Agenda Item M/s. Varahi Pharma Pvt Ltd, Plot No.233 to 238, Growth Centre, Sy. No. 98 No:10 (Part) and 103 (Part) of Thumakunta (V), at Growth Centre, (M), Dt: 18.09.2019 District - CFO&HWA (Change of Product Mix) - Reg.

M/s. Varahi Pharma Pvt Ltd, has applied CFO&HWA (Change of Product Mix) for a period upto 31.05.2024 through APOCMMS.

The details of the industry as reported by the RO: Anantapur are as follows: 1. Line of Activity: Bulk Drugs & Intermediates Unit with a project cost of Rs.16.39 crores. 2. Date of commissioning of industry: 06/2013. 3. EC Status: -- 4. CFE Status: The Board issued CFE (Change of Product Mix) to the industry on 14.06.2019. 5. CFO Status: The Board issued CFO&HWA to the industry on 17.01.2017 with validity upto 31.05.2019 and subsequently, the Board vide auto renewal order dated 04.06.2019 has extended the validity of the CFO&HWA order dated 17.01.2017 for period upto 31.05.2024. 6. Details of Present CFO&HWA application: Now, the industry applied for CFO&HWA (Change of Product Mix) for a period upto 31.05.2024. Date of receipt of application at RO 14.08.2019 and submitted additional on 29.08.2019 Date of RO inspection 29.08.2019 Date of receipt of application at HO 01.09.2019 (through e-mail) Land particulars Total area of the plant: 2.23 acres Built Up Area: About 3033.0 Sqmts. Green belt developed: The industry has planted about 500 Nos of saplings in North and Eastern directions along boundary of the industry.

7. Products & By Products manufactured : Permitted Quantity Sl. in Kgs/Month as Nos of Name of the Product Starting raw material No. per the CFE order stages dt:14.06.2019 Group A: 1 Clopidogrel bisulphate 7700 4 DL-2-Chlorophenyl glyeine 2 Telmisartan 3000 6 3-methyl-4-Nitro-Benzoic acid Total Group A: 10700 Kgs/month Group B: 1 Amolodipine besylate 550 4 Pthalic Anhydride 2 Montelukast 2500 7 7-Chloquinnalidine 3 Turbinafin 600 6 Napthyl methyl chloride 4 Valsartan 1600 4 L-valine 5 Losartan potassium 850 3 BromoCyano bi-phenyl 6 Lamivudine 1000 3 Menthol 7 Olmesartan 2750 4 Domethyl-2-propyl imidazole- 4, 5-dicarboxylate Total Group B: 9850 Kgs/month Group C: 1 Clopidogrel bisulphate 3500 4 DL-2-Chlorophenyl glycine 2 Telmisartan 2200 6 3-Methyl-4-Nitro-Benzoic acid 3 Levetiracetam 5000 02 S-2- Aminobutyric Acid Total Group C: 10700 Kgs/month Worst case scenario: 10700 kg/Month

Note: The industry is permitted to manufacture any one group of products at any point of time with a maximum production capacity of 10,700 kgs/month. List of Bi- Products: S.No Bi-Product Generated from which product & stage Quantity in Kgs/day 1. Sodium Phosphate Stage – I of Telmisartan. 13.97 2. Hydrobromic acid Stage – I of Losartan Potassium. 4.99 3. Potassium chloride Stage – 2 of Levetiracetam 255.70

8. Details of Un consented products, if any: During inspection, the month wise production details for the period from January, 2019 to July, 2019 were verified and the month wise production details are as follows: Month Quantity of Couple Quantity of Quantity of Total quantity Amine Hydrochloride Clopidogrel Telmisartan manufactured (N-1 Stage Clopidogrel Bisulphate manufactured during the month bisulphate) manufactured during during the (in Kgs) manufactured during the month(in Kgs) month(in Kgs) the month (in Kgs) January, 2019 0 2575 940 3515 February, 2019 0 3925 917 4842 March, 2019 0 6480 710 7190 April, 2019 0 2110 1100 3210 May, 2019 1000 1965 0 2965 June, 2019 1000 2906 5 3911 July, 2019 2500 765 0 3265 Total 4500 20726 3672 28898

From the above, the industry has manufactured 2 Permitted products i.e., Clopidogrel Bisulphate of 3603.714 Kgs/month (avg) as against the permitted capacity 7700 Kgs/month and Telmisartan of 524.57 Kgs/month (avg) as against the permitted capacity 3000 Kgs/month. The industry has manufactured in total about 4128.28 Kgs/month of the permitted products as against consented quantity of 10,700 Kgs/month.

