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)
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ACKNOWLEDGEMENT It’s a great pleasure acknowledge these people to have cont contri ribu bute ted d to the the succ succes essf sful ul comp comple leti tion on of my proj projec ect. t. Th Thee 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 pro projec ject and con onti tinu nuo ous to have a posit ositiv ivee infl influ uenc ence 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.
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CONTENT Sl. No 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34
Topic INTRODUCTION OBJECTIVE OF THE STUDY NEED TO KNOW PHARMA INDUSTRY PHARMA INDUSTRY TODAY KEY ISSUE FOR PHARMACEUTICAL INDUSTRY INDUSTRY SEGMENTATION BULK DRUG CLASSIFICATION OF INDUSTRY GOVERNMENT POLICY SCOPE IN INDIA FUTURE SCENARIO SWOT ANALYSIS TOP TEN INDIAN COMPANY INDIAN PHARMA MARKET TOP TEN COMPANIES CONTRIBUTION MARKET SHARE OF KEY DRUG MERGERS AND ACQUISITIONS DISTRIBUTION CHANNEL ORGANISATION STRUCTURE OF C.F.A. STOCKIEST MARKET TREND CONCLUSION SUGGETION LIMITATION OF THE STUDY RESEARCH METHODOLOGY LEADING COMPANY ANALYSIS RANBAXY CIPLA LUPIN PHARMACEUTICALS ALKEM LABORATORIES DR. REDDY COMPARATIVE ANALYSIS ANNEXURE BIBLIOGRAPHY
Page No. 5 6 7 7 8 9 10 10 12 15 18 19 20 21 23 25 26 27 28 29 30 33 34 35 35 37 37 41 49 53 58 67 68 71
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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 largest econo economy my in the worl world d poss possesses esses a fore foreign ign exchange reserve reserve of USD.17 USD .177.0 7.00 0 bi bill llion ion.. The cou countr ntry y is fas fastt ada adapti pting ng to ind indust ustri riali alizat zatio ion, n, the spe speed ed 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, min ing, petr petroleu oleum, m, phar pharmace maceutica uticals, ls, stee steel, l, tran transpor sportati tation on equip equipment ment,, andte andtextil xtiles. es. 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 Indi India, a, mode modern rn sy syst stem em of medi medici cine ne is a 20 20th th cent centur ury y phen phenom omen ena, a, thou though gh the 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: 19001900-197 1970, 0, 1970-1 1970-1990 990 and and the the deca decade de of 1990s 1990s.. The period period 1900-19 1900-1970 70 signifies the dominance of the multinationals multinationals in this field that were basically importing bulk drugs and formulations formulations from abroad. Most domestic manufacturers were engaged in repacking the formulations formulations produced by the multinationals multinationals and production was concentrated in the hands of the multinationals. 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 Alembic c Chemic Chemical al works works in 1907 1907 and Bengal Bengal Immuni Immunity ty in establis establishmen hmentt of Alembi 1919. At this point in time, the Patents Act of 1911 was in practice, which facilitated patenting patenting all the known and possibl possible e processes processes of manufactur manufacturing ing 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 years if the workin working g of the patent patent had not been suffic sufficien iently tly remune remunerat rative ive to the patentee. This gave them the monopoly power initially. The domestic firms were also for for bidd bidden en from from proc proces essi sing ng a pate patent nted ed drug drug into into form formul ulat atio ions ns or impo import rtin ing g it. 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 inde indepe pend nden entt Indi India a emph emphas asiz ized ed on creat creatin ing g a stro strong ng publ public ic sect sector or unit unit.. In the 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
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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 More unit units s larg larger er in size size and and capa capaci city ty set set up in the the 19 1970 70s s and and 19 1980 80s s star starte ted d producing drugs, which were primarily imported till then. The technical institutes that were were set set up in the the earl early y 19 1950 50s s and and 19 1960 60s s resu result lted ed in crea creati ting ng tech techni nica call and and engineeri engineering ng skills, skills, which which could could easily easily adapt adapt the technolog technology y developed developed elsewhere, 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 leprotic drugs, drugs, analgesi analgesics, cs, antipyre antipyretics, tics, vitamins, vitamins, tranquill tranquilliser isers, s, photochem photochemical ical and various other pharmaceutical chemicals were produced in India from basic stages . A signif sig nifica icant nt increa increase se in the produc productio tion n of bulk bulk drugs drugs and formu formulat lation ions s is observ observed ed 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 equi equity ty and and rene renewa wall of thei theirr lice licenc nce e was was also also su subj bjec ectt to thei theirr brin bringi ging ng in new new technology. This resulted in the dilution of the foreign equity, which is reported in the Table Table As a strat strategy egy to protec protectt the domest domestic ic indus industry try from from compet competiti ition, on, the FERA FERA companies were also not permitted to produce a list of drugs, which were delicensed during the 1980s.
STRUCTURE OF INDUSTRY • • • •
Fragmented Fragmented with 24000 players – 300 organized organized Leading Leading 250 – 70% 70% of the market market Market Market leaders leaders hold 7% Manufac Manufacture turess : Bulk drugs drugs – APIs Formulations (75:25) • Adopts high technology technology & produces 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.
