TELANGANA STATE POLLUTION CONTROL BOARD

REGIONAL OFFICE, MAHABUBNAGAR

Dated 23/05/2017
From
The Environmental Engineer,
Regional Office,
T.S.Pollution Control Board,

To

The Member Secretary / The Joint Chief Environmental Engineer (Zonal Office),

Sir,

Sub:PCB – RO- SHILPAMEDICARE LIMITED--- Verification report – Submitted- Regarding.

Ref:The details of the industry and inspection report are submitted as below:

1.Name and Address of the industry: SHILPAMEDICARE LIMITED,TSIIC,PHARMA-

SEZ,GREEN INDUSTRIAL PARK, POLEPALLY
(V),JADCHERLA(M),MAHBUBNAGAR(D)
2.Status of Consent and HWA :
(i)Fresh / Renewal : expansion
(ii)Date of receipt of application / Additional 08/05/2017
information :
3. Project Cost(in Lakhs) :
4. Total investment on pollution control measures and recurring cost and percentage :
Latitude :
Longitude :
Total Area of the plant :
Extent of Greenbelt :
(vi)Boundaries of the site
North: Main road of SEZ followed by open lands
South: M/s Hetero Drugs
East: Open land
West: Open Land
5. Date of commissioning : 28/03/2016
6. Status of E.C :
(i)Line of Activity as per EIA Notification : Pharmaceutical and Formulation
(ii)Environmental Clearance order No. and date :
(iii)Violations of EIA Notification :
7. (i)Inspection conducted by SARITHAGURUVAGALLA
(ii)Date of Inspection : 12/05/2017
8. Raw materials / Fuels required for production at Consented capacity per Month :

1
Name of the Major Raw material Quantity Unit
/ material used in the Activity
1.00803.9029 TARTARIC ACID 25 Kg/month
(POWDER)
ANHYDROUS LACTOSE 350.00 Kg/month
USP/NF,(SUP ERTAB USP/NF)
BUTYLATED HYDROXY 12 Kg/month
TOLUENE IH
CROS POVIDONE USP/NF 10 Kg/month
DICALCIUM PHOSPHATE 50 Kg/month
ANHYDROUS (A- TA
USP/PH.EUR)
EUDRAGIT NE 30 D 10 Kg/month
USP/PH.EUR
HPMC (PHARMACO AT-606) 70.5 Kg/month
PH.EUR USP/BP/IP
HYDROXY PROPYL METHYL 220.72 Kg/month
CELLULOSE E5
HYPERMELL OSE 29 Kg/month
USP/PH.EUR USP/PH.EUR
INSTACOAT AQUA III 12 Kg/month
A03G30245 IH
IRON OXIDE YELLOW USP/NF 10 Kg/month
MAIZE STARCH 5 % USP 75 Kg/month
MANNITOL PF IP/BP/USP 244.84 Kg/month
MCC (AVICEL PH102) PH.EUR 745 Kg/month
IP/BP
METHACRYLIC ACID AND 10 Kg/month
ETHYL ACRYLATE
USP/PH.EUR
MICROCRYSTALLINE 789.75 Kg/month
CELLULOSE, USP-NF(A
USP/NF)
OPADRY YELLOW 03B82401 172.8 Kg/month
NA
PEG-400 USP/NF 105 Kg/month
POLOXAMER 188 50 Kg/month
(KOLLIPHOR P 188) NA
PEG (PEG 4000) USP/PH.EUR 25 Kg/month
SODIUIM LAURYL SULPHATE 45 Kg/month
USP NF/BP
SODIUM ACETATE 15 Kg/month
ANHYDROUS (USP) USP
MAROON IH EPMPTY 40 Nos./month
HGCRED
BUSULFAN USP/PH.EUR 1.095 Kg/month
CARFILZOMIB IH 1.5 Kg/month
CLOFARABIN E NA 0.225 Kg/month
DECITABINE( RM) IH 0.655 Kg/month

