CFE AGENDA ITEM No. Dt: 08.08.2019

AP Single Desk application 01) Name of the Industry &

Location address with Sy. Nos.

: M/s. RA Chem Pharma Ltd, R.S.No.50/1, Mukteswarapuram (V), Jaggaiahpet (M), Krishna District. Applied for CFE for Change of Product Mix

Longitude and Latitude : 80° 3'38. "E and 16°50'14 "N

02) EC status : EC order dt. 19.08.2003 issued by MoE&F, GoI, New Delhi.

03) Project cost :

No additional project cost.

04) Project site details: : i) Total area of the land : 21.5 acres

ii) Built up area : About 7.4 Acres

iii) Greenery : About 7.0 Acres

iv) Nearest Human habitation : Mukthyala (V) at a distance of 1.5 km.

v) Nearby water body : River Krishna about 3 km

vi) Surroundings of the site :

North : Open land South : Open lands East : Approach road followed by open lands and industry canteen. West : Open land followed by M/s. Vivin Life Sciences Industry (formerly M/s.

Mylan laboratories)

05) Products & By Products: Bulk drug & Intermediates manufacturing industry.

As per CFE order dt: 27.06.2016: Sl. No.

Product name Quantity (kg/day)

1. 2-(2,3-dichlorophenyl)-2-phenyl methylene hydrazine carboxidimianmidine (Intermediate)

111.11

2. 2-amino methyl-7-chloro-1,3-dihydro-5-(2-florophenyl)1h-1,4-benzo diazepine dimaleate (Intermediate)

69.44

3. Drotaverine Hydrochloride (API) 611.11

4. Entacapone (API) 277.78

5. Fexofenadine Hydrochloride (API) 97.22

6. Lamotrigine (API) 527.77

7. Mebeverine Hydrochloride (API) 902.78

8. Tamsulosin Hydrochloride (API) 1.39

9. Midazolam Hydrochloride (API) 14

10 Fomepizole (API) 2.78

11 Hydralazine Hydrochloride (API) 83.33

12 Metaxalone (API) 111.11

13 Meclizine Hydrochloride (API) 83.33

14 Itraconazole (API) 50

15 Levocetirizine Dihydrochloride (API) 33.33

16 Pranlukast Hemihydrate (API) 55.56

17 Tilidine Hydrochloride (API) 27.78

18 Agomelatine (API) 22.22

19 Mebendazole (API) 13.89

20 Piroxicam (API) 27.78

21 Posaconazole (API) 27.78

Sl. No.

Product name Quantity (kg/day)

22 Praziquantel (API) 41.67

23 Efavirenz (API) 694.44

24 Emtricitabine (API) 277.78

25 Trazodone (API) 55.56

26 Ciprofloxacin Hydrochloride (API) 166.67

27 Phthaloyl Amlodipine (API) 555.56

28 Articaine Hydrochloride (API) 111.11

29 Dipyridamole (API) 555.56

30 Ractopamine Hydrochloride (API) 833.33

31 Venlafaxine Hydrochloride (API) 41.67

32 Mesna (API) 27.78

33 Benserazide Hydrochloride (API) 33.33

34 Doxazosin Mesylate (API) 55.56

35 Epinastine Hydrochloride (API) 33.33

36 Zilpaterol Hydrochloride (API) 27.78

37 Fluvoxamine Maleate (API) 41.67

38 Lansoprazole (API) 25.0

39 Tolterodine Tartrate (API) 13.89

40 Tolcapone (API) 13.89

41 Flurbiprofen (API) 69.44

42 Diflunisal (API) 27.78

43 Baclofen (API) 55.56

44 Brivudine (API) 5.56

45 Oxolamine Citrate (API) 763.89

46 Zaltoprofen (API)

13.89

47 Zonisamide (API) 27.78

48 Tianeptine Sodium (API) 16.67

Total

6000.00 kg/day

The industry shall manufacture any 10 products at any point of time such that the maximum production capacity shall not exceed 6000 kg/day.

After Change of Product Mix:

Sl. No.

Product name Existing (kg/day)

Proposed (kg/day)

Status of the product

1. 2-(2,3-dichlorophenyl)-2-phenyl methylene hydrazine carboxidimianmidine (Intermediate)

111.11 200.00 Increased

2. 2-amino methyl-7-chloro-1,3-dihydro-5-(2-florophenyl)1h-1,4-benzo diazepine dimaleate (Intermediate)

69.4 69.44 Retained

3. Drotaverine Hydrochloride (API) 611.11 972.22 Increased

4. Entacapone (API) 277.78 222.22 Reduced

5. Fexofenadine Hydrochloride (API) 97.22 97.22 Retained

6. Lamotrigine (API) 527.77 833.33 Increased

7. Mebeverine Hydrochloride (API) 902.78 1111.11 Increased

8. Tamsulosin Hydrochloride (API) 1.39 1.39 Retained

9. Midazolam Hydrochloride (API) 14.0 14.00 Retained

Sl. No.

