PART-A

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SHILPA MEDICARE LTD, 100% EOU PAR T-A INDUSTRY PROFILE The roots of the pharmaceutical industry lie back with the apothecaries and pharmacies that offered traditional remedies as far back as the middle ages, but the industry as we understand it today really has its origins in the second half of the 19th century. Whilst the scientific revolution of the 17th century had spread ideas of rationalism and experimentation, and the industrial revolution had transformed the production of goods in the late 18th century, the marrying of the two concepts for the benefit of human health was a comparatively late development. Merck in Germany was possibly the earliest company to move in this direction. Originating as a pharmacy founded in Darmstadt in 1668, it was in 1827 that Heinrich Emanuel Merck began the transition towards an industrial and scientific concern, by manufacturing and selling alkaloids¹. Similarly, whilst GlaxoSmithKline’s origins can be traced back as far as 1715, it was only in the middle of the 19th century that Beecham became involved in the industrial production of medicine, Page 1

Transcript of PART-A

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SHILPA MEDICARE LTD, 100% EOU

PART-A

INDUSTRY PROFILE

The roots of the pharmaceutical industry lie back with the apothecaries and

pharmacies that offered traditional remedies as far back as the middle ages, but the

industry as we understand it today really has its origins in the second half of the

19th century. Whilst the scientific revolution of the 17th century had spread ideas

of rationalism and experimentation, and the industrial revolution had transformed

the production of goods in the late 18th century, the marrying of the two concepts

for the benefit of human health was a comparatively late development.

Merck in Germany was possibly the earliest company to move in this direction.

Originating as a pharmacy founded in Darmstadt in 1668, it was in 1827 that

Heinrich Emanuel Merck began the transition towards an industrial and scientific

concern, by manufacturing and selling alkaloids¹. Similarly, whilst

GlaxoSmithKline’s origins can be traced back as far as 1715, it was only in the

middle of the 19th century that Beecham became involved in the industrial

production of medicine, producing patented medicine from 1842, and the world’s

first factory for producing only medicines in 1859².

Meanwhile, in the USA, Pfizer was founded in 1849, by two German immigrants,

initially as a fine chemicals business. They expanded rapidly during the American

civil war as demand for painkillers and antiseptics rocketed³. Whilst Pfizer was

providing the medicines needed for the Union war effort, a young cavalry

commander named Colonel Eli Lilly was serving in their army. A trained

pharmaceutical chemist, Lilly was an archetype of the dynamic and multi-talented

19th century American industrialist, who after his military career, and trying his

hand at farming, set up a pharmaceutical business in 1876. He was a pioneer of

new methods in the industry, being one of the first to focus on R&D as well as

manufacturing. Another military man in the drugs business was Edward Robinson

Squibb, who as a naval doctor during the Mexican-American war of 1846–1848

threw the drugs he was supplied with overboard due to their low quality. He set up

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a laboratory in 1858, like Pfizer supplying Union armies in the civil war, and

laying the basis for today’s BMS.

Switzerland also rapidly developed a home-grown pharmaceutical industry in the

second half of the 19th century. Previously a centre of the trade in textiles and

dyes, Swiss manufacturers gradually began to realise their dyestuffs had antiseptic

and other properties and began to market them as pharmaceuticals, in contrast to

the origin in pharmacies of other enterprises. Switzerland’s total lack of patent

laws led to it being accused of being a “pirate state” in the German Reichstag.

Sandoz, CIBA-Geigy, Roche and the Basel hub of the pharmaceutical industry all

have their roots in this boom.

It wasn’t just Swiss companies had their roots in the dye trade. Bayer was founded

in 1863 as a dye maker in Wuppertal, the hometown of Karl Marx’s collaborator

Friedrich Engels. It later moved into medicines, commercializing aspirin around

the turn of the 20th century, one of the most successful pharmaceuticals ever at

that point.

The unregulated nature of the trade in medicines during this period ensured there

was a far less strict delineation between “pharmaceutical” and “chemical”

industries than we have nowadays. These companies focused as much on cod liver

oil, toothpaste, citric acid for soft drinks, and hair gel as on prescription

medicines, as well as selling products like heroin on the over-the-counter market.

The national rivalries and conflicts that characterized this period also had their

impact on the developing industry; Bayer had the aspirin trademark and its US

assets seized during World War One, whilst “American” Merck (now Merck &

Co. in the US or Merck Sharp & Dohme [MSD] elsewhere) was compulsorily

split off from its Germany parent company (Merck KGaA) at the same time.¹

Bayer also had its Russian subsidiary seized during the Russian revolution. This

disruption to Germany’s position as the leader in pharmaceuticals in the early 20th

century by the war meant that others, particularly in the US, could take relative

advantage. The beginnings of the globalization of the industry were seen both

before and after the war – in the UK, import duties incentivized many foreign

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companies such as Wyeth, Sandoz, CIBA, Eli Lilly and MSD to set up

subsidiaries in Britain in the post-war years.

