Pre- Feasibility Report
PRE FEASIBILITY REPORT
OF
M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd
Proposed Synthetic Organic Chemical Manufacturing Industry
AT
SY.NO. 203/A1 OF MIRZAPALLE VILLAGE, SHANKARAMPET (R), MANDAL, MEDAK DISTRICT,
TELANGANA
1.0 EXECUTIVE SUMMARY
M/s. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd was incorporated to produce Synthetic Organic Chemical Manufacturing Industry with registered address at 2-22-93 Ground Floor, Vijayanagar Colony, Near Patelkunta Park, Montessori school, Kukatpally Hyderabad Telangana State 500072
The company proposes for its proposed Synthetic Organic Chemical Manufacturing Industry at Sy.No. 203/A1 of Mirzapalle village, Shankarampet (r) mandal, Medak district, Telangana State.
S. No Parameter Description 1. Category of Project as per EIA Notification & Amendments 5 (f) “A” 2. Project cost 5 Crores 3. Plot area 9469.65 sq.m 4. Geographical coordinates Latitude: 18° 0’50.06"N Longitude: 78°24’39.07"E 5. Proposed Products Proposed : 4.5 MT/M The details of products& Quantities are mentioned in Section 3.1 6. Resources (I)Electricity Requirement 1000 KVA Source of electricity TSSPDCL D. G. Sets 2 X 250 KVA (II) Water consumption 150 KLD Source of water Bore well water Waste water generation 97.0 KLD 7. Mode of disposal Zero Liquid Discharge System (III)Boiler 2000 KG/Hr; 1 no. (V)Fuel Coal – 5.0 MT / Day 8. Solid waste generation Mentioned in Para 3.3 of report 9. Work force Construction phase: 100 No.s Operation phase: 50 No.s 10. Highway No.7 (Hyderabad – Nizamabad ) - 2.5Kms Nearest Highway in E 11. Nearest Railway Station Chegunta Railway Station – 6.5 Kms in SE 12. Nearest Air Port Rajivgandhi International Air Port – 85 Kms in S
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As per EIA Notification 2006, and its amendments thereof, the proposed industry requires environmental clearance from MoEF&CC under the project or activity 5(f), Category A for Synthetic organic chemicals industry (dyes & dye intermediates; bulk drugs and intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and chemical intermediates).
The project will run on Zero Effluent Discharge (ZLD) scheme. Generated effluent will be treated in inhouse ETP followed by Multi-Effect Evaporator system. Solid waste will be categorized as hazardous & non-hazardous on the basis of its characteristics. Hazardous waste will send to CHWTSDF and non-hazardous waste to the authorized vendor for its disposal.
Keeping in consideration the Environment & Social safety, proposed project activity will involve following studies such as Environment Impact Assessment (EIA), Environment Management Plan (EMP), Disaster Management Plan (DMP), Risk & Hazards study, Solid waste management, Public Consultation.
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2.1 INTRODUCTION OF THE PROJECT
2.2 Identification of project
The proposed project activity falls under 5(f) for Synthetic organic chemicals industry (dyes & dye intermediates; bulk drugs and intermediates excluding drug formulations; synthetic rubbers; basic organic chemicals, other synthetic organic chemicals and chemical intermediates). As the project is located outside the notified industrial area/ estate, hence falls in „A… Category and will require Environmental Clearance (EC) from the Expert Appraisal Committee (EAC-Industry2), MoEF&CC, New Delhi as per Environmental Impact Assessment (EIA) Notification, September 14, 2006 and amendments thereof.
2.3 Project Proponent
Sri. Rangineni Karthik a MBA graduate and having 15 years experience in the field of pharma and synthetic organic chemical industry. Under his able guidance, supervision and technological skills, successful implemented a unit in Hyderabad. A part from the above is also having enough innovating marketing experience in trading of Bulk Drugs Intermediates. Has been involved in developing a growing portfolio of best-in-class pharmaceutical formulations in the health care arena.
2.4 Brief description of nature of the project.
Proposed unit will be involved in API manufacturing, which are used in drug formulation mainly Anti- Hypertensive, Antidepressant, Antiulcer drug, Gastric Acid, Secretion Inhibitor, Anti-ulcerative, Anti- adrenergic. The proposed production quantity is 4.5 MT/Month.
