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PRE FEASIBILITY REPORT

For

PROPOSED BULK DRUG PRODUCTS MANUFACTURING UNITS

Of

M/s. M.K. DRUGS

F-10, Industrial Area, Focal Point,

Tehsil: Derabassi

Dist: Mohali, Punjab


INTRODUCTION

M/s. M.K. Drugs is proposing a new unit & Proposed of chemical products like Betamethasone
Sodium Phosphate, Betamethasone Dipropionate, Betamethasone Valerate, Beclomethasone
Dipropionate, Clobetasol Propionate, Dexamethasone Sodium Phosphate, Methyl Prednisolone,
Prednisolone Acetate, Deflazacort, Methylcobalamin, Prednisolone Sodium Phosphate and
Budesonide at Plot No. F-10, Industrial Area, Focal Point, Derabassi, District: Mohali, in the state of
Punjab. The proposed capacity of the project is 15 TPA. The proposed project is to be located within
the premises of notified industrial area. These drugs are used in the formulation of medicines. The
company has been promoted by Dr. Manav Malhotra, Ankit Malhotra and Manoj Malhotra
experienced entrepreneur who has business interest in pharmaceuticals. Dr. Manav Malhotra has
done (M. Pharm, Ph. D) in Pharmaceutical Sciences in the field of Steroids. He has research
experience of 7 yrs in Drug Synthesis. Ankit Malhotra has done B.Com and along with Manoj
Malhotra experienced entrepreneur having keen interest in Pharmaceuticals.

DEMAND - SUPPLY GAP

The Indian pharmaceutical Industry has witnessed a robust growth of around 14% since the
beginning of the 11th Plan in 2007 from about Rs 71000 crores to over Rs 1 lac crores in 2009-10
comprising some Rs 62,055 crores of domestic market and exports of over Rs 42,154 crores. This
also amounts to around 20% of total volume of global generics. However, the Industry is quite
fragmented and comprises of nearly 10,500 units with majority of them in unorganized sector. Of
these, about 300-400 units are categorized as belonging to medium to large organized sector with the
top 10 manufacturers accounting for 36.5% of the market share. As regards the Bulk drugs
component of the industry, the market is around Rs 42,000 crores giving it a share of around 50% of
the total domestic market. This gives the Indian Bulk Drug industry a share of about 9% of the global
bulk drug market. As the demand of drugs are increasing day by day due to various reasons is the
reason continuous growth in this sector.

OBJECTIVE

The demand for pharmaceutical products in India is significant and is driven by low drug
penetration, rising middle-class & disposable income, increased government & private spending on
healthcare infrastructure, increasing medical insurance penetration etc. The role of Indian bulk drug
manufacturers in the global pharmaceutical supply chain is gradually evolving with increasing
presence in synthesis and manufacture of late stage intermediates and APIs. Globally, India ranks
third in terms of manufacturing Pharma products by volume. India is having very good engineering
& research scientist pool and long proven expertise of producing quality bulk drugs. The bulk drug
market has a fast progressing growth and there is ample opportunity in indigenous as well as export
market. With an ever-changing market scenario influenced by the impending new patent laws and
the opening up of international trade, the companies are undergoing a continuous process of
diversification these days. And it has to be seen how the industry is going to survive this period of
transition and attain its critical mass, which has to serve as one of the crucial factors for its future
growth.

VISION
 To set an example in the area by becoming a leading organization in the business of Bulk
Drugs.
 To become a well known and reputed organization as a manufacturing company with strong
focus on research.

MISSION
To achieve growth in business by
 Attaining globally competitive cost levels
 Enhancing the value we deliver to stakeholders
 Commitments to corporate responsibility
 To Deliver the customer satisfaction
 Create an environment that fosters achievement, innovation and teamwork.

GOAL
The main goal of the company is to be a major player in the manufacture of Bulk Drugs and to Serve
the Indian and International demand.

PROJECT PROMOTERS
Dr. Manav Malhotra is the Director of the Company. He has wide research experience in Drug
Synthesis and Ankit Malhotra and Manoj Malhotra looks after marketing and general administration
of the unit.
PROJECT
The project proponent proposes to set up its manufacturing activity at F-10, Industrial area, Focal
Point, Tehsil-Derabassi, District-Mohali (Punjab), using the state of art technology, adopting
modernized machineries and equipment and novel process technologies, with waste minimization
techniques. The total capacity of the proposed project to manufacture API Bulk Drugs shall be 15
TPA.
Project Site at Google Image

In order to meet growing market demand, M/s M.K. DRUGS proposed Bulk Drug Products (API)
manufacturing unit. The list of proposed products alongwith their productions capacity is given in
Table 1.1.
STUDY AREA AT A GLANCE
Table 1.1.
LIST OF PROPOSED PRODUCTS ALONG WITH PRODUCTION CAPACITY

