PRE-FEASIBILITY REPORT FOR TERMS OF REFERENCES

Size: px
Start display at page:

Download "PRE-FEASIBILITY REPORT FOR TERMS OF REFERENCES"

Transcription

1 PRE-FEASIBILITY REPORT FOR TERMS OF REFERENCES October, 2016 SRI KRISHNA PHARMACEUTICALS LIMITED PLOT NO. F-1, MIDC CHINCHOLI, TALUKA- MOHOL, SOLAPUR DISTRICT MAHARASTRA Studies & Documentation By M/S Pridhvi Enviro Tech pvt. Ltd Submitted by (MoE&F O.M S.NO: 122, rev 46, dated ) Sri Krishna pharmaceuticals Ltd, 184/C, Lawn House Plot No. F-1 Vengal Rao Nagar MIDC, Chincholi Hyderabad Taluka Mohol Ph: Solapur (D) Fax: Maharastra SUBMITTED TO MINISTRY OF ENVIRONMENT & FORESTS, GOI PARYAVARAN BHAWAN, CGO COMPLEX, LODHI ROAD, NEW DELHI

2 S.No. Description CONTENTS Page No. 1 Introduction 1 2 Introduction of the project 2 Introduction of the company and the proponent 3 Project Description Production Capacity Manufacturing Process Raw materials Water Requirement Waste generation and control systems Liquid effluents Solid waste management 9 4 Site Analysis Plant location 10 5 Planning in Brief 16 6 Resource requirement Power requirement and Supply/ Source Production facilities, Utilities and effluent handling facilities 6.3 Land requirement 17 7 Air pollution 18 8 Bulk chemical storage 18 9 Base line data studies Project financial

3 LIST OF TABLES Table No. Description Page No. 1.0 Salient Features of the Project List of Proposed Products Water Balance Proposed Solid Waste and Disposal Utilities /ETP-Proposed Land Statement Emission Source Proposed Storage facilities of bulk chemicals 18 LIST OF FIGURES Fig No Description Page No. 1.1 Schematic treatment scheme of high 7 TDS effluents 1.2 Low TDS Effluent Treatment System Topo Map of the Study Area Base Map of the Study Area Photographs of current condition of the 14 site 1.6 Site layout plan 15 LIST OF ANNEXURES Annexure I II Description Typical Technical details of proposed products List of Raw materials

4 1. Introduction Sri Krishna Pharmaceuticals Ltd., engaged in manufacturing of Active Pharmaceutical Ingredients, and Intermediates was established in the year Research and Development forms the backbone of the organization with state of the art instrumentation facilities. They have Five manufacturing sites in India four in Telangana manufacturing bulk drugs & formulations and one in Maharastra manufacturing Drug intermediates. Sri Krishna Pharmaceuticals limited proposed to establish a new unit at Plot. No. F-1, MIDC, Chincholi, Taluka-Mohol, Sholapur District, Maharastra state. The unit obtained TOR for the proposed unit from SEAC, Maharastra and submitted draft EIA Report based on Model TOR s on April 5 th The proposed unit is located in Notified industrial Area, MIDC, Chincholi, As the unit is within 5 KM from the proposed eco sensitive zone of the Nanaj Sanctuary Great Indian Bustard sanctuary. In the year 2014, Hon. Supreme Court had given directions to all State Govts. to finalize the ESZs for all the PAs coming under them. Further, directions were given by Hon. Supreme Court that in absence of finalized ESZ or for a period till the ESZ gets finalized, a distance of 10 Km from the boundary of PA would be treated as ESZ. Under such circumstances, as per the provisions in MoEF notification dated , any project in Cat. B coming in ESZ of a Protected Area would be treated as Cat. A and hence the State Level EIA Authority rejected the case and advised the company to approach MOEF in Delhi for the clearance 1

