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CIPLA LIMITED
Prefeasibility Report for Existing Formulation & API Manufacturing Plant at Plot No. A – 42, MIDC Patalganga, Khalapur, District Raigad, Maharashtra
SEPTEMBER 2017
KadamEnvironmental Consultants w w w . k a d a m e n v i r o . c o m
Env i ronmentfor Deve lopment
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PREFEASIBILITY REPORT
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 2
CIPLA LIMITED
Prefeasibility Report for Existing Formulation & API Manufacturing Plant at Plot No. A – 42, MIDC Patalganga, Khalapur, District Raigad, Maharashtra © Kadam Environmental Consultants (‘Kadam’), September, 2017
This report is released for the use of the M/s. CiplaLimited, Regulators and relevant stakeholders solely as part of the subject project’s Environmental Clearance process. Information provided (unless attributed to referenced third parties) is otherwise copyrighted and shall not be used for any other purpose without the written consent of Kadam.
PROJECT DETAILS
Name of Publication
Prefeasibility Report for Existing Formulation & API Manufacturing Plant at Plot No. A – 42, MIDC Patalganga, Khalapur, District Raigad, Maharashtra
Project Number 1730482106 Report No. Version 1 Released September,
2017
Prepared & Managed By
Arpana Patel & Jitixa Upadhyay Released By Sangram Kadam
CONTACT DETAILS
Vadodara (Head Office)
871/B/3, GIDC Makarpura, Vadodara, India – 390 010.
E: [email protected]; T:+91-91-265-6131000
Delhi / NCR
SPAZE IT PARK, Unit no. 1124, 11th Floor, Tower B 3, Sector 49, Near Omaxe City Centre mall,
Sohna Road, Gurgaon -122 002 (Haryana) E: [email protected];T: 0124-4242430; M:+91-98998-04300
DISCLAIMER
Kadam has taken all reasonable precautions in the preparation of this report as per its auditable quality plan. Kadam also believes that the facts presented in the report are accurate as on the date it was written. However, it is impossible to dismiss absolutely, the possibility of errors or omissions. Kadam therefore specifically disclaims
any liability resulting from the use or application of the information contained in this report. The information is not intended to serve as legal advice related to the individual situation.
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PREFEASIBILITY REPORT
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 3
CONTENTS
1 EXECUTIVE SUMMARY ............................................................................... 6
1.1 PLANT FEATURES AND PRODUCTION CAPACITY .......................................................... 6 1.2 ENVIRONMENT .......................................................................................... 9
1.2.1 Water ............................................................................................. 9 1.2.2 Effluent Generation, Treatment and Disposal ............................................... 9 1.2.3 Power ............................................................................................. 9 1.2.4 Air Emission ...................................................................................... 9 1.2.5 Hazardous Waste Generation and Disposal ................................................. 9
1.3 SUBMISSION ............................................................................................. 9
2 INTRODUCTION ...................................................................................... 10
2.1 BRIEF DESCRIPTION OF THE PROJECT ................................................................. 10 2.2 NEED FOR THE PROJECT AND ITS IMPORTANCE TO REGION ............................................ 10 2.3 DEMAND SUPPLY GAP ................................................................................. 10
2.3.1 Global Market .................................................................................. 10 2.3.2 Domestic Market .............................................................................. 10
2.4 IMPORT VS.INDIGENOUS PRODUCTION ................................................................ 10 2.5 EXPORT POSSIBILITY .................................................................................. 10 2.6 EMPLOYMENT GENERATION (DIRECT AND INDIRECT) DUE TO THE PROJECT. .......................... 10
3 PROJECT DESCRIPTION ............................................................................ 11
3.1 TYPE OF PROJECT INCLUDING INTERLINKED AND INTERDEPENDENT PROJECTS, IF ANY ......... 11 3.2 LOCATION (MAP SHOWING GENERAL LOCATION, SPECIFIC LOCATION AND PROJECT BOUNDARY &
PROJECT LAY OUT) WITH COORDINATES ....................................................................... 11 3.3 DETAILS OF ALTERNATE SITES CONSIDERED AND THE BASIS OF SELECTING THE PROPOSED SITE, PARTICULARLY THE ENVIRONMENTAL CONSIDERATIONS GONE INTO SHOULD BEHIGHLIGHTED ................. 11 3.4 SIZE OR MAGNITUDE OF OPERATION .................................................................. 11 3.5 TECHNOLOGY AND PROCESS DESCRIPTION ............................................................ 14
3.5.1 Salient Features of Technology ............................................................. 15 3.6 RAW MATERIALS ...................................................................................... 15 3.7 PROCESS DESCRIPTION ............................................................................... 15 3.8 ADDITIVES AND CHEMICALS ........................................................................... 15 3.9 RAW MATERIAL REQUIRED ALONG WITH ESTIMATED QUANTITY, LIKELY SOURCE, MARKETING AREA OF
FINAL PRODUCTS, MODE OF TRANSPORT OF RAW MATERIAL AND FINISHED PRODUCT. ......................... 15 3.9.1 Transportation details of Raw Materials ................................................... 15
3.10 AVAILABILITY OF WATER ITS SOURCE, ENERGY/POWER REQUIREMENT AND SOURCE SHOULD BE GIVEN
17 3.10.1 Water consumption ........................................................................... 17 3.10.2 Power Consumption .......................................................................... 18
