1K.B. Institute of Pharmaceutical Education and Research, Kadi Sarva Vishwa Vidyalaya, Gandhinagar, Gujarat
2HOD of Pharmacognosy & Regulatory Affairs, K.B. Institute of Pharmaceutical Education and Research, Kadi Sarva Vishwa Vidyalaya, Gandhinagar, Gujarat
3US Head - Regulatory Affairs, Neoplus Translation and Neocubes Pharma
4Associate Professor, Department of Regulatory Affairs, K.B. Institute of Pharmaceutical Education and Research, Kadi Sarva Vishwa Vidyalaya, Gandhinagar, Gujarat
The Over-the-Counter (OTC) Drug Monograph System in the United States (US) serves as a vital regulatory framework for non-prescription medications. Through the monograph review process there is a low regulatory burden for industry to market OTC drugs and that helps to keep OTC drug costs low to consumers. As, this process is applicable only in the US the OTC drug filing and review process becomes streamline and due to its limited time exposure this process is not time consuming.
There are mainly two pathways to bring a OTC drug in the US: (a) NDA, (b) OTC drug review process. By comparing both the procedures NDA submission is time consuming process and as of that for OTC review process, if drugs meet the conditions specified in the monograph OTC drug can be marketed in a more streamline process. Administrative order process provides sponsor or requestors and the FDA to issue an order. As, the three phase rulemaking process is removed after the enactment of CARES act, the OTC monograph reform encountered several challenges and is beneficial. OTC Monograph System, serves as a cornerstone for ensuring the accessibility, safety, and efficacy of a diverse range of OTC drugs.
The proposed study is based on review process for various OTC monograph drugs. This research is focused on the regulatory pathway that facilitates the approval of non-prescription medications, the study explores the historical evolution and current functioning of the OTC Monograph System.
Over the counter (OTC) drug review process, OTC Monograph Order Request (OMOR), Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER)