5 Hence this application is made for obtaining fresh TOR. As the unit is located in IE, Chincholi which is notified industrial area established prior to 2006 notification, Public hearing may be exempted for this unit. In order to meet the market demand it is now proposed to manufacture 6 API s with a production capacity of 2545 TPM. 2. Introduction of the Project The proposed unit is to manufacture Bulk Drugs (APIs) to a tune of 1250 TPA. The salient features of the project are described in the table given below TABLE 1.0 Salient Features of the Project Location F-1, MIDC Chincholi (V), Mohol (Taluk), Solapur (district), Maharashtra Longitude and Latitude Product Category Project Category as per EIA notification Proposed Activity Total investment on the plant Rs. 125 Crores Total Investment on Rs. 8 Crores Environmental Infrastructure Total area of the plant 25.0 Acres Total area of green belt 9.3 Acres Water requirement 17 o N 75 o E 17 o N 75 o E 17 o N 75 o E 17 o N 75 o E 5(F) Bulk Drugs & Intermediates Category A (located within 5 Km distance from the proposed ESZ of GIB Nanaj Sanctuary) Drugs & Drug intermediates TPM Total water requirement for project will be 1430 KLD. Fresh water requirement- 973 KLD Recycled water- 457 KLD Source of water MIDC, Chincholi. Nearest habitation and Chincholi Village-0.97 Km from the site (S) distance from the site Nearest surface water bodies Nanaj Odha is at a distance of 0.83 km from the site Nearest reserve forest There are no reserve forests in 10 km radius from the site Environmentally sensitive None 2

6 areas within 10 km radius Any national parks, wild life sanctuaries within 10 km radius GIB Nanaj Sanctuary is at a distance of 7.68 Kms from the site. Proposed ESZ of GIB Nanaj Sanctuary Kms Nearest air port and distance Solapur Airport km Nearest railway station and Pakni Railway Station-5.76 km distance National Highway NH 9 is at a distance of 3.1 Km from the site i) Introduction of the company and proponent Sri Krishna Pharmaceuticals Ltd., engaged in manufacture, custom manufacturing of Active Pharmaceutical Ingredients, and Intermediates was established in the year Research and Development forms the backbone of the organization with state of the art instrumentation facilities. They have four manufacturing sites in India with a cumulative monthly production capacity of 200 TPM of chemical entities (APIs and APIs formulations about 710 TPM). Sri Krishna have handled a wide spectrum of chemical unit processes significantly being plant scale column chromatography, carbohydrate chemistry, natural product extraction and other complex synthetic chemical reactions for high purity compounds. The company recognized the vital role of R & D for becoming successful in the generic market. The proposed project under consideration would be located at Plot No. F-1, MIDC, Chincholi, Taluka -Mohol, Dist. Solapur, State Maharashtra. state. The company has Headquarter in Hyderabad, India, and is catering to the ever growing demand of Active Pharmaceutical Ingredients (API s) from single Stateof-the-art manufacturing facility. Already established unit in Chincholi MIDC (Maharashtra) and has built up a reputation for excellence on the foundations of consistent high quality, a constantly expanding product portfolio and timely launches of new API s. The in-house QC Laboratories are equipped with sophisticated instruments to assure the quality of the raw materials, intermediates and API s. The company believes in quality by design and continuous improvement in all aspects of its operations. By this endeavor, Sri Krishna Pharma necessitates to recognize in the global market of Pharmaceuticals as an important partner for API s. 3

7 About Proponent The management at Sri Krishna Pharmaceuticals Limited consists of highly qualified and richly experienced persons who have given the company the edge in terms of quality, consistency, timely delivery and ability. The Group is headed by a technocrat with academic excellence. Dr. V.V. Subba Reddy, Founder Chairman is a Post Graduate in Technology, Doctorate in Science and a Post-Doctoral fellow from National Cancer Institute, NIH, Maryland, USA. He also serves various trade associations, Government bodies and Institutions as a representative of the pharmaceutical industry in India. Quality Management: Strict quality control measures, Good Manufacturing Practices (GMP) are integrated throughout the manufacturing process to ensure strict adherence to the quality parameters for both in-process and finished products. 3. Project Description 3.1 Production Capacity SKPL intends to manufacture 2545 TPM of API (Bulk Drug & Intermediates) products. Product wise capacity is given below: TABLE 2.0 PROPOSED PRODUCTS & CAPACITY S.No Name of the Products Quantity in TPM Remarks 1A Paracetamol- 4 stages 400 Starting from PNCB -4 Stages 1B Paracetamol 2 stages 1100 Starting from Penultimate stage-2 Stages 2 Ibuprofen Metformin Domperidone 15 5 Dextromethorphan Hydrobromide 20 6 Omega Total 2545 By Product 1 Acetic Acid Soap 40.0 Generates in the process and sold to consumers 4

