Pharmaceutical Industry a Project Amit Rai Mmm

8/6/2019 Pharmaceutical Industry a Project Amit Rai Mmm

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PROJECT REPORT ON

GROWING PHARMACEUTICAL INDUSTRY

A Case Study

Mr. Amit Rai

MMM -V

Batch 2005 - 2008

N . L. Dalmia Institute ofManagement Studies And Research


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Contents

1 History

2 Research and development

o 2.1 The cost of innovation

o 2.2 Controversy about drug development and testing

o

3 Product approval in the USo 3.1 Orphan drugs

o 3.2 Legal issues

o 3.3 Patentso

4 Industry revenueso 4.1 Sales leaders

o 4.2 Patents and generics

o 4.3 Medicare Part D

o 4.4 Mergers, acquisitions, and co-marketing of drugs

o

5 Marketingo 5.1 To healthcare professionals

o 5.2 To insurance and public health bodies

o 5.3 To retail pharmacies and storeso 5.4 Direct to consumer advertising

o 5.5 Controversy about drug marketing and lobbying

o

6 Developing worldo 6.1 Nigerian clinical trial

o 6.2 Charitable programmes

o

7 Industry associations

8 Regulatory authorities
http://en.wikipedia.org/wiki/Pharmaceutical_company#History%23Historyhttp://en.wikipedia.org/wiki/Pharmaceutical_company#Research_and_development%23Research_and_developmenthttp://en.wikipedia.org/wiki/Pharmaceutical_company#The_cost_of_innovation%23The_cost_of_innovationhttp://en.wikipedia.org/wiki/Pharmaceutical_company#Controversy_about_drug_development_and_testing%23Controversy_about_drug_development_and_testinghttp://en.wikipedia.org/wiki/Pharmaceutical_company#Product_approval_in_the_US%23Product_approval_in_the_UShttp://en.wikipedia.org/wiki/Pharmaceutical_company#Orphan_drugs%23Orphan_drugshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Legal_issues%23Legal_issueshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Patents%23Patentshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Industry_revenues%23Industry_revenueshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Sales_leaders%23Sales_leadershttp://en.wikipedia.org/wiki/Pharmaceutical_company#Patents_and_generics%23Patents_and_genericshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Medicare_Part_D%23Medicare_Part_Dhttp://en.wikipedia.org/wiki/Pharmaceutical_company#Mergers.2C_acquisitions.2C_and_co-marketing_of_drugs%23Mergers.2C_acquisitions.2C_and_co-marketing_of_drugshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Marketing%23Marketinghttp://en.wikipedia.org/wiki/Pharmaceutical_company#To_healthcare_professionals%23To_healthcare_professionalshttp://en.wikipedia.org/wiki/Pharmaceutical_company#To_insurance_and_public_health_bodies%23To_insurance_and_public_health_bodieshttp://en.wikipedia.org/wiki/Pharmaceutical_company#To_retail_pharmacies_and_stores%23To_retail_pharmacies_and_storeshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Direct_to_consumer_advertising%23Direct_to_consumer_advertisinghttp://en.wikipedia.org/wiki/Pharmaceutical_company#Controversy_about_drug_marketing_and_lobbying%23Controversy_about_drug_marketing_and_lobbyinghttp://en.wikipedia.org/wiki/Pharmaceutical_company#Developing_world%23Developing_worldhttp://en.wikipedia.org/wiki/Pharmaceutical_company#Nigerian_clinical_trial%23Nigerian_clinical_trialhttp://en.wikipedia.org/wiki/Pharmaceutical_company#Charitable_programmes%23Charitable_programmeshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Industry_associations%23Industry_associationshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Regulatory_authorities%23Regulatory_authoritieshttp://en.wikipedia.org/wiki/Pharmaceutical_company#History%23Historyhttp://en.wikipedia.org/wiki/Pharmaceutical_company#Research_and_development%23Research_and_developmenthttp://en.wikipedia.org/wiki/Pharmaceutical_company#The_cost_of_innovation%23The_cost_of_innovationhttp://en.wikipedia.org/wiki/Pharmaceutical_company#Controversy_about_drug_development_and_testing%23Controversy_about_drug_development_and_testinghttp://en.wikipedia.org/wiki/Pharmaceutical_company#Product_approval_in_the_US%23Product_approval_in_the_UShttp://en.wikipedia.org/wiki/Pharmaceutical_company#Orphan_drugs%23Orphan_drugshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Legal_issues%23Legal_issueshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Patents%23Patentshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Industry_revenues%23Industry_revenueshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Sales_leaders%23Sales_leadershttp://en.wikipedia.org/wiki/Pharmaceutical_company#Patents_and_generics%23Patents_and_genericshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Medicare_Part_D%23Medicare_Part_Dhttp://en.wikipedia.org/wiki/Pharmaceutical_company#Mergers.2C_acquisitions.2C_and_co-marketing_of_drugs%23Mergers.2C_acquisitions.2C_and_co-marketing_of_drugshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Marketing%23Marketinghttp://en.wikipedia.org/wiki/Pharmaceutical_company#To_healthcare_professionals%23To_healthcare_professionalshttp://en.wikipedia.org/wiki/Pharmaceutical_company#To_insurance_and_public_health_bodies%23To_insurance_and_public_health_bodieshttp://en.wikipedia.org/wiki/Pharmaceutical_company#To_retail_pharmacies_and_stores%23To_retail_pharmacies_and_storeshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Direct_to_consumer_advertising%23Direct_to_consumer_advertisinghttp://en.wikipedia.org/wiki/Pharmaceutical_company#Controversy_about_drug_marketing_and_lobbying%23Controversy_about_drug_marketing_and_lobbyinghttp://en.wikipedia.org/wiki/Pharmaceutical_company#Developing_world%23Developing_worldhttp://en.wikipedia.org/wiki/Pharmaceutical_company#Nigerian_clinical_trial%23Nigerian_clinical_trialhttp://en.wikipedia.org/wiki/Pharmaceutical_company#Charitable_programmes%23Charitable_programmeshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Industry_associations%23Industry_associationshttp://en.wikipedia.org/wiki/Pharmaceutical_company#Regulatory_authorities%23Regulatory_authorities


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History

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 andpenicillin,became mass-manufactured and distributed. Switzerland, Germany and Italy hadparticularly strong industries, with the UK and US following suit.

Legislation was enacted to test and approve drugs and to require appropriate labeling.Prescription and nonprescription drugs became legally distinguished from one another asthe pharmaceutical industry matured. The industry got underway in earnest from the1950s, due to the development of systematic scientific approaches, understanding ofhuman biology (including DNA) and sophisticated manufacturing techniques.

Numerous new drugs were developed during the 1950s and mass-produced and marketedthrough 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 psychiatricmedication. Valium(diazepam), discovered in 1960, was marketed from 1963 andrapidly became the most prescribed drug in history, prior to controversy over dependencyand habituation.

Attempts were made to increase regulation and to limit financial links companies andprescribing physicians, including by the relatively new US FDA. Such calls increased inthe 1960s after the thalidomidetragedy came to light, in which the use of a newtranquilizer in pregnant women caused severe birth defects. In 1964, the World MedicalAssociation issued its Declaration of Helsinki, which set standards for clinical researchand demanded that subjects give their informed consent before enrolling in anexperiment. Phamaceutical companies became required to proveefficacy in clinical trials

before marketing drugs.
http://en.wikipedia.org/wiki/Insulinhttp://en.wikipedia.org/wiki/Penicillinhttp://en.wikipedia.org/wiki/Penicillinhttp://en.wikipedia.org/wiki/DNAhttp://en.wikipedia.org/wiki/Chlorpromazinehttp://en.wikipedia.org/wiki/Chlorpromazinehttp://en.wikipedia.org/wiki/Haldolhttp://en.wikipedia.org/wiki/Haldolhttp://en.wikipedia.org/wiki/Valiumhttp://en.wikipedia.org/wiki/Valiumhttp://en.wikipedia.org/wiki/FDAhttp://en.wikipedia.org/wiki/FDAhttp://en.wikipedia.org/wiki/Thalidomidehttp://en.wikipedia.org/wiki/Thalidomidehttp://en.wikipedia.org/wiki/Efficacyhttp://en.wikipedia.org/wiki/Efficacyhttp://en.wikipedia.org/wiki/Insulinhttp://en.wikipedia.org/wiki/Penicillinhttp://en.wikipedia.org/wiki/DNAhttp://en.wikipedia.org/wiki/Chlorpromazinehttp://en.wikipedia.org/wiki/Haldolhttp://en.wikipedia.org/wiki/Valiumhttp://en.wikipedia.org/wiki/FDAhttp://en.wikipedia.org/wiki/Thalidomidehttp://en.wikipedia.org/wiki/Efficacy


