Adarsh institute of

management
Margao - goa
ADARSH INSTITUTE OF
MANAGEMENT
MARGAO – GOA

Indian Biotech Queen-Kiran

Mazumdar Shaw

Done by:
The Biocons
Khalandar Sha Khan
Prajot Morajkar
Swati Jampala
Saiesh Prabhu
Vinod Sawant
 Contents of the Project:

1) Kiran Mazumdar Shaw

1)Introduction

2) Educational Qualifications & Personal life

2)Industry Review of Biotechnology

1) Introduction of Biotechnology.

2)Biotechnology Industry in India

3)Company Review of Biocon

1)History

2)Major Products of Biocon

3) Profitability Position

4) Strength of Employees

5) Success of Biocon

6)Controversy related to Biocon

7)Achievements of Biocon

8)Corporate Governance

4) Analysis of Kiran Mazumdar Shaw

 1) As an Entrepreneur

2) Personality Traits

3) As a Leader

4)Awards

5) Conclusion

1) KIRAN MAZUMDAR SHAW

Introduction:

Kiran Mazumdar Shaw is an Indian Businesswoman who was born on March 23, 1953 in
Bangalore. She founded the company Biocon in India in the year 1978. From what started as
an Indian subsidiary company of the Irish parent company Biocon, today Biocon is the
leading biotechnology company in India. She has been a huge factor in making the company
evolve from an industrial enzymes manufacturing company to a fully integrated bio-
pharmaceutical company. Biocon today is no longer a subsidiary company and it is a full
enterprise of its own of which Kiran Mazumdar Shaw is a Chairman and the Managing
Directori. Biocon is also India’s first biotech company. She has established two subsidiaries
to Biocon named Syngene (a custom research organization) in 1994 and Clinigene (a clinical
research organization) in 2000 where she is the Chairman of both the companies.

She is a huge promoter of biotechnology sector in India and is a member of the Advisory
Council of the Indian government’s Department of Biotechnology where she has played a
great role in bringing the Indian government, industry and academia together for the growth
of this sector in India. She is highly respected in the corporate world because of her
tremendous work in biotechnology.

Kiran Mazumdar Shaw is responsible for steering Biocon on a trajectory of growth and
innovation over the years. Within a year of its inception, Biocon became the first Indian
company to manufacture and export enzymes to USA and Europe. In 1989, Biocon became
the first Indian biotech company to receive US funding for proprietary technologies. In 1990,
she upgraded Biocon’s in-house research program, based on a proprietary solid substrate
fermentation technology. The commercial success of this program led to a three-fold
expansion by 1996 and Biocon entered the biopharmaceuticals and statins segments. In 1997,
she undertook initiatives in human healthcare through a dedicated manufacturing facility.

Under her leadership, Biocon is building cutting-edge capabilities, global credibility and
global scales in its manufacturing and marketing activities. It has Asia’s largest insulin and
statin facilities as also the largest perfusion-based antibody production facilities. It was
included in ‘The best under a billion’ listing by Forbes in 2009. Her efforts in biotechnology
have drawn global recognition both for the industry in India and for Biocon and she has been
termed India’s Biotech Queen by ‘The Economist’ and India’s mother of invention by ‘The
New York Time

Educational Qualifications & Personal Life

Kiran Mazumdar Shaw was born in Bangalore. She did her schooling from Bishop Cotton
Girl’s High School in Bangalore. She wanted to join a medical school but took up biology
instead and completed her B.Sc. in Zoology with Honors from Bangalore University in 1973.
She did her post graduation in Malting and Brewing from Ballarat College, Melbourne
University in 1975. Her father was also a brewer and she worked as a Trainee Brewer in
Carlton and United Breweries, Melbourne and as a Trainee Malster at Barrett Brothers and
Burston, Australia but when she returned to India she found out that daughters were not
welcome in India’s breweries. In India, she was unable to find a job because of her gender,
hence she was planning to go abroad to have a career in brewing. She is married to a
Scotsman John Shaw, who is currently the Vice-Chairman of Biocon.iv
 2) Industry Review
Introduction of Biotechnology:

Biotechnology refers to the use of microorganisms such as bacteria or biological substances

such as enzymes, to perform industrial or manufacturing processes. Biotechnology is being
used to produce drugs and synthesize hormones.

Biotechnology is divided into three sub fields:-

1) Red Biotechnology

Red biotechnology deals with genetically changed microorganisms being used for
manufacturing products like insulin and vaccine for medical use. It is due to research
in red biotechnology that antibiotics for various infections have been developed and
vaccines to bolster the bodies’ resistance to various diseases were developed. It has
also been used in reproductive technologies like invitro fertilization, DNA profiling,
forensics and transplantation technologies.

2) White Biotechnology

White biotechnology deals with creating useful chemicals for the industrial sector
through organisms like moulds or yeast. This type of bio technology is also referred to
as grey biotechnology. White biotechnology has proven to be of immense benefit
environmentally in cleaning oil spills and in storing DNA samples of endangered
species for future research. It is also useful for removing excess nutrients in soil and
water and for detection of landmines.

3) Green Biotechnology
Green biotechnology also called agricultural biotechnology is to do with factors
pertaining to agriculture. Green biotechnology is concerned with the genetic
modification of plants and animals to produce environmentally friendly species.
The Biotechnology Industry

Before 1970, biotechnology was used mainly in the agricultural and food processing
industries. Today, their area of expertise extends much further. Biotech companies view their
work as an amalgamation of disciplines like genetics, biochemistry, embryology, molecular
biology and cell biology. This industry is about over 30 years old and is generating over $85
billion in revenues. There are 8,550 companies worldwide, of which 1420 are public
company.