9. Water consumption: 1. Source of Water supply as per CFE – Borewell 2. Present Source of Water supply - Borewell

S.No. Purpose Consented quantity as Applied as Actual per CFE dated: per consumption 14.06.2019 (Product mix) application 1. Process 8.70 8.70 The industry has 2. Washings 3.00 3.00 not provided 3. Boiler Blow Down 12.00 12.00 water meters for 4. Cooling blow down 30.00 30.00 assessing the 5. DM Plant Regeneration 1.00 1.00 water 6. R & D 1.50 1.50 consumption for 7. Scrubber 6.00 6.00 various purposes. 8. Gardening 2.00 2.00 9. Domestic 2.00 2.00 Total 66.20 66.20 10. Waste Water Generation: S.No. Source Consented quantity as Applied as per Actual per CFE dated: application consumption 14.06.2019 (Product mix) 1. Process 7.5 KLD 7.5 KLD The industry has 2. Washings 3.0 KLD 3.0 KLD provided water 3. Boiler Blow Down 4.0 KLD 4.0 KLD meters for the high 4. Cooling blow down 4.0 KLD 4.0 KLD TDS waste water 5. DM Plant 1.0 KLD 1.0 KLD generated and yet Regeneration to provide meter 6. R & D 1.5 KLD 1.5 KLD for assessing the 7. Scrubber 6.0 KLD 6.0 KLD quantity of low 8. Domestic 2.0 KLD 2.0 KLD TDS waste water Total 29.0 KLD 29.0 KLD generated 11. Out let – as per CFE order (product mix) dated : 14.06.2019 Outlet Description Max Daily Point of Disposal Discharge High TDS effluents 18.5 KLD  The HTDS effluents Shall be Stripped off for (Process – 7.5 KLD, Boiler blow down recovery of organics – 4.0 KLD, DM Plant Regeneration–  Stripper condensate for distillation. Recovered 1.0 KLD & Scrubber – 6.0 KLD) organics shall be disposed to cement plants for co-processing.  Stripped effluents shall be evaporated in MEE  Condensate from MEE shall be sent to ETP for further treatment.  MEE Concentrate shall be sent to ATFD  ATFD Condensate to ETP for further treatment.  ATFD salts to TSDF. Low TDS effluents: 10.5 KLD  The treated effluents from ETP shall be treated (Washings – 3 KLD , Cooling blow in RO plant. (2KL/hr) down – 4.0 KLD, R&D–1.5KLD,  RO permeate shall be reused in the industry and Domestic 2.0 KLD) RO rejects shall be sent to MEE.

12. ETP Details & Mode of Disposal:

I. Outlet No. 1 a. Stream Details: High TDS effluents (Process – 7.5 KLD, Boiler blow down – 4.0 KLD, DM Plant Regeneration–1.0 KLD & Scrubber – 6.0 KLD) b. Treatment unit’s details with The industry has 2 Production blocks (Block – I & II) and dimensions and treatment has provided 02 No’s of HDPE Tanks of capacity – 2KL capacity each for the collection of high TDS effluents. The industry is pumping the high TDS effluents from the production blocks to the above ground level high TDS effluents storage tanks – 2 Nos of 17 KL and provided treatment system consists of High TDS: 1. Strippers followed by MEE of capacity – 20 KLD. 2. AFTD of capacity – 100 ltrs/hour. The salts from the MEE are sent to authorized cement industries for co – processing. The MEE and ATFD condensate is being mixed with low TDS effluents and further treated in ETP followed by RO. c. Point of disposal After pre-treatment, the effluents are treated in striper for recovery of organics. The stripped of effluents are evaporated in MEE. The MEE concentrate is being disposed through ATFD. The Condensate from MEE and ATFD are being sent to ETP further treatment and disposal. II. Outlet No. 2 a. Stream Details: Low TDS effluents: (Washings – 3 KLD , Cooling blow down – 4.0 KLD, R&D–1.5KLD, Domestic 2.0 KLD) b. Treatment unit’s details with The industry has provided 2 Nos of MS tanks of capacity – dimensions and treatment 1 KL each for the collection of Low TDS effluents at the capacity production blocks. The Low TDS effluents are mixed with condensate from MEE and ATFD and then treated in the treatment system consisting of: 1. Two No’s of PP FRP tanks provided with diffusers of capacity – 30 KL each. 2. One No. of Settling tank of capacity – 6 KL, 3. MS tank followed by RO Plant of capacity of 2KL/hour. 4. c. Point of disposal After treatment in ETP, the treated effluents from ETP are further treated in RO system. The RO Permeate is being re- used for cooling tower make-up and RO rejects are mixed with High TDS effluents and then treated in MEE.

Effluent Analysis: During inspection, the industry is not operating the RO system due to the low volume of Low TDS effluents and Board Officials have collected samples of i) High TDS effluents from collection tank ii) Low TDS effluents from collection tank iii) stripper feed iv) MEE feed v) MEE condensate vi) MEE concentrate and the submitted the samples to the Zonal laboratory and the results are awaited.

13. Water Cess:

I Returns filed upto (Month & Year) --- II Assessment issued upto (Month & Year) --- III Assessment paid upto (Month & Year) 31.01.2015 IV Assessment amount due (In Rs.) A copy of the verification report is being submitted to JCEE (unit-2) for taking further necessary action. 14. Air pollution: (after change of product Mix):

S. Source of Pollution Control Flow rate Stack height Limiting No. equipment in m3/hr. in Mts - Standard provided above GL prescribed by Board 1. Attached to Coal cyclone dust --- 30 mts SPM – 115 /briquette fired Boiler collector mg/Nm3 (existing) of capacity 2 TPH 2. Attached to 250 KVA Silencer with --- 3.5 mtrs SPM – 115 DG set acoustic enclosure mg/Nm3 15. Emissions from chimneys – as per CFE order dt : 14.06.2019 (after Change of product mix):

Chimney Description of Chimney Quantity of Limiting Board No. Emissions at Standard Monitorin peak flow g Data 1. Attached to Coal fired Boiler (existing) --- SPM – 115 --- of capacity 2 TPH mg/Nm3 2. Attached to 250 KVA DG set --- SPM – 115 --- mg/Nm3

16. Process emissions: Sources / outlets and control systems adopted: The industry has provided double stage scrubbers with caustic lye as a scrubbing solution for scrubbing the HCl emissions from the production blocks. The industry has installed PH meter for the scrubber and is yet to provide auto recording system to the scrubber.