The interwar years also marked two breakthroughs that presaged the arrival of the

pharma industry as we know it today. The first was insulin; Frederick Banting and

colleagues managed to isolate insulin that could treat diabetes, up until that point a

fatal condition. But it was only in collaboration with the scientists at Eli Lilly that

they were able to sufficiently purify the extract and industrially produce and

distribute it as an effective medicine.

The second was penicillin, a discovery of an impact possibly unparalleled by any

other in medicine. After Alexander Fleming’s initial discovery of the penicillium

mould’s antibiotic properties in 1928, and Howard Florey and Ernst Chain’s

further experimentation, a government-supported international collaboration

including Merck, Pfizer and Squibb worked on mass producing the drug during

World War Two, saving thousands of soldiers’ lives. The immense scale and

sophistication of the penicillin development effort marked a new era for the way

the pharmaceutical industry developed drugs.

After the war, the arrival of social healthcare systems such as the UK’s National

Health Service (NHS) in Europe created a much more structured system; both for

prescription of drugs and their reimbursement. In 1957, the NHS brought in what

was essentially a price fixing scheme to allow reasonable return on investment for

drug manufacturers, solidifying the incentive to invest in new medicines. This

greater role for the state in healthcare was paralleled on both sides of the Atlantic

in increasing government regulation of medicine production. The Thalidomide

scandal of 1961 prompted an increase in the regulation and testing of drugs before

licensing, with a new amendment to US Food and Drug Administration (FDA)

rules demanding proof of efficacy and accurate disclosure of side-effects for new

medications (the Kefauver Harris Amendment) being implemented in 19624.

Likewise, the 1964 Declaration of Helsinki put greater ethical strictures on clinical

research, clearly cementing the difference between production of scientific

prescription medicines and other chemicals.

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But whilst there were some breakthroughs, the enormous expense and risks

involved in R&D caused many to merely ape their competitors, trying to get a cut

of market-share using “me too” formulations rather than innovating novel

medications. For example, AstraZeneca’s popular proton pump inhibitor Nexium

(esomeprazole), released in 2001, is merely a purified single isomeric version of

an older drug which happened to be losing patent protection. Patents, or the lack

of them, became a problem for the industry. The Hatch-Waxman Act of 1984

regularised generic production in the US, and some developing countries made

policy decisions to ignore medical patents. The industry’s focus increased on

marketing to maintain market share, on lobbying politicians to protect commercial

interests, and on lawyers to enforce legal claims on intellectual property rights.

These activities have brought a greater suspicion of the industry in the public at

large. However, this can be linked to a wider anti-science feeling and more

pessimistic outlook on the possibilities of technology in society, as seen in panics

over issues such as genetically-modified crops and suspicion towards nuclear

power.

Companies have tried to overcome some of these problems by outsourcing various

aspects of their processes, and through buying up smaller companies that perhaps

retain more of the innovative entrepreneurialism of the pioneers of the 19th

century. But new technologies are what really promise a positive future for the

industry in the 21st century. Both computing and biotechnology have allowed

great leaps forward in both development and production of new drugs.

Automation of the drug discovery process through high-throughput screening, and

the computerisation of genomics have allowed breakthroughs at a much higher

rate than previously. Starting with insulin in the 1970s, genetic modification has

allowed production of human proteins by bacteria. And biological drugs such as

the monoclonal antibodies, introduced around the turn of the millennium, hint at a

whole new panorama of far more specific drugs that could impact on human

health as much as the medicines of last century.

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Pharmaceutical industry in India :

The Pharmaceutical industry in India is the world's third-largest in terms of volume and

stands 14th in terms of value. According to Department of Pharmaceuticals, Ministry of

Chemicals and Fertilizers, the total turnover of India's pharmaceuticals industry between

2008 and September 2009 was US$21.04 billion. While the domestic market was worth

US$12.26 billion. Sale of all types of medicines in the country is expected to reach

around US$19.22 billion by 2012.

Exports of pharmaceuticals products from India increased from US$6.23 billion in

2006-07 to US$8.7 billion in 2008-09 a combined annual growth rate of 21.25%.

According to PricewaterhouseCoopers (PWC) in 2010, India joined among the

league of top 10 global pharmaceuticals markets in terms of sales by 2020 with

value reaching US$50 billion. Some of the major pharmaceutical firms including

Sun Pharmaceutical, Cadila Healthcare and Piramal Healthcare.

The government started to encourage the growth of drug manufacturing by Indian

companies in the early 1960s, and with the Patents Act in 1970. However,

economic liberalization in the 1990s by the former Prime Minister P.V.

Narasimha Rao and the then Finance Minister, Dr. Manmohan Singh enabled the

industry to become what it is today. This patent act removed composition patents

from food and drugs, and though it kept process patents, these were shortened to a

period of five to seven years.

The lack of patent protection made the Indian market undesirable to the

multinational companies that had dominated the market, and while they streamed

out. Indian companies carved a niche in both the Indian and world markets with

their expertise in reverse-engineering new processes for manufacturing drugs at

low costs. Although some of the larger companies have taken baby steps towards

drug innovation, the industry as a whole has been following this business model

until the present.

India's biopharmaceutical industry clocked a 17 percent growth with revenues of

Rs.137 billion ($3 billion) in the 2009-10 financial year over the previous fiscal.