Product name Existing (kg/day)

Proposed (kg/day)

Status of the product

10. Fomepizole (API) 2.78 2.78 Retained

11. Hydralazine Hydrochloride (API) 83.33 83.33 Retained

12. Metaxalone (API) 111.11 138.88 Increased

13. Meclizine Hydrochloride (API) 83.33 83.33 Retained

14. Itraconazole (API) 50.0 50.00 Retained

15. Levocetirizine Dihydrochloride (API) 33.33 33.33 Retained

16. Pranlukast Hemihydrate (API) 55.56 0 Dropped

17. Tilidine Hydrochloride (API) 27.78 27.78 Retained

18. Agomelatine (API) 22.22 22.22 Retained

19. Mebendazole (API) 13.89 0 Dropped

20. Piroxicam (API) 27.78 0 Dropped

21. Posaconazole (API) 27.78 27.78 Retained

22. Praziquantel (API) 41.67 0 Dropped

23. Efavirenz (API) 694.44 0 Dropped

24. Emtricitabine (API) 277.78 0 Dropped

25. Trazodone (API) 55.56 0 Dropped

26. Ciprofloxacin Hydrochloride (API) 166.67 0 Dropped

27. Phthaloyl Amlodipine (API) 555.56 0 Dropped

28. Articaine Hydrochloride (API) 111.11 111.11 Retained

29. Dipyridamole (API) 555.56 555.56 Retained

30. Ractopamine Hydrochloride (API) 833.33 833.33 Retained

31. Venlafaxine Hydrochloride (API) 41.67 41.67 Retained

32. Mesna (API) 27.78 0 Dropped

33. Benserazide Hydrochloride (API) 33.33 33.33 Retained

34. Doxazosin Mesylate (API) 55.56 55.56 Retained

35. Epinastine Hydrochloride (API) 33.33 33.33 Retained

36. Zilpaterol Hydrochloride (API) 27.78 50.00 Increased

37. Fluvoxamine Maleate (API) 41.67 0 Dropped

38. Lansoprazole (API) 25.0 0 Dropped

39. Tolterodine Tartrate (API) 13.89 13.89 Retained

40. Tolcapone (API) 13.89 13.89 Retained

41. Flurbiprofen (API) 69.44 81.60 Increased

42. Diflunisal (API) 27.78 27.78 Retained

43. Baclofen (API) 55.56 55.56 Retained

44. Brivudine (API) 5.56 5.56 Retained

45. Oxolamine Citrate (API) 763.89 763.89 Retained

46. Zaltoprofen (API) 13.89 13.89 Retained

47. Zonisamide (API) 27.78 50.00 Increased

48. Tianeptine Sodium (API) 16.67 16.67 Retained

49. Solastay S1 -- 166.67 New

50. Verapamil Hydrochloride -- 83.33 New

51. Tapentadol Hydrochloride -- 3.33 New

52. Ferric Citrate -- 5.55 New

53. Tapentadol Dihydrogen Phosphate -- 33.33 New

54. Dabigatran Etexilate Mesylate -- 16.67 New

55. Propiomazine Maleate -- 5.55 New

56. Oxolamine Phosphate -- 16.67 New

57. Losartan Potassium -- 27.77 New

58. Celecoxib -- 178.81 New

59. Dolutegravir -- 33.33 New

60. Vanillylamine Hydrochloride -- 16.67 New

61. Dorzolamide Hydrochloride -- 1.38 New

62. Irbesartan -- 83.33 New

63. Pantoprazole Sodium -- 27.77 New

64. Phloroglucinol -- 55.55 New

65. Trimethyl Phloroglucinol -- 27.77 New

66. Abacavir Sulfate -- 55.55 New

67. Darunavir Ethanolate -- 55.55 New

68. Etoricoxib -- 13.88 New

69. Sitagliptin Phosphate Monohydrate -- 33.33 New

70. Sitagliptin L-Tartrate Hymihydrate -- 33.33 New

71. Tenofovir Alafenamide Hemifumarate -- 83.33 New

72. Piribedil -- 33.33 New

Sl. No.

Product name Existing (kg/day)

Proposed (kg/day)

Status of the product

73. Mexiletine Hydrochloride -- 16.67 New

74. Telmisartan -- 55.55 New

75. 2,2'-(9,10-anthracenediylidene)bis (2-cyano-1,1'-dibutyl ester) acetic acid

-- 33.33 New

76.

(2R,3R,3aR,9aR)-2,3,3a,9a-Tetrahydro-3-hydroxy-2-(hydroxymethyl)-7-methyl-6H-furo[2',3':4,5]oxazolo[3,2-a]pyrimidin-6-one

-- 5.55 New

77. Dantron -- 4.17 New

Total Production Capacity 6000.0

(10 products at a time)

6601.0 (18 products

at a time)

The total production capacity of the proposed expansion (Maximum any 18 products at a time) is 6601.0 kg/day.

Sl. No.

Product name Starting Raw Material

Quantity of Starting Raw

material (kg/day)

Number of stages manufact

ured

1.

2-(2,3-dichlorophenyl)-2-phenyl methylene hydrazine carboximidamidine

2,3-Dichlorobenzoyl chloride 365.22 2

2.

