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SMS PHARMACEUTICALS LTD. UNIT ‐ II PLOT NO. 24 & 24B, SVCIE

BACHUPALLY VILLAGE, QUTHBULLAPUR MANDAL, RANGAREDDY DISTRICT, ANDHRA PRADESH

FORM I

Project No. 1213‐21‐02December 2013

SMS Pharmaceuticals Ltd., Plot No. 19‐III, Opp. Bharatiya Viday Bhavan Public School, Road No. 71, Jubilee Hills, Hederabad – 502307 Phone: +91 040‐6628 8888, 8374455510 E‐mail ID: [email protected]

STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants B‐115‐117 & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/23748616, Telefax: 040‐23748666

SUBMITTED TO MINISTRY OF ENVIRONMENT AND FORESTS,

GOVERNMENT OF INDIA PARYAVARAN BHAVAN, LODHI ROAD, NEW DELHI

SMSPharmaceuticalsLtd.,UnitII

Form I Page 1

APPENDIX – I (See Paragraph – 6)

FORM I I) Basic Information

S.No. Item Details 1 Name of the Project/s M/s SMS Pharmaceuticals Ltd., Unit II 2 S. No in the Schedule 5 f – A category 3 Proposed capacity/area/length/tonnage

to be handled/command area/lease area/number of wells to be drilled

Proposed to enhance the production capacity of Active Pharma Ingredients (API’s) from 13.27 TPM to 32.2 TPM. Cost of the project (Expansion): 30 Crores

4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: 13.27 TPM

Area Existing: 2.57 Acres 6 Category of Project i.e 'A' or 'B' “A” 7 Does it attract the general condition? If

yes, please specify Yes. The Unit is Located in Notified Industrial Estate / Area. Critically Polluted Area of Pattancheru and Bollaram are located at a distance of 0.1 KM’s from the Site.

8 Does it attract the Specific condition? If yes, please specify.

No

9 Location Plot/Survey/Khasra No. Plot No.s 24 & 24B, SVCIE Village Bachupally (V) Tehsil Quthbullapur (M) District Rangareddy District State Andhra Pradesh

10 Nearest railway station/airport along with distance in kms.

Nearest Railway Station is Bollaram distance of 11.7 KM from the site.

11 Nearest Town, City, District Headquarters along with distance in kms.

Town & District HQ – Rangareddy

12 Village Panchayats, Zilla Parishad, Municipal Corporation, Local body (complete postal address with telephone nos. to be given)

Bachupally Village

13 Name of the Applicant Mr.C. Chandra Shekar 14 Registered Address SMS Pharmaceuticals Ltd.,

S.No. 180/2, IDA Khazipally, Khazipally Village, Jinnaram Mandal, Medak District – 502 319.


Form I Page 2

15 Address for Correspondence: Name Mr.C. Chandra Shekar Designation(Owner/Partner/CEO) Sr. Manager Address SMS Pharmaceuticals Ltd.,

Plot No. 19‐III, Opp. Bharatiya Viday Bhavan Public School, Road No. 71, Jubilee Hills, Hederabad.

Pin Code 5020 096 E‐mail [email protected] Telephone Number Direct : 040‐6628 8888

Mobile : +91 8374455510 Fax No. +91 40‐23551402

16 Details of alternative Sites examined, if any. Location of these sites should be shown on a topo sheet.

‐NA‐

17 Interlinked Projects ‐NA‐ 18 Whether separate application of

interlinked project has been submitted? No

19 If yes, date of submission 20 If no, reason 21 Whether the proposal involves

approval/clearance under: if yes, details of the same and their status to be given. (a) The Forest (Conservation) Act, 1980? (b) The Wildlife (Protection) Act, 1972? (c) The C.R.Z Notification, 1991?

‐NA‐

22 Whether there is any Government Order/Policy relevant/relating to the site?

No

23 Forest land involved (hectares) No 24 Whether there is any location pending

against the project and /or land in which the project is propose to be set up? (a) Name of the Court (b) Case No (c) Orders/directions of the Court, if any and its relevance with the proposed project.

No Individual Court case against the Project.

However Green Tribunal Case, W.P. No. 19661 of 2002 on the file of Hon’ble High Court of Andhra Pradesh / Application No. 90 of 2013 before NGT is filed against CETP Members.


Form I Page 3

(II) Activity

1. Construction, operation or decommissioning of the Project involving actions, which will cause physical changes in the locality (topography, land use, changes in water bodies, etc.) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities

/rates, wherever possible) with source of information data

1.1 Permanent or temporary change in land use, land cover or topography including increase in intensity of land use (with respect to local land use plan)

NO The proposal is for expansion of API’s manufacturing capacity in the existing unit. No additional land. Total Land area after proposed expansion 2.57 Acres.

