List of Annexures

S. No Description Page No.

I Plant Layout 12

II Manufacturing Description & Flow Chart Details 13-25

III Effluent Treatment Plant Flow Chart & Solid Waste Handling Details 26

IV Water Requirement and Wastewater generation details 27

V List of Hazardous Chemicals 28

VI Details of Hazardous / Solid Waste and other waste 29

VII Fuel Consumption and Emission Details 30

VIII Details of Emissions from Process Reactions 31

IX Environmental Clearance 32-36

Other Annexures

X Location Map 37

XI Topographical Map 38

XII Google Imagery Map 39

XIII CA Certificate 40

XIV Certificate of Incorporation 41

XV NOC from Gram Panchayat 42

XVI Agreement of Sale 43-44

XVII Soil Analysis Report 45

XVIII Water Analysis Report 46

XIX Compliance to the EC Conditions 47-50

XX Consent for Establishment 51-59

XXI High Court Directions for Proposing CFE Application 60-64

ANNEXURE - I

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ANNEXURE - II

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WASTEWATER TREATMENT METHOD AND SOLID WASTE

HANDLING DETAILS

Item Treatment Method

Process

• Shall be stripped off for Organics recovery • Stripper condensate to distillate for separation of

organic compounds followed by disposal to cement plants for co-processing & distilled effluents shall be routed to ETP.

• Stripped effluents for forced evaporation in MEE followed by ATFD.

• Condensate from MEE & ATFD will be sent to ETP. • ATFD salts to TSDF. • ETP shall be provided for primary & secondary

treatment. • Treated effluents from ETP will be filtered in the RO

Plant. • RO permeate to reuse and RO reject to MEE.

Floor & Reactor washings

Boiler, Cooling tower & D.M. Regeneration

Scrubber & Q.C

Domestic Sent to Septic tank followed by soak pit

Sl. No. Source Handling

Method Disposal

1. Organic residue HDPE Drums

Sent to SPCB Authorized Cement industries / TSDF

2. Inorganic & Evaporation salt (Process) HDPE Bags

3. Spent Carbon HDPE Drums 4. ETP Sludge HDPE Bags

5. Boiler Ash Stored in covered area

Sold to Cement Brick Manufacturers

6. Container and Container liners

Designated covered area

After complete detoxification, it will be disposed of to the outside

agencies

7. Spent solvents Stored in Drums

/ Tanks Recovery within the premises duly

sending the residue to SPCB Authorized agencies

8. Mixed solvents Stored in Drums / Tanks

Sent to SPCB Authorized agencies

9. Waste oils Stored in Drums Sent to SPCB Authorized agencies

10. Used Lead acid Batteries Designated covered area

Sent to suppliers on buy-back basis.

ANNEXURE - III

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WATER REQUIREMENT, WASTEWATER GENERATION AND ITS TREATMENT

Item Water

Requirement ( KLD)

Wastewater Generation

( KLD) Treatment Method

Process 18.7 20.05

• Shall be stripped off for Organics

recovery • Stripper condensate to distillate

for separation of organic compounds followed by disposal to cement plants for co-processing & distilled effluents shall be routed to ETP.

• Stripped effluents for forced evaporation in MEE followed by ATFD.

• Condensate from MEE & ATFD will be sent to ETP.

• ATFD salts to TSDF. • ETP shall be provided for primary

& secondary treatment. • Treated effluents from ETP will

be filtered in the RO Plant. • RO permeate to reuse and RO

reject to MEE.

Floor & Reactor washings 3.0 3.0

Boiler, Cooling tower & D.M. Regeneration

45.0 3.0

Scrubber & Q.C 1.0 1.0

Domestic 2.2 2.0 Sent to Septic tank followed by soak pit

Gardening 5.0 -- --

Total 74.9 29.05

ANNEXURE - IV

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LIST OF HAZARDOUS CHEMICALS

Ammonia (20%) soln

Chloroacetonitrile

Chloroform

Dimethyl Formamide

Epichlorohydrin

Formaldehyde (37%)

Hydrochloric Acid

Methyl Isobutyl Ketone

Methylene Dichloride

n-Hexane

Sulfuric Acid

Toluene

Triethyl Amine

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ANNEXURE - V

HAZARDOUS SOLID WASTE GENERATION FROM THE PLANT Sl. No. Source Quantity

TPD* Handling Method Disposal

1. Organic residue 0.462 HDPE Drums

Sent to SPCB Authorized

Cement industries /

TSDF

2. Inorganic & Evaporation salt (Process)

0.84 HDPE Bags

3. Spent Carbon 0.065 HDPE Drums

4. ETP Sludge 0.025 HDPE Bags

5. Boiler Ash 4.8 Stored in

covered area Sold to Cement

Brick Manufacturers

Total 6.192

Sl. No. Source Handling

Method Disposal

Other Solid Waste

6. Container and Container liners

Designated covered area

After complete detoxification, it will be disposed of to the

outside agencies

7. Spent solvents Stored in

Drums / Tanks Recovery within the premises

duly sending the residue to SPCB Authorized agencies

8. Mixed solvents Stored in Drums / Tanks

Sent to SPCB Authorized agencies

9. Waste oils Stored in Drums

Sent to SPCB Authorized agencies

10. Used Lead acid Batteries

Designated covered area

Sent to suppliers on buy-back basis.