2-amino methyl-7-chloro-2,3-dihydro-5-(2-florophenyl)1H-1,4-benxodiazepine dimaleate

2-amino-5-chloro-2-floro benzophenone

48.22 4

3. Drotaverine Hydrochloride 3,4-diethoxybenzyl cyanide 461.67 5

4. Entacapone 3-methoxy-4-hydroxy-5-nitro

benzaldehyde 177.77 3

5. Fexofenadine Hydrochloride

Methyl-4(4-chloro-1-oxobutyl) 2,2-dimethylphenyl acetate

75.61 3

6. Lamotrigine 2,3-Dichloro benzoyl chloride 1521.73 3

7. Mebeverine Hydrochloride N-ethyl-1-(4-methoxyphenyl)

propan-2-amine 542.63 1

8. Tamsulosin Hydrochloride 4-Methoxyphenyl acetate 0.62 5

9. Midazolam Hydrochloride 2-aminomethyl-7-chloro-2,3-

dihydro-5-(2-fluorophenyl)-1H-1,4-benzodiazepine

11.87 4

10. Fomepizole 1,1-Diethoxy propane 4.76 4

11. Hydralazine Hydrochloride 1(2H)-Phthalazinone 71.56 3

12. Metaxalone 3-(3',5'-Dimethylphenoxy)-1,2-

propane diol 129.62 2

13. Meclizine Hydrochloride m-Xylene 131.0 8

14. Itraconazole 4-[4-[(4-Methoxy phenyl)-1-

piperazinyl]-2,4-dihydro-2-(1-methyl propyl)-3H-1,2,4-trizole

55.55 3

15. Levocetirizine Dihydrochloride

4-Chloro benzhydryl piperazine 39.21 5

16. Tilidine Hydrochloride Phenyl acetic acid 34.19 6

17. Agomelatine 2-(2-methoxynaphhalen-8-yl)

acetonitrile 25.25 3

18. Posaconazole

2-((2R,3S)-2-(benzyloxy)pentan-3-yl)-4-(4-(4-(4-

hydroxyphenyl)piperazin-1-yl)phenyl)-2H-1,2,4-triazol-3(4H)-

one

24.51 2

19. Articaine Hydrochloride 2-bromo propionic acid 69.44 2

20. Dipyridamole 2,6-dichloro-4,8-dipiperidino-pyrimido-(4,5-d) pyrimidine

462.97 2

21. Ractopamine Hydrochloride

Octopamine Hydrochloride 572.91 1

22. Venlafaxine Hydrochloride 4-Methoxy phenyl acetonitrile 25.0 3

Sl. No.

Product name Starting Raw Material

Quantity of Starting Raw

material (kg/day)

Number of stages manufact

ured

23. Benserazide Hydrochloride

DL-Serine 26.88 4

24. Doxazosin Mesylate 1-[(2,3-Dihydro-1,4-benzodioxan-

2-yl) carbonyl] piperazine 31.75 2

25. Epinastine Hydrochloride 6-Amino methyl-6,11-dihydro-5H dibenzo [b, e] azepine fumarate

50.0 2

26. Zilpaterol Hydrochloride 8,9-dihydro-2,9a-

diazabenzo[cd]azulene-1,6(2H,7H)-dione

110.0 4

27. Tolterodine Tartrate N,N-diisopropyl-3-(2-methoxy-5-methyl phenyl)-3-phenylpropane

-1-amine Fumarate 34.72 3

28. Tolcapone 3,4-dihydroxy-5-nitro

benzaldehyde 23.15 3

29. Flurbiprofen 4-bromo-2-fluorobiphenyl 91.8 1

30. Diflunisal 4-(2,4-difluorophenyl) phenyl

acetate 40.0 3

31. Baclofen 3-(P-Chlorophenyl)-glutaric acid 72.23 2

32. Brivudine 5-Ethyl uracil 7.3 5

33. Oxolamine Citrate Oxolamine base 534.72 2

34. Zaltoprofen 2-Chloro phenyl acetic acid 13.89 5

35. Zonisamide Sodium-1,2-benzisoxazole-3-

methane sulfonate 55.55 1

36. Tianeptine Sodium 3,11-dichloro-6-methyl-6,11-

dihydrobenzo[c,f][1,2] thiazepine 5,5-dioxide

17.78 2

37. Solastay S1 4-Methoxybenzophenone 112.61 2

38. Verapamil Hydrochloride N-Methyl Homoveratrylamine 62.65 2

39. Tapentadol Hydrochloride 3-Methoxy Propiophenone 6.66 4

40. Ferric Citrate Ferric chloride hexahydrate 6.94 1

41. Tapentadol Dihydrogen Phosphate

3-Hydroxypropiophenone 33.33 5

42. Dabigatran Etexilate Mesylate

Ethyl-3-[(4-methylamino-3-amino-benzoyl)-pyridin-2-yl-

amino]-propanoate 9.01 4

43. Propiomazine Maleate Phenothiazine 2.64 3

44. Oxolamine Phosphate Oxolamine citrate 25.65 1

45. Losartan Potassium 2-Cyano 4-methyl biphenyl 19.56 3

46. Celecoxib 4,4,4,-Trifluoro 1-(4-

Methylphenyl) butane-1,3- dione 126.22 1

47. Dolutegravir Methyl 4-chloroacetoatetate 53.57 5

48. Vanillylamine Hydrochloride

Vanillin 27.78 2

49. Dorzolamide Hydrochloride

6-Methyl-4-oxo-5,6-dihydro-4H-thieno [2,3-b] thiopyran-2-

sulfonamide 9.41 4

50. Irbesartan 2-N-butyl-1,3-diazaspir[4.4]non-

1-en-4-one hydrochloride 63.79 2

51. Pantoprazole Sodium 5-(Difluoro methoxy) -1-H-

benzimidazole-2-thiol 15.6 3

52. Phloroglucinol 2,6-Dichloro phenol 154.3 2

53. Trimethyl Phloroglucinol 2,6-Dichloro phenol 69.42 2

54. Abacavir Sulfate N-(2-Amino-4,6-dichloro-pyrimidinyl) formamide

50.5 2

55. Darunavir Ethanolate (2S,3S)-1,2-Epoxy-3-(Boc-

amino)-4-phenylbutane 45.45 4

56. Etoricoxib 2-(4-methanesulfonyl phenyl)-1-(6-methylpyridin-3-yl) ethane-1-

one 19.66 2

57. Sitagliptin Phosphate Monohydrate

2-(2,4,5-Trifluorophenyl) acetic acid

33.33 4

58. Sitagliptin L-Tartrate 2-(2,4,5-Trifluorophenyl) acetic 33.33 4

Sl. No.