According to Ernst & Young's 2007 Global Biotechnology Report, the biotech industry made
historic progress with strong product pipelines and product successes, record-breaking
financing totals, unprecedented deal activity and impressive financial results. The global
biotech revenues of the public listed companies in 2006 grew to $73.5 billion recording a 14
percent growth over that in 2005 ($64 billion). Further, according to the report, all the leading
regions in the world recorded a strong double digit growth, with the US and Europe recording
13 percent growth each and Canada registering 22 percent growth.

The biotech industry can be classified into five different segments: Biopharma, Agri-biotech,
Bioinformatics, Bio industrial and Bio services with each concentrating on a particular area.

• Biopharma deals with the production of vaccines, therapeutics and diagnostics, while
the end products of the biotech industry find two different kinds of buyers, the first
type include private hospitals, governments, patients and the second type include
industries like pharmaceutical.
• Agri-biotech deals with hybrid seeds and transgenic crops, biopesticides and
biofertilizers.
• Bio informatics deals with creation and maintenance of extensive electronic
databases on various biological systems.
• Bioservices market deals with clinical trial, contract research and manufacturing
activities.
• Bio Industrial industry deals with enzyme manufacturing and marketing companies
and these enzymes are used in detergent, textile, food, leather, paper and
pharmaceutical industry.

Role of the Biotechnology Industry:

• 200 plus vaccinations, products, therapies have been created by the biotechnology
industry to combat cancer, autoimmune syndromes, diabetes, HIV/AIDS etc.
• Biotechnology industry has developed several environment friendly products treating
elements which pollute the environment.
• Biotechnology is also used in industrial houses for the optimum usage of the various
forms of energy.
• Biotechnology industry also plays a significant role in taking forensic science ahead
by using methods relating to DNA fingerprinting.
• Biotechnology companies use biological systems, living organisms or their
derivatives to make products for specific use. The general opinion about top biotech
companies is that they spend billions of dollars in research and development, and do
 little else. With such large inputs, such companies must create novel technologies and
products to stay solvent.

Bio Technology Industry in India

In India the Department of Biotechnology (DBT) was established in the year 1986 under the
ministry of Science and Technology This industry is one of the sunrise sectors in India. In
terms of number of biotechnology companies, India was ranked at number three position after
Korea and Japan in the entire South-Easter Asia and Globally India is in the list of top 12
biotech markets.

Out of these Bio-pharma is the largest on that contributes 65% of the total revenue from this
industry.

At present there are more than 350 biotech companies in India providing employment for
over 20,000 scientists. Most of the companies are located in the six major cities of Delhi,
Mumbai, Pune, Chennai, Bangalore, Hyderabad and Ahmadabad. To keep pace with the
competitive world, India has launched a comprehensive programme in biotechnology to make
use of the resources available. In India Biotechnology is been used in a wide range of
economic activity ranging from environment, animal husbandry, medicinal and aromatic
plants, bio fuels, aquaculture and products like silk and leather.

Bio technology industry in India is the fourth largest adopter of biotech crop in the world,
replacing Canada. India is gaining recognition in the field of clinical trial. A large number of
companies are providing research and development expertise to global pharmaceutical
companies. Many Indian Bio technology companies are also expanding overseas, for example
Biocon has acquired 70 per cent stake of the German pharma company AxiCorp by Biocon is
a case in testimony.

Growth in the Biotech Industry in India

With the growth in the customer base and more investments taking place in the biotech
sector, Biotech Industry is expected to grow to around Rs. 4, 40,000 crores by the year 2020.
The high demand for different biotech products has also opened up scopes for the foreign
companies to set up bases and reap great profits. Some of the positive facts about the growth
of the biotech sector in India are:

• The biotech sector has crossed $1 billion

• There has been a high growth of the Bio Agri sector in the country.
• With the introduction of new technologies, the sector has grown to Rs 598 crore from
Rs 330 crore

The government has also taken good steps to boost the biotech industry in the country, more
and more innovations have been made in this field to combine rich knowledge with skilled
manpower. A number of research laboratories have been set up in this regard to facilitate the
growth of the sector. This has led to the innovation of various drugs for the production of
insulin, blood clotting, human growth and so on. Life saving vaccines and enzymes have also
been manufactured.
Challenges faced by the Indian biotech industry

Despite having established drug development firms and renowned research expertise, the
Indian biotechnology industry is facing a cash crunch. Inherent challenges facing the biotech
outsourcing business are the lack of appropriate infrastructure, issues arising under the
Intellectual Property Rights (“IPR”) laws, product liabilities, ensuring exclusivity and the
need for increased industry-academia partnerships. Other issues that require attention include
but are not limited to: Exchange Control regulations; labour laws; contract terms and
conditions; mechanisms for dispute resolution and the tax issues relating to withholding tax,
transfer pricing and tax holidays/exemptions, etc.

Key drivers of the Indian biotech industry

- A number of biogenerics are slated to go off patent in the coming years, opening
opportunities for Indian firms. Frost & Sullivan reckons that the US and Europe alone offer
potential to generate sales of $16.4 billion by 2011. Besides, the Indian market itself is
quite large, thanks to changing economic demographics .

- Our competitive edge comes from strong bio- manufacturing skills coupled with low-cost
base, generating high capital efficiency.

- It is now possible to establish that indigenously made biosimilar drugs are comparable to
the original products through pharmacokinetic, pharmacodynamic, and clinical studies. A
plus factor from India's perspective.

