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Indian Economy Is One of the Fastest Growing in the World

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Indian Economy Is One of the Fastest Growing in the World SUBMITTED BY GAUTAM KUMAR PGDM (MBA) ROLL NO. - 17 UNDER THE GUIDANCE OF PROF. B. SHANKAYE SINHGAD INSTITUTE OF MANAGEMENT & COMPUTER APPLICATION NARHE, AMBEGAON, (PUNE-41) Page 1 of 75 ACKNOWLEDGEMENT It’s a great pleasure acknowledge these people to have contributed to the successful completion of my project. The project report instead of being an individual effort is a collective on where in help from various quarters specially business and academic ones have been derived. The list of those providing a helping hand is quite played a major role in completion of the project and continuous to have a positive influence in my thought process. First of all I would like express my deep sense of gratitude to Prof. B. SHANKAYE and faculty member of PGDM {AICTE} for providing me this opportunity. Page 2 of 75 Page 3 of 75 CONTENT Sl. No Topic Page No. 1 INTRODUCTION 5 2 OBJECTIVE OF THE STUDY 6 3 NEED TO KNOW PHARMA INDUSTRY 7 4 PHARMA INDUSTRY TODAY 7 5 KEY ISSUE FOR PHARMACEUTICAL INDUSTRY 8 6 INDUSTRY SEGMENTATION 9 7 BULK DRUG 10 8 CLASSIFICATION OF INDUSTRY 10 9 GOVERNMENT POLICY 12 10 SCOPE IN INDIA 15 11 FUTURE SCENARIO 18 12 SWOT ANALYSIS 19 13 TOP TEN INDIAN COMPANY 20 14 INDIAN PHARMA MARKET 21 15 TOP TEN COMPANIES CONTRIBUTION 23 16 MARKET SHARE OF KEY DRUG 25 17 MERGERS AND ACQUISITIONS 26 18 DISTRIBUTION CHANNEL 27 19 ORGANISATION STRUCTURE OF C.F.A. 28 20 STOCKIEST 29 21 MARKET TREND 30 22 CONCLUSION 33 23 SUGGETION 34 24 LIMITATION OF THE STUDY 35 25 RESEARCH METHODOLOGY 35 26 LEADING COMPANY ANALYSIS 37 27 RANBAXY 37 28 CIPLA 41 29 LUPIN PHARMACEUTICALS 49 30 ALKEM LABORATORIES 53 31 DR. REDDY 58 32 COMPARATIVE ANALYSIS 67 33 ANNEXURE 68 34 BIBLIOGRAPHY 71 Page 4 of 75 Indian Pharmaceutical Industry Introduction Indian economy is one of the fastest growing in the world. Its GDP growth rate is 9.2% with a GDP of rupees 177000 crore, which is the fourth largest in the world. India, the 12th largest economy in the world possesses a foreign exchange reserve of USD.177.00 billion. The country is fast adapting to industrialization, the speed of which is measured as the second fastest in the world. The major industries of India are automobiles, cement, chemicals, consumer electronics, food processing, machinery, mining, petroleum, pharmaceuticals, steel, transportation equipment, andtextiles. In the post liberalization era the country has capitalised on its vast pool of educated, English speaking manpower to become a major power in outsourcing, Information Technology, financial and biomedical technology research, banking & insurance, and real estate development EVOLUTION OF INDUSTRY In India, modern system of medicine is a 20th century phenomena, though the traditional system of medicine has been in practice for many centuries. Therefore, in discussing the evolution of the IPI, three points of time are very relevant. These are: 1900-1970, 1970-1990 and the decade of 1990s. The period 1900-1970 signifies the dominance of the multinationals in this field that were basically importing bulk drugs and formulations from abroad. Most domestic manufacturers were engaged in repacking the formulations produced by the multinationals and production was concentrated in the hands of the multinationals. Production of modern medicine by indigenous units started with the setting up of Bengal Chemical and Pharmaceutical works in 1892, which was followed by the establishment of Alembic Chemical works in 1907 and Bengal Immunity in 1919. At this point in time, the Patents Act of 1911 was in practice, which facilitated patenting all the known and possible processes of manufacturing of the said drug besides patenting the drug itself. Hence, the indigenous firms were legally prevented from manufacturing most of the new drugs during the life of the patent secured by the latter, i e, for 16 years, which could be extended to a maximum of another 10 years if the working of the patent had not been sufficiently remunerative to the patentee. This gave them the monopoly power initially. The domestic firms were also for bidden from processing a patented drug into formulations or importing it. However, the Second World War and the introduction of sulpha drugs and penicillin gave on impetus to the pharmaceutical industry. The policy instruments of independent India emphasized on creating a strong public sector unit. In the pharmaceutical front, specific areas of production were defined for the public, private and the domestic sector. The setting up of the public sector units and the technical institutes meant for creating technical skills in the country contributed to the growth of the domestic industry. By 1952, a few drugs like tetanus anti-toxin, PAS and Indocblorhydroxyquinoline were produced in India from their basic stages . However, the import content of the basic drugs was high due to which the prices of the Page 5 of 75 pharmaceutical products of India were the highest in the world. The second period of 1970-1990 is very significant for the IPI since, a few