JB INSTITUTE OF POST GRADUATE COURSESRENIGUNTA ROAD, TIRUPATHI.

BUSINESS INFORMATION SHARING CONFERENCE (BISCON)

On

Dr.Reddy’s Laboratories

Under esteemed guidance of

Mrs. V. Kalpana MBA, M.Phil.

By

TRIVIKRAMA SAI S

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I MBA (2009-11)

1.COMMENCEMENT

Dr. Reddy’s Laboratories Ltd. trading as Dr. Reddy's, founded in 1984 by Dr. K. Anji Reddy, has become India’s second biggest pharmaceutical company. Dr. Anji Reddy had worked in the publicly-owned Indian Drugs and Pharmaceuticals Ltd. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has more than 190 medications ready for patients to take, 60 active pharmaceutical ingredients for drug manufacture, diagnostic kits, critical care and biotechnology products.

Dr. Reddy’s began as a supplier to Indian drug manufacturers, but it soon started exporting to other less-regulated markets that had the advantage of not having to spend time and money on a manufacturing plant that that would gain approval from a drug licensing body such as the U.S. Food and Drug Administration (FDA). Much of Reddy’s early success came in those unregulated markets, where process patents – not product patents – are recognized. With that money in the bank, the company could reverse-engineer patented drugs from more developed countries and sell them royalty-free in India and Russia. By the early 1990s, the expanded scale and profitability from these unregulated markets enabled the company to begin focusing on getting approval from drug regulators for their formulations and bulk drug manufacturing plants in more-developed economies. This allowed their movement into regulated markets such as the US and Europe.

By 2007, Dr. Reddy’s had six FDA-plants producing active pharmaceutical ingredients in India and seven FDA-inspected and ISO 9001 (quality) and ISO 14001 (environmental management) certified plants making patient-ready medications – five of them in India and two in the UK.

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2. ABOUT PROMOTION

Pharmaceutical Services and Active Ingredients

Humanity’s health needs are greater than any one company’s ability to solve them; yet we can work with others to bring new drugs quickly to the market and provide the building blocks of affordable medicines. Through our PSAI business, which comprises the Active Pharmaceutical Ingredients (API) and Custom Pharmaceutical Services (CPS) businesses, we offer IP advantaged, speedy product development and cost-effective manufacturing services to our customers – generic companies and innovators. This allows us to help make good medicines available to more people around the world. The core strengths of our PSAI business are the state-of-the-art infrastructure, resources and skills we are able to offer to our customers:

Large and diverse product portfolio Eight FDA-inspected plants and three technology centers World class chemistry expertise Robust, large-scale manufacturing capabilities Intellectual Property (IP) driven product development for freedom to operate Total, seamless supply chain management

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Global Generics

Both in the developing and developed world, it is a grim fact that millions of people suffer from treatable illnesses and disease simply because they cannot afford the medicines that will restore them to health. Even in high income countries like the US, brand name drugs are often prohibitively expensive, particularly for the growing numbers of uninsured. Around the world, having access to lower-cost generic medicines can mean the difference between health and sickness, solvency and bankruptcy for countless people.

Generic drugs hold great promise for the future. Growing acceptance of generics and favorable legislation in many geographies, combined with the large volume of branded products losing patent protection over the coming years is expanding the generic pharmaceuticals market.

Through our branded and unbranded Global Generics business, we fulfill our purpose of providing affordable medicines to more people around the world by offering lower-cost alternatives to highly-priced innovator brands both directly and through key partnerships.

Our capabilities span the entire value chain – from process development of the active pharmaceutical ingredient (API) to submission of the finished dosage dossier to the regulatory agencies – giving us control over the supply chain and the ability to offer high quality products at the right time and at competitive prices. Our state-of-the-art manufacturing facilities are ISO14001 and ISO9001 certified and have an excellent record of regulatory compliance. Our generics business is supported by our integrated Product Development Infrastructure which is dedicated to bringing new medicines to the market.