8 3.2 Manufacturing Process Brief process description and process flow charts are given at Annexure I 3.3 Raw Materials List of raw material product wise is given at Annexure II 3.4 Water Requirement The water requirement for process, domestic, gardening, boiler feed & for cooling water make up is about KLD. The source of water is already available from existing water works of MIDC and the same is adequate and satisfactory. The water balance for daily consumption is presented below. S. No 1 Process Stream TABLE 3.0 Water Balance Proposed Water requirement in KLD 2 Washings Laboratory washings 4 Scrubbers Waste Proposed Method Water of Treatment and discharge in Disposal KLD Stripper, MEE and ATFD (Condensate to RO) Stripper, MEE and ATFD (Condensate to RO) 5 Boiler ETP followed by RO 6 DM/Softener ( RO Reject to MEE) 7 Cooling & Regeneration 8 Domestic Sewage Treatment Plant & reused for gardening & flushing s 9 Gardening Total

9 3.5 Wastes generation and control systems Liquid Effluents As detailed in Table 3.0 waste water generation due to process, domestic, scrubbers, boilers and other activities would be KLD. The quantity of process effluent from the proposed activity will be segregated as high TDS and low TDS streams. High TDS and High COD stream would be treated in stripper followed by MEE and ATFD. The resultant sludge would be disposed to TSDF, Hyderabad. The Low TDS stream would be treated along with MEE/ATFD condensates in biological ETP followed by RO. The RO rejects would be fed back to MEE. The Permeate from RO would be used for cooling tower make up. Domestic effluents are treated in sewage treatment plant. Thus the treatment system proposed is based on Zero Liquid Discharge (ZLD) Concept. The schematic diagrams of ETP proposed are given in Figure 1.1 and Figure 1.2 below 6

10 Fig 1.1 Schematic Treatment Scheme of High TDS Effluents Effluent from Process and Aq. Distillate to Washings, Scrubber Equalization Tank Neutralization Tank Settling Tank Stripper Cement Plant/TSDF Recovery RO Reject To TSDF MEE Condensate to Biological Treatment ATFD Condensate to Biological Treatment Sludge to TSDF 7

11 Fig 1.2 Low TDS Effluent Treatment System Domestic effluent Effluents from utilities & MEE condensate Screen Chamber Screen Chamber Equalization Tank Neutralization Tank Clarifier 1 Aeration Tank1 Aeration Tank2 Sludge Holding Tank Sludge to TSDF Sludge Cake Filter Press Permeate for re-use RO Rejects to MEE Clarifier 2 Holding Tank Sand filter Carbon Filter Ultra filtration 8

12 3.5.2 Solid wastes management Hazardous and non - hazardous wastes generated from the proposed project are detailed below. Mode of disposal are also identified and listed. Adequate storage of hazardous waste is ensured at the site TABLE 4.0 Solid Wastes and Disposal S. No Type of waste Hazardous waste Schedule No. Quantity in TPM Disposal 1 ETP Sludge CHWTSDF 2 MEE salts / ATFD salts and inorganic residue CHWTSDF 3 Spent carbon CHWTSDF 4 Distillation bottom Residue/process sludge Authorized cement Industries/ CHWTSDF 5 Spent solvents CHWTSDF 6 Iron sludge Waste oil oil from process E- Waste Used Lead acid batteries - 2 Nos. Authorized cement Industries Authorized recyclers/ CHWTSDF Authorized recyclers/ CHWTSDF Send to E- waste Recycler Return to supplier for replacement in exchange Biodegradable waste 1 ETP Bio sludge Composting and used as manure for gardening 9