Product name Starting Raw Material

Quantity of Starting Raw

material (kg/day)

Number of stages manufact

ured

Hymihydrate acid

59. Tenofovir Alafenamide Hemifumarate

(R)-9-[(2-phosphonylmethoxy) propyl] adenine hydrate

111.11 3

60. Piribedil Piperonyl alcohol 30.3 3

61. Mexiletine Hydrochloride 2,6-Xylenol 16.67 2

62. Telmisartan (4-methylbiphenyl -2-carboxylic

acid methyl ester) 37.03 2

63.

2,2'-(9,10-anthracenediylidene)bis (2-cyano-1,1'-dibutyl ester) acetic acid

Anthraquinone 16.65 1

64.

(2R,3R,3aR,9aR)-2,3,3a,9a-Tetrahydro-3-hydroxy-2-(hydroxymethyl)-7-methyl-6H-furo[2',3':4,5]oxazolo[3,2-a]pyrimidin-6-one

5-Methyluridine 9.91 2

65. Dantron 1,8-Dinitroantharaquinone 10.02 2

06) Water consumption:

Source of Water supply : Bore wells

SI. No.

Purpose

Existing Quantity as per CFO dt.

10.08.2016 (KLD)

CFE dt. 22.02.2018 (for addl. 16 TPH

Boiler) (KLD)

After change of product mix (KLD)

1. Process 43.0 43.0 72.0

2. Equipment Washings

5.0 5.0

5

3. Floor Washings 6.0 6.0 6.0

4. Boiler feed & Cooling make up

85.0 155.0

(Fresh Water – 90.0 Recycled – 65.0)

155.0 (Fresh Water – 53.0 Recycled – 102.0)

5. DM Plant regeneration

7.0 7.0

7.0

6. Domestic, Canteen & Gardening

30.0 30.0

(Fresh Water – 15.0 Recycled – 15.0)

30.0 (Fresh Water – 15.0

Recycled – 15.0)

Total 176.0 246.0

(Fresh water-166.0 & Recycled – 80.0)

275.0 (Fresh Water – 158.0

Recycled – 117.0)

Out of 275 KLD of water requirement, the industry proposes to recycle the 117 KLD of treated waste water after treatment and 158 KLD of fresh water. The proposed fresh water requirement of 158 KLD is less than the permitted water consumption of 176 KLD as per EC.

07) Waste Water Generation:

SI. No.

Source

Existing Quantity as per CFO dt.

10.08.2016 (KLD)

CFE dt. 22.02.2018 (for addl. 16 TPH

Boiler) (KLD)

After change of product

mix (KLD)

1. Process effluent 57.0 57.0 83.96

2. Equipment washings 5.0 5.0 5.0

3. Floor washings 6.0 6.0 6.0

4. Boiler blow down & Cooling tower bleed

10.0 15.0 15.0

5. DM Plant washings 6.0 6.0 6.0

6. Domestic & Canteen 13.0 13.0 13.0

Total 97.0 102.0 128.96

Out of 128.96 KLD of waste water generation , the industry proposes to recycle the 117 KLD of treated waste water after treatment. The waste water generation – 129.96 KLD is less than the permitted waste water generation of 142 KLD as per EC order 19-08-2003 for the proposed change of product mix.

ETP Details & Mode of Disposal after CPM:

Source of effluent Treatment Mode of final disposal

Combined Process effluents (High TDS & LTDS), and DM plant back wash are pretreated in ETP consisting of the following units:

Effluent Collection tanks 2nos, Total capacity 50Kl Effluent Neutralization tanks 2 nos, Capacity: 20KL ( Each 10KL) Filter Press 1 No Effluent Passing Bed : 10 KL Neturaziled effluent Holding Tanks 3 Nos, Capacity Total 90 KL( 40 KL+20KL+30KL)

The pretreated effluent is sent to Stripper followed by MEE. The MEE condensate along with boiler blow down / cooling tower blow down and ATFD condensate are sent Biological treatment followed by RO Plant. The RO permeate is used for cooling tower make up. RO Reject is sent to MEE along with process effluent. The MEE concentrate is sent to ATFD. The ATFD salts will be disposed to TSDF.

Boiler blow down, Cooling tower bleed & Washings

Collection tank of 7 KL capacity.

Sent to Biological treatment followed by RO Plant.

Domestic The industry proposed to provide 30 KLD STP to treat the domestic waste water 13 KLD.

The industry is in the process of construction of STP to treat domestic waste water. After treatment the domestic waste water will be utilized for on-land for gardening.

08) Hazardous / Solid Waste details:

Sl. No.

