Introduction

Research & Development is the key to the future of pharmaceutical industry. The pharmaceutical advances for considerable improvement in life expectancy and health all over the world are the result of a steadily increasing investment in research. There is considerable scope for collaborative R & D in India. India can offer several strengths to the international R & D community. These strengths relate to availability of excellent scientific talents who can develop combinatorial chemistry, new synthetic molecules and plant derived candidate drugs. R & D in the pharmaceutical industry in India is critical to find answers for some of the diseases peculiar to a tropical country like India and also for finding solutions for unmet medical needs. Industrial R & D groups can carry out limited primary screening to identify lead molecules or even candidate drugs for further in vivo screening, pre-clinical pharmacology, toxicology, animal and human pharmacokinetics and metabolic studies before taking them up for human trials. In such collaborations, harmonized standards of screening can be assured following established good laboratory practices. The R & D expenditure by the Indian pharmaceutical industry is around 1.9% of the industrys turnover. This obviously, is very low when compared to the investment on R & D by foreign research-based pharma companies. They spend 10 - 16% of the turnover on R & D. However, now that India is entering into the Patent protection area, many companies are spending relatively more on R & D. When it comes to clinical evaluation at the time of multi-center trials, India would provide a strong base considering the real availability of clinical materials in diverse therapeutic areas. Such active collaboration will be mutually beneficial to both partners. According to a survey by the Pharmaceutical Outsourcing Management Association and Bio/Pharmaceutical Outsourcing Report, pharmaceutical companies are utilizing substantially the services of Contract Research Organizations (CROs). Indian Pharmaceutical Industry, with its rich scientific talents, provides cost-effective clinical trial research. It has an excellent record of development of improved, costbeneficial chemical syntheses for various drug molecules. Some MNCs are already sourcing these services from their Indian affiliates. The Pharmaceutical and Biotechnology Industry is eligible for weight deduction for R&D expense upto 150%. These R&D companies will also enjoy tax holiday for 10 years. A promotional research and development fund of Rs.150 crores is set up by the Government to promote research and development in the pharmaceuticals sector.

Scope of the project:

Executive Summary

Overview of pharmaceutical industry

Company profile:
Company History

Aurobindo Pharma was born of a vision. Founded in 1986 by Mr. P.V.Ramaprasad Reddy, Mr. K.Nityananda Reddy and a small, highly committed group of professionals, the company became a public venture in 1992. It commenced operations in 1988-89 with a single unit manufacturing semi synthetic penicillins (SSPs) at Pondicherry. Aurobindo Pharma had gone public in 1995 by listing its shares in various stock exchanges in the country. The company is the market leader in semi-synthetic penicillin drugs. It has a presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc. Over the years, the Aurobindo Pharma has evolved into a knowledge driven company. It is R&D focused, has a multi-product portfolio with multi-country manufacturing facilities, and is becoming a marketing conglomerate across the world. Aurobindo Pharma created a name for itself in the manufacture of bulk actives, its area of core competence. After ensuring a firm foundation of cost effective production capabilities and a clutch of loyal customers, the company has entered the high margin speciality generic formulations segment, with a global marketing network. The formulation business is systematically organised with a divisional structure, and has a focused team for each key international market. Aurobindo believes in gaining volume and market share in every business/segment it enters. Aurobindo has invested significant resources in building a mega infrastructure for APIs and formulations to emerge as a vertically integrated pharmaceutical company. Aurobindos five units for APIs and four units for formulations are designed for the regulated markets. Aurobindo Pharma Limited (Aurobindo Pharma) engages in manufacturing pharmaceuticals. The company is engaged in manufacturing active pharmaceutical ingredients (APIs), intermediates and generic formulations. The product portfolio encompasses of 250 finished dosage formulations and 200 API with diversified products. Aurobindo Pharma offers products for the treatment of cardio vascular, central nervous system, anti-retroviral, gastro-intestinal, anti-infective, pain management and osteoporosis. The company has received approvals for both API and formulation facilities from regulatory agencies such as UKMHRA, WHO, Health Canada, MCC South Africa, USFDA and ANVISA-Brazil. The company has global presence in over 100 countries through its 34 subsidiaries, 2 joint ventures, strategic alliances and own infrastructure. The company is headquartered in Hyderabad, Andhra Pradesh, India.

