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The Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, has launched online portal of Gene Therapy Advisory and Evaluation Committee (GTAEC) aiming to streamline submission of clinical trial applications and pre-IND consultations pertaining to gene therapy research in the country.
The 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, Union ministry of health and family welfare to oversee the activities in the field of gene therapy research in India.
The GTAEC provides a hand holding for the investigators/ industry. It examines scientific, technical, ethical, legal and social issues in the field and provides Pre-IND (Investigational New Drug) consultations.
It reviews all gene therapy product clinical trial applications and provides recommendations prior to approval from Central Drugs Standard Control Organization (CDSCO).
The GTAEC also reviews and updates the guidelines and their possible therapeutic applications keeping pace with global scientific developments in the field periodically.
It sets up standards for safety and efficacy, quality control, procedures for gene therapy product and its licensing / approval in co-ordination with the CDSCO and other existing regulations.
The GTAEC responds to queries and representations from stakeholders in the community including investigators, industry, R&D institutions, entrepreneurs, media, patient groups, government agencies etc.
It addresses suggestions and feedback received from other government agencies and stakeholders and raises awareness amongst the stakeholders.
It also compiles data related to gene therapy product clinical trials being done in the country, including international collaborative projects.
National guidelines for gene therapy product development and clinical trials have been issued by ICMR. 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.
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