Project Report

PROJECT REPORT

ON

DOCUMENTATION OF SALES INVOICE AND OTHER RELATED

DOCUMENTS

AT

WINDLAS BIOTECH LIMITED

DEHRADUN

SUBMITTED FOR THE PARTIAL FULFILLMENT OF

BACHELOR OF BUSINESS ADMINISTRATION

(FINANCE)

(2009-2011)

BY

MOHIT SEHGAL

INTERNAL GUIDE EXTERNAL GUIDE Mr. N.S. Vohra

1

2

CONTEXT PAGE.NO

3

ACKNOWLEDGEMENT

Presenting a summer Training project of this is an arduous task, demanding a lot of time.

I cannot in full measure reciprocate the kindness shown and contribution made by various

persons in this endeavor. I will remember all of them with gratitude.

My sincere thanks towards GRAPHIC ERA UNIVERSITYfor giving me a

chance to take this project and for his valuable guidance, which helped me on all those

points, which I needed to include in, with full intensity.

I am extremely gratified to Mr. Sanjeev Verma, Manager HR &Admn.,

Windlas Biotech Limited who was extremely helpful in offering his professional

expertise and bestowing me practical knowledge in all spheres related to the whole

organization working.

I am very grateful to my mentors Mr. Amar Johri & Mr. N.S. Vohra for

his significant support extended for the successfully completion of the project as he

support me all through the project and devoted his precious time for me. I am really

appreciative to this organization and the employees of WBL for full co-operation, support

and motivation that helped me a lot in completing my project here.

I am always beholden to my God, for always being with me and showing

me the right way, my family, for always doing favor to me and my friends and colleagues

consistently helped with encouragement, creative inputs and criticism throughout the

project work, for always lifting my sights to higher vision, raising my personality beyond

normal limitation and for realizing me my strengths and potential.

In the end I apologize for any mistake made by me in the project and once again thank

everyone for their support and guidance.

MOHIT SEHGAL

B.B.A 5th (Finance)

4

PREFACE

BBA is a stepping-stone to the management carrier and to develop good manager it is

necessary that the theoretical must be supplemented with exposure to the real

environment.

Modern business world is full of competition, uncertainty and exposed to different

types of risks. The complexity of managerial problems has led to the development of

various managerial tools, techniques and procedures useful for the management in

managing the business successful.

Theoretical knowledge just provides the base and it’s not sufficient to produce a

good manager that’s why practical knowledge is needed. Therefore the research product

is an essential requirement for the student of BBA. This research project not only helps

the student to utilize his skills properly learn field realities but also provides a chance to

the organization to find out talent among the budding managers in the very beginning.

In accordance with the requirement of B.B.A course I have summer training

project on the topic “DOCUMENTATION OF SALES INVOICE AND OTHER

RELATED DOCUMENTS.” The main objective of the research project was to study the

company’s sales procedure and other complications involved in it.

An attempt has been made to study and understand the sales procedure in Windlas

Biotech Limited and convert the theoretical practices into the practical working life.

5

REF: WBL/PERS/2010

DATE: 31.07.2010

TO WHOM IT MAY CONCERN

This is to certify that Mr. Mohit Sehgal Student of B.B.A ( Finance) 3rd year from

“Graphic Era University” Dehradun, successfully completed his industrial training in

our organization w.e.f 1st July-10 to 31st July-10 in “Finance Department”

During the tenure of his training, we found him sincere and hardworking towards his

work.

For WINDLAS BIOTECH LTD.

(Sanjeev Verma)

Manager – HR & Admn.

6

GRAPHIC ERA UNIVERSITY

566/6,BELL ROAD,CLEMENTOWN

DECLARATION

I, MOHIT SEHGAL , hereby declare that the project entitled “DOCUMENTATION

OF SALES INVOICE AND RELATED DOCUMENTS” is my original work, done by

me. Now it is an asset of “WINDLAS BIOTECH LTD. DEHRADUN”. All the rights

for using this project report lie with the company. Unauthorized copying, hiring,

broadcasting, or rental of this project without permission from the organization will be

considered illegal.

MOHIT SEHGAL

B.B.A 5th (Finance)

7

INTRODUCTION

INDUSTRY PROFILE

The Indian pharmaceutical industry

The Indian pharmaceutical industry is the world's second-largest by volume and is

likely to lead the manufacturing sector of India. India's bio-tech industry clocked a 17

percent growth with revenues of Rs.137 billion ($3 billion) in the 2009-10 financial year

over the previous fiscal. 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. The first pharmaceutical company are Bengal Chemicals and

Pharmaceutical Works, which still exists today as one of 5 government-owned drug

manufacturers, appeared in Calcutta in 1930. For the next 60 years, most of the drugs in

India were imported by multinationals either in fully-formulated or bulk form. The

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

in the early 1960s, and with the Patents Act in 1970, 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 started to

take their places. They 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.

A highly organized sector, the Indian Pharma Industry is estimated to be worth $ 4.5

billion, growing at about 8 to 9 percent annually. It ranks very high in the third world, in

terms of technology, quality and range of medicines manufactured. From simple

headache pills to sophisticated antibiotics and complex cardiac compounds, almost every

type of medicine is now made indigenously. Playing a key role in promoting and

8

sustaining development in the vital field of medicines, Indian Pharma Industry boasts

of quality producers and many units approved by regulatory authorities in USA and UK.

International companies associated with this sector have stimulated, assisted and

spearheaded this dynamic development in the past 53 years and helped to put India on the

pharmaceutical map of the world. The Indian Pharmaceutical sector is highly fragmented

with 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 with

market leader holding nearly 7% of the market share. It is an extremely fragmented

market with severe price competition and government price control.

The pharmaceutical industry in India meets around 70% of the country's demand for bulk

drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules,

orals and injectibles. 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.

Following the de-licensing of the pharmaceutical industry, industrial licensing for most of

the drugs and pharmaceutical products has been done away with. Manufacturers are free

to produce any drug duly approved by the Drug Control Authority. Technologically

strong and totally self-reliant, the pharmaceutical industry in India has low costs of

production, low R&D costs, innovative scientific manpower, strength of national

laboratories and an increasing balance of trade. The Pharmaceutical Industry, with its rich

scientific talents and research capabilities, supported by Intellectual Property Protection

regime is well set to take on the international market.

9

The Indian pharmaceutical industry

Top 10 Pharmaceuticals in India, as of 2004

Rank CompanyRevenue 2004 (Rs crore)

Revenue 2004 (USD millions)

1 Ranbaxy Laboratories 4,461 1,026

2 Dr. Reddy's Laboratories 1,933 444

3 Cipla 1,842 423

4 Piramal Healthcare 1,387 319

5 Aurobindo Pharma 1,260 290

6 GlaxoSmithKline 1,228 282

7 Lupin Laboratories 1,180 271

8 Sun Pharmaceutical Industries 1,110 255

9 Cadila Healthcare 1,091 251

10 Wockhardt 980 225

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.

10

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 New Drug Applications (ANDA) to the FDA are

expected to be filed by Indian companies. Growths 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.

Patents

As it expands its core business, the industry is being forced to adapt its business model to

recent changes in the operating environment. The first and most significant change was

the January 1, 2005 enactment of an amendment to India’s patent law that reinstated

product patents for the first time since 1972. The legislation took effect on the deadline

set by the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS)

agreement, which mandated patent protection on both products and processes for a period

of 20 years. Under this new law, India will be forced to recognize not only new patents

but also any patents filed after January 1, 1995. Indian companies achieved their status in

the domestic market by breaking these product patents, and it is estimated that within the

next few years, they will lose $650 million of the local generics market to patent-holders.

In the domestic market, this new patent legislation has resulted in fairly clear

segmentation. The multinationals narrowed their focus onto high-end patients who make

up only 12% of the market, taking advantage of their newly-bestowed patent protection.

Meanwhile, Indian firms have chosen to take their existing product portfolios and target

semi-urban and rural populations.

11

Product development

Companies are also starting to adapt their product development processes to the new

environment. For years, firms have made their ways into the global market by

researching generic competitors to patented drugs and following up with litigation to

challenge the patent. This approach remains untouched by the new patent regime and

looks to increase in the future. However, those that can afford it have set their sights on

an even higher goal: new molecule discovery. Although the initial investment is huge,

companies are lured by the promise of hefty profit margins and the recognition as a

legitimate competitor in the global industry. Local firms have slowly been investing more

money into their R&D programs or have formed alliances to tap into these opportunities.