2
DOCETAXEL TRIHYDRATE 7.1 Kg/month
USP
DOXORUBICI N HYDROCHLO 1.85 Kg/month
RIDE USP
GEMCITABIN E HYDROCHLO 29.04 Kg/month
RIDE USP
IRINOTECAN 8.053 Kg/month
HYDROCHLORIDE
Anastrozole Tablets 1 mg 0.7 Kg/month
Fingolimode capsule 0.5 mg 0.7 Kg/month
Imatinib Tablets 400 mg 720 Kg/month
Capecitabine Tablets 150 mg 270 Kg/month
Capecitabine Tablets 500 mg 1000 Kg/month
Axitinib Tablets 1 mg 0.7 Kg/month
Diethyl stibestrrol 1 mg tablets 0.7 Kg/month
Everolimus Tablets 5.0 mg 3.5 Kg/month
Cyclophospha mide and 28 Kg/month
capecitabine Tablets 40
CITRIC ACID ANHYDROUS 10 Kg/month
USP/BP/PH.EUR
COLLOIDAL SILICON 31 Kg/month
DIOXIDE USP/NF
CROSCARM ELLOSE SODIUM 184.9 Kg/month
USP-NF/IP (AC PH.EUR/BP)
MAGNESIUM STEARATE(L 149.24 Kg/month
IGAMED MF- 2 -V)
POTASSIUM DIHYDROGEN 10 Kg/month
PHOSPHATE
POTASSIUM HYDROXIDE NF 1 Kg/month
PH.EUR/BP
POVIDONE K-30 (KOLLIDONE 75 Kg/month
30 LP) NA
PRE GELATINIZED STARCH 300 Kg/month
USP/PH.EUR
SIMETHICON E EMULSION 1 Kg/month
USP-30 % USP/NF
SODIUM CHLORIDE(LOW IN 5 Kg/month
ENDO TOXINS)
SODIUM CITRATE 11 Kg/month
ANHYDROUS IH
SODIUM HYDROXIDE 10 Kg/month
USP/BP/EP
SODIUM LAURYL SULPHATE 6 Kg/month
USP/NF
SODIUM STARCH 145 Kg/month
GLYCOLATE( TYPE-A)
USP/NF
SODIUM STEARYL 4 Kg/month
FUMARATE PH.EUR

3
TALC (LUZENAC PHARMA) 25 Kg/month
USP/PH.EUR
TRIETHYL CITRATE 2.27 Kg/month
USP/PH.EUR
ZOLEDRONIC ACID IH 0.14 Kg/month
METHYL ALCOHOL USP/NF 1.5 Kg/month
N,NDIMETHYLA CETAMIDE 0.0525 Kl/month
BP/PH.EUR
PROPYLENE GLYCOL 0.240 Kg/month
USP/PH.EUR
TERT. BUTANAOL HP IH 0.100 Kl/month
TERT-BUTYL ALCHOL 0.113 Kl/month
SPECIAL GRADE IH
ACETONE NA 0.725 Kl/month
ACETONITRI LE SPECIAL 0.240 Kl/month
GRADE IH
ETHYL ALCOHOL 0.150 Kl/month
DEHYDRATED ( USP)
DICHLOROM ETHANE IH 0.175 Kl/month
Everolimus Tablets 2.5 mg 1.75 Kg/month
Everolimus Tablets 7.5 mg 5.25 Kg/month
Everolimus Tablets 10.0 mg 7 Kg/month
Cyclo phosphasmide capsule 25 17.5 Kg/month
mg
Cyclophosphasmide capsule 50 35 Kg/month
mg
Enzalutamide Capsule 40 mg 28 Kg/month
Dimethyl Fumarate Tablets 120 168 Kg/month
mg
Dimethyl Fumarate Tablets 240 336 Kg/month
mg
Abiraterone Tablets 250 mg 175 Kg/month
Erlotinib Tablets 25 mg 37.5 Kg/month
Erlotinib Tablets 100 mg 150 Kg/month
Erlotinib Tablets 150 mg 225 Kg/month
Cyclophosphasmide and 14 Kg/month
capecitabine Tablets 20mg
Cyclophospha mide and 210 Kg/month
capecitabine Tablets 300 mg
Temozolomide capsule 20 mg 14 Kg/month
Temozolomide capsule 100 mg 70 Kg/month
Temozolomide capsule 180 mg 126 Kg/month
ISOPROPYL ALCOHOL 1920 Kg/month
USP/BP/PH.E UR/IP NA
"L(+) - TARTARIC ACID 5 Kg/month
POWDER (1.0080 USP/NF"

