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JPSBR: Volume 2, Issue 5: Sept Oct 2012 (219-229)ISSN NO. 2271-3681Evolution of Pharmaceutical Industry: A global Indian & Gujarat perspectiveProf.Viral shahNew LJCC, Gujarat University, Ahmedabad, Gujarat, IndiaABSTRACT:Most of today's major pharmaceutical companies were founded in the late 19th and early 20th centuries. Key discoveries of the1920s and 1930s, such as insulin and penicillin, became mass-manufactured and distributed. Global pharmaceutical market ishighly dynamic and is characterized by greater levels of R&D expenditure and extensive regulation of its products. Globalpharmaceutical sales are estimated to be US 643 billion in 2006, a growth of 7% over the previous year. All of these changes areultimately good for the Indian pharmaceutical industry, which suffered in the past from inadequate regulation and largequantities of spurious drugs. They force the industry to reach a level necessary for global competitiveness. At the time ofindependence in 1947, India’s pharmaceutical market was dominated by Western MNCs that controlled between 80 and 90percent of the market primarily through importation. Approximately 99 percent of all pharmaceutical products under patent inIndia at the time were held by foreign companies and domestic Indian drug prices were among the highest in the world. Accordingto industry estimates, a great chunk --almost 40 per cent --of machinery used in the pharmaceutical manufacturing in India isproduced in Gujarat. This creates a very good local and global opportunity for Gujarat in the manufacturing of pharmaceuticalmachinery, given its strong and well established engineering sector, points out a recent study titled Gujarat Pharma-Industrystriding into the future, KPMG, India The strong growth prospects of the pharmaceutical exports segment and growing demandfrom the domestic market, will further fuel growth in the pharmaceutical machinery sector. However, Gujarat's engineering sectoris highly fragmented, especially the pharma-machinery manufacturing segment. Due to the highly fragmented nature, there is adearth of pricing power and critical scale. This in turn restricts the ability to produce the technology-driven products required foroperating in global markets.KEY WORDS: Global scenario, India Pharma industry, Industry in GujaratINTRODUCTION:Article history:Received 1 Sep 2012Accepted 11 Nov 2012Available online 13 Dec 2012For Correspondence:Prof.Viral shahNew LJCC,Gujarat University,Ahmedabad, Gujarat, IndiaEmail: viral lj@yahoo.com(www.jpsbr.org)Shah V. et alIntroduction of PharmacyThe first known drugstore was opened by Arabian pharmacists in Baghdad in754, and many more soon began operating throughout the medieval andeventually medieval Europe. By the 19th century, many of the drugstores in Europeand North America had eventually developed into larger pharmaceuticalcompanies. Most of today's major pharmaceutical companies were founded in thelate 19th and early 20th centuries. Key discoveries of the 1920s and 1930s, suchas insulin and penicillin, became mass-manufactured and distributed. Switzerland,Germany and Italy had particularly strong industries, with the UK, US, Belgium andthe Netherlands following suit. Legislation was enacted to test and approve drugsand to require appropriate labeling. Prescription and non-prescription drugsbecame legally distinguished from one another as the pharmaceutical industrymatured. The industry got underway in earnest from the 1950s, due to thedevelopment of systematic scientific approaches, understanding of human biology(including DNA) and sophisticated manufacturing techniques. Numerous new drugswere developed during the 1950s and mass-produced and marketed through the1960s. These included the first oral contraceptive, "The Pill", Cortisone, bitors, chlorpromazine (Thorazine), Haldol (Haloperidol) and the tranquilizersushered219

JPSBR: Volume 2, Issue 5: Sept Oct 2012 (219-229)ushered in the age of psychiatric medication. Valium(diazepam), discovered in 1960, was marketed from 1963 andrapidly became the most prescribed drug in history, prior tocontroversy over dependency and habituation. Attempts weremade to increase regulation and to limit financial linksbetween companies and prescribing physicians, including bythe relatively new U.S. Food and Drug Administration (FDA).Such calls increased in the 1960s after the thalidomide tragedycame to light, in which the use of a new anti-emetic inpregnant women caused severe birth defects. In 1964, theWorld Medical Association issued its Declaration of Helsinki,which set standards for clinical research and demanded thatsubjects give their informed consent before enrolling in anexperiment. Pharmaceutical companies became required toprove efficacy in clinical trials before marketing drugs. Cancerdrugs were a feature of the 1970s. From 1978, India took overas the primary center of pharmaceutical production withoutpatent protection.The History of the Pharmaceutical