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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 agreater rate Legislation allowing for strong patents, to cover both the process ofmanufacture 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 formationof mutually beneficial partnerships with large pharmaceutical companies and a host ofcorporate buyouts of the smaller firms. Pharmaceutical manufacturing becameconcentrated, 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 newregulations, both safety and environmental, but also transformed by new DNAchemistries and new technologies for analysis and computation.Drugs for heart disease and for AIDS were a feature of the 1980s, involving challenges toregulatory bodies and a faster approval process

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

Marketing changed dramatically in the 1990s, partly because of a new consumerism ] TheInternet made possible the direct purchase of medicines by drug consumers and of rawmaterials 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 in1997 that liberalized requirements for the presentation of risks. The new antidepressants,the SSRIs, notably Fluoxetine (Prozac), rapidly became bestsellers and marketed foradditional disorders
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Drug development progressed from a hit-and-miss approach to rational drug discovery inboth laboratory design and natural-product surveys. Demand for nutritional supplementsand so-called alternative medicines created new opportunities and increased competition

in the industry. Controversies emerged around adverse effects, notably regarding Vioxxin the US, and marketing tactics. Pharmaceutical companies became increasingly accusedofdisease mongering or over-medicalizing personal or social problems

There are now more than 200 major pharmaceutical companies, jointly said to be moreprofitable than almost any other industry, and employing more political lobbyists thanany other industry.Advances in biotechnology and the human genome project promiseever more sophisticated, and possibly more individualized, medications.

Research and development

Drug discovery is the process by which potential drugs are discovered or designed. Inthe past most drugs have been discovered either by isolating the active ingredient fromtraditional remedies or by serendipitous discovery. Modern Biotechnology often focuseson understanding the metabolic pathwaysrelated to adiseasestate orpathogen, andmanipulating these pathways using molecular biology orBiochemistry. A great deal of

early-stage drug discovery has traditionally been carried out by universities and researchinstitutions.

Drug development refers to activities undertaken after a compound is identified as apotential drug in order to establish its suitability as a medication. Objectives of drugdevelopment are to determine appropriateFormulation and Dosing, as well as to establishsafety. Research in these areas generally includes a combination ofin vitrostudies,invivo studies, and clinical trials. The amount of capital required for late stage developmenthas made it a historical strength of the larger pharmaceutical companies.

Often, large multinational corporations exhibitvertical integration, participating in abroad range of drug discovery and development, manufacturing and quality control,marketing, sales, and distribution. Smaller organizations, on the other hand, often focuson a specific aspect such as discovering drug candidates or developing formulations.Often, collaborative agreements between research organizations and large pharmaceuticalcompanies are formed to explore the potential of new drug substances

.
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The cost of innovation

Drug discovery and development is very expensive; of all compounds investigated foruse in humans only a small fraction are eventually approved by theFDA. Each year, onlyabout 25 truly novel drugs (New chemical entities) are approved for marketing. Thisapproval comes only after heavy investment inpre-clinical developmentandclinical

trials, as well as a commitment to ongoing safety monitoring. Drugs which fail part-waythrough this process often incur large costs, while generating no revenue in return. If thecost of these failed drugs is taken into account, the cost of developing a successful newdrug (New chemical entityor NCE), has been estimated at about 1 billion USD[3](notincluding marketing expenses). A study by the consulting firm Bain & Company reportedthat the cost for discovering, developing and launching (which factored in marketing andother business expenses) a new drug (along with the prospective drugs that fail) rose overa five year period to nearly $1.7 billion in 2003.

These estimates also take into account the opportunity cost of investing capital manyyears before revenues are realized (seeTime-value of money). Because of the very longtime needed for discovery, development phamaceuticals, these costs can accumulate tonearly half the total expense. Some approved drugs, such as those based on re-formulation of an existing active ingredient(also referred to as Line-extensions) are muchless expensive to develop. The consumer advocacy group Public Citizen suggests on itsweb site that the actual cost is under $200 million, about 29% of which is spent on FDA-required clinical trials. For me-too-drugs and for generics, the cost are even less.

Calculations and claims in this area are controversial because of the implications forregulation and subsidizationof the industry through federally funded research grants.

Controversy about drug development and testing

. In western countries generally the law allows pharmacy companies to withholdinformation from research that they do not wish to disclose and the usual procedure isthat severl aresearch programmes are carried out and only the most favorable ones arepublished. In response to public outcry about specific cases in which unfavorable datafrom pharmaceutical company-sponsored research was suppressed, the Pharmaceutical

Research and Manufacturers of America have published new guidelines urgingcompanies to report all findings and limit the financial involvement in drug companies ofresearchers.

Drug researchers not directly employed by pharmaceutical companies often look tocompanies for grants, and companies often look to researchers for studies that will maketheir products look favorable. Sponsored researchers are rewarded by drug companies,
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Nexium, the heartburn pill from AstraZeneca; and Advair, the asthma inhaler fromGlaxoSmithKline.[12]

IMS Health publishes an analysis of trends expected in the pharmaceutical industry in2007, including increasing profits in most sectors despite loss of some patents, and new

'blockbuster' drugs on the horizon

Teradata Magazine predicted that by 2007, $40 billion in U.S. sales could be lost at thetop 10 pharma companies as a result of slowdown in R&D innovation and the expiry ofpatents on major products, with 19 blockbuster drugs losing patent.

Sales leaders

The top ten pharmaceutical companies by 2006 sales are

Rank Company Sales ($m) Growth (%) Market Share (%)

1 Pfizer 45,083 1.8 7.2

2 GlaxoSmithKline 37,034 9.7 5.93 Sanofi-Aventis 35,638 5.0 5.7

4 Novartis 28,880 18.0 4.6

5 HoffmannLa Roche 26,596 21.8 4.2

6 AstraZeneca 25,741 10.5 4.1

7 Johnson & Johnson 23,267 4.2 3.7

8 Merck & Co. 22,636 2.8 3.6

9 Wyeth 15,683 2.4 2.5

10 Eli Lilly and Company 14,814 7.5 2.4

Patents and generics

Drugs are patentable, granting exclusivity rights typically for 20 yearsHowever, it oftentakes as long as 12 years to approve a drug for patient use Patent protection enables theowner of the patent to recover the costs of research and development through high profitmargins for thebranded drug. When the patent protection for the drug expires, a genericdrug is usually developed and sold by a competing company. The development andapproval of generics is less expensive, allowing them to be sold at a lower price. Oftenthe owner of the branded drug will introduce a generic version before the patent expiresin order to get a head start in the generic market.

Medicare Part D

In 2003 the United States enacted the Medicare Prescription Drug, Improvement, andModernization Act (MMA), a program to provide prescription drug benefits to the elderlyanddisabled. This program is a component ofMedicare (United States) and is known asMedicare Part D. This program, set to begin in January 2006, will significantly alter the
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revenue models for pharmaceutical companies. Revenues from the program are expectedto be $724 billion between 2006 and 2015.

Pharmaceuticals developed by biotechnological processes often must be injected in aphysician's office rather than be delivered in the form of a capsule taken orally. Medicare

payments for these drugs are usually made through Medicare Part B (physician office)rather than Part D (prescription drug plan).

Mergers, acquisitions, and co-marketing of drugs

A merger, acquisition, orco-marketingdeal between pharmaceutical companies mayoccur as a result of complementary capabilities between them. A smallbiotechnologycompany might have a new drug but no sales or marketing capability. Conversely, a largepharmaceutical company might have unused capacity in a large sales force due to a gap

in the company pipeline of new products. It may be in both companies' interest to enterinto a deal to capitalize on the synergy between the companies. The difference betweenthe value of the two companies after the deal and before the deal is known as the synergyvalue of the deal.