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Bio-pharma was the biggest contributor generating 60 percent of the industry's

growth at Rs.8,829 crore, followed by bio-services at Rs.2,639 crore and bio-agri

at Rs.1,936 crore.

Pharmaceutical industry today

The number of purely Indian pharma companies is fairly low. Indian pharma

industry is mainly operated as well as controlled by dominant foreign companies

having subsidiaries in India due to availability of cheap labour in India at lowest

cost. In 2002, over 20,000 registered drug manufacturers in India sold $9 billion

worth of formulations and bulk drugs. 85% of these formulations were sold in

India while over 60% of the bulk drugs were exported, mostly to the United States

and Russia. Most of the players in the market are small-to-medium enterprises;

250 of the largest companies control 70% of the Indian market. Thanks to the

1970 Patent Act, multinationals represent only 35% of the market, down from

70% thirty years ago.

Most pharma companies operating in India, even the multinationals, employ

Indians almost exclusively from the lowest ranks to high level management.

Mirroring the social structure, firms are very hierarchical. Homegrown

pharmaceuticals, like many other businesses in India, are often a mix of public

and private enterprise. Although many of these companies are publicly owned,

leadership passes from father to son and the founding family holds a majority

share.

In terms of the global market, India currently holds a modest 1-2% share, but it

has been growing at approximately 10% per year. India gained its foothold on the

global scene with its innovatively engineered generic drugs and active

pharmaceutical ingredients (API), and it is now seeking to become a major player

in outsourced clinical research as well as contract manufacturing and research.

There are 74 U.S. FDA-approved manufacturing facilities in India, more than in

any other country outside the U.S, and in 2005, almost 20% of all Abbreviated

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New Drug Applications (ANDA) to the FDA are expected to be filed by Indian

companies. Growth in other fields notwithstanding, generics are still a large part

of the picture. London research company Global Insight estimates that India’s

share of the global generics market will have risen from 4% to 33% by 2007. The

Indian pharmaceutical industry has become the third largest producer in the world

and is poised to grow into an industry of $ 20 billion in 2015 from the current

turnover of $ 12 billion

Advantage to India

Competent workforce:

India has a pool of personnel with high managerial and technical

competence as also skilled workforce. It has an educated work force and English is

commonly used. Professional services are easily available.

Cost-effective chemical synthesis:

Its track record of development, particularly in the area of improved cost-

beneficial chemical synthesis for various drug molecules is excellent. It provides a

wide variety of bulk drugs and exports sophisticated bulk drugs.

Globalization:

The country is committed to a free market economy and globalization.

Above all, it has a 7 million middle class market, which is continuously growing.

Consolidation: For the first time in many years, the international pharmaceutical

industry is finding great opportunities in India. The process of consolidation , which

has become a generalized phenomenon in the world pharmaceutical industry, has

stated taking place in India.

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The growth scenario

India’s US$ 3.1 billion pharmaceutical industry is growing at the rate of 14

percent per year. It is one of the largest and most advanced among the developing

countries.

Over 20,000 registered pharmaceutical manufacturing exist in the country.

The domestic pharmaceutical industry output is expected to exceed Rs260 billion in

the financial year 2002, which accounts for merely 1.3 percent of the global

pharmaceutical sector. Of this, the remaining Rs 210 billion (79 percent). In financial

year 2001, imports were Rs 20 billion while exports were Rs87 billion.

Shilpa Medicare Ltd., formerly known as Shilpa Antibiotics was

incorporated as a private limited company in Nov.'87 and has been promoted by

Vishnukant C Bhutada and his associates. The company produces trimethoprim, an

anti-biotic bulk drug. It also manufactures the product for other reputed companies like

Eskayef, Bombay Drugs & Parma’s, Bombay Drug House, US Vitamins, Sandoz

India, etc, for their export commitments. Circa 1992, the company installed production

facilities to manufacture sodium methoxide. SAL is the recipient of the World Health

Organization - Good Manufacturing Practices (GMP) certificate. It exports its products

to hard-currency areas. The company manufactures 1-methyl, amino-1-methyl, thio-2-

nitro ethane, a drug intermediate used in the manufacture of ranitidine, an anti-ulcer

drug. The company proposes to embark upon an expansion project which involves the

addition of one more bulk drug to its existing product range -- norfloxacin -- and

expand the production capacity of the existing products of the company -- sodium

methoxide and trimethoprim

Indian pharmaceutical industry is mounting up the value chain. From

being a pure reverse engineering industry focused on the domestic market, the industry

is moving towards basic research driven, export oriented global presence, providing

wide range of value added quality products and services, innovation, product life cycle

management and enlarging their market reach. The old and mature categories like anti-

infective, vitamins, analgesics are de-growing while, new lifestyle categories like

Cardiovascular, Central Nervous System (CNS), Anti Diabetic are expanding at

double-digit growth rates.