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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 Alla Allan n Jord Jordan an,, Seni Senior or Medi Medici cina nall Chem Chemis istt at Vern Vernal alis is will will pres presen entt a clea clearr pict pictur ure e of toda today' y's 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 demonstrating their safety and efficacy must be filed with government agencies in order to move through clinical development, to obtain appr approv oval al to sell sell a new new drug drug and and at regu regula larr inte interv rval alss ther therea eaft fter er.. 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
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• • •
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. In this highly regulated environment, a programme of studies, designed to be relevant to the proposed therapeutic use of the drug, must be undertaken. Additional studies will also be required as the compound passes through the different phases of clinical development. The speaker will address the following points: • • • •
What key questions do the preclinical studies attempt to answer? Which studies need to be undertaken When these studies should be performed How we use the information i nformation produced
Clinical Trials Phases I-IV
Clinical trials are one of the most important areas of research simply because human patients are involved. In this presentation, Dr Jörg Täubel, Managing Director of Richmond Pharmacology, will describe the stages of the clinical trial process, explaining the importance i mportance of each stage.
• • • • •
What is a clinical trial? What are the stages of the clinical trial process – Phases I-IV? Who’s who in clinical trials The contribution of each department to the clinical trial Demystifying the jargon and terminology
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Key Legal Issues for the Pharmaceutical Industry
In order to protect the huge investment in time and money necessary to bring a product to market, knowledge must be protected as an asset. Consequently, workers in the Pharmaceutical Industry need an understanding of the relevant intellectual property rights. This talk examines some of the basics, with particular emphasis on patents. It will assist pharmaceutical personnel to spot issues where further advice may be needed. Topics covered will include: • •
•
Update on intellectual property rights Pharmaceutical patent litigation - revocation - infringement - interim injunctions European enlargement - data exclusivity - parallel importation
Anatomy of a Licensing Deal
This session will look at the key features of a pharmaceutical licensing deal. Topics that will be covered include: •
•
The scope of the licence - what is being licensed, where, for how long and for what purpose? Payments - royalties - milestones - auditing
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quality bulk drugs and formulations manufacturer and supplier. Contract Research, a nascent industry in India has witnessed commendable commendable growth in the last few years. As per Yes Bank Bank /OPPI /OPPI repor reportt (2007(2007-08) 08),, formu formulat latio ion n segme segment nt (inclu (includin ding g domest domestic ic formul formulati ation on and formul formulati ation on expor exports) ts) consti constitut tuted ed 72%of 72%of the total total pharm pharmaceu aceutic tical al industry (in terms of sales) while bulk drugs and contract research constituted 25% and 3% of pharmaceutical industry industry respectively.
Fig: Segment-wise sales BULK DRUGS Bulk drug industry is the backbone of the Indian pharmaceutical industry. Growth of Indian bulk drug industry in the last five decades has been impressive and highest among among develo developin ping g countr countries ies.. From From a mere mere proces processin sing g indust industry, ry, Indian Indian bulk bulk drug drug indust industry ry has evolv evolved ed into into sophi sophisti sticat cated ed indust industry ry today, today, meeti meeting ng global global stand standard ards s inproduction, technology and quality control. Today, India stands among the top five producers of bulk drugs in the world. The market is fragmented with far too many players. About 300 organised companies are involved in the production of bulk drugs in India. Over 70 percent of India’s bulk drug production is exported to more than 50 countries and the balance is sold locally to other formulators. Indian bulk drugindustry is mainl mainly y concen concentra trated ted in the follo followin wing g region regional al belts belts - Mumbai Mumbai to An Ankle kleshw shwar, ar, Hyderabad to Madras and Chandigarh. Around, 18000 bulk drug manufacturers exist in India. Some major producers of bulk drugs in Indian pharmaceutical industry are Ranbaxy Laboratories, Sun Pharma, Cadila, Wockhardt, Aurobindo Pharma, Cipla, Dr. Reddy’s Laboratories, Orchid Pharmaceuticals & Chemicals, Nicholas Piramal, Lupin, Aristo Aristo Pharmaceut Pharmaceutical icals, s, etc. Most are involved bulk as well as formulatio formulations ns while a few are solely into bulk drugs. India is the world’s fifth largest producer of bulk drugs. The market size is expected to grow at higher percentages in future years with more and more international companies depending on India to meet their bulk-drug supply
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Classification of Indian Pharmaceutical Industry On the basis of formulations, the pharmaceutical industry can further be classified into into::
•
•
Prescription medicines: Also Al so kn know own n as et ethi hica call fo form rmul ulat atio ions ns.. Th They ey ca can n be di disp spen ense sed d on only ly on th the e
prescription prescriptio n from a qualified medical practitioner. •
•
Over-the-counter medicines: Also known as OTC formulations. They can be dispensed even in the absence of
prescription, prescriptio n, e.g. analgesics, cough drug, etc.
On the basis of form formulati ulations ons patent, pharmaceutic pharmaceutical al indus industry try can be classified as •
Branded formulations : They are ethical formulations prepared using a bulk
drug under product patent and are marketed by a single pharmaceutical company. •
Generics: They are formulations that do not contain any patented bulk drug
and can be manufactured by more than one company.
