Audio Interview

Management of generic drug development: challenges and opportunities

Published on October 6, 2022   31 min

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Interviewer: Today I'm interviewing Sandeep Patil. An experienced hands-on project manager, and author of, "Generic Drug Development Project Management" published by Notion Press in 2021. The production of generic drugs is a big industry in India. I'm seeking an Indian perspective on the regular day-to-day issues that determine the success or otherwise of this activity. Mr. Patil, thank you for sparing the time for this interview. To provide context, I would first like to ask both from a business and scientific standpoint, what do you see as the current major opportunities and challenges in the production and sale of generics? Mr. Patil: First of all, thank you for inviting me. Before I answer your question, let us first get introduced to generic drugs and their types. Generic drugs well, in simple words, we can say that generic drugs are copies of branded drugs. It has the same dosage, safety, effectiveness, trends, stability, quality, and the way it is administered. Generic drugs can be further classified as authorized generics, company-branded generics, and non-branded generics. Authorized generics are created by the manufacturer of innovative products under the same NDA license as the original branded drugs. These drugs are sold before the drug patent is expired. Company-branded generics on the other hand use propriety names to the generic drug molecules.

Management of generic drug development: challenges and opportunities

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