Today, we have a strong presence both in highly regulated markets like the US, UK and Germany and in emerging markets, including India, Russia, Venezuela, Romania, and CIS (Belarus, Ukraine and Kazakhstan). Moreover, we are steadily building our presence in other key markets

Proprietary Products

Science and innovation hold the key to unlocking the mysteries of diseases that continue to afflict humanity. While scientific advances have either obliterated many deadly diseases or brought them under control, there are still far too many diseases that lack satisfactory treatments or cures. These unmet medical needs of humanity drive our research enterprise.

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Our Proprietary Products business comprises NCE research, Biologics and Differentiated Formulations. In each of these areas, we are building world-class capabilities and partnerships to accelerate the discovery and development of new and improved therapies.

Within our highly advanced and integrated R&D infrastructure, scientists with diverse functional expertise seek innovative solutions to medical needs in the therapeutic areas of metabolic diseases, anti-infectives and inflammatory disease. Our scientific capabilities span a wide range of areas, such as medicinal chemistry, analytical chemistry, pharmacology, genomics, proteomics, molecular biology, microbiology, toxicology, formulation and clinical development

3. MISSION & VISION

We are committed to providing Affordable and Innovative medicines for healthier lives.

AffordabilityThe high cost of many medicines puts them out of the reach of millions of people who

desperately need them. As a global pharmaceutical company, we take very seriously our responsibility to help alleviate the burden of disease on individuals and on the world.

Through our Global Generics business, we provide high quality, lower-cost alternatives to innovator drugs. Our wide ranges of generic medicines bring hope and health to people

around the globe.

InnovationDespite the great advances of medical science, there are still far too many diseases for which there are no cures or no satisfactory treatments. We believe that innovation – in research, processes and technologies – holds the key to finding solutions for unmet or

inadequately met medical needs. Our Proprietary Products business is dedicated to discovering new or better treatments than currently exist. In addition, our Custom

Pharmaceutical Services business works with Innovator companies and emerging biotech firms to accelerate the development of new molecules, while lowering research costs.

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4. PRODUCTS & SERVICES

5. BRANCHES / MANUFACTURING UNITS

Dr. Reddy's bulk manufacturing operations are spread across six units in Andhra Pradesh, India, a state-of-the-art facility in Mexico and a manufacturing site based in Mirfield, UK. These facilities have been built and are operated in accordance with the latest regulatory guidelines on cGMP. Our facilities have been inspected by the USFDA and numerous other international regulatory agencies for all major products.

A brief overview of our API manufacturing facilities.

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Unit 1 Set up in 1985 Located at Bollaram, Hyderabad Has a Reaction Volume Capacity of 130 KL

Is USFDA Inspected and ISO-9001 certified

Unit 2 Set up in 1986 Located at Bollaram, Hyderabad Has a Reaction Volume Capacity of 152 KL

Is USFDA Inspected and ISO-9001 certified

Unit 3 Set up in 1995 Located at Bollaram, Hyderabad Has a Reaction Volume Capacity of 71 KL

Is USFDA Inspected and ISO-9001 certified Unit 4

Set up in 1984 Located at Jeedimetla, Hyderabad Has a Reaction Volume Capacity of 110 KL

Is USFDA Inspected and ISO-9001 certified Unit 5

Set up in 1987 Located at Miriyalaguda, 150 kms from

Hyderabad Has a Reaction Volume Capacity of 700 KL Is USFDA Inspected and ISO-9001 certified

Has achieved 'Zero Discharge' Unit 6

Set up in 1990 Located at Pydibheemavaram, 800 kms from

Hyderabad Has a Reaction Volume Capacity of 570 KL

Is USFDA Inspected and ISO-9001 certified

Unit 7 Our API facility in Mexico gives us niche

steroidal API capacities and has the world’s largest capacity for sodium naproxen

   

6. MILE STONES

2009 Dr. Reddy’s crosses $150 million revenue milestone in Russia & CIS region

2008

Acquires BASF’s Pharmaceutical manufacturing contract business and related facility at Shreveport, Louisiana

Acquires Dowpharma’s small molecule business at its Mirfield and Cambridge facilities, UK.

Dr. Reddy’s formally announces its US Specialty Business, Promius Pharma, LLC.