4
 "LACTOSE MONOYDRA TE 2250 Kg/month
SUPERTAB 30 USP/BP/IP"
SORBITAL IH 108 Kg/month
SOYABEAN HIVEG MEDIUM 76 Kg/month
STERILE
STEARIC ACID (KOLLIWAX ® 25 Kg/month
S FINE) USP/NF
SUNSET YELLOW SUPRA IH 1 Kg/month
HYDROCHLORIC ACID 0.004 Kl/month
USP/BP/EP
NITROGEN GAS USP IH 697 Nos./month
EMPTY HGC WHITE A 110190 Nos./month
CARBON DIOXIDE USP/NF 17 Nos./month
HGC SHELL(SIZE- 4)GREYISH 9940000 Nos./month
RED OPAQUE
AZACITIDINE ( IH) RM IH 3.952 Kg/month
BENDAMUSTINE 1.906 Kg/month
HYDROCHLORIDE IH
BORTEZOMIB. IH 0.829 Kg/month
OXALIPLATI N USP (RM) IH 2.729 Kg/month
PEMETREXED DI POTASSIUM 15.6 Kg/month
PEMETREXED DI POTASSIUM 15.6 Kg/month
PEMETREXE D DISODIUM 23.141 Kg/month
Letrozole Tablets 2.5 mg 2 Kg/month
Bicalutamide Tablets 50 mg 30 Kg/month
Bicalutamide Tablets 150 mg 105 Kg/month
Tereflunomide Tablets 7 mg 7 Kg/month
Tereflunomide Tablets 14 mg 14 Kg/month
Tacrolimus Capsuel 0.5 mg 0.35 Kg/month
Tacrolimus Capsuel 1.0 mg 0.7 Kg/month
Tacrolimus Capsuel 5.0 mg 3.5 Kg/month
Imatinib Tablets 100 mg 180 Kg/month
Imatinib Tablets 100 mg 180 Kg/month
Cyclophosphasmide and 420 Kg/month
capecitabine Tablets 600 mg
Sorafenib tablets 200 mg 140 Kg/month
Temozolomid e capsule 5 mg 3.5 Kg/month
Temozolomide capsule 140 mg 98 Kg/month
Temozolomide capsule 250 mg 175 Kg/month
9. Products & By Products manufactured / Storage capacity of Petroleum products / Mining capacity etc per
Day / Month :

5
 Line of activity / Products Capacity Unit
Azacitadine for injection 100 1325 Nos./month
mg/vial
Bendamustine HCL 2.5 mg/ ml 3952 Nos./month
(25 mg/vial)
Bendamustine HCL 2.5 mg/ ml 1980 Nos./month
(100 mg/vial)
Pemetrexed For Injection 100 mg/ 5995 Nos./month
vial (Biocon)
Pemetrexed For Injection 500 mg/ 3206 Nos./month
vial (Biocon)
Bortezomib for injection 3.5 mg/ 11428 Nos./month
vial (Pfizer)
Bortezomib for injection 3.5 mg/ 7389 Nos./month
vial (shilpa)
Bortezomib for injection 1 mg 16722 Nos./month
(KRKA)
Bortezomib for injection 3.5 mg/ 7389 Nos./month
vial (KRKA)
Carfilzomib for injection 60 mg/ 4098 Nos./month
vial
Clofarabine injection 1mg / ml (20 2413 Nos./month
ml fill)
Decitabine for injection 50 mg/ 1986 Nos./month
vial
Docetaxel injection USP 160 mg / 2920 Nos./month
8 ml
Docetaxel injection USP 80 mg / 4 3456 Nos./month
ml
Docetaxel injection USP 20 mg / 1 8849 Nos./month
ml
Doxorubicin HCL injection 2 mg / 2803 Nos./month
ml (5 ml fill)
Doxorubicin HCL injection 2 mg / 1896 Nos./month
ml (10 ml fill)
Doxorubicin HCL injection 2 mg / 1926 Nos./month
ml (25 ml fill)
Doxorubicin HCL injection 2 mg / 732 Nos./month
ml (100 ml fill)
Bortezomib Injection (0.2 ml fill) 25000 Nos./month
(FTF)
Gemcitabine for Injection USP 1 2600 Nos./month
gm/vial
Gemcitabine for Injection USP 3960 Nos./month
200 mg/vial
Irinotecan hydrochloride 40 mg / 2 4587 Nos./month
ml (20 mg/ml)
Irinotecan hydrochloride 100 mg / 3738 Nos./month
5 ml (20 mg/ml)
Irinotecan hydrochloride 300 mg / 2547 Nos./month
15 ml (20 mg/ml)