17. Online AAQM and stack monitoring stations: Not applicable 18. Hazardous chemicals used and their storage facilities: The storage details provided by the industry for the major hazardous chemicals are as follows:

Name of the Chemical / Storage capacity Name of the Storage capacity Fuel Chemical / Fuel Methanol 24 KL Toulene 24 KL Acetone 2 Nos of storage Methelyne Di 2 Nos of 14 KL each tanks of capacity Chloride 24 KL & 14 KL H2SO4 10 KL HCL 2Nos of 10 KL each 19. Solid Waste details: a) Hazardous Solid waste:

S. No. Name of the Stream Quantity of Disposal Option Hazardous Waste Number as per Hazardous waste HWM Rules (after change of product mix) 1 Organic solid waste 28.1 of Sch-I 219.68 Kgs/day To the authorized 2 Spent carbon 28.3 of Sch-I 55.93 Kgs/day Cement industries for co-processing (or) TSDF, Parawada for incineration. 3 Inorganic solid 28.1 of Sch-I 51.27 Kgs/day To TSDF, Parawada waste for secured land 4 MEE salts 34.3 of Sch-I 157.29 Kgs/day filling. 5 ETP sludge 34.3 of Sch-I 20Kgs/day

6 Used oil & grease 5.1 of Sch-I 100 Ltrs/annum Disposed to authorized Re - Processors/ Recyclers/ to the Cement Industries for co processing 7 Detoxified 33.3 of Sch-I 100 No’s /month To authorized container and agencies, agencies, container liners after complete detoxification for re use/ recycle. b) Non-Hazardous Solid Waste details:

S. No. Name of the waste Source of Quantity of waste Disposal Option generation (kg/day) 01 Boiler Ash --- 7.0 TPM Sold to Brick manufacturers

20. Compliance status of conditions stipulated in CFE order dated: 14.06.2019. S. Condition Compliance No. 1. The proponent shall obtain Consent for Operation (CFO) Complied from APPCB, as required Under Sec.25/26 of the Water (P&C of P) Act, 1974 and under sec. 21/22 of the Air (P&C of P) Act, 1981, before commencement of the trail runs. 2. The applicant shall provide separate energy meters for The industry has to provide Effluent Treatment Plant (ETP) and Air pollution Control separate energy meter for the equipments to record energy consumed. An alternative operation of ETP and APCE electric power source sufficient to operate all pollution provided to the Boiler. control systems shall be provided. 3. The industry shall construct separate storm water drains. No Not constructed. effluents shall be discharged in to the storm water drains. 4. The source of water is APIIC Supply & road tankers from The source of water supply for outside parties and the maximum permitted water the industry is APIIC supply and consumption is as following after Change of Product Mix: also by means of tankers S. Purpose Existing After change purchase from outside. The No. permitted of industry has provided water consumpti product mix meters for the APIIC supply as on as per (KLD) well as water purchase by means CFO of tankers and is maintaining order dt. records. As per the records, the 29.12.2017 water consumption is within the (KLD) permitted quantity. 1 Process 8.70 8.70 2 Washings 3.00 3.00 3 Boiler feed 12.00 12.00 4 Cooling Towers 30.00 30.00 5 DM Plant 1.00 1.00 6 R & D 1.50 1.50 7 Scrubber 6.00 6.00 8 Gardening 2.00 2.00 9 Domestic 2.00 2.00 Total 66.20 KLD 66.20 KLD Separate meters with necessary pipe-line shall be provided for assessing the quantity of water used for each of the purposes mentioned above. 5. The maximum waste water generation shall not exceed the The industry is segregating the following after Change of Product Mix waste water into high and low S. Source Existing After change TDS streams. The industry has No permitted waste of product provided flow meter with . water generation mix (KLD) totalizer for the assessing the as per CFO order quantity of High TDS stream dt.: 29.12.2017 only. (KLD) The industry has adopted ZLD 1 Process 9.2 7.5 system by providing stripper 2 Washings 3.0 3.0 followed by MEE and ATFD for 3 Boiler 4.0 4.0 the disposal of High TDS Blow effluents. The condensate from Down MEE and ATFD is further treated 4 Cooling 4.0 4.0 in ETP along with low TDS blow effluents. The industry has down provided bio-logical treatment 5 DM Plant 1.0 1.0 consisting collection, Regenerati equalization tank, clarifier and on RO plant. The RO permeate is re- 6 R & D 1.5 1.5 used and also RO rejects is send 7 Scrubber 6.0 6.0 to MEE. 8 Domestic 2.0 2.0 There is no discharge of waste Total 30.7 29.0 water outside the premises.