* Maximum solid waste quantities on various combinations i.e., (any 3 Bulk Drug products will be manufactured at a time).

ANNEXURE - VI

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FUEL CONSUMPTION AND EMISSIONS DETAILS Source Stack

Height (m)

Diameter (m)

Temperature in oK

Flue Gas Flow rate

(m3/Hr)

Exit Gas

Velocity in m/sec

SPM SO2 NOx

Kg/hr

3.0TPH Coal fired Boiler 30 0.5 473 7365 10.42 0.432 1.382 0.712

2.0 Lac Kilo cal /hr 20 0.3 473 775.7 3.05 Traces 0.094 0.047

Coal is used in the proposed boiler of 1 No. of 3 TPH. The Coal

consumption is about 12 TPD. Diesel will be used in the proposed 2 Nos. of

250 KVA & 125 KVA D.G. Sets, which will be about 75 Ltrs/hr at full

operation load. Furnace oil will be used in the proposed 2.0 lac K.cal/hr

Thermic Fluid heater, which will be about 19 Ltrs/hr.

ANEXURE - VII

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PROCESS EMISSIONS-PRODUCT WISE

Sl. No.

Product Name of the

Process Emission

Quantity in

Kg/day Treatment Method

Proposed Bulk Drugs

1. Carvedilol H2 2.2 Diffused with flame arrestor

2. Fluconazole HCl 36.0 Scrubbed with water

3. Quetiapine Hemifumarate CO2 37.6 Dispersed into atmosphere

4. Sibutramine Hydrochloride

CO2 32.7 Dispersed into atmosphere

5. Lansoprazole Nil -- ---

6. Zotepine H2 0.7 Diffused with flame arrestor

7. Itraconazole Nil -- ---

8. Fenoterol Hydrobromide

H2

CO2 3.2

20.2 Diffused with flame arrestor Dispersed into atmosphere

9. Omeprazole Nil -- ---

10. Olanzapine Nil -- ---

11. Rabeprazole Sodium Nil -- ---

12. Pantoprazole Sodium Nil -- ---

ANNEXURE - VIII

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ANNEXURE - IX

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ANNEXURE - IX

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ANNEXURE - X

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ANNEXURE - XI

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Google Image of Nucleus Drugs Pvt. Ltd.

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ANNEXURE - XIV

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ANNEXURE - XV

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ANNEXURE - XVI

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PHYSICAL AND CHEMICAL PROPERTIES OF SOIL

Sl.No. Parameters Project Site

1. Color Brown

2. PH (1:5) 7.57

3. E C (µ mhos ) 0.3

4. Texture Silty clay

5. Moisture in % 1.4

6. Sand in % 32.9

7. Silt in % 38.4

8. Clay in % 28.7

9. Organic Matter in % 0.2

10. Nitrogen as N kg/ha 187.0

11. Phosphorus as P kg/ha 11.6

12. Potassium as K kg/ha 129

13. Sodium as Na in % 0.1

14. Calcium as Ca in % 0.25

15. Magnesium as Mg in % 0.014

16. Iron as Fe in % 0.003

17. Manganese as Mn ppm 40.0

18. Boron as B ppm 5

19. Lead as Pb ppm 0.02

20. Zinc as Zn ppm 10

ANNEXURE - XVII

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WATER QUALITY IN THE STUDY AREA (GROUND WATER)

Sl. No. LOCATIONS Units Project Site

Physical Parameters

1 PH 7.14

2 Elec. Cond. µmhos/cm 1420

3 Turbidity NTU 3.90

4 Total Dis. Solids mg/l 920

5 Total Sus. Solids mg/l Nil

Chemical Parameters

6 Total Hardness as CaCO3 mg/l 568

7 Total Alkalinity as CaCO3 mg/l 300

8 Chlorides as Cl mg/l 184.6

9 Fluorides as F mg/l 1.20

10 Nitrate as NO3 mg/l 56

11 Sulphate as SO4 mg/l 201.6

12 Calcium as Ca mg/l 150.4

13 Magnesium as Mg mg/l 46.08

14 Sodium as Na mg/l 67.16

15 Potassium as K mg/l 1.56

Nutrients & Organics 16 DO mg/l 5.0

ANNEXURE - XVIII

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ANNEXURE - XIX

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CONDITION-WISE COMPLIANCE REPORT OF ENVIRONMENTAL CLEARANCE Ministry of Environment and Forests, Govt. of India

