Gene Therapy is one of the exciting avenues in the field of biological therapeutics. Globally, a very few gene therapy products have been approved. The Gene Therapy Products need systematic evaluation for its safety and efficacy in view of the underline ethical and scientific concerns. The scientists and industry involved in the field seek advice and directions regarding regulatory requirements for preclinical studies and clinical translation.

 

Taking cognisance of this gap, ICMR proactively initiated the process of drafting the National Guidelines for Gene Therapy Product Development and Clinical Trials in consultation with the experts in the field and government agencies including DBT and CDSCO.

 

The draft document is being placed in public domain for comments/suggestions from the concerned stakeholders (scientists, academics, industries working in the field). You are requested to send your inputs in following format before 1 st August 2019 to the undersigned through email/post: Name Affiliation Email/ contact details Postal address Comments/suggestions

 

Contact details: Dr. Geeta Jotwani Scientist ‘F’ Division of Basic Medical Sciences Indian Council of Medical Research Ansari Nagar –New Delhi- 110029.

Email: NGGTPDCT2019@gmail.com

The draft document is being placed in public domain for comments/suggestions from the concerned stakeholders (scientists, academics, industries working in the field).