2007

Becomes No.1 pharmaceutical company in India in turnover and profitability. Launches Reditux ™ (Rituximab) – the World’s first biosimilar of a monoclonal

antibody Blaglitazone (DRF 2593) enters Phase III of clinical trials becoming India’s most

advanced NCE

2006

Revenues touch USD 1 Billion in December 2006. Dr. Reddy's obtains its second 180-day marketing exclusivity for a generic drug in

the US market with the launch of Ondenesetron Hydrochloride Tablets. Becomes an Authorized Generic Partner for Merck’s Proscar® & Zocor® in the US

market during 180 day exclusivity period. Acquires betapharm- the fourth-largest generics company in Germany for a total

enterprise value of € 480 million.

2005

Acquires Roche's API Business at the state-of-the-art manufacturing site in Mexico with a total investment of USD 59 million.

Announces India's first major co-development and commercialization deal for it's molecule Balaglitazone (DRF 2593), with Rheoscience.

Announces a unique partnership for the commercialization of ANDAs with ICICI Venture..

2004

Acquires Trigenesis gives access to drug delivery technology platforms

2003

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Unit 1 Set up in 1985 Located at Bollaram, Hyderabad Has a Reaction Volume Capacity of 130 KL

Is USFDA Inspected and ISO-9001 certified

Unit 2 Set up in 1986 Located at Bollaram, Hyderabad Has a Reaction Volume Capacity of 152 KL

Is USFDA Inspected and ISO-9001 certified

Unit 3 Set up in 1995 Located at Bollaram, Hyderabad Has a Reaction Volume Capacity of 71 KL

Is USFDA Inspected and ISO-9001 certified Unit 4

Set up in 1984 Located at Jeedimetla, Hyderabad Has a Reaction Volume Capacity of 110 KL

Is USFDA Inspected and ISO-9001 certified Unit 5

Set up in 1987 Located at Miriyalaguda, 150 kms from

Hyderabad Has a Reaction Volume Capacity of 700 KL Is USFDA Inspected and ISO-9001 certified

Has achieved 'Zero Discharge' Unit 6

Set up in 1990 Located at Pydibheemavaram, 800 kms from

Hyderabad Has a Reaction Volume Capacity of 570 KL

Is USFDA Inspected and ISO-9001 certified

Unit 7 Our API facility in Mexico gives us niche

steroidal API capacities and has the world’s largest capacity for sodium naproxen

   

Launches Ibuprofen, first generic product to be marketed under the “Dr. Reddy’s” label in the US

2002

Conducts its first overseas acquisition – BMS Laboratories Limited and Meridian Healthcare in UK

2001

Becomes the first Asia Pacific pharmaceutical company, outside Japan, to list on the New York Stock Exchange. Listed with the symbol ‘RDY’ on April 11, 2001.

Out-licenses DRF 4158 to Novartis for up to US $55 million upfront payment Launches its first generic product, Ranitidine, in the US market Becomes the first Indian pharmaceutical company to obtain an 180-day exclusive

marketing rights for a generic drug in the US market with the launch of Fluoxetine 40 mg capsules on August 3, 2001

2000

Dr. Reddy's Laboratories becomes India's third largest pharmaceutical company with the merger of Cheminor Drugs Limited, a group company

Reddy US Therapeutics, a wholly-owned subsidiary, is established at Atlanta, US to conduct target based drug discovery

1999

Acquisition of American Remedies Limited, a pharmaceutical company based in India.

1998

Licenses anti-diabetic molecule, DRF 2725 (Ragaglitazar), to Novo Nordisk

1997

Licenses anti-diabetic molecule, DRF 2593 (Balaglitazone), to Novo Nordisk. Becomes the first Indian pharmaceutical company to out-license an original molecule.

First ANDA filed with the United States Food and Drug Administration for Ranitidine

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1995

Sets up of a Joint Venture in Russia.

1994

Makes a GDR issue of USD 48 million Foundation stone laid for a finished dosages facility to cater to the highly regulated

markets such as the US.

1993

Dr. Reddy's Research Foundation established. The company's drug discovery programme starts.

1991

First formulation exports to Russia commence

1990

Dr. Reddy’s, for the first time in India, exports Norfloxacin and Ciprofloxacin to Europe and Far East

1988

Acquires Benzex Laboratories Pvt. Limited to expand its Bulk Actives business.