2.5 Need for the project and its importance to the country and or region
In the last few decades, India’s population is skyrocketing and so is the demand for Drugs to support this population. In order to satisfy this need, more production of bulk drugs and active pharma ingredients is needed.
Active pharmaceutical ingredients are the active substances that are used in the manufacture of a drug and have a pharmacological effect. They provide health benefits and play a vital role in disease diagnosis, prevention, and treatment. Active pharmaceutical ingredients may be synthesized either chemically or through biotechnological methods. They are used in a wide range of therapeutic areas such as oncology, respiratory disorders, and rheumatoid arthritis. The analysts forecast the API market in India to grow at a CAGR of 10.76 percent over the period 2014-2019.
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As per the report -Market Entry - Active Pharmaceutical Ingredients (API) Industry in India: Analysis of Growth, Trends and Progress (2016 - 2021),the API market is surging due to the increased demand for pharmaceutical drugs, which in turn is driven by the aging population, rising prevalence of chronic diseases such as cancer, diabetes, cardiovascular, neurological and infectious diseases. India and China are the major suppliers of APIs to North America due to their low production capacities, labor costs and the presence of a large number of global and domestic players. In order to cut down on expenses and increase profits, companies have begun outsourcing the creation of APIs to the developing countries in Asia, leading to growth in the Asian market.
Apart from this there are several other challenges faced by the industry as Pricing, Remaining & Retaining Declining Markets, and Transparency in supply chain, Regulatory issues.
Since there is a need to look at the API market from a sustainable and quality perspective as well as from a price perspective to exploit its potential to become a brand, M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd has come out to develop the API manufacturing industry at Telangana.
To form an international reach through their commitment to customer satisfaction, comprehensive product range, unflagging attention to quality, and by building mutually beneficial business relationships. To be an eco-friendly in all our practices.
The finished goods will be sold in domestic market and would be largely exported to the Regulated International Market as per demand all over the world. In view of future market demand, it is the best opportunity which may lead to employment generation to local youth and economical upliftment of local region.
Hyderabad has developed as a major production center for bulk drugs due to the location if the many major Pharmaceutical Industries such as Dr. Reddys Laboratories, Aurobindo Pharma, Ravoos Labs, Neuland Laboratories, Siris, Hetaro Drugs, Divis Labs, Natco Pharma Limited, Matrix Labs, Nicholas Piramal etc., besides a large number of medium and small industries manufacturing bulk drugs of all kinds.
In support of this growth in Hyderabad and Bangalore, many basic chemical units and drug intermediate units have also come up to meet the input requirements of Bulk Drug manufacturing Companies. Large numbers of these units are still dependent on supply of basic chemicals mainly from Mumbai, Gujarat and other parts of the country involving heavy expenditure on transport and transit risks.
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2.6 Demand-Supply Gap
The demand for APIs and API intermediates is a derived demand. It gets derived from the demand for various medicinal formulations (final administrable drugs) for the formulation industry.
The APIs and API intermediates being manufactured by basic drug manufacturers are exported as such or used by domestic formulators in their production processes. The formulation firms further produce final medicines and export these as well as sell these in the domestic market. There is a wide gap in the demand and availability of cheap and quality medicines in India and the world over. Generic medicines and off patent drugs have significant potential to increase access to cheap and effective medicines to poor people and in general to bridge the demand supply gap. Indian basic drug manufacturers are playing a significant role in increasing access to affordable off patent drugs. The products envisaged include third generation antibiotics, anticancer, antipsychotic, etc drugs which address the problems associated with present day stressful lifestyles and demand for these outstrips their demand and is increasing by the day.
2.7 Pharmaceutical Industry – Domestic Scenario
The Indian Pharmaceutical Industry today is in the front rank of India…s Science- based industries with wide ranging capabilities in the complex field of drug manufacture and technology. The Indian Pharmaceutical industry is estimated to be worth US $ 8.0 billion at present, growing at a CAGR of over 15 % annually. If India„ s high Economic growth rate holds steady, the pharmaceuticals market will triple to $ 24 billion by 2015 and become one of the world‘ s top 10 markets according to a study by McKinsey and company ,a leading management consulting firm. At a compounded annual growth rate of 15.0 %, the absolute growth of $ 24 billion will be next to the growth potential of the US and China, and in the same league as the growth in Japan and Canada and the UK. Five factors will drive the growth of the Indian Pharmaceuticals market over the next decade; Doubling of disposable incomes and the increase in numbers of middle class households, significant expansion of medical infrastructure, greater penetration of health insurance, a gradual shift in disease profile and adoption of patented products, and finally population growth.