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How the Price of a Product is Set – An Introduction to Global Pharmaceutical Pricing and Reimbursement
Establ Establish ishing ing prices prices for pharma pharmaceu ceutic tical al produc products ts is a comple complex x proces process s involv involving ing integr integrate ated d approache approaches s to strategy strategy developm development, ent, as well as an appreciati appreciation on of the very different different pricing and funding systems and requirements adopted by governments. In this introduction to pharmaceutical pricing and reimbursement, Adam Barak, Director of ABPPC and former Head of European Pricing at GlaxoW GlaxoWell ellcom come, e, will will review review the main main issues issues facing facing pharma pharmace ceuti utical cal manufa manufactu cturer rers s when when developing optimal pricing strategies including:
•
The corporate strategy: company commercial objectives as it impacts pricing Implementing the corporate strategy: integration of pricing within wi thin the commercial strategy Price and value Government health spending controls: demand-side and supply-side Different price-setting systems in Europe Which price? How prices are built up International price differentials
•
Parallel trade
• • • • • •
Indian Pharmaceutical Sector: Economic value & Government police The Indian pharmaceutical industry, which is now meeting over 95% of the country's pharmaceutical needs, was almost non-existent before 1970. With the compound annual growth of 19.8% the industry has grown from Rs.4 billion in 1970 to Rs.290 billion in 2003. The pharma sector has shown tremendous growth over the years. About 250 Indian pharmaceutical companies hold 70% of the market share with top
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So now the companies have started exploring new business opportunities, including contra contract ct resear research ch (drug (drug disco discover very y and clinic clinical al trial trials), s), co-ma co-marke rketin ting g allian alliances ces and contract manufacturing. A few years ago, investment in R&D was as low as 0.001% of the total R&D worldwide, but now companies are focusing on drug discovery and R&D. They are spending over 5% of thei theirr turn turnov over er on R&D R&D e.g. e.g. Wock Wockha hard rdtt (8%) (8%),, Cipl Cipla a (4%) (4%),, Cadi Cadila la (4.4 (4.45% 5%). ). The value value of Indian Indian Over-T Over-Thehe-Cou Counte nterr Medici Medicines nes (OTCs) (OTCs) marke markett is over over US$ 940 million and is growing at the rate of 20% per year. There are about 61 US FDA approved plants in India, which will help Indian companies grab the opportunity of contract manufacturing. manufacturing.
The NPPA (National Pharma Pricing Authority), sets prices of different drugs, which leads to lower profitability for the companies. Indian pharma market is one of the least penetrated in the world: India accounts for almost 16% of the world population while the total size of industry is just 1-2% of the global pharma industry
Large no. of small players increases competition and reduces efficiency
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High growth in generic segment as $123bn worth patent will expire by 2012 ($18.4bn benegit to India) generics generics space and the increasing litigation litigation instances instances in the US are compelling Indian companies companies to consider opportunities beyond US
CUSTOM DUTY . . Exemption Exemption of custom duty for import of all capital goods inputs, inputs, consumables consumables and reference reference standards standards for R&D purposes Extens Extension ion of custom customss duty duty exempt exemption ion to more more life life saving saving drugs drugs and other anti–Ai anti–Aids ds and anti–ca anti–cance ncer r formulations EXCISE DUTY Goods manufactured in R&D centres centres should be exempted from excise duty and and service tax Extension of excise duty exemption exemption to more life saving Extension of excise duty exemption exemption to more life saving OTHERS Strengthen and increase capital outlay outlay for academic institutions engaged in scientific scientific research Requirement of a single window clearances instead of multiple clearances from different institutions for testing a new molecule Passing of Central Drug Authority Bill –pending for the last five years Removal of cost based price controls Continuation of the tax shelter in specified zones like Himachal Himachal Pradesh, Sikkim and Jammu Cut off date for the tax holiday should be extended till March 31, 2012.{1} Benefit should be expanded to cover expenditure incidental to research carried outside R&D facility such as clinical trials, bio- equivalence studies etc carried on in India or in any foreign country.
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Legal & Financial Framework:
India is a democratic democratic country with a solid legal framework and strong financial markets. There is already an established international industry and business community.
Information & Technology:
It has a good network of world-class educational institutions and established strengths in Information Technology. Globalization:
The country is committed to a free market economy and globalization. Above all, it has a 70 million middle class market, which is constantly growing.
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Indian Ind ian
Pharm Ph armace aceut utic ical al
Sect Se ctor or::
Fut utur ure e
Scenario
The Indian companies are using the revenue generated from generic drug sales to promote drug discovery projects and new delivery technologies. Contract research in India is also growing at the rate of 20-25% per year and was valued at US$ 10120m 12 0mil illi lion on in 20 2005 05.. In Indi dia a is ho hold ldin ing g a ma majo jorr sh shar are e in wo worl rld' d's s co cont ntra ract ct re rese sear arch ch business activity and it continues to expand its presence.