1.2 Clearance of existing land, vegetation and buildings?

NO Industrial

1.3 Creation of new land uses? NO 1.4 Pre‐construction investigations e.g.

bore houses, soil testing? YES Soil Testing completed

1.5 Construction works?

YES Construction activity involves creation of additional utilities like Boiler, Chilling Plant etc and ZLD System.

1.6 Demolition works? NO

1.7 Temporary sites used for construction works or housing of construction workers?

NO Construction labor from local villages shall be employed.

1.8 Above ground buildings, structures orearthworks including linear structures, cut and fill or excavations

YES Storage facilities shall be constructed. No major cut and fill or excavation is anticipated.

1.9 Underground works including mining or tunneling?

NO

1.10 Reclamation works? NO 1.11 Dredging? NO 1.12 Offshore structures? NO 1.13 Production and manufacturing

processes? YES Enclosed in Annexure – I

1.14 Facilities for storage of goods or materials?

NO Raw materials and solvents shall be stored with safety precautions.

1.15 Facilities for treatment or disposal of solid waste or liquid effluents?

YES Solid waste shall be disposed to end users/recyclers or sent to incineration. Effluent generated from the plant are treated and reused. Details presented in Annexure II

1.16 Facilities for long term housing of operational workers?

NO Local people shall be employed.

1.17 New road, rail or sea traffic during NO


Form I Page 4

construction or operation? 1.18 New road, rail, air waterborne or

other transport infrastructure including new or altered routes and stations, ports, airports etc?

NO

1.19 Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements?

NO

1.20 New or diverted transmission lines or pipelines?

NO

1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers?

NO

1.22 Stream crossings? NO 1.23 Abstraction or transfers of water

form ground or surface waters? YES Total water required after expansion shall be

93.4 KLD out of which 58.4 KLD shall be met from APIIC and the balance shall be recycled water.

1.24 Changes in water bodies or the land surface affecting drainage or run‐off?

NO

1.25 Transport of personnel or materials for construction, operation or decommissioning?

YES The construction material shall be drawn from local sources within 10 – 15 km. There is no transport of personnel, as the construction workers shall be drawn from local villages.

1.26 Long‐term dismantling or decommissioning or restoration works?

NO

1.27 Ongoing activity during decommissioning which could have an impact on the environment?

NO

1.28 Influx of people to an area in either temporarily or permanently?

YES The proposed project shall increase the employment potential and hence may lead to migration to surrounding villages.

1.29 Introduction of alien species? NO 1.30 Loss of native species or genetic

diversity? NO

1.31 Any other actions? NO


Form I Page 5

2. Use of Natural resources for construction or operation of the Project (such as land, water, materials or energy, especially any resources which are non‐renewable or in short supply): S.No. Information/checklist confirmation Yes/No Details thereof (with approximate quantities

/rates, wherever possible) with source of information data

2.1 Land especially undeveloped or agricultural land (ha)

NO Existing Unit

2.2 Water (expected source & competing users) unit: KLD

YES Total water required after expansion shall be 93.4 KLD out of which 58.4 KLD shall be met from APIIC and the balance shall be recycled water. (Water Balance Enclosed in Annexure III)

2.3 Minerals (MT) NA 2.4 Construction material – stone,

aggregates, sand / soil (expected source – MT)

YES Shall be sourced from the local villages.

2.5 Forests and timber (source – MT) NO 2.6 Energy including electricity and fuels

(source, competing users) Unit: fuel (MT), energy (MW)

YES The required energy shall be drawn from APTRANSCO. Backup DG sets of 500 & 320 KVA proposed, 320 KVA and 75 KVA (shall be removed) existing shall be provided to cater to energy requirement during load shut downs. The other energy source is Furnace Oil fired boiler of 2TPH, which shall be changed to coal fired boiler in proposed expansion, Diesel fired boiler of 0.8TPH (shall be removed) existing and proposed 3 TPH coal fired boiler to meet the steam requirement both for process & ZLD. The required quantity of fuel (coal) is 21.74TPD. Diesel for Standby DG sets shall be 0.26 KL/hr.

2.7 Any other natural resources (use appropriate standard units)

NA


Form I Page 6

3. Use, storage, transport, handling or production of substances or materials, which could be harmful to human health or the environment or raise concerns about actual or perceived risks to human health. S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate

quantities/rates, wherever possible) with source of information data

3.1 Use of substances or materials, which are hazardous (as per MSIHC rules) to human health or the environment (flora, fauna, and water supplies)

YES Solvents shall be used as reaction media. MSIHC rules shall be followed during storage, transportation and handling of raw materials and hazardous chemicals.

3.2 Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases).

NO

3.3 Affect the welfare of people e.g. by changing living conditions?

YES Shall increase the employment potential for locals and affect the living conditions for betterment.

3.4 Vulnerable groups of people who could be affected by the project e.g. hospital patients, children, the elderly etc.,

NO No sensitive receptors are present in the immediate vicinity of the site. The project shall not have any significant impact on vulnerable groups of people.