The Indian Pharmaceutical sector has more than 20,000 registered units. It has expanded drastically in the last two decades. The leading 250 pharmaceutical
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Companies control 70% of the market. The pharmaceutical industry in India meets around 70% of the country…s demand for bulk drugs, drugs intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and injectable.
There are about 250 large units and about 8000 small Scale Units, which form the core of the pharmaceutical industry in India (including 5 Central Public Sector Units). These units produce the complete range of pharmaceutical formulations, i.e. medicines ready for consumption by patients and about 350 bulk drugs, i.e. chemicals having therapeutic value and used for production of pharmaceutical formulations.
2.8 Employment Generation (Direct and Indirect) due to the project
The total direct employment potential of the industry is about 100 people. We have a strong team of R&D, Manufacturing, Quality Control and Quality Assurance chemists with very pertinent skills in process development, manufacture and testing of our product range. The team comprises of Doctorates, Post Graduates, Graduates and Chemical Engineers from some of the premier institutes in India. Hyderabad has emerged as major drug manufacture city with a presence in global market. Pharma industry in the state contribute more than one third to the country…s total production.
Most of the companies have set up their R&D facilities in the state, thus making the state the pharmaceutical capital of the country.
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3.1 PROJECT DESCRIPTION
3.2 Type of Project
The main activity of the industry is manufacturing of Synthetic Organic Chemicals.
3.3 Location of Project
M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd proposes Synthetic Organic Chemical Manufacturing Industry at Sy.No. 203/a1 of Mirzapalle village, Shankarampet (r) mandal, Medak district, Telangana State. The Location map is shown at Figure –1 and Site photographs are given in Figure 2.
There are no archaeological, historical sites located nearby. Therefore, the project site does not offer any negative impact on the local area, but rather has a positive impact on socio economic conditions of the habitants around it.
The proposed plant is well connected road and rail connectivity.
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FIGURE 1: LOCATION MAP
M/s. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd Sy.no. 203/A1 of Mirzapalle Village, Shankarampet (M), Medak District, Telangana State
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FIGURE 2: SITE PHOTOGRAPH
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FIGURE – 3: MASTER LAYOUT PLAN 10 M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd.
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3.4 Size or Magnitude of operation
The proposed industry will manufacture following products with the production quantity 112.5 MT/month .Details of proposed production are presented below table:
Table 1: Product Details
Name of the CAS Therapeutic Quantity In Quantity In S.No Product Number category MT/ Month Kg/Day
1 Citalopram 59729-33-8 Antidepressant 7.5 250 2 Escitalopram 128196-01-0 Antidepressant 7.5 250 3 Doxazosin 74191-85-8 antihypertensive 7.5 250 Anti 250 4 Prazosin 19216-56-9 7.5 Hypertensive Anti 250 5 Terazosin 63590-64-8 7.5 Hypertensive
6 Omeprazole 73590-58-6 Antiulcer drug 7.5 250 Gastric Acid 250 7 Lansoprazole 103577-45-3 7.5 Secretion Inhibitor
8 Dexlansoprazole 138530-94-6 Anti-ulcerative 7.5 250 9 Esomeprazole 119141-88-7 Anti-ulcerative 7.5 250 10 Pantaprazole sodium 138786-67-1 7.5 250
11 Rabeprazole 117976-89-3 Anti-ulcerative 7.5 250 12 Domperidone 57808-66-9 Antiemetic 7.5 250 13 Tamsulosin 106133-20-4 Anti-adrenergic 7.5 250 14 Venlafaxine 93413-69-5 7.5 250 15 Fenofibrate 49562-28-9 7.5 250 Total 112.5 3750
Pharmaceutical molecules are variable and unit cannot produce all the molecules at a time. Production quantity of drugs may vary according to market demand but the total proposed production will not exceed the production limit as mention above.
3.5 Raw materials required and Quantities
All the raw materials required for manufacturing of above products will be sourced from local market.
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Pre- Feasibility Report 3.6 Manufacturing Process
The manufacturing process of bulk drugs consists of chemical synthesis extending to stages of processing involving different type of chemical reactions. The generalized Flow chart for bulk drug manufacturing is shown in Figure 4.