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SWOT ANALYSIS Strengths:•
Cost effective technology
•
Strong and well-developed manufacturing base
•
Clinical research and trials
•
Knowledge based, low- cost manpower in science & technology
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•
Incredible export potential
•
Increasing health consciousness
•
New innovative therapeutic products
•
Globalization
•
Drug delivery system management
•
Increased incomes
•
Production of generic drugs
•
Contract manufacturi manufacturing ng
•
Clinical trials & research
•
Drug molecules
Threats Small number of discoveries
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INDIAN PHARMA MARKET India pharma Mkt size FY09 Rs 93881 ($19 bn) cr on the basis of sales, g=13% India is the world’s 4th largest producer of pharmaceuticals by
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Top 10 companies contributes 30% of market share (or basis of standalone sales)
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Market Share of key drug
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Distribution confers place and time utility on product by making it available to the user at the right time. Distribution involves planning, implementing and controlling of the physical flow of materials and final goods from the point of origin to the point of use to meet consumer requirements at a profit
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Ranbaxy’s CFA handle the order of the distributors from all parts of Maharastra & Goa and accordingly checks stock. Forecasts the demand if possibly and place the order with the company and receives the order.
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Stores Department: Stores are the warehouse or godown of the depot where the medicines of the different divisions are
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- 6,83,125 rights shares issued (prem. Rs. 15 per share; prop. 1:2). Additional 1,02,470 shares allotted to retain oversubscription. oversubscription. Another 34,155 shares (prem. Rs 15 per share) allotted to employees. 1990 - The Company started manufacturing a new bulk drug by the name Omeprazole which was launched in the market by the brand name "OMEZ". 1991
- 10,92,950 bonus equity shares issued in prop. 1:2. 1992
- 32, 78,850 bonus equity shares issued in prop. 1:1. 1993
- Subject to necessary approvals being obtained, a separate company in the name of `Dr. Reddy's Dignostics Ltd.' was to be set up for the manufacture of dragnostics kits. The Company proposes to invert to the extent of 60% in the equity capital of the company. 1994
- The Company proposed to invest Compact Electric Ltd., which was in the process of setting up a plant at Chennai for manufacturing energy efficient electric filament/discharge lamps in Collaboration with Li-Tech Corporation, South Korea. The Company set up a subsidiary `Reddy Hong Kong Ltd.' in Hong Kong for marketing the Company's products in Main Land China and Far East countries.
Partnership Process / Partnering Areas Dr. Reddy’s is actively pursuing a wide range of partnering interests that leverage its diverse product development activities, broad commercial presence, and unique infrastructure and capabilities.
Commercial Partnerships: We have a strong commercial presence in some of the largest and fastest growing pharmaceutical markets such as the US, UK, Germany, India, Russia, Russia, CIS, Romania and Venezuela. Venezuela. In all these markets, our strong product product pipeline and custom customer er focus have delivered successful product launches and increase in market share. In the unbranded generic markets, we have built a broad customer base, including all major retailers, wholesalers/ distributors, pharmacy benefit managers, regional/nonwarehousing chains and independents. We have successfully in-licensed, co-developed, and acquired products with various partners in the US. In the branded space, our regulatory expertise, highly motivated and knowledgeable field force and large product portfolio have driven sales, market position and market share. We welcome opportunities to leverage our commercial organization to maximize the value of our partners' assets.
Pharmaceutical Services (CPS) business is today a partner of choice for all the strategic outsourcing needs of innovators worldwide. With strengths in IP - advantaged product development & scale up, world-class manufacturing capability and a strong network of strategic partners, CPS provides integrated services to our partners, including extensive Chemistry & Process R&D expertise (including steroids, cytotoxic and hormonal APIs), cGMP compliant API & USFDA inspected finished dosages manufacturing.
Product Development partnerships: Dr. Reddy’s vertically-integrated product development platform includes an R&D team of over 950 professionals that develop products across the entire pharmaceutical value chain – Active Pharmaceutical Ingredients, Branded/Generic Formulations, Specialty Pharmaceutica Pharma ceuticals, ls, Biolog Biologics, ics, and New Chemical Entities. We welcom welcome e the opportunity opportunity to explor explore e variou various s licensi licensing ng and co-development co-development partnerships across this entire pipeline spectrum.
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Commercial Partnerships: Dr. Reddy’s have a strong commercial presence in some of the largest and fastest growing pharmaceutical markets such as the US, US, UK, Germany, India, Russia, CIS, Romania and Venezuela. In all these markets, our strong product pipeline and customer focus have delivered successful product launches and increase in market share. In the unbranded generic markets, we have built a broad customer base, including all major retailers, wholesalers/ distributors, pharmacy benefit managers, regional/nonwarehousing chains and independents. We have successfully in-licensed, co-developed, and acquired products with various partners in the US. In the branded space, our regulatory expertise, highly motivated and knowledgeable field force and large product portfolio have driven sales, market position and market share. We welcome opportunities to leverage our commercial organization to maximize the value of our partners' assets.
Contract/ Outsourcing services: Dr.. Reddy’s Custom Pharmaceutical Services (CPS) business is today a partner of choice for all the strategic outsourcing needs of innovators worldwide. With strengths in IP - advantaged product development & scale up, world-class manufacturing capability and a strong network of strategic partners, CPS provides integrated services to our partners, including extensive Chemistry & Process R&D expertise (including steroids, cytotoxic and hormonal APIs), cGMP compliant API & USFDA inspected finished dosages manufacturing.