Small and medium enterprises

As promising as the future is for a whole, the outlook for small and medium enterprises

(SME) is not as bright. The excise structure changed so that companies now have to pay a

16% tax on the maximum retail price (MRP) of their products, as opposed to on the ex-

factory price. Consequently, larger companies are cutting back on outsourcing and what

business is left is shifting to companies with facilities in the four tax-free states -

Himachal Pradesh, Jammu & Kashmir, Uttarakhand and Jharkhand.

As SME’s wrestled with the tax structure, they were also scrambling to meet the July 1

deadline for compliance with the revised Schedule M Good Manufacturing Practices

(GMP). While this should be beneficial to consumers and the industry at large, SMEs

have been finding it difficult to find the funds to upgrade their manufacturing plants,

resulting in the closure of many facilities. Others invested the money to bring their

facilities to compliance, but these operations were located in non-tax-free states, making

it difficult to compete in the wake of the new excise tax.

12

Challenges

All of these changes are ultimately good for the Indian pharmaceutical industry, which

suffered in the past from inadequate regulation and large quantities of spurious drugs.

They force the industry to reach a level necessary for global competitiveness. However,

they have also exposed some of the inadequacies in the industry today. Its main weakness

is an underdeveloped new molecule discovery program. Even after the increased

investment, market leaders such as Ranbaxy and Dr. Reddy’s Laboratories spent only 5-

10% of their revenues on R&D, lagging behind Western pharmaceuticals like Pfizer,

whose research budget last year was greater than the combined revenues of the entire

Indian pharmaceutical industry. This disparity is too great to be explained by cost

differentials, and it comes when advances in genomics have made research equipment

more expensive than ever. The drug discovery process is further hindered by a dearth of

qualified molecular biologists. Due to the disconnect between curriculum and industry,

pharmas in India also lack the academic collaboration that is crucial to drug development

in the West.

R&D

Both the Indian central and state governments have recognized R&D as an important

driver in the growth of their pharma businesses and conferred tax deductions for expenses

related to research and development. They have granted other concessions as well, such

as reduced interest rates for export financing and a cut in the number of drugs under price

control. Government support is not the only thing in Indian pharma’s favor, though;

companies also have access to a highly-developed IT industry that can partner with them

in new molecule discovery.

Labor force

India’s greatest strengths lie in its people. India also boasts a cheap, well-educated,

English-speaking labor force that is the base of its competitive advantage. Although

molecular biologists are in short supply, there are a number of talented chemists who are

equally as important in the discovery process. In addition, there has been a reverse brain-

13

drain effect in which scientists are returning from abroad to accept positions at lower

salaries at Indian companies. Once there, these foreign-trained scientists can transfer the

benefits of their knowledge and experience to all of those who work with them. India’s

wealth of people extends benefits to another part of the drug commercialization process

as well. With one of the largest and most genetically diverse populations in any single

country, India can recruit for clinical trials more quickly and perform them more cheaply

than countries in the West. Indian firms have just recently started to leverage.

ADVANTAGE INDIA I. 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.

II. Legal & Financial Framework: India has a 53 year old democracy and hence

has a solid legal framework and strong financial markets. There is already an

established international industry and business community.

III. Information & Technology: It has a good network of world-class educational

institutions and established strengths in Information Technology.

IV. Globalization: The country is committed to a free market economy and

globalization. Above all, it has a 70 million middle class market, which is

continuously growing.

V. 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 started taking place in India.

14

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 manufacturers exist in the country. The

domestic pharmaceuticals industry output is expected to exceed Rs260 billion in the

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

sector. Of this, bulk drugs will account for Rs 54 billion (21%) and formulations, the

remaining Rs 210 billion (79%). In financial year 2001, imports were Rs 20 billion

while exports were Rs87 billion.

STEPS TO STRENGTHEN THE INDUSTRY

Indian companies need to attain the right product-mix for sustained future growth.

Core competencies will play an important role in determining the future of many

Indian pharmaceutical companies in the post product-patent regime after 2005. Indian

companies, in an effort to consolidate their position, will have to increasingly look at

merger and acquisition options of either companies or products. This would help

them to offset loss of new product options, improve their R&D efforts and improve

distribution to penetrate markets. Research and development has always taken the

back seat amongst Indian pharmaceutical companies. In order to stay competitive in

the future, Indian companies will have to refocus and invest heavily in R&D.

The Indian pharmaceutical industry also needs to take advantage of the recent

advances in biotechnology and information technology. The future of the industry

will be determined by how well it markets its products to several regions and

distributes risks, its forward and backward integration capabilities, its R&D, its

consolidate. The Indian pharmaceutical industry is highly regulated. The Government

controls prices of a large number of bulk drugs and formulations. Profit margins of

players vary widely in both domestic and export sales due to many factors.

Domestic Trade

More than 85% of the formulations produced in the country is sold in the domestic

15

market. India is largely self-sufficient in case of formulations. Some life saving, new

generation under-patent formulations continue to be imported, especially by MNCs,

which then market them in India. Overall, the size of the domestic formulations

market is around Rs160 billion and it is growing at 10% p.a.

Exports

Over 60% of India’s bulk drug production is exported. The balance is sold locally to

other formulators. India’s pharmaceutical exports are to the tune of Rs87billion, of

which formulations contribute nearly 55% and the rest 45% comes from bulk drugs.

In financial year 200, exports grew by 21%. India’s pharmaceuticals imports were to

the tune of Rs20.3billion in FY2001. Imports have registered a CAGR of only 2% in

the past 5 years. Import of bulk drugs have slowed down in the recent years through

mergers and acquisitions, co-marketing and licensing agreements.

The exports of Pharmaceuticals during the year 1998-97 were Rs 49780 million.

From a meager Rs 46 crores worth of Pharmaceuticals, Drugs and Fine Chemicals

exports in 1980-81, pharmaceutical exports has risen to approximately Rs 6152

Crores (Prov.1998-99), a rise of 11.91% against the last year exports. Amongst the

total exports of India, the percentage share of Drugs, Pharmaceuticals and Fine

Chemicals during April-October (2000-2001) was 4.1%, an increase of 7%.

As per WTO, from the year 2005, India will grant product patent recognition to all

new chemical entities (NCEs) i.e., bulk drugs developed then onwards. The Indian

Government's decision to allow 100 percent foreign direct investment into the drugs

and pharmaceutical industry is expected to aid the growth of contract research in the

country. Technology transfer to 100 percent Indian subsidiaries of MNCs is expected

only in 2005.

Indian pharmaceutical interests in making a mark on the global scene got a boost

when Dr. Reddy's licensed two of its anti-diabetic molecules to Novo Nordisk and

when Ranbaxy licensed its Novel Drug Delivery System (NDDS) of ciprofloxacin to

Bayer. MNCs in India faced the problem of having a very high DPCO coverage,

weakening their bottom lines as well as hindering their growth through the launch of

16

new products. DPCO coverage is expected to be diluted further in the near future

benefiting the MNCs. New legislation is also expected in the OTC segment

increasing the number of brands in the Over the Counter (OTC) segment.

The Indian pharmaceutical industry is also getting increasingly U.S. FDA compliant

to harness the growth opportunities in areas of contract manufacturing and research.

Indian companies such as Ranbaxy, Sun Pharma, and Dr. Reddy's are increasingly

focusing on tapping the U.S. generic market, projected to be around $18 billion by

2004.

Biotechnology

Relationship between pharmaceuticals and biotechnology

Unlike in other countries, the difference between biotechnology and pharmaceuticals

remains fairly defined in India. Bio-tech there still plays the role of pharma’s little sister,

but many outsiders have high expectations for the future. India accounted for 2% of the

$41 billion global biotech market and in 2003 was ranked 3rd in the Asia-Pacific region

and 11th in the world in number of biotechs. In 2004-5, the Indian biotech industry saw

its revenues grow 37% to $1.1 billion. The Indian biotech market is dominated by

biopharmaceuticals; 75% of 2004-5 revenues came from biopharmaceuticals, which saw

30% growth last year. Of the revenues from biopharmaceuticals, vaccines led the way,

comprising 47% of sales. Biologics and large-molecule drugs tend to be more expensive

than small-molecule drugs, and India hopes to sweep the market in biogenerics and

contract manufacturing as drugs go off patent and Indian companies upgrade their

manufacturing capabilities.

