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ISSN 2063-5346
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Detailed analysis of Drug Development and the Non-Proprietary Drug Approval Process

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Hindustan Abdul Ahad*, Haranath Chinthaginjala, Aladin Khalaf Alla Elhaj Eltahir, Mallem Venkata Barath Kethandapatti Srinivasa Sainath
» doi: 10.48047/ecb/2023.12.10.010

Abstract

After the original drug's patent period has passed, companies other than the corporation that invented it begin to manufacture and market generic versions of the drug. In the EU and the US, bioequivalence is regarded as the primary requirement for the approval of generic medications. The medications must have the same strength, dose form, and amounts of the same active pharmaceutical component to be considered bioequivalent. Their bioavailability must be comparable at a level where their expected therapeutic effects may be predicted. Two types of rules are present for generic drugs: supply-side and demand-side. Supply-side policies include guidelines for generic drug approval, market access, and pricing. Generic prescribing, substitution, targeting information, academic status, and public awareness campaigns are part of the demand-side policy. The final goal of these two sets of rules is to enhance the accessibility of generic drugs globally, reduce drug prices, and avoid drug scarcity and supply interruption. In particular, the accessibility of cheap generic drugs is essential to boost the financial attitude to drug treatment in relatively poor and middle-income countries. Despite these precautions taken by the government in the aspect of generic drugs, most of the present policies are not executed in the current immature healthcare systems.

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