- Imminent introduction in the U.S. and Europe of a regulatory framework for approving
generic versions of biologicals considerably improves our sales and marketing prospects

Suggested measures for growth of biotech industry in India

- To allow 100% FDI by automatic route in the biotech sector

- Biotechnology should also get the “priority sector” tag for lending funds by banks for long
gestation projects

- To introduce fiscal measures that support incremental R&D investment

- To desist from any price control measures

- To strengthen human resources with an objective of meeting the industry demand in terms
of specialized skills.

- To improve the Regulatory and IP infrastructure.

Future Growth of the Indian biotech industry

The Indian Biotech sector is on a growth trajectory with the potential to deliver $5 billion
revenues by 2010 and $20 billion by 2020. If the National Biotech Strategy is successfully
implemented, this ambition will be easily achieved. We need to focus on creating a strong
educational foundation in terms of higher and specialized education and on forging strong
links between Industry and Academia.

International Biotech Top Indian Biotech International Biotech

Companies Companies Companies in India
Genentech Inc. Biocon Monsanto
Amgen Inc. Shantha Biotechnics Pfizer
Gilead Sciences Inc. Bharat Biotech Astra Zeneca
Genzyme Corporation Wockhardt Unilever
Serono S.A Dr. Reddy's Laboratories Dupont
Biogen Idec Inc. Serum Institute of India Bayer
MedImmune Inc. Zydus Cadila Eli Lilly
Chiron Corporation Aventis Pharma Hoechst Roussel Vet
Amylin Pharmaceuticals
Inc. Reliance Life Sciences Millipore
Invitrogen Corporation Panacea Biotec Novozymes
ii
 3) Company Review
History

While planning for a brewing career abroad, Kiran Mazumdar had a meeting with Les
Auchincloss who had started a biotechnology company called Biocon in Ireland. He asked
her to be his business partner and start Biocon in India. As she wasn’t having any
entrepreneurial background, she refused the offer. However, Les Auchincloss persuaded her
to give it a try with a buy-back clause if the business failed, she finally accepted and spent six
months in Ireland and underwent training for the job.

She started Biocon in 1978 in Bangalore with Rs. 10,000 as the initial capital as she faced
credibility challenges because of her youth, gender and her untested business model. Funding
was a big problem for her as no bank wanted to lend finance to her. After failing to find any
financial institution to back her, she also found it difficult to recruit people for her start-up.
She began operations out of the garage of a rented house with two employees. She faced
several hurdles. Uninterrupted power, superior quality water, sterile labs, imported research
equipment, and advanced scientific skills were not easily available in India during the time.
The company was operating in an environment with sub-optimal infrastructure and
personally she was a 25-year-old first-generation woman entrepreneur without business
experience. There was the risk of the business of biotechnology itself, an unknown business
in 1978.iii

Biocon’s first product to go to market was peptinpapain, an enzyme found in papaya which is
used to prevent beer from turning hazy. Until 1983, the company blended enzymes and
supplied them to brewing, textiles, biofuels, animal feed and other such industries across the
world. In the mid-1980s with a loan of US $250,000 from ICICI Bank, Biocon was able to
build a solid-state fermentation plant which helped in the growth of its R&D. iv

In 1989, the Irish Biocon was acquired by Unilever. In the 1990s, Kiran Mazumdar-Shaw
decided to focus on biopharmaceuticals rather than enzymes. Unilever, which was a major
shareholder, did not want to be in the biopharmaceuticals business. John Shaw, the Scotsman
whom Kiran Mazumdar-Shaw had married in 1998, used his savings to reclaim the entire
Biocon stake from Unilever.v
Biocon ventured into the lucrative biopharmaceutical segment. They sensed a great
opportunity when branded drugs went off patent. They began to develop lovastatin, a
cholesterol-lowering drug whose patent expired in 2001. Biocon eventually began making
other forms of statins. The company’s revenue went up from Rs. 70 crore in 1998, to Rs. 500
crore in 2004 when it went public.

In 2007, Biocon made a strategic decision to divest its historic enzymes business to
Novozymes A/S of Denmark. Today, Biocon has evolved from an enzyme company to a fully
integrated biopharmaceutical company.vi vii

It is the first company globally to manufacture human insulin, Insugen® using a Pichia
expression system. In 2006, Biocon launched BIOMAb EGFR® the first indigenously
developed humanized monoclonal antibody for head-and-neck cancer.
Major Products of Biocon:

Biocon’s products are based in four areas such as Diabetology, Cardiology, Nephrology and
Oncology. Biocon’s cardiology, nephrology, diabetology and oncology products including
BESTOR®, BASALOGTM, BioMAb EGFR®, STATIX®, NUFIL safeTM, INSUGEN®,
TACROGRAFTM, ERYPRO safeTM, and MYOKINASETM are considerably less expensive
than other leading brands. Two of its novel programs on the verge of proof-of-concept stage
are IN-105, which is the only oral insulin in the world to be in long duration clinical trials,
and the T1h, a novel humanized monoclonal antibody (MAb), the only first-in-class novel
MAb being tested in India for rheumatoid arthritis and psoriasis.viii

Biocon has a wide range of products under different categories as listed below:-

Biopharmaceuticals:

Active Pharmaceutical Ingredients (APIs)

• Anti-Diabetic Agents
• Anti-Inflammatory Agents
• Anti-Oxidants
• Cardiovascular Agents
• Anti-Obesity Agents
• Digestive-Aid Enzymes
• Anti-Hypertensive Agents
• Haemostatic Agents
• Hepatoprotective Agents
• Immunosuppressants
• Gastro-Intestinal Agents
• Nutraceuticals

Biological:

• Insulin
• Streptokinase
• EPO
• GCSF
• Monoclonal Antibodies

Branded Formulations

Oncology

• BIOMAb EGFR®
• NUFIL safe™ (Pre-filled Syringe)
 • NUFIL™ (Vials)
• Abraxane® for injectable suspension