17

Biotechnology statistics

Top 20 Biotechnology Companies in India, 2004

Rank CompanyRevenue 2004

(Rs crore)

Revenue 2004 (USD millions)

1 Biocon 646 148.6

2 Serum Institute of India 565 129.9

3 Panacea Biotec 217 50.0

4 Venkateshwara Hatcheries 188 43.2

5 Mahyco Monsanto 166 38.3

6 Novo Nordisk 135 31.0

7 Rasi Seeds 87 20.0

8 Aventis Pharma 84 19.4

9 Bharat Serums 81 18.6

10 Chiron Behring Vaccines 78 17.9

11 GlaxoSmithKline 78 17.9

12 Indian Immunologicals 72 16.6

13 Shantha Biotechnics 70 16.1

14 Novozymes 69 15.9

15 Eli Lilly and Company 68 15.7

16 Wockhardt 67 15.4

17 Bharat Immunological & Biological Corp. 53 12.3

18 Bharat Biological International 41 9.4

19 Advanced Biochemicals 40 9.1

20 Biological E 36 8.3

Most companies in the biotech sector are extremely small, with only two firms breaking

100 million dollars in revenues. At last count there were 265 firms registered in India,

over 75% of which were incorporated in the last five years. The newness of the

18

companies explains the industry’s high consolidation in both physical and financial

terms. Almost 50% of all biotechs are in or around Bangalore, and the top ten companies

capture 47% of the market. The top five companies were homegrown; Indian firms

account for 62% of the biopharma sector and 52% of the industry as a whole. The

Association of Biotechnology-Led Enterprises (ABLE) is aiming to grow the industry to

$5 billion in revenues generated by 1 million employees by 2009, and data from the

Confederation of Indian Industry (CII) seem to suggest that it is possible.

Comparison with the U.S.

The Indian biotech sector parallels that of the U.S. in many ways. Both are filled with

small start-ups while the majority of the market is controlled by a few powerful

companies. Both are dependent upon government grants and venture capitalists for

funding because neither will be commercially viable for years. Pharmaceutical companies

in both countries have recognized the potential effect that biotechnology could have on

their pipelines and have responded by either investing in existing start-ups or venturing

into the field themselves. In both India and the U.S., as well as in much of the globe,

biotech is seen as a hot field with a lot of growth potential.

Relationship with IT

Many analysts have observed that the hype around the biotech sector mirrors that of the

IT sector. Biotech colleges have been popping up around the country eager to service the

pools of students that want to take advantage of a growing industry. The International

Finance Commission, the private investment arm of the World Bank, called India the

“centerpiece of IFC’s global biotech strategy.” Of the $110 million invested in 14 biotech

projects investment globally, the IFC has given $43 million to 4 projects in India.

According to Dr. Manju Sharma, former director of the Department of Biotechnology,

the biotech industry could become the “single largest sector for employment of skilled

human resource in the years to come.” British Prime Minister Tony Blair was similarly

impressed, citing the success of India’s biotech industry as the reason for his own

19

country’s own biotech opportunities. Malaysia is also looking to India as an example for

growing its own biotech industry.

Government support

The Indian government has been very supportive. It established the Department of

Biotechnology in 1986 under the Ministry of Science and Technology. Since then, there

have been a number of dispensations offered by both the central government and various

states to encourage the growth of the industry. India’s science minister launched a

program that provides tax incentives and grants for biotech start-ups and firms seeking to

expand and establishes the Biotechnology Parks Society of India to support ten biotech

parks by 2010. Previously limited to rodents, animal testing was expanded to include

large animals as part of the minister’s initiative. States have started to vie with one

another for biotech business, and they are offering such goodies as exemption from VAT

and other fees, financial assistance with patents and subsidies on everything ranging from

investment to land to utilities.

Foreign investment

The government has also taken steps to encourage foreign investment in its biotech

sector. An initiative passed earlier this year allowed 100% foreign direct investment

without compulsory licensing from the government. In April, a delegation headed by the

Kapil Sibal, the minister of science and technology and ocean development, visited five

cities in the U.S. to encourage investment in India, with special emphasis on biotech. Just

two months later, Sibal returned to the U.S. to unveil India’s biotech growth strategy at

the BIO2005 conference in Philadelphia.

Challenges

20

The biotech sector faces some major challenges in its quest for growth. Chief among

them is a lack of funding, particularly for firms that are just starting out. The most likely

sources of funds are government grants and venture capital, which is a relatively young

industry in India. Government grants are difficult to secure, and due to the expensive and

uncertain nature of biotech research, venture capitalists are reluctant to invest in firms

that have not yet developed a commercially viable product. As previously mentioned,

India hopes to solve its funding problem by attracting overseas investors and partners.

Before these potential saviors will invest significant sums in the industry, however, there

needs to be better scientific and financial accountability. India is slowly working towards

these goals, but it will be a while before they are up to the standards of Western investors.

India’s biotech firms share another problem with their pharmaceutical cousins: a lack of

qualified employees. Biotech has the additional disadvantage of competing against IT for

ambitious, science-minded students but not being able to guarantee the same

compensation. An aspiring researcher in India needs 7–10 years of education covering a

range of specialties in order to qualify to work in biotech. Even if a student does choose

to go on the biotech path, the ineffectual curriculum at many universities makes it

doubtful as to whether he will be qualified to work in the field once finished. One

estimate shows that 10% of upper-echelon biotech recruits have come from foreign

countries. While this is not a problem, per se, it drives up cost in a country whose

competitive advantage is based on cheap, high-quality labor. Far from ending with

scientists, there is also a shortage of people with knowledge of biotechnology in related

fields: doctors, lawyers, programmers, marketing personnel and others.

While little has been done about the latter half of the employee crunch, the government

has addressed the problem of educated but unqualified candidates in its Draft National

Biotech Development Strategy. This plan included a proposal to create a National Task

Force that would work with the biotech industry to revise the curriculum for

undergraduate and graduate study in life sciences and biotechnology. The government’s

strategy also stated intentions to increase the number of PhD Fellowships awarded by the

Department of Biotechnology to 200 per year. These human resources will be further

21

leveraged with a “Bio-Edu-Grid” that will knit together the resources of the academic and

scientific industrial communities, much as they are in the U.S.

Major players

I. Ranbaxy Laboratories: Arun Puri, Chairman.Ranbaxy is the leader in the Indian pharmaceutical market, taking in $1.174 billion in

revenues for a net profit of $160 million in 2004. It was the first Indian

pharmaceutical to have a proprietary drug approved by the U.S. FDA, and the U.S.

market accounts for 36% of its sales. 78% of Ranbaxy’s sales are from overseas

markets; its offices in 44 countries manage manufacturing in 7 countries and

distribution in over 100.

IMS Health estimated that Ranbaxy is among the top 100 pharmaceuticals in the

world and that it is the 15th fastest growing company. By 2012, Ranbaxy hopes to be

one of the top 5 generics producers in the world, and it consolidated its position with

the purchase of French firm RGP Aventis in 2003. Ranbaxy also has higher

aspirations, however, “to build a proprietary prescription business in the advanced

markets.” To this end, it keeps a dedicated research facility in Gurgaon staffed with

over 1100 scientists. They currently have two molecules in Phase II trials and 3-5 in

pre-clinical testing. It spent $75 million in R&D in 2004, a 43% increase over its

2003 expenditure

II. Dr. Reddy's Laboratories: K. Anji Reddy, Chairman.

Founded in 1984 with $160,000, Dr. Reddy’s was the first Asia-Pacific

pharmaceutical outside of Japan and the sixth Indian company to be listed on the New

York Stock Exchange. It earned $446 million in fiscal year 2005, deriving 66% of

this income from the foreign market. In order to strengthen its global position, Dr.

Reddy acquired UK-based BMS Laboratories and subsidiary Meridian Healthcare.

22

Although 58% of Dr. Reddy’s revenues come from generic drugs, the company was

committed to WTO-compliance long before the 2005 bill took effect, and most of

these products were already off patent. Dr. Reddy has long been a research-oriented

firm, preceding many of its peers in setting up a New Drug Development Research

(NDDR) in 1993 and out-licensing its first compound just four years later. Dr.

Reddy’s has since outlicensed two more molecules and currently has three others in

clinical trials.

Although Dr. Reddy’s is publicly-traded, the Reddy family (including

founder/chairman K. Anji Reddy, son-in-law/CEO GV Prasad and son/COO Satish

Reddy) holds a hefty 26% share in the company.

III. Nicholas Piramal : Asish Mishra, Chairman

Now a company grossing $350 million per year, Nicholas Piramal started its

existence with the 1988 acquisition of Nicholas Laboratories and grew through a

series of mergers, acquisitions and alliances. The company has formed a name for

itself in the field of custom manufacturing. It cites its 1700-person global sales force

as another core strength; with its acquisition of Rhodia’s inhalation anaesthetics

business, Nicholas Piramal gained a sales and marketing network spanning 90

countries.