Research & Development The Company's R & D strengths are in developing intellectual property in the area of non-infringing processes and resolving complex chemistry challenges. In the process, Aurobindo Pharma is developing new drug delivery systems, new dosage formulations, applying new technology for better processes. The APL Research Center, two in Hyderabad covers over 13000 sq meter, and provides a nurturing environment to a multi-disciplinary team of over 700 scientists striving for excellence. The Centre meets cGLP requirements, and is focused on the areas of organic synthesis, analytical research, dosage form development, pharmacology, bio-equivalence studies and drug delivery systems. The instrumentation and analytical knowledge base at the Centre facilitate, Process development life cycles of less than three months, even if it involves complex multi step synthesis with multiple chiralitys. Complete impurity profiling in all products developed. Development of analytical methods and specifications from raw materials, to noncompendia finished products. In-house synthesis of reagents for analyzing organo lithiums and noble metals. Accelerated and real-time stability studies.

Top Competitors
Shasun Chemicals & Drugs Ltd.
Shasun Chemicals and Drugs Limited (SCDL) was incorporated in 1976 and is headquartered in Chennai, India. It manufactures active pharmaceutical ingredients (APIs), their intermediates and enteric coating excipients with a significant presence in some key generics. Shasun has created a strong product portfolio, building on its R & D Expertise, regulatory capabilities and multi scale production capacities. Shasun has also emerged as a key player in various service segments in the pharmaceutical field besides APIs and intermediaries, and is strengthening its offer of contract research, custom synthesis, contract manufacturing and contract formulation services to clients. Today, Shasun is one of the largest producers of Ibuprofen worldwide. The company offers derivatives of Ibuprofen like Ibuprofen Sodium, Ibuprofen Lysinate and S+Ibuprofen. It is also one of the major producers of Ranitidine and Nizatidine in the world. Its products are exported to countries across North America, Europe, Asia and Latin America.

Shasun in its endeavour to become a true one-stop shop for global pharma companies, is evolving its business model to become a complete service provider, offering services right from the discovery stage to manufacturing formulations. The company has recently added finished formulations capability as forward integration, and has invested in large facility to cater to the international regulated market. It has tied up with multinational companies in the formulations space wherein it will be developing and supplying products for the US market. The recent acquisition of the business and facilities of Rhodia Pharma Solutions by Shasun's wholly owned subsidiary Shasun Pharma Solutions Ltd (SPSL), UK equipped the company to evolve as a technology based service provider than as a contract manufacturing and research provider. Its services include innovative process research and development, rapid response small scale manufacture for clinical trial supply and full scale commercial manufacture of advanced intermediates and APIs, all with seamless technology transfer with and without cGMP. The formulation unit at Puducherry has been approved by US FDA. By integrating its facilities in India and UK, the company is trying to offer the benefits of operations in both the countries to its clients. The company has aligned its facilities so that while research can be conducted in India, development and manufacturing in kilo labs and pilot plant can be conducted either in UK or India and the optimal mix could be decided based on the regulatory, IP and cost. The company is planning to set up a multi-product pilot plant facility at Vizag, Andhra Pradesh, focusing on Contract Manufacturing Services business. In FY06, CRAMS business revenue has reached INR 3430 million.

Pfizer Inc.

Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life. We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them. We have a leading portfolio of products and medicines that support wellness and prevention, as well as treatment and cures for diseases across a broad range of therapeutic areas; and we have an industry-leading pipeline of promising new products that have the potential to challenge some of the most feared diseases of our time, like Alzheimer's disease and cancer. To ensure we can continue to deliver on our commitments to the patients, customers and shareholders who rely on us, we are focused on improving the way we do business;

on operating with transparency in everything we do; and on listening to the views of all of the people involved in health care decisions. Through working in partnership with everyone from patients to health care providers and managed care organizations to world governments and non-governmental organizations, our goal is to ensure that people everywhere have access to innovative treatments and quality health care.

R&D in Pfizer:
With the integration of Pfizer and Wyeth, we continue to build the world's premier biopharmaceutical R&D organization. Together, our aspirations are to deliver unparalleled innovation, the best internal and external science, and industry leading productivity within a vibrant, diverse culture. Pfizer now has broader and deeper disease area knowledge in our Research Units, increased modality and technology capabilities in our Biotechnology Units, and a new approach that harnesses our combined strengths to find the newest, most innovative and valuable medical solutions. Our combined organizations have the scale, portfolio, talent and capabilities that we believe will unlock new levels of productivity. Drug discovery requires both disease area and technology expertise. While most in the industry are constrained to primarily focus on one of those dimensions, our new model has the breadth and depth of Research Units and Biotechnology Units across R&D that frees us to realize the power and possibilities of these combinations to deliver high impact medicines for patients.

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