Nephrology:

• ERYPRO safe™ (Pre-filled Syringe)

• TACROGRAF™
• RAPACAN™
• CYCLOPHIL ME™
• RENODAPT®
• RENODAPT® – S
• CeRACaL™

Cardiology:

• STATIX®
• STATIX®-F
• STATIX®-EZ
• BESTOR®
• TELMISAT™
• TELMISAT™-H
• ZARGO®
• ZARGO®-H
• ZIGPRIL®
• ACTIBLOK™-IPR
• BRADIA™
• CLASPRIN®
• THINRIN™
• MYOKINASE™
• CLOTIDE™
• DYNALIX®

Diabetology:

• INSUGEN®-R
• INSUGEN®-N
• INSUGEN®-30/70
• INSUGEN®-50/50
• BASALOG™ 3ml, 10 ml
• BLISTO™ 1, 2 & 4
• BLISTO™-MF 1, 2 & 4
• METADOZE-IPR® 500 & 850
• PIODART®
• PIODART®-MF
• TriGPM™
• ZUKER™-MF
• GABIL™
• GMAB™ Plus
• OLISAT™
PROFITABILITY:-

Biocon Ltd’s profitability improved in the quarter ended September, as it benefited from
higher sales and licensing income. During the quarter, sales of biopharmaceuticals rose by
19% to Rs. 601 crore, with product sales rising by 16%, while licensing income doubled to
Rs. 23 crore. It has an alliance with US-based Mylan Inc. and receives license income based
on the progress of work. The first biosimilar product under this alliance has entered the pre-
clinical trials phase, said the company.

Biocon has also announced a $350 million (around Rs. 1,500 crore) licensing arrangement
with Pfizer Inc. pertaining to its insulin products. Its share price has risen nearly 10% since
the announcement was made, explaining why the good results did not move the stock.

Biocon’s revenue rose by 17% and its material costs rose by only 15%. But a decline in other
expenses and slower growth in material costs enabled it to improve its operating profit
margin by 170 basis points. Its profit-before-tax rose by 26% but higher taxes lowered the net
profit growth to 20%.

The company’s biopharmaceuticals business is doing well, with branded formulations’ sales
up by 32% year-on-year in the first half of the year. It has started two new divisions of
immunotherapy and comprehensive care. Its German subsidiary AxiCorp GmbH won some
key tenders for supplying generic drugs, and its sales rose by 30% to Rs. 523 crore in the first
half. Biocon’s biopharmaceutical division is expected to do well in the second half as well.

On the research front, a key development is the company deciding to launch its oral insulin
simultaneously worldwide, which will involve carrying out US clinical trials. Earlier, the
company was contemplating an India launch, followed by a roll-out in other markets. The
company believes the benefits of following this approach will be substantially higher. Its
research services business saw slow growth of 7% in the second quarter, which appears to
partly be a result of an effort to focus only on value-added work.

In the near term, the inflows from the Pfizer transaction will hold investor interest. Around
$200 million will be in the form of an upfront payment, though it will reflect in Biocon’s
profit and loss statement in stages. It will use this money to fund its capital investments and
regulatory filing fees, which would have otherwise put a strain on its finances. This will
ensure that Biocon can fund its growth without resorting to more borrowings. As of
September, its debt levels have fallen by 17%. Biocon’s per share earnings, based on
consensus estimates, are expected to rise by 13% in fiscal 2011 and by 17% in fiscal 2012. Its
share trades at around 26 times its fiscal estimated 2011 earnings. That appears justified,
given the boost to its business from the Pfizer transaction, and its earnings so far having risen
much faster.
Biocon Continues to Deliver Strong Performance

Biocon Limited announces earnings for the half year ended September 30, 2010. Revenues at
Rs 1,360 crores; EBITDA at Rs 293 crores; PAT at Rs 166 crores

Commenting on recent developments, Chairman and Managing Director Kiran Mazumdar-

Shaw said, “This is an exciting time for Biocon. Our strategy of building and unlocking high
value innovation in Biotechnology has seen us enter into a new phase of growth. The recently
announced global commercialization alliance with Pfizer is a validation of this approach. All
our core businesses have delivered robust performance for the first half of this fiscal and are
expected to sustain this level of growth for the rest of the year.”

For Half-Year ended September 30, 2010

• Total Income at Rs 1,360 crores. Up 24% YoY.

• EBITDA at Rs 293 crores. YoY growth was 24%.
• PAT at Rs 166 crores. YoY growth was 26%.
• Operating Margin at 22%.
• Earnings Per Share at Rs 8.5.
• Headcount at 5,100+ employees.

For three months ended September 30, 2010

• Total Income at Rs 688 crores. Up 16% YoY.

• EBITDA at Rs 153 crores. YoY growth was 21%.
• PAT at Rs 89 crores. YoY growth was 20%.
• Operating Margin at 22%.
• Earnings Per Share at Rs 4.5

The global bio-similars market is expected to be worth $19 billion by 2014. Biocon
outsourced Research and Development globally for the year 2009 which was worth $30
billion. Between 2005-10, more than 2.200 high value R&D licensing and other deals were
done within the biopharmaceutical and pharmaceutical space. Net income increased 44% to
Rs. 24,048 million crossing the $ half billion mark. Profits grew 215% to Rs. 2933 million.
Pharmaceutical Business exceeded Rs. 20,871 million in revenue and the Net R&D
expenditure increased to Rs. 917 million, up 42% over 2008 and up 282% over 2005. It
acquired The Bulk Pharmaceutical Plant of IDL Specialty Chemicals Limited in this fiscal
year. Research services business crossed Rs. 2807 million.vii
STRENGTH OF EMPLOYEES:-

Today, Biocon has world-class research outsourcing capabilities, US FDA-compliant bio-

manufacturing facilities and a self-financed R&D pipeline. As we can see in the table below, Biocon
has been providing employment to the youth and employs about 4478 employees including the
subsidiaries.The hire Biologists, chemists, medical practitioners, pharmacologists, engineers,
finance/legal/marketing analysts, HR generalists and general administrators. Around 6% of its
employees have PhD degrees, 45% have a post graduate master’s degree, and 33% are graduates.
Biocon also collaborates with educational institutes to make courses more industry oriented. It is
regarded as the 7th largest employer among the top 100 global biotechnology companies.