3.5 Any other causes NO

4. Production of solid wastes during construction or operation or decommissioning (MT/month) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate


4.1 Spoil, overburden or mine wastes NO 4.2 Municipal waste (domestic and or

commercial wastes) NO Wastes from canteen, other commercial

wastes like paper, empty containers etc. The canteen wastes and commercial wastes shall be in the range of 5 kg/day

4.3 Hazardous wastes (as per Hazardous Waste Management Rules)

YES The quantity of hazardous waste generated during operation contain salts from evaporators, stripper distillate, process residue, and solvent residues, ETP sludge and filtration media etc. enclosed in Annexure – IV

4.4 Other industrial process wastes YES Enclosed at Annexure IV 4.5 Surplus product NO 4.6 Sewage sludge or other sludge from

effluent treatment YES Sludge from Effluent treatment plant and

Salts from MEE & ATFD shall be sent to TSDF.


Form I Page 7

4.7 Construction or demolition wastes YES Construction activity involves creation of additional utilities like Boiler, Chilling Plant etc.

4.8 Redundant machinery or equipment NO

4.9 Contaminated soils or other materials NO

4.10 Agricultural wastes NO

4.11 Other solid wastes NO Enclosed at Annexure IV

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate


5.1 Emissions from combustion of fossil fuels from stationary or mobile sources

YES Coal be used as fuel. Quantity of fuel and emissions details are enclosed in Annexure V

5.2 Emissions from production processes YES Enclosed in Annexure ‐ VI 5.3 Emissions from materials handling

including storage or transport NO Material transfer takes place in closed

pipeline systems. 5.4 Emissions from construction activities

including plant and equipment YES Dust may rise during transport of material and

construction activity. The dust emissions shall be mitigated by water spraying on the roads within the premises.

5.5 Dust or odors from handling of materials including construction materials, sewage and waste

YES Dust may rise during transport of material and construction activity. The dust emissions shall be mitigated by water spraying on the roads within the premises.

5.6 Emissions from incineration of waste NO 5.7 Emissions from burning of waste in

open air (e.g. slash materials, construction debris)

NO

5.8 Emissions from any other sources NO


Form I Page 8

6. Generation of Noise and Vibration, and Emissions of Light and Heat: S.No. Information/Checklist

confirmation Yes/No Details thereof (with approximate

quantities/rates, wherever possible) with source of information data with source of information data

6.1 From operation of equipment e.g. engines, ventilation plant, crushers

YES Material transport and construction equipment shall be source of noise, while transfer pumps, vacuum systems, DG sets are the sources of noise during operation.

6.2 From industrial or similar processes

YES DG sets, compressors, pumps etc are controlled by providing Acoustic Enclosures.

6.3 From construction or demolition YES Noise during construction shall be due to construction equipment and emergency DG sets.

6.4 From blasting or piling NO

6.5 From construction or operational traffic

NO The increased traffic shall not have any significant impact.

6.6 From lighting or cooling systems NO

6.7 From any other sources NO

7.Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface waters, groundwater, coastal waters or the sea: S.No. Information/Checklist

confirmation Yes/No Details thereof (with approximate


7.1 From handling, storage, use or spillage of hazardous materials

NO All the hazardous materials will be stored in MS drums, in a covered shed and no contamination of soil is expected

7.2 From discharge of sewage or other effluents to water or the land (expected mode and place of discharge)

NO All the wastes from domestic operations are sent to Biological treatment in “ZLD” system.

7.3 By deposition of pollutants emitted to air into the land or into water

NO All the emissions from process are controlled by providing control equipment like scrubbers, Dust Collectors and emissions from boiler shall be controlled by providing bag filters.

7.4 From any other sources NO 7.5 Is there a risk of long term build

up of pollutants in environment from these sources?

NO


Form I Page 9

8.Risk of accidents during construction or operation of the Project, which could affect human health or the environment S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate


8.1 From explosions, spillages, fires etc from storage, handling, use or production of hazardous substances

YES All Inbuilt Safety precautions will be adopted and there will not be any damage to environment or human health

8.2 From any other causes NA 8.3 Could the project be affected by natural

disasters causing environmental damage (e.g? Floods, earthquakes, landslides, cloudburst etc)?

NO

9.Factors which should be considered (such as consequential development) which could lead to environmental effects or the potential for cumulative impacts with other existing or planned activities in the locality S. No. Information/Checklist confirmation Yes/No Details thereof (with approximate


9.1 Lead to development of supporting. facilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.: • Supporting infrastructure (roads, power supply, waste or waste water treatment, etc.)• housing development • extractive industries • supply industries • other

YES The project shall enhance the socio economic status of the area by increasing the demand for housing, improving the employment. There are no major support industries required for this plant.

9.2 Lead to after‐use of the site, which could haven impact on the environment

NO

9.3 Set a precedent for later developments NO 9.4 Have cumulative effects due to proximity to

other existing or planned projects with similar effects

NO The baseline environmental status of the surrounding areas is within the prescribed limits as observed from the Secondary data.