Marketing

Pharmaceutical companies commonly spend a large amount on advertising, marketingand lobbying. In the US, drug companies spend $19 billion a year on promotions.Advertising is common in healthcare journals as well as through more mainstream mediaroutes. In some countries, notably the US, they are allowed to advertise direct to the

general public. Pharmaceutical companies generally employ sales people (often called'drug reps' or, an older term, 'detail men') to market directly and personally to physiciansand other healthcare providers.In some countries, notably the US, pharmaceuticalcompanies also employ lobbyists to influence politicians. Marketing of prescription drugsin the US is regulated by the federal Prescription Drug Marketing Act of 1987

To healthcare professionals

Physicians are perhaps the most important players in pharmaceutical sales because theywrite the prescriptions that determine which drugs will be used by the patient. Influencingthe physician is often seen as the key to prescription pharmaceutical sales. A medium-sized pharmaceutical company might have a sales force of 1000 representatives. Thelargest companies have tens of thousands of representatives. Currently, there areapproximately 100,000 pharmaceutical sales reps in the United States pursuing some120,000 pharmaceutical prescribers. The number doubled in the four years from 1999 to2003. Drug companies spend $5 billion annually sending representatives to physicianoffices. Pharmaceutical companies use the service of specialized healthcare marketing
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research companies to perform Marketing research among Physcians and otherHealthcare professionals.

To insurance and public health bodies

Private insurance or public health bodies (e.g. the NHS in the UK) decide which drugs topay for, and restrict the drugs that can be prescribed through the use of formularies.

This, along with the high-margin companies that can realise for their most successfulmedicines, makepharmaceutical marketing complex. There are a number offirms thatspecialize in data and analytics for pharmaceutical marketing (Yellowikis).

Public and private insurers restrict the brands, types and number of drugs that they willcover. Not only can the insurer affect drug sales by including or excluding a particular

drug from a formulary, they can affect sales by tiering or placing bureaucratic hurdles toprescribing certain drugs as well. In January 2006, the U.S. instituted a new publicprescription drug plan through its Medicare program known as Medicare Part D. Thisprogram engages private insurers to negotiate with pharmaceutical companies for theplacement of drugs on tiered formularies.

To retail pharmacies and stores

Commercial stores and pharmacies are a major target of non-prescription sales andmarketing for pharmaceutical companies

.

Direct to consumer advertising

Since the 1980s new methods of marketing for prescription drugs to consumers havebecome important. Direct-to-consumer media advertising was legalised in the FDAGuidance for Industry on Consumer-Directed Broadcast Advertisements.

Controversy about drug marketing and lobbyingThere has been increasing controversy surrounding pharmaceutical marketing andinfluence. There have been accusations and findings of influence on doctors and otherhealth professionals through drug reps, including the constant provision of marketing'gifts' and biased information to health professionals; highly prevalent advertising injournals and conferences; funding independent healthcare organizations and healthpromotion campaigns; lobbying physicians and politicians (more than any other industry
http://en.wikipedia.org/wiki/Healthcare_marketing_researchhttp://en.wikipedia.org/wiki/Pharmaceutical_marketinghttp://en.wikipedia.org/wiki/Companyhttp://en.wikipedia.org/wiki/Companyhttp://yellowikis.org/wiki/index.php/Transwiki:List_of_companies_that_provide_data_and_analytic_services_for_pharmaceutical_sales_and_marketinghttp://en.wikipedia.org/wiki/Medicare_Part_Dhttp://www.fda.gov/cder/guidance/1804fnl.htmhttp://www.fda.gov/cder/guidance/1804fnl.htmhttp://en.wikipedia.org/wiki/Healthcare_marketing_researchhttp://en.wikipedia.org/wiki/Pharmaceutical_marketinghttp://en.wikipedia.org/wiki/Companyhttp://yellowikis.org/wiki/index.php/Transwiki:List_of_companies_that_provide_data_and_analytic_services_for_pharmaceutical_sales_and_marketinghttp://en.wikipedia.org/wiki/Medicare_Part_Dhttp://www.fda.gov/cder/guidance/1804fnl.htmhttp://www.fda.gov/cder/guidance/1804fnl.htm


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in the US; sponsorship ofmedical schools or nurse training; sponsorship of continuingeducational events, with influence on the curriculum; and hiring physicians as paidconsultants on medical advisory boards.

Some advocacy groups, such asNo Free Lunch, have criticized the effect of drug

marketing to physicians because they say it biases physicians to prescribe the marketeddrugs even when others might be cheaper or better for the patientThere have been relatedaccusations ofdisease mongeringover-medicalising) to expand the market formedications. An inaugural conference on that subject took place in Australia in 2006A2005 review by a special committee of theUKgovernment came to all the aboveconclusions in a European Union context whilst also highlighting the contributions andneeds of the industry.

Developing world

The role of pharmaceutical companies in the developing world is a matter of somedebate, ranging from those highlighting the aid provided to the developing world, tothose critical of the use of the poorest in human clinical trials, often without adequateprotections, particularly in states lacking a strong rule of law. Other criticisms include analleged reluctance of the industry to invest in treatments of diseases in less economicallyadvanced countries, such as malaria; Criticism for the price ofpatentedAIDS medication,which could limit therapeutic options for patients in theThird World, where the mostpeople have AIDS

.

UnderWorld Trade Organizationrules, a developing country has options for obtainingneeded medications undercompulsory licensingor importation of cheaper versions of thedrugs, even beforepatentexpiration (WTO Press Release). Pharmaceutical companiesoften offer much needed medication at no or reduced cost to the developing countries.Proposals to allow the manufacture of generic AIDS drugs are not without controversy; itis sometimes claimed that this might cause pharmaceutical companies to move awayfrom AIDS drug research and focus their research on other, more profitable areas. InMarch of2001,South Africa was sued by 41 pharmaceutical companies for theirMedicines Act, which allowed the import and generic production of cheap AIDS drugs.

The case was later dropped after protest around the world.

Nigerian clinical trial

In 1996, a pediatric clinical trial conducted on behalf ofPfizertested the antibioticTrovan allegedly without first obtaining the informed consent of participants or theirparents.
http://en.wikipedia.org/wiki/Medical_schoolhttp://en.wikipedia.org/wiki/No_Free_Lunch_(organization)http://en.wikipedia.org/wiki/Disease_mongeringhttp://en.wikipedia.org/wiki/UKhttp://en.wikipedia.org/wiki/UKhttp://en.wikipedia.org/wiki/Stateshttp://en.wikipedia.org/wiki/Rule_of_lawhttp://en.wikipedia.org/wiki/Rule_of_lawhttp://en.wikipedia.org/wiki/Malariahttp://en.wikipedia.org/wiki/Patenthttp://en.wikipedia.org/wiki/AIDShttp://en.wikipedia.org/wiki/AIDShttp://en.wikipedia.org/wiki/Third_Worldhttp://en.wikipedia.org/wiki/Third_Worldhttp://en.wikipedia.org/wiki/World_Trade_Organizationhttp://en.wikipedia.org/wiki/World_Trade_Organizationhttp://en.wikipedia.org/wiki/Compulsory_licensinghttp://en.wikipedia.org/wiki/Compulsory_licensinghttp://en.wikipedia.org/wiki/Patenthttp://en.wikipedia.org/wiki/Patenthttp://www.wto.org/english/news_e/pres03_e/pr350_e.htmhttp://en.wikipedia.org/wiki/2001http://en.wikipedia.org/wiki/2001http://en.wikipedia.org/wiki/South_Africahttp://en.wikipedia.org/wiki/Medicines_Acthttp://en.wikipedia.org/wiki/Medicines_Acthttp://en.wikipedia.org/wiki/Pfizerhttp://en.wikipedia.org/wiki/Trovafloxacinhttp://en.wikipedia.org/wiki/Medical_schoolhttp://en.wikipedia.org/wiki/No_Free_Lunch_(organization)http://en.wikipedia.org/wiki/Disease_mongeringhttp://en.wikipedia.org/wiki/UKhttp://en.wikipedia.org/wiki/Stateshttp://en.wikipedia.org/wiki/Rule_of_lawhttp://en.wikipedia.org/wiki/Malariahttp://en.wikipedia.org/wiki/Patenthttp://en.wikipedia.org/wiki/AIDShttp://en.wikipedia.org/wiki/Third_Worldhttp://en.wikipedia.org/wiki/World_Trade_Organizationhttp://en.wikipedia.org/wiki/Compulsory_licensinghttp://en.wikipedia.org/wiki/Patenthttp://www.wto.org/english/news_e/pres03_e/pr350_e.htmhttp://en.wikipedia.org/wiki/2001http://en.wikipedia.org/wiki/South_Africahttp://en.wikipedia.org/wiki/Medicines_Acthttp://en.wikipedia.org/wiki/Pfizerhttp://en.wikipedia.org/wiki/Trovafloxacin


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Largest 50 pharmaceutical companies

The following is a list of the largestpharmaceuticalandbiotech companies ranked byhealthcare revenue. Some companies (eg, Bayerand Procter & Gamble) have additionalrevenue not included here. The phraseBig Pharma is often used to refer to companies

with revenue in excess of $3 billion, and/orR&D expenditure in excess of $500 million,and represents the first 30 or so companies in this list.