1987

Obtains its first USFDA approval for Ibuprofen API Starts its formulations operations

1986

Dr. Reddy’s goes public Dr. Reddy’s listed on Bombay Stock Exchange (BSE) Dr. Reddy’s enters international markets with exports of Methyldopa

1984

Dr Anji Reddy establishes Dr. Reddy's Laboratories with an initial capital outlay of Rs.25 lakhs

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7. INNOVATIONS BY THE COMPANY

Innovation

Despite the great advances of medical science, there are still far too many diseases for which there are no cures or no satisfactory treatments. We believe that innovation – in research, processes and technologies – holds the key to finding solutions for unmet or

inadequately met medical needs. Our Proprietary Products business is dedicated to discovering new or better treatments than currently exist. In addition, our Custom

Pharmaceutical Services business works with Innovator companies and emerging biotech firms to accelerate the development of new molecules, while lowering research costs.

Our commitment to Environment is the driving force for achieving Sustainability.

We measure the environmental impact of our operations through certain key parameters like water consumption, effluent discharge, COD and TDS, load dicharge. For five units of our API plants, out of six we have achieved Zero Discharge status.Our performance on these paramters normalised to unit sales is presented below.

Graphs for Water | Effluent | COD | TDS

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8. BEST LEADER IN COMPANY

Mr. Amit Patel - Vice President, Corporate Development & Strategic Planning Dr. K Anji Reddy, chairman Mr. GV Prasad - vice chairman & chief executive Mr. Satish Reddy - managing director & COO Mr. B.Koteswar rao - independent director Mr. Anupam Puri - independent director Dr. Krishna G Palepu - independent director (Following the Satyam accounting

scandal, media has reported that Prof Palepu has been informally asked to quit the Dr. Reddy's Laboratories Board[9].)

Dr. Omkar Goswami - independent director Mr. P N Devarajan - independent director Mr. Ravi Bhoothalingam - independent director Dr. V. Mohan - independent director Dr. Rajinder Kumar - president, Research, Development and Commercialization

(joined on April 30 2007)

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COMPOSITION OF BOARD & BOARD COMMITTEES OF DR. REDDY’SBoard of Directors of Dr. Reddy’s

1. Dr. K Anji Reddy (Chairman)2. Mr. G V Prasad (Vice Chairman & CEO)3. Mr.Satish Reddy (Managing Director & COO)4. Mr. Anupam Puri5. Dr. Bruce Carter6. Dr. J P Moreau7. Ms. Kalpana Morparia8. Dr. Omkar Goswami9. Mr. Ravi Bhoothalingam

BOARD COMMITTEESAudit CommitteeMembers Dr. Omkar Goswami (Chairman)Ms. Kalpana MorpariaMr. Ravi Bhoothalingam

Governance & Compensation CommitteeMembers Mr. Anupam Puri (Chairman) Dr. Bruce CarterDr. J P MoreauMs. Kalpana MorpariaDr. Omkar GoswamiMr. Ravi Bhoothalingam

Investment CommitteeMembers Mr.G.V.Prasad (Chairman) Mr.Satish ReddyMr. Ravi Bhoothalingam

Shareholders’ Grievance CommitteeMembers Mr. Ravi Bhoothalingam (Chairman) Mr.G.V.PrasadMr.Satish Reddy

Management CommitteeMembers Mr.Satish Reddy (Chairman)Mr.G.V.PrasadMr. Ravi Bhoothalingam

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9. ACHEIVEMENTS

2009

AIF Annual Spring Award 2009 American India Foundation

Best Workplace Biotech/ Pharma Industry The Economic Times & Great Places to Work Institute

ICT Platinum Award Institute of Chemical Technology, Pune

Corporate Collateral AwardsPublic Relations Council of India

In-House Communications Excellence Awards Shailaja Nair Foundation

Global HR Excellence Awards 2008-09 Asia Pacific HR Congress

2008

Corporate Citizen of the Year 2007-08 The Economic Times Award for Corporate Excellence