Name of the Waste Existing as per

CFO order dt.10.08.2016

After change of product mix

Disposal Method

1. Insoluble Solids (Inorganic) (kg/day)

295.85 977.87 To TSDF

2. Salts from MEE (kg/day)

2536.7 3676.6

3. Process Organic Residue (kg/day)

1459.39 2119.91 TSDF for incineration/ Authorized cement plants for co-processing.

4. Spent Carbon (kg/day) 95.74 151.97

5. Spent Nickel (kg/day) 60.93 92.9 To Supplier / Manufacturer 6.

Spent Palladium Carbon (kg/day)

63.33 46.9

7. Cuprous Chloride (kg/day)

459.0 644.91 Sent to Supplier for regeneration

8. Dilute Sulfuric acid (kg/day)

1360.37 Kg/day 2448.7 Kg/day Sent to Cement industries/Authorised agencies

9. Spent HCl (kg/day) -- 0.73 To Authorised agencies

10. Waste oil from DG set (LPA)

700 700 Authorised Re-processors / Recyclers

11. Detoxified Containers & Container Liners (Nos./Annum)

2500

5000

After complete detoxification, shall be disposed off to outside agencies

12. Used Lead Acid Batteries (Nos./Annum)

5 5 Sent back to suppliers on buy back basis

13. Spent Mixed Solvents (KLD)

-- 3

Shall send to authorised agency for recovery / authorized Cement industries for co-processing

14. Insulation Waste (TPA) -- 5 To TSDF

15. Bio medical waste from OHC (kg/month)

-- 2 To Authorised Bio medical waste treatment facility

16. Boiler Ash (Non-Haz) (TPD)

9 20 Send to Brick Manufacturers

After change of product mix, the hazardous waste generation details viz., Insoluble sludge – 977.87 kgs/day (as per EC permitted quantity 1100 kgs/day), Soluble sludge - 2119.91 kgs/day (as per EC permitted quantity 3200 kgs/day), spent nickel - 92.9 kgs/day (as per EC permitted quantity 41 kgs/day), totaling 3190.68 kgs/day (as per EC permitted total quantity 4341 kgs/day). As per the EMP report of the change of product mix, no iron sludge generation was mentioned whereas as per EC iron sludge generation was 200 kgs/day. In addition to the solid waste mentioned in the EC, the Board permitted the industry to generate MEE salts – 2536.7 kgs/day, Spent carbon – 95.74 kgs/day, Dilute Sulfuric acid – 1360.37 kgs/day, Spent Palladium Carbon – 63.33 kgs/day, cuprous chloride – 459 kgs/day in the CFO order dt.10.08.2016. In addition to the solid waste mentioned in the EC, the proposed change of product mix the hazardous waste generation details i.e., MEE salts –3676.6 kgs/day (permitted quantity as per CFO order – 2536.7 kgs/day), Spent carbon – 151.97 kgs/day (permitted quantity as per CFO order – 95.74 kgs/day), Dilute Sulfuric acid – 2448.7 kgs/day (permitted quantity as per CFO order – 1360.37 kgs/day), Spent Palladium Carbon – 46.9 kgs/day (permitted quantity as per CFO order –63.33 kgs/day), Cuprous chloride – 644 kgs/day (permitted quantity as per CFO order – 459 kgs/day) totaling 6968.17 kgs/day (total permitted quantity as per CFO order – 4515.14 kgs/day). In addition change of product mix also generates spent HCL – 0.73 kgs/day, spent mixed solvents – 3 KLD, insulation waste – 5 TPA and Bio medical waste from OHC – 2 kgs/month. As compared with the hazardous waste generation quantity with respect to CFO order, the proposed change of product mix hazardous waste generation quantity is exceeding i.e., 1302.71 kgs/day. This may be examined.

09) Air pollution:

Existing: Existing 10 TPH & 4 TPH (Standby) Coal fired Boilers. Industry proposed 16 TPH Coal fired boiler. They obtained the CFE vide order number 298/APPCB/CFE/RO-VJA/HO/2012, dated 22.02.2018. Boilers connected with Multi cyclone separator followed by Bag filter with 31m of stack height for control of dust emissions. Existing 2 Lakh K.cal Thermic fluid heater. The industry not installed 16 TPH coal fired boiler till date. Existing 2 Nos. of 500 KVA & 1 No. of 1000 KVA D.G. Sets and proposed to remove existing 2 Nos. of 500 KVA D.G.sets. D.G.sets are used for standby power supply in case of power supply failure.

Sl. No

Details of Stack Stack 1 Stack 2 Stack 3 Stack 4

Stack 5 Stack 5

a) Attached to Boiler Boiler Boiler Thermic fluid

heater

DG set DG set

b) Capacity 10 TPH 4 TPH (Standb

y)

16 TPH Not yet installed

2 lakhs k.cal.

1010 KVA 2x500 KVA

c) Name of the Fuel Coal Coal Coal Coal HSD HSD

d) Stack height above ground (m.)

31 31 31 31 5 5

e) Air Pollution Control Equipment

Multi cyclone separator followed by Bag filter.

Acoustic silencer

Acoustic silencer

Proposed: Industry proposed to install 1010 KVA and 125 KVA D.G. Sets

10) Compliance status of conditions stipulated in Schedule B of CFO order dt. 10.08.2016:

S.No. Specific Condition Compliance

SCHEDULE –B

Water Pollution

3 The industry shall segregate the effluents and treat the same as per the CFE order.

Not Complied. The industry not segregating the effluents into LTDS & HTDS. The industry treating the unsegregated effluents.