IndustryAs a result of introduction and success of penicillin in the earlyforties and the relative success of other innovative drugs,research and development (R&D) became a major thrust areaof the pharmaceutical industry. The industry expanded rapidlyin the sixties, benefiting from new discoveries. In the 1960sattempts were made by the U.S. Food and DrugAdministration (FDA) to increase regulation of pharmaceuticalindustries and to limit financial links between companies andprescribing physicians. In 1964, after the thalidomide tragedy(in which the use of a new tranquilizer in pregnant womencaused severe birth defects in the new born child), the WorldMedical Association set standards for clinical research.Pharmaceutical companies were required to prove efficacyand safety of the drug in clinical trials before marketing them.Tighter regulatory controls were introduced in the seventies.The new regulations revoked permanent patents andestablished fixed periods on patent protection for brandedproducts. As a result industries flourished by producinggeneric products and they started earning huge profits,because generic manufacturers do not incur the cost of drugdiscovery.Global scenario:Global pharmaceutical market is highly dynamic and ischaracterized by greater levels of R&D expenditure andextensive regulation of its products. Global pharmaceuticalsales are estimated to be US 643 billion in 2006, a growth of7% over the previous year. Sales have grown from US 334billion in 1999 to US 643 billion in 2006, witnessing a CAGR of10%. North America is the major pharmaceutical marketaccounting for around 48% of global pharmaceutical sales,followed by Europe (30%), Japan (9%). Leading therapy classesin world-pharmaceutical market include lipid regulators (witha market share of 5.8%), oncologics (5.7%), respiratory agents1(4%), acid pump inhibitors (4%), and anti-diabetics (3.5%)Shah V. et alISSN NO. 2271-3681Figure-1.1: Market cap of Pharmaceutical companies hasgrown substantially over 25 yearsThe Pharmaceutical industry in India is the world's thirdlargest in terms of volume and stands 14th in terms of value.According to Department of Pharmaceuticals, Ministry ofChemicals and Fertilizers, the total turnover of India'spharmaceuticals industry between 2008 and September 2009was US 21.04 billion, while the domestic market was worthUS 12.26 billion. Sale of all types of medicines in the countryis expected to reach around US 19.22 billion by 2012. Exportsof pharmaceuticals products from India increased fromUS 6.23 billion in 2006-07 to US 8.7 billion in 2008-09 acombined annual growth rate of 21.25%. According toPricewaterhouseCoopers (PWC) in 2010, India joined amongthe league of top 10 global pharmaceuticals markets in termsof sales by 2020 with value reaching US 50 billion. Some ofthe major pharmaceutical firms include Sun Pharmaceutical,Cadila Healthcare and Piramal Healthcare. 2Relationship between pharmaceuticals and biotechnology:Unlike in other countries, the difference betweenbiotechnology and pharmaceuticals remains fairly defined inIndia. Bio-tech there still plays the role of pharma’s little sister,but many outsiders have high expectations for the future.India accounted for 2% of the 41 billion global biotechmarket and in 2003 was ranked 3rd in the Asia-Pacific regionand 11th in the world in number of biotechs. In 2004-5, theIndian biotech industry saw its revenues grow 37% to 1.1billion. The Indian biotech market is dominated bybiopharmaceuticals; 75% of 2004-5 revenues came frombiopharmaceuticals, which saw 30% growth last year. Of therevenues from biopharmaceuticals, vaccines led the way,1comprising 47% of sales.Comparison with the U.S.:The Indian biotech sector parallels that of the U.S. in manyways. Both are filled with small start-ups while the majority ofthe market is controlled by a few powerful companies. Bothare dependent upon government grants and venturecapitalists for funding because neither will be commerciallyviable for years. Pharmaceutical companies in both countrieshave recognized the potential effect that biotechnology couldhave on their pipelines and have responded by either investingin existing start-ups or venturing into the field220

JPSBR: Volume 2, Issue 5: Sept Oct 2012 (219-229)themselves. In both India and the U.S., as well as in much ofthe globe, biotech is seen as a hot field with a lot of growthpotential. 3Relationship with IT:Many analysts have observed that the hype around thebiotech sector mirrors that of the IT sector. Biotech collegeshave been popping up around the country eager to service thepools of students that want to take advantage of a growingindustry. The International Finance Commission, the privateinvestment arm of the World Bank, called India the“centerpiece of IFC’s global biotech strategy.” Of the 110million invested in 14 biotech projects investment globally, theIFC has given 43 million to 4 projects in India. According toDr. Manju Sharma, former director of the Department ofBiotechnology, the biotech industry could become the “singlelargest sector for employment of skilled human resource inthe years to come.” British Prime Minister Tony Blair wassimilarly impressed, citing the success of India’s biotechindustry as the reason for his own country’s own biotechopportunities. Malaysia is also looking to India as an examplefor growing its own biotech industry. 