Form I Page 10

(III) Environmental Sensitivity S.No. Areas Name/

IdentityAerial distance (within 15 km.) Proposed project location boundary

1 Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value

NA

2 Areas which are important or sensitive for ecological reasons ‐ Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests

YES Kazipalli RF – N ‐ 4.5Km Gajularamaram – E ‐7Km Suraram RF – E – 9.2 Km Wailal RF – N – 9 Km Pottaguda RF – NW – 9.7 Km Dundigal RF – NE – 8 Km Kistapalli RF – NW – 8 Km

3 Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration

NA

4 Inland, coastal, marine or underground waters

NO

5 State, National boundaries NO 6 Routes or facilities used by the public for

access to recreation or other tourist, pilgrim areas

NO

7 Defense installations NO 8 Densely populated or built‐up area YES Bachupally is at a distance of 0.1 Km. 9 Areas occupied by sensitive man‐made

land uses (hospitals, schools, places of worship, community facilities)

NA 0.5 Km from the site

10 Areas containing important, high quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals)

NO

11 Areas already subjected to pollution or environmental damage. (those where existing legal environmental standards are exceeded)

YES Patancheru and Bollaram Industrial areas at a distance of 0.1Km.

12 Areas susceptible to natural hazard which could cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions)

NO


Form I Page 11

(IV) Proposed Terms of Reference for EIA studies Scope of Work of EIA “...The EIA shall cover the following: Description of the proposed project: The first task:” Description of the proposed project” forms a vital component of the Environmental Impact Assessment (EIA) as it provides the basis for evaluating the likely causes of Environmental Impacts.

Existing Environment and Baseline Conditions: The baseline assessment will be carried out to identify potentially sensitive and critical areas that may be affected by the project in an area of 10 km surrounding the project location. The critical and sensitive targets shall be plotted on land use map of project impact area. The existing environment and baseline conditions should be established from:‐ Analysis of existing information published and secondary data. ‐Consultation with relevant statutory authorities, and Field visits for supplementation of missing gaps.

The key subject areas which the EIA shall address include Ecology and Nature conservation, Air quality, surface and water quality in project impact area, soil quality, cultural heritage, landscape, land use, noise quality, etc. Natural habitats like national parks, wildlife reserves, sanctuaries, sacred grove, protected areas, forests, wetlands, major rivers and waterways if any, shall also be identified and marked.

Assessment of Environmental Impacts: Based upon the results from the review of existing information, field visits, site data collection and consultation, for each component of environment (physical, biological and socio economic) the positive, negative, direct and indirect, temporary and permanent impacts will be evaluated along with an indication of the degree of impact, i.e., whether the impact is significant, moderate, minor or negligible. The degree of impact shall also be quantified by using state of the art air quality impact prediction models based on ISCST3 algorithms.

Environment Management Plan And Mitigation Plan: For each significant negative impact identified, specialist shall work closely with the engineering team/technical consultants to suggest practicable measures to avoid or mitigate the impact. The mitigation of environmental impacts will be by three mechanisms. =>Introduction of mitigation features through the engineering practices. =>Implementation of environmental controls during construction and operation. =>Legislative control involving compliance with Indian environmental laws. The Environmental management plan shall include an estimate of capital and recurring costs of mitigation measures and will identify the institutional framework for implementation.

Monitoring Plan: Having identified the significant environmental impact that is likely to arise as a result of the project, the project team shall specify what monitoring is required during the various phases of the project cycle. The monitoring plan will identify parameters and frequency of monitoring and responsible organization.


Form I Page 12

I hereby give the undertaking that data and information given in the application and enclosures are true to the best of my knowledge and belief and I am aware that if any part of the data and information submitted is found to be false or misleading at any stage, the project will be rejected and clearance given, if any to the project will be revoked at our risk and cost.

Date:

Place:

Signature of the applicant With Name and Full Address

(Project Proponent/Authorized Signatory)

M. C. Chandra Shekar Sr. Manager

SMS Pharmaceuticals Ltd., Plot No. 19‐III,

Opp. Bharatiya Viday Bhavan Public School, Road No. 71, Jubilee Hills,

Hederabad – 502307


BACHUPALLY VILLAGE, QUTHBULLAPUR MANDAL, RANGAREDDY DISTRICT, ANDHRA PRADESH

ANNEXURES

SUBMITTED TO MINISTRY OF ENVIRONMENT AND FORESTS,

GOVERNMENT OF INDIA PARYAVARAN BHAVAN, LODHI ROAD, NEW DELHI

SMS Pharmaceuticals Ltd., Unit II Form I Annexures

A-1 Team Labs and Consultants

M/s. SMS Pharmaceuticals Ltd., Unit II located at Plot No.s 24 & 24B, SVCIE, Bachupally

Village, Quthbullapur Mandal, Rangareddy District, Andhra Pradesh. The plant area falls at

the intersection of 17º32’06” (N) Latitude 78º21’13” (E) Longitude respectively according to

the Survey of India Topo sheet. The site is situated at an altitude of 5856m above MSL. The

site is surrounded by internal road in north, open land in south, Inwinex Pharmaceuticals

Ltd., in east, open land in in west directions. Location map and site layout is shown below;



Fig

1.1

Loca

tion

of S

MS

Phar

mac

eutic

als

Ltd.