Success of Biocon:

The Biocon India Group story began in 1978 when Leslie Auchincloss, owner of the small
Irish multinational company Biocon Biochemicals and Kiran Mazumdar founded Biocon
India - owned 70 per cent by Kiran and 30 per cent by the Irish company. The business was
established In Bangalore and Ms Mazumdar was appointed Chairman & Managing Director.
In 1983 the company acquired 20 acres of land close to Bangalore city and moved its
operation where it is presently located.

In 1989 a new phase in the development of Biocon India opened when Biocon Ireland was
acquired by the Anglo Dutch giant - Unilever. Unilever thereby acquired the 30 per cent
holding in Biocon India owned by Biocon Ireland. As a result of this, Biocon India became
an associate of the multinational giant.

In 1997 when Unilever put its Specialty Chemicals Division up for sale. it was purchased by
lCI (Imperial Chemical Industries) in a global deal valued at $9 million. As a result, the
shareholding In the Biocon India Group was transferred from Unilever to ICI ownership. This
gave Ms Shaw the opportunity to negotiate with ICI as the articles of the various companies
in the Biocon Group gave pre-emptive rights to existing shareholders.

Eventually her husband John Shaw purchased the entire shareholding of ICI in the various
Biocon India Group companies and joined the management team of the group. As a result of
this transaction, the Biocon India Group Companies were owned and controlled by Ms Shaw
and her husband with key employees participating via various stock option schemes.

An associate company or Biocon, Syngene International was established in 1994 to carry out
drug-based contract research as well as informatics- based software development for the
pharmaceutical industry. Syngene International designs and manages research projects for
companies with interests in pharmaceuticals and biotechnology. Syngene's strengths lie in the
areas of molecular biology, synthetic chemistry and informatics.

In August 2000, Clinigene International was established to conduct longitudinal clinical

studies in select disease segments.
The diversity and density of Indian patient populations was perceived to be a unique niche for
Clinigene to pursue a new approach in specialised clinical studies with a view to create new
medical wisdom.

The objective was to create clinical data bases that can be used to identify new biomarkers as
well as other genotypic and phenotypic disease indicators. For this purpose Biocon has tied
up with Strand Genomics. Strand Genomics studies the trends and patterns in the data to
identify new biomarkers. Biocon has also entered into a joint venture with Shantha Biotech to
produce and market Human Insulin.

Controversies:

In the year 2008, villagers of the Hebbagodi region claimed that the company had polluted air
and ground water, where the company's factory is located. They held a protest march and the
angry villagers protested in front of the Biocon factory in Hebbagodi. K M Muniratnam, a
handicapped fisherman accused the company over the huge losses he had sustained over the
last 3 years, as the fish he reared in the lakes were dying due to chemical effluents from the
factory. He had taken the licence to fish in two lakes in the Hebbagodi region, but there had
been at least six occasions when the fish had died. The company had told K M Muniratnam
that they'll pay compensation, but he didn’t get anything. Hebbagodi residents complained
about the contamination before, but no one took notice is what they claimed.

A government analysis in 2007 showed industrial discharge was harming water quality.
People were suffering from skin diseases, headaches, kidney problems. A government
assurance about starting a river water supply to these areas got the protestors to put off their
strike.

But the Biocon company officials replied that they were being unfairly blamed. The COO of
Biocon Arun Chandavarkar claimed that Biocon in no way was connected to quality of water.
Bad smell had been a problem earlier but over the last two years, they claimed to have taken
many steps to reduce the odour.

Biocon’s Methylcobalamin Row

In 2006, there was a lot of controversy surrounding Biocon Ltd, one of the leading biotech
companies in India, for allegedly violating certain norms of manufacturing Methylcobalamin.
The controversy was that Biocon had requested the Union Government for a license to import
the base material and manufacture Methylcobalamin (MeB12) in India.

The company had also obtained license from the Karnataka government to manufacture the
drug in seven stages. On March 17, 2003, the Karnataka government had given license (No.
46 A-MF 668) to manufacture the drug in seven stages. On January 17, 2006, the office of the
drug controller of Karnataka on a routine inspection found that Biocon was not
manufacturing the product in its Bangalore facility and that it was importing the drug from
China. The state government then cancelled the license due to this.

The Karnataka health minister during that year, R Ashok pointed out that the company had
not manufactured the drug as per the seven stages and that government rule clearly states that
if there are any changes in the manufacturing of the drug, which was not according to the
license, then the company had to obtain permission from the government. Else it violates the
Rule 18 (g) under Drugs and Cosmetics Act.

Following the state government's notice to Biocon, the company admitted that they were
importing the drug without the government's permission. The State Drug Controller wrote a
letter to the Chief Drug Controller in Delhi on March 28, 2006 on this issue to take action
against the company.

On February 10, 2006, Biocon got the license from the Central government to import
Methylcobalamin. Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd
informed, "Methylcobalamin is a form of Vitamin B12 and an internet search will indicate
that it is available internationally as a dietary supplement or nutritional supplement and is not
regulated as a drug in many countries. The other common forms of Vitamin B12 are
cyanocobalamin and hydroxocobalamin. However, in India, it has been regulated as a drug
since 2002."

