M Sc. Ind. Chemistry

GM (Engg.) Mr. Chirag Shah B.E Mechanical

GM- ADL & QC Dr. Rajesh Thekdi Ph.D. Organic synthesis

DGM- QA Mr. Biren Shah B.Sc. Chemistry

GM - RA Mr.Prashant Chudasama

M pharm

AM- EHS Mr. Virat Patel M.Sc. Environment

Sr. Executive- EHS Mr. kanu Patel Diploma Tech

Executive- EHS Mr. Jaimin Vyas M.E Chemical

Officer -EHS Mr.Samarth Mukhekar M.Sc. Environment

Environmental Management Cell equipped with full-fledged laboratory

facilities had been set up to carry out the environmental management and

monitoring functions on continuous basis.

List of parameters being tested in ETP lab are as under:

pH

COD

BOD

TDS

Chloride

Ammonical nitrogen

The organogram is attached here as Annexure-13.

Complied.

xiv The company shall earmark

adequate funds to implement

the conditions stipulated by the

Ministry of Environment and

Forests as well as the State

Government along with the

implementation schedule for all

the conditions stipulated herein.

The funds so earmarked for

environment management

pollution control measures shall

not be diverted for any other

purpose.

Unit will not divert funds allocated for environment management pollution

control measures in other activities. Annual Amount spent on the activities is as

under:

Activity Capital Cost (In Lakhs) Recurring Cost (In Lakhs per annum)

2017-18 2018-19

2019-

20 (Up

to Jun-

2019)

2017-18 2018-19 2019-20 (Up

to Jun-2019)

Continuous Stack Gas

Measurements system

10.46

PTZ

camera and

Electomegnetic

Flowmeters

1.24

TDS Meter, PH Meter

0.86

Submersibl

e Mud Sewage

Pump

0.24

Air blower- 15 HP

1.15

ETP

operation & maintenanc

e Expense

8.33 8.29 6.01



Projected budget for Year 2019-20:

Capital – Free Budget for EHS

Complied.

xv A copy of the clearance letter

shall be sent by the project

proponent to concerned

Panchayat, Zila Parisad

Municipal Corporation, Urban

local Body and the local NGO,

if any, from who suggestions!

Representations, if any, were

received while processing the

proposal.

A copy of the clearance letter has been submitted to various bodies.

Complied.

xvi The project proponent shall

also submit six monthly reports

on the status of compliance of

the stipulated Environmental

Clearance conditions including

results of monitored data (both

in hard copies as well as by e-

mail) to the respective Regional

Office of MoEF, the respective

Zonal Office of CPCB and the

Gujarat Pollution Control

board. A copy of

Environmental Clearance and

six monthly compliance status

reports shall be posted on the

website of the company.

We have already submitted the 6 monthly compliance report to the authority for

all six monthly periods between 2015 to 2019. The submission details are as

below:

Sr. No. EC Compliance

Report Period Submission Date

1 January-June’ 2019 To be submit

2 July-December’ 2018 03/06/2019

3 January-June’ 2018 24/01/2019

4 July-December’ 2017 18/09/2018

5 January-June’ 2017 13/10/2017

6 July-December’ 2016 28/9/2017

7 January-June’ 2016 19/09/2017

8 July-December’ 2015 10/04/2017

9 January-June’ 2015 10/04/2017

Complied.

xvii The environmental statement

for each financial year ending

31st March in Form-V as is

mandated shall be submitted to

the concerned State Pollution

Control Board as prescribed

under the Environment

(Protection) Rules, 1986, as

amended subsequently, shall

also be put on the website of

the company along with the

status of compliance of

environmental clearance

conditions and shall also be

sent to the respective Regional

Offices of MoEF by email.

The environmental statement for each financial year ending 31st March in

Form-V is being submitted to GPCB – Vadodara and Gandhinagar. We will put

EC compliance and Form-V on our website. Submission proof is enclosed as

Annexure-8.

Complied.



xvii

i

The project proponent shall

inform the public that the

project has been accorded

environmental clearance by the

Ministry and copies of the

clearance letter are available

with the SPCB

Committee and may also be

seen at Website of the Ministry

at http://envfor.nic.in. This

shall be advertised within seven

days from the date of issue of

the clearance letter, at least in

two local newspapers that are

widely circulated in the region

of which one shall be in the

vernacular language of the

locality concerned and a copy

of the same shall be forwarded

to the concerned Regional

Office of the Ministry.