13 Non Biodegradable waste 1 Waste paper - 2 Corrugated boxes 3 Broken glass Decontaminated used drums Decontaminated HDPE Bags Kgs/month Kgs/month Kgs/month Kgs/month Kgs/month Sale Sale Sale Sale Sale 6 Coal ash Sale CHWTSDF facility at Ranjangaon which is at a distance of 200 Km from the site has agreed to cater the solid waste from the proposed site. Transport of Hazardous wastes to TSDF is done by the CHWTSDF. In case other hazardous wastes, authorized recyclers will transport the wastes. 4. Site Analysis 4.1 Plant Location M/S Sri Krishna Pharmaceuticals Limited, F-1, MIDC, Chincholi(V), Mohol (T), Solapur(D), Maharastra state. The site is situated at the following Latitudes and longitudes 17 o N 75 o E 17 o N 75 o E 17 o N 75 o E 17 o N 75 o E The land area of the plant is 25.0 acres. The nearest habitation from the site is Chincholi (V) at a distance of 0.97 km. The nearest railway station located at Pakni 5.76 KM from the Plant. GIB Nanaj Sanctaury which is ecologically sensitive area is at a distance of 7.68 Km from the site and the proposed Eco sensitive zone of GIB Sanctuary is at a distance 1.84 Km from the site. There are no reserve forests in 10 Km radius 10

14 Following are the surroundings of the site North MIDC Road and Tara Hydro laboratories South MIDC Road East Road followed by LR indust ries West - Open land and Challa Chlorides Topo graphic features of the site and 10 KM study area and base map are given at Fig 1.3 & 1.4. Plant & Green Belt Photographs are given at Fig. 1.5 Site lay out map is given at Fig

15 Fig 1.3 Topo Sheet of the 10 KM study area 12

16 Fig 1.4 Base map of the study area 13

17 Fig 1.5 Plant Photographs 14

18 Fig 1.6 Site Lay Out Plan 15

19 5.0 Planning in Brief The project is envisaged to be completed by November 2017, and the production shall be initiated thereon. Consultants are identified for preparing the detailed project report. 6. Resource requirements 6.1 Power Requirement and Supply/Source The total power requirement for this proposed project will be 6000 HP. The required power connection is available from MSEDCL. In case of emergency, backup of three nos. of DG sets of capacity 1000 KVA each are proposed with acoustic enclosure. 6.2 Production facilities, Utilities and effluent handling facilities SKPL it is proposed to arrange the production facilities, utilities and effluents treatment infrastructure with an investment of Rs Crores. The details are outlined in the below table TABLE 7.0 Production facilities/utilities/etp Proposed S.NO Details Capacity/ No Proposed Production facilities 1 Production Blocks Nos 5 2 Clean rooms Nos 1 3 Boiler (coal Fired) TPH 2 x15 & 1x10* 4 DG sets KVA 2 X Cooling tower TR Softener/DM plant M 3 /hour Fresh water RO Plant M 3 /hour 2.5 Effluent handling & treatment facilities 8 Collection tanks- KL 400 Storage 9 Neutralization tanks KL Stripper, MEE, ATFD KLD 2 X RO & Biological KLD 600 treatment 12 Sewage treatment plant KL 40 * 1 X 10 TPH Boiler is stand by boiler 16

20 6.3 Land Requirement The unit is proposed to build the plant in 25 Acres of land and out of which 6.0 acres will be built up area and 9.3 acres of green belt will be developed. Below table provides the land statement. Detailed site lay out plan outlining proposed activities is given at Figure 1.6 Table 8.0 Land Statement S.No Purpose Units Extent 1 Built up area Acres Green belt Acres Open area Acres 9.7 Total Acres Air Pollution The Proposed sources of air emissions from the plant are 15 TPH coal fired Boilers two in number and 10 TPH boiler and 3 X 1000 KVA DG sets. The process emissions containing Acetic acid & HCl are scrubbed with caustic and scrubbed waste send to MEE. Below Table gives proposed emission sources from the plant Table 9.0 Emission Source Proposed S.No Proposed Capacity Fuel Anticipated emissions 1 Process Acetic acid fumes, HCl 2 Boiler 15 TPH Coal Stack (2 nos) SPM,SO2 &NOx 3 Boiler Stack 10 TPH Coal SPM,SO2 &NOx Control system Scrubber Stack Ht 47 meters, cyclone & Dust collector Stack Ht 41.5 m cyclone & Dust collector 4 DG sets 3 X 1000 KVA HSD SPM,SO2 &NOx Stack height of 6.3 meters & acoustic enclosure 17