Revenue

Rank

2006

Company Country

Healthcare

Revenue

2006(USD millions)

Healthcare

R&D 2006(USD millions)

Net income/

(loss) 2006(USD millions)

Employees

2006

1

Johnson &

Johnson USA 53,324 7,125 11,053 138,000

2 Pfizer USA 48,371 7,599 19,337 122,200

3 GlaxoSmithKlineUnitedKingdom

42,813 6,373 10,135 106,000

4 Novartis Switzerland 37,020 5,349 7,202 102,695

5 Sanofi-Aventis France 35,645 5,565 5,033 100,735

6HoffmannLaRoche

Switzerland 33,547 5,258 7,318 100,289

7 AstraZenecaUnited

Kingdom

26,475 3,902 6,063 98,000

8 Merck & Co. USA 22,636 4,783 4,434 74,372

9 Abbott USA 22,476 2,255 1,717 66,800
http://en.wikipedia.org/wiki/Pharmaceuticalhttp://en.wikipedia.org/wiki/Pharmaceuticalhttp://en.wikipedia.org/wiki/Biotechhttp://en.wikipedia.org/wiki/Biotechhttp://en.wikipedia.org/wiki/Bayerhttp://en.wikipedia.org/wiki/Procter_%26_Gamblehttp://en.wikipedia.org/wiki/R%26Dhttp://en.wikipedia.org/wiki/Johnson_%26_Johnsonhttp://en.wikipedia.org/wiki/Johnson_%26_Johnsonhttp://en.wikipedia.org/wiki/Pfizerhttp://en.wikipedia.org/wiki/GlaxoSmithKlinehttp://en.wikipedia.org/wiki/Novartishttp://en.wikipedia.org/wiki/Sanofi-Aventishttp://en.wikipedia.org/wiki/Hoffmann%E2%80%93La_Rochehttp://en.wikipedia.org/wiki/Hoffmann%E2%80%93La_Rochehttp://en.wikipedia.org/wiki/AstraZenecahttp://en.wikipedia.org/wiki/Merck_%26_Co.http://en.wikipedia.org/wiki/Abbott_Laboratorieshttp://en.wikipedia.org/wiki/Pharmaceuticalhttp://en.wikipedia.org/wiki/Biotechhttp://en.wikipedia.org/wiki/Bayerhttp://en.wikipedia.org/wiki/Procter_%26_Gamblehttp://en.wikipedia.org/wiki/R%26Dhttp://en.wikipedia.org/wiki/Johnson_%26_Johnsonhttp://en.wikipedia.org/wiki/Johnson_%26_Johnsonhttp://en.wikipedia.org/wiki/Pfizerhttp://en.wikipedia.org/wiki/GlaxoSmithKlinehttp://en.wikipedia.org/wiki/Novartishttp://en.wikipedia.org/wiki/Sanofi-Aventishttp://en.wikipedia.org/wiki/Hoffmann%E2%80%93La_Rochehttp://en.wikipedia.org/wiki/Hoffmann%E2%80%93La_Rochehttp://en.wikipedia.org/wiki/AstraZenecahttp://en.wikipedia.org/wiki/Merck_%26_Co.http://en.wikipedia.org/wiki/Abbott_Laboratories


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Laboratories

10 Wyeth USA 20,351 3,109 4,197 66,663

11 Bayer Germany 18,216 1,791 1,577 61,880

12Bristol-MyersSquibb

USA 17,914 3,067 1,585 60,000

13 Eli Lilly and Co. USA 15,691 3,129 2,663 50,060

14 Amgen USA 14,268 3,366 2,950 48,000

15BoehringerIngelheim

Germany 13,284 1,977 2,163 43,000

16 Schering-Plough USA 10,594 2,188 1,057 41,500

17BaxterInternational

USA 10,378 614 1,397 38,428

18TakedaPharmaceuticalCo.

Japan 10,284 1,620 2,870 35,000

19 Genentech USA 9,284 1,773 2,113 33,500

20 Procter & Gamble USA 8,964 n/a 10,340 29,258

21 TevaPharmaceutical

Israel 8,408 495 546 26,670
http://en.wikipedia.org/wiki/Abbott_Laboratorieshttp://en.wikipedia.org/wiki/Wyethhttp://en.wikipedia.org/wiki/Bayerhttp://en.wikipedia.org/wiki/Bristol-Myers_Squibbhttp://en.wikipedia.org/wiki/Bristol-Myers_Squibbhttp://en.wikipedia.org/wiki/Eli_Lilly_and_Co.http://en.wikipedia.org/wiki/Amgenhttp://en.wikipedia.org/wiki/Boehringer_Ingelheimhttp://en.wikipedia.org/wiki/Boehringer_Ingelheimhttp://en.wikipedia.org/wiki/Schering-Ploughhttp://en.wikipedia.org/wiki/Baxter_Internationalhttp://en.wikipedia.org/wiki/Baxter_Internationalhttp://en.wikipedia.org/wiki/Takeda_Pharmaceutical_Co.http://en.wikipedia.org/wiki/Takeda_Pharmaceutical_Co.http://en.wikipedia.org/wiki/Takeda_Pharmaceutical_Co.http://en.wikipedia.org/wiki/Genentechhttp://en.wikipedia.org/wiki/Procter_%26_Gamblehttp://en.wikipedia.org/wiki/Teva_Pharmaceutical_Industrieshttp://en.wikipedia.org/wiki/Teva_Pharmaceutical_Industrieshttp://en.wikipedia.org/wiki/Abbott_Laboratorieshttp://en.wikipedia.org/wiki/Abbott_Laboratorieshttp://en.wikipedia.org/wiki/Wyethhttp://en.wikipedia.org/wiki/Bayerhttp://en.wikipedia.org/wiki/Bristol-Myers_Squibbhttp://en.wikipedia.org/wiki/Bristol-Myers_Squibbhttp://en.wikipedia.org/wiki/Eli_Lilly_and_Co.http://en.wikipedia.org/wiki/Amgenhttp://en.wikipedia.org/wiki/Boehringer_Ingelheimhttp://en.wikipedia.org/wiki/Boehringer_Ingelheimhttp://en.wikipedia.org/wiki/Schering-Ploughhttp://en.wikipedia.org/wiki/Baxter_Internationalhttp://en.wikipedia.org/wiki/Baxter_Internationalhttp://en.wikipedia.org/wiki/Takeda_Pharmaceutical_Co.http://en.wikipedia.org/wiki/Takeda_Pharmaceutical_Co.http://en.wikipedia.org/wiki/Takeda_Pharmaceutical_Co.http://en.wikipedia.org/wiki/Genentechhttp://en.wikipedia.org/wiki/Procter_%26_Gamblehttp://en.wikipedia.org/wiki/Teva_Pharmaceutical_Industrieshttp://en.wikipedia.org/wiki/Teva_Pharmaceutical_Industries


