Error message

Deprecated function: The each() function is deprecated. This message will be suppressed on further calls in theme_biblio_custom() (line 367 of /home/ajphs/public_html/sites/all/modules/biblio/includes/biblio_theme.inc).

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 Kapoor2,*, 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.

Comparison between Regulatory frame work of India and USA