, Uni

t II



ANNEXURE - I

M/s. SMS Pharmaceuticals Ltd., Unit II obtained consent for establishment and operation

for Bulk Drugs & intermediates at Plot No.s 24 7 24B , SVCIE, Bachupally Village,

Quthbullapur Mandal, Rangareddy District, Andhra Pradesh. It is proposed to expand the

manufacturing capacity of API’s, the expansion entails a capital cost of Rs. 30 crores towards

modernization of zero liquid discharge facility, debottlenecking by way of incorporating the

advanced technology and state of the art equipment. Manufacturing capacity is permitted

and proposed presented in Table A-1.

Table A-1 Manufacturing Capacity – Permitted & After Expansion S.No Name of the Product Capacity

TPM Kg/day Permitted

1 Sumatriptan Succinate 0.1 3.3 2 Quinapril Hydrochloride 0.09 3.0 3 Enalapril Malaete 0.28 9.3 4 N-Ethoxy Carbonyl Phenyl Propyl Amine 0.8 26.7 5 Nicotine Polacrilex 6 200 6 Fenugreek Powder 6 200 Total 13.27 442.3

After Expansion 1 Sumatriptan Succinate 1 33.3 2 Eletriptan 1 16.7 3 Famotidine 3 100 4 Itraconazole 1.5 50 5 Ramiprill 0.1 3.3 6 Almotriptan malate 0.1 3.3 7 Rizatriptan Benzoate 0.2 6.7 8 Tadalafill 0.5 16.7 9 Zolmitriptan 0.1 3.3

10 Imidapril 0.1 3.3 11 Nicotine Polacrilex 2 66.7 12 Sildenafil Citrate 2 66.7 13 Ondensetron HCl 0.1 3.3 14 Sumatriptan Intermediate II 1 33.3 15 Sumatriptan Intermediate VI 20 666.7

Total 32.2 1073.3



Process Description of Sumitriptan Succinate

Reaction Schemes

Stage I

NH

NH2

SN

CH3

O

OH

ClH

1-(4-hydrazinophenyl)-N-methylmethanesulfonamide Hychloride

N

CH3

CH3 O

O

CH3

CH3

+

251. 77 189. 27

4,4-diethoxy-N,N-dimethylbutan-1-amine

.

N

SN

CH3

O

OH

N

NCH3

H

CH3

1-(4-{(2E)-2-[4-(dimethylamino)butylidene]hydrazino}phenyl)-N-methylmethanesulfonamide

+

ethanol

+ ClH

312. 42 92. 12 ( 2 X 46. 06) 36. 5

2 CH3CH2OH

Stage II

N

SN

CH3 O

OH

N

N

CH3

H

CH3

1-(4-{(2E)-2-[4-(dimethylamino)butylidene]hydrazino}phenyl)-N-methylmethanesulfonamide

937. 26 ( 3 X 312. 42 )

3 O C2H5P-

O

O

OP-

O

O

OP-

O

O

OH5C2n

+ + 3 K2CO3

Polyphosphoric acid Potassium carbona

311 360. 66 ( 3 X 120. 22)

N

SN

CH3

O

OH

NCH3

H

CH3

1-{3-[2-(dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide

Sumatriptan

+ [NH4]3PO4 2 K3PO4 C7H7O7+ +3

Ammonium phosphatePotassium phosphateBy produc

886. 2 ( 3 X 295. 40 )

149 370. 6 ( 2 X 185. 3 ) 203. 12

Stage III

N

SN

CH3

O

OH

NCH3

H

CH3

1-{3-[2-(dimethylamino)ethyl]-1H-indol-5-yl}-N-methylmethanesulfonamide

Sumatriptan

295. 40

+ OH OHO O

succinic acid

118. 08

N

SN

CH3

O

OH

NCH3

H

CH3OH

OH

O

O.

Sumatriptan Succinate

413. 48



Process Description:

Stage: I (Cystofer)

1-(4-hydrazinophenyl)-N-methyl methane sulfonamide hydrochloride is reacting with 4,4-

diethoxy-N,N-dimethyl butan-1-amine to form 1-(4-{2-[4-(dimethyl amino) butylidene]

hydrazino} phenyl)-N-methyl methane sulfonamide.

Stage: II (NMSM)

Stage-I compound is reacting with polyphosphoric acid and potassium carbonate to form

Sumatriptan.

