ENVIRONMENTAL COMPLIANCES

ENVIRONMENTAL

COMPLIANCES

JUNE 2012

Ipca Laboratories LimitedCOMPLIANCE ON EC GENERAL

CONDITIONS(F.N. No. J-11011/850/2007-IA(II) Dated

12.05.2008)Sr. No.

Conditions Remarks(As on 30.06.2012)

01. The project authorities shall strictly adhere to the stipulations of the SPCB/state government or any statutory body.

Agreed

02. 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 alteration 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 the add additional environmental protection measures required, if any.

Agreed

03 The project authorities shall strictly comply with the rules and regulations under Manufacture, Storage and Import of Hazardous Chemical Rules, 1989 as amended. Authorization from the SPCB shall be obtained for collection, treatment, storage, and disposal of Hazardous wastes.

Agreed and complying.

04. 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 State Pollution Control Board.

Ambient Air quality station is operative and Ambient air monitoring reports submitted

to State Pollution Control Board on regularly basis. Copy enclosed as per Annexure No.1

05. For control of process emissions, stacks of appropriate height as per the Central Pollution Control Board guidelines shall be provided. The scrubbed water shall be sent to ETP for further treatment.

Stacks of suitable height have been provided and scrubbing solutions regularly treated at our ETP.

06. The company shall undertake following waste minimization measures:-Metering of quantities of active ingredients to minimize waste.Reuse of by-product from the process as raw materials or as raw materials substitutes in other processes.Maximizing recoveries.Use of automated material transfer system to minimize spillage.Use of “Closed Feed” system into batch reactors.

Batch wise quantity is closely monitored.Continues efforts are done to optimize raw material consumption and to get maximum yield. Solvents are recovered and reused.Hazardous chemicals are handled in close system with suitable operation control procedures.Closed Powder Charging System is also provided.

07. The project authorities must strictly comply with the rule and regulation with regard to handling and disposal of hazardous wastes in accordance with the hazardous waste(Management and Handling) Rules, 2003 .Authorization from the SPCB shall be obtained for collection/treatment/storage/ disposal of hazardous waste.

Industry already complying with Hazardous waste management and handling rules.Necessary approval from state pollution control board (i.e. consent to establish / operate) under Water Act, Air Act & and under hazardous waste management and handling rules is taken.

08. 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, 1986 Rules, 1989 viz. 75 dBA (day time) and 70 dBA (night time).

Noise level is regularly monitored and it is well within limits. Copy enclosed as per Annexure No.2.

09. 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 full-fledged Environment management cell and Environment Monitoring Laboratory. Details of the same are enclosed herewith as per Annexure No. 3 & 4.

10. The project authorities shall provided rainwater harvesting system and ground water recharge.

Rain water harvesting facility has been provided as per the Geographical survey conducted and CGWA recommendations.

11. The implementation of the project vis-a-vis environment action plans shall be monitored by Ministry’s Regional Office / SPCB / CPCB. A six monthly compliance status report shall be submitted to monitoring agencies.

We are submitting the same on six monthly bases.

12. The project proponent shall inform the public that the project has been accorded environment clearance by the Ministry a copies of the clearance letter are available with the SPCB 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 latter, 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.

We already publish details of Environmental clearance in local newspapers.

13. The project authorities shall inform 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.

Date of financial closure is 31st March.Date of start of project is 15th May’08 and it was commissioned from 10th ofAug.’2008

Ipca Laboratories LimitedCOMPLIANCE ON EC SPECIFIC CONDITIONS

(F.N. No. J-11011/850/2007-IA(II) Dated 12.05.2008)

Sr. No.

Conditions Remarks(As on 30..06.2012)

01. The company shall install full-fledged effluent treatment plant to treat the wastewater and treated wastewater shall be utilised within the plant for gardening, washing, cooling purposes etc. to achieve zero discharge.

Company have full-fledge ETP with 495 KL/D treatment capacity. ETP is having Primary, Secondary and tertiary treatment facility. Treated water is utilized for in house gardening/agriculture work and utility purposes.Zero discharge status is maintained with the help of reverse osmosis and evaporation plants.