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3.6 Resource – Utilize & Recycling 3.6.1 Water Water requirement of the project for domestic and industrial activity during operation phase will be 150 KLD. The water requirement will be met through Bore well. The detailed water requirement shown in below Table 2.
TABLE 2: WATER REQUIREMENT DETAILS Water Requirement (KLD) Waste Sr. Loss Remark Use of Water Water No. Consumption Remark (KLD (KLD) Sewage treated in 12 1. Domestic 12 Fresh-12 2 10 CMD of STP 30 Industrial Fresh from Treated in ETP 2 35 5 Industrial Process RO-35 followed by MEE Process Cooling tower Fresh-8 Treated in ETP of 3 32 8 24 makeup Recycle-24 100 CMD Fresh-10 Treated in ETP of 4 Boiler makeup 24 8 16 Recycle-14 100 CMD Fresh-5 Treated in ETP of 5 Washing 15 0 15 Recycle-10 100 CMD Treated in ETP of 6 Scrubber 2 Fresh-2 0 2 100 CMD 7 Gardening 30 Recycle-30 30 0 Fresh-72 Sewage-10.0 KLD Total 150 97.0 Recycle-78 Effluent-87 KLD
3.6.2 Resource optimization/recycling and reuse Resources such as infrastructure, equipments and manpower will be required in proposed project. In proposed project, industry will recycle waste water from cooling tower, make up through inhouse ETP and propose RO & multiple effect evaporator system.
3.6.3 Power Requirement Power requirement of proposed project will be made available through TSSPDCL. Total power requirement of proposed project will be 1000 KVA. In case of Emergency, 2 no. of DG sets of 250 kVA will be installed on the site which will be used to run inhouse ETP, STP and common lights.
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Pre- Feasibility Report 3.6.4 Fuel Requirement It is proposed to install 2.0 TPH coal fired boiler. Total fuel requirement will be around 5.0 TPD. Coal is procured form local sources.
3.6 Quantity of wastes to be generated Waste Generation & Management Construction Phase: Average construction waste generation over the period of construction would be 25MT which is inclusive of metal pieces, steel, cardboard, rags etc. which will be segregated as per their characteristics & disposed off through authorized vendor. Hazardous solid waste generated will be collected, stored, transported and disposed as per Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. Municipal solid waste generated from labours will be segregated into dry and wet waste which will be disposed off through local municipal body.
Operation Phase: In operation phase generated domestic solid waste will be in the form of dry waste and wet waste. Domestic wet waste and dry waste will be disposed off through local body. Hazardous solid waste generated will be collected, stored, transported and disposed as per Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016. Details of hazardous & non-hazardous are presented in below tables respectively.
E-waste will be disposed off with the help authorized E waste vendors. Almost all computer & server providing companies like IBM, DELL, Acer and Wipro provide services for E-waste management like buyback, recycling or disposal facility.
TABLE 3: DETAILS OF NON-HAZARDOUS WASTE
Sr. No. Description UOM Total Treatment 1 Wooden Material Kg/M 500 Sale to Authorized recycler 2 Glass scrap Kg/M 500 Sale to Authorized recycler 3 HDPE Drums Nos/M 150 Sale to Authorized recycler Plastic scrap & other non 4 Kg/M 250 Sale to Authorized recycler biodegradable waste 5 Paper waste Kg/M 100 Sale to Authorized recycler 6 e-Waste Kg/A 100 Sale to Authorized recycler
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TABLE 4: DETAILS OF HAZARDOUS WASTE
Sr. No. Description Cat UOM Total Method Of Disposal 1 Spent Oil/ used 5.1 kg/month 50 TSPCB Authorized Agencies for Reprocessing/Recycling waste 2 Spent Solvents 20.2 kg/month 10000 Sent to TSDF
3 Distillation residue 20.3 kg/month 1000 Sent to TSDF
4 Spent Catalyst/ 28.2 kg/month 500 Sent to Cement industries Spent Carbon 5 Discarded 33.3 no. / Month 100 Sale to authorized dealer containers 6 Sludge from 34.3 kg/month 75 Sent to TSDF waste water treatment 7 Spent Mother 28.4 kg/month 10000 Sent to TSDF Liquor 8 Spent organic 28.5 kg/month 5000 Sale to authorized solvent recycler/ reprocessor 9 Chemical Sludge, 34.3 kg/month 75 TSPCB Authorized Agencies for Reprocessing/Recycling oil & grease skimming residue 10 Used Lead Acid No…s/Annum 4 Send back to suppliers for Batteries buyback of New Batteries
3.6 Schematic representations of the feasibility drawing which give information of EIA purpose.
The applicability of the S.O 1533 for the proposed project was explored by considering different possibilities & provision made in the said notification. Considering the products & project location of the proposed project it is noticed that the proposed project falls under Category 5 (f) “A” of the Schedule-I of EIA Notification SO 1533 and its amendments.