Treatment & disposal:

Source of Treatment Point of effluent Disposal High TDS Stripper 20  The HTDS effluents KLD, MEE effluents (Process – 7.5 (20 KLD), Shall be KLD, Boiler ATFD Stripped off blow down – 4.0 (100 / for recovery KLD, DM Plant hr) of organics. regeneration –  Stripper 1.0 KLD, condensate Scrubber – 6 for KLD) distillation. Recovered organics shall be disposed to cement plants for co- processing.  Stripped effluents shall be evaporated in MEE  Condensate from MEE shall be sent to ETP for further treatment.  MEE Concentrate shall be sent to ATFD  ATFD Condensate to ETP for further treatment.  ATFD salts to TSDF.

Low TDS Collection  The treated effluents and tank - effluents domestic equalization from ETP effluents tank – shall be (washings – 3.0 diffused treated in RO KLD, Cooling aeration tank plant. blow down – 4.0 – settling tank (2KL/hr) KLD, R&D – – RO plant  RO permeate 1.5 KLD, (2KL/hour). shall be Domestic – 2.0 reused in the KLD) industry and RO rejects shall be sent to MEE.

6. The ZLD system consisting of stripper, MEE, ATFD system with condenser and Biological ETP, RO plant shall be properly operated and maintained. All the units of the ZLD system shall be impervious to prevent ground water pollution. The units of ZLD system shall be constructed above the ground level Effluents shall not be discharged on land or into any water bodies or aquifers under any circumstances. 7. The industry shall properly operate and maintain digital The industry has provided flow flow meters with totalisers at the inlet and outlet of Stripper, meter at the inlet of the stripper, MEE, ETP and RO MEE condensate and also high TDS effluent received from the production blocks. The industry is yet to provide flow meter for the outlet of the stripper, MEE concentrate, Inlet RO, RO Permeate and RO rejects. 8. The industry shall properly operate and maintain online real The industry is a zero liquid time monitoring system along with web camera facilities discharge Unit and has installed and shall ensure that it is connected to APPCB / CPCB Effluent Monitoring System i.e., websites as per CPCB directions. web camera, flow meters and also provided connectivity to CPCB website. 9. Floor washing shall be admitted into the effluent collection Complied. system only and shall not be allowed to find their way in storm drains or open areas. All pipe valves, sewers, drains shall be leak proof 10. The Air pollution Control equipment shall be maintained The industry is utilizing the properly with the following for controlling air pollution existing boiler and DG sets for after Change of Product Mix the change of product mix Sl. Details of Stack Stack 1 Stack 3 No. 1 Attached to Coal fired DG Set Boiler (existing) (existing) 2 Capacity 2 TPH 250 KVA 3 Fuel Coal HSD 4 Stack Height: Above 30 m 3.5 m the Ground (m) 5 Details of Air Cyclone Silencer Pollution Control dust with Equipment: collector acoustic enclosure

11. A sampling port with removable dummy of not less than 15 Complied. cm diameter shall be provided in the stack at a distance of 8 times the diameter of the stack from the nearest constraint such as bends etc. A platform with suitable ladder shall be provided below 1 meter of sampling port to accommodate three persons with instruments. A 15 AMP 250 V plug point shall be provided on the platform. 12. The industry shall properly operate and maintain the Not submitted monitoring system to all the stacks / vents in the plant. Regular monitoring shall be carried out and report shall be submitted to the Regional officer 13. The industry shall properly operate and maintain multi- The industry has provided double stage scrubbers to the process vents to control the process stage scrubber for scrubbing the emissions. The industry shall ensure that online pH process emissions and also the measuring facility with auto recording system is connected industry has installed online pH to the scrubbers monitoring system for the scrubber t 14. The industry shall properly operate and maintain VOC Not complied monitoring system with auto recording facility The industry has provided portable VOC analyser and there is no recording facility to the analyser. 15. The industry shall implement adequate measures to control --- all fugitive emissions from the plant. 16. The proponent shall ensure compliance of the National The industry has provided Ambient Air quality standards notified by MoEF, GoI vide silencer with acoustic enclosures notification No. GSR. 826 (E), dated. 16.11.2009 during for controlling the noise from the construction and regular operational phase of the project at D.G sets. the periphery. The generator shall be installed in a closed area with a silencer and suitable noise absorption systems. The ambient noise level shall not exceed 75 dB(A) during day time and 70 dB(A) during night time. 17. The proponent shall not use or generate odour causing Characteristics odour of solvents substances or Mercaptans and cause odour nuisance in the were observe in the surrounding surroundings. of the industry. 18. The industry shall send the used / spent solvents to the The industry has 1No. of in recyclers (or) process them at their own solvent recovery house solvent recovery plant of facility within the premises. capacity 6,000 LPD with a column height of 30ft. The industry representative has informed that they are recovering the solvents in their own solvent recovery plant and after recovery, the recovered solvents are being re-used in the process. 19. The evaporation losses in solvents shall be controlled by taking the following measures: i) Chilled brine circulation shall be carried out to Complied effectively reduce the solvent losses into the atmosphere. ii) Transfer of solvents shall be done by using pumps Complied instead of manual handling. Complied iii) Closed centrifuges shall be used to reduce solvent losses. Complied iv) All the solvent storage tanks shall be connected with vent condensers to prevent solvent vapours. The industry has provided v) The reactor vents shall be connected with primary & primary, secondary and vent secondary condensers to prevent escaping of solvent condensers for the solvent vapour emissions into atmosphere. recovery column to minimize the escaping the solvent into atmosphere. 20. The manufacturing process of Group - C Levetiracetam is The industry is scrubbing the SO2 revised. The SO2 emission formed is reacted with Sodium emissions during the hydroxide and Sodium bisulphate is formed. It is sold as by- manufacturing of Levetiracetam product. So there are no SO2 emission from the product and with caustic lye to form sodium the total group – C process emissions are 29.17 kg/day only, by sulphate and is sold as bi and the worst case emission are from Group – B 64.17 product. kg/day same as that of existing and so there is no increase in process emissions. Revised material balance of levetiracetam, Loads and overall pollution loads are submitted. 21. The industry shall comply with the following for disposal of The industry generates hazardous Solid waste after Change of Product Mix: waste i.e., MEE salts, ETP S Solid Existin After Method of sludge, inorganic solid waste, . Waste g change Disposal organic solid waste and spent N generated (kg/day of carbon. The industry has lifted o ) product organic waste of 18.50 Tons to mix M/s.JSW Cements Ltd., Kurnool (kg/day) district during March, 2019. Hazardous waste with disposal option: The industry has not lifted MEE 1 Organic 219.68 219.68 To the salts, ETP sludge and inorganic solid authorized waste to TSDF, Parawada till Waste Cement now. At present, the industry 2 Spent 55.93 55.93 industries for has stored about 8 Tons of MEE carbon co-processing and ETP sludge and also about 2 (or) TSDF, Tons of spent carbon within the Parawada for premises. incineration 3 In organic 51.27 51.27 To TSDF, solid Parawada for waste secured land filling. 4 MEE Salts 157.29 157.29

