Perspectives in Clinical Research

REVIEW ARTICLE
Year
: 2021  |  Volume : 12  |  Issue : 3  |  Page : 118--125

National guidelines for gene therapy product (2019): A road-map to gene therapy products development and clinical trials


Kiruthika Sivagourounadin1, Mirunalini Ravichandran2, Priyadharsini Rajendran2 
1 Department of Pharmacology, Sri Manakula Vinayagar Medical College and Hospital, Puducherry, India
2 Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India

Correspondence Address:
Dr. Kiruthika Sivagourounadin
Department of Pharmacology, Sri Manakula Vinayagar Medical College and Hospital, Puducherry - 605 107
India

The “National Guidelines for Gene Therapy Product (GTP) Development and Clinical Trials” prepared by the Indian Council of Medical Research and Department of Biotechnology in 2019 came as a welcome step in the process of regulation of gene therapy research, as there was a lack of Indian guidelines earlier specific to gene therapy. Indian researchers have taken their step in setting the path of gene therapy research, and this guideline serves to provide the standards starting from its development up to translation to new drug including the ethical, scientific, and regulatory requirements to be followed during the conduct of trial. The Indian guidelines were framed with reference to United States-Food and Drug Administration and European Union guidelines on gene therapy. It is the responsibility of all the stakeholders involved in the development of GTP to adhere to the national guidelines. This review provides an outline of the Indian regulatory guidelines on GTP.


How to cite this article:
Sivagourounadin K, Ravichandran M, Rajendran P. National guidelines for gene therapy product (2019): A road-map to gene therapy products development and clinical trials.Perspect Clin Res 2021;12:118-125


How to cite this URL:
Sivagourounadin K, Ravichandran M, Rajendran P. National guidelines for gene therapy product (2019): A road-map to gene therapy products development and clinical trials. Perspect Clin Res [serial online] 2021 [cited 2021 Jul 24 ];12:118-125
Available from: https://www.picronline.org/article.asp?issn=2229-3485;year=2021;volume=12;issue=3;spage=118;epage=125;aulast=Sivagourounadin;type=0