Last Updated on January 14, 2024 by The Health Master
The Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, has launched an 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 periodically, keeping pace with global scientific developments in the field.
It sets up standards for safety and efficacy, quality control, procedures for gene therapy products 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 the cornerstones 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.
Pharmacist के बिना बिजनेस शुरू करने का मौका, 12वीं पास बेच सकेंगे Medical Devices
Imp: 15 things not to do when using a Rapid Antigen Covid Test
Licenses of two Pharma Companies suspended: NDPS Act
WHO adds this drug to Covid medicines list for severe cases
Govt issues notification on stockpiling of new drug under phase III Clinical trial
Drug alert: 27 out of 1227 samples declared as NSQ in January 2022
Gap in Price of Branded and Janaushadhi Medicine
DTAB recommendations to DCGI granting licenses under Clinical Trial
Govt issues draft notification on amendment on sale of Medical Devices
Latest Notifications regarding Pharmaceuticals
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