Product Development partnerships: Dr. Reddy’ Reddy’ss vertica vertically lly-int -integra egrated ted product product developm development ent platform platform includes includes an R&D team of over 950 professionals that develop products across the entire pharmaceutical value chain – Active Pharmaceutical Ingredi Ingredients ents,, Branded Branded/Ge /Generi nericc Formul Formulatio ations, ns, Specia Specialty lty Pharmac Pharmaceut eutical icals, s, Biologi Biologics, cs, and New Chemic Chemical al Entities. Entities. We welcome the opportunity to explore various licensing and co-development co-development partnerships across this entire pipeline spectrum. - `Reddy Biomed Ltd.' was incorporated as a joint venture between the Company and a Russian Company `Joint Stock Company of open type named after 1:1. Machnikov' for manufacturing and marketing formulation in Russia.
- Effective 1st April, Standard Equity Fund was merged with the Company. Pursuant to the scheme of amalgamation 2,63,062 equity shares of Rs 10 each of the Company were issued to the shareholders of erstwhile Standard Equity Fund in the ratio of one equity share of the Company for ten equity shares of the erstwhile Standard Equity Fund Ltd. - During July the Company issued 4301076 Global Depository Receipts at a price of US $11.16 per GDR. The Company allotted 4301076 equity shares of Rs 10 each at a premium of Rs 340 per share underlying the GDRs. - The company issued 4,301,076 GDSs representing 4,301,076 equity shares of the Company, par value Rs.10 ("Shares"), in a private placement in 1994 pursuant to Regulation S and Rule 144A under the Securities Act of 1933 (the "Securities Act"). The GDSs are listed on the Luxembourg Stock Exchange and each GDS represents one Share. As of May 4, 2001, there were 1,789,285 GDSs outstanding representing 1,789,285 Shares. 1995 - Formulation division launched two new products namely Lanzap, an anti-Ulcerant drug and Peristil, drug for gastric disorder. disorder. The bulk drug division division commenced commenced the productio production n of six new products viz., Finaster Finasteride, ide, Nimesulide, Nimesulide, Fluoxetine, Hydrochloride, Terbinafine, Hydrochloride, Risperidone and Clozapine. The Company was in the process of setting up a subsidiary in the Antilles Kingdom of Netherlands for licensing the manufacture and marketing of drugs. - 263,062 equity shares issued to the shareholders of erstwhile standard Equity Fund Ltd. Pursuant to the scheme of amalgamation. 1996
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- The diagnostics division entered into a technical collaboration agreement with Board of Radiation and Isolope, technology for manufacture & marketing of radioimmonuassay kits for the production of diagnostic and therapeutic recombina recombinant nt protectio protections, ns, the Bio-techn Bio-technolog ology y division division entered entered into a technical technical collabora collaboration tion agreeme agreement nt with Viral Viral Therapeutics Therapeutics Inc. U.S.A. 1997 - In view of the company's long term plans in the area of diabetic care, the company launched Reclide (Glicazide), its first product in the theraupeutic segment. Also, in its commitment to promote innovative products, the company entered into a marketing alliance to market Netacryl, a bio adhesive (n-butyl-2-cyno acrylate) used for the closure of external surgical and post traumatic wounds. - The Company set up a Critical care division to commercialise products from the research foundation and the first product to be marketed by the division was Miitotax an anti-cancer product used in the treatment of breast and ovarian cancer. - The city-based drug major Dr. Reddy's Laboratories has perfected the formulation of an anti-diabetic compound, glitazone for commercial marketing. - DRF has signed a licensing agreement with the Denmark-based Novo Nordisk, according to which the latter would obtain obtain an exclusive exclusive worldwide worldwide license license to develop develop and market market pharmace pharmaceutica uticall products products based based on compoun compounds ds discovered and patented by the former. - Dr. Reddy's Research Foundation Foundation has finally signed the agreement for clinical testing of its four diabetes compounds compounds of glitazone with the European drug major; Nova Nordisk. - Dr Reddy's Labs, the Hyderabad based pharmaceutical company, is forming two new joint ventures in Brazil and Uzbekistan. - The Hyderabad-based Dr Reddy's Laboratories is manufacturing an anti-ulcer formulation right from the basic stage for competitor, Ranbaxy Laboratories, as part of its strategy aimed at creating more value for its bulk drugs. 1998 - Dr. Reddy's Laboratories (DRL) has launched its first anti-cancer drug Mitotax (Paclitaxel). The product is produced in-house at Dr. Reddy's Research Foundation (DRF) from the extracts of the yew tree and formulated in a dedicated facility in Hyderabad. Hyderabad. - Dr. Reddy's Laboratories Laboratories (DRL) has ended its collaboration with the French company, bioMerieux. The collaboration agreement, which envisaged DRL to market bioMerieux's diagnostic reagents and instruments in India, has come to an end on 13th November. - Dr. Parvinder Singh, Chairman & Managing Director of Ranbaxy Laboratories and Dr. K Anji Reddy, Chairman of the Rs 5000 million Dr. Reddy's Group of pharmaceutical companies, were conferred with the prestigious `Ishidate Award' of the Federation of Asian Pharmaceutical Associations (FAPA). - The merger with Cheminor Drugs (the swap ratio at nine shares of Dr. Reddy's Laboratories for 25 shares of Cheminor), has made DRL the third largest pharmaceutical pharmaceutical company in Inida with participation in every element of the value chain. 1999 - Dr. Reddy's Laboratories Ltd. (DRL) has set up an in-house effluent treatment plant at its bulk pharmaceuticals manufacturing manufacturing facility located at Bollaram Industrial Development Area. - Dr. Reddy's Laboratories Laboratories is setting a new trend in the Indian pharmaceutical sector by installing a `satellite' discovery research laboratory in the United States.
