Home  |  About us  |  Editorial board  |  Ahead of print  | Current issue  |  Archives  |  Submit article  |  Instructions |  Search  |   Subscribe  |  Advertise  |  Contacts  |  Login 
  Users Online: 1898Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
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


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
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/picr.PICR_189_20

Rights and Permissions

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.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed1131    
    Printed38    
    Emailed0    
    PDF Downloaded112    
    Comments [Add]    

Recommend this journal