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Industries

22 Astellas Pharma Japan 7,850 1,435 1,122 23,613

23 Daiichi Sankyo Japan 7,158 1,459 671 20,100

24 Novo Nordisk Denmark 6,520 1,063 1,086 15,358

25 Eisai Japan 5,583 926 604 14,993

26 Merck KGaA Germany 5,175 772 1,258 13,900

27 Alcon Switzerland 4,897 512 1,348 13,500

28 Akzo Nobel Netherlands 4,694 741 1,449 13,000

29 UCB Belgium 4,426 1,024 492 12,741

30 Nycomed Switzerland 4,264 n/a -105 10,533

31ForestLaboratories

USA 3,442 941 454 9,649

32 Solvay Belgium 3,268 533 1,026 9,000

33 Genzyme USA 3,187 650 -17 8,477

34 Allergan USA 3,063 1,056 -127 8,423
http://en.wikipedia.org/wiki/Teva_Pharmaceutical_Industrieshttp://en.wikipedia.org/wiki/Astellas_Pharmahttp://en.wikipedia.org/wiki/Daiichi_Sankyohttp://en.wikipedia.org/wiki/Novo_Nordiskhttp://en.wikipedia.org/wiki/Eisai_Co.http://en.wikipedia.org/wiki/Merck_KGaAhttp://en.wikipedia.org/wiki/Alconhttp://en.wikipedia.org/wiki/Akzo_Nobelhttp://en.wikipedia.org/wiki/UCB_(company)http://en.wikipedia.org/wiki/Nycomedhttp://en.wikipedia.org/wiki/Forest_Laboratorieshttp://en.wikipedia.org/wiki/Forest_Laboratorieshttp://en.wikipedia.org/wiki/Solvay_(company)http://en.wikipedia.org/wiki/Genzymehttp://en.wikipedia.org/wiki/Allerganhttp://en.wikipedia.org/wiki/Teva_Pharmaceutical_Industrieshttp://en.wikipedia.org/wiki/Teva_Pharmaceutical_Industrieshttp://en.wikipedia.org/wiki/Astellas_Pharmahttp://en.wikipedia.org/wiki/Daiichi_Sankyohttp://en.wikipedia.org/wiki/Novo_Nordiskhttp://en.wikipedia.org/wiki/Eisai_Co.http://en.wikipedia.org/wiki/Merck_KGaAhttp://en.wikipedia.org/wiki/Alconhttp://en.wikipedia.org/wiki/Akzo_Nobelhttp://en.wikipedia.org/wiki/UCB_(company)http://en.wikipedia.org/wiki/Nycomedhttp://en.wikipedia.org/wiki/Forest_Laboratorieshttp://en.wikipedia.org/wiki/Forest_Laboratorieshttp://en.wikipedia.org/wiki/Solvay_(company)http://en.wikipedia.org/wiki/Genzymehttp://en.wikipedia.org/wiki/Allergan


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Pharma

47Kyowa Hakko

KogyoJapan 1,698 268 108 2,895

48 Shionogi & Co. Japan 1,640 320 159 2,868

49MylanLaboratories

USA 1,612 104 217 2,800

50 H. Lundbeck Denmark 1,552 329 186 2,515

Source: Top 50 pharmaceutical companies, MedAdNews, September 2007

Indian Pharmaceutical Industry: An Overview

Domestic & External Trade Future Prospects Research & Development

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 Indias 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
http://en.wikipedia.org/w/index.php?title=Dainippon_Sumitomo_Pharma&action=edithttp://en.wikipedia.org/w/index.php?title=Kyowa_Hakko_Kogyo&action=edithttp://en.wikipedia.org/w/index.php?title=Kyowa_Hakko_Kogyo&action=edithttp://en.wikipedia.org/w/index.php?title=Shionogi_%26_Co.&action=edithttp://en.wikipedia.org/wiki/Mylan_Laboratorieshttp://en.wikipedia.org/wiki/Mylan_Laboratorieshttp://en.wikipedia.org/wiki/H._Lundbeckhttp://en.wikipedia.org/w/index.php?title=MedAdNews&action=edithttp://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/domestic-external-trade.htmlhttp://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/future-prospects.htmlhttp://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/research-development.htmlhttp://en.wikipedia.org/w/index.php?title=Dainippon_Sumitomo_Pharma&action=edithttp://en.wikipedia.org/w/index.php?title=Dainippon_Sumitomo_Pharma&action=edithttp://en.wikipedia.org/w/index.php?title=Kyowa_Hakko_Kogyo&action=edithttp://en.wikipedia.org/w/index.php?title=Kyowa_Hakko_Kogyo&action=edithttp://en.wikipedia.org/w/index.php?title=Shionogi_%26_Co.&action=edithttp://en.wikipedia.org/wiki/Mylan_Laboratorieshttp://en.wikipedia.org/wiki/Mylan_Laboratorieshttp://en.wikipedia.org/wiki/H._Lundbeckhttp://en.wikipedia.org/w/index.php?title=MedAdNews&action=edithttp://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/domestic-external-trade.htmlhttp://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/future-prospects.htmlhttp://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-industry/research-development.html


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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 ofnational 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.

ADVANTAGE INDIA

Competent workforce: India has a pool of personnel with high managerial and technical competence as

also skilled workforce. It has an educated work force and English is commonly used. Professional services

are easily available.

Cost-effective chemical synthesis: Its track record of development, particularly in the area of improvedcost-beneficial chemical synthesis for various drug molecules is excellent. It provides a wide variety of bulk

drugs and exports sophisticated bulk drugs.

Legal & Financial Framework: India has a 53 year old democracyand hence has 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.

Globalisation: The country is committed to a free market economy and globalization. Above all, it has a 70

million middle class market, which is continuously growing.


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Consolidation: For the first time in many years, the international pharmaceutical industry is finding great

opportunities in India. The process of consolidation, which has become a generalized phenomenon in the

world pharmaceutical industry, has started taking place in India.

THE GROWTH SCENARIO

India's US$ 3.1 billion pharmaceutical industry is growing at the rate of 14 percent per year. It is one of thelargest and most advanced among the developing countries.

Over 20,000 registered pharmaceutical manufacturers exist in the country. The domestic pharmaceuticals

industry output is expected to exceed Rs260 billion in the financial year 2002, which accounts for merely

1.3% of the global pharmaceutical sector. Of this, bulk drugs will account for Rs 54 bn (21%) and

formulations, the remaining Rs 210 bn (79%). In financial year 2001, imports were Rs 20 bn while exports

were Rs87 bn.

STEPS TO STRENGTHEN THE INDUSTRY

Indian companies need to attain the right product-mix for sustained future growth. Corecompetencies will play an important role in determining the future of many Indianpharmaceutical companies in the post product-patent regime after 2005. Indiancompanies, in an effort to consolidate their position, will have to increasingly look atmerger and acquisition options of either companies or products. This would help them tooffset loss of new product options, improve their R&D efforts and improve distribution topenetrate markets.

Research and development has always taken the back seat amongst Indianpharmaceutical companies. In order to stay competitive in the future, Indian companieswill have to refocus and invest heavily in R&D.

The Indian pharmaceutical industry also needs to take advantage of the recent advancesin biotechnology and information technology. The future of the industry will bedetermined by how well it markets its products to several regions and distributes risks, itsforward and backward integration capabilities, its R&D, its consolidation throughmergers and acquisitions, co-marketing and licensing agreements.

Emerging Trends Some In Indian Pharmaceutical Industry

Pharma Industry in West Bengal: The Road Ahead

Prof. Arup Mukherjee and Debashis Bhattacharya

Pharmaceutical sector is by far one of the most diverse, knowledge driven,technology intensive growth area, where fast track advancements can surely

generate significant resources. Despite competitions and regulatory issues loominglarge, current Indian scenario remains more or less intact. Indian domestic market

by 2005 stands at $ 5.3 billion dollar, export in value terms stands at $ 3.7 billionand import about $ 985 million, which is delivered by about 5 million people in direct

and 24 million in indirect employment. It is interesting to note that in 1995 when


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India joined WTO, the pharmaceuticals export was valued at around $600 million. By2005, the export value stands at $3.7 billion and accounts for more than 61 percent

of industry turn over. Indian market for pharmaceuticals was projected an averagegrowth of 15-20% during 2005-20010. Sector wise growth tilt is visible in way of

increasing contract manufacturing, outsourcing, and foreign acquisition mostly ingenerics field, joint ventures and value addition. Scenario in West Bengal has not

seen much change and is currently looking for some fast track decisions to takeadvantages in a complex global growth market. The doors of the neighboring state of

Sikkim have opened up recently in both manufacturing activity related taxconcession and in market terms with extended competitive possibilities through

China for opening up of road routs through Nathula Pass.

