The Gene Therapy Advisory and Evaluation Committee (GTAEC) is an independent body of experts representing diverse areas of biomedical research, concerned government agencies and other stakeholders constituted and notified by the Department of Health Research, Ministry of Health and Family Welfare, Govt. of India to oversee the activities in the field of gene therapy research in India. The GTAEC shall provide a hand holding for the investigators/ industry and also give pre-Investigational New Drug (IND) consultations.
These guidelines have been issued by ICMR and released with co-affiliation of DHR, DBT and CDSCO. The aim of this document is to clearly outline the ethical and scientific requirements for gene therapy trials, keeping in mind patient safety, efficacy and clinical rigor as cornerstone of this initiative. It intends to provide the basis of an enabling environment and guide scientifically sound practice that is ethical and beneficial to the patient. The document will be periodically updated on basis of scientific development in the field. These guidelines are not meant to be construed to replace or overrule other regulatory requirements. To all those who refer this document, we implore that you to pay attention to details and work in compliance of these guidelines and we wish you the greatest success in your endeavors.