Nicholas Piramal is well-poised for the challenge of surviving in the aftermath of

product patent protection. The company has respected intellectual property rights

since its inception and refused to "support generic companies seeking first-to-file or

early-to-market strategies." Instead, it decided to make its own intellectual property

and opened a research facility last November in Mumbai with hopes of launching its

first drug in 2010 at a cost of $100,000.

IV. Cipla : Dr. Yusuf K. Hamied, Chairman and Managing Director.

23

Cipla burst into the international consciousness in 2000 with Triomune, an AIDS

treatment costing between $300 and $800 per year that infringed upon patents held by

several companies who were selling the cocktail for $12,000 per year. Long before

this news, Cipla had been building a strong global presence, and it now distributes its

800-odd products in over 140 countries. Privately-held Cipla holds a prominent spot

in its home country as well; it is the leader in domestic sales, having just unseated

GlaxoSmithKline for the first time in 28 years. Revenue in 2004 totaled $552 million

(using Rs 43.472 = $1) about 75% of which was derived in India. Cipla did not report

having a research program.

V. Biocon : Dr. Kiran Mazumdar-Shaw, Chairman and Managing Director.

Originally an extension to an Irish chemicals company seeking to break into the

Indian market, Biocon is now the leading biotech in India, bringing in Rs 646.36

crore (almost $150 million) in revenue for fiscal year 2004. It initially made its

money by producing enzymes, but Biocon recently decided to become a research-

oriented company with the goal of bringing a proprietary new drug to market.The

company went public in March 2004, and "its shares were oversubscribed by 33 times

on opening day." Eight months later it launched Insugen, a bio-insulin that is its first

branded product. Biocon also has two wholly-owned subsidiaries, Syngene and

Clinigene, that perform custom research and clinical trials.

VI. Serum Institute of India : Dr. Cyrus Poonawalla, Chairman.

The Serum Institute of India can make the enviable claim that 2 out of every 3

children in the world are immunized with one of their vaccines. It is the world’s

largest producer of measles and DTP vaccines, and its portfolio includes other

vaccines, antisera, plasma products and anticancer compounds. The Serum Institute

earned Rs 565 crore ($130 million) in revenue in fiscal year 2005, selling mainly to

UN agencies and to the Indian government. The Serum Institute is part of the

Poonawalla Group, whose holdings include a horse stud farm and manufacturers of

industrial equipment and components.

24

COMPANY’S PROFILE

25

WINDLAS GROUP

The Windlass family has been an established business house since 1937. With its early

beginnings in manufacturing of steel handicrafts, the family expanded into many sectors

like garments, oil-field drilling equipment, real-estate, hotels and Pharmaceuticals over

the last 72 years. The combined annual turnover of the group exceeded Rs. 350 crores.

Our companies are entrepreneur owned but professionally run, and we pride ourselves in

being partners to success of our clients.

Diversified Business Domains

As a highly diversified name in business ranging from the manufacturing of authentic

replicas of historic battle arms, modern and period clothing, real estate development to

hospitality in India, Windlas Group also has spread its wings further to United States with

mail order retail and amusement park business.

The seeds of our development were duly sown by honourable late Mr. Ved Prakash

Windlass when he under the patronage of Windlass Steel Crafts started to manufacture

Gurkha Khukris for the British Army in India, way back in 1943.

At Windlass, we firmly believe that it's the spirit and the unbound zeal that drives in the

real focus on successful businesses, ensuring commitment for progress and creation of

value. At work and off it, we are guided by the soul and flesh of these golden words:

Technology, Finance, Strategy and Planning. As each segment focuses on the areas, the

whole group aims to develop a successful, highly efficient cooperation with profitability

thrown in good measure.

CORPORATE STRUCTURE

26

Windlass Group is a family owned diversified business house since last 70 years in

Pharmaceuticals, Steel-crafts, Garments, Real-estate development, Hotels, Engineering

services, etc.

With a pioneering spirit at its core, the Windlass Group of Companies is ever growing

enterprise. Branching forth and diversifying as it builds on its strength and stability

through an uncompromising resolve to surmount the challenges of the times. Established

in 1943, they are involved in the ventures ranging from the manufacture of sharp edged

theyapons to clothing, pharmaceuticals, real estate and hotels. Today, with a strong

foothold in the global market, the group is surging ahead achieving success in all its

endeavors. This success has been achieved by implementing key principles which are:

Maintaining good quality

Achieving reliable delivery

Continuous innovation in research, Design and development

Atlanta Cutlery Corp - Specialty Retailer of Hunting Gear,

Antique Militaria and authorized US Govt Contractor  

27

Museum Replicas Ltd - Specialty Retailer of Swords,

Licensed Collectibles and Period Clothing

Supreme Replicas - Retailer and Distributor of period

theyapons, armor and clothing in Europe

Windlass Biotech - Manufacturer and distributor of

Pharmaceutical drugs for the Indian Market  

Windlass Engineers and Services - Manufacturer and

Technological Service provider for the Oil and Gas industry 

Windlass Realtors and Developers - Engaged in developing

commercial and residential real-estate in India 

WSC has been manufacturing high quality theyapons and handicrafts since its inception

in 1943. Its founder, Mr. V. P. Windlass set up this manufacturing plant to supply the

British Gurkha regiments with Kukris, their main sidearm theyapon. Through some key

partnerships, they started exporting to United States and Theystern Europe in 1979 and

since then, they have outfitted many armies of the world, provided props to the biggest

Hollywood productions, designed and manufactured some amazing licensed replicas for

many top collectible companies and have continued to create products that are both fully

functional theyapons and works of art.

WINDLAS STEELCRAFT LIMITED

28

“Some men of noble stock theyre made, some glory in the murder-blade,

Some praise a Science or an Art, but I like hontheirable Trade”

  - James Elroy Flecker

”Quality is never an accident. It is always the result of intelligent effort.

There must be a will to produce superior things”.

  - John Ruskin

Products: Their products are unique, because they are fully functional and usable. Their

edged theyapons will always cut, behave and feel like the originals, while their armor and

helmets are fully theyarable and articulated. Their products will always be a work of art

that will be a true statement when either displayed in an office setting or den or when

used in a battle scenario.

Clients: Customer satisfaction is of utmost important to Windlass Steelcrafts and it is one

in which they strive to excel. Through R&D, they are continuously looking to rein in

their manufacturing costs, so they may provide their customers with the highest quality

products, at the lotheyst price point possible. They try to be efficient yet adaptable to

accommodate every customer request and more importantly, to meet their customer's

deadlines.

Employees: Ultimately, their quality of work, and all that they stand for, is defined by

their employees. As the fabric of their company, they truly respect and care for each and

every one of their employees. Windlass Steelcrafts is an equal opportunity employer and

does not discriminate on the basis of color,race, caste, creed or gender. They do not

support nor endorse child labtheir,prison labtheir or any kind of exploitation. They either

have full time employees or contractors manufacturing certain special parts exclusively

for their needs.

Society and Philanthropy: Windlass Steelcrafts is a good citizen of India and of the

world. They have always stayed active in social programs to help build the communities

in which they live. Apart from donations to several Non Profit Organizations, they

actively work towards improving the standard of living in the villages around their

29

factory. Their factory is also very environment friendly, with little or no emissions and

has enough trees to even be considered as a park!

R.S. Windlas & Sons

R.S. Windlass & Sons is proud of its international reputation as a manufacturer of top

quality readymade garments for ladies and children in a wide range of fabrics. They

specialize in manufacturing exquisite period costumes that recreates the splendor of lords

and ladies of the bygone era. Some of the most glamorous and remarkable items

manufactured at R.S. Windlass includes fully licensed replicas of the costumes from the

Hollywood blockbusters like Lord of the rings, Gladiator, Kingdom of Heaven and many

more. Their other products include Cotton, Rayon, Polyesters, Silk, Georgettes, Chiffon

and other combinations but their prime focus and expertise are heavy fabrics (Tapestry,

Brocade, Quilting and Denims). They also provide trading in brass handicrafts and light

category leather goods. They believe in high standards of quality and a prompt delivery at

most competitive prices. Their key to success is their firm commitment to provide

excellent services to their customers and taking care of their business by providing world

class quality products in a fascinating range.

