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 Order FDIForeign 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 Children’s 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.
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.