3.11 QUANTITY OF WASTE TO BE GENERATED (LIQUID AND SOLID) AND SCHEME FOR THEIR MANAGEMENT
/DISPOSAL .................................................................................................... 18
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PREFEASIBILITY REPORT
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 4
4 SITE ANALYSIS ....................................................................................... 19
4.1 CONNECTIVITY ........................................................................................ 19 4.2 LAND FORM, LAND USE AND LAND OWNERSHIP ....................................................... 19 4.3 TOPOGRAPHY (ALONG WITH MAP) ..................................................................... 19 4.4 EXISTING LAND USE PATTERN (AGRICULTURE, NON-AGRICULTURE, FOREST, WATER BODIES (INCLUDING
AREA UNDER CRZ)), SHORTEST DISTANCES FROM THE PERIPHERY OF THE PROJECT TO PERIPHERY OF THE
FORESTS, NATIONAL PARK, WILD LIFE SANCTUARY, ETC SENSITIVE AREAS, WATER BODIES (DISTANCE FROM THE
HFL OF THE RIVER), CRZ. IN CASE OF NOTIFIED INDUSTRIAL AREA, A COPY OF THE GAZETTE NOTIFICATION
SHOULD BE GIVEN. ............................................................................................ 20 4.5 EXISTING INFRASTRUCTURE ........................................................................... 20 4.6 SOIL CLASSIFICATION ................................................................................. 20 4.7 CLIMATIC DATA FROM SECONDARY SOURCES .......................................................... 20
4.7.1 Temperature ................................................................................... 21 4.7.2 Wind ............................................................................................ 21 4.7.3 Rainfall.......................................................................................... 21 4.7.4 Cloud Cover .................................................................................... 21 4.7.5 Humidity ........................................................................................ 21
4.8 SOCIAL INFRASTRUCTURE AVAILABLE .................................................................. 22
5 PLANNING BRIEF ..................................................................................... 23
5.1 POPULATION PROJECTION ............................................................................. 23 5.2 LAND USE PLANNING (BREAK UP ALONG WITH GREEN BELT ETC.) ..................................... 23 5.3 ASSESSMENT OF INFRASTRUCTURE DEMAND (PHYSICAL AND SOCIAL) ................................ 23 5.4 AMENITIES / FACILITIES .............................................................................. 24
6 PROPOSED INFRASTRUCTURE ................................................................... 25
6.1 INDUSTRIAL AREA (PROCESSING AREA) ............................................................... 25 6.2 RESIDENTIAL AREA (NON-PROCESSING AREA) ......................................................... 25 6.3 GREEN BELT ........................................................................................... 25 6.4 SOCIAL INFRASTRUCTURE ............................................................................. 25 6.5 CONNECTIVITY (TRAFFIC AND TRANSPORTATION ROAD/ RAIL/METRO/WATER WAYS ETC) ............. 25 6.6 DRINKING WATER MANAGEMENT (SOURCE & SUPPLY OF WATER) ...................................... 25 6.7 SEWAGE SYSTEM ...................................................................................... 25 6.8 INDUSTRIAL WASTE MANAGEMENT ..................................................................... 25 6.9 SOLID WASTE MANAGEMENT ........................................................................... 26 6.10 POWER REQUIREMENT & SUPPLY/ SOURCE .......................................................... 26
7 REHABILITATION AND RESETTLEMENTS (R& R) PLAN ................................... 27
7.1 POLICY TO BE ADOPTED (CENTRAL/STATE) IN RESPECT OF THE PROJECT AFFECTED PERSONS INCLUDING
HOME OUSTEES, LAND OUSTEES AND LANDLESS LABOURERS (A BRIEF OUTLINE TO BE GIVEN) ......... 27
8 PROJECT SCHEDULE AND COST ESTIMATE ................................................... 28
8.1 LIKELY DATE OF START OF CONSTRUCTION AND LIKELY DATA OF COMPLETION (TIME SCHEDULE FOR THE
PROJECT TO BE GIVEN) ........................................................................................ 28
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PREFEASIBILITY REPORT
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 5
8.2 ESTIMATED PROJECT COST ALONG WITH ANALYSIS IN TERMS OF ECONOMIC VIABILITY OF THE PROJECT. 28
8.2.1 Fixed Capital ................................................................................... 28 8.2.2 Working Capital ............................................................................... 28 8.2.3 Revenues ....................................................................................... 28 8.2.4 Breakeven Point ............................................................................... 28 8.2.5 Profitability ..................................................................................... 28
9 ANALYSIS OF PROPOSAL .......................................................................... 29
9.1 FINANCIAL AND SOCIAL BENEFITS WITH SPECIAL EMPHASIS ON THE BENEFIT TO THE LOCAL PEOPLE
INCLUDING TRIBAL POPULATION, IF ANY, IN THE AREA ........................................................ 29
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PREFEASIBILITY REPORT
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 6
1 EXECUTIVE SUMMARY
1.1 Plant Features and Production Capacity
The unit is involved in API manufacturing located at Plot No. A – 42, MIDC, Patalganga, Khalapur, District Raigad, Maharashtra. Total area of the plot is 34505 m2. Total employment is 582 and total cost of the project is INR 280.73 crores Details of proposed project is provided in Table 1-1.