5 ETP 20.0 20.0 sludge

Total 504.17 504.17 Kg/day kg/day Hazardous waste with recycling option: 6 Used oil 100 100 Disposed to and grease liters/an liters/ann authorized Re- num um processors / Recyclers / to the Cement industries for co-processing. 7 Detoxified 100 100 To authorized container No’s/M No’s/Mo agencies, after and onth nth Complete container detoxification liners for re-use/ recycle.

22. The proponent shall place the chemical drums and / or any The industry has placed the drums in a shed provided with concrete platform only. The chemical drums in open area on Platform shall be provided with sufficient dyke wall and the naked soil near the solvent effluent collection system. The industry shall provide recovery plant and also near the containers detoxification facility. Container & Container production block – II in the liners shall be detoxified at the specified covered platform premises. Spillages of chemicals with dyke walls and the wash wastewater shall be routed to were observed in the area and the low TDS collection tank. industry has to provide closed shed with concrete platform and leachate collection facility for the storage of chemical drums. 23. The following rules and regulations notified by the Noted by the unit MoEF&CC, GoI shall be implemented a) Regulation of Persistent Organic Pollutants Rules, 2018. b) Hazardous waste and other wastes (Management and Transboundary Movement) Rules, 2016. c) Plastic Waste Management Rules, 2016. d) Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 e) Fly Ash Notification, 2016. f) Batteries (Management & Handling) Rules, 2010. g) E-Waste (Management) Rules, 2016. h) Construction and Demolition waste Management Rules, 2016. i) Solid Waste Management Rules, 2016.

24. The industry shall comply with the following as committed vide lr. dt. 13.06.2019:  The original Bank Guarantee for Rs. 4.0 lakhs shall be The industry has extended the submitted at Regional Office, Anantapuram. bank Guarantee for Rs.4.0 Lakhs for the period upto 12.06.2020.

 The existing 20 TR Chilling plant is being replaced with The industry has disconnected new 30 TR Chilling plant. The old one shall be the 20 TR Chilling plant and is dismantled after commissioning of the new Chilling operating only 30 TR chilling plant. plant.

 The HTDS and LTDS storage tanks shall be covered Complied. with sheets within 10 days.  Six monthly compliance reports shall be submitted to Submitted the Regional Office.  Inorganic waste and Organic waste shall not be mixed. The industry has stored the Inorganic waste shall be disposed to TSDF for secured inorganic waste of about 8 Tons landfill, and Organic waste to Cement Industries for co- within the premises and has to processing. dispose the same to TSDF, Parawada