Biocon initially intended to manufacture the product starting from cyanocobalamin using a
multi-step process for which it obtained a manufacturing license from the state drug
controller's office. But competition from cheaper imports made this unviable. Hence, Biocon
revised its manufacturing process to begin from an advanced intermediate with fewer
manufacturing steps without compromising the quality of the final product. However, there
was a regulatory oversight in not updating the manufacturing license to reflect the new
manufacturing process. During a routine inspection, the state drug controller's office noticed
this lapse and issued a show cause notice to Biocon. Biocon admitted the lapse and hence the
manufacturing license for the product was cancelled.

Biocon immediately stopped manufacturing the product and also stopped importing the
advanced intermediate. Biocon made a fresh application to the Central and state drug
controller's office and has obtained a fresh license from both. This is how the issue was then
resolved.
Awards and Achievements
Biocon has the following awards and achievements to its credit

2010:
Bio-Excellence Award for Outstanding Achievement in the Healthcare Sector at Bangalore
Bio

2009:
- Among Top 20 Indian companies in Forbes ‘Best Under A Billion’ list
- Bio-Excellence Award for Outstanding Achievement in the Healthcare Sector at Bangalore
Bio
- Bio-Excellence Award for outstanding achievement in the Biotech Service Sector at
Bangalore Bio for Syngene IDMA ‘Best Patent of the year’ award
- BIOMAb EGFR® voted ‘Bio-Spectrum Asia-Pacific Product of the year’, 2008
- BioSingapore Asia Pacific Biotechnology Award for Best Listed Company

2008:
- Ranked among the top 20 global biotechnology companies (Source: Med Ad News, June
2008)
- 7th largest biotech employer in the world (Source: Med Ad News, June 2008)

2007:
‘BioServices Company of the Year’ for Syngene, BIOMAb EGFR® wins ‘Product of the
Year’, BioSpectrum Awards

2006:
Best IT User Award in the Pharmaceutical Sector, NASSCOM

2004:
- India's first and No. 1 biotech company with a global ranking of 16 (Source: Biospectrum,
July 2004)
- India's top 5 Life Sciences companies (at close of trade as on July 30, 2004)
- Best Reinvention of HR Function Award, Indira Group, Mumbai
- Best Employer of India Award, Hewitt

2003:
- Bio-Business Award for bio-entrepreneurship, Rabo India
- Express Pharma Pulse Award for excellence in the pharmaceutical industry

2001:
- Biotech Product, Process Development and Commercialisation Award, Department of
Biotechnology, Ministry of Science and Technology, Government of India

2000:
- Technology Pioneer Recognition, World Economic Forum 1985:
- Export Performance Award, Karnataka State Financial Corporation (KSFC)
- National Award for Best Small Industry, Government of India

Firsts

Set up in 1978, Biocon is India's first biotech company

• First Indian biotech company to receive US funding for proprietary technologies

(1989)
• Sets up India's first clinical research organization, Clinigene (2000)
• First Indian company to be approved by US FDA for the manufacture of lovastatin, a
cholesterol-lowering molecule (2001)
• First company worldwide to develop human insulin on a Pichia expression system
(2003)
• Biocon enters the stock market with its IPO and becomes only the second Indian
company to cross the $1-billion mark on the day of listing (2004)
• Launches India’s first cancer drug, BIOMAb EGFR® (2006)
• First Indian company to manufacture and export enzymes to USA and Europe
• India’s largest producer and exporter of enzymes
• Releases country’s first 24-hour diabetes drug, Glargine (2009)
• First biotech company to receive ISO 9001 certification in India
• Syngene is country’s first custom research company in drug discoveryiv
CORPORATE GOVERNANCE

Biocon Foundation provides essential primary healthcare services to individuals and families
in target communities by means acceptable to them through their full participation and at
costs that they can afford. They have established Arogya Raksha Yojana (ARY) Clinics.

Delivering on its commitment to affordable healthcare, Biocon Foundation has been setting
up ARY Clinics in areas where large numbers of people are enrolled with the ARY health
micro insurance program. These Clinics have been set up to make primary healthcare
facilities more accessible and more affordable for surrounding communities. Supporting the
ARY micro insurance program, the Clinics will guide member patients to network hospitals
and help them avail of the benefits due to them.

Each Clinic is equipped with:

• a full-time doctor
• an ARY pharmacy stocking subsidized generic drugs
• a Laboratory offering basic diagnostic tests, at discounted rates
• a Mobile Medical Service to enable the clinic doctor and staff to travel to and provide
consultation at remote villages.

The Foundation currently runs seven clinics in both urban and rural settings. In Bangalore
their clinics are located at Austin Town, Huskur, Hennagara and K.R.Puram. The rest of the
clinics are in Mandya, Chickballapur and Bagalkote districts of Karnataka.

In 2008-09, the Arogya Raksha Yojana through its clinics had treated around 22,000 patients
and had assisted many with minor and major surgeries through the ARY health insurance
program. The ARY Clinic in Kaladgi, Bagalkote was an anchor point during the
Foundation’s flood relief effort in the aftermath of the devastating floods that hit North
Karnataka in October 09

Health Camps

General and specialized health camps are conducted in remote areas where good medical
facilities are not available. These camps provide cardiac, neurological, ophthalmic,
orthopedic, gynecological and general health checks. Three to four camps are held every
month in collaboration with Narayana Hrudayalaya and other network hospitals. Every camp
is attended by an average of 300 people.