The genesis of Indian pharmaceutical industry is always traced to the state of WestBengal. The starting point was in 1901 when the noted teacher and scientist Acharya

Prafulla Chandra Ray laid the foundation stones of Bengal Chemical & PharmaceuticalWorks Ltd (BCPL). BCPL is still a success story with four factories - two in West

Bengal, one in Mumbai and one in Kanpur, with sales outlets in 11 cities, and a wide

self distribution network across the country and abroad with about 1500 listeddistributors. BCPL business model is unique in that, it has a wide range of related

product mix, that include, fine chemicals, active pharmaceutical ingredients (APIs),perfumeries, toiletries, hospital and surgical equipments, sera, vaccine and fire

extinguisher. The state capital, Kolkata was considered, at one point of time, forproduction of cost effective and quality drugs. Pharmaceutical industries of Kolkata

shared more than 80 per cent of the national drug production in 1940, which hasgradually been reduced to less than eight per cent in 2004.

The Indian pharmaceutical sector in general is highly fragmented, both in terms ofthe number of manufacturers and in number and variety of products. A vast majority

of Indian pharmaceutical firms are small in global terms having annual revenues ofless than $5 million. Confederation of Indian Industries (CII) estimates that about

80% of them are engaged in some type of contract manufacturing. West Bengal does

extend several bulk drugs and formulation products standing on available technologystrength. However, product mix of any pharmaceutical unit should adequately bespread across therapeutic segments for growth and to provide a protection net that

needs to concentrate currently on individual concerns in West Bengal. Interestingmodels can be the surviving original companies like BCPL. Major India centric

therapeutic segments include antidiabetics, cardiovascular medicines, anti-infective,

anti-cancer and anti-HIV medicines and anti-inflammatory groups. Gradually, qualitylife drugs like steroid hormone products, anxiolytics and anti-arthritis are also

creating impact in India. It is not relevant to further compete in low margin me-too

formulation areas. West Bengal is currently in a position to provide a contractmanufacturing hub in synthetic as well as formulation areas particularly in specific

therapeutic segments like anti-cancer, anxiolytics, cardiovascular, gastrointestinaland anti-infectives. Skilled manpower is the basic input and that is a plenty in West

Bengal. Environment controlled location for Pharma- Biotech processing zone canprovide a great impetus to this sector growth. CRO agencies are also expected to

grow in region particularly in discovery research. Entrepreneur orientation of theregion and the existent entrepreneurship knowledge gap and increasing capital input

requirements in pharmaceutical manufacturing however remains a bottleneck.

The State Directorate of Drugs Control has extended a helping hand to the

pharmaceutical producers in meeting global standards in stages. The West Bengal


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government is planning to announce a comprehensive Drug Policy for the state.Recent years have seen increased academia-industry initiatives. Academic

institutions like the Department of Pharmaceutical Technology of Jadavpur Universityand Indian Institute of Chemical Biology (IICB) have done commendable job in this

direction. A strong motivation within the pharmaceutical industry is now required toregain its lost pride and position.

Trends in pharmaceutical industry in West Bengal can be seen as:

Synthetic specialty drugs as also some biotechnology focus might be seen soon inWest Bengal through major players like Dabur and Biocon. Multinationals (MNC's)

like Pfizer and Organon initiated their manufacturing activities in West Bengal with a

focus on bulk drugs. The effect was negated in government taxation and pricingpolicies. The driving factors, however, remained as availability of skilled manpower

and phytochemical raw materials and access to different global regions through east.

Pharmaceutical industry of West Bengal is trying to achieve and develop expertise on

formulation and development for a number of sustained release formulations.

Presently some such formulations have gained confidence of medical fraternity andhave seen commercial success in the market. Since all surviving industries in WestBengal are GMP compliant, requirements of advanced tools and technology, validated

and aseptic processing will no more be a problem centers.

Expertise in synthetic chemistry and pharmaceutical manufacturing in West Bengal

remains a traditional strength that will allow the West Bengal pharmaceutical sectorto position itself as the provider of quality products at competitive price at least for

the generics market in India.

Biotechnology is set to sweep all aspects of life around the world. The Biotech sector

is poised to create arguably, the greatest revolution that the business-world hasseen. With adequate human resource input, investments in this sector are expecting

to grow. India is already set to become the vaccine hub of the world with a silenttransformation of institutions going on in India over the last 4-5 years. The

government is taking several initiatives to create and facilitate an environment ofinnovation and research culture in the country. The achievements in the field of

biotechnology will not be sustainable for long if participation of private sectorenterprises in the field is not encouraged. Emphasis is being laid on participation of

internationally acclaimed biotech firms in joint ventures.

Relatively recently, several contract Research Organisations (CRO's) mostly in

discovery research have started full functioning from West Bengal. The global CROmarket is estimated at $10 billion and growing at an annual rate of 14 to 16 percent.

The 2004 market size for CRO was pegged at Rs. 300-400 crore. The trend is to set

up bioequivalence, clinical trial and discovery based CROs as service growth sector.

The pharmaceutical industry sector is in fact more intellectually -driven than the IT

industry. IT in itself plays a larger role in the development of pharmaceutical sector.Constant IT solution inputs are today required in areas ranging from data

management, clinical trial management, statistical analysis, data backup, compliance

to regulatory requirements and validation of systems. In this regard bioinformatics isthe next big opportunity. Few Indian companies that have a focus on the

bioinformatics market like TCS, are active in West Bengal. TCS is offering services


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for understanding all aspects of the use of bioinformatics in drug discovery,comparative genomics, protein structure, integrated database design. The global

biotechnology market is in the range of $30-40 billion, growing at around 25 percenta year. Bioinformatics constitutes about 8-10 percent of the total market size of

about $2.5 billion currently and is estimated to rise to about $5-6 billion by the endof this decade.

Contract research and manufacturing services (CRAMS) market in India as well as inWest Bengal is growing at a significant rate of about 20 per cent. In 2005 Indian

CRAMS market was estimated at $532 million with contract manufacturingaccounting for almost 84% of the total. Intellectual Property Rights (IPR) being

firmly in place investments in developments and innovations are poised to grow and

West Bengal is only to gain significantly from that. Experts maintained that Indiancompanies have a capacity to gain 35 to 40 % of global CRAMS market. The

Associated Chamber of Commerce and Industry of India (Assocham) projected thedomestic Indian CRAMS market will reach % 900 million by 2010 and the demand in

clinical research will grow to $200 million by end of 2007 and to $ 1 billion by 2010.

India has emerged as an attractive destination for outsourcing, as it provides lowcost manufacturing at a world-class quality. Pharmaceutical production costs are

almost 50 percent lower in India than in Western nations, and R&D costs are aboutone-eighth and clinical trial expenses around one-tenth of Western levels.

Expectations are for sizable revenue generation because innovator companies aretrying to concentrate more on the research side of the value chain than on the sales

and marketing.

An increasing number of Indians are also dipping into their own pockets to buy over-

the-counter (OTC) drugs. The OTC market is currently worth about $940m andgrowing at 20% a year - more than double the rate at which the market for

prescription products is rising. In market value terms West Bengal constitutes asignificant market, both for dense population and population awareness levels. West

Bengal is also in access route to very densely populated regions of globe throughChina, South East Asia and Myanmar. Significant opportunity lies here to take aspecialized market leadership.

In view of a significant market access location, a strong knowledge based manpower

support, very good transport, communication and manpower supply position addedwith proactive and favorable government support, West Bengal currently is a

springboard for pharmaceutical industry developments. Hence, with its enormousadvantages, including a large well-educated, skilled and english speaking workforce,

low operational costs, huge domestic market including South East Asia, Kolkata hasthe potential to become the region's hub for pharmaceutical discovery, research,

manufacturing and healthcare services. However, to make this happen, it is

imperative that the regulatory environment, West Bengal government's strongcommitments towards pro-industry policies should continue to improve.