Stage:III (Rani HCl)

Sumatriptan base is reacts with Succinic acid to form Sumatriptan Succinate. Schematic

diagram of Sumitriptan Sccinate is shown in Fig A.1 and material balance for Sumitriptan

Sccinate is presented in Table A.2.



1 -(4-

hyd razinop he nyl)-N -m ethyl m eth an e

su lfo nam id e h ydroc hlo ride

4 ,4 -d iethoxy -N ,N -d im ethyl bu ta n-1-

am ine So diu m carb on ate

Ch loro form D M w ate r

S tag e I p rod uc t a nd ch loro form

Poly ph osp ho ric e ster P otassiu m carb on ate

Act ivated carb on E th yl a cetate

Aceton itrile Aceton e

Stage I prod uct Chlorof orm W ater W aste

S tag e-I I produ ct E thyl acetate r ecovery E thyl acetate lo ss Ac etoni tri le r ecovery Ac etoni tri le loss Ac etone reco very Ac etone los s C hlorofo rm r ecovery C hlorofo rm loss S olid W aste

Su m atriptan Su ccinate M eth an ol r ecove ry M eth an ol loss W ater W aste Solid W aste

Sta ge- II pr odu ct Su ccin ic acid

M etha nol D M W ate r

Stage - I II

Stage - I I

S tag e - I

Fig A.1 Process Flow Diagram of Sumitriptan Succinate



Table A.2 Material Balance for Sumitriptan Succinate Stage I Input Kg per

Batch Output Kg per

Batch 1-(4-hydrazinophenyl)-N-methyl methane sulfonamide hydrochloride

40 Stage I product 40

4,4-diethoxy-N,N-dimethyl butan-1-amine

30 Chloroform recovery 538

Sodium carbonate 7 Chloroform loss 19.8 Chloroform 560 Ethanol Recovery 11 DM water 560 Water Waste Water 560 Input water 560 Organics 16.53 1-(4-hydrazinophenyl)-N-

methyl methane sulfonamide HCl

7.77

4,4-diethoxy-N,N-dimethyl butan-1-amine

5.77

Ethanol 0.79 chloroform 2.2 Inorganic 11.67 Hydrochloric acid 4.67 Sodium carbonate 7 Total 1197 Total 1197 Stage II Input Kg per

Batch Output Kg per

Batch Stage I product and chloroform

40 Stage-II product 14.5

Poly phosphoric ester 70 Ethyl acetate recovery 241 Potassium carbonate 90 Ethyl acetate loss 8.1 Activated carbon 6.5 Acetonitrile recovery 48.2 Ethyl acetate 250 Acetonitrile loss 1.62 Acetonitrile 50 Acetone recovery 145 Acetone 150 Acetone loss 4.5 Solid Waste Organics 91.15 Stage I product and

chloroform 24.66

Poly phosphoric ester 64.91 Ethyl acetate 0.9 Acetonitrile 0.18 Acetone 0.5



Inorganic 91.15 95.93 Potassium carbonate 84.1 Ammonium phosphate 2.44 Potassium phosphate 6.06 Polymer 3.33 Spent carbon 6.5 Spent carbon 6.5 Total 656.5 Total 656.5 Stage III Input Kg per

Batch Output Kg per

Batch Stage-II product 14.5 Sumatriptan Succinate 17.5 Succinic acid 8 Methanol recovery 73.5 Methanol 76 Methanol loss 2.25 DM Water 14.5 Water Waste Activated carbon 10 Water 14.5 Water input 14.5 Organics 5.25 Stage-II product 2 Succinic acid 3 Methanol 0.25 Solid Waste Spent carbon 10 Spent carbon 10 Total 123 Total 123



ANNEXURE – II: Wastewater Treatment Facilities

The effluent generated from the proposed expansion of M/s. SMS Pharmaceuticals Ltd.,

Unit II is mainly from process, washings, scrubbers, cooling towers & boiler blow downs

and domestic effluent. Effluent from process, HTDS effluent sent to Stripper, Multiple

Effect Evaporator followed by ATFD, Biological treatment and RO. LTDS effluent from

process, washings, scrubbers, Solvent recovery system, DM rejects, Cooling towers, boiler

bow downs, detoxification effluent, ZLD washings and domestic effluents shall be sent to

Biological treatment system followed by RO. The treated effluent shall be reused for cooling

towers. Total Effluent generated and mode of treatment before and after expansion is

presented in Table A.3 and quantity and quality of effluent generated from process after

expansion is presented in Table A.4.

Table A.3 Total Effluent Generated and Mode of Treatment (Tentative)

Description Quantity (KLD) Mode of Treatment Permitted After

Expansion HTDS Effluents

Process 4.7 13.03 Sent to Stripper. Stripper condensate sent to cement industries for co-processing/TSDF. Stripper bottom sent to MEE.

Washings 3

Scrubber Effluent -- 2 Sent to MEE followed by AFTD and biological treatment plant. DM rejects -- 4

Total Phase I 4.7 22.03 LTDS Effluents

Boiler Blow downs 0.2 2.5 Sent to Biological Treatment System followed by RO. RO permeate reused for cooling tower makeup. RO rejects sent to MEE.