6
Irinotecan hydrochloride 500 mg / 1941 Nos./month
25 ml (20 mg/ml)
Pemetrexed For Injection 100 mg/ 5995 Nos./month
vial (Wokardth)
Pemetrexed For Injection 500 mg/ 3205 Nos./month
vial (Wokardth)
Bortezomib for Injection 3.5 mg / 2824 Nos./month
vial (Non- sugar)
Oxaliplatin Injection USP 5 1892 Nos./month
mg/ml (10 ml fill)
Oxaliplatin Injection USP 5 1686 Nos./month
mg/ml (20 ml fill)
Oxaliplatin Injection USP 5 1097 Nos./month
mg/ml (40 ml fill)
Zoldronic acid injection (4 mg / 5 3738 Nos./month
ml)
Media fill (5 ml 20 mm neck) 11750 Nos./month
Media fill (10 ml 20 mm neck) 11551 Nos./month
Media fill (10 ml 13 mm neck) 11551 Nos./month
Media fill (20 ml 20 mm neck) 9038 Nos./month
Media fill (30 ml 20 mm neck) 1000 Nos./month
Media fill (50 ml 20 mm neck) 7580 Nos./month
Media fill (100 ml 20 mm neck) 2370 Nos./month
Cabazitaxel Inj Nill Nos./month
Gemcitabine Inj 52.6 ml Nill Nos./month
Gemcitabine Inj 5.26 ml Nill Nos./month
Malphalan Inj Nill Nos./month
Zoledronic Acid(104ml fill) Nill Nos./month
Gemcitabine Inj 26.3 ml Nill Nos./month
Anastrozole Tablets 1 mg 700000 Nos./month
Letrozole Tablets 2.5 mg 800000 Nos./month
Bicalutamide Tablets 50 mg 600000 Nos./month
Bicalutamide Tablets 150 mg 700000 Nos./month
Teriflunomide Tablets 7 mg 1000000 Nos./month
Teriflunomide Tablets 14 mg 1000000 Nos./month
Tacrolimus Capsule 0.5 mg 700000 Nos./month
Tacrolimus Capsule 1.0 mg 700000 Nos./month
Tacrolimus Capsule 5.0 mg 700000 Nos./month
Fingolimode capsule 0.5 mg 1400000 Nos./month
Imatinib Tablets 100 mg 1800000 Nos./month
Imatinib Tablets 400 mg 1800000 Nos./month
Capecitabine Tablets 150 mg 1800000 Nos./month
Capecitabine Tablets 500 mg 2000000 Nos./month
Axitinib Tablets 1 mg 700000 Nos./month

7
 Diethyl stilbesterol 1 mg tablets 700000 Nos./month
Everolimus Tablets 2.5 mg 700000 Nos./month
Everolimus Tablets 5.0 mg 700000 Nos./month
Everolimus Tablets 7.5 mg 700000 Nos./month
Everolimus Tablets 10.0 mg 700000 Nos./month
Cyclophospha mide capsule 25 mg 700000 Nos./month
Cyclophospha mide capsule 50 mg 700000 Nos./month
Enzalutamide Capsule 40 mg 700000 Nos./month
Dimethyl Fumarate Tablets 120 1400000 Nos./month
mg
Dimethyl Fumarate Tablets 240 1400000 Nos./month
mg
Abiraterone Tablets 250 mg 700000 Nos./month
Erlotinib Tablets 25 mg 1500000 Nos./month
Erlotinib Tablets 100 mg 1500000 Nos./month
Erlotinib Tablets 150 mg 1500000 Nos./month
Cyclophospha mide and 700000 Nos./month
capecitabine Tablets 20/300 mg
Cyclophospha mide and 700000 Nos./month
capecitabine Tablets 40/600 mg
Sorafenib tablets 200 mg 700000 Nos./month
Temozolomid e capsule 5 mg 700000 Nos./month
Temozolomide capsule 20 mg 700000 Nos./month
Temozolomide capsule 100 mg 700000 Nos./month
Temozolomide capsule 140 mg 700000 Nos./month
Temozolomide capsule 180 mg 700000 Nos./month
Temozolomide capsule 250 mg 700000 Nos./month
10. Water Source :
S.No. Source Type Source Name Quantity(KLD)
1. Ground Bore well 271.0
11. Average daily consumption of water:
Sl. No. Purpose Exiting Quantity Expansion Total Quantity Unit
Quantity after change of
product mix
1. Boiler 12 KLD 2. Cooling water
feed/make up makeup
24 KLD 3. Others Chiller 1.5 KLD
Make up
4. Domestic 15 KLD 5. Greenbelt
7.5 KLD 6. Process 6 KLD
12. Waste Water Discharge :

