PRE FEASIBILITY REPORTenvironmentclearance.nic.in/writereaddata/Online/TOR/12... · 2019-09-12 · Pre- Feasibility Report As per the report -Market Entry - Active Pharmaceutical

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

M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd.

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:

Operation phase:

100 No.s

50 No.s

10. Nearest Highway

Highway No.7 (Hyderabad – Nizamabad ) - 2.5Kms

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

1


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.

2


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.

M/S. Sri Karthikeya Bio & Pharma Projects Pvt. Ltd. 3


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.



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



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.



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.



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



FIGURE 2: SITE PHOTOGRAPH




FIGURE – 3: MASTER LAYOUT PLAN

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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

S.No Name of the

Product

CAS

Number

Therapeutic

category

Quantity In

MT/ Month

Quantity In

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

4 Prazosin 19216-56-9 Anti

Hypertensive

7.5 250

5 Terazosin 63590-64-8 Anti

Hypertensive

7.5 250

6 Omeprazole 73590-58-6 Antiulcer drug 7.5 250

7 Lansoprazole 103577-45-3 Gastric Acid

Secretion Inhibitor

7.5 250

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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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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16

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

Sr.

No.

Use of Water

Water Requirement (KLD) Loss

(KLD

Waste

Water

(KLD)

Remark

Consumption Remark

1. Domestic 12 Fresh-12 2 10 Sewage treated in 12

CMD of STP

2

Industrial

Process

35

Fresh from

RO-35

5

30

Industrial

Process

Treated in ETP

followed by MEE

3 Cooling tower

makeup 32

Fresh-8

Recycle-24 8 24

Treated in ETP of

100 CMD

4 Boiler makeup 24 Fresh-10

Recycle-14 8 16

Treated in ETP of

100 CMD

5 Washing 15 Fresh-5

Recycle-10 0 15

Treated in ETP of

100 CMD

6 Scrubber 2 Fresh-2 0 2 Treated in ETP of

100 CMD

7 Gardening 30 Recycle-30 30 0

Total 150 Fresh-72

Recycle-78

97.0 Sewage-10.0 KLD

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.

13



17

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

4 Plastic scrap & other non

biodegradable waste Kg/M 250 Sale to Authorized recycler

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

waste

5.1 kg/month 50 TSPCB Authorized Agencies for Reprocessing/Recycling

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/

Spent Carbon

28.2 kg/month 500 Sent to Cement industries

5 Discarded

containers

33.3 no. / Month 100 Sale to authorized dealer

6 Sludge from

waste water

treatment

34.3 kg/month 75 Sent to TSDF

7 Spent Mother

Liquor

28.4 kg/month 10000 Sent to TSDF

8 Spent organic

solvent

28.5 kg/month 5000 Sale to authorized

recycler/ reprocessor

9 Chemical Sludge,

oil & grease

skimming residue

34.3 kg/month 75 TSPCB Authorized Agencies for Reprocessing/Recycling

10 Used Lead Acid

Batteries

No…s/Annum 4 Send back to suppliers for

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.

15


19


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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.

16


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

3 Open and Road 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.



18

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.


GOOGLE IMAGE OF THE PROJECT SITE

Documents

PRE FEASIBILITY REPORTenvironmentclearance.nic.in/writereaddata/Online/TOR/12... · 2019-09-12 · Pre- Feasibility Report As per the report -Market Entry - Active Pharmaceutical