The pharmaceuticals industry is grappling with the highest level of attrition. There is

an acute shortage of manpower at all levels in the industry. It is becomingincreasingly difficult to find the right people for the right position. Human resources

in the pharma industry is not well developed at all.


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As far as emerging trends are concerned, consolidation will take place and is a logicalthing to happen. An exemption on excise and other taxes, subsidies in capital

investment and interest and reimbursement of insurance premium etc., are theprime reasons for selecting Sikkim for investment against West Bengal. Similar

support also needs to be devised along with encouragements to regional enterprisefor a faster growth in industrialization in this sector.

(Prof. Arup Mukherjee is Senior Professor and Ex-Head, Department of Chemical Technology, CalcuttaUniversity and Debashis Bhattacharya is a Researcher at the Division of Pharmaceuticals and Fine

Chemicals Technology, Department of Chemical Technology, Calcutta University)

Key Players in the Indian Pharmaceutical Industry

WTO TRIPS and in the midst of the practical implications of ensuring compliance with product

patents, how is the Indian pharmaceutical industry facing up to new regulations to its market?

Indian pharmaceutical companies are able to provide FDA approved facilities for the complete

range of services for drug development. R&D services, API sourcing, finished formulation

manufacture and clinical trials can all be completed in India, at less cost than in many developed

markets. The leading Indian pharmaceutical companies are also beginning to increase market

presence and market share in the US and EU markets.

Pivotal period of change

The Indian pharmaceutical market is entering a pivotal period of change. Although it is unlikely tosee significant growth before 2011, visiongain expects extensive company activity as the leading

Indian pharmaceutical companies strive towards international competitiveness. Global

pharmaceutical companies have already begun to take advantage of the changing regulatory and

economic conditions in India. The following five years will see further merger and acquisition

activity, including key overseas acquisitions.

The Leading Pharmaceutical Companies Within India

1. Ranbaxy Laboratories

2. Cipla3. Dr Reddy's Laboratories

4. Sun Pharmaceuticals5. Nicholas Piramal

6. Zydus Cadila

7. Biocon8. Glenmark Pharmaceuticals

9. Wockhardt Ltd


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10. Orchid Chemicals

A Focus On Top Indian Pharmaceutical Companies

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, headquartered in India, isan integrated, research based, international pharmaceutical company, producing a wide range ofquality, affordable generic medicines, trusted by healthcare professionals and patients acrossgeographies. It is ranked amongst the top ten generic companies worldwide. The Company hasmanufacturing operations in 11 countries with a ground presence in 49 countries and its productsare available in over 125 countries. The Company is driven by its ambition to achieve US $5 BnSales by 2012 and be amongst the top five generic players worldwide. To translate these objectivesinto reality and to optimize value creation, the Company has adopted a multi-pronged strategy.Acquisition of generic brands overseas, strong emphasis on brand marketing in the US and Europe,entering high potential new markets with value added product offerings, are the major thrust areas.Successful business development transactions form a key component of it's business strategy.

In each of our partnerships, we strive to build enduring, mutually beneficial relationships that canproduce positive results for both parties.

We are interested in sales and marketing partnerships and product acquisition opportunities in allthe markets where we operate. We are exploring opportunities through Licensing and Alliances todraw maximum value from such arrangements. We continue to evaluate opportunities to add to ourproduct basket, enhance our therapeutic presence and expand our distribution reach.

We are also interested in building winning drug discovery and development collaborations in the

following therapeutic areas:

Anti-infectives

Inflammation & Respiratory

Metabolic Diseases

Oncology


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In addition, we have active R&D programs in oral controlled release drug delivery systems and arelooking for suitable partnerships. We are also actively evaluating options for acquiring newtechnology platforms to develop differentiated high margin products.

CiplaCIPLA Limited

Type

Founded 1935

Headquarters Mumbai,India

Key people Y. K. Hamied (CMD), ChairmanIndustry Pharmaceuticals

Revenue Rs. 37.6 billion (~939M USD) (2006)

Net income Rs. 9.1 billion (2006)

Employees over 7,000

Website www.cipla.com

Cipla, originally founded as The Chemical, Industrial & Pharmaceutical Laboratories isa prominent Indianpharmaceutical company, best-known outside its home country for

producing low-cost anti-AIDS drugs for HIV-positive patients in developing countries.The company was founded in 1935 by Khwaja Abdul Hamied, and its chairman today isYusuf Hamied(b. 1936), the founder's eldest son.
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Cipla and the Fight against HIV/AIDS in the

Developing World

Today (2007), Cipla is the world's largest manufacturer ofantiretroviral drugs (ARVs) to

fight HIV/AIDS, as measured by units produced and distributed (multinational brand-name drugs are much more expensive, so in money terms Cipla medicines are probablysomewhere down the list). Roughly 40% of HIV/AIDS patients undergoing antiretroviraltherapy worldwide take Cipla drugs. Ranked third in Generic market share statistics inSouth African Private Sector.

Because Indian law from 1972 has allowed no (end-product) patents on drugs, andprovided forcompulsory licensing, Cipla was able to manufacture medicines which enjoypatentmonopoly in certain other countries (particularly those where large, multinational

pharmaceutical companies are based). By doing so, as well as by making an executivedecision not to make profits on AIDS medication, Cipla reduced the cost of providingantiretrovirals to AIDS patients from $12,000 and beyond (monopoly prices charged byinternational pharma conglomerates) down to around $300 per year. Today they are ableto do so for under $150 per patient per year. While this sum remains out of reach formany millions of people in Third World countries, government and charitable sourcesoften are in a position to make up the difference for destitute patients.

The customary treatment of AIDS consists of a cocktail of three drugs. Cipla produces anall-in-one pill called Triomune which contains all three substances (Lamivudine,stavudine and Nevirapine), something difficult elsewhere because the three patents are

held by different companies. One more popular fixed dose combination is there, with thename Duovir-N. This contains Lamivudine, Zidovudine and Nevirapine.

AHF Campaign

In August of 2007 Cipla was confronted by a US-based group known as AIDS HealthcareFoundation (AHF) with a well-funded campaign of full-page ads in various Indiannewspapers suggesting Cipla was pricing an AIDS drug called Viraday higher in India

than in Africa.

[1]
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In response to AIDS Healthcare Foundation's claims Cipla issued a short statementpointing out that the company had not sold a single pack of Viraday in Africa. It alsounderlined that Cipla sells its other AIDS drugs to the Indian government at the sameprices it sells to Africa, and questioned AHF's agenda.[3] According to AHF and newsreports, Cipla threatened a defamation lawsuit against the organization.

On August 21, 2007 the Indian Monopolies and Restrictive Trade Practices Commission(MRTPC) announced that it would look into Cipla's pricing and claims made by AHF. [2]

On September 1, 2007, The Economic Times of Delhi wrote that:

It has now emerged that Aids Healthcare Foundation (AHF), the US-based NGO thataccused Cipla of over pricing anti-AIDS drug, Viraday, in India is part funded byAmerican anti-AIDS drug maker Gilead and the NGO's treasurer is a senior Gileadexecutive.

This is largely the reason why foreign and Indian NGOs such as Medicins Sans

Frontieres (MSF), Delhi Network of Positive People (DNP+), Indian Network of PositivePeople (INP+), Sahara and others refused to be part of AHF's anti-Cipla campaign.

is also the only Indian company opposing Gilead's patent application for its blockbusteranti-HIV drug Viread in India. The hearing for the patent case of Viread is due inOctober. ... Says a head of an NGO, who did not participate in the anti-Cipla campaign:There is a conflict of interest in the campaign. AHF is funded by multinational pharma

companies. A senior Gilead executive is one of the directors of AHF and the campaignchoose to target Cipla for over pricing at a time when it is fighting Gilead's patent case inIndia. There is a discomfort and many civil society groups decided to stay away from thecampaign.
http://cipla.com/whatsnew/news.htm#09aughttp://en.wikipedia.org/wiki/Cipla#_note-1%23_note-1http://cipla.com/whatsnew/news.htm#09aughttp://en.wikipedia.org/wiki/Cipla#_note-1%23_note-1


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Dr. Reddy's Laboratories

Dr. Reddy's Laboratories is India's leading pharmaceutical company with presence in over 100 countries. Dr

Reddy's manufactures a range of products such as Active Pharmaceutical Ingredients, Generic & Branded

Finished Dosages, Specialty Pharmaceuticals, and Biopharmaceuticals

.