4 The existing ZLD system consisting of Stripper, MEE, ATFD, RO system and Biological Effluent Treatment Plant shall be operated regularly. All the units of the ZLD system shall be impervious and shall be above the ground level. The industry shall maintain zero liquid discharge.

Partially complied. The industry is having stripper (3500 lts/hr), MEE (305 kl/hr) & ATFD (400 ltrs/hr). Industry has provided aeration and not provided sludge removal facility / filter press after aeration tank. The industry representative informed that they are stopping the aeration system for removal of sludge. This may be reviewed. The industry is having aeration followed by RO system as Biological Treatment. During inspection aeration and RO plant are in operation.

8 The industry shall provide continuous online VOC monitoring system with auto recording facility.

Not complied. The industry is not having continuous online VOCs monitoring system. The industry is having portable VOC Measuring device.

17 The industry shall sort out the technical issues and connect the web camera to the websites within one month.

Not complied. The industry has provided digital flow meter with totalizer facility at stripper inlet and also provided web camera focusing the digital flow meter. As per CPCB instructions the industry has to provide digital flow meter with totalizer facility for RO permeate and shall provide web camera for real time monitoring of RO permeate utilization. The industry may be directed to provide flow meter with totalizer facility at RO permeate collection tank and shall change the location of the web camera for real time monitoring of the RO permeate utilization.

18 The industry shall comply with the conditions mentioned in the CFE order dt. 27.06.2016.

The industry is still in the process of establishment of biological ETP, not provided VOC meter with auto recording facility. Not provided auto recording facility for on-line pH measuring, not provided digital flow meters with totalized facility at stripper outlet, at plant inlet, stripper outlet, MEE inlet, MEE concentrate, RO feed and RO reject.

20 The industry install online monitoring systems and connect monitoring system to APPCB/CPCB websites as per CPCB directions dated 05.02.2014 & 02.03.2015 and guidelines issued regarding online monitoring systems from time to time.

The industry has provided digital flow meter with totalizer facility at stripper inlet and also provided web camera focusing the digital flow meter. As per CPCB instructions, the industry has to provide digital flow meter with totalizer facility for RO permeate and shall provide web camera for real time monitoring of RO permeate utilization. The industry may be directed to provide flow meter with totalizer facility at RO permeate collection tank and shall change the location of the web camera for real time monitoring of the RO permeate utilization.

23 The industry shall submit compliance report on the conditions mentioned in the consent order every six months to the Regional Office/ Zonal Office.

Not Complied. The industry not submitting the 6 monthly compliance status report.

11) Compliance status of directions stipulated in Task Force order dt. 13.06.2019:

S.No Conditions Compliance

1 The industry shall intimate the details of trail test for R&D works to concerned authority.

Complied. The industry submitted R&D trail braches proposed to carry out in the industry premises. The details are as follows:

S.No. Name of the product

1 Dantran

2 Micah

3 Ferric citrate

4 EMC

5 R+Octabase

6 Propiomazine maleate

7 Chlorophenesin

8 Tapentado HCL, Tapentadol Dihydrogen Phosphate

9 TK-112690

10 Rabiprazole sodium

11 Vanillylamien HCL

12 Mida Advanced Intermediate

13 Fexo Methyl Ester

14 Oxolamine Phosphate

15 Desvenlafaxine succinate

16 Oxybutynin

17 Levodopa

18 Hydrochlorothiazide

19 Vildagliptin

20 Verapamil HCL

21 Debigatran Etexilate Mesylate

22 Telmisartan

23 Losartan Potassium

24 TKI

The industry carried out R&D trail batches for the following products for the period from June, 2018 to March, 2019. The industry produced the following products without CFE/CFO of the Board.

Month Name of the product Quantity (kgs)

June, 18 Ferric citrate 36

June, 18 Mida Advanced Intermediate

48.1

June, 18 Propiomazine maleate 29.9

Aug, 18 Vanillylamien HCL 59.7

Dec, 18 Dantran 25.8

Mar, 19 EMC 25

Mar, 19 Tapentadol 48.3

2 The industry shall complete the installation of Biological Effluent Treatment Plant within one month.

Partially complied. Industry has provided aeration and not provided sludge removal facility / filter press after aeration tank. The industry representative informed that they are stopping the aeration system for removal of sludge. This may be reviewed. The industry is having aeration followed by RO system as Biological Treatment. During inspection aeration and RO plant are in operation.

3 The industry shall provide continuous VOC monitoring system with auto recording facility within one month.

The industry is still in the process of establishment of biological ETP, not provided VOC meter with auto recording facility. Not provided auto recording facility for on-line pH measuring, not provided digital flow meters with totalized facility at stripper outlet, at plant inlet, stripper outlet, MEE inlet, MEE concentrate, RO feed and RO reject.

4 The industry shall immediately lift the Hazardous Waste

During inspection the following hazardous waste stored in the industry premises in a secured closed shed:

present in the premises to TSDF, Parawada for safe disposal. Before lifting of Hazardous Waste, the characteristics of Hazardous waste shall be carried out and kept the records.