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marketing and distribution agreement with Organics, Israel, for a wide range of sophisticated diagnostic kits. The products are recognized by WHO and other leading organisations in the healthcare industry. 2000 - Dr. Reddy's Laboratories and the Gribbles Group of Australia have signed a memorandum of understanding to form a joint venture company for establishing a network of 50 pathology laboratories and up to 200 specimen collection centres in India over the next five years. - The Board has approved merger of Cheminor Drugs Ltd. with the company. Nine equity shares of the company will be allotted for every 25 equity shares of CDL held. The Company has decided to issue 7,50,000 equity shares under ESOS. - The employees of the formulation unit-II of the company at Bachupally have decided to go on an indefinite strike from 17th June. - The Company has introduced a five-day week from January and change in timings. A small group of employees has called for a strike from June 19. - For the first time in the country, pharma major Dr. Reddy's Laboratories has launched an initiative to document clinical studies of drugs on the Internet. - DRF 2725, an anti-duabetic molecule discovered by Dr. Reddy's Research Foundation Foundation and licensed to Novo Nordisk in June 1998, has entered phase II trials of clinial development. - Dr. Reddy's Laboratories Ltd., the Hyderabad-based pharmaceutical company, has acquired three brands in the segment of women's health from Dai-Ichi Karkaria Ltd. - In a move to enhance the market share in the domestic formulations segment, Dr. Reddy's Laboratories Ltd. has decided to set up a specialised field-force to work in close partnership with the medical community community besides regroupes its older products. - The company has entered into an exclusive co-marketing and development agreement with Par Pharmaceuticals Inc. covering fourteen generic pharmaceuticals products. 2001 - In April 2001, as a first step towards taking its molecules through clinical development on its own, Dr. Reddy's Laboratories has selected Simbec Research Limited, a well-known UK-based Clinical Research Organization (CRO), for conducting clinical trials of DRF 4832. DRF 4832 is a PPAR agonist for treatment of cardiovascular complications. - Dr. Reddy' Reddy's s Labor Laborato atorie ries s Ltd. Ltd. has has ended ended a two-ye two-yearar-old old marke marketin ting g partn partners ership hip with with the US-ba US-based sed Schein Schein Pharmaceutical Inc following Schein's takeover by Watson Pharmaceutical Inc. - The Company has entered into an exclusive co-marketing and development agreement with Par Pharmaceuticals Inc., the US-based manufacturer and distributor of a broad line of generic drugs. - Dr Reddy's Laboratories has gone online with all its phase III and phase IV clinical trials on new products using an application being deployed on a website. -Eli Lilly has sued Dr Reddy's for infringement of one of the patents on olanzapine, the key ingredient in Lilly's antidepressant drug Zyprexa. - Reddy US Therapeutics, Inc, a biopharmaceutical company based in suburban Atlanta and a subsidiary of Dr Reddy's Laboratories Limited, has announced the formation of a scientific advisory board consisting of scientists and
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- In April 2001, Dr. Reddy's Laboratories began trading on the New York Stock Exchange (code: RDY). The price to the public per ADS was $10.04. Total amount raised (net) was $ 124 million. - In May 2001, the company decided to terminate the GDS programme. Once the facility is terminated, the Shares underlying the GDSs will be deposited in Dr. Reddy's American Depositary Share ("ADS") facility with Morgan Guaranty Trust Company of New York as depositary ("the Depositary"). In May 2001, Novartis Pharma AG and Dr. Reddy's Laboratories announced that they have entered a licensing agreement for a novel anti-diabetes agent. Under terms of the agreement Dr. Reddy's will grant Novartis worldwide exclusive rights to development development and commercialisation of their insulin sensitiser DRF 4158 in type 2 diabetes, in return for up to USD 55 million in upfront and milestone payments for specific clinical and regulatory endpoints, endpoints, as wellas royalties. Dr. Reddy's will have co-promotion co-promotion rights for DRF 4158 in India. - The agreement has received US regulatory clearance and has become effective from July 30, 2001. This event has triggered an upfront payment of 5 million US dollars from Novartis. Dr. Reddy's hasreceived hasreceived this payment. 2002 - The Board has appointed Mr. Krishna G.Palepu as Additional Director on the Board of the Company. - Dr Norton Peet to head Dr. Reddy's discovery services venture. venture. - Appointment of Mr Anupam Puri as Additional Director, Recommended a dividend of Rs 2.50 on equity share of Rs 5 each. To convene AGM on August 26, 2002, To re-appoint Mr Satish Reddy as Managing Director and COO for a period of 5 years wef October 01, 2002 subject to the approval of the shareholders. -Dr Reddy's appoints Uday Saxena as Chief Scientific Officer. -Dr Reddy's Laboratories Ltd has informed that the Company has granted 1813 stock options to an employee of the Company at the meeting of the Compensation Committee of Board of Directors held on August 26, 2002.The options have been granted at a price of Rs 884 per option, which is equivalent to weighted average share price of the Company of last 30 days on BSE. -DataEdge deploys direct material procuremet solution for Dr Reddy's -DCGI orders for the removal of word 'filgrastim' from its anti-cancer drug Grastim -Introduces VRS scheme in the company -Decides to revoke interim dividend of Rs 2 per share -Signs definitive agreement to acquire BMS Lab & Meridian Healthcare UK -Pondicherry unit starts operations -Files application for a new drug- amlodipine maleate -Launches Bicalutamide under the brand name 'Tabi' which is indicated for the treatment of advanced prostate cancer -Launches Montelukast Montelukast (generic name), a non-steroidal drug indicated for prohylaxis and treatment of asthma, in India -Unveils asthma drug Emlucast -Launches Mizolastine, non-sedative anti-histamine drug under the brand name Elina -Grants 2,59,400 stock options under ESOP (Employee Stock Option Plan)