Dr. Reddy's Laboratories was founded in 1984 by Dr Anji Reddy. In 1986, Dr. Reddy's went public and

entered international markets with exports of Methyldopa. In 1987, Dr. Reddy's obtained its first USFDA

approval for Ibuprofen API and started its formulations operations. In 1988, Dr. Reddy's acquired Benzex

Laboratories Pvt. Limited to expand its Bulk Actives business. In 1990, Dr. Reddy's, entered a new territory

when it, for the first time in India, exported Norfloxacin and Ciprofloxacin to Europe and Far East. In 1993,

Dr. Reddy's Research Foundation was established and the company started its drug discovery programme.

In 1994, Dr. Reddy launched a GDR issue of US$ 48 million. In 1995, the company set up a joint venture in

Russia. In 1997, Dr. Reddy's became the first Indian pharmaceutical company to out-license an originalmolecule when it licensed anti-diabetic molecule, DRF 2593 (Balaglitazone), to Novo Nordisk. In 1998, Dr.

Reddy's licensed anti-diabetic molecule, DRF 2725 (Ragaglitazar), to Novo Nordisk. In 1999, the company

acquired American Remedies Limited, a pharmaceutical company based in India. In the year 2000, became

the first Asia Pacific pharmaceutical company, outside Japan, to be listed on the New York Stock Exchange.

In 2001, Dr. Reddy's Laboratories became India's third largest pharmaceutical company with the merger of

Cheminor Drugs Limited, a group company. In 2002, Dr. Reddy's made its first overseas acquisition - BMS

Laboratories Limited and Meridian Healthcare in UK. In 2003, Dr. Reddy's launched Ibuprofen, first generic

product to be marketed under the "Dr. Reddy's" label in the US. In 2006, Dr. Reddy's achieved a revenue of

US$ 1 Billion. In the same year, Dr. Reddy's acquired Betapharm- the fourth-largest generics company in

Germany. Today, Dr. Reddy's Laboratories is leading pharmaceutical company in India in terms of turnover

and profitability.

Products of Dr. Reddy's Laboratories

Active Pharmaceutical Ingredients (API): Dr. Reddy's Laboratories product list span 24 major chemistries

including stereo-selective synthesis, cryogenics, hydrogenations and cyanations. It has filed 84 US DMFs,

the highest in India and second highest in the world.


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Custom Pharmaceutical Services: Dr. Reddy's executes cost-effective and time-bound projects for its

customers, and provides them cGMP-compliant products manufactured in FDA-inspected, ISO-certified

facilities.

Generic Dosages: Dr. Reddy's Lab is a leading generic drugs manufacturer. It is the fourth largest player in

Germany after the acquisition of betapharm. The company has expertise in customer-specific packaging,compliance packaging, anti-counterfeit packaging, and has won several awards globally for its packaging

efforts, including the Asia Star, AmeriStar and WorldStar awards

.

Branded Dosages: Dr. Reddy's brands such as Omez (Omeprazole), Nise (Nimesulide), Stamlo

(Amlodipine), Ciprolet (Ciprofloxacin), Enam (Enalapril) and Ketorol (Ketorolac) are leaders in their category

in several countries.

Discovery Research: Dr. Reddy's is actively involved in drug-discovery and clinical development programs.

Specialty Pharmaceuticals: In the field of speciality pharmaceuticals, Dr. Reddy's deals in deals acquiredproprietary technologies, internally developed proprietary drug-delivery platforms, and current internal

compounds under pre-clinical and clinical development.

Biopharmaceuticals: Grafeel (Filgrastim) was the first biologics product by Dr. Reddy's to enter the market.

The company's second product Reditux (Rituximab) is the first biosimilar monoclonal antibody to be

developed and launched anywhere in the world.

Major Achievements of Dr. Reddy's Laboratories:

Dr. Reddy's is the 1st Asia Pacific pharmaceutical company, outside Japan to be listed on

the New York Stock Exchange.

Dr. Reddy's biologics product Reditux (Rituximab) is the first biosimilar monoclonal

antibody to be developed and launched anywhere in the world.


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NICHOLAS PIRAMAL INDIA LIMITED

People Philosophy

Nicholas Piramal is in many ways a unique organization. With a long history of Mergers andAcquisitions, NPIL is an amalgam of many cultures, most of them being multi-national innature. As a result the company has develop its own Nicholas Way - a best practicesprogramme that imbibes the best of all cultures and creates its own - one that reflects unity inits diversity. Because of a conscious M&A strategy over the years, the harmonization ofcultures at the company has been challenge that we have successfully met. It is a story thathas been heralded in the Indian pharma industry, wherein the Nicholas Piramal skills atefficiently integrating all acquired companies at the people, finance and manufacturing levels.

Nicholas Piramal's strongest attributes are the unwavering focus on ethics, transparency,corporate culture, stakeholder relationships, contribution to society and a commitment togrowth!

Nicholas Piramal is a company that dares to dream the impossible and motivates andempowers its 4,000 strong team to go on and achieve it. It is a work culture that is focused onhigh performance, innovation, entrepreneurship and empowerment, based on mutuallybeneficial personal development that understands and helps employees manage their dreamsand goals.


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A key element of Nicholas Piramal's success is the empowerment of its people, with a strongperformance and consequence management element, where the company uses a proprietaryformula to convert employee Key Result Areas into a performance-based pay system, withparity with industry pay structures and a stress on internal equity with all employees.

The HR system is designed with transparency and feedback as the primary pivots of employeeevaluation and growth. It identifies leaders who can be thrown up quickly through acombination of self and sponsored learning. Organisational learning and study opportunitiesare provided by the company through dedicated, regular training programmes run throughout

the year for all members of the sales, marketing and research teams.

Given the fact that the company is in the intellectual capital driven business ofpharmaceuticals, Nicholas Piramal lays great stress on Knowledge Management anddevelopment as a Knowledge-based company.

Nicholas Piramal, as a consequence of its HR practices, has attracted some of the finest talentin industry. Its senior management team of 41 comprises 39 people who are Doctorates,MBAs, CAs or have post-graduates from some of the best institutes in India and across theworld. Their work experience also spans some of the top global and Indian firms in theirindustry.

In keeping with the M&A ethos, Nicholas Piramal has built a culture where diversity thrives,thanks to its skill of integrating acquisitions quickly and efficiently, contrary to most practicesin industry. People from acquired companies at all levels are able to quickly craft and define acareer process and follow it up very successfully. The company has several such examples inFinance, Sales and Marketing and Manufacturing who are now at top or senior managementpositions.

Within its acquired companies Nicholas Piramal has set up a culture wherein talent at all levelswith leadership potential can be spotted quickly and potential leaders presented with anopportunity to grow. This can be seen from the fact that the attrition levels within acquiredcompanies are largely lower than industry norms.


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At Nicholas Piramal with its accent on entrepreneurship, the company has recentlydelayered management to create growth and entrepreneurial opportunity. Entrepreneurialspirit among middle and senior management is encouraged with high levels ofempowerment. Communication is also a priority for top management. The company'sChairman regularly shares successes and triumphs with the company as a whole through

personalized meetings and digital house-journals, which reach to more than 3,000employees

Cadila Healthcare

Cadila Healthcare Limited

Image:Cadila Healthcare.jpeg

Type Public

Founded 1954

Headquarters Ahmedabad,India

Key people Pankaj Patel, Chairman

Industry Pharmaceuticals

Revenue INR15 billion (2006)

Net income INR1.7 billion (2006)

Employees 4000 (2006)

Slogan dedicated to life

Website http://www.zyduscadila.com/

Cadila Healthcare is an Indian pharmaceutical company headquartered atAhmedabad inGujarat state of western India. The company is the fifth largest pharmaceutical company

in India, with US$290m in turnover in 2004. It is a significant manufacturer ofgenericdrugs.

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Documents

Pharmaceutical Industry a Project Amit Rai Mmm