In Oct 2009, the team from Biocon Foundation’s Health Program held numerous health
camps in the various flood hit villages in Bagalkote district of North Karnataka. The teams
also collaborated with the Government doctors and Public Health Center’s to ensure
maximum reach and effectiveness.. Through these health camps our doctors were able to
reach and help more than 5,000 people.

There has been tremendous progress in the treatment strategies for various diseases, which
were once considered inoperable. Unfortunately, most Indians cannot afford the cost of high
technology healthcare. For example, India requires a 2.5 million heart surgeries a year, but
has the capacity to do only about 80,000-90,000. India also has a very high incidence of head
and neck cancer, which can be cured if diagnosed early and proper treatment is given.

EDUCATION:-

In the area of child education, Biocon Foundation has collaborated with Pratima Rao, a
prominent educationist and Macmillan India, a leading educational publisher to inculcate a
love for math and self reliance in learning through innovative mathematics text books -
‘Chinnara Ganita’.

The project covered 11,000 children in Grade 1 & 2 in its first year and 15,000 children from
Grade 1 to 4 in the second year in rural districts of Karnataka.

Because of Biocon Foundation’s effort to increase access and exposure to learning

opportunities from children, the Aata Pata Wadi project was launched in 2009 with its first
Aata Pata Wadi (after school resource center) in Thithimati in Kodagu district of Karnataka.

The aim of these centers is to provide an open and fun learning environment for children,
many of who come from marginalized communities thus enabling them to nurture their
interests, learn new skills and awaken their spirit of enquiry.

Objectives:

• To provide access to computer aided leaning

• To emphasize experiential learning and extracurricular activities
• To boost language skills
• To provide life skills education

To encourage talent and support academics, Biocon Foundation has initiated a grant for
talented and deserving students of the Guha Centre for Genetic Engineering and
Biotechnology, University of Kolkata.

Kiran Mazumdar Shaw’s view about corporate social responsibility:- “I sincerely believe
that it is important to give back to society - the very society that has allowed us to attain the
heights we have. At Biocon, our efforts extend beyond the realm of biotechnology through
our community-support initiatives and corporate citizenship programmes. We recognise our
responsibility to India - her health, education and environment. Our particular focus is on
child welfare as we realise the importance of investing in children, to positively impact their
future. Biocon Foundation has been established with the aim of identifying and implementing
projects that will impact the social and economic scenario in the country. The main focus
areas of the Biocon Foundation are providing quality healthcare and health education for the
betterment of Indian society.”
 4) Analysis of Kiran Mazumdar
Shaw
As an Entrepreneur
Kiran Mazumdar Shaw, the chairperson of Biocon started her own business with just
Rs.10,000 in hand and a degree in Brewery, and went on to become the richest woman
entrepreneur in India though she actually became an entrepreneur by accident. Mrs. Shaw
wanted to start her Brewing industry and in spite of her degree she established Biocon in
1978 which lead to the foundation of India’s Biotech industry. But still she had to overcome
difficulty as banks refused to provide her loans due to the lack of assets and as she was a
woman entrepreneur which was a rare phenomenon. Above all, Biotechnology industry was a
new field at that point of time.

She has become the Poster Girl for Indian women entrepreneurs, and also a source of
inspiration to many others, though she had a number of failures, she still became a successful
leader. In India, Kiran Mazumdar Shaw is a motivator of all aspiring women entrepreneurs.

Personality Traits
According to us, a combination of several factors such as Determination, Confidence and
Motivation led her to build up a valuable organisation. Let us look at these traits in detail and
let us see how they have been factors for the success of Biocon.

Determination:

Initially when Kiran Mazumdar Shaw approached financial institutions, they refused it as:

 Company had no assets.

 Woman entrepreneur was a new word.

 Biotechnology was a new concept to Indians.

In that stage also her determination to build up Biocon didn’t turn down. As a leader she used
to set possible goals like production of enzymes and antibodies from fermentation and
research process.

Confidence:

Her confidence level is clearly seen through her activities as she started her business in
relatively new and innovative field, even when banks refused loans to Kiran, she still went
against all odds as a belief that women can be entrepreneurs. The confidence of Kiran is
commendable when comparing that with the challenges that she faced. These challenges have
evolved with the growth of Biocon. Initial challenge that she faced was her young age, her
gender and the nature of unfamiliar business. There was no inflow of fund as banks refused to
give loans. Once she overcame all these, she had to face technological challenges to build a
Biotech business in a country like India which was not so good in infrastructure at that point
of time. The high-tech biotech industry was dependent on high quality, power, high
technological lab, equipments etc.

Now the challenges have moved on to maintain quality, about growth, managing a large
company and managing investor expectations like other CEO’s.

Motivation:

In Biocon, employee feedbacks are being regularly asked so as to motivate them and it will
further help them to excel in their field. In Biocon, performance checks are done annually and
implemented at the end of the financial year. It helps to measure employee performance and
also helps to reduce grievances. They also conduct Behavioural training, leadership
programs, and also provide with compensation packages. Due to all these HR policies, the
rate of attrition is less than 1% in Biocon. She has set up a mission for her to build pride into
her workplace and also into her country.

Work place principles which helped her to keep employees motivated are Excellence,
Integrity, Accountability, Organizational Pride, Fairness,Learning, Informality in work place,
Elegant and refined working environment.

Socially Responsible:

Along with the growth of Biocon she also involved her support in various community
programs and corporate citizenship initiatives with a focus in the areas of healthcare,
education, and environment. The Biocon Foundation in 2004, setup “Arogya Raksha Yojana”
which is a unique health initiative for rural India.

In her effort to protect the uniqueness of her hometown Bangalore, she has been involved in
various city improvement programs like the Bangalore Agenda Task Force (BATF).