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-Hikes annual spend on R&D from 6% to 8% of turnover -Leads among Indian companies in getting international patents -Files Paragraph IV certifications on two patents for Pfizer's Norvasc -Pfizer files suit against Dr Reddy's over Norvasc patent -Announces USFDA approval for Tizanidine HCL tablets -Gets USFDA approval for Zanaflex -Gets final approval from US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin Tablets 100, 250, 500 and 750 mg -Announces ANDA filing for Terbinafine Terbinafine tablets -Novo Nordisk announces its decision to suspend the ongoing clinical trials on the anti-diabetic molecule of Dr Reddy's Laboratories Ltd. -Values its brand at Rs 3,362 crore in March 2002 -Judgment of US court goes against Dr Reddy's Laboratories Laboratories in a patent violation case over the antibiotic Cipro -Promoters holding slips from 31.5% to 26% -Gets ex-parte ex-parte temporary temporary injunctio injunction n stopping stopping Sun Generics Generics from manufac manufacturin turing g and marketing marketing pharmac pharmaceutic eutical al preparations bearing the trademark OMZ 20 -Launches Dr. Reddy's Foundation For Health Education -Launches Breast Cancer Helpline in Mumbai -Receives USFDA approval for Amlodipine Amlodipine Maleate -Launches Broncho-Vaxom Broncho-Vaxom for patients suffering from repeated respiratory tract infections -Launches OncoQuest, OncoQuest, India's first real time helpline for doctors -Unveils Omeprazole in injectable form in the domestic market -Wins the case against Pfizer in US court -Wins national award for excellence in corporate governance
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-Dr Reddy's anti-diabetis drug receives a set back as Danish Pharma company Novo Nordisk suspends the trails on the drug -Announces completion completion of Insulin trails by Novo Nordisk -Pfizer files patent application against Dr Reddy's -Announces the completion of a 15 year agreement with Leiner Health -Filed a second case against Pfizer in the US -Announces ANDA filing for Olanzapine ODT -Aventis sues Dr Reddy's Lab for patent infringement infringement -Announces ANDA filing for Ondansetron HC1 Tablets, Equivalent to 16 mg Base -Dr. Reddys Board approves merger of Zenovus Biotech Ltd., a wholly owned subsidiary -Files a new drug application (NDA) with the US Food and Drugs Administration Administration (USFDA) -Gets US approval for Serzone generic -Dr Reddy's complaint on Sertraline dismissed -Closes down its 14 year old diagnostic business -DRL's brand value estimated at Rs 2,767 crore, human resources valued at Rs 2,908 crore as on 31/03/2003 -Eli Lilly agrees to dismiss with prejudice its wilful infringement infringement claim in Olanzapine Olanzapine patent challenge -Announces ANDA filing for Rosiglitazone Rosiglitazone Maleate -Glaxo files suit over Dr Reddy's for patent infringement - Gets USFDA approval for Nefazodone HCL tablets -Dr. Venkateswarlu retires from Dr Reddy's Laboratories Laboratories Board -Company has announced that it has signed an agreement with PLIVA for development and marketing of oncology products in Europe. 2004
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-Dr Reddy's Laboratories Laboratories Ltd, the Hyderabad-based global pharmaceutical pharmaceutical major, has obtained the tentative approval of the United States Food and Drugs Administration (USFDA) for the abbreviated new drug application filed on Fluconazole, indicated for the treatment of fungal infection - Receives approval from US Food and Drug Administration (FDA) for ciprofloxacin tablets. -Establishes new captive BPO unit -Dr. Reddy's wins award for energy management management 2005 -Dr Reddys launches India's first drug for treatment of diabetic foot ulcers
-Dr Reddys wins WorldStar awards for anti-counterfeit & patient protection packaging -DRL unveils new programme programme for underprivileged underprivileged youth -India's Dr Reddy's Laboratories Ltd has received approval from the US Food and Drug Administration to market nizatidine tablets in multiple strengths -Dr Reddys sets up India's first major drug development company -Dr Reddys launches 'Voboliv' Metaoxine Metaoxine to enter hepatoprotactives hepatoprotactives market -Dr Reddys announces the launch of "Save The Foot" initiative to reduce Diabetic Food Amputations 2006 -Dr Reddys Laboratories Ltd has informed that the Company has entered into an agreement with Merck -Dr Reddys Laboratories Ltd has launches 'Z&D'- a Zinc Sulphate formulation indicated as Adjuvant therapy along with ORS in the management management of Acute and persistent Diarrhea. Available in 10 & 20 mg Dispersible orange flavoured Tablets as well as in 10mg/ml & 20mg/ml Dry Syrup for pediatric use, this product is intended to supplement the ORS (Oral Rehydration Salt) market. -Dr Reddy's launches 'Doxobid' - a new oral bronchodilator for asthma & COPD -Dr Reddys Laboratories Ltd has filed a shelf registration statement on Form F-3 with the U.S. Securities and Exchange Commission relating to a proposed offering of American Depositary Shares, or ADSs of up to 13.5 million shares, excluding the underwriter's underwriter's over-allotment over-allotment option. 2007 - Dr Reddy's Laboratories Ltd rolled out Redituxa, its brand of rituximab, a monoclonal antibody (MAb) used in
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- Dr Reddys Laboratories Ltd has appointed Dr. Bruce L A Carter as an Additional Director on the Board of the Company.