Details of proposed project is provided in Table 1-1.
Table 1-1: Details of product Sr. No.
Category Product Name Capacity TPA
1 Anti-Hypertensive Alfuzosin Hydrochoride 200
Doxazosine Mesylate
Torsemide
Telmisartan
Perindropil Ebumine
Olmesartan Medoxionil
Irinotecan Hydrocloride Trihydrate
Irbesartan
Valsartan
Lecarnadipine
2 Anti-Histaminic Cetrizene Dihydrochloride
Levocetrizine
Desloratidine
Azelastin
Terfenadine
3 Antimalarial Artisunate
Artimether
Lumefantrine
4 Anti-Retroviral Efavirenz
Saquinavir Mesylate
Zidovudine
Abacavir
5 Anti-Depressant Escitalopram Oxalate
Venlafaxin Hydrochloride
Citalopram hydrobromide
Mirtazapine
6 Anti-Viral Valacyclovir Hydrochloride
Adafovir
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PREFEASIBILITY REPORT
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 7
Valgancyclovir
Imiquimod
lamivudine
Stavudine
Zanamavir
7 Treatment of Benign Prostatic Hypertrophy Tamsulusin Hydrochloride
Dutasteride
Finasteride
8 Anti-Migraine Sumatripton Succinate
Rizatriptan Benzoate
9 Bronchodilator Salmetrol Xinafoate
Troventol Hydrochloride
10 Anti-Asthamatic Levo Salbutamol Hydrochloride
Terbutaline Sulphate
Bambterol Hydrochloride
Albuterol Sulphate
Levo Salbutamol Sulphate
11 Anti-Bacterial Dorzalomide Hydrochloride
Ciprofloxacin HCL monohydrate
Roxithromycin
Gatifloxacin
12 Anti-Convulsant Levoteracetum
Pregablin
13 Competitive Inhibitor of Hmga-Coa Reductase Simvastatin
14 Anti-Glaucoma Brimonidine
Dorzalomide Hydrochloride
Brimonidine Tartarate
15 Anti-Gonadotropin Danazol
16 Anti-Sedative, Anxiolytic Lorazepam
17 Nootropic Revastigmine
18 Anti-Spasmodic Tolteredine
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PREFEASIBILITY REPORT
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 8
19 Anti-Fungal Fluconazole
Varriconazole
20 Anthelmintic Praziqantel
21 Anti-Diabetic Repiglinde
22 Non-Ergoline Dopamine agonist Ropinirole HCL
23 Chelating Agent Deferisivox
24 Anthemetic Ondansetron Hydrochloride Dihydrate
25 Anti-Ulcerative Ranitidine hydrochloride
26 Antianginal Trimetazidine Dihydrochloride
Ranolizine
27 Anti-Pneumocystic Atovaquone
28 Glucorticoid Ciclesonide
29 Antilipemic Guggelsterone
30 Immunomodulator in treatment of multiple sclerosis Glatiramer Acetate
31 Pharmaceutics Miscllaneous Formulation
32 Antineoplastic Exemestane
33 Ophthalmic Proparacaine HCL
34 Mitotic Inhibitor Placitaxel
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PREFEASIBILITY REPORT
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 9
1.2 Environment
1.2.1 Water Existing fresh water consumption is 450 KLD. Water is being sourced from MIDC Water Supply System.
1.2.2 Effluent Generation, Treatment and Disposal Effluent generation is 160 KLD, in which 140 KLD is generated from industrial effluent and 20 KLD is generated from domestic sewage. Industrial effluent after treatment in ETP at site is being partly recycled and remaining is sent to CETP. Domestic sewage is being treated in ETP.
1.2.3 Power
Existing power requirement is 3000 kVA and it is sourced from Maharastra State Electricity board.
1.2.4 Air Emission Adequate stack heights are provided to flue gas stacks of Boilers &D.G. Sets. Stack emission quality are maintained as per the SPCB norms. Caustic scrubber is attached to process vent.