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COMPANY PROFILE

Name of the Company : SHILPA MEDICARE PVT LTD

Address of the Company : Plot No: 33-33A Raichur Industrial Grow,

Wadloor Raod Chicksugur Cross,Hyderabad

Road, Chicksugur-584170

Incorporation Date : 20/11/1987

Area : 20 Acers

BOARD OF DIRECTORS : Shri Omprakash Inani (Chairman)

Shri Vishnukant Bhutada(ManagingDirector )

Shri Pramod Kasat (Director)

Shri Carlton Periera (Director)

Shri Abhay B Upsani (Director)

Shri Ajeet Singh Karan (Director)

AUDITORS : M/S Bohra Bhandari Bung & Associate, Raichur

BANKERS : Lakshmi Vilas Bank Ltd

State Bank of India

ICICI Bank Ltd

Axis Bank Ltd

Company Head Office / Quarters : 10/80 1st Floor, Rajendra gunj, Raichur,

Karnataka-584102

Fax : 91-08532-235876

Phone : 91-08532-235006/23570

E-mail : [email protected]

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Web : http://www.vbshilpa.com

Background and inception of the company :

Established in 1987, Shilpa Medicare Limited has carved a niche for itself

in the exceedingly competitive and quality-conscious sphere of pharmaceutical

manufacturing. It produce and export consistently high-quality active pharmaceutical

ingredients fine chemicals, intermediates, herbal products and specialty chemical

products using sophisticated technology, meticulously following international

specifications. The company has earned its spurs as a successful and reliable partner

within the pharmaceutical industry. Buyers within the country and from across the

borders count on its fast track integrated process development and finely honed

expertise of its skilled and experienced personnel. The Company is already exporting

to USA, Canada, Australia, Japan and European Countries viz., Germany, Switzerland,

Netherlands, Belgium, Spain, Greece, Cyprus, Italy, United Kingdom etc., South

American Countries like Mexico, Brazil, Columbia etc., African Countries like Kenya,

Nigeria and West Indies etc., Asian Countries like Singapore, Taiwan, China,

Malaysia, Thailand and closer to home to Iran, Egypt, Pakistan and Bangladesh. Shilpa

Medicare is synergizing strength through tie-ups for manufacturing products and co-

marketing rights, for it believes in working together and sharing success. Being

proactive in approach, the company continually seeks out enquiry's for development of

new products drawing from the extensive knowledge-base of its qualified and

experienced people as well as sophisticated facilities.

Nature of the business carried:

Reliable Partner for API's & Customs Synthesis; recognized by Govt. of

India & Export House. It is the largest Manufacturer and Exporters of Oncology API's

from India & Bulk Drugs. Products registered in Europe, Russia, Korea, Iran, Canada,

Japan, Australia, etc. With World class State of the art facility. WHO GMP Approved

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Plant. Patents filed for non-infringing manufacturing process. Highly efficient & cost

effective technology & manufacturing process.

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Vision, Mission and Quality policy:

Vision

To become a leading supplier in pharmaceuticals in the world by 2010 with a

focus on Oncology API's and formulations and contract research and manufacturing

Services.

Mission

Shilpa's primary goal is to create cGMP facilities to manufacture Oncology

Products that will enable to obtain approvals from EDQM, UK MHRA, TGA

Australia, Health Canada and USFDA. By supplying products complying the above

regulatory authorities to the pharmaceutical companies worldwide, Shilpa will provide

an optimum return on investment to our investors, shareholders and our employees.

The common people will also enjoy the highest quality products at affordable prices

Quality policy

To provides consistent quality to the customers. Our business aim is to

follow a safety system, and adhere to the responsible care programme and most of all

provide customer satisfaction. To achieve and sustain market leadership for the

products in national & international market by providing to meet the requirements of

customer. Adherence to cGMP norms as an integral part of the total quality

management system.

Product/ Service Profile:

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1. Oncology products 2. Non-Oncology product

Anastrozole Abacavir Sulfate

Bendamustin HCI Ambroxol HCl

Bicalutamide Acebrophylline

Bortezomib Buflomedil HCl

Busulfan Lamivudine

Capecitabine Nifedipine

Carboplatin Phenylephrine HCI

Cisplatin Sildenafil Citrate

Cladribine Ranelate

Decarbazine Terfenadine

Docetaxel Ticlopidine HCl

5-Fluoro Uracil

Gefitinib

Gemcitabine HCl

Hydroxy urea

Imatinib Mesylate

Irinotecan HCl Trihydrate

Lenalidomide

Letrozole

Oxaliplatin

Paclitaxel

Pemetrexed Disodium

Temozolomide

Thalidomide

Topotecan HCl

Zoledronic acid

1. Under Development-Oncology

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Altretamine

Azacytidine

Cladribine

Cyclophospamide

Dasatinib Monohydrate

Disodium Pamidronate

Cytrabine

Decitabine

Estramustine

Erlotinib HCl

Exemestane

Fludarabine Phosphate

Ifosfamide

Lapatinib Distosylate

Melphalan

Mitotane

Methotrexate

Nilotinib

Pazopanib

Sorafenib Tosylate

Sunitinib

Tandutinib

2. Under Development- Non Oncology

Aliskiren

e. Area of Operation: (Global)

o Italy

o Germany

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o China

o Japan

o Australia

o USA

o Turkey

Ownership Pattern:

