Drug regulatory framework in India and its differences from Food and Drug Administration, United States

Authors

  • Indra Bhadu Department of Clinical Operations, SIARAM Clinical Research P Ltd., Bikaner, Rajasthan, India. Author
  • Shekhar Goyal Department of Clinical Operations, SIARAM Clinical Research P Ltd., Bikaner, Rajasthan, India. Author
  • Akhil Kapoor Department of Radiation Oncology, Acharya Tulsi Regional Cancer Treatment and Research Institute, S.P. Medical College and AG of Hospitals, Bikaner, Rajasthan, India. Author
  • Surender Beniwal Department of Medical Oncology, Acharya Tulsi Regional Cancer Treatment and Research Institute, S.P. Medical College and AG of Hospitals, Bikaner, Rajasthan, India. Author

DOI:

https://doi.org/10.5530/vnyxkm61

Keywords:

Drug regulatory framework, US-FDA, Indian regulatory board

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.

 

 

 

Author Biographies

  • Indra Bhadu, Department of Clinical Operations, SIARAM Clinical Research P Ltd., Bikaner, Rajasthan, India.

     

     
  • Shekhar Goyal, Department of Clinical Operations, SIARAM Clinical Research P Ltd., Bikaner, Rajasthan, India.

     

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

     

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

     

     

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Published

2014-12-30

Issue

Vol. 4 No. 4 (2014)

Section

Articles

How to Cite

Drug regulatory framework in India and its differences from Food and Drug Administration, United States. (2014). Asian Journal of Pharmaceutical and Health Sciences, 4(4), 1162-1166. https://doi.org/10.5530/vnyxkm61