1.2.5 Hazardous Waste Generation and Disposal
The hazardous waste is being disposed at CHW-TSDF site or sent to authorize recycler as per consent.
1.3 Submission
Application to MoEF&CC is done for receipt of Environmental Clearance to streamline existing operation.
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 10
2 INTRODUCTION
2.1 Brief Description of the Project
Cipla is one of the top pharmaceutical companies in India, whose goal is to ensure that no patient shall be denied access to high quality and affordable medicine and support. Our mission is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients.
2.2 Need for the project and its importance to region
In addition to business objectives, project is important considering indigenous production of medicines and contribute nation for being self-stuffiest for supply for critical medicines at low cost. The location of project is in backward region which had given employment to skilled, semi-skilled and unskilled labour force. A significant portion of the revenue generated is spent in the local market by the employer, this result into economic development and improvement of the surrounding society at large. The project also generates self-employment for the locals.
2.3 Demand Supply Gap
The production of critical API and formulations would be bridging the Gap of demand/requirement and supply.
2.3.1 Global Market
The production of critical API and formulations would be exported to global market as per demand.
2.3.2 Domestic Market
Domestic market should be served with life saving medicines.
2.4 Import vs.Indigenous Production
The indigenous production is definitely cost effective while maintaining the global quality standards.
2.5 Export Possibility
API as well as formulations would be exported globally.
2.6 Employment Generation (Direct and Indirect) due to the project.
Employment generation during the project will be as follows
Operational Phase: 582
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 11
3 PROJECT DESCRIPTION
3.1 Type of Project including interlinked and interdependent projects, if any
Not applicable
3.2 Location (map showing general location, specific location and project boundary & project lay out) with coordinates
3.3 Details of alternate sites considered and the basis of selecting the proposed site, particularly the environmental considerations gone into should be highlighted
Not Applicable
3.4 Size or Magnitude of Operation
Table 3-1: Production Capacity Sr. No.
Category Product Name Capacity TPA
1 Anti-Hypertensive Alfuzosin Hydrochoride 200
Doxazosine Mesylate
Torsemide
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 12
Telmisartan
Perindropil Ebumine
Olmesartan Medoxionil
Irinotecan Hydrocloride Trihydrate
Irbesartan
Valsartan
Lecarnadipine
2 Anti-Histaminic Cetrizene Dihydrochloride
Levocetrizine
Desloratidine
Azelastin
Terfenadine
3 Antimalarial Artisunate
Artimether
Lumefantrine
4 Anti-Retroviral Efavirenz
Saquinavir Mesylate
Zidovudine
Abacavir
5 Anti-Depressant Escitalopram Oxalate
Venlafaxin Hydrochloride
Citalopram hydrobromide
Mirtazapine
6 Anti-Viral Valacyclovir Hydrochloride
Adafovir
Valgancyclovir
Imiquimod
lamivudine
Stavudine
Zanamavir
7 Treatment of Benign Prostatic Hypertrophy Tamsulusin Hydrochloride
Dutasteride
Finasteride
8 Anti-Migraine Sumatripton Succinate
Rizatriptan Benzoate
9 Bronchodilator Salmetrol Xinafoate
Troventol Hydrochloride
10 Anti-Asthamatic Levo Salbutamol Hydrochloride
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 13
Terbutaline Sulphate
Bambterol Hydrochloride
Albuterol Sulphate
Levo Salbutamol Sulphate
11 Anti-Bacterial Dorzalomide Hydrochloride
Ciprofloxacin HCL monohydrate
Roxithromycin
Gatifloxacin
12 Anti-Convulsant Levoteracetum
Pregablin
13 Competitive Inhibitor of Hmga-Coa Reductase Simvastatin
14 Anti-Glaucoma Brimonidine
Dorzalomide Hydrochloride
Brimonidine Tartarate
15 Anti-Gonadotropin Danazol
16 Anti-Sedative, Anxiolytic Lorazepam
17 Nootropic Revastigmine
18 Anti-Spasmodic Tolteredine
19 Anti-Fungal Fluconazole
Varriconazole
20 Anthelmintic Praziqantel
21 Anti-Diabetic Repiglinde
22 Non-Ergoline Dopamine agonist Ropinirole HCL
23 Chelating Agent Deferisivox
24 Anthemetic Ondansetron Hydrochloride Dihydrate
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 14
25 Anti-Ulcerative Ranitidine hydrochloride
26 Antianginal Trimetazidine Dihydrochloride
Ranolizine
27 Anti-Pneumocystic Atovaquone
28 Glucorticoid Ciclesonide
29 Antilipemic Guggelsterone
30 Immunomodulator in treatment of multiple sclerosis Glatiramer Acetate
31 Pharmaceutics Miscllaneous Formulation
32 Antineoplastic Exemestane
33 Ophthalmic Proparacaine HCL
34 Mitotic Inhibitor Placitaxel
3.5 Technology and Process Description
Manufacturing Process
The manufacturing process of bulk drugs is a synthetic process and the starting materials for the process are the drug intermediates of the individual bulk drugs. The starting raw materials drug intermediates are dispensed in a loose container and subsequently added in the reactor along with all other ingredients, solvents and deminerialized water to initiate the starting of the batch. The reaction mass is completely mixed and the solid materials gets dissolved and mixed with the solvent. The reaction mass is heated till the distillation starts and subsequently the reflux / distillation will continue to complete the condensation / addition reactions. The reacted mass will be transferred in another reactor and subsequently the solvents are added to extract the desired intermediates products. The mixture of solvent and the intermediates products are washed with water to remove all the impurities present in the solutions. The process of extracting the material from the reaction mass is called solvent extractions.