3Innovation:Several studies on the economics of technological change andtechnology gap approach to international trade (e.g.,Fegerberg 1987, Verspagen 1991) have brought out thatgrowth performance and competitive advantages of countriesgo together with their activities of technological innovationand imitation. They have shown that technologicaldevelopment measured by patent and R&D expenditures havesignificant impact on the trade performance of the countries.The pharmaceutical industry being one of the mosttechnology‐intensive industries, the extent and nature ofinnovation is crucial for countries to prolong their productivitygrowth and competitiveness in the long run. In broad termsthe process of technological change can occur throughimprovements in the products, production process, rawmaterial and intermediate inputs, and through enhancementsin the efficiency of the management system.Challenges:All of these changes are ultimately good for the Indianpharmaceutical industry, which suffered in the past frominadequate regulation and large quantities of spurious drugs.They force the industry to reach a level necessary for globalcompetitiveness. However, they have also exposed some ofthe inadequacies in the industry today. Its main weakness is anunderdeveloped new molecule discovery program. Even afterthe increased investment, market leaders such as Ranbaxy andDr. Reddy’s Laboratories spent only 5-10% of their revenueson R&D, lagging behind Western pharmaceuticals like Pfizer,whose research budget last year was greater than thecombined revenues of the entire IndianShah V. et alISSN NO. 2271-3681pharmaceutical industry. This disparity is too great to beexplained by cost differentials, and it comes when advances ingenomics have made research equipment more expensivethan ever. The drug discovery process is further hindered by adearth of qualified molecular biologists. Due to the disconnectbetween curriculum and industry, pharmas in India also lackthe academic collaboration that is crucial to drug developmentin the West. 4Evolution of pharmaceutical industry in IndiaState of the economy:Economic growth decelerated in 2008-09 to 6.7 per cent. Thisrepresented a decline of 2.1 per cent from the average growthrate of 8.8 per cent in the previous five years (2003-04 to2007-08). The five years of high growth has raised theexpectations of the people. Few remember that duringslowdown from the average growth of 7.3 per cent per annumduring the previous five years, it is the preceding five-yearperiod from 1998-99 to 2002-03 average growth was only 5.4per cent, while the highest growth rate achieved during theperiod was 6.7 per cent (in 1998-99). Per capita GDP growth, aproxy for per capita income, which broadly reflects theimprovement in the income of the average person, grew by anestimated 4.6 per cent in 2008-09.Though this represents asubstantial still significantly higher than the average 3.3 percent per annum income growth during 1998-99 to 2002-03.5Background analysis:Introduction:The Indian Pharmaceutical Industry has come a long way frombeing almost non-existent in the 1970’s to being one of thelargest and most advanced Pharmaceutical industries in theworld. The domestic Pharmaceutical output has increased at aCAGR of 13.4.Currently the Indian Pharmaceutical Industry isvalued at 8 billion (approx).Globally the industry ranks 4th interms of volume and 13th in terms of value. It providesemployment to millions and ensures that essential drugs areavailable to the vast population of India at affordable prices.Relevance for growth:India has the highest number of manufacturing plantsapproved by US FDA, which is next only to that in the US.More than 85% of the formulations produced in the countryare sold in the domestic market. Over60% of India's bulk drugproduction is exported. India holds the lion's share of theworld's contract research business as activity in thePharmaceutical market continues to explode, over15prominent contract research organizations (CROs) are nowoperating in India attracted by her ability to offer efficientR&D on a low cost basis. Thirty five per cent of business is inthe field of new drug discovery and the rest 65 per cent ofbusiness is in the clinical trials arena. India offers a huge costadvantage in the clinical trials domain compared to Westerncountries. India got a major boost with the signing of TradeRelated Intellectual Property Rights (TRIPS) under the General221