Hazardous waste Quantity (in tons)

Mixed salts (MEE salts & insoluble salts)

19.948

Insoluble solids (in organic)

18.155

Spent carbon 6.408

Organic residue 16.585

Diluted sulphuric acid

7.185

Cuprous chloride 1.639

Spent Palladium Carbon 10%

0

Spent Nickle 5.05

Total 74.97

The hazardous waste disposal for the period from Jan 2019 to June 2019 is as follows:

Month

Hazardous waste (in tons)

Mixed salts

Insoluble solids

Sent carbon

Organic residue

Diluted sulphuric acid

Cuprous chloride

Jan, 19

19.91 7.64 0 0 27.16 0

Feb, 19

28.94 8.97 0 0 23.11 0

March, 19

31.47 0 0 0 26.63 18.3

April, 19

49.02 0 15.15

0 27.02 0

May, 19

41.04 0 0 19.5

27.74 0

June, 19

25.00 0 0 40.1

25.95 20.95

Total 195.38

16.61

15.15

59.6

157.61

39.25

Month Hazardous waste (in tons)

Spent Palladium Carbon 10%

Spent Nickle

Jan, 19 135.5 0

Feb, 19 64 0

March, 19 38 0

April, 19 35 88.15

May, 19 48 0

June, 19 56 0

Total 376.5 88.15

As per the above it is ascertained that the industry not disposing the hazardous waste within 90 days and not complied with the hazardous and other wastes (management and transboundary movement) rules, 2016.

12) Recommendations of the Regional Officer:

a) M/s. RA Chem Pharma Ltd is located at R.S.No.50/1, Mukteswarapuram (V), Jaggaiahpet (M), Krishna Dist involved in the manufacturing of Bulk drugs and intermediates.

b) Earlier, the industry was being operated with name and style of M/s IGOR Pharmachem Pvt Ltd and obtained EC from MOE&F, New Delhi, Dt.19.08.2003 for manufacturing of

Folic acid – 255 kgs/day, Trichloro Acetone – 4325 kgs/day, Butyl Cyano Acetate – 421 kgs/day, Tri amino Pyrlmidine Sulphate – 800 kgs/day and Para Amino Benyoyl Glutamic Acid – 800 kgs/day totaling 6601 kgs/day.

c) As per EC order, the total area of the project 6.688 acres. The total water requirement is 176 KLD. The total waste water generation is 142 KLD.

d) As per EC no further expansion are modification in the plant should be carried out without prior approval of the Ministry of Environment Forest. In case of deviations or alteration in the project proponent from those submitted to the Ministry for clearance, the fresh reference should be made to the Ministry to assess the adequacy of conditions imposed and to add additional environmental protection measures required, if any.

e) As per EC order, the hazardous waste generation and disposal details is as follows:

S.no Name of the hazardous waste

Quantity Disposal

1 Insoluble sludge 1100 kgs/day Cement Industries

2 iron sludge 200 kgs/day

3 Soluble sludge 3206 kgs/day M/s. Hyderabad waste management project, (TSDF) Secured land fill.

4 spent nickel 41 kgs/day Authorized reprocessors.

Total 4547 kgs/day

f) M/s IGOR Pharmachem Pvt Ltd had obtained CFE of the Board vide Order Dt. 09.10.1999 for manufacturing of 6 nos of products and obtained Environmental Clearance (EC) vide EC Order Dt 19.08.2003. Later the industry obtained CFE for Change of product mix Of the Board on 21.08.2004 for 14 nos of products .The industry further obtained CFE of the Board for Change of product mix vide CFE Order Dt. 26.03.2011 & 29.11.2014 for 24 nos of products. Further industry obtained CFE for expansion products CFE order dated 27.06.2016 for 48 products. The Board issued CFO to the industry which is valid upto 30.09.2021 for manufacturing of the 48 nos. of API’s and Intermediates.

g) Now, the industry applied for Change of Product Mix with no change in pollution load in water and air. However, the industry mentioned the project cost of the industry as Rs.80.32 crores on 21-07-2016. Now, as per the gross value of fixed assets as on 31-03-2019 is Rs. 98.67 crores. Hence, industry has paid balance CFE fee of Rs.1,20,000/- for the enhanced project cost. The representative of the industry informed that the enhanced project cost of Rs.18.35 crores is due to installation of ZLD system and biological ETP. In the present proposal the industry proposed to drop the existing 12 nos products, retain 36 nos of products and to add 28 new drugs making a total of 64 nos of products with a total production capacity of 6601 Kgs/day, whereas the total production capacity of the existing products as per the CFO is 6000.0 Kgs/Day.

h) In the proposed expansion the industry has not proposed any additional boiler, ETP, ZLD System, Solvent recovery unit and proposed to install 1010 KVA and 125 KVA D.G.sets only. The industry proposes to utilize remaining existing systems.

i) The details of the proposed change of product mix is as follows:

i) as per EMP report, the industry proposed to produce 64 no of products on campaign basis with 18 products at a time to produce maximum capacity of 6601 kgs/day as against the permitted capacity of EC order dt.19-08-2003 i.e., 6601 kg/day.

ii) 72 KLD of water for process, 5 KLD of water for equipment washings, 6 KLD for floor washings, 155 KLD for boiler feed and cooling make up (out of which fresh water is 53 KLD and recycled water – 102 KLD, 7 KLD for DM plant regeneration and 30 KLD for domestic, canteen and gardening (fresh water 15 KLD and recycled water 15 KLD) totaling 275 KLD (out of which fresh water consumption - 158 KLD and recycled water – 117 KLD). The proposed fresh water requirement of 158 KLD which is less than the permitted water consumption of 176 KLD as per EC order dt.19-08-2003.