SALES & MARKETING
, Through a field force of 600 marketing associates. This helps us develop and market an exclusive portfolio for local needs, with a pricing strategy that promotes both access and profitability. IT aim to bring the Rural team on par with other divisions in terms of field processes and to ramp up productivity, while we expand to other states. Mahara Maharasht shtra ra and Uttar Uttar Prades Pradesh h to reach reach 180,00 180,000 0 doctor doctorss and 40,000 40,000 ret retaile ailers rs In FY 2009, 2009, the India Marketing Marketing Team initiated a project project to cover cover the rural areas in the states of
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:- Questionnaire for C&F Agent
Name of CFA
Address:-
Telephone:
1. How many companies do you handle as CFA?
2. What is the commission that u receive from the various companies? companies?
3. What are the various modes of payment to the company?
4. If the payment is on credit-basis, then what is the t he average credit period that the companies allow?
5. Do you have to make some deposits in advance to the companies, if yes what is the value?
6. How many distributors do supply the product?
7. How prompt are the distributors in making their payments? Very prompt prompt not prompt 8. What is the average credit time period you allow for the distributors?
9. How much inventory levels do you maintain?
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14. What is the total number of employees at the CFA?
15. What is your turnover (monthly)?
16. Do you give frequent feedback &appraisals &appraisals to the companies about their product? Yes Sometimes Never
Questionnaire for Distributors Distributor name:DL number:Address:-
Telephone:1. What is the margin given by the pharmaceuticals pharmaceuticals company?
2. Which are the territories that you cover?
3. What are various modes of payment?
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10. Are you motivated by such non-financial rewards? Yes No 11. What is credit policy you follow with the t he retailer\chemists?
12. What is procedure expiry\breakage settlement?
13. What is your monthly turnover?
14. Mention 3 best companies on the following parameters? Settlement of issues Product Services
Questionnaire for Chemists Name:Address:-
Telephone:-
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9. How many customers on an average do you cater to a daily basis? 10. What is your monthly sales revenue?
BIBLIOGRAPHY www.google.com 2. www www.scribd. .scribd.com com 3. www.wikipidia.com 4. www.enclopedia.com 5. www www.pharmac .pharmaceutical euticals.com s.com 1.
This is to certify that AMIT RANJAN student of SINHGAD INSTITUTE OF BUSINESS ADMINISTRATION ADMINISTRATION & RESEARCH, Pune has com pleted his field work report at LUMBINI BEVERAGES PVT. LTD. on the topic topic of of “ A COMPRATIVE ASSESSMENT ON SALES PROMOTION ACTIVITIES AND MARKET SHARE OF PEPSI vis-a-vis COCA-COLA” and has GRADUATE has submit submitte ted d the fiel field d work work report report in parti partial al fulfi fulfill llmen mentt of POST GRADUATE DIPLOMA IN MANAGEMENT for the academic year 2007-09 He has worked under our guidance and direction. The said report is based on bonafide information.
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I herby declare that the project titled “ A COMPRATIVE ASSESSMENT ON SALES PROMOTION ACTIVITIE ACTIVITIES S AND MARK MARKET ET SHAR SHARE E OF PEPSI PEPSI vis-a-vi vis-a-viss COCA-COL COCA-COLA” A” is an orig origin inal al piec piecee of Prof. Vishal Vishal Bhole. Bhole. The resea research rch work work carri carried ed out by me under under the guidance guidance and superv supervisi ision on of Prof.
information has been collected from genuine & authentic sources. The work has been submitted in partial fulfillment of the requirement of POST GRADUATE DIPLOMA IN MANAGEMENT for the academic year 2007-09.
Place:
Date
Signature:
AMIT RANJAN