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Shilpa Medicare Ltd is a privately owned company which is under taken by

the following members:

Chairman : Shri Omprakash Inani

Managing Director : Shri Vishnukant Bhutada

Directors : Shri Pramod Kasat (Director)

Shri Carlton Periera (Director)

Shri Abhay B Upsani (Director)

Shri Ajeet Singh Karan (Director)

Other Directors : Shri Rajendra Sunki Reddy

Shri N P S Shinh

f. Competitors information:

Anjaneya Life Care Ltd

Aarey Drugs & Pharmaceutical Ldt

Aarti Drugs Ltd

Abbott India Ltd

ABL Bio-Technologies Ltd

Addlife Pharma Ltd

Cipla

Piramal Healthcare

Ranbaxy Labs

Dr Reddys Lab

Sun Pharma

Infrastructural Facilities:

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The Company has state of the art facilities for the employees. It gives

importance to the environment and takes the utmost care of health of the workers. The

company is situated in the outskirts of the city and is away from the pollution causing

due to vehicles. The company has 20 acres. The space is also used for greenery

concentrating on the environment that creates a good working condition for the

employees. The company provides all the facilities to the employees, like:

Canteen Facility

Quality assurance

Planning

Better Sales and services

Wash rooms

Drinking water

Transport facility

First Aid

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ACHIEVEMENTS/ AWARDS:

Karnataka State Govt. ''Best Enterpreneur Award''.

Govt. of India ''Best Enterpreneur Award''.

''Star Export House'' Status from Ministry of Commerce and Industry, Govt. of

India.

''Best Export Award'' from Visvesvaraya Industrial Trade Centre, Bangalore,

Govt. of Karnataka, India.

''Outstanding Industrial Award'' from Indian Junior Chamber.

''Registration with ''Russian Health Authority'' for Ambroxol HCl.

''Certificate of Suitability'' received from EDQM for Ambroxol HCl (R0-CEP

2004-201-Rev 00).

''Certificate of Suitability'' received from EDQM for Ticlopidine HCl (R0-CEP

2005-004-Rev 00).

''Certificate of Suitability'' received from EDQM for Carboplatin (R0-CEP 2006-

212-Rev 00).

Patent application on Irinotecan HCl Trihydrate "An improved process for the

preparation of Irinotecan HCl Trihydrate" published as WO2006016203 on date

2006-02-16.

Patent file for Gemcitabine HCl and Anastrozole manufacturing process.

Filed ASMF/EDMF of Gemcitabine HCl over 21 EU countries.

Filed ASMF/EDMF of Irinotecan HCl Trihydrate HCl over 27 EU countries.

Filed ASMF/EDMF of Oxaliplatin HCl over 11 EU countries.

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"Best District Export Award" received from FKCCI, Bangalore on 16.06.2007.

Korean FDA Approved for Gemcitabine HCl & Ambroxol HCl.

COS received from EDQM for Buflomedil HCl (R0-CEP 2006-080-Rev.00).

COS received from EDQM for Oxaliplatin EP (R0-CEP 2006-201-Rev.00).

"Best District Export Award" received from FKCCI, Bangalore on 20.06.2008.

COS received from EDQM for Gemcitabine HCl EP (R0-CEP 2006-222-Re

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Work flow model (End to End):

STAGE: 1

STAGE: II Stage: I

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QC Analysis

Drying

Filtration

Additions

Raw material

Addition of Raw materials

Filtrations

Drying

QC Analysis

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STAGE: III

STAGE: II

Reaction

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Addition Raw materials

Filtration

Drying

Milling

Shifting

Packing

Product Export

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Future growth and prospects:

Shilpa medicare is expecting to construct Raichem Medicare Pvt Ltd

opposite to shilpa medicare ltd

Constructing Raichem Life sciences Pvt Ltd (Formulation Unit).

It has strong determination to expand its plant.

The important plan of the company is to be the leader in the market or to be

in the leading position.

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MCKINSEY’S 7S FRAME WORK

Introduction

The 7-S framework of Mckinsey is a management model that describes 7 factors

to organize a company in a holistic and effective way. Together these factors

determine the way in which a corporation operates. Management should take into

account all of these factors, to be sure successful implementation of strategy. Large

or small, they are interdependent, so if u fails to pay proper attention to one of them,

this may affect all others as well. On top of that the relative importance of each

factor may vary over time.

The 7-S framework was first mentioned in “The art of Japanese Management” by

Richard Pascale and Anthony Athos in 1981. They had been investigating how

Japanese industry had been so successful. At around the same time that Tom Peters

and Robert Waterman were exploring what made a company excellent. The 7-S

model was born at a meeting of these four authors in 1978. It appeared also in “In

search of Excellence” by Peters and Waterman, and was taken up as a basic tool by

the global management consultancy company Mckinsey. Since then it is known as

their 7-S Model.

Let’s look at each of the elements specifically:

Strategy: The plan devised to maintain and build competitive advantage over

the competition.

Structure: The way the organization is structured and who reports to whom.

Systems: The daily activities and procedures that staff members engage in to get

the job done.

Shared Values: Called “Super Ordinate Goals” when the model was first

developed these are the core values of the company that are evidenced in the

corporate culture and the general work ethic.

