Drug Rgulatory Framework in India and its Differences from Food and Drug Administration, United States

Indra Bhadu; Shekhar Goyal; Akhil Kapoor; Surender Beniwal

Drug Rgulatory Framework in India and its Differences from Food and Drug Administration, United States

Asian Journal of Pharmaceutical and Health Sciences,2014,4,4,1162-1166.

Published:November 2014

Type:Review Article

Authors:

Author(s) affiliations:

Indra Bhadu¹, Shekhar Goyal¹, Akhil Kapoor^2,*, Surender Beniwal³

¹Department of Clinical Operations, SIARAM Clinical Research P Ltd., Bikaner, Rajasthan, India.

²Department of Radiation Oncology, Acharya Tulsi Regional Cancer Treatment and Research Institute, S.P. Medical College and AG of Hospitals, Bikaner, Rajasthan, India.

³Department of Medical Oncology, Acharya Tulsi Regional Cancer Treatment and Research Institute, S.P. Medical College and AG of Hospitals, Bikaner, Rajasthan, India.

Abstract:

Presently the Indian industry is gripped with rising allegations of unethical trials and time-consuming regulatory approvals. Governing intellectual property protection regulatory processes are currently being updated to harmonize with United States and international standards, and plans are afoot to create a regulatory body in line with FDA, a central authority governing all drug development related activities. This article reviews the differences and similarities between present Indian regulatory board and the internationally acclaimed agency of Food and Drug Administration, United States.

Keywords:Drug regulatory framework, Indian regulatory board, US-FDA