8
 SI.No. Purpose Existing Quantity Expansion Total Quantity Units
Quantity after change of
product mix
Dom 7.5 60 67.5 KLD Washing
estic
2.58 6 8.5875 KLD Others Process 6.0375
75
14 20.0375 KLD Boiler Blow 2.0 5
Down
7 KLD Cooling bleed 9.0 25 34
off
13. Out let – as per CFO order dt:17/12/2014
Outlet Description Max Daily Discharge Point of Disposal
14. ETP Details & Mode of Disposal :
Stream Details Treatment units details Point of disposal
Standards stipulated as per CFO order dated 17/12/2014
15. Water Cess
(i)Returns filed upto (Month & Year)
(ii)Assessment issued upto (Month & Year)
(iii)Assessment paid upto (Month & Year)
(iv)Assessment amount due (In Rs.)
16. Air pollution
Source of Pollution Control equipment Stack height in ms Stack dia in ms Flow Rate m3/hr
provided
17. Emissions from chimneys – as per CFO order 17/12/2014
Description of Chimney Quantity of Emissions at peak Limiting Standard(mg/Nm3)
flow m3/hr
18.Hazardous chemicals used and their storage facilities:
Name of the Chemical / Fuel Storage capacity in KL or Tons
19. SOLID WASTES
19.1 HWA Details

9
S.No. Name of Hazardou Quantity Storage Reuse/rec Disposal Permitted Proposed Total
Waste s Waste generated & ycling(in as per the
Descripti per day treatment house) Existing
on /Pre- HWA
treatment
1. 33 200 500 Collecti Recycle After 200 500 700
Disposa on & Comple NPM NPM NPM
l of Storage te
barrels / Detoxifi
contain cation,s
ers hall be
used for sold to
handlin outside
g of agencie
hazardo s
us /parties
wastes
/
chemic
als
2. 5 Waste 100 Collecti Recycle Shall be 100 300 400
Industri oil/ on and sent to LPM LPM LPM
al Used oil Storage authoriz
operatio ed
ns waste
using oil Re-
mineral/ process
syntheti ors/
c oil as Recycli
lubrican ng units
t in
hydrauli
c
system
s
3. 34 ETP 500 Treatm Recycle To M/s 500 1000 1500
Purificat Sludge ent and Ramky Kg's/Mo Kg's/Mo Kg's/Mo
ion and storage HWMP, nth nth nth
treatme TSDF,
nt of Dundig
exhaust al RR
air, Dist.
water
and
waste
water
from
the
process
es in
this
schedul
e and
CETPs
4. 28 Residu 100 Collecti Recycle To M/s 100 200 300
Product es on and Ramky Kg's Kg's Kg's
ion/form Storage HWMP,
ulation TSDF,
of Dundig
drugs/ al RR
pharma Dist.
ceutical
s&
health
care
product

10
 5. 28 Date 1 Collecti Recycle To M/s 1.0 3.0 4.0
Product Expired on and Ramky TPM TPM TPM
ion/form medicin Storage HWMP,
ulation es and TSDF,
of Chemic Dundig
drugs/ als al RR
pharma Dist.
ceutical
s&
health
care
product
6. 33 Packing 2.0 Collecti Recycle To M/s 2.0 4.0 6.0
Disposa Material on and Ramky TPM TPM TPM
l of Storage HWMP,
barrels / TSDF,
contain Dundig
ers al RR
used for Dist.
handlin
g of
hazardo
us
wastes
/
chemic
als
19.2 Solid Wastes Details
Nature Quantity Mode of Disposal
Waste sharps (category-4) 510 Kg's/M Shall be sent to Common bio
medical waste treatment facilities
Microbiology Waste(Category-3) 510 Kg's/M Shall be sent to Common bio
Generated from QC and R&D Lab medical waste treatment facilities
20. HWA Details