important changes that had implications on the growth of the IPI took place during this time. The Patent Act of 1911 was amended in 1970, which came into force in 1972. The 1970 Patent Act provides protection for the processes of manufacturing the drug for seven years from the date of filing the application or five years from the date of the grant of the patent. Under this Act only one process that was used in the actual manufacturing could be patented. This change brought a renaissance to the pharmaceutical industry of India. More units larger in size and capacity set up in the 1970s and 1980s started producing drugs, which were primarily imported till then. The technical institutes that were set up in the early 1950s and 1960s resulted in creating technical and engineering skills, which could easily adapt the technology developed elsewhere, proved to be very advantageous for the industry. By 1972, over 100 essential drugs covering a wide spectrum of therapeutic groups like antibiotics, sulpha drugs, anti leprotic drugs, analgesics, antipyretics, vitamins, tranquillisers, photochemical and various other pharmaceutical chemicals were produced in India from basic stages . A significant increase in the production of bulk drugs and formulations is observed before and after the 1970s. In the early 1970s, the government introduced the MRTP Act the FERA, which aimed at reducing the concentration of economic power with few units and controlling the flight of foreign exchange from the country. Basically units, which were not bringing in any new technology were asked to reduce their foreign equity and renewal of their licence was also subject to their bringing in new technology. This resulted in the dilution of the foreign equity, which is reported in the Table As a strategy to protect the domestic industry from competition, the FERA companies were also not permitted to produce a list of drugs, which were delicensed during the 1980s. STRUCTURE OF INDUSTRY • Fragmented with 24000 players – 300 organized • Leading 250 – 70% of the market • Market leaders hold 7% • Manufactures : Bulk drugs – APIs Formulations (75:25) • Adopts high technology & produces high value products Objective of the study A. To identify the various forces which are affecting the distribution channel of pharmaceutical industry? B. To understand the process of pharmaceutical marketing. C. To suggest appropriate modification in the distribution channel for pharmaceutical industry. Page 6 of 75 Page 7 of 75 Need to know about the Pharmaceutical Industry The Pharmaceutical Industry Today The pharmaceutical industry is one of the largest and most exciting sectors to be working in today. It is a rapidly changing environment where many advances have taken place over the past 20 years. Furthermore, it will continue to develop and evolve at an ever-increasing pace over the next decade. New drugs, new technologies and exciting new discoveries have driven this evolution. Dr Allan Jordan, Senior Medicinal Chemist at Vernalis will present a clear picture of today's pharmaceutical industry. • The origins of the industry • Where are we now and what issues are we likely to face in the future? • How do generic medicines and parallel trade affect the industry? • What is Biotech and how does it fit into the sector? Regulatory Control of Medicines As a result of the Thalidomide disaster of the late 1950s and early 1960s, medicines have become one of the most highly regulated products in the world. Data demonstrating their safety and efficacy must be filed with government agencies in order to move through clinical development, to obtain approval to sell a new drug and at regular intervals thereafter. Each country has its own regulatory authority and laws governing the development and sale of medicines. In addition, in Europe, there is a regulatory agency at the European level (EMEA). Internationally, there is regulatory co-operation between Europe, the USA and Japan (ICH). As a result, the regulatory control of medicines is a complicated business. The speaker will discuss the current regulatory framework for medicines including: • Why we have regulatory control of medicines • Who the major regulatory bodies are (MHRA, FDA, EMEA, ICH) • What their role is within drug development • What the main regulatory submissions are that a company will make • Drug Discovery and Development Why is drug discovery so important and what are the key stages in drug development? Dr Allan Jordan, Senior Medicinal Chemist at Vernalis will take you through the whole lifecycle of drug discovery - a process that normally takes the Pharmaceutical Industry 10 years. He will explain how new technologies are shaping the future of the industry and discuss the strengths and benefits of conducting pharmaceutical research in the UK. • Drugs and drug targets • Drug discovery: where do leads come from? • From lead to candidate: turning a good lead into a good drug Page 8 of 75 • Early pre-clinical development • Research priorities • The UK Pharmaceutical Industry: the best in the world? Preclinical Studies Before first administration to man, the safety of a new drug has to be evaluated in animals.
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