25. Existing green belt shall not be disturbed due to the The industry has planted about proposed expansion. Thick green belt shall be maintained 500 Nos of saplings in North and all along the boundary & vacant spaces with tall growing Eastern directions along trees with good canopy and it shall not be less than 33% of boundary of the industry. the total area. 26. The industry shall submit the information regarding usage Noted by the unit of Ozone Depleting Substance once in six months to the Regional Office and Zonal Office of the Board. 27. Concealing the factual data or submission of false --- information / fabricated data and failure to comply with any of the conditions mentioned in this order attracts action under the provisions of relevant pollution control Acts. 28. Notwithstanding anything contained in this conditional --- letter or consent, the Board hereby reserves its right and power Under Sec. 27(2) of Water (Prevention and Control of Pollution) Act, 1974 and Under Sec.21(4) of Air (Prevention and Control of Pollution) Act, 1981 to revoke the order, to review any or all the conditions imposed herein and to make such modifications as deemed fit and stipulate any additional conditions. 29. Any person aggrieved by an order made by the State Board --- under Section 25, Section 26, Section 27 of Water Act, 1974 or Section 21 of Air Act, 1981 may within thirty days from the date on which the order is communicated to him, prefer an appeal as per Water Rules, 1976 and Air Rules,1982, to such authority (hereinafter referred to as the Appellate Authority) constituted under Section 28 of Water (Prevention and Control of Pollution)Act,1974 and Section 31 of the Air (Prevention and Control of Pollution) Act, 1981. 21. Compliance status of directions stipulated in Task Force order dated:

The Board has received from Sri Nandamuri Balakrishna Hon’ble MLA, Hindupur Constituency on 29/10/2015 with regard to the irregularities causes by the chemical industries located in IDA, Thumakunta, Hindupur Mandal. In this regard, the Board Officials have inspected the industry and the status of the industry was reviewed by the Task force committee at Board office, from time to time and issued with directions to the industry on 04.04.2016, 09.08.2016, 06.05.2017 and the recent directions was issued on 31.12.2018. The Compliance of the industry on the directions issued by the Board vide order dt.31.12.2018 is as follows: S.No. Directions Compliance status 1. The industry shall segregate the effluents into Complied. LTDS & HTDS effluents and treat them The industry is segregating the waste water separately in compliance with the CFO order into high TDS and low TDS effluents conditions. streams. The industry is disposing the high TDS waste water using stripper, MEE and ATFD and Low TDS effluents using ETP followed by RO plant and thereby achieving Zero liquid discharge for effluents. 2. The industry shall cover the HTDS and LTDS complied effluents storage tanks and the vents shall be connected to the scrubber to avoid smell nuisance at effluent storage area. 3. The industry shall install separate flow meter for Not installed LTDS collection tank and shall maintain the records. 4. The industry shall ensure online pH meter to the The industry has provided online pH double stage scrubber and shall provide auto monitoring system to the double stage recording facility with data logger system within scrubber and has to provide recording one month. facility to the scrubber. 5. The industry shall provide data logger system to Complied the VOC analyzer within one month. 6. The industry shall provide scrubber facility for The industry has provided ducting system scrubbing of fugitive emissions from the storage (with one inch line) connected to scrubber of HCL in PPFRP tank within two months. for scrubbing the fugitive acidic emissions from the storage of HCL.

7. The industry shall maintain good housekeeping The industry has provided dyke wall near near MEE area. All the pump mechanical seals the MEE area to avoid spillages. and piping shall be maintained without leakage. 8. The industry shall shift the solvent drums stored The industry has to construct closed shed openly into closed shed. The industry shall with concrete plat form with leachete detoxify the barrels stored in the industry collection facility for the storage of solvent premises and dispose to outside agencies. drums. 9. The industry shall provide elevated platform with a provision to collect leachate/spillages and shall treat the same in ETP followed by MEE system within one month. 10. The industry shall dismantle the existing FE The industry has dismantled the 5 KL FE reactors (6KL and 5 KL capacity) in compliance reactor and utilizing the 6 KL graphite vat with the CFO order conditions immediately. (without any heating jacket) for the neutralization of the High TDS effluents.

11. The facility shall renew the Bank Guarantee for The industry has extended the bank Rs.4.0 Lakhs within 15 days in favour of EE, Guarantee for Rs.4.0 Lakhs for the period RO, Kurnool in prescribed format valid for up to 12.06.2020. period of one year.

12. The industry shall ensure continuous The condition wise compliance on the compliance of the of the conditions issued in the Schedule - B conditions stipulated in the CFO & HWA order dt.16.11.2015 latest CFO order.29.12.2017. 22. Hazardous Waste Authorization details: i) Particulars of Authorization obtained under HW The industry was granted an authorization (M&H) Rules, 2003 (No. & Validity date) vide order dated: 29.12.2017 with a validity of 31.05.2019. Subsequently, the Board vide auto renewal order dated. 04.06.2019 has extended the validity of the CFO & HWA order dated. 29.12.2017 for period up to 31.05.2024 ii) Authorization issued for The industry was granted an authorization (Transportation, reception, storage, treatment to operate a facility for collection, and disposal) reception, storage, treatment, transport and disposal of the hazardous waste viz, Hazardous Waste with disposal option: Sl. Name of the Stream Qty. Mode of disposal No. Hazardous waste 1. Organic solid waste 28.1 of 219.68 Disposed to TSDF Schedule- Kgs/day for incineration/ 2. Spent carbon 28.3 of 55.93 Kgs/day Cement industries for Schedule-I co-incineration. 3. Inorganic solid waste 28.1of 51.27 Kgs/day Disposed to TSDF Schedule-I for secured land 4. MEE salts 34.3 of 157.29 filling Schedule-I Kgs/day 5. ETP sludge 34.3 of 20 Kgs/day Schedule-I Hazardous wastes with Recycling option: Sl. Name of the Stream Qty. Mode of disposal No. Hazardous waste 1. Used oil and grease 5.1 of Sch-I 100 Lts/Year Authorized re- processors / Recyclers. 2. Detoxified container 33.3 of Sch-I 100 After complete and container liners Nos/month detoxification, shall be disposed to authorized parties.

