Regulatory Concerns in Imports, Exports and Registration of Drugs and Dietary Supplements

Abstract

The main aim of this article was to study the various pharmaceutical products registration processes, regulations 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 dietary supplements and to evaluate the available guidelines and map the general requirements for registration.

Keywords: regulatory approvals, import, export, registration

Cite this Article

Dhar MJD, Puranik SB, Mithun EG. Regulatory Concerns in Imports, Exports and Registration of Drugs and Dietary Supplements. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(1): 13–22p