We have obtained the EC in year 2010 vide letter no. F.No: J-11011/690/2008-

IA (I) dated 23rd December 2010, and inform the public that the project has

been accorded environmental clearance letter and advertised in two local

newspapers that are widely circulated in the region with one in the vernacular

language Gujarati and another in English as per below details;

1. Gujarati News Paper Gujarat Samachar, Dt.02/01/2011,

2. English News Paper Times of India, Dt. 02/01/2011.

The copies of the newspapers are attached here as Annexure-14.

Construction work is going on at site for API plant facility and We have

obtained EC Extension vide file No: J-11011/186/2009-IA (I), dated 5th March

2018 up to 23rd December 2020. EC extension letter is enclosed as Annexure-9.

xix The project authorities shall

inform the Regional Office as

well as the Ministry, the date of

financial closure and final

approval of the project by the

concerned authorities and the

date of start of the project.

We are periodically submitting the Monthly Patraks, Monthly Returns, Annual

Returns such as Water Cess, Form-4 Hazardous Waste Returns, Form-V

Environment Statement, etc. as a part of informing the authorities for the

environmental status / conditions during the financial years. The proof of

submission is enclosed as Annexure-8.

Complied.

Project starting date: 01/04/2017

Project work under process so financial closer date pending.

8. The Ministry may revoke or

suspend the clearance, if

implementation of any of the

above conditions is not

satisfactory.

We clearly understand and assure to comply all the requirements. We also

understand that ministry may revoke and suspend the clearance, if any of the

above condition is not satisfactory.

Noted and Agreed

9. The Ministry reserves the right

to stipulate additional

conditions, if found necessary.

The company in a time bound

manner will implement these

conditions.

We understand that the ministry reserves the right to stipulate additional

conditions, if found necessary. We assure to implement the conditions in a time

bound manner.

Noted and Agreed

10. Any appeal against this

environmental clearance shall

lie with the National Appellate

Authority, if preferred, within a

period of 30 days as prescribed

under section 11 of the

National Environment

Appellate Authority Act, 1997.

We understand that Any appeal against this environment clearance shall lie with

the National Environment Appellate Authority, if preferred within a period of

30 days as prescribed under Section 11 of the National Environment Appellate

Authority Act, 1197.

Noted and Agreed

11. The above conditions will be

enforced, inter-alia under the

provisions of the Water

(Prevention & Control of

Pollution) Act, 1974, Air

(Prevention &. Control of

Water Pollution) Act, 1981 ,

the

Environment (Protection) Act,

1986 Hazardous Wastes

We are complying and will continue to comply with all the statutory

requirements as per the provisions of the Water (Prevention & Control of

Pollution) Act, 1974, Air (Prevention &. Control of Water Pollution) Act, 1981,

the Environment (Protection) Act, 1986 Hazardous Wastes (Management and

Handling) Rules, 2003, 2008 along with their amendments and rules.

PLI Policy is enclosed as Annexure- 15.

The copy of the Onsite Emergency Plant – Apothecon Pharmaceuticals Private

Limited -April-2017 is attached here as Annexure-16.

http://envfor.nic.in/



(Management and Handling)

Rules, 2003, 2008 and the

Public Liability Insurance Act,

1991 along with their

amendments and rules.

License As per Hazardous Rules

Sr.

No.

Licenses &

Permits

Refere

nce

Numb

er

Expiry Measured

Values

Responsible

Authority

1. Factory License 7571 31/12/2019 Factory

Licence

DISH

2. Stability

certificate

NA/ST

B/APP

L/07/2

016/01

15/7/2021 STABILIT

Y

CERTIFIC

ATE

COMPETE

NT

PERSON

3. Explosive

License for

Petroleum

Storage

P/WC/

GJ/16/

337

(P2521

40)

31/12/2024 CLASS-A PESO

Factory License is enclosed as Annexure-17.

Stability certificate is enclosed as Annexure-18.

Explosives licence is enclosed as Annexure-3.

Complied.

Attachment-B Revised EC Compliance Report

Documents