02. The water consumption and waste water generation shall not exceed 1050 KLD and 495 KLD respectively. Permission for drawl of ground water shall be obtained from CGWA/CGWB and copy shall be submitted within 3 months from date of issue of this order to Ministry’s Regional Office at Bhopal.

Permission for CGWA is obtained

03. The project authority shall obtain the membership TSDF for disposal of hazardous waste and copy of the same shall be submitted to the Ministry and Ministry’s Regional Office at Bhopal. The company shall maintain the valid membership of TSDF.

Company has taken membership of TSDF site (Madhya Pradesh Waste Management Project, Pithampur)

04. The company shall install scrubbers, Bag filters and dust collection system for control of emissions to achieve the norms prescribed by MPPCB or under EP Act, 1986 whichever is stringent.

Company has installed scrubber systems at process plant and dust collector (Mechanical cyclone) at Boiler to control emission.

05. The project authority shall ensure that the solvent shall not be less than 95% and provide the condensers with solvent storage tank to achieve solvent recovery more than 95% and all the solvent shall be provided breather valves to prevent solvent losses. The monitoring arrangement for solvent with the vents shall be provided. Solvent management shall be as follows:A.Reactor shall be connected to chilled brine condenser system.B.Reactor and solvent handling pump shall have mechanical seals to prevent leakages.

C.The condensers shall be provided with sufficient HTA and residence time so as to achieve more than 85% recovery.

D.Solvent benzene shall be stored separately specified with all safety measures.

E.Proper earthing shall be provided in all the electrical equipment wherever there is solvent handling.

F.Entire plant shall be flame proof. The solvent storage tank shall be provided with breather valve to prevent losses.

A. Reactors condensers are connected with necessary cooling arrangement like Brine, Chilling, Cooling water etc.

B. Mechanical seal pump are used for handling of solvent.

C. For effective recovery efficient condensers has been installed after calculating required HTA.

D. We are not using Benzene in our plant.

E. Proper earthing has been provided to all equipments and regular inspections are done to maintain continuity.

F. All electrical fitting are flame proof in all flammable areas /Zone. Solvent storage tanks has been provided with suitable safety systems like flame arrestors, fire hydrant system etc. We will provide breather valves to solvent storage tank.

06. The company shall provide the monitoring arrangement with vents and regular monitoring shall be carried out and reports submitted to the SPCB, CPCB and Ministry’s Regional Office at Bhopal.

Regular monitoring done and report submitted to pollution control board.

07. The project authorities shall provide the chilled brine solution in secondary condenser for condensation of VOCs. The process emissions, VOCs and particulate matter from various 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 unit shall be immediately put out of operation and shall not be restarted until the desired efficiency has been achieved.

Secondary condensers are provided with chilled brine solution and VOC is monitoring on regular intervals.

08. Fugitive emissions in the work zone environment, product, raw materials storage area etc. shall be regularly monitored. The emissions shall conform of the limits imposed by MPPCB. For control of fugitive emission and VOCs following steps shall be followed:A.Closed handling system shall be provided for chemicals.B.Reflux condenser shall be provided with mechanical seals to prevent leakages.C.Solvent handling pump shall be provided with mechanical seals to prevent leakages.D.System of leak detection and repair of pump/pipeline on preventive maintenance.E.Solvent shall be taken from underground storage tank to reactors through closed pipeline. Storage tanks shall be vented through trap receiver and condenser operated on chilled water.

Work Zone monitoring is conducted on regular basis.A. Hazardous chemical are handled in close system.B. N.A.C. Mechanical seal pump are used for handling of solvents.D. Before start of a campaign leak detection or pneumatic test is carried our and preventive maintenance is done to keep system close and effective.E. Solvents are transfer in close system and receivers are connected with condensers.

09. The company shall carry out the HAZOP study and the report shall be submitted to Ministry’s Regional Office at Bhopal.

HAZOP studies of manufacturing processes is a continuously done by our Hazop cell. List of products for which Hazop is completed is enclosed as per Annexure no.5.

10. The company shall comply with the CREP guideline prepared by CPCB for Bulk Drug plants.

Company is complying with CREP guideline.