21 8.0 Bulk Chemical Storages: Following bulk chemical storage facilities are proposed Table No 10.0 Storage facilities of bulk chemicals S.No Name of the Solvent MOC No Of Tanks Storage Quantity 1 Isopropyl alcohol MS 1 20KL 2 Isobutyl Benzene MS 1 20KL 3 Isobutyl Acetophenone MS 1 20KL 4 Isopropyl Chloro MS 1 20KL acetate 5 Acetone MS 1 20KL 6 O-Xylene MS 1 20KL 7 Toluene MS 2 40KL 8 Methanol MS 1 20KL 9 MIBK MS 1 20KL 10 Caustic Lye (48%) MS 2 50KL 11 Sulphuric Acid MS 1 25KL 12 Acetic anhydride Aluminum 4 100KL 13 HCl PP-FRP 2 50KL 14 Liquor ammonia 25% MS 1 25KL 15 Acetic acid SS 4 100KL 16 Ammonia-LIQ cylinders 1 25KL 9. Baseline data studies We have a unit at B-14/2 in MIDC Chincholi which is in the same MIDC of the proposed site for which baseline data has been collected during the 18

22 period of April 2016 to June 2016 so we request you to kindly allow us to consider the same data for current study. 10. Project Financial The estimated cost of the proposed project is approximately 125 Crores. Out of this Rs. 8.0 Crores will be for effluents treatment facilities and rest for other process equipment and safety equipment Project cost Rs. In Crores Plant& machinery 50.0 Civil & Structural 20.0 Pipe lines & insulation Electricals & instrumentation Erection & commissioning & painting Total % on plant & machinery % on plant & machinery 7.0 8% on plant & machinery and structures 5.6 Safety & Environment 10.0 Furniture, fixtures, computers, lighting etc 0.5 Total Contingencies & pre-operative expenses 17.5 Project cost say 125 Crores 19

23 Annexure I Typical technical details of the proposed products

24 PARACETAMOL Process description and flow sheets Brief manufacturing process of Paracetamol Stage-1 (Hydrolysis) Para Nitro Chloro Benzene is treated with aqueous sodium hydoexide at a temperature of o C in an autoclave and neutralized with sulphuric acid to get Para Nito Phenol. Stage- 2 (Reduction) Para Nitro Phenol is reduced in boiling water under mild acidic condition with iron poweder and acetic acid to get Para Amino Phenol, Stage -3 (Acetylation) Para Amino Phenol is condensed with Acetic Anhydride in aqueous medium to get paracetamol and acetic acid. Stage-4 (Purification) Paracetamol technical is dissolved in hot water, treated with carbon, crystallized to get Paracetamol with is dred, milled and packed in LDPE lined HDPE bags.

25 CHEMICAL PATHWAY OF PARACETAMOL SYSNTHESIS Stage I -P-Nitro Phenol: Cl ONa Step NaOH + NaCl + H 2 O 2 x NO 2 PNCB NO ONa OH Step H 2 SO Na 2 SO x 142 NO NO Para Nitro Phenol (PNP) Stage -II - P-Amino phenol: OH OH Fe + 7H 2 O + 9FeO +3Fe 3 O 4 +xch 3 COONa + xh 2 O xch3cooh + xnaoh 18x x Fe 3 O 3.5 (Av) NO 2 NH 2 6 x x x 109 PNP Para Am ino Phenol (PAP)

26 STAGE III - Paracetamol Technical OH O OH + CH 3 C CH 3 C O + CH 3 COOH 60 NH 2 O NHCOCH PAP Acetic Anhydride Paracetamol Stage - IV- Paracetamol Pharma OH OH Active Carbon Pharma ML + Spent carbon NHCOCH 3 NHCOCH 3