Cooling Tower Blow downs

8

Domestic 0.2 8.5

Total after Phase II 0.4 19 Grand Total (I+II) 5.1 41.03



Table A.4 Effluent Generated and Characteristics from Process – Product Wise (Tentative)

S.No Name of the Product Quantity (Kg/day) Conc. (mg/l) Water Input

TDS COD Total Effluent (Kg/day)

TDS COD

1 Sumatriptan Succinate 1095 22.3 51.9 1159.2 19196 44782 2 Eletriptan 65 12.5 2.2 131.0 95501 17071 3 Famotidine 135 25.6 21.7 296.1 86393 73265 4 Itraconazole 1415 4.8 38.9 1452.0 3279 26814 5 Ramiprill 67 8.0 7.7 92.2 86780 83237 6 Almotriptan malate 3511 232.1 96.9 3960.8 58596 24474 7 Rizatriptan Benzoate 171 3.1 23.0 225.1 13692 102019 8 Tadalafill 9 Zolmitriptan 1942 238.6 201.5 2600.2 91778 77504

10 Imidapril 450 42.4 43.6 546.3 77557 79809 11 Nicotine Polacrilex 157 0.0 7.0 112.0 0 62500 12 Sildenafil Citrate 229 0.0 0.9 229.3 0 4075 13 Ondensetron HCl 13 0.2 1.0 14.4 13125 68867 14 Sumatriptan Intermediate II 103 1.1 7.7 124.8 8573 61399 15 Sumatriptan Intermediate VI 0 94.6 84.3 2088.4 45314 40369 Total 9352.6 685.2 588.4 13031.8 52578 45149



ANNEXURE III: Water Requirement

Water is required for process, scrubbers, washing, cooling tower makeup, steam

generation and domestic purposes. The total required water after expansion shall be

drawn from APIIC in addition to reuse of treated wastewater. The total water requirement

after expansion shall be 93.4KLD out of which 58.4 KLD fresh water and 35 KLD of

recycled water. The water balance for daily consumption after expansion is presented in

Table A.5

Table A.5 Total Water Balance (Tentative) Purpose INPUT (KLD) OUTPUT (KLD)

Fresh Water Recycled Water Loss Effluent Process 9.4 13.03* Washings 3 3 Scrubber 2 2 Boiler Feed 20 17.5 2.5 Cooling Tower 5 35 32 8 RO/DM Plant 4 4 Domestic 10 1.5 8.5 Gardening 5 5 Gross Total 58.4 35 56 41.03 Total 93.4 97 * Process Effluents contains unreacted raw materials, soluble solvents, by-products etc.



ANNEXURE – IV Solid Waste

Solid wastes are generated from the process, solvent distillation, wastewater treatment and

utilities. The effluent treatment system generates, stripper distillate, ATFD salts and ETP

sludge. The process operations generate process residue, filter media, used catalysts,

activated carbon and inorganic residue. The utilities i.e., coal fired boiler generates ash

while DG sets generate waste oil and used batteries. The hazardous wastes of process

residue, stripper distillate, solvent residue, and activated carbon are sent cement plants for

co-incineration. Mixed solvents shall be sent to authorized recyclers/cement plant for co-

incineration while spent solvents are recovered within plant premises. The inorganic

wastes, filter media, used catalysts, salts from ATFD, and ETP sludge are sent to TSDF

facility located at Dundigal, Ranga Reddy district. The waste oil and used batteries are sold

to authorized recyclers. Coal ash is sold to brick manufacturers in the local area. The

quantity of solid waste generated in the plant and the disposal practice is presented in

Table A.6.

Table A.6 Total Solid Waste Generated and Mode of Disposal – After Expansion

(Tentative)

Description Units Permitted After Expansion

Mode of Disposal

Ash from Boiler TPD 9.78 Sold to Brick manufactures Process Organic residue

TPD 1.27 Sent to TSDF/Cement Industries

Solvent Residue TPD 0.78 Sent to TSDF/Cement Industries Spent Carbon Kg/day 3.33 108 Sent to TSDF/Cement Industries Sodium Sulphate Kg/month 250 -- Sent to TSDF Magnesium Chloride Kg/month 750 -- Spent Solvents KLD 5.6 Recovered within the plant

premises. Mixed Solvents KLD 0.75 Sent to authorized recovery units/

Cement plants for co-incineration Evaporation Salts TPD 0.06 0.68 Sent to TSDF Stripper Distillate KLD 0.6 Sent to Cement Industries for Co-

incineration. ETP Sludge TPD 0.4 Sent to TSDF Detoxified containers No.s/Month 25 100 After detoxification sent to

Authorized agencies Waste oil Lts/Month 100 250 Sent to Authorized Recyclers Used batteries No.s/year 15 Sent to Authorized Recyclers



ANNEXURE V: Air Pollution

The main source of emissions is utilities, and reactions of organic chemical synthesis. The

other sources of emission are process operations, and spillage/leakage.