Style: The style of leadership adopted.

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Staff: The employees and their general capabilities.

Skills: The actual skills and competencies of the employees working for the

company.

Fig 1: Mckinsey’s 7s frame work

Strategy :

To maintain and build competitive advantage over the competition.

Shilpa Medicare follows competitive strategy. As the company wants to expand their

business by providing good quality and to create good work environment in the

organization.

The other strategies used by the company are:

To perform beyond customer expectation and to create a long term

relationship with customers.

To provide products and services of high quality.

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Staff :

The employees and their general capabilities which are necessary to

accomplish the job which leads to achieve organization goals effectively and

efficiently. Staff refers to the number of employees and types of employees in an

organization. Staff is responsible for the development of the organization. Shilpa

Medicare consists of skilled, semiskilled and unskilled employees. The Strength (size)

is 190 on role (permanent employees), 60 contractors all together 250 employees.

Shilpa Medicare PVT LTD staff

* Office Staff - 80

* Skilled employees - 60

* Semi – Skilled - 30

* Unskilled - 20

Structure :

The way the organization is structured and who reports to whom is all

included in the structure of the organization. The design of the organization structure

is critical task of the management of an organization. It is the skeleton of the whole

organization. The organization structure refers to relatively more durable

organizational arrangements and relations. Shilpa medicare pvt ltd has implemented

and successfully working with “FUNCTIONAL ORGANIZATION STRUCTURE”.

ORGANISATION CHART

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Chairman

Omprakash Inani

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PRODUCTION DEPARTMENT

Production is the basic activity of all industrial units. All other activities

revolve around this activity. The end product of the production activity is the creation

of goods and services for the satisfaction of the human wants. The production activity

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Managing Director

B.Vishnukant

Finance Manager Ramakant Inani

General Manager Operations

K.Sharath Reddy

Vice President, R&D

Prashant Purohit

Vice president Q.A & Regulatory affairs Pramod kumar

Store & excise Manager

Purchase manager

HRD Manager

Accounts Manager

Manager, R&D

R&D chemist

Q.A manger

QC, QA chemist & microbiologist

Maintenance manger

Maintenanace supervisor

Chemists

Shift in charges

Production manger

Operators

Electricians Filters Welders

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is nothing but the step-by-step conversion of one form of material into another either

chemically or mechanically. This is done in factories which house manufacturing

processes. The basic input of the production processes is men, machines, plants,

services and methods

World-class production facilities

Reactor capacities ranging from 63 L to 6000 L capacities for low volume-high

cost and high volume-low cost products.

State-of-the-art facilities at Shilpa Medicare are geared to manufacture quality

bulk drugs. They include stainless steel and glass-lined reactors having capacity

ranging from 350-5000 liters. Production processes used at Shilpa Medicare are

environment friendly.

Served by steam, brine, nitrogen and vacuum services.

Range of Temperatures: - 25ºC to +300ºC.

Vacuum: < 1 mm/Hg.

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Tray and Air-bed Drier, Centrifuges, Blenders and Jet Mill.

Bulk storage of solvents including fully closed and delivery systems to reactors.

Chemical and biological waste water treatment.

RESEARCH AND DEVELOPMENT DEPARTMENT

Shilpa Medicare is a fast growing pharmaceutical active ingredient

manufacturing company engaged in manufacturing of world class pharmaceutical

bulk drugs, under WHO-GMP guide lines. Our manufacturing plant is equipped to

manufacture API’S and chemicals and having all the facilities of in house testing and

R & D.

Shilpa Medicare is fully focused on R&D as a means to offer quality

products at competitive price and also for development of new products. We

undertake innovation of new products as per customers' requirement. The production

technologies of all existing products have been developed in-house and the R&D

efforts are aimed at developing highly efficient and cost-effective technologies and

manufacturing process

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Quality Assurance Department

Shilpa Medicare provides consistent quality to the customers. Strict quality

assurance is inherent in every step of our process, from incoming raw materials to

shipment of the finished product. Each of our raw materials is selected by our

experienced purchasing department, based on strict physical and chemical criteria.

Upon arrival at shilpa’s facility, each ingredient lot is carefully checked and analyzed

by our quality control personnel.

The Quality Assurance Department ensures that the manufacturing

facilities and procedures are standardized to provide the international quality

attributes to the products consistently for each batch through a well-documented,

validated and audited system.

Shilpa Medicare is fully equipped with gas chromatograph, spectrophotometers

and other high-tech apparatus; as also micro-biological facilities to check the quality

of raw material, semi-finished products and finished products following Good

Laboratory Practices by qualified and approved chemists.

Skill :

Skilled: The actual skills and competencies of the employees working for the

company. Skills of the work force are technically qualified like ITI’s, chemical

technology (practical knowledge), Engineers or any specified courses completed.

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Semi killed: Semi skilled employees will be having basic knowledge about the

work, they will not be holding any technical education Semiskilled employees

qualifications like 8th or 10th pass out.

Unskilled: No qualification is required, employees like Helper (loading and

unloading the material, movement of materials from one place to another), Office

Boys.