iii) Process in which the industry is covered (Please 28 of Schedule-I give Sl. No of process as per HW Rules) iv) Description of Hazardous waste with quantities The industry has applied for hazardous and Stream No. as per HWM Rules, 2003 waste authorization for handling of hazardous waste as follows:

Sl. Name of the Stream Qty. Mode of disposal No. Hazardous waste Hazardous Waste with disposal option: 1. Organic solid waste 28.1 of Sch-I 219.68 Disposed to TSDF for Kg/day incineration/ Cement 2. Spent carbon 28.3 of Sch-I 55.93 industries for co- Kg/day incineration. 3. Inorganic solid waste 28.1 of Sch-I 51.27 Kg/day Disposed to TSDF for 4. MEE Salts 34.3 of 157.29 secured land filling Sch-I Kgs/day 5. ETP sludge 34.3 of Sch-I 20 Kg/day Hazardous wastes with Recycling option: Sl. Name of the Stream Qty. Mode of disposal No. Hazardous waste 1. Used oil and grease 5.1 of Sch-I 100 Lts/Year Authorized re- processors / Recyclers. 2. Detoxified container 33.3 of Sch-I 100 After complete and container liners Nos/month detoxification shall be disposed to authorized parties.

v) Particulars of on-site Secured Storage (Capacity The industry is storing the Hazardous with dimensions) and mention period for which waste in the area below the above ground secured storage is sufficient. level storage tanks of HTDS & LTDS effluents storage tanks. vi) Quantity of Haz Waste stored on-site presently. At present, the industry has stored about 8 *Furnish specific remarks on the storage of Haz. Tons of Inorganic waste including MEE Waste for more than 90 days. Salts & ETP sludge and also about 2 Tons of Organic waste & Spent carbon in the premises. vii) Quantity of Hazardous waste disposed for last The industry generates hazardous waste six months as per the following break-up: i.e., MEE salts, ETP sludge, inorganic Common TSDF – solid waste, organic solid waste and spent Common HW Incinerator – carbon. The industry has lifted organic For recycle / reused - waste of 18.50 Tons to M/s.JSW Cements Ltd., Kurnool district during March, 2019. The industry has not lifted MEE salts, ETP sludge and inorganic waste to TSDF, Parawada till now. viii) Whether industry has submitted annual returns, Not submitted date of latest submission. ix) Whether industry has installed incinerator or Not installed sending to common HW Incinerator x) Particular of own incinerator --- (if applicable) xi) Whether log books are maintained for --- incinerator. (if applicable) xii) Whether industry has taken adequate steps to --- prevent contaminated runoff from storage areas of Hazardous Waste. xiii) Steps taken by industry towards waste --- minimization and cleaner production. xiv) Future plan for waste minimization. --- xv) Facilities available with, industry for waste --- characterization. xvi) Overall House Keeping within the factory Satisfactory premises. xvii) Details of disposal of lead acid batteries along --- with nos. and agencies to whom they are disposed

23. Inspecting Officer’s Remarks: Status of functioning of flow meters of water and effluent The industry has not provided flow meter for assessing the water consumption for each of the various purposes. Also, the industry has not provided magnetic flow meter for assessing the Low TDS effluent generation, stripped off effluents in Stripper, MEE concentrate, and also ATFD Feed & ATFD condensate. Status of energy meters in ETP and Air Pollution Control Not provided Equipment (APC) Remarks on ETP performance and Analysis results --- Remarks on APC equipment performance and Analysis --- results Details of specific and serious non-compliance --- Details of Court cases & Status Nil Details of complaints --- The Board has received from Sri Nandamuri Balakrishna Hon’ble MLA, Hindupur Constituency on 29/10/2015 with regard to the irregularities causes by the chemical industries located in IDA, Thumakunta, Hindupur Mandal. In this regard, the Board Officials have inspected the industry and the status of the industry was reviewed by the Task force committee at Board office, from time to time and issued with directions to the industry on 04.04.2016, 09.08.2016, 06.05.2017 and the recent directions was issued on 31.12.2018.. The directions along with the compliance is reported above at Sl.No.21. Amendments required in the existing CFO/CFE order --- Irrelevant Conditions that need deletion in view of present --- compliance / non-compliance Additional conditions to be imposed --- Specific comments on quantities of Hazardous Wastes as --- per application, existing CFO Order and actual generation Details of non-hazardous solid waste generation and --- disposal details separately Compliance of the industry with reference to Notifications under E(P) Act & Rules a) Fly Ash Notification --- b) PLI Act Policy --- c) Environmental Statement in Form – V Submitted d) Other if any --- Mitigation Measures ---