11. The company shall develop greenbelt in 33% of the project area as per the guidelines of CPCB to mitigate the effect of fugitive emission.

complying

12. Requisite financial provision shall be made in the budget of the project for implementation of the above suggested environment safeguards. Fund so earmarked shall not be diverted for any other purposes.

Agreed and it is being followed.

13. During transfer of materials, spillage shall be avoided and garland drains be constructed to avoid mixing of accidental spillages with domestic waste and storm drains.

Necessary operating procedures are made for handling and transferring of material including spill control system and handling is done under supervision of trained staff.Moreover suitable Dykes / Bunds are provided in material handling areas.

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

Health check of all employees is conducted periodically as per guideline of Factory Act and records are maintained.

15. The company shall make the arrangement for protection of possible fire hazards during manufacturing process in material handling.

For safety purpose Hazop study and risk analysis is done.Regular safety inspections are conducted and necessary fire protection arrangements are made available to meet any emergency.

Annexure Particulars

Annexure No.1 AMBIENT AIR QUALITY MONITORING REPORT

Annexure No.2 AMBIENT NOISE LEVEL MONITORING REPORT

Annexure No. 3 ORGANOGRAM

Annexure No. 4 INSTRUMENT IN ENVIRONMENT LAB

Annexure No. 5 LIST OF PRODUCT FOR WHICH HAZOP STUDIES IS CONDUCTED

Annex 1

Annexure No. 4INSTRUMENT IN ENVIRONMENT LAB

1. pH Meter 2. pH Meter (Online)3. Oven4. BOD Incubator 5. Hot Plate6. Stirrer with regulator7. High Volume Sampler8. Stack Monitoring Kit9. Heating Mantel 10. Noise Level Meter 11. Spectrophotometer12. Digital Conductivity Meter 13. Oxygen Level Meter 14. Mono Pan balance (Electronic - digital)15. Dragger Tube16. Muffle Furnace 17. COD Digester (Open Reflux)18. COD Digester (Closed Reflux)19. Refrigerator 20. Ammonical Nitrogen distillation apparatus 21. Desiccators22. Vacuum Pump and Vacuum line

Annexure No. 5

LIST OF PRODUCT HAZOP STUDY COMPLETED

S. No. PRODUCTS STUDY STATUS

1 Flumequine Completed

2 Metoclopramide HCL Completed

3 Trimethoprim Completed

4 Atenolol Completed

5 Chloroquine Phosphate Completed

6 Pyrantel Pamoate Completed

7 Morantel Citrate Completed

8 Furosemide Completed

9 N- Amyl Meta Cresol Completed

10 Artesunate Completed

11 Dihydroartemisinin Completed

12 Alpha Beta Arteether Completed

13 Artmether Completed

14 Artimisinin Completed

15 Cetirizine Di HCL Completed

16 Chlorothalidone Completed

Trend & Action Plan

17 Cilostazole Completed

18 Citalopram Hydrobromide Completed

19 Clopidogrel Bi-Sulphate Completed

20 Fluconazole Completed

21 Glimepride Completed

22Hydroxy Chloroquine

Sulphate Completed

23 Hydrochlorothiazide Completed

24 Losartan Potassium Completed

25 Metoprolol Succinate Completed

26 Metoprolol Tartrate Completed

27 Methyl Phenidate-HCl Completed

28 Nabumeton Completed

29 Propanolol HCL Completed

30 Paroxetine Di Hemihydrate Completed

31 Metformin HCL Completed

32 Lumefantrine Completed

33 Mesalamine Completed

34 Ondansetron HCL Completed

35 Bendroflumethiazide Completed

36 Quetiapine Hemifumarate Completed

37 Alendronate Sodium Completed

38 Ritalinic Acid Completed

39 Indapamide Completed

40 Proguanil HCl Completed

41 Sulfadoxine Completed

42 Allopurinol Completed

43 Etodoloc Completed

44 Warfarin Sodium Completed

45 Isotretinoin Sodium Completed

46 Valsartan Completed

47 Tramadole Hydrochloride Completed

48 Triclabendazole Completed

Thank you!