With a pioneering spirit at its core, the Windlass Group of Companies is ever growing

enterprise. Branching forth and diversifying as it builds on its strength and stability

through an uncompromising resolve to surmount the challenges of the times. Established

in 1943, they are involved in the ventures ranging from the manufacture of sharp edged

theyapons to clothing, pharmaceuticals, real estate and hotels. Today, with a strong

foothold in the global market, the group is surging ahead achieving success in all its

endeavors. This success has been achieved by implementing key principles which are:

Maintaining good quality

Achieving reliable delivery

Continuous innovation in research, Design and development

30

At R.S Windlass, with its vast amount of group experience and know-how in different

manufacturing technologies as they as product development and design.

They work very closely with their customers to provide them developments of various

fabric qualities, garment designs, embellishment or garment washing techniques.

QUALITY ASSURANCE

Their policy is to manufacture products which comply with the specifications established

and agreed with their customers at a realistic and marketable cost, and to deliver them on

time. In order to implement the policy, they will follow a continuous programme of

improvement, based on prevention rather than detection of faults. The department of

Quality Assurance is carrying out checks at the following stages:

FABRIC PROCUREMENT

APPROVAL OF SIZE SETS, PHOTO SAMPLES

DUMMY FITTINGS

INITIAL PRODUCTION

FINAL PRODUCTION

Working with TQM (Total Quality Management) principles they equip each of their

personnel with the knowledge and restheirces required to successfully contribute towards

their on-going search for excellence.

They believe in high standards of quality and a prompt delivery at most competitive

prices. Their key to success is their firm commitment to provide excellent services to

their customers and taking care of their business by providing world class quality

products in a fascinating range.

WINDLAS ENGINEERS & SERVICES

31

The Windlass group of companies estd. 1943, specializes in many fields and lays strong

emphasis on quality, R&D and Customer Service. Their companies are proud to have

earned multiple Top Export awards. Windlass Engineers & Services is manufacturing a

wide range of oil field equipment. Their facilities are located on over 10 acres with

manufacturing area of 60,000 sq ft that house state-of-the-art manufacturing processes

manned by a highly qualified, motivated and experienced team. Windlass Engineers &

Services is manufacturing a wide range of oil field equipment. Their facilities are located

on over 10 acres with manufacturing area of 60,000 sq ft that house state-of-the-art

manufacturing processes manned by a highly qualified, motivated and experienced team.

Quality comes from a passion for Creating Excellence

Their quality and customer focus is evident in everything They design, manufacture, test

and deliver. It's this emphasis on quality, innovative technology and complete end-to-end

manufacturing solutions that drives Their business and provides Their customers with

significant competitive advantages in the global marketplace. At the heart of the company

is a team of skilled and dedicated technical people with an average of 10-20 years in Oil

Field Equipment manufacturing.

32

33

WINDLAS BIOTECH LIMITED

Windlas Biotech Limited is an independent contract manufacturer serving the Indian and

international pharmaceutical industry. They are a company of professionally alive,

forward looking and committed team members serving the medical fraternity. Their

primary focus is to consistently meet the global manufacturing requirements of their

customers by providing cost-effective services and delivering quality products efficiently

and reliably. Windlas Biotech, the trusted name in Indian Pharmaceutical industry

ventured into marketing of pharmaceutical products in 2008. At Windlas, they

manufacture and market formulations under their own brands in the domestic market and

export their own formulations to Asia, Africa & Latin America.

Their international quality products and services are geared towards meeting customer

requirements and providing care and support to health care professionals. With medicines

across a wide range of therapeutic areas, WBL is committed to help prevent some of the

most common and the most challenging healthcare conditions of their times.

As the flagship company of the reputed Windlas Group, they at Windlas Biotech Ltd.

would like to think beyond their thoughts. Thoughts, that would take them higher towards

their sustenance for human development initiatives.

As a highly diversified name in business ranging from the manufacturing of authentic

replicas of historic battle arms, modern and period clothing, real estate development to

hospitality in India, Windlas Group also has spread its wings further to United States with

mail order retail and amusement park business.

The seeds of their development theyre duly sown by honourable late Mr. Ved Prakash

Windlas when he under the patronage of Windlas Steel Crafts started to manufacture

Gurkha Khukris for the British army in India, way back in 1943.

34

At Windlas, they firmly believe that it's the spirit and the unbound zeal that drives in the

real focus on successful businesses, ensuring commitment for progress and creation of

value. At work and off it, they are guided by the soul and flesh of these golden words:

Technology, Finance, Strategy and Planning. As each segment focuses on the areas, the

whole group aims to develop a successful, highly efficient cooperation with profitability

thrown in good measure.

Company Name:

Windlas Biotech Limited

Business Owner:

Manoj K. W

Employees:

500 People

Main markets:

North America South America western Europe Eastern Europe

Business Type:

Manufacturer

Product/Service:

Antibacterials, analgesics, anti-inflammatory, multivitamins, haemostatics,

cardiovascular, anti-hiv, anti-TB; all categories-in capsules, tablets, syrups, dry-syrups&

injectables.

About Them:

Windlas Biotech Limited is engaged in the formulation of variothem pharmaceutical

products at its state of the art WHO-GMP and ISO 9001:2000 certified pharmaceutical

manufacturing plant, located amid the lthemh green and pollution free environment of

Dehradun, capital of Uttaranchal, at the foothills of Himalayas. The plant is at a well-

connected five-hour drive and one hour flight from the Indian National Capital, New

Delhi. Besides formulations they also specialize in supplying the ready-to-compress

granules of all pharmaceutical raw materials as well as herbal and aromatic extracts and

formulations along with several essential oils.

35

The company has a vast generic range of products specifically to cater to the international

government tenders, institutional and pharmacies chains network purchases worldwide.

Windlas Biotech is into ethical sales of its own brand formulations covering the North

Indian belt with a field force of more than 500 people. They are currently exporting their

formulations to some African, CIS, and S. E. Asian countries like Namibia, Tanzania,

Kazakhstan, and Cambodia.

Several others of their products are under registration in many more countries like Sri

Lanka, Vietnam, Brazil, Chile, Colombia, Trinidad& Tobago, Mexico and Bulgaria.

They continuously strive to expand their business operations and associations all over the

globe by strategically aligning themselves according to the needs of their buyers.

Windlas Biotech is a wholly owned subsidiary of the reputed Windlass Group of

Companies, which is diversified into businesses ranging from the manufacture of

authentic historical battle arms and armor and period clothing, real estate, hospitality, and

amusement parks businesses since 1943 in India and the THEM. The parent company,

Windlass Steel Crafts is an approved vendor to the United States government

They also undertake contract manufacturing for selected leading pharmaceutical

companies to utilize the bulk of their excess capacities.

They would be glad to register themselves as an approved vendor for your purchases,

where they can assure you of their commitment towards highest quality standards with

guaranteed timely deliveries.

In case you need any more information from them, they would be pleased to furnish it.

They look forward to hearing from you soon.

Category:

Health & Medical - Drugs

Region:

India Windlas Biotech Limited

Link Tool:

India Health & Medical - India Drugs

36

Tags:

dry syrups - antibacterials - multivitamins

Contact Person:

Mr. Manoj Windlass

Zip Code:

110016

Theybsite:

http://www.windlasbiotech.com

Address:

Y-8A Hauz Khas, New Delhi, Delhi, India

Telephone:

91-11-6856860

Fax: 91-11-6569871Firm Type : Public. Ltd.Nature of Business : ServicesLevel to Expand : National

COMPANY’S PHILOSOPHY

Quality

They strive to:

1. Do the right things right

2. Continuously learn, develop and improve

3. Take pride in their work

Discipline

They strive to:

1. Make and meet commitments

2. Properly plan, fund and staff projects

3. Pay attention to detail

37

Customer Orientation

They strive to:

1. Listen and respond to their customers, suppliers and stakeholders

2. Clearly communicate mutual intentions and expectations

3. Enctheirage and reward informed risk taking

Result Orientation

They strive to:

1. Set Challenging and competitive goals

2. Focus on output

3. Constructively confront and solve problems

4. Execute flawlessly

Risk Taking

They strive to:

1. Listen to all ideas and viewpoints

2. Learn from their successes and mistakes

3. Enctheirage and reward informed risk taking

Great Place to Work

They strive to:

1. Be open and direct

2. Work as a team with respect and trust for each other

3. Manage performance fairly and firmly

Through their contract manufacturing experience, they at Windlas Biotech form an in-

depth understanding of ytheir product. They become an extension of ytheir company,

anticipating changes, overcoming challenges, and developing on-the-spot solutions for

advancement.

38

To achieve robust and efficient process qualification for scale-up, they make extensive

use of modern tools and equipment. Their highly qualified staff and detailed scheduling

processes ensure quality-minded production, on-time delivery and cost control.

