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Article Vol. 3 No. 5 (2020) PP. 1307 - 1330

Issues Challenges of Patentability of Generic Drugs in India

Lead author · Corresponding
Sayani Chandra
LLM student, KIIT Law School (Deemed to be University), India
Co-author
Ritwika Mazumdar
LLM student, KIIT Law School (Deemed to be University), India
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Abstract

Generic drugs are the same as those already approved in the dosage type, safety, strength, path, consistency and performance characteristics of an already approved brand name medication. Only after a thorough review by FDA and after a certain period of time the generic drugs be available, the brand name version is exclusively on the market. This is because new drugs are generally protected by patents, like all new goods and the emerging pharmaceutical R&D scenario in India has several constraints in the context of global models and approaches for new drugs from concept to market. India should give a thought on the growth and of the pharmaceutical market and on how to balance the cost of innovation in drug research and universal access to the fruits of this research.

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Article
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International Journal of Law Management and Humanities, Volume 3, Issue 5, Page 1307 - 1330
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CC BY-NC 4.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution–NonCommercial 4.0 International (CC BY-NC 4.0) (https://creativecommons.org/licenses/by-nc/4.0/), which permits remixing, adapting, and building upon the work for non-commercial use, provided the original work is properly cited.
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Copyright © IJLMH 2026
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The views and opinions expressed in this manuscript are those of the author(s) alone and do not reflect the views, policies, or position of the Journal.

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