EC Order No. : J-11011/511/2007-IA II(I) dated 10.09.2007

SI. No. Specific Conditions Compliance

A. Specific Conditions 1 This environmental clearance is subject to measures to be taken

by the industrial associations as identified by the Andhra Pollution Control Board vide its letter no. 45/PCB/CFE/BO/EC/2007 dated 15th June, 2007.

APPCB accorded CFE on 24-10-2011 and planning to initiate the Construction activity.

2 Cyclone separator followed by wet scrubber shall be provided to control the air emissions from the boiler. The reactors shall be provided with appropriate stack height for the dispersion of pollutants as per the CPCB guidelines to control acid mist and HCl. HCl and Ammonia shall be scrubbed using water scrubber and dilute solutions shall be either reused after neutralization or evaporated along with other high TDS effluent in the evaporator. SO2 shall be scrubbed using caustic lye solution and sold to authorized parties or neutralized and sent to CETP, Patancheru for further treatment.

We have noted and will install the proper pollution control equipment to control the air emissions.

3 Solvent recovery system shall be installed and recovery shall not be less than 95 percent. All the solvents shall be handled in closed conditions and vent condensers shall be provided to the solvent storage tanks to reduce the evaporation losses. All the venting equipments shall have vapour recovery system and condensers used for solvent recovery. All the vents should be monitored for the solvents regularly and report submitted. Chillers shall be provided for chilled brine circulation to condensate the solvent vapors and reduce solvent losses. Volatile Organic compounds (VOCs) shall also be monitored in solvent storage areas along with other parameters. Action shall be taken to reduce the fugitive emissions as far as possible.

We have noted and will comply with the condition.

4 Solvents generated from the vents and in the work zone environment shall be monitored and reports submitted to the APPCB, CPCB and Ministry’s Regional Office at Bangalore.

We have noted and will comply with the condition.

5 Total ground water requirement and wastewater generation shall not exceed 74.9 m3/day and 29.05 m3/day respectively. Prior permission for the drawl of ground water shall be obtained from the SGWB/CGWA. Effort shall be made to recycle and reuse maximum treated wastewater in the process. The effluent shall be segregated into high TDS and low TDS streams. The high TDS effluent shall be forced evaporated in the forced evaporator and condensate from the evaporator shall be used in cooling towers or sent to CETP, Patancheru of M/s PETL alongwith the Low TDS effluent. The salts from the evaporation system shall be sent to TSDF of M/s Hyderabad Waste Management Project (HWMP), Dundigal for incineration. The Low effluent shall be treated in Effluent Treatment Plant (ETP) and sent to CETP Patancheru after primary treatment. Domestic effluent shall be treated in septic tanks followed by soak pit.

We have noted and we will install the Zero Liquid Discharge to the effluent. Treated water reused in the Boiler / Cooling tower makeup.

ANNEXURE - XIX

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6 If the common effluent treatment plant (CETP) is not operational by the time project is commissioned, full-fledged effluent treatment plant (ETP) with primary, secondary and tertiary treatment plant shall be installed.

We have noted and we will install the Zero Liquid Discharge to the effluent. Treated water reused in the Boiler / Cooling tower makeup.

7 All the solid waste from the process, ETP Sludge and salts from the evaporation system, shall be sent to Treatment, Storage and Disposal Facility (TSDF) of M/s Hazardous Waste Management Plant (HWMP) at Dundigal, Hyderabad. Organic residue shall be incinerated in the incinerator of common incinerator facility. Fly ash shall be given to local brick manufacturers.

We have noted and solid waste generated from the activity will be sent to TSDF, Dundigal / SPCB Authorized Cement Industries.

8 Out of total 1.3575 ha., green belt shall be developed in 0.8938 ha. with suitable species of the plants as per the CPCB guidelines to mitigate the effect of fugitive emissions.

We will develop greenbelt as per CPCB Guidelines.

B. General Conditions 1 The project authorities shall strictly adhere to the stipulations

made by the Andhra Pradesh Pollution Control Board (APPCB). We are strictly adhering to the stipulations made by the State Pollution Control Board and ensure that we will not violate the norms prescribed by the Board.

2 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.

We have noted and we are submitting the Form-I application for EC validity extension.