The purified mixture of the solvent and the intermediates products are reacted with acid/alkali to require pH and to get the crude bulk drugs. The reaction mass is cooled with the help of cooling tower and chilled water and subsequently filtered by centrifuging operations. The solid materials recovered from the centrifuge are called crude bulk drugs.
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 15
The crude bulk drugs are treated with carbon to purify the crude materials and removes all the impurities form the crude products. The purified materials are the finished bulk drug product. The finished bulk drugs are dried and subsequently milling, sifting and packing is done.
All type of processes is nearly similar for each product, which are carried out for more than 10 years. All the reactions are carried out at the atmospheric conditions. Temperature is attained by steam from boilers.
Flow Diagram
3.5.1 Salient Features of Technology
The choice of technology was based on following criteria.
a. Best in class energy and conversion efficiency. b. Minimal adverse environmental impact. c. Reliable and tested technology.
3.6 Raw Materials
Details of raw materials and it’s storage is provided in point 1.14 of Form-1.
3.7 Process Description
Process description of existing as well as proposed product is provided in Annexure 6 of additional attachment in Form-1.
3.8 Additives and Chemicals
Details of Raw materials are given in point 1.14 of Form-1.
3.9 Raw material required along with estimated quantity, likely source, marketing area of final products, mode of transport of raw material and finished product.
3.9.1 Transportation details of Raw Materials
Table 3-2: Details of Raw Material and Transportation Details
S. No. Raw Material State
(Solid/Liquid) Means of
Transportation Source
Dispensing Batch InitiationReflux/
Distillation
Extraction/
CoolingFiltration
PurificationFiltrationDrying, Sifting,
Milling and Packing
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 16
S. No. Raw Material State
(Solid/Liquid) Means of
Transportation Source
1 2 Chloro Ethanol Liquid By road Local
2 2-(2-Chloro Ethoxy) Acetamide Solid By road Local
3 2,3 Dichloro-5,6-Dicyno-P-Benzoquinone (DDQ) Solid By Air / By Sea Imported
4 4 Dimethyl Amino Pyridine Solid By sea Imported
5 4-Chloro Benzyl Piperazine (Cetirizine Stage II) Solid By road Domestic
6 Acetic Acid-Glacial Liquid By road Domestic/Local
7 Acetone Liquid By road Local
8 Activated Charcoal AR grade Solid By road Local
9 Activate Charcoal SX ULTRA Solid By road Local
10 Alumina Neutral Solid By road Local
11 Artemisinn Solid By Sea Imported
12 Artemisinn+D6:D21DD6:D30 Solid By Sea Imported
13 BIS (Trimethylsilyl) Trifluroacetamide Liquid By Sea Imported
14 Cetirizine Stage III Solid Own Own
15 CME Compound Solid By Sea Imported
16 CTM-I Solid By road Domestic
17 Dimethyl Formamide Liquid By road Local
18 DI-para Toluoul D-Tartaric Acid Solid By road Local
19 Dipotassium Hydrogen Phosphate Solid By road Local
20 DMF Liquid By road Local
21 Escitalopram Oxalate Stage II Solid Own Own
22 Ethyl acetate Liquid By road Local
23 Formaldehyde solution Liquid By road Local
24 Formic acid Liquid By road Local
25 HCl CP Liquid By road Local
26 Hydrobromic acid Liquid By road Local
27 Hydrochloric Acid - CP Liquid By road Local
28 Hydrogen Chloride Gas GAS By road Domestic
29 Hyflo Solid By road Domestic
30 Hyflow Supercel Solid By road Domestic
31 IPA + HCl Liquid By road Local
32 Isopropyl alcohol Liquid By road Local
33 LCZ-6 Solid By road Domestic
34 LCZ-7 Solid OWN OWN
35 Liquir Ammonia 25% Liquid By road Domestic
36 Loratadine Solid By road Domestic
37 Loratadine BP/PH EUR Solid By road Domestic
38 Methane Sulphonyl Chloride Distillation Liquid By road Local
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 17
S. No. Raw Material State
(Solid/Liquid) Means of
Transportation Source
39 Methanol Liquid By road Local
40 Methylene Chloride Liquid By road Imported/Domestic
41 n-Heptane Liquid By road Local
42 N-Heptane (Commercial) Liquid By road Local