With a full range of services from pre-formulation, analytical & formulation development

to scale-up and commercial manufacturing, WBL can take ytheir compound from bench

to market. Their facilities at WBL feature a GMP pilot plant as they as analytical and

formulation development laboratories with state-of-the-art equipment, staffed by

analytical chemists, formulation design experts, and manufacturing specialists.

PRODUCTS

Anti - Malarials

Anti-Parasitic

Anti-Viral, HIV

Cough, Allergy & Respiratory

Fertility, BPH & Erectile Dysfunction

Gynaecologicals

Nutritional Supplements

Anti-Infective

Anti-Psychotics & Anti-Convulsants

Cardiac & Diabetes

Dermatologicals

Formulations for G.I. Disorders

Lifestyle & Pain Management

39

SERVICES

WBL focuses on meeting client needs through flexibility, creativity and service

excellence. Their turnkey services are lead by project managers with extensive business

management experience and realistic foresight. Through effective communication,

interactions and follow-through with their customers throughout the project life cycle and

beyond, they ensure that all requirements and project specifications of their customers are

met with absolute quality and timeliness.

Their dedicated team at WBL encompasses experts in Drug Development,

Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Logistics,

Planning and Purchasing.

Their services range from pre-formulation development and scale-up to commercial GMP

manufacturing of pharmaceutical drugs. Their range of services include:

1. Pre-formulation & Formulation Development:

- Raw material stheircing

- Characterization of physical properties

- Powder characterization

- Dissolution testing

- Excipient compatibility studies

- Stability assessment

- Formulation and packaging compatibility

- Formulation development for early safety studies

2. Analytical Development:

- Molecule characterization

- Method development & validation

- Cleaning residuals development & validation

- Dissolution and drug release profiling

- Forced degradation studies

- Specifications development

- Stability monitoring to ICH guidelines

40

3. Process Validation

4. Manufacturing, Packaging & release testing of registration batches

5. Distribution & Logistics

6. Adequate documentation for drug application

7. Experienced PAI (Pre-Approval Inspection team)

8. Complete data for notification dossier

CUSTOMERS

At WBL, they use their customer's satisfaction as a benchmark to evaluate and

continually improve upon the quality of their products and services. WBL is a partner of

choice of many leading Multi-national pharmaceutical corporations including:

1. Ajanta Pharma Ltd. 2. Alembic Ltd.

3. Blue Cross Laboratories Ltd. 4. Cadilla Pharmaceuticals Ltd.

5. Cosme Farma Laboratories 6. Elder Pharmaceuticals Ltd.

7. Emcure Pharmaceuticals Ltd. 8. German Remedies Ltd.

9. Ind-Swift Laboratories Ltd. 10. Indi Pharma Pvt. Ltd.

11. Indoco Remedies Ltd. 12. Intas Pharmaceuticals Ltd.

13. Khandelwal laboratories Ltd 14. Lupin Ltd.

15. Mankind Pharma Ltd. 16. Meyer Organics Pvt. Ltd.

17. Orchid Healthcare 18. Systopic Laboratories Ltd.

19. Torrent Pharmaceuticals Ltd. 20. Troikaa Pharmaceuticals Ltd.

21. Wallace Pharmaceuticals Ltd. 22. Win Medicare Ltd.

41

23. Wockhardt Ltd. 24. Zuventus Healthcare Ltd.

They provide services in pharmaceutical area.

Their Services :

* Product Development

• Analytical Development

• Galenical Development

* Quality Control Services

* Product Validation • HACCP

(Hazard Analysis & Critical Control Point)

• Product specific validation

• Process and cleaning validation

• Validation of sterilization procedure • Storage & warehouse administration

* Distribution & Logistics services

• Storage of controlled drugs

• Complete documentation and archive

• Invoicing

• Worldwide dispatch and preparation of all delivery papers

Company Profile :

At WINDLAS Biotech Limited, they have the facility, the equipment, the professional,

experienced staff and the commitment to be your full service contract manufacturer.

Their services include all phases of manufacturing, from product development to the

distribution of your product. You select the services you require.

Windlas Biotech achieves excellence via investment in people, systems and procedures,

process optimization, and infrastructure. We can assure you a well-trained team, state of

art facilities and product quality that meet International standards.

42

PHARMACEUTICAL PRESENCE

In pharmaceutical vertical, the family has two companies – Windlas Biotech Limited

(WBL) and Windlas Healthcare Private Limited (WHC). WBL was founded in year 2000

with and provides contract manufacturing services for the Indian pharma market,

employing over 400 staff and workers, and has a revenue of about Rs. 80 crores in the

last fiscal (FY ‘08-’09). WBL also promotes its own branded generic products in India

with a small sales team of 180 people. WHC is a brand new oral solid dosage (tablets and

capsules) formulations facility commissioned in 2009. This plant has been designed to be

compliant with the US FDA and EU GMP standards.

THEIR MISSION

Windlas Healthcare is committed to deliver innovative and unique value proposition to

enable success of our customers in the pharmaceutical ecosystem. We provide innovative

yet cost effective contract manufacturing and Research & Development (R&D) services

to pharmaceutical companies.

THEIR VISION

The firm believe that the pharmaceutical industry must reinvent itself in face of the

clinical, regulatory, intellectual properties and economic challenges presented to it.

Windlas Healthcare intense to emerge as a pre-eminent supplier of choice to the reach

based pharmaceutical industry. Their services and products will help our clients achieve a

faster time to market, lower development cost and long term competitors cost advantage

for their existing and forthcoming products portfolio.

43

PRODUCT PROFILE

CONTRACT MANUFACTURING

Contract manufacturing is performed by a company that was hired to do the

manufacturing services on behalf of another company. Many businesses take part in

contract manufacturing because of the reduced production costs and because it is easier to

hire a manufacturing plant instead of building and operating a facility. Companies on

both sides of the contract deal are attracted to this kind of manufacturing. The

manufacturer is guaranteed steady work for the duration of the contract which creates a

sense of financial stability and security while the hiring firm benefits by saving costs and

avoiding the stresses associated with managing a production facility. The involved

businesses enter into a contract for a predetermined length of time or until a certain

number of units are manufactured. The contracts can range from a few months to years;

the average length is between three and five years. The hired firm provides a range of

manufacturing processes including turning, boring, drilling, milling, sawing, shaping,

planning, tapping or grinding as well as new technologies like electrical discharge,

electrochemical or ultrasonic machining. The materials use during manufacturing vary

greatly depending on the product and application but may include stainless steel,

aluminum, brass, bronze, iron, plastic, ceramic or wood. Contract manufacturing is a

widely used by many companies including the aerospace, automotive, construction,

electronics, food and beverage, marine, medical and pharmaceutical industries.

There are multiple terms that are used to refer to the same practice; these terms are often

used interchangeably because their definitions are fairly open. Subcontract machining is

completed by companies that were hired by a firm for the specific purpose of providing

their manufacturing services. The term outsource manufacturing is mostly used in

reference to subcontracting that takes place outside of North America. The manufacturing

work that needs to be completed is hired out to an external source that is ultimately

responsible for the manufacturing. Contract manufacturers are the companies that are

hired to complete manufacturing work for another company. This is usually their sole

44

form of business. Contract manufacturing services are the processes and performed by

businesses that were hired as external service providers. There are many different kinds

of manufacturing processes; contract machining is one example. Machining is also a

broad term that refers to material-working processes that use devices with cutting tools to

cut and remove material from the product. Another process that can be performed by

contract manufacturers is contract assembly in which one company assembles the parts of

a product for a second company. Contract assembly is used to assemble materials or

components into finished products. Often the contract assembly process is realized

through the use of an assembly line, in which each person or machine puts the same part

on the product again and again. This contract assembly process enables many products to

be assembled in a short period of time.

Contract manufacturing is often identified by the final product that is produced.

Electronic contract manufacturing produces electronic products. Electronic products, due

to their complexity, are often contracted for manufacture. In many cases, the hiring firms

choose to have their electronics made by another company who specializes in the product

they need. Medical device contract manufacturing is the system by which a

manufacturing company makes medical devices or components of those devices that are

later sold by another company. Pharmaceutical contract manufacturing produces goods or

services for a pharmaceutical company such as pills, capsules, lotions, liquids and other

items sold by a pharmaceutical company, in addition to containers or packaging. Military

contract manufacturing is completed by a company that is hired to produce products for

the military. There is a large variety of products made through military contract

manufacturing ranging from vehicles to aircraft, weapons, shelters, body armor and other

equipment. During chemical contract manufacturing, a company performs chemical

manufacturing and synthesis on behalf of another. Chemical contract manufacturers

obtain the necessary starting materials, compounds and equipment in order to fulfill their

end of the contract. Aerospace contract manufacturing produces components related to

the aerospace field. Aircraft of all kinds such as airplanes, helicopters, unmanned aircraft

and military jets can be manufactured using subcontractors; defense and military contract

manufacturing is provided by specially approved companies.