JPSBR: Volume 2, Issue 5: Sept Oct 2012 (219-229)ISSN NO. 2271-3681Agreement on Tariffs and Trade (GATT) in January 2005 withwhich it began recognizing global patents.6Export profileExports constitute a substantial part of the total production ofPharmaceutical in India. The formulations contribute nearly55% of the total exports and the rest 45% comes from bulkdrugs. Pharmaceutical exports clocked 7.2 billion in 2007-08,accounting for six per cent of the country’s total exports.Indian companies export drugs to over 200 countries, but thetop 25 markets, which includes the US, Germany, Russia, Chinaand few European and African countries, account for abouthalf of the total. Indian drug makers exported medicines worthRs 31,608 crore during April 2008-January 2009 and exportsshot up 30.7% as compared to last year due to a weak Indiancurrency and increased demand for low-cost genericmedicines. US is the Largest importer of drugs followed byRussia and Germany.7Foreign participationDrugs and Pharmaceuticals ranks 8th in India’s top 10 FDIattracting sectors. The government of India has allowedforeign direct investment up to 100% through the automaticroute in the drugs and Pharmaceuticals industry of thecountry, on the condition, that the activity should not fall intothe categories that require licensing. Pharmaceutical industryaccounts for about 2.91% of total FDI into the country. The FDIin Pharmaceutical sector is estimated to have touched US 172million, thereby showing a compounded annual growth rate ofabout 62. The Industry has received almost Rs 2141 croreinvestment from 36 countries through FDI between April 2007to April 2009 with most of the fund infusion directed tohealthcare and biotech ventures. 7Detailed analysis ofpharmaceutical growth:thepharmaceuticalsectorThe Indian Pharmaceutical industry has grown from a mere Rs.1,500 crore turnover in 1980 to over Rs. 78,000crore in 2008with about 10 per cent of share volume of global production.High growth has been achieved through; the creation ofrequired infrastructure, capacity building in ingredients(APIs) and formulations, entering into drugdiscovery through original and contract research andmanufacturing (CRAM) and clinical trials and product specificstrategies of acquisition and mergers. The domestic sector hada production turnover of Rs. 47,241 crore from about 10,000small-scale and 300 large and medium manufacturing units in2008. 7Evolution of industry:In India, modern system of medicine is a 20th centuryphenomena, though the traditional system of medicine hasbeen in practice for many centuries. Therefore, in discussingthe evolution of the IPI, three points of time are very relevant.Shah V. et alThese are: 1900-1970, 1970-1990 and the decade of 1990sTheperiod 1900-1970 signifies the dominance of themultinationals in this field that were basically importing bulkdrugs and formulations from abroad. Most domesticmanufacturers were engaged in repacking the formulationsproduced by the multinationals and production wasconcentrated in the hands of the multinationals. Production ofmodern medicine by indigenous units started with the settingup of Bengal Chemical and Pharmaceutical works in 1892,which was followed by the establishment of Alembic Chemical,works in1907 and Bengal Immunity in 1919. At this point intime, the Patents Act of 1911 was in practice, which facilitatedpatenting all the known and possible processes ofmanufacturing of the said drug besides patenting the drugitself. Hence, the indigenous firms were legally preventedfrom manufacturing most of the new drugs during the life ofthe patent secured by the latter, i e, for 16 years, which couldbe extended to a maximum of another 10 years if the workingof the patent had not been sufficiently remunerative to thepatentee. This gave them the monopoly power initially. Thedomestic firms were also forbidden from processing apatented drug into formulations or importing it. However, theSecond World War and the introduction of sulpha drugs andpenicillin gave on impetus to the pharmaceutical industry.India’s Pharmaceutical industry in 2005: Share of global sales: Value 1%, Volume 8% Global ranking: 4th in volume, 13th in value Domestic market: 5.3 billion Exports: 3.7 billion Imports: 985 million Bulk drug production: 2.1 billion Employment: 5 million direct, 24 million indirect. Capital investment: 1.2 billion Production costs: Among the lowest in the World, estimated to be 70% less than the WestIndia’s Pharmaceutical industry: independence to 2005:At the time of independence in 1947, India’s pharmaceuticalmarket was dominated by Western MNCs that controlledbetween 80 and 90 percent of the market primarily throughimportation. Approximately 99 percent of all pharmaceuticalproducts under patent in India at the time were held byforeign companies and domestic Indian drug prices wereamong the highest in the world. The Indian pharmaceuticalmarket remained import-dependent through the 1960s untilthe government initiated policies stressing self-reliancethrough local production.5 At that time, 8 of India’s top 10pharmaceutical firms, based on sales, were subsidiaries of8MNCs.222