3 The gaseous emissions (SO2, NOX, H2S, HCl, NH3) and particulate matter from various process units shall conform to the standards prescribed by the concerned authorities from time to time. 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 noted and we will comply with the condition. Regular monitoring will be carried out through Authorized Laboratories.

4 Ambient air quality monitoring stations shall be set up in the downwind direction as well as where maximum ground level concentration are anticipated in consultation with the APPCB

We have noted and will comply with the condition. Regular Ambient Air Quality monitoring is carried out through authorized laboratories.

5 Fugitive emissions in the work zone environment, product, raw materials storage area shall be controlled. The emissions shall conform to the limits imposed by APPCB. Fugitive emissions including HCl concentrations shall be monitored in work zone environment

We have noted and we will comply with the condition. Regular monitoring carried out through Authorized Laboratories.

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6 The company shall undertake following Waste Minimization measures :-

Metering and control of quantities of active ingredients to

minimize waste. Reuse of by-products from the process as raw materials or

as raw material substitutes in other processes. Use of automated filling to minimize spillage. Use of “Close Feed” system into batch reactors. Venting equipment through vapour recovery system. Use of high pressure hoses for equipment clearing to

reduce wastewater generation.

We have noted and we will take all necessary precautions to minimize the Waste.

7 The project authorities shall strictly comply with the rules and regulations under Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 as amended in October 1994 and January 2000. Authorization from the APPCB shall be obtained for collection, treatment, storage, and disposal of hazardous wastes.

We have noted the condition.

8 The project authorities must strictly comply with the rules and regulations with regard to handling and disposal of hazardous wastes in accordance with the Hazardous Wastes (Management and Handling) Rules, 2003. Authorization from the A.P. Pollution Control Board must be obtained for collections/treatment/storage/disposal of hazardous wastes.

We have noted the condition.

9 The overall noise levels in and around the plant area shall be kept well within the standards (85 dBA) 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, Rules, 1989 viz. DBA (day time) and 70 dBA (night time).

We have taken all possible measures to control the noise and we will ensure that the noise levels will not exceed the standards prescribed by the Board.

Regular monitoring will be carried out through authorized laboratories.

10 Occupational health surveillance of the workers shall be done on a regular basis and records maintained as per the Factories Act.

Noted and will comply with the factories act.

11 The company shall undertake eco-developmental measures including community welfare measures in the project area for the overall improvement of the environment.

Noted and will comply with the proposed condition.

12 The company shall adopt suitable surface as well as roof top rain water harvesting measures to harvest the run off water for recharge of ground water. Methods shall also be adopted for the conservation of water through and recycling and reusing the treated wastewater.

We have noted and will comply with the condition.

13 The project proponent shall also comply with all the environmental protection measures and safeguards recommended in the EIA report.

We have noted and comply with the condition.

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14 A separate Environmental Management Cell equipped with full-fledged laboratory facilities shall be set up to carry out the Environmental Management and Monitoring functions.

Laboratory facilities for analyzing effluent samples before and after treatment will be provided. Environmental Management cell consisting of Environmental Engineer, supervisors and helpers will be set up.

15 As proposed in EIA/EMP, Rs. 45.00 Lakhs earmarked towards environmental pollution control measures shall be utilized to implement the conditions stipulated by the Ministry of Environment and Forests as well as the State Government and an implementation schedule shall be submitted to Ministry’s Regional Office at Bangalore for implementing all the conditions stipulated herein. The funds so provided shall not be diverted for any other purpose.

We have noted the condition.

16 The implementation of the project vis-à-vis environmental action plans shall be monitored by Ministry’s Regional Office at Bangalore / APPCB / CPCB. A six monthly compliance status report shall be submitted to monitoring agencies.

We have noted and complying with the condition.

17 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 APPCB/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 Ministry`s Regional Office at Bhopal.

We have already published in two local news papers and the same is submitted to the Regional office.

18 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 have received for Consent for Establishment and will keep inform regularly the project status to the Regional Office of the Ministry the date of financial closure and final approval and date of start of the project.

19 The Ministry may revoke or suspend the clearance, if implementation of any of the above conditions is not satisfactory.

We have noted the condition.

20 The Ministry reserves the right to stipulate additional conditions,

if found necessary. The company in a time bound manner will implement these conditions.

We have noted and will comply with the condition.

21 The above conditions will be enforced, inter-alia under the provisions of the Water (Prevention & Control of Pollution) Act, 1981, the Environment (Protection) Act, 1986 Hazardous Wastes (Management and Handling) Rules, 2003 and the Public Liability Insurance Act, 1991 along with their amendments and rules.

We have noted and comply with the rules and regulations of the applicable acts along with their amendments.

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