43 Ortho Phosphoric acid Liquid By road Local
44 Oxalic acid Solid By road Domestic
45 P-7 Compound (N-T-Butyl-4-Aza-5-Alpha-Androsta-3-One-17 Beta-Carboxamide) Solid By Air / By Sea Imported
46 Potassium Carbonate Powder Solid By road Domestic
47 Potassium Carbonate Powder 40 Mesh Solid By road Domestic
48 Potassium Hydroxide pellets Solid By road Domestic
49 Potassium Iodide Solid By road Domestic
50 Salicylic Acid Solid By road Local
51 Sodium Borohydride Solid By Road/ By Sea local/ IMPORTED
52 Sodium Chloride Solid By road Domestic
53 Sodium Chloride IP Solid By road Domestic
54 Sodium Hydro Flakes Solid By road Domestic
55 Sodium Hydroxide Flakes Solid By road Domestic
56 Sodium Metabisulphite (Commercial) Solid By road Domestic
57 Sodium Monochloro Acetate Solid By road Domestic
58 Special Denatured Spirit with Toluene Liquid By road Local
59 Succinic Anhydride Solid By road Local
60 Sulphuric Acid (LR Grade) Liquid By road Local
61 Tetra Hydro Furan (THF) Liquid By Road/ By Sea Local/ Imported
62 Toluene Liquid By road Local
63 Trimethylamine Liquid By road Local
64 Trimethyl Orth acetate Liquid By Sea Imported
65 Venlafaxine HCl Solid By road Own
66 VF-II Solid By road Local
3.10 Availability of water its source, energy/power requirement and source should be given
3.10.1 Water consumption
Cipla has permission of Maharashtra Industrial Development Corporation (MIDC) of 450 m3/day water supply. Water bill is attached in Annexure 7 of Additional attachment of Form1. Fresh water consumption as per consent is 450 KLD.
Table 3-3: Details of Fresh Water Consumption S. No. Area of Consumption Fresh Water Quantity, KLD
CIPLA LTD
EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 18
S. No. Area of Consumption Fresh Water Quantity, KLD
1 Processing 70
2 Washing (Reactor and Floor) 80
3 Boiler 75
4 Cooling Tower 165
5 Gardening 30
6 Domestic 30
Total 450
3.10.2 Power Consumption
Maharastra State Electricity board
Unit-2 (Existing: 3000 kVA)
Existing power requirement is 3000kVA and it is sourced from Maharastra State Electricity board (MSEB).
3.11 Quantity of waste to be generated (liquid and solid) and scheme for their management /disposal
Existing effluent generation is 160 KLD. Detailed Effluent treatment Scheme is provided in Annexure 7 of Additional attachment of Form1.
The hazardous waste will be disposed at TSDF site or sent to authorized recycler as per consent. Details of Hazardous waste are explained in Annexure 10 of Additional attachment of Form1.
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 19
4 SITE ANALYSIS
4.1 Connectivity
4.1.1 By Road
The site is adjacent to the Mumbai-Pune expressway – 3.65 in East direction and National Highway-NH-04 is about ~4.63 Km in North-East direction from the site.
4.1.2 By Rail
Panvel Railway station is ~7.0 km in North-East direction from the site. Nearest Railway Line is about 3.3 km in NW direction from proposed site.
4.1.3 By Air
The nearest Chhatrapati Shivaji International & National airport, Mumbai is ~40 Km in West North-West direction from the site.
4.2 Land Form, Land Use and Land ownership
The total plot area of the unit is 34505 m2.
4.3 Topography (along with map)
Site is located within MIDC industrial area Rasayani, in Raigad district of Maharashtra state. Raigad district is situated at the west coast and the uneven highly dissected coastal topography forms the governing physical feature along with the lofty mountainous and highly rough terrain of the Western Ghats.
The Patalganga, Kundalika, Amba and Savitry are the major rivers constitute the westerly drainage system of the coastal region. The drainage pattern is subparallel which is controlled by joints and fractures. (Source: Geological Survey of India, DRM, Raigad District)
Especially nearby site area the drainage pattern is observed from south to north direction. There is hill at the western and southern part. It has an altitude of about 50 - 200 mtr. An altitude at river Patalganga is about 14-15 meter. Patalganga is a major river within study area and as said earlier it has westerly drainage pattern.