Best Workplaces 2008 In Biotech/ Pharma Industry SectorThe Econimoic Times

2007

NDTV Profit Business Leadership Awards 2007 Business Leader in the Pharmaceutical Sector

Best Performing CFO in the Pharma Sector for 2007 CNBC-TV18's CFO AwardSaumen Chakroborty - CFO

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Amity Leadership Award Best Practices in HR in Pharmaceutical Sector.4th HR Summit '08

Dun & Bradstreet American ExpressCorporate Awards 2007 Top Indian company in the harmaceutical sector

Best Corporate Social Responsibility Initiative 2007 BSE & NASSCOM Foundation - Social and Corporate Governance Award

Pharma Excellence Awards 2006-07 Category : The Lifetime Achievement Award to Dr. K. Anji Reddy, Chairman

Pharma Excellence Awards 2006-07 Category: Sustained Growth The Indian Express

Pharma Excellence Awards 2006-07 Category : Corporate Social Responsibility The Indian Express

Pharma Excellence Awards 2006-07 Category: Shareholder Protection The Indian Express

The Best Companies to Work for in India Survey, 2007 BT - Mercer - TNS Survey Rank 10

Best Employers in India 2007 Award Hewitt Associates & The Economic Times

South Asian Federation of Accountants (SAFA) Award 2007 2nd Best Annual Report in the South Asian Region

Asia-Pacific HRM Congress 2007 Global HR Excellence Award for Innovative HR Practices

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Asia-Pacific HRM Congress 2007 Recruitment and Staffing Best In Class (RASBIC) Award - Best Overall Recruiting and Staffing Organization of the Year

Employer Branding Awards 2007 Excellence in Human Resources Award - Talent Management

2006

FinanceAsia Achievement Awards 2006 Best India Deal - Acquisition of betapharm for $570 million

The Best Companies to Work for in India 2006 4th Best Company to Work for in India Business Today, Mercer & TNS

Pharma Excellence Awards 2005-06 Category: Leveraging Global OpportunityThe Indian Express

Pharma Excellence Awards 2005-06 Category: Business Development DealThe Indian Express

Pharma Excellence Awards 2005-06 Category: Operational ExcellenceThe Indian Express

2005

Best Management Award 2005 Labour Department, Govt. of Andhra Pradesh, India

India Business Leader Awards (IBLA) 2005 Indian Corporate Citizen of the YearCNBC

India's Best Managed Company 2004-05 Business Today

2004

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Most Respected Company Awards 2004 Most Respected Company - Pharma SectorThe Businessworld

Best Employers in India 2004 Award Hewitt Associates & CNBC

Asia-Pacific HR Congress 2004 Organization with Innovative HR Practices

Pharmabio Award 2004 Chemtech Foundation

2003

WORLDSTAR Award for Packaging Excellence 2003

For Omez capsules pack with Anti-Counterfeiting Features

DH Avenue Awards for HR Excellence 2003 Organization with Innovative HR Practices Centre for Change Management

Express Pharma Pulse Awards 2003 Best Bulk Drug Company The Indian Express

Express Pharma Pulse Awards 2003 Best Bulk Drug CompanyThe Indian Express

Express Pharma Pulse Awards 2003 Excellence in ResearchThe Indian Express

2002

Best Employers in India 2002 Award Hewitt Associates & Business Today

INDIASTAR Award for Packaging Excellence 2002 Indian Institute of Packaging

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ASIASTAR Award for Packaging Excellence 2002 Mintop Forte – Customer Convenience Pack Asian Packaging Federation

2001

Healthcare and Life Sciences India 2001 Awards Entrepreneur of the Year – Dr. Anji Reddy Ernst & Young

2000

CHEMTECH CEW Award 2000 Achiever of the Year – Dr. Anji ReddyChemtech Foundation

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10. TRIUMPHS BY THE LEADERS

Dr. K. Anji ReddyChairmanDr. Reddy’s Laboratories Ltd.

Dr. K. Anji Reddy (a Bachelor’s of Science in Pharmaceuticals & Fine Chemicals from Bombay University, and a Ph.D in Chemical Engineering from the National Chemical Laboratory, Pune) is the Founder-Chairman of Dr. Reddy’s. He served in the state-owned Indian Drugs and Pharmaceuticals Limited from1969 to 1975, was Founder-Managing Director of Uniloids Ltd from 1976 to 1980 and Standard Organics Limited from 1980 to 1984, before founding Dr. Reddy’s in 1984.