JPSBR: Volume 2, Issue 5: Sept Oct 2012 (219-229)Table 1.1 Top 20 Publicly Listed Life Science companies inIndia, as of aRanbaxyDr. Reddy's LaboratoriesLupin LtdAurobindo PharmaDaburSun PharmaceuticalCadila HealthcareJubilant LifesciencesPiramal HealthcareGlaxoSmithKlinePharmaceuticals LtdIpca LaboratoriesWockhardtTorrent PharmaceuticalsSterling BioBioconOrchidChemicals&Pharmaceuticals LimitedAlembicAventis PharmaGlenmark PharmaceuticalsRevenue2011(USD 629.45561.03480.26ISSN NO. 2271-3681release, Aug. 16, 2005.2006 Chain Pharmacy Industry Profile,The National Association of Chain Drug Stores.10Pharmaceuticals in the United States, Industry Profile.Labour forceIndia’s greatest strengths lie in its people. India also boasts ofwell-educated, English-speaking labor force that is the base ofits competitive advantage. Although molecular biologists arein short supply, there are a number of talented chemists whoare equally as important in the discovery process. In addition,there has been a reverse brain drain effect in which scientistsare returning from abroad to accept positions at lower salaries11at Indian companies.475.8390381.23380.2358.1340.38Table 1.2: India’s pharmaceutical firms, by size, sales,function, exports, and R&D capabilities320.62270.62263.75260.14Research and development (R & D)Both the Indian central and state governments haverecognized R&D as an important driver in the growth of theirpharma businesses and conferred tax deductions for expensesrelated to research and development. They have grantedother concessions as well, such as reduced interest rates forexport financing and a cut in the number of drugs under pricecontrol. Government support is not the only thing in Indianpharma’s favor, though; companies also have access to ahighly developed IT industry that can partner with them innew molecule discovery in R&D. 9Table 1.3: Growth of pharmaceutical R & D, PPThe role of Indian generic drugs in the U.S. market:The United States is the world’s largest single market forpharmaceutical products accounting for nearly 50 percent ofthe value of the total world market. According to the GenericPharmaceutical Association, U.S. retail drug sales for 2006totaled 221 billion and generic pharmaceutical sales totaled 54.1 billion.61 U.S. pharmaceutical sales grew by 73 percentfrom 128.1 France is next spending 457 per capita 62followed by Japan at 339. Economist Intelligence Unit.“Express Scripts Study Shows Substantial Savings Opportunityfor Consumers, states, Health Care Purchasers with Generics,says GPhA,” Generic Pharmaceutical Association, PressShah V. et al223

JPSBR: Volume 2, Issue 5: Sept Oct 2012 (219-229)PatentsAs it expands its core business, the industry is being forced toadapt its business model to recent changes in the operatingenvironment. The first and most significant change was theJanuary 1, 2005 enactment of an amendment to India’s patentlaw that reinstated product patents for the first time since1972. The legislation took effect on the deadline set by theWTO’s Trade-Related Aspects of Intellectual Property Rights(TRIPS) agreement, which mandated patent protection onboth products and processes for a period of 20 years. Underthis new law, India will be forced to recognize not only newpatents but also any patents filed after January 1, 1995. Indiancompanies achieved their status in the domestic market bybreaking these product patents, and it is estimated that withinthe next few years, they will lose 650 million of the localgenerics market to patent-holders. (Slater et al.)13In the domestic market, this new patent legislation hasresulted in fairly clear segmentation. The multinationalsnarrowed their focus onto high-end patients who make uponly 12% of the market, taking advantage of their newlybestowed patent protection. Meanwhile, Indian firms havechosen to take their existing product portfolios and targetsemi-urban and rural populations.12Product developmentIndian companies are also starting to adapt their productdevelopment processes to the new environment. For years,firms have made their ways into the global market byresearching generic competitors to patented drugs andfollowing up with litigation to challenge the patent. Thisapproach remains untouched by the new patent regime andlooks to increase in the future. However, those that can affordit have set their sights on an even higher goal: new moleculediscovery. Although the initial investment is huge, companiesare lured by the promise of hefty profit margins and thus alegitimate competitor in the global industry. 12Role of GovernmentThe Indian government has been very supportive. Itestablished the Department of Biotechnology in 1986 underthe Ministry of Science and Technology. Since then, there havebeen a number of dispensations offered by both the centralgovernment and various states to encourage the growth of theindustry. India’s science minister launched a program thatprovides tax incentives and grants for biotech start-ups andfirms seeking to expand and establishes the BiotechnologyParks Society of India to support ten biotech parks by 2010.Pharmaceutical industry todayThe number of purely Indian pharma companies is fairly low.Indian pharma industry is mainly operated as well ascontrolled by dominant foreign companies having subsidiariesin India due to availability of cheap labour in India due toavailability of cheap labour in India at lowest cost. In 2002,over 20,000 registered drug manufacturers in India sold 9Shah V. et alISSN NO. 2271-3681billion worth of formulations and bulk drugs. 