Slope Pattern: From Hill to River
Table 4-1: Topography Pattern West and South Area (Upper) Project area (Middle) North & East (Lower)
Location Altitude MSL (mtr)
Location Altitude MSL (mtr)
Location Altitude MSL (mtr)
Hill area 30-200 Unit II 32 River Patalganga
(N) 12-15 mtr
Village Kaire near unit II 27 River Patalganga
(NNW) 9-10 mtr
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 20
4.4 Existing land use pattern (agriculture, non-agriculture, forest, water bodies (including area under CRZ)), shortest distances from the periphery of the project to periphery of the forests, national park, wild life sanctuary, etc sensitive areas, water bodies (distance from the HFL of the river), CRZ. In case of notified industrial area, a copy of the Gazette notification should be given.
Land use pattern: Industrial
Table 4-2: Distance of Project Site from Sensitive Areas Attribute Source Location ~ Dist. in km Dir.
Mountains + Forest Karnala Hill Bird Sanctuary
Karnala 4.53 W
Mountains + Forest Hill with R.F Kaire Adjacent W & S
Breeding + Nesting Karnala Bird Sanctuary
Karnala 4.53 W
Water Bodies Patalganga River MIDC Rasayani 1.16 N Water Bodies Jambivali Dam Nr Savne 3.47 S Water Bodies Dam Nr Chauk 7.95 NE Water Bodies Pond Nr Posari 4.65 NW
Table 4-3: Distance of Project site from Water Bodies Attribute Source Location ~ Dist. in km Dir.
Water Bodies Patalganga River MIDC Rasayani 1.16 N Water Bodies Jambivali Dam Nr Savne 3.47 S Water Bodies Dam Nr Chauk 7.95 NE Water Bodies Pond Nr Posari 4.65 NW
Inland Patalganga River MIDC Rasayani 1.16 N
Inland Jambivali Dam Nr Savne 3.47 S
Inland Dam Nr Chauk 7.95 NE
Inland Pond Nr Posari 4.65 NW
4.5 Existing Infrastructure
This is an existing site. No construction activity will take place.
4.6 Soil classification
Not required
4.7 Climatic data from secondary sources
The general agro-climatic zone of the study area is arid.
Information presented in subsequent paragraphs is from the most recently published Long Term Climatological Tables for the nearest observatory, at Kulaba, Mumbai by the Indian Meteorological Department (IMD) 1981-2010.
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 21
4.7.1 Temperature
Mean daily maximum temperature is recorded in the month of May at 33.8 °C.
From November to January, both day and night temperatures begin to decrease rapidly. January is generally the coldest month, with a minimum temperature of 19.3 °C.
During the post-monsoon months of October and November, day temperatures remain between 33-33.5 ºC. In winters, i.e. December, January and February, average day temperatures remain between 30.2-32.2 ºC.
4.7.2 Wind
Table 4-4: Predominant Wind Direction
Month
Predominant Wind
First Second Third
Morning Evening Morning Evening Morning Evening
January NE NW E N N W
February NE NW E W N NE
March NE NW N N SE W
April SE NW NW W NE N
May NW NW W W SW SW
June W W SW SW NW NW
July W W SW SW NW NW
August W W SW NW NW SW
September W NW NW W SE SW
October E NW NE N SE W
November NE NW E N SE W
December NE NW E N SE W
4.7.3 Rainfall
The total rainfall in year is observed to be 2184.1 mm. Distribution of rainfall by season is 3.7 mm in winter (December, January, February), 21.1 mm in summer (March, April, May), 2066 mm in monsoons (June, July, August, September) and 93.3 mm in post-monsoon (October - November).
4.7.4 Cloud Cover
The area remains cloudy between June-September, which is the active period of the monsoon season. Cloud cover is 5-7 oktas during monsoon season, while it is 0-1 oktas in post monsoon, winter and summer season.
4.7.5 Humidity
Most humid conditions are found in the monsoon, followed by summer, post-monsoon and winter in that order. Mornings are more humid than evenings and humidity ranges from a high of 83-89% in monsoon mornings to a low of 62-63% in winter evenings. During post-monsoon season, in morning humidity remains between 78-84% and in the evening it remains between 65-72%.
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA SITE ANALYSIS
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4.8 Social infrastructure available
Not Applicable
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PLANNING BRIEF
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 23
5 PLANNING BRIEF
The proposed expansion will be done in existing premises.
5.1 Population Projection
This is an existing unit.
5.2 Land Use planning (Break up along with green belt etc.)
The Land use breakup at site is given in Table 5-1.
Table 5-1: Land Use Breakup at Site S. No. Title Area in m2 % of total Area
1 Processing Area 4579.08 15.633
2 Storage Area 0.000
a Hazardous Chemicals 848.35 2.896
b Other Non-hazardous chemicals 1782.79 6.086
c Hazardous Waste 24 0.082
d Water Storage 280.6 0.958
e Fuel Storage 342.42 1.169
3 Effluent Treatment Plant 92.17 0.315
4 Boiler 136.97 0.468
5 Cooling tower 265.43 0.906
6 DG Sets 665.18 2.271
7 Roads 7289 24.884
8 Administrative Building 269.29 0.919
9 Open Space 9982.45 34.079
10 Greenbelt Area 7947.27 27.131
11 Area for proposed Expansion 0 0.000
Total 34505 100
5.3 Assessment of Infrastructure Demand (Physical and Social)
Physical Demand: Water: Existing fresh water consumption at full capacity is 450 KLD (420 KLD Industrial + 30 KLD Domestic).