As per the provision of the SO 1533, it is necessary to get Environmental Clearance by applying to MoEF along with the Environmental Impacts Assessment Study Report for the proposed project prior to commissioning of the project activities.
Therefore the EIA is required to conduct to comply with provisions of SO 1533 made for Category 5(f) “A” of schedule –I of the notification.
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4.1 Site Analysis
4.2 Connectivity
M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd is located at Sy.No. 203/a1 of Mirzapalle village, Shankarampet (r) mandal, Medak district, Telangana State
The nearest habitation from the site is Mirzapalle (Village) at a distance of 1. 0 Km. Highway No.7 (Hyderabad – Nizamabad ) - 4.5Kms in E Railway Station – 1.5 Kms in SE Rajivgandhi International Air Port – 85 Kms in S
4.3 Land Form, Land use and Land ownership.
The project site is located in Non Agricultural Land. There would be no change in Land Use, Land Cover or Topography of plot. After implementation of project a dense green belt would be developed. Total 33 % of Plant area will be allocated for green belt development.
4.4 Existing Infrastructure.
Proposed project in industrial land and the basic infrastructure is already there.
4.5 Soil classification
The district is mainly covered by three types of soils Sandy Loam, Black clay Loam, Laterate types of soil.
4.6 Climatic data from secondary sources.
Temperature Maximum: 44.40C Minimum: 6.9 0C
Normal annual rainfall 1120 mm
4.7 Social Infrastructure available. Well developed social infrastructure facilities are available at nearby Habitations.
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5.0 Planning Brief Further proposed project activities will take care of all the rules and regulation of statutory authority and provide the control measure and devices to achieve the standard norms
6.1 Proposed Infrastructure 6.2 Industrial Area The proposal is new installation, the infrastructure and other facilities are already well developed. Only additional Building and Plant & machinery need to constructed and installed
6.3 Residential Area No residential area is involved in the proposed project. The employs are accommodated in nearby Residential areas during construction phase.
6.4 Green Belt:
Approximately 51.0 % of Green Belt will be provided and maintained.
Sr.no Particulars Area in Sq.m Area in (%) 1 Plant Area 2589.75 27.3 2 Greenbelt Area 4911.66 51.9 Open and Road 3 Area 1968.24 20.8 Total 9469.65 100
6.5 Social Infrastructure:
Facilities like road and communication are good...Banks, ATM’s and medical facilities are also adequate.
Amenities: Education- schools including middle, secondary and higher secondary schools available nearby vicinity. Medical and Health- Community Health Centre, & Primary Health center Are available near villages Power and water- All the villages are electrified and drinking water facilities are extended to all villages. 6.6 Water management Water requirement will be fulfilled through Bore well water.
6.7 Sewerage System: There will be no discharge of industrial effluent (Zero Liquid Discharge). The treated effluent will be reused. Domestic waste water will be disposed off through soak pit system.
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6.8 Industrial Waste Management: Due to proposed project, the effluent from cooling and Plant/Equipment washing will be generated and treated in the well designed Effluent Treatment Plant. The treated effluent will be reused.
7.0 Rehabilitation and Resettlement (R & R) Plan Rehabilitation & Resettlement (R&R) plan is not applicable to proposed project.
8.0 Project Schedule & Cost Estimates Proposed project activities will be started after getting statutory clearance form related authorities. The project will be completed within two years.
Proposed activity will provide benefits to the local people in terms of financial and social welfare. Project cost for the proposed Expansion projects is Rs. 5 Crores which includes the cost of new Buildings and plant & machinery.
9.1 Analysis of proposal (Final Recommendations) Local people will get direct financial benefit by way of employment. Local people will get some contracts of supply and services to get indirect income. Company will contribute in improving education and health facilities in nearby area.
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GOOGLE IMAGE OF THE PROJECT SITE