3.2.2.1 Emissions from Utilities

The sources of air pollution in the plant are from the existing 2 TPH Furnace fired boiler

(shall be changed to coal after expansion), and proposed 3 TPH coal fired boiler to meet the

steam requirement both for process and ZLD and existing backup DG sets of 320 and

proposed 320 and 500 KVA, to cater to energy requirement during load shut downs. The

proposed air pollution control equipment for coal fired boiler is multi-cyclone separators.

DG sets shall be provided with stack heights based on the CPCB formula for effective stack

height. The emission rates of SPM, SO2, NOx and SPM from each stack are presented in

Table A-7.

Table A.6 Emission Details of Pollutants from Stack (Tentative)

S. No

Stack Connected to Stack Ht (m)

Dia of stack

at top(m)

Temp. of

exhaust gases (OC)

Exit Velocity (m/sec)

Pollutant Emission Rate (g/sec)

SPM SO2 NOx

Existing 1 2TPH Coal Fired Boilers* 20 0.4 180 7.5 0.05 0.08 0.21 2 320 KVA DG Set** 4.0 0.2 160 8.5 0.06 0.11 0.13

Proposed 1 3 TPH Coal Fired Boiler 30.0 0.5 200 5.4 0.09 0.14 0.16 2 320 KVA DG Set** 4.0 0.2 160 8.5 0.06 0.11 0.13 3 500 KVA DG Set** 5 0.25 185 7.2 0.004 0.16 0.028

* Permitted 2TPH FO fired boiler changed to Coal fired boiler ** DG sets stack heights are above the roof level.

Emissions from Process

The manufacturing process consists of reaction, separation and purification. The reaction is

conducted in closed reactors, while the separation is conducted in centrifuge, filtration

equipment etc. The purification would be conducted in reactors or filtration equipment.



The transfer of materials is through closed pipelines. Various sources of emissions are

identified;

Process Emissions: The process emissions contain Carbondioxide (1.6 Kg/day), Hydrogen

(0.35 Kg/day), ammonia (0.24 Kg/day). In the case of generation of ammonia the scrubber

will have acidic media and the resultant medium containing ammonium chloride

bicarbonate are sent to effluent. The other gases expected in the process are Carbon

dioxide and hydrogen gas which are let out into atmosphere following a standard operating

procedure.

"l.:fWf ~

q~lGl"U'f ~ er;; ~

GOVERNMENT OF INDIAMINISTRY OF ENVIRONMENT & FORESTS

~;ft7.r~fw:f (~ ~)Regional Office (Southern Zone)

Kendrrya Sadan. 4th Floor. E&F Wings, 17th Main Road.2nd Block. Koramangala. Bangaiore . 560 034.

No. :

=rrr . ~,~Telegram: PARYAVARAN

BANGALORE~'1TlSf:Telephone: 080-25502577Tele Fax: 080-25537184

F. No. EP112.1/330 & 365 lAPzs" October 2013

To

Mr C. Chandra shaker, Sr. Manager,SMS Pharmaceuticals Ltd,Plot No: 19-III, Road No: 71,Opp to Bharatiya Vidya Bhavan Public School, Jubilee Hills,Hyderabad-500 096. Andhra Pradesh.

Subject Request for the current status of compliance of the environmental clearance for the (1)Bulk Drug unit by MIs SMS Pharmaceuticals Ltd (Unit -1) at village Kazipally, TehsilJinnaram in Medak Reddy District in Andhra Pradesh issued vide MoEF Ref No J-110111152/2005-IA.II (I) dt07-07-2005 (2) Bulk Drug unit by MIs SMSPharmaceuticals Ltd (Unit -2) at village Bachupally, Tehsil Miyapur in Ranga ReddyDistrict in Andhra Pradesh issued vide MoEF Ref No J-I10111123/2005-IA.II (I) dt07-07-2005

Sir,

This is in response to your letter dated 1ih September 2013 requesting for a certified copy of thecompliance report to the existing above said environmental clearances; the undersigned is directed toenclose herewith the recent monitoring report of the above projects monitored by this office on 4thOctober 2013, for necessary action at your end.

Encl: as above

Yours faithfully,

~~~(Dr. U. Sridharan)

Scientist "F"/DirectorPh: 25502577 (0) 26493485 (R) Fax: 080-25537184


BUCHUPALLY, QUTHBULLAPUR MANDAL, RANGAREDDY DISTRICT, ANDHRA PRADESH

STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants QCI: MoE&F OM, List A-1, S.No. 150. (An ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 Certified Organization) B-115, Annapurna Block, Aditya Enclave Ameerpet, Hyderabad-500 038. Phone: 040-23748 555/616, Telefax: 040-23748666 Email: [email protected]

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