iii) 83.96 KLD from process, 5 KLD from equipment washings, 6 KLD from floor

washings, 15 KLD from boiler blow down and cooling tower bleed off, 6 KLD from DM plant washings and 13 KLD from domestic and canteen waste water totaling 128.96

KLD which is less than the permitted waste water generation of 142 KLD as per EC order dt.19-08-2003.

iv) After change of product mix, the hazardous waste generation details viz., Insoluble

sludge – 977.87 kgs/day (as per EC permitted quantity 1100 kgs/day), Soluble sludge - 2119.91 kgs/day (as per EC permitted quantity 3200 kgs/day), spent nickel - 92.9 kgs/day (as per EC permitted quantity 41 kgs/day), totaling 3190.68 kgs/day (as per EC permitted total quantity 4341 kgs/day). As per the EMP report of the change of product mix, no iron sludge generation was mentioned whereas as per EC iron sludge generation was 200 kgs/day.

In addition to the solid waste mentioned in the EC, the Board permitted the industry to generate MEE salts – 2536.7 kgs/day, Spent carbon – 95.74 kgs/day, Dilute Sulfuric acid – 1360.37 kgs/day, Spent Palladium Carbon – 63.33 kgs/day, cuprous chloride – 459 kgs/day in the CFO order dt.10.08.2016.

In addition to the solid waste mentioned in the EC, the proposed change of product mix the hazardous waste generation details i.e., MEE salts –3676.6 kgs/day (permitted quantity as per CFO order – 2536.7 kgs/day), Spent carbon – 151.97 kgs/day (permitted quantity as per CFO order – 95.74 kgs/day), Dilute Sulfuric acid – 2448.7 kgs/day (permitted quantity as per CFO order – 1360.37 kgs/day), Spent Palladium Carbon – 46.9 kgs/day (permitted quantity as per CFO order –63.33 kgs/day), Cuprous chloride – 644 kgs/day (permitted quantity as per CFO order – 459 kgs/day) totaling 6968.17 kgs/day (total permitted quantity as per CFO order – 4515.14 kgs/day). In addition change of product mix also generates spent HCL – 0.73 kgs/day, spent mixed solvents – 3 KLD, insulation waste – 5 TPA and Bio medical waste from OHC – 2 kgs/month. As compared with the hazardous waste generation quantity with respect to CFO order, the proposed change of product mix hazardous waste generation quantity is exceeding i.e., 1302.71 kgs/day. This may be examined.

j) The industry is having valid PLI Policy valid upto 31/03/2020.

k) The non-compliances observed in the existing industry is as follows:

i) The industry not segregating the effluents into LTDS & HTDS. The industry treating the un-segregated effluents.

ii) Industry has provided aeration and not provided sludge removal facility / filter press after aeration tank. The industry representative informed that they are stopping the aeration system for removal of sludge. This may be reviewed.

iii) The industry is not provided continuous online VOCs monitoring system. The industry is having only potable VOC Measuring device.

iv) As per CPCB instructions, the industry has to provide digital flow meter with totalizer facility for RO permeate and shall change the location of the web camera for real time monitoring of RO permeate utilization.

v) Not provided auto recording facility for on-line pH measuring, not provided digital flow meters with totalized facility at stripper outlet, at plant inlet, stripper outlet, MEE inlet, MEE concentrate, RO feed and RO reject.

vi) Carried out R&D and produced 7 products (Ferric citrate, Mida Advanced Intermediate, Propiomazine maleate, Vanillylamien HCL, Dantran, EMC and Tapentadol without CFE & CFO of the Board.

vii) The industry is having 3 no of solvent recovery units viz., 3 kl/hr and 2x7 kl/hr. the industry not provided i) the vent of the condenser at least 6 meters above the roof top, ii) not provided condenser facility for vent of all solvent storage tanks (spent solvent and recovered solvent), iii) not provided VOC absorption media like activated carbon attached to vent of the condenser and shall comply with process vent emission standard of total organic carbon (TOC) ≤ 20 ppm, iv) not provided TOC analyzer for stack attached to vent of the condenser and online emission data shall be connected to the server of the APPCB website.

l) The industry in the process of construction of 30 KLD STP to treat the domestic waste water. Industry may be directed for early construction and commencement of STP.

The industry may be called for personal presentation to review the above observations for issuing the CFE for change of product mix. CFE for change of product mix may be considered after taking specific commitment on the above and also after thorough verification of treated waste water utilization , the hazardous waste generation quantity is exceeding the permitted quantity mentioned in the CFO order dt. 10.08.2016 and also exceeding the permitted quantities mentioned in the EC order dt.19.08.2003.

13) Head Office Remarks:

a) The industry has to comply with several conditions as mentioned above.

b) The industry has produced 7 un-consented products. c) The Board reviewed the status of the industry and issued directions vide order dt.

13.06.2019. d) The quantity of Hazardous waste is increasing after change of product mix. Hence,

the industry has to restrict the Hazardous quantity to the quantity permitted in CFO. e) The industry vide mail dt. 05.08.2019 requested to include one more product viz.,

Dantron – 4.17 kg/day in addition to 64 products already submitted. 18 products will be manufactured at any point of time even after inclusion of above product.

The item is placed before the CFE Committee for taking a decision.