85% of theseformulations were sold in India while over 60% of the bulkdrugs were exported, mostly to the United States and Russia.Most of the players in the market are small-to-mediumenterprises; 250 of the largest companies control 70% of theIndian market. Thanks to the 1970 Patent Act, multinationalsrepresent only 35% of the market, down from 70% thirty yearsago.Biotechnology StatisticsTable 1.4 Top 20 Biopharmaceutical & Biotechnologycompanies in India, as of 2011RevenueRankCompany2011(Rs crore)1Biocon14832Serum Institute of India10413Panacea Biotec928.41Nuziveedu Seeds Private4610Limited5Reliance Life Sciences4906Quintiles476.257Novo Nordisk4628Rasi Seeds371.889Mahyco364.910Trans Asia35011Ankur Seeds32512Syngene International31813Bharat Biotech International298.3414Indian Immunologicals Limited283Krishidhan Seeds15276.13ChallengesThe biotech sector faces some major challenges in its quest forgrowth. Chief among them is a lack of funding, particularly forfirms that are just starting out. The most likely sources offunds are government grants and venture capital, which is arelatively young industry in India. Government grants aredifficult to secure, and due to the expensive and uncertainnature of biotech research, venture capitalists are reluctant toinvest in firms that have not yet developed a commerciallyviable product. As previously mentioned, India hopes to solveits funding problem by attracting overseas investors andpartners. Before these potential saviors will invest significantsums in the industry, however, there needs to be betterscientific and financial accountability. 13Regulatory environmentTo end the dominance of foreign drug companies, the Indiangovernment enacted a series of policies designed to fosterself-sufficiency in the production of basic drugs. Because thesemeasures lowered barriers to entry, thousands of medium andsmall Indian pharmaceutical companies entered the marketchallenging the MNCs for control. These actions laid thefoundation for today’s highly competitive domestic industrythat is capable of offering some of the lowest drug prices in14the world.224

JPSBR: Volume 2, Issue 5: Sept Oct 2012 (219-229)The Patent Act, 1970The Act’s stated objective was to foster the development of anindigenous Indian pharmaceutical industry and to guaranteethat the Indian public had access to low-cost drugs. The Actreplaced intellectual property rights laws left over from theBritish colonial era and ended India’s recognition of Westernstyle “product” patent protection for pharmaceuticals,agricultural products, and atomic energy. Product-specificpatents were disregarded in favor of manufacturing “process”patents that allowed Indian companies’ to reverse engineer or13copy foreign patented drugs without paying a licensing fee.Drug Price Control Order, 1970 (DPCO)The order was introduced when most of India’s drugs wereunder strict price controls. Since its introduction, the numberof bulk drugs under price controls gradually declined from 347in 1987 to 163 in 1994 to 74 in 1995.8 In 2005, thegovernment capped prices on 74 bulk drugs and 260formulations that account for approximately 25 percent ofIndia’s retail pharmaceutical market (attachment).9 Trademargins for these drugs were capped at 8 percent for retailersand 16 percent for wholesalers. The National PharmaceuticalPricing Authority, founded in 1997, is responsible formonitoring prices using the DPCO to fix ceiling prices on drugsand ensure that no Indian company in a monopoly positiontakes advantages of its monopolistic position by profiteering.In June 2006, the National Pharmaceutical Policy 2006 (Part A)proposed to add price controls on 354 specific drugs listed asessential medicines. 13ISSN NO. 2271-3681Contract research and manufacturing, outsourcing, and otherservices: The passage of the Patents (Amendment) Act 2005has significant implications for both Indian and multinationalcompanies competing in the Indian market. Leading Indiancompanies are moving away from a reliance on the domesticmarket to the development new drugs, exports to regulatedmarkets, and cooperative agreements with MNCs. Facinglagging sales of patented drugs by MNCs in their home

eventually medieval Europe. By the 19th century, many of the drugstores in Europe and North America had eventually developed into larger pharmaceutical companies. Most of today's major pharmaceutical companies were founded in the late 19th and early 20th centuries. Key discoveries of

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