Under Dr. Anji Reddy’s leadership, Dr. Reddy’s has become a pioneer and a trendsetter in the Indian Pharmaceutical industry. It turned the Indian bulk drug industry from import-dependent in the mid-80s to self-reliant in the mid-90s and, finally, into the export-oriented industry that it is today. Dr. Reddy’s was the first company to begin drug discovery research in India in 1993 and has led the industry in turning from ‘copycats’ into innovators. Dr. Reddy’s was listed on the New York Stock Exchange in April 2001 (RDY) – the first non-Japanese Asian pharmaceutical company to be listed on the NYSE. The present turnover of the company is in excess of 1 Billion U.S. dollars.

Dr. Reddy is a serving member of the Prime Minister’s Council on Trade & Industry, Government of India. He is also a member of the Board of Governors of the Institute of Chemical Technology, University of Mumbai. He is the Chairman of the Institute of Life Sciences, a public-private partnership initiative, set up on the campus of the University of Hyderabad, the first of its kind in the country. Dr. Reddy serves on the board of the Hyderabad Eye Research Foundation and also on that of the Vision Research Foundation, Chennai. He serves as a board member of GAIN (Global Alliance for Improved Nutrition), Switzerland, and is also the Chairman of Water Health International (India), an organization that raises awareness about water and health. The Naandi Foundation, a non-profit development institute that strives towards the eradication of poverty, has Dr. Reddy as its Chairman. He is also Founder-Chairman of Dr. Reddy’s Foundation, the social arm of Dr. Reddy’s, which acts as a catalyst of change towards achieving sustainable development. Dr. Reddy is a Fellow of the Indian National Academy of Engineering and a member of the General Body of the Birla Institute of Technology & Science, Pilani (Rajasthan).

Dr. Reddy has been the recipient of several awards and honors. Notable among them are the Sir P.C. Ray award, twice conferred on Dr. Reddy by the Indian Chemical Manufacturers Association in1984 and 1992, and the Federation of Asian Pharmaceutical Associations’ (FAPA) FAPA-Ishidate Award for Pharmaceutical Research in 1998. He was voted Businessman of the Year by India’s leading business magazine Business India in the year 2001. Dr. Reddy is a recipient of the ‘Padmashri’ Award in year 2001, conferred on him by the Government of India for his distinguished service in the field of Trade & Economic Activity and Industry. In recognition of his pioneering work and introduction of affordable medicine, the Chemtech Foundation bestowed on him the Achiever of the Year award in the year 2000 and the ‘Hall of Fame’ award in 2005, for his Entrepreneurship, Leadership and thrust towards Innovation.

GV Prasad, Vice Chairman and Chief Executive Officer Dr. Reddy’s Laboratories Ltd.

GV Prasad leads the core team that drives the growth and performance of Dr Reddy’s. Prasad has played a key role in the evolution of Dr. Reddy’s from a mid-sized pharmaceutical company into a globally respected pharmaceutical major.

Prasad has been Vice-Chairman and CEO of Dr. Reddy’s since 2001, when Cheminor Drugs Ltd, the company of which he was then Managing Director, merged with Dr Reddy’s. Prasad nurtured new lines of business, helped to build a high-talent organization, and was instrumental in introducing best-in-class practices in corporate governance.

Prasad is widely credited as the architect of Dr. Reddy’s successful global generics strategy. He envisioned new business platforms like the Custom Pharmaceutical Services business and Specialty Pharmaceuticals and is dedicated to building the innovation side of the business. He is also a champion of sustainability thinking and has spearheaded efforts to reduce the company’s ecological footprint by embracing green technologies and processes.

Prasad’s personal mission is to create high performing organizations which can sustain and thrive through changing generations of people, products and technologies. He firmly believes that a strong human resource base is crucial for seamlessly integrating diverse businesses and cultures to perform as a cohesive business force. He has focused on transformation through people processes and has launched several initiatives which won the company the Best Employers in India 2007 Award.