27 PARACETAMOL PROCESS FLOW DIAGRAM 4-Nitrochlorobenzene Caustic soda Lye Water Hydrolysis Conversion of PNCB to Nitrophenol (PNP) Stage I Sulphuric acid Neutralisation PNP Aq layer PAP ML / Water Dilute Acetic acid Iron powder Caustic soda Lye Reduction Conversion of PNP to Aminophenol (PAP) Filtration candle filter Iron sludge Stage II Hydros SMBS Cooling and Filtration Pusher Centrifuge PAP Aq layer PAP ML Pharma ML Acetic anhydride Soda ash EDTA Hydros SMBS Acetylation Conversion of 4-Aminophenol (PAP) to Paracetamol technical Filtration Pusher Centrifuge Stage III

28 Process water/pharma ML Soda ash Activated carbon Hydros SMBS Acetaminophen Technical Carbon treatment Filtration through Leaf filter and Polishing filter Stage IV Recrystallisation (cooling) Hydros DM Water Filtration through Agitated Nutsche Filter Pharma ML Acetaminophen (Paracetamol) pharma (wet)

29 Annexure II List of Raw Materials

30 List of Raw Materials of Paracetamol (Starting from PNCB) S.No Name of raw material Qty (Kgs/day) 1 PNCB Caustic Lye (48%) Sulphuric Acid Iron Powder Acetic Acid (20%) Acetic anhydride EDTA Hydros SMBS Activated Corbon Sodium Hydro Sulphite(Hydros) Sodium Meta Bisulphite(SMBS) Caustic flakes 93.3 List of Raw Materials of Paracetamol (Starting from PAP) S.No Name of raw material Qty (Kgs/day) 1 PAP (1%) moisture) Acetic anhydride EDTA Hydros SMBS Activated Corbon Sodium Hydro Sulphite(Hydros) Sodium Meta Bisulphite(SMBS) Caustic flakes 256.6

31 List of Raw Materials of Metformin HCl S.No Name of raw material Qty (Kgs/day) 1 Dicyanodiamide Dimethylamino hydrochloride Dimethyl formamide Toluene Methanol Activated carbon Methanol

32 List of Raw Materials of Domperidone S.No Name of raw material Qty (Kgs/day) 1 Orthophenylene di amine(opda) Methyl Aceto acetate(maa) Xylene Caustic lye 48 % Carbon Conc. HCl 30 % bromo-3-chloro-propane Toluene Potassium carbonate Conc. HCl 30 % Caustic lye 48 % N- Methyl Piperidone Ethyl chloro formate CS Flakes Toluene Methanol Raney Nickel Ammonia gas Hydrogen DCNB K2 CO Toluene Potassium carbonate Potssium chloride Toluene Methanol Raney Nickel Hydrogen Urea Caustic lye 47 % Ammonium chloride Carbon Conc. HCl 30 % Ammonia 30% Soda ash MIBK Methanol Carbon Acetic acid Ammonia 50.0

33 List of Raw Materials of Ibuprofen S.No Name of raw material Qty (Kgs/day) 1 Mono Chloro acetic acid Iso propyl alcohol Sulphuric acid Sodium bi carbonate Sodium carbonate Isobutyl benzene Acetyl chloride Aluminum chloride Conc. Hcl 30% Liq Ammonia 25 % Sodium metal Isopropyl alcohol CS Lye 48% Sodium dichromate dehydrate Sulphuric acid Acetone N- Hexane

34 List of Raw Materials of Dextromethorphan Hydrobromide S.No Name of raw material Qty (Kgs/day) 1 2-[1-Cyclohexyl) ethylamine Methoxy phenyl acetic acid O-xylene Phosphorous oxy chloride Sodium borohydride C S lye 48 % Toluene (-) Mandelic acid Acetone Toluene Acetone C S lye Toluene Caustic Methyl formate Methanol Toluene Phosphoric acid Potassium hydroxide Toluene Formaldehyde (40%) Formic acid Toluene % Hydroboric acid Activated carbon Toluene Conc. HCl 441.3

35 List of Raw Materials of Omega-3 S.No Name of raw material Qty (Kgs/day) 1 Sea water Dextrose Toluene Crude oil Alkali Solution 666.0