45

The widespread usage of contract manufacturing is made possible by improvements in

transportation, communication technology and globalization. To some extent, this type of

manufacturing has been used for centuries in the sense that multiple skilled tradesmen

would have been necessary to create certain products such as a carpenter, upholsterer or

blacksmith. Contract manufacturing still requires special skills and technology but now

the product might be shipped all over the world for various processes. A part might be

designed in Germany and assembled in the Philippines from materials that were produced

in China before it is finally sold in the United States. This globalization could not have

happened without fast and reliable methods of transportation. Companies are usually tied

to deadlines and production dates; if the contract manufacturer can produce the part but

cannot ship it quickly and safely then they will probably not get the job. Improved

communications have also contributed to the rise of contract manufacturing because now

companies and firms all over the world are able to effectively communicate with each

other, giving bids, taking orders and overseeing production. Contract manufacturing is no

longer limited by borders but is open to firms who can meet the demands of interested

companies.

Types of Contract Manufacturing

Aerospace contract manufacturing is used to produce parts and components of

air- and spacecraft.

Chemical contract manufacturing is used to mix, create and synthesize liquids

and solid chemicals.

Contract assembly refers to a process that involves one company sending loose

or modifiable components to a contract assembler. The business that receives the

separate parts assembles or changes them and makes a profit once the final

products are sold back to the business.

Contract machining is a service offered by many contract manufacturers that

includes such processes as milling, wire eroding, punch press and laser cutting.

Contract manufacturers produce products for another company, whose name

appears on the finished product when it is sold. Contract manufacturing services

involve any procedural actions performed by a contract manufacturer to meet the

46

needs of a buying company. These services include but are not limited to product

design and validation, rapid prototyping, assembly, testing, and sustained

engineering.

Electronic contract manufacturing is the agreement by which one company

manufactures electronic goods for a different company, which sells the product as

their own.

Medical device contract manufacturing is the process through which one company

manufactures medical devices for another company's line.

Military contract manufacturing produces vehicles, weapons, body armor,

structures and other items that are used by the military. 

Outsource manufacturing is an alternate name given to contract manufacturing

that frequently has international connotations.

Pharmaceutical contract manufacturing refers to the services provided by an

outside company for a pharmaceutical company; this often includes packaging

and labeling.

Subcontract machining is another name for contract machining and is any one of

many mechanical processes involving a cutting tool.

Contract Manufacturing Terms & Conditions

Bill of Materials (BOM) - a list which includes all subassemblies and

components that go into a certain product. The BOM also shows quantities of

each material used.

Box-Built - refers to any assembly work that does not involve printed circuit board

production.

Core Competencies - procedures or actions that are essential to a company's long

-term growth and success. Core competencies tend to be skills and knowledge

rather than company functions or products.

Corrective Action Request (CAR) - an action request usually filed by an OEM that

asks the responsible business to conduct a cause analysis regarding the error and

47

to resolve the issue at hand.

Engineering Change Order (ECO) - an alteration to a bill of materials (BOM) such

as the replacement of a specified component by a substitute for it. ECOs

commonly contain a reason and description for the change, and the date for

implementation of the change.

High-Mix, Low-Volume - a production where low quantity products assembled

vary in design and process.

Intellectual Property (IP) - any unique product developed by human intellect. IPs

include inventions, ideas, and business methods.

Joint Service Agreement (JSA) - A contract and document used to define

processes, performance estimations, and expectations for the contract

manufacturer and the OEM. It also serves to reduce misunderstandings which

sometimes occur.

Low-Mix, High-Volume - a production that includes one or few variations of a

high quantity good.

Manufacturing and Supply Agreement (MSA) - a contract designed to outline

responsibilities between a contract manufacturer and the OEM which purchases

the product(s). MSAs describe what the manufacturer is to provide for the OEM

and at what cost.

48

New Product Introduction (NPI) - a set of procedures used to turn a product design

into a product ready for manufacturing. The product must also meet quality, cost,

and time -to -market requirements.

Nonrecurring Expense (NRE) - one or more activities/items required by a contract

manufacturer that are specific to a single OEM's product program. Some NREs

include special tooling, programming, and setup.

Original Design Manufacturer (ODM) - any company that manufactures its own

unique product. From the ODM, the product is commonly sold to an OEM. ODM

designs are based on their own intellectual property.

Original Equipment Manufacturer (OEM) - a business that specifies and designs

products under its own name. With outsourcing, many OEMs obtain "their"

products from another source.

Outsourcing - the procedure used to subcontract a process. Product designs and

manufacturing techniques are commonly outsourced by a third -party company

such as a contract manufacturer.

Prototype - an original model or mock -up of a technological process or device.

They're used to generate criticisms and other information that will help the final

design before production takes place.

49

Request for Quote (RFQ) - a document prepared by an OEM and submitted to a

contract manufacturer. The RFQ contains product quantities and specifications, as

well as aBOM.

Time to Market - the time required to bring a quality product into the market.

Time to Volume - length of time necessary to turn a prototype into a high -volume

production good.

Volume Price Agreement (VPA) - a contract service agreement that contains

deliverables, pricing, and cost reductions based on volume production.

CONTRACT MANUFACTURING PROCESS

50

DOCUMENTATION

Documentation may refer to the process of providing evidence ("to document

something") or to the communicable material used to provide such documentation (i.e. a

document). Documentation may also (seldom) refer to tools aiming at identifying

documents or to the field of study devoted to the study of documents and bibliographies.

Subfields of documentation include:

Medical documentation

Technical documentation (e.g. software documentation, product specifications,

data sheets, or a patent)

Legal documentation (e.g. a travel document system)

Administrative documentation

Historical documentation

Documentation In Computer Science:

The following are different types of documentations usually seen in the Computer

Science field.

Architectural and Design documentation.

Technical Documentation.

User Documentation.

System Documentation.

Marketing Documentation.

There are various types of Documentation Tools which are available for this purpose.

Documentation understood as document is any communicable material (such as text,

video, audio, etc., or combination thereof) used to explain some attributes of an object,

system or procedure. It is often used to mean engineering documentation or software

documentation, which is usually paper books or computer readable files (such as HTML

51

pages) that describe the structure and components, or on the other hand, operation, of a

system/product.

A professional whose field and work is documentation used to be termed a documentalist.

Normally, documentalists are trained or have a background in both a specific subject and

in the field of documentation (today information science). A person who more or less

exclusively writes technical documentation is called a technical writer. Technical writers

are similarly trained or have a background in technical writing, along with some

knowledge of the subject(s) they are documenting. Often, though, they collaborate with

subject matter experts (SMEs), such as engineers.

Common types of computer hardware/software documentation include online help,

FAQs, how-to, and user guides. The term RTFM is often used colloquially in regard to

such documentation, especially to computer hardware and software user guides.

A common type of software document frequently written by software engineers in the

simulation industry is the SDF (software documentation folder). While developing the

software for a simulator, which can range from embedded avionics devices to 3D terrain

databases by way of full motion control systems, the engineer keeps a notebook detailing

the development lifecycle of the project. The notebook can contain a requirements

section, an interface section detailing the communication interface of the software, a

notes section to detail the proof of concept attempts to track what worked or didn't work

in solving certain problems, and a testing section to detail how the software will be tested

to prove conformance to the requirements of the contract. The end result is a detailed

description of how the software is designed, how to build and install the software on the

target device, and any known weaknesses in the design of the software. This document

will allow future developers and maintainers of the trainer to come up to speed on the

software design in as short a time as possible and have a documented reference when

modifying code or searching for bugs.

Principles

52

While associated ISO standards are not easily available publicly, a guide from other

sources for this topic may serve the purpose. David Berger has provided several

principles of document writing, regarding the terms used, procedure numbering and even

lengths of sentences, etc.

The following is a list of guides dealing with each specific field and type:

Documentation in health care

Thesis writing

Further information: Dissertation

Papers for academic journal publishing (i.e. Journal of Food Science and

Analytical Chemistry)

Procedures and techniques

The procedures of documentation vary from one sector, or one type, to another. In

general, these may involve document drafting, formatting, submitting, reviewing,

approving, distributing, repositing and tracking, etc., and are convened by associated

SOPs in a regulatory industry.