Risk Taker:

Kiran Mazumdar Shaw is a risk taker, and it can be seen from the beginning of Biocon itself.
She has also proved it when she had done her Post-Graduate in brewery which had never
been touched by a woman in India. Further when she failed to continue her career in
Brewery, she was directed towards Biotechnology industry which was a new business to
Indians. But due to her confidence and determination she was able to be India’s richest
woman.

Other risks which she had taken in her organization were:

 Beacon’s R&D programme was rapidly advanced

 Took the risk to produce Oral Insulin an Anti - CD6 Monoclonal antibody.
These two are the leading discoveries in the field of research programs.
Innovative:

Kiran is an innovator in all sense, in creating a successful company, developing innovative

ideas, new products, etc. Also she has a clear vision and prefixed objective for her
organisation and to achieve those objectives, she encouraged her employees to think
innovative and keep on researching.

Some of the products of Biocon are:

 INSUGEN R: It is useful when Oral agents fail to control blood glucose levels or
when therapy with Insulin.

 BIOMAB-EGFR: This is used in head and neck cancer.

 RAPACAN: This is used for the prevention of rejection and rescue therapy for
rejection in renal transplantation.

As a Leader
We say that Kiran Mazumdar Shaw is a transformational leader as she has similar personality
traits like that of other transformational leaders such as Richard Branson of Virgin group,
A.G. Lafley CEO of Proctor & Gamble. Kiran Shaw had a vision of her own and she never
followed the footsteps of others or never bothered about what others think or say about her.
She also possesses the ability to bring the changes or transform her organisation, and she also
has influential power to motivate and encourage her employees to think innovative and
research.

Eg. As the book Introduction to Organisational Behaviour by Robins, Judge, Sanghi;

describes A. G. Lafley as a transformational leader as he has brought flexibility and creativity
to a slow growing company and also the innovations which helped them to achieve the no. 1 st
position from the 5th position in United States for their brand and doubled the sales
worldwide. Whereas Mrs. Shaw started her business with the initial capital of Rs 10,000 and
at present the company is worth Rs. 1.79 crore. From this we can observe that she was
determined about her company’s success and also has taken number of risks and continued
innovating new products. As a result Biocon has become the number 1 biotech company in
India. ix

Kiran Mazumdar Shaw has transformed Biocon from an enzyme company to a fully
integrated biopharmaceutical company therefore on this basis we say that Mrs. Shaw is a
transformational leader.
Achievements of Kiran Mazumdar Shaw
Kiran Mazumdar Shaw is an entrepreneur who has the potential to take risk and she succeeded in
turning Biocon as India’s largest biotechnological firm. She has won many awards and honours. Some
of the major awards and prizes are:

 She is the list of 100 most powerful women (by Forbes, 2010)

 Nikkei Asia Prizes- Regional Growth by Nikkei Inc. (2009)

 Express pharmaceutical leadership summit award for dynamic entrepreneur (2009)

 Businesswomen of the year by Economic Times (2009)

 Honorary Doctorate from university of Abertay Dundee UK.(2007)

 Wharton Infosys Business transformation Award (2006)

 Padma Bhushan (2005)

 Honorary Doctorate from Manipal Academy of Higher education –MAHE (2005)

 Life time Achievement Award from Indian chamber of Commerce (2005)

 Honorary Doctorate of Science from Ballard University (2004)

 The Economic Times Business Women of the year (2004)

 Whirlpool GR8 women award for science and technology (2004)

 Australian Alumni High Achiever Award from the IDP Australian Alumni
Association (2003)

 Ernst & Young Entrepreneur of the Year Award in Healthcare & Life Sciences
Category (2002)

 Woman of the Year from the International Women's Association, Chennai (1998–
1999)

 Padma Shri (1989)

 Outstanding Young Person Award by Jaycees (1987)

 Rotary award for the Best Model Employer (1983)

 Outstanding Contribution Award (AWAKE) (1983)

 Gold for Best Woman Entrepreneur, Institute of Marketing Management (1982)

Conclusion:

We would like to conclude our project by mentioning the words of Kiran Mazumdar Shaw
herself. This is what she has to say:

“Life is about the very difficult journey. But it’s those difficulties that make it very
interesting, very exciting. If you had smooth sailing all the way I think life will be
very boring. But it’s those challenges that overcoming those challenges that gives you
a sense of confidence to move on. So my advice to young people is Don’t Give Up.
Life and entrepreneurship is about failures, but learn from these failures. Because
failing is big experience, big learning. It makes you stronger, it makes you very
confident when you actually overcome that failure. You know, Yes it’s demoralising
and demotivating if you keep failing and if you keep making same mistakes over and
over again then there is something radically wrong, but by failing and picking
yourself up and then succeeding believe me that failure is a big big deal in itself. I
have done it and I belong to it all the way.” but its most failure that they made very
strong because every time I picked myself up and then succeeded. It’s those failures
that I remember which they really made me very strong.”x
i
http://www.moneycontrol.com/news_html_files/news_attachment/2010/Biocon.pdf
ii
http://www.mariosalexandrou.com/definition/biotechnology.asp

iii
http://www.hindu.com/mp/2010/04/27/stories/2010042750410100.htm
iv
http://www.outlookmoney.com/article.aspx?88528
v
http://www.forbes.com/forbes/2004/1018/088.html
vi
http://en.wikipedia.org/wiki/Biocon
vii
http://www.technologyreview.in/biomedicine/23610/
viii
Annual Report 2009-2010 (http://www.biocon.com/docs/AR10-BIOCON.pdf)
ix
Introduction to Organisational Behaviour by Robins, Judge, Sanghi
x
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