Style :

Autocratic leadership style is followed in Shilpa Medicare. Employees are very

cooperative with their co-workers.

System :

Shilpa Medicare Pvt Ltd. uses the complete systematic processes in all the

fields liquality control systems, standardized Operating Procedure (SOP), and the date

and time analysis Systems for manufacturing processes.

Employee attandence

Attendance is one of the most important tools of evaluation of an employee.

In Shilpa Medicare Pvt. Ltd., the employee attendance is maintained manually in a

register. Whenever the employee enters the organization, he needs to enter the name,

date, time of entrance, signature etc in a register that is maintained at the office as well

as punch card machine is used where employees need to punch the card while incoming

and outgoing from the organization. At the end of every month the number of days

attended by the employee will be assessed and the salary is calculated accordingly.

Wages and salary system

The employees get adequate and equitable remuneration for the work done by

them. In Shilpa Medicare Pvt. Ltd., the jobs are evaluated and based on this salary to be

paid is determined. Salary is paid to the employees in the first week of the every month.

Share value :

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Shared Values observed in Shilpa Medicare Pvt. Ltd., are:

Discipline

Unity

Team work

Belongingness

Coordination

Concern for environment

Aim for excellence in every area.

SWOT analysis

Strengths:

Communication channels operate well, the ways and directions of the

communication channels are clearly defined.

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The products are well-packed and precisely labeled, they can be clearly

identified.

The delivery takes place subsequently to the event of ordering, payments

deadlines are kept.

Low cost of production

Experienced staff

Benefits provided by government to 100% EOU Unit

Weaknesses:

Company not getting quality man power available in this region.

Workers absenteeism

Transportation costs are high

Modern machines are equipments are not installed in the company.

Opportunities:

Better network of customers

Availability of cheap and efficient labor in Raichur.

Better opportunity to set up a new plant in abroad since the export market for

Shilpa Medicare Products is very well established

Drugs that address rising multifactorial disorders such as cancer as well as

lifestyle disorders such as obesity are also likely to experience strong revenue

growth

Threats:

Competitors

Competitive prices

Economic crisis

Analysis of Financial statement :

PROFIT AND LOSS ACCOUNT FOR THE YEAR ENDED 31st MARCH 2011

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Particulars Current year

(31st March, 2011)

Previous year

(31st March, 2010)

INCOME

Sales Turnover 263.37 240.67

Excise Duty 5.82 5.43

NET SALES 257.54 235.24

Other Income 0.00 0.00

TOTAL INCOME 261.30 235.44

EXPENDITURE:

Manufacturing Expense 7.79 6.67

Material Consumed 154.26 128.36

Personal Expenses 17.59 12.12

Selling Expenses 3.89 5.56

Administrative Expenses 4.23 4.33

Expenses Capitalised 0.00 0.00

Provisions Made 0.00 0.00

TOTAL EXPENDITURE 187.76 157.05

Operating Profit 69.79 78.19

EBITDA 73.54 78.40

Depreciation 10.42 9.76

Other Write-offs 0.00 0.00

EBIT 63.12 68.63

Interest 2.27 5.49

EBT 60.85 63.14

Taxes 14.91 21.23

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Profit and Loss for the Year 45.94 41.91

Non Recurring Items 4.86 3.96

Other Non Cash Adjustments 0.09 0.24

Other Adjustments 0.04 -01

REPORTED PAT 50.93 46.01

KEY ITEMS

Preference Dividend 0.00 0.00

Equity Dividend 1.92 1.54

Equity Dividend (% 40.00 35.00

Shares in Issue (Lakhs) 240.24 220.24

EPS - Annualised (Rs) 21.20 20.89

Balance Sheet as at 31st March 2010

Particulars Current year Previous year

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(31st March, 2011) (31st March, 2010)

Liabilities

Share Capital 9.18 4.40

Reserves & Surplus 226.03 107.79

Net Worth 235.21 112.19

Secured Loans 50.97 67.47

Unsecured Loans 0.00 0.00

T OTAL LIABILITIES 286.18 181.19

Assets

Gross Block 163.00 155.96

(-) Acc. Depreciation 35.90 28.02

Net Block 127.09 127.94

Capital Work in Progress 3.01 3.69

Investments 28.08 3.69

Inventories 37.44 43.65

Sundry Debtors 33.63 31.49

Cash And Bank 83.75 2.09

Loans And Advances 32.09 42.23

Total Current Assets 186.91 120.45

Current Liabilities 41.05 52.02

Provisions 17.87 21.93

Total Current Liabilities 58.91 73.95

NET CURRENT ASSETS 128.00 46.50

Misc. Expenses 0.00 0.00

TOTAL ASSETS (A+B+C+D+E) 286.18 181.19

Analysis of financial statement:

Calculation of working capital: Current asset-Current liability

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2010= 119.46 – 45.53 = 73.93

2011= 186.91 – 128 = 58.91

Calculation of current ratio: Current asset

Current liability

2010= 119.46 / 73.95 = 1.6154

2011= 186.91 / 58.91 = 3.1729

Calculation of quick Ratio: Current Asset – Inventory

Current liability

2010= 119.46 – 43.65= 1.0251

73.95

2011= 186.91 – 37.44 = 2.5372

58.91

Calculation of cost benefit ratio = Profit

Capital

2010= 46.01= 10.4569

4.40

2011= 50.93= 39.8692

9.18

Profit margin increased in the year 2011 compared to 2010.