SR. NO. NAME OF PRODUCT QUANTITY (TPA)

1. Betamethasone Sodium Phosphate 1.5

2. Betamethasone Dipropionate 1.5

3. Betamethasone Valerate 1.2

4. Beclomethasone Dipropionate 1.2

5. Clobetasol Propionate 1.8

6. Dexamethasone Sodium Phosphate 1.5

7. Methyl Prednisolone 1.2

8. Prednisolone Acetate 0.8

9. Deflazacort 1.2

10. Methylcobalamin 1.2

11. Prednisolone Sodium Phosphate 1.2

12. Budesonide 0.7

Total 15

RAW MATERIAL
It is proposed to procure raw materials from the domestic market and certain quantity of some raw
materials can be imported from China or any other country. The mode of transport will be by
Air or Sea for Imported raw materials.

FINAL PRODUCTS

The final product will be Bulk Drugs an Active Pharmaceutical Ingredients which will transported in
India by Rail / Road or Air while the same will be exported to out-side by Air or Sea.
PLANT

Total land requirement for the proposed project is 4500 feet2. It provides adequate space for the
following areas of working:-
1. Stores for raw material and finished goods.
2. Production halls
3. Quality Assurance / Control Deptt.
4. Offices
5. Utility Section

RESOURCE – UTILIZE & RECYCLING


Water requirement of the project for domestic and industrial activity during operation phase will be
6.7 KLD. The water requirement will be met through from municipal supply. The detailed water
requirement shown in below.
WATER CONSUMPTION DETAIL

Sr. No. Purpose Water Requirement in KLD


1. Process 2
2. Reactor and Floor Washing 1
3 Chiller 2
4 DM Plant 0.2
5 Domestic 1
6 Green Belt 0.5
Total 6.7

PROJECT COST & FEASIBILITY

PROJECT COST
The total capital investment of Proposed Project is Rs. 85 Lakhs. It includes Land and Building,
Plant & Machinery, Environment Protection Measures and its installation and Environment
protection measures cost.
BREAK UP OF PROPOSED INVESTMENT

SR. NO. PARTICULARS AMOUNT

(RS. IN LAKHS)

1. Land and Building 30

2. Plant & Machinery 40

3. Environment Protection Measures 15

Total 85

ENVIRONMENT MANAGEMENT PLAN


AIR QUALITY MANAGEMENT
It is proposed to have a Green Belt plantation along the boundary of the plot, which will intercept the
dispersing particulates.
The sprinkling of water is recommended in areas where dust emission is expected within the plant.
The internal roads of plant are asphalted and hence dust emission shall be to minimum.
WATER MANAGEMENT
The total effluent shall be treated in a full-fledged Zero Discharge Effluent Treatment Plant within
the complex comprising of Primary, Secondary and Tertiary treatment facility with Evaporator and
DMF Sump, Sand Filter, Carbon Filter for reuse of treated.
NOISE MANAGEMENT
The occasional noise has been attenuated by the development of Green Belt around the industrial
complex, and ear-protecting devices will be provided to personnel working in high noise generating
zones. Anti-vibrating pads and acoustic enclosure shall be provided to the DG set.
SOLID WASTE MANAGEMENT
The solid wastes shall be segregated according to their properties, packed, transported and stored in a
separate impervious storage area demarcated for them. They will then be disposed off according to
the requirements of statutory authorities.
HAZARDOUS WASTE MANAGEMENT
The Hazardous wastes generated from the unit are Sulphur Sludge, Catalyst dust and used DG
Set oils. The Sulphur sludge & Catalyst Dust will be sent to TSDF site Nimbuan Dera Bassi which is
developed by PPCB for final disposal & used oil from D.G. Set shall be sold to recyclers. There are
no other hazardous wastes.

OCCUPATIONAL HEALTH & SAFETY


Masks and other PPE’s will be provided as additional personal protection equipment to the workers.
Workers are informed, kept aware and trained about occupational health hazards, due to such
activities and preventive measures. Workers health related problem if any, will be properly
addressed.

BUDGETORY COST OF ENVIRONMENT PROTECTION MEASURES

S.No. Particulars Capital Cost (Rs. In Recurring


Lakhs) Cost/annum
(Rs. In Lakhs)

1. Effluent Treatment Plant 25 12


2. Evaporator 20 14
3. Reverse Osmosis 22 10
4. Rain Water Harvesting 15 4
5. Air Pollution Control 15 5
6. Solid Waste Disposal/Green 7 7
Belt Development
7. 104 52

THE ENVIRONMENT MANAGEMENT CELL shall include:


 Representative of Management (Head of Environment Cell)
 Process Incharge
 Incharge Maintenance Department
 A representative of Environmental Consultants