24. Environmental Engineer’s Remarks: 1. M/s. Varahi Pharma Pvt Ltd, is located at Plot No.233 to 238, Growth Centre, Sy.No.98 (part) and 103 (part) of Thumakunta Village at Growth Centre, Hindupur(V), Anantapur District and is engaged in the manufacture of Bulk Drugs and its intermediates. 2. The industry was issued with Consent for Operation (CFO) & Hazardous Waste Authorization (HWA) vide order dated 29.12.2017 with a validity up to 31.05.2019 for manufacture of 9 Bulk Drugs & its intermediate products with a total production capacity of 10,700 Kgs/month. Subsequently, the Board vide auto renewal order dated. 04.06.2019 has extended the validity of the CFO & HWA order dated.17.01.2017 for further period up to 31.05.2024. 3. The industry was issued with Consent for Establishment of the Board (CFE) for change of Product Mix vide order dated: 14.06.2019 on basis of no increase in pollution load & production capacity to produce 12 products in three groups in such a way that any one group of products will be manufactured at any given point of time. A copy of the CFE order is enclosed. At present, the industry has applied for CFO of the Board for the products permitted by the Board vide CFE order dated: 14.06.2019. 4. During inspection the production details for the period from January to July, 2019 were verified and as per the production records, the industry has manufactured only 2 of the permitted products i.e Clopidogrel Bisulfate – 3603.714 Kgs/month (avg) as against the permitted capacity 7700 Kgs/month and Telmisartan – 524.57 Kgs/month (avg) as against the permitted capacity 3000 Kgs/month. The industry has manufactured in total about 4128.28 Kgs/month of the permitted products as against consented quantity of 10,700 Kgs/month. 5. The industry is segregating the waste water into high TDS and low TDS effluents streams. The industry is disposing the high TDS waste water using stripper, MEE and ATFD. The low TDS along with condensate from MEE & ATFD are being treated in ETP followed by RO plant and thereby achieving Zero liquid discharge for effluents. 6. During the inspection it was observed that it was not operating the RO system due to the low volume of Low TDS effluents and the industry has to provide flow meter with totalizer for the i) low TDS effluents generated v) ETP outlet vi) RO Feed vii) RO Permeate viii)RO Rejects 7. The industry has installed Effluent Monitoring System i.e., web camera, flow meters and also provided connectivity to CPCB website. 8. The industry is utilizing the existing coal fired boiler of capacity 2.0 TPH for the change of product mix and there are no additional boilers and DG sets for the change of product mix. 9. The industry has stored the chemical drums in the open area on the naked soil and spillages of chemicals were observed in the drums storage area. The industry shall construct closed shed with concrete plat form and leachate collection facility for the storage of drums within the premises. 10. As per the HWA order 29.12.2017, the industry is supposed to send inorganic waste (inorganic solid waste, MEE salts and ETP sludge) – 228.56 Kgs/day to TSDF for secured land filling. Whereas, the industry has not sent any hazardous waste to TSDF, Parawada till now. The industry has stored about 8 Tons of inorganic waste within the premises. 11. As per the HWA order 29.12.2017, the industry is supposed to send organic waste (organic solid waste and spent carbon) – 275.61 Kgs/day to TSDF for incineration/ Cement industries for co- incineration. Whereas, the industry has lifted 18.5 Tons i.e., 88.09 Kgs/day (avg) to Cement industries for co-processing during January 2019 to July, 2019. Also, the industry has stored about 2 Tons of organic waste within the premises. 12. From the above, it is evident that the industry has not sent any hazardous inorganic waste i.e., inorganic solid waste, MEE salts and ETP sludge to TSDF Parawada for secured land filling till now and the unit may be directed to dispose the inorganic waste to TSDF Parawada. 25. Recommendations of Environmental Engineer: In view of the above, the industry’s application for CFO&HWA for the change of product mix may be examined.

26. HO Remarks: A. M/s. Varahi Pharma Pvt Ltd, Anantapur District is involved in the manufacturing of Bulk Drugs & Intermediates. B. The Board issued CFO&HWA to the industry on 29.12.2017 with validity upto 31.05.2019 and subsequently, the Board vide auto renewal order dated 04.06.2019 has extended the validity of the CFO&HWA order dated 17.01.2017 for period upto 31.05.2024. C. The Board issued CFE (Change of Product Mix) to the industry on 14.06.2019. D. Now, the industry applied for CFO&HWA (Change of Product Mix) for a period upto 31.05.2024. E. The Non-compliances and violations are as follows: - The industry has not submitted compliance report on the conditions mentioned in the consent order every 6 months to the Regional office/Zonal office. - The industry has stored about 8 Tons of inorganic waste within the premises and the industry has not sent any hazardous waste to TSDF, Parawada till now. - Hazardous waste was stored below the effluent storage tanks. - The industry has stored the chemical drums in the open area on the naked soil and spillages of chemicals were observed in the drums storage area. - The industry has not provided flow meter for the inlet of low TDS collection tank. - The industry has not installed separate energy meters to MEE, ETP & RO Plant. - The industry has not provided auto recording facility to the scrubber. - The industry has not constructed separate storm water drains to collect 1st runoff to treat as LTDS effluent. - The industry shall properly operate and maintain VOC monitoring system with auto recording facility. But, the industry has provided portable VOC analyser and there is no recording facility to the analyser. - The industry has not constructed closed shed with concrete platform with leachate collection facility for the storage of solvent drums.

The issue is placed before the CFO Committee for Review and Recommendations. ***