Switch Movement: Overview of Various Key Attributes on Regulatory Scenario of OTC Legislations in U.S.

Authors

  • Gaurav Agnihotri
  • Deepak Pandurang Belsare

DOI:

https://doi.org/10.37591/rrjodfdp.v4i2.49

Abstract

The Rx-to-OTC switch was a phenomenal success in USA, which was based on risk/benefit ratio of all scientific evidences in collaboration with FDA, manufacturer and consumers. Different surveys speak about the success stories of Rx-to-OTC movement as consumers experience the benefit from self-care in terms of empowerment, convenience, savings of money and time, etc. OTC perspective of scientific and regulatory bodies is based upon a valid procedure and just not goes on the benefits of manufacturers. Before switching any of the drug or molecule or ingredient, specific target population is looked out and followed by easily recognizable conditions, symptoms and evaluating the actual need of identified switch. There are various regulatory angles to OTC legislations, and this article have focused on few key of them such as safety, efficacy, clinical trial requirements, manner of labeling to be, and available regulatory pathways.

 

Keywords: Switch, over-the-counter, safety, efficacy, labeling, regulations

 

Gaurav Agnihotri, Deepak Pandurang Belsare. Switch Movement: Overview of Various Key Attributes on Regulatory Scenario of OTC Legislations in U.S. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2017; 4(2): 24–31p.

Downloads

Published

2018-01-19

Issue

Vol. 4 No. 2 (2017)

Section

Review Article

License

Declaration and Copyright Transfer Form

(to be completed by authors)

I/ We, the undersigned author(s) of the submitted manuscript, hereby declare, that the above manuscript which is submitted for publication in the STM Journals(s), is not published already in part or whole (except in the form of abstract) in any journal or magazine for private or public circulation, and, is not under consideration of publication elsewhere.

  • I/We will not withdraw the manuscript after 1 week of submission as I have read the Author Guidelines and will adhere to the guidelines.
  • I/We Author(s ) have niether given nor will give this manuscript elsewhere for publishing after submitting in STM Journal(s).
  • I/ We have read the original version of the manuscript and am/ are responsible for the thought contents embodied in it. The work dealt in the manuscript is my/ our own, and my/ our individual contribution to this work is significant enough to qualify for authorship.
  •  I/We also agree to the authorship of the article in the following order:

Author’s name                                    

 

1. ________________

2. ________________

3. ________________

4. ________________

 

We  Author(s) tick this box and would request you to consider it as our signature as we agree to the terms of this Copyright Notice, which will apply to this submission if and when it is published by this journal.