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The Emergence of India’s Pharmaceutical Industry

The Emergence of India’s Pharmaceutical Industry

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No. 2007-05-A
William GreeneU.S. International Trade CommissionMay 2007The author is with the Office of Economics of the U.S. International TradeCommission. Office of Economics working papers are the result of the ongoingprofessional research of USITC Staff and are solely meant to represent theopinions and professional research of individual authors. These papers are notmeant to represent in any way the views of the U.S. International TradeCommission or any of its individual Commissioners. Working papers arecirculated to promote the active exchange of ideas between USITC Staff andrecognized experts outside the USITC, and to promote professionaldevelopment of Office staff by encouraging outside professional critique of staff research.Address correspondence to:Office of EconomicsU.S. International Trade CommissionWashington, DC 20436 USA
The Emergence of India’s Pharmaceutical Industryand Implications for the U.S. Generic Drug Market
The Emergence of India’s Pharmaceutical Industry andImplications for the U.S. Generic Drug Market
William GreeneU.S. International Trade CommissionABSTRACT:
This paper presents an overview of India’s pharmaceutical industry and itsevolution from almost non-existent to one of the world’s leading suppliers of generic drugs. The Indian pharmaceutical industry was allowed to take off when India met its WTO TRIPs obligations andamended its patent laws with the passage and implementation of the Patents (Amendments) Act 2005.When India re-instituted “product” patents, it effectively ended 36 years of protection for Indiancompanies and terminated legal reverse engineering or copying of patented foreign pharmaceuticalsdrugs. To meet the short fall in revenues, many of India’s leading pharmaceutical companies turned toforeign acquisitions and exports, especially to the United States. Indian companies benefit from agreater acceptance of generic drugs among the U.S. public, tremendous pressure on healthcare providers to reduce costs, and impending expiration of patents on drugs with annual sales of $50 billion. India’s major pharmaceutical companies are positioning themselves to offer generic versions of these drugs and some have predicted that they will capture at least 30 percent of the U.S. genericreplacement market. However, Indian companies face severe price compression in the U.S. for their generic drug market and stiff competition from domestic U.S. generic manufactures and suppliers fromother low-cost countries.
Sources: Department of Chemicals & Petrochemicals, Government of India, MedicineNet.com, U.S. Food and Drug
Administration, KPMG, Pharmabiz.com.
AIDsAcquired Immune Deficiency SyndromeAPIActive pharmaceutical ingredientANDAAbbreviated New Drug ApplicationAssochamAssociated Chambers of Commerce and Industry of IndiaCAGRCompound annual growth rateCIIConfederation of Indian IndustryCISCommonwealth of Independent StatesCNSCentral nervous systemCRAMSContract manufacturing and research servicesDMFsDrug Master FilesDPCODrug Price Control OrdeFDIForeign direct investmentGSKGlaxoSmithKleinHIVHuman immunodeficiency virusHTSHarmonized Tariff ScheduleIPRIntellectual property rightsM&AMergers and acquisitionsMNCMultinational corporation NCENew chemical entities (new patented drug) NDANew drug applicationsOTCOver-the-counter drugs (dispensed without prescription)R&DResearch and developmentTBTuberculosisTRIPsTrade-Related Aspects of Intellectual Property RightsUS FDAUnited States Food and Drug Administration (FDA)UNICEFUnited Nations Childrens FundWTOWorld Trade Organization
Abbreviated New Drug Applications (ANDAs)
: an application submitted to the U.S. Food & Drug Administration by a generic drug manufacturer challenging a patent held by an innovator company. Once approved, an applicantmay manufacture and market the generic drug product of an existing formulation to the American public.
Active pharmaceutical ingredient (APIs):
the primary, active ingredient(s) of a final pharmaceutical product, produced in the first stage of pharmaceutical production and usually in bulk quantities.
medical preparation made from living organisms and their products, such as insulin, erythropoietin, andvaccines.
industry term referring to drugs with very large sales, generally in excess of $1 billion.
Branded generics:
generic drugs for which a drug manufacturing company has attached its brand name and mayhave invested in its marketing to differentiate it from other generic brands.

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