Prasad earned his degree in Chemical Engineering from the Illinois Institute of Technology in Chicago in 1982 and his Masters in Industrial Administration from Purdue University in 1983.

Professional Affiliations

AP State Committee, WWF-India Member of the Advisory Board, Acumen FundMember of the Board, Infotech Enterprises Ltd.Member of the Board, Diana Hotels, IndiaMember of the Board, Ocimum Bio SolutionsMember, American Chemical SocietyMember, American Institute of Chemical EngineersServed as Chairman of the CII National Committee on Environment and the Intellectual Property Committee (2006-2007)

11.FINANCIALPERFORMANCE

12. FUTURE PLANS

OUR ASPIRATIONS

FINANCIAL TARGETS

13. HR DETAILS

PHARMACEUTICAL INDUSTRY

The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies can deal in generic and/or brand medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs.

The earliest drugstores date back to the Middle Ages. The first known drugstore was opened by Arabian pharmacists in Baghdad in 754, and many more soon began operating throughout the medieval Islamic world and eventually medieval Europe. By the 19th century, many of the drug stores in Europe and North America had eventually developed into larger pharmaceutical companies.

Most of today's major pharmaceutical companies were founded in the late 19th and early 20th centuries. Key discoveries of the 1920s and 1930s, such as insulin and penicillin, became mass-manufactured and distributed. Switzerland, Germany and Italy had particularly strong industries, with the UK, US, Belgium and the Netherlands following suit.

Legislation was enacted to test and approve drugs and to require appropriate labelling. Prescription and non-prescription drugs became legally distinguished from one another as the pharmaceutical industry matured. The industry got underway in earnest from the 1950s, due to the development of systematic scientific approaches, understanding of human biology (including DNA) and sophisticated manufacturing techniques.

Numerous new drugs were developed during the 1950s and mass-produced and marketed through the 1960s. These included the first oral contraceptive, "The Pill", Cortisone, blood-pressure drugs and other heart medications. MAO Inhibitors, chlorpromazine (Thorazine), Haldol (Haloperidol) and the tranquilizers ushered in the age of psychiatric medication. Valium (diazepam), discovered in 1960, was marketed from 1963 and rapidly became the most prescribed drug in history, prior to controversy over dependency and habituation.

Attempts were made to increase regulation and to limit financial links between companies and prescribing physicians, including by the relatively new U.S. Food and Drug Administration (FDA). Such calls increased in the 1960s after the thalidomide tragedy came to light, in which the use of a new tranquilizer in pregnant women caused severe birth defects. In 1964, the World Medical Association issued its Declaration of Helsinki, which set standards for clinical research and demanded that subjects give their informed consent before enrolling in an experiment. Phamaceutical companies became required to prove efficacy in clinical trials before marketing drugs.

Cancer drugs were a feature of the 1970s. From 1978, India took over as the primary center of pharmaceutical production without patent protection.

The industry remained relatively small scale until the 1970s when it began to expand at a greater rate. Legislation allowing for strong patents, to cover both the process of manufacture and the specific products, came in to force in most countries. By the mid-1980s, small biotechnology firms were struggling for survival, which led to the formation of mutually beneficial partnerships with large pharmaceutical companies and a host of corporate buyouts of the smaller firms. Pharmaceutical manufacturing became

concentrated, with a few large companies holding a dominant position throughout the world and with a few companies producing medicines within each country.

The pharmaceutical industry entered the 1980s pressured by economics and a host of new regulations, both safety and environmental, but also transformed by new DNA chemistries and new technologies for analysis and computation. Drugs for heart disease and for AIDS were a feature of the 1980s, involving challenges to regulatory bodies and a faster approval process.

Managed care and Health maintenance organizations (HMOs) spread during the 1980s as part of an effort to contain rising medical costs, and the development of preventative and maintenance medications became more important. A new business atmosphere became institutionalized in the 1990s, characterized by mergers and takeovers, and by a dramatic increase in the use of contract research organizations for clinical development and even for basic R&D. The pharmaceutical industry confronted a new business climate and new regulations, born in part from dealing with world market forces and protests by activists in developing countries. Animal Rights activism was also a problem.

