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Regulatory Requirements for Registration of Biosimilar Products and Imports in India: A Recent Scenario

Jinish Dhar M, S. B. Puranik

Abstract


The main aim of this article is to study the various biosimilar products registration processes, regulations in imports and requirements by the Indian Regulatory Authorities. The study emphasizes on the challenges faced by stakeholders entering into the Indian market without difficulty by demonstration of strategy arrived from the established guidelines, regulations and expert opinion. The study was undertaken to identify the challenges in biosimilar developments and to evaluate the available guidelines and map the general requirements for registration.

 

Keywords: Biosimilar, import, export, registration

 

Jinish Dhar M, S.B. Puranik. Regulatory Requirements for Registration of Biosimilar Products and Imports in India: A Recent. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(2): 32–39p.


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