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Indian Biotech Queen- Kiran Mazumdar Shaw HKE Society’s SLN College of Engineering Yeramarus Camp, Raichur. Department of MBA

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Indian Biotech Queen-Kiran Mazumdar Shaw

HKE Societys

SLN College of Engineering

Yeramarus Camp, Raichur.

Department of MBAPresented by:












Contents of the Project:

1) Kiran Mazumdar Shaw1) Introduction2) Educational Qualifications & Personal life 2) Industry Review of Biotechnology1) Introduction of Biotechnology.2) Biotechnology Industry in India3) Company Review of Biocon

1) History

2) Major Products of Biocon3) Profitability Position

4) Strength of Employees

5) Success of Biocon6) Controversy related to Biocon7) Achievements of Biocon

8) Corporate Governance4) Analysis of Kiran Mazumdar Shaw

1) As an Entrepreneur 2) Personality Traits 3) As a Leader4) Awards

5) Conclusion 1) KIRAN MAZUMDAR SHAW


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 Director. Biocon is also Indias 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 governments 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 Biocons 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 Asias 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 Indias Biotech Queen by The Economist and Indias mother of invention by The New York TimeEducational Qualifications & Personal LifeKiran Mazumdar Shaw was born in Bangalore. She did her schooling from Bishop Cotton Girls 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 Indias 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.iv2) 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 BiotechnologyGreen 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 industryDespite 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 industryThe 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 Companies Top Indian Biotech Companies International Biotech 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 BiotecNovozymes

3) Company Review


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 wasnt 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.

Biocons 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.

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.

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 companys 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.

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:Biocons products are based in four areas such as Diabetology, Cardiology, Nephrology and Oncology. Biocons 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.

Biocon has a wide range of products under different categories as listed below:-Biopharmaceuticals:Active Pharmaceutical Ingredients (APIs) Anti-Diabetic Agents

Anti-Inflammatory Agents


Cardiovascular Agents

Anti-Obesity Agents

Digestive-Aid Enzymes

Anti-Hypertensive Agents

Haemostatic Agents

Hepatoprotective Agents


Gastro-Intestinal Agents


Biological: Insulin




Monoclonal Antibodies

Branded FormulationsOncology BIOMAb EGFR

NUFIL safe (Pre-filled Syringe)

NUFIL (Vials)

Abraxane for injectable suspension

Nephrology: ERYPRO safe (Pre-filled Syringe)







Cardiology: STATIX
















Diabetology: INSUGEN-R




BASALOG 3ml, 10 ml

BLISTO 1, 2 & 4

BLISTO-MF 1, 2 & 4

METADOZE-IPR 500 & 850







Biocon Ltds 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.

Biocons 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 companys 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. Biocons 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 Biocons 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%. Biocons 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 4.5The 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.viiSTRENGTH 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 masters 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 didnt 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.

Biocons Methylcobalamin RowIn 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

FirstsSet 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 Indias first cancer drug, BIOMAb EGFR (2006)

First Indian company to manufacture and export enzymes to USA and Europe

Indias largest producer and exporter of enzymes

Releases countrys first 24-hour diabetes drug, Glargine (2009)

First biotech company to receive ISO 9001 certification in India

Syngene is countrys first custom research company in drug discoveryivCORPORATE 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 Foundations flood relief effort in the aftermath of the devastating floods that hit North Karnatakain October 09

Health CampsGeneral 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 Foundations 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 Centers 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.


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 Foundations 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.


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 Shaws 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 Indias 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.


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 didnt turn down. As a leader she used to set possible goals like production of enzymes and antibodies from fermentation and research process.


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 CEOs.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, and 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 Indias richest woman.

Other risks which she had taken in her organization were:

Beacons 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. 1st 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 companys 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.

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 Indias 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 (19981999)

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)


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 its 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 its those challenges that overcoming those challenges that gives you a sense of confidence to move on. So my advice to young people is Dont 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 its 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. Its those failures that I remember which they really made me very strong.