Marketing changed dramatically in the 1990s, partly because of a new consumerism. The Internet made possible the direct purchase of medicines by drug consumers and of raw materials by drug producers, transforming the nature of business. In the US, Direct-to-consumer advertising proliferated on radio and TV because of new FDA regulations in 1997 that liberalized requirements for the presentation of risks. The new antidepressants, the SSRIs, notably Fluoxetine (Prozac), rapidly became bestsellers and marketed for additional disorders.

Drug development progressed from a hit-and-miss approach to rational drug discovery in both laboratory design and natural-product surveys. Demand for nutritional supplements and so-called alternative medicines created new opportunities and increased competition in the industry. Controversies emerged around adverse effects, notably regarding Vioxx in the US, and marketing tactics. Pharmaceutical companies became increasingly accused of disease mongering or over-medicalizing personal or social problems.

Industry associations European Federation of Pharmaceutical Industries and Associations (EFPIA) European Pharmaceutical Market Research Association (EphMRA) International Federation of Pharmaceutical Manufacturers and Associations

(IFPMA) Japan Pharmaceutical Manufacturers Association (JPMA) New York Health Products Council (NYHPC) Pharmaceutical Research and Manufacturers of America (PhRMA) Irish Pharmaceutical Healthcare Association (IPHA)

Regulatory authorities International Conference on Harmonisation of Technical Requirements for

Registration of Pharmaceuticals for Human Use (ICH) European Medicines Agency (EMEA) U.S. Food and Drug Administration (FDA)

Ministry of Health, Labour and Welfare (Japan) Medicines and Healthcare products Regulatory Agency (MHRA) Central Drugs Standards Control Organisation (India) CDSCO Ukrainian Drug Registration Agency

ABOUT PHARMA INDUSTRY IN INDIA

“The Indian pharmaceutical industry is a success story providing employment for millions and ensuring that essential drugs at affordable prices are available to the vast population of this sub-continent.”

Richard Gerster

The Indian Pharmaceutical Industry today is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian Pharma Industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent annually. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously.

Playing a key role in promoting and sustaining development in the vital field of medicines, Indian Pharma Industry boasts of quality producers and many units approved by regulatory authorities in USA and UK. International companies associated with this sector have stimulated, assisted and spearheaded this dynamic development in the past 53 years and helped to put India on the pharmaceutical map of the world.

The Indian Pharmaceutical sector is highly fragmented with more than 20,000 registered units. It has expanded drastically in the last two decades. The leading 250 pharmaceutical companies control 70% of the market with market leader holding nearly 7% of the market share. It is an extremely fragmented market with severe price competition and government price control.

The pharmaceutical industry in India meets around 70% of the country's demand for bulk drugs, drug intermediates, pharmaceutical formulations, chemicals, tablets, capsules, orals and injectibles. There are about 250 large units and about 8000 Small Scale Units, which form the core of the pharmaceutical industry in India (including 5 Central Public Sector Units). These units produce the complete range of pharmaceutical formulations, i.e., medicines ready for consumption by patients and about 350 bulk drugs, i.e., chemicals having therapeutic value and used for production of pharmaceutical formulations.

Following the de-licensing of the pharmaceutical industry, industrial licensing for most of the drugs and pharmaceutical products has been done away with. Manufacturers are free to produce any drug duly approved by the Drug Control Authority. Technologically strong and totally self-reliant, the pharmaceutical industry in India has low costs of production, low R&D costs, innovative scientific manpower, strength of national laboratories and an increasing balance of trade. The Pharmaceutical Industry, with its rich scientific talents and research capabilities, supported by Intellectual Property Protection regime is well set to take on the international market.

KEY PLAYERS IN INDIAN PHARMA INDUSTRY

PRODUCTS & SERVICES IN PHRMA INDUSTRY

Company

Ranbaxy Laboratories

Dr. Reddy's Laboratories

Cipla

Nicholas Piramal

Aurobindo Pharma

GlaxoSmithKline

Lupin Laboratories

Sun Pharmaceutical Industries

Cadila Healthcare

Wockhardt