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THE PHARMA REVIEW (JANUARY FEBRUARY 2015)

USFDA Orange Book-A Lead to Indian Drug Regulatory Approval Database Maintenance and Management in The Post GATT Era

Dr. Bayya Subba Rao

Introduction: Understanding USFDA orange book is a network of information relating to drug product availability in US market, patent and market exclusivity status. Furnishing information wrongly by innovators that is being reflected in Orange book led to early entry of generics in US markets through litigations. Indian central drug regulatory authority have to develop database on similar grounds for entry of especially generics in Indian market as WTO scenario reached to twenty years and status of patents granted in India relating pharmaceuticals have crucial role. The current article emphasizes the need of a drug product database that furnish information not only of drug product availability but also the status of exclusivities. 

 

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