INTRODUCTION TO TOPIC- “Quality of work life”.

I have under taken project on “Quality of work life”. The main reason is to

learn how different work life situations affect employees in their working styles. The

main aim is to understand what good quality work life means to employees and how it

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affects the companies. The project helps me to understand how a company‟s HR

Department try to improve their business by keeping good relation with employee. It

helps to understand how good working conditions help employees to work more

efficiently. “Quality work life” emphasises on how an employee and employer should

keep a proper balance between their work and family

WHAT IS QWL?

The term refers to favorableness and unfavourableness of a total job environment for

people. QWL program are another way in which organizations recognize their

responsibility to develop jobs and working conditions that are excellent for people as

well as for economic health of the organization. The elements in a typical QWL

program includes - open communication. The reward system. A concern for employees

job security and satisfying careers and participation in decision making.QWL

programs usually emphasis development of employee’s skills, the reduction of

occupational stress and the development of more co-operative employee-employer

relations.

QWL means having good supervision, good working conditions, good pay and

benefits and an interesting, challenging and rewarding job. High QWL means an

employee philosophy that encourages the use of QWL efforts, which are

systematically attempts by an organization to give workers greater opportunities to

affect their jobs and their contribution to the organization’s overall effectiveness. i.e.;

a protective human resource department finds ways to empower employees so that

they draw on their “brains and wits,” usually by getting the employees more involved

in their decision making process.

Employee welfare measures are provided in almost all organizations today. However

quality of work life goes beyond just welfare measures. Many studies have been on

the quality of work life in software or high-tech companies, but very few studies are

conducted on manufacturing industry, Therefore, this study intends to establish the

impact of work environment on the quality of work life of employees in a

manufacturing company.

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There has been much concern today about the decent wages, convenient

working hours, conducive working conditions, etc. Their term “Quality of Work life”

has appeared in Research Journals and press in USJ only in 1970s.There is no

generally acceptable definition about this term. However, some attempts were made to

describe the term quality of work life QWL. It refers to the favorableness or

unfavourableness of a job environment for people. J. Richardand J. Lay define QWL

as ‘ the degree to which members of a work organization are able to satisfy important

personnel needs through their experience in the organization.”Quality of work life

improvements are defined as any activity which takes place at every level of an

organization, which seeks greater organizational effectiveness through the enhance me

of human dignity and growth. A process through which the tock-holders in the

organization management, unions and employees—learn how to work together better

to determine for themselves what actions, changes and improvements are desirable and

workable in order to achieve the twin and simultaneous goals of an improved quality

of life at work for all members of the organization and greater effectiveness for both

the. company and the unions. Richard E. Walton explains quality of work life in terms

of eight broad conditions of employment that constitute desirable Quality of Work life

(QWL). He proposed the same criteria for measuring QWL.

The quality of work life(QWL) is a wide term covering an immense

variety of programmes, techniques, theories and management styles through which

organizations and jobs are designed so as grant employees more autonomy,

responsibility and authority than is usually done. It is a comprehensive, department-

wide program designated to improve employee satisfaction, strengthening workplace

learning and helping employees (Anonymous, 2005).A high quality of work life is

essential for organizations to continue, to attract and retain employees (Sandrick,

2003). Many factors contribute to QWL which includes adequate and fair

remuneration, safe and healthy working conditions and social integration in the work

organization that enables an individual to develop and use all his or her capacities; it

holds that people are the most important resource in the organization as they are

trustworthy, responsible and capable of making valuable contribution and they should

be treated with dignity and respect. (Straw, R.J. and C.C. Heckscher, 1984).

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NEEDS &SIGNIFICANCE OF THE STUDY

Quality of work life programs has become important in the work place for the following

reasons:

Social integration in the company

Increased responsibility for elders

Increased demands at work

Loss of long term employment guarantees

The need for enhanced work place skills

QWL Plans are designed to accomplish the following:

Improve communication with employees;

Strengthen family friendly programs;

Increase investment in work place learning;

Increase the effectiveness of the supervisors and team leaders;

Improve ability to manage change and transition.

QWL programs have been found to:

Improve work place morale

Encourage employees commitment

Support recruitment

Encourage retention

Enhance productivity

Reduce absenteeism

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ANALYSIS, INTERPRETATION OF RESULTS:

1. Experience in SHILPA MEDICARE PVT LTD

Rating scale Total Percentage

Less than one year 17 34

One-Tow years 18 36

Two-Five years 2 4

Five years 13 26

34%

36%

4%

26%

Less than one yearOne-two yearsTow-five yearsFive years or more

Analysis:

Above table already says that 36% of respondents are having experience of less than two

year & 34% people are having less than one years experience, 26% are having experience

of more than five years & 4% are having experience of less than five years.

Interpretation:

From the above analysis it shows that more number of employees who are working in

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