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PLANNING BRIEF
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 24
Electricity: The electricity will be sourced from Maharastra State Electricity board (3000kVA).
Machinery: Reactors, Storage tanks, columns, condensers, Chilled Water unit, Brine Plant, Air compressor, scrubbers, Boiler, D.G.Set, FBD and other equipment:
Materials and Others: The Raw Material supply will be met by local and other markets. Other general utilities facilities are available in the area.
5.4 Amenities / Facilities
Following facilities will be made available at site:
First Aid Facility Hygienic Drinking Water Facility Green Area Occupational Health Centre
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PROPOSED INFRASTRUCTURE
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 25
6 PROPOSED INFRASTRUCTURE
6.1 Industrial Area (processing area)
Total plot area of the Unit-2, Plot No. A-42 is 34505m2.
6.2 Residential Area (non-processing area)
The unit is in notified industrial Area.
6.3 Green belt
27.131 % of total plot area will be developed as greenbelt.
6.4 Social Infrastructure
Not Applicable
6.5 Connectivity (Traffic and transportation road/ rail/metro/water ways etc)
6.5.1 By Road
The site is adjacent to the Mumbai-Pune expressway – 3.65 in East direction and National Highway-NH-04 is about ~4.63 Km in North-East direction from the site.
6.5.2 By Rail
Panvel Railway station is ~7.0 km in North-East direction from the site. Nearest Railway Line is about 3.3 km in NW direction from proposed site.
6.5.3 By Air
The nearest Chhatrapati Shivaji International & National airport, Mumbai is ~40 Km in West North-West direction from the site.
6.6 Drinking water management (source & supply of water)
Domestic water will be sourced from MIDC. Existing fresh water consumption is 450 KLD.
6.7 Sewage system
Quantity of Domestic sewage i.e. 20 KLD is being treated in ETP.
6.8 Industrial waste management Waste water generation is 160 KLD. Industrial effluent after treatment in ETP at site is being partly recycled and remaining is sent to CETP. Domestic sewage is being treated in ETP.
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA PROPOSED INFRASTRUCTURE
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 26
6.9 Solid waste management
Solid Waste sale to authorized party user/ Preprocessor or shall be sent to CHWTSDF
6.10 Power requirement & supply/ source
The electricity will be sourced from Maharashtra State Electricity Board (3000kVA).
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA
REHABILITATION & RESETTLEMENTS (R& R) PLAN
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 27
7 REHABILITATION AND RESETTLEMENTS (R& R) PLAN
7.1 Policy to be adopted (central/state) in respect of the project affected persons including home oustees, land oustees and landless labourers (a brief outline to be given)
Not required
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA ANALYSIS OF PROPOSAL
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 28
8 PROJECT SCHEDULE AND COST ESTIMATE
8.1 Likely date of start of construction and likely data of completion (time schedule for the project to be given)
Cipla’s operating this plant since September 2006.
8.2 Estimated project cost along with analysis in terms of economic viability of the project.
INR 280.73 Crore.
8.2.1 Fixed Capital
INR 280.73 Crore
8.2.2 Working Capital
INR Crore / Year
8.2.3 Revenues
INR Crore / Year
8.2.4 Breakeven Point
2 years.
8.2.5 Profitability
After Breakeven point
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EXISTING FORMULATION & API MANUFACTURING PLANT AT PLOT NO. A-42, MIDC, PATALGANGA, KHALAPUR, DISTRICT RAIGAD, MAHARASHTRA ANALYSIS OF PROPOSAL
KADAM ENVIRONMENTAL CONSULTANTS SEPTEMBER 2017 29
9 ANALYSIS OF PROPOSAL
9.1 Financial and social benefits with special emphasis on the benefit to the local people including tribal population, if any, in the area
The project is improving the socio-economic status of the society in the region by generating direct and indirect employment opportunities. The project is contributing additional revenue to the State & Central exchequers in the form of taxes, cess, etc.
The anticipated impacts of the project are explained below:
The project is providing employment to the skilled as well as un-skilled persons. The local population is given preference depending upon their suitability to the job requirement. Besides direct employment, indirect employment opportunities is also generated. Social investment in the form of CSR would help improve the healthcare, education, sanitation,
infrastructure and other areas wherein the project proponent is actively involved as part of its CSR commitments.
KadamEnvironmental Consultants w w w . k a d a m e n v i r o . c o m
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