11
 (i) Particulars of Authorisation obtained under
HW(M&H) Rules, 2016(No. & Validity date):
(ii) Particulars of on-site Secured Storage (Capacity
with dimensions) and mention period for which
secured storage is sufficient:
(iii) Quantity of Haz Waste stored on-site presently:
(iv) Quantity of Hazardous waste disposed for last
six months as per the following break-up:
(v) Whether industry has submitted annual returns,
date of latest submission :
(vi) Whether industry has installed incinerator or
sending to common HW Incinerator :
(vii) Particular of own incinerator (if applicable) :
(viii) Whether log books are maintained for
incinerator(if applicable) :
(ix) Whether industry has taken adequate steps to
prevent contaminated runoff from storage areas
of Hazardous Waste :
(x) Steps taken by industry towards waste
minimization and cleaner production :
(xi) Future plan for waste minimization :
(xii) Facilities available with, industry for waste
characterization :
(xiii) Overall House Keeping within the factory
premises :
(xiv) Details of disposal of lead acid batteries along
with nos and agencies to whom they are
disposed :
21.Compliance of the industry on Conditions of CFO (Schedule- B) order dt :17/12/2014
CFO Conditions Compliance status
21.1.Compliance of the industry on previous Hazardous Waste Authorisation conditions :
HWA Conditions Compliance status
22.Compliance For the TasK force Directions :17/12/2014
Directions Compliance status
Inspection Officer’s Remarks :

12
 1. M/s. Shilpa Medicare Limited (SEZ Formulation unit) (Formerly
Raichem Life Sciences Private Limited), Plot No.S-20, S-21, S-22, S-23, &
S-24-A at GIP, Jadcherla, Polepally (V), Balanagar (M), Mahaboobnagar
District and involved in pharmaceutical formulation.
2. The industry has obtained CFO of the Board vide order dated 17.12.2014
for manufacturing Liquid Vials (5ml,10 ml & 50 ml) -4.2 millions / annum,
Lyophilized (10ml & 50 ml) – 2.0 million / annum, Tablets – 30.0
million/annum and capsules – 3.6 millions/annum which is valid upto
31.05.2017.
3. The industry has obtained CFE expansion vide order dated 29.08.2016 for
the following :
Sl.
No.ProductsExisting Production Capacity as per CFO Order dated
04.05.2011
(Nos./Month)Proposed Expansion
(Nos./Month)Total Capacity after expansion
(Nos./Month)
1. Liquid Vials (5ml, 10 ml & 50 ml)4.2 millions/annum3.8 millions/annum8
millions/annum
2. Lyophilized (10 ml & 50 ml)2.0 million/annum18.0 million/annum20.0
million/annum
3. Tablets30.0 million/annum20.0 million/annum50.0 million/annum
4. Capsules3.6 millions/annum3.4 millions/annum7 millions/annum
4. Subsequently, the industry has obtained Amendment to the CFE
Expansion vide order dated 17.10.2016.for the following:
Details of StackAttached toCapacityFuelStack height from GLDetails of Air
Pollution Control EquipmentStandards to be complied with
Existing:
Stack – 1Attached to oil fired boiler of capacity2.5 TPHDiesel----

SPM – 115 mg/NM3

Stack – 2DG Set 1000 KVADieselH=h+0.2 (KVA)0.5
H=height of the stack from GL in mtrs.
H=height of building where DG sets are installed, in mtrs. Acoustic
enclosures with silencer for each DG Set
Stack - 3DG Set 1000 KVADiesel
Expansion:
Stack- 4DG Set 1500 KVADiesel H=h+0.2 (KVA)0.5
H=height of the stack from GL in mtrs.
H=height of building where DG sets are installed, in mtrs.Acoustic
enclosures with silencer for each DG SetSPM – 115 mg/NM3
Shall be read as
Deta

Yours faithfully

SARITHAGURUVAGALLA

RO Remarks
In view of the above, the issue of renewal of CFO may be examined before
placing CFO Committee.

13
 M Dayanand
Environmental Engineer
(Name and Designation)

14