53

DOCUMENTS INVOLVED IN HOME TRADE

1. Enquiry :- the prospective buyer writes a letter to the seller to know details about

the quality and price of goods and the terms and conditions related to it. Such a letter

is called enquiry. An enquiry may be made on telephone and through a letter. A

written inquiry is preferable. It should :

i. State fully type and quantity of goods required.

ii. Specify if samples of goods required.

iii. Give the approximate quantity required

iv. Indicate whether the seller pays carriage or not.

v. Mention the time period within which goods are to be delivered and the mode of

delivery.

A SPECIMEN given below:

54

2. Quotation:- A quotation is a written reply by the seller to an inquiry

from the buyer containing detail about the quantity, quality, price, terms

and conditions, etc.

A SPECIMEN of quotation is given below :-

55

3. Order:- If the terms & conditions mentioned in the quotation are

acceptable, the buyer sends an order to the seller for purchase of goods.

A SPECIMEN of order is given below :-

4. Dispatch note:- When seller dispatch goods, he sends a dispatch note to the buyer

to inform him that the goods are being dispatched.

56

A SPECIMEN of dispatch note is given below :-

Invoice:- An invoice or bill is a commercial document issued by a seller to the buyer,

indicating the buyer must pay the seller, according to the payment terms. An invoice or

bill is a commercial document issued by a seller to the buyer, indicating the products,

quantities, and agreed prices for products or services the seller has provided the buyer.

An invoice indicates the buyer must pay the seller, according to the payment terms. The

buyer has a maximum amount of days to pay these goods and are sometimes offered a

discount if paid before.

In the rental industry, an invoice must include a specific reference to the duration of the

time being billed, so rather than quantity, price and discount the invoicing amount is

57

based on quantity, price, discount and duration. Generally speaking each line of a rental

invoice will refer to the actual hours, days, weeks, months etc being billed. From the

point of view of a seller, an invoice is a sales invoice. From the point of view of a buyer,

an invoice is a purchase invoice. The document indicates the buyer and seller, but the

term invoice indicates money is owed or owing. In English, the context of the term

invoice is usually used to clarify its meaning, such as "We sent them an invoice" (they

owe us money) or "We received an invoice from them" (we owe them money).

58

A SPECIMEN of invoice is given below :-

59

5. Transfer ticket:- It is a document which is issued by the production department to

the sales and distribution department when the goods are handed over to that

department to distribute the goods.

A SPECIMEN of transfer ticket is given below :-

6. Docket document:- It is a document issued and signed by the shipping company

acknowledging that the goods mentioned in it have been received and also

undertaking to deliver the goods to the concerned party. A docket is a written

acknowledgement that a specified article or sum of money has been received as an

60

exchange for goods or services. The docket acts as the title to the property obtained in

the exchange.

In English speaking countries the term most frequently applies to the printed record

given to a consumer at checkout that lists the purchases made, the total amount of the

transaction including taxes, discounts and other adjustments, the amount paid and the

method of payment. Increasingly, these dockets may also include messages from the

retailer, warranty or return details, special offers, advertisements or coupons. Dockets

may also be provided for non-retail operations such as banking transactions. A docket

is a legal document. In many countries it is mandatory by law for retailers to give

dockets and to store information about every docket, so that the tax authority can

check that sales are not hidden.

Printed dockets are usually produced by thermal printing on rolls of narrow paper

tape, although dot-matrix technology is also used. Recent innovations have led to

multi-colored thermal printing technology and the ability to print double-sided

dockets.

61

A SPECIMEN of docket document is given below :-

62

63

64

RESEARCH METHODOLOGY

MEANING OF RESEARCH:Research in common parlance refers to a search for knowledge. One can also define

research as a scientific & systematic search for pertinent information on a specific topic.

In fact, research is an art of scientific investigation. The Advanced learner's Dictionary of

current English lays down the meaning of research as a 'careful investigation as inquiry

especially through search for new facts in any branch of knowledge.’ Redman & Mory

define research as a 'systematized effort to gain new knowledge.’ Some people consider

research as a movement, a movement from the know to the unknown. It is actually a

voyage of discovery. We all possess the vital instinct of inquisitiveness for, when the

unknown comforts us, we wonder & our inquisitiveness makes probe & attain full &

fuller understanding of the unknown. This inquisitiveness is the mother of all knowledge

& the method which man employs for obtaining the knowledge of whatever the unknown

can be termed as research.

Research is an academic activity & as such the term should be used in a technical sense.

According to Clifford woody research comprises defining & redefining problems,

formulating hypothesis or suggested solutions, collecting, organizing & evaluation data,

making deductions & reaching conclusions, and at last carefully testing the conclusions

to determine whether they fit the formulating hypothesis. D. Slesings & M. Stephenson in

the encyclopedia of social sciences define research as "the manipulation of things,

concept or symbol for the purpose of generalizing to extend, correct or verify knowledge,

whether that knowledge aids in construction of theory or in the practice of an art".

Research is, thus, an original contribution to the existing stock of knowledge making for

its advancement. It is the pursuit of truth with the help of study, observation, comparison

& experiment. In short, the search for knowledge through objective & systematic method

65

of finding solution to a problem is research. The systematic approach concerning

generalization & the formulation of a theory is also research. As such the term 'research'

refers to the systematic method consisting of enunciating the problems, formulating a

hypothesis, collecting the facts of data, analyzing the facts & reaching certain conclusion

either in the form of solutions towards the concerned problem or in certain

generalizations for some the theoretical formulation.

SOURCES OF DATA:

The task of data collection being after a research problem has been defined & research

design checked out. While deciding about the method of data collection to be used for the

study, the researcher should keep in mind two types of data i.e.:

1. Primary Data

2. Secondary Data.

Primary Data

Primary data is one which is collected by the investigator himself for the

purpose of a specific inquiry or study.

Primary data are collected afresh and for first time.

Such data is original in character and is generated by surveys conducted

by individuals or research institutions.

Secondary Data

Secondary Data when an investigator uses the data which has already

collected by others such data is called secondary data.

This data is primary data for the agency that collects it and becomes

secondary data for someone else who uses this for his own purposes.

66

This can be obtain from journals, reports, govt. publication, publication of

professional and research organizations and so on.

METHODS OF DATA COLLECTION

Method of collecting primary data

Observation method

Interview method

Schedules

Questionnaires

i. Observation method-: The observation method is used to study relating to

behavioral sciences. Ex.-: Super Market.

ii. Interview method-: The interview method of collecting of data involves

presentation of oral stimuli and reply in terms of oral response. It can be used

through personal interviews and if possible, through telephone interview.

iii. Schedules method-: Schedule may be defined as a Performa that contains a

set of questions which are asked and filled by interviewer in a face to face

situation with another.

iv. Questionnaires method-: In this method questionnaire is fulfilled by

individual meet or sent (usually by post & email) to the persons concerned

with a request to answer the questions and return to questionnaire.

Types of Questions-:

Background question

Multiple choice or closed-end question

Intensity question

Free response or open-end question

67

Collection of Secondary Data

Data which is collected at first hand either by the researcher or a particular person

especially for purpose of the study is known as primary data. Primary data

become secondary data to another person for further study upon the topic.

Example-: internet search engine Google. Available data on this always be the

primary data but when we use to search any topic related to our study called

secondary data.

RESEARCH DESIGN:-

68

A research design is a framework or blueprint for conducting the marketing

research project. It details the procedures necessary for obtaining the information

needed to structure and/or solve marketing research problems.

The present project “Auditing and entry of sales invoice and other related documents”

was studied on the basis of observations, records and data available of Windlas Biotech

Limited. The data used in this project is secondary data which is collected from

concerned authorities.

Methodology adopted:

I have studied and understood the procedure of sale and purchase in the

Organization.

The existing procedure of sale and purchase that is running in Windlas Biotech

Limited is studied in and understood. For this purpose actual observation, on the job

training, and gathering information from the concerned authorities and few past records.

69

RESEARCH DESIGNCONCLUSIVE RESEARCH DESIGNDESCRIPTIVE RESEARCH DESIGNCAUSAL RESEARCH DESIGNEXPLORATORY RESEARCH DESIGN

BIBLIOGRAPHY

1. Website: www.windlasbiotech.com.

2. Books : Commercial studies by C.B. Gupta.

3. Research Methodology : C. R. Kothari

4. Secondary data : Collected from my supervisor and heads of various

departments such as:

Performa of various sales related documents.

Sales figures of the company.

Information about the working of the company.

70