91- 11 - 26589272



Scope

Scope of the GTAEC

    1. Examine scientific, technical, ethical, legal and social issues in the field.
    2. Provide Pre-IND (Investigational New Drug) consultations.
    3. Review all GTP (Gene Therapy Product) clinical trial applications and provide recommendations prior to approval from Central Drugs Standard Control Organization (CDSCO).
    4. Review and update the guidelines and their possible therapeutic applications keeping pace with global scientific developments in the field periodically.
    5. Set-up standards for safety and efficacy, quality control, procedures for GTP and its licensing / approval In co-ordination with the CDSCO and  other existing regulations.
    6. Respond to queries and representations from stakeholders in the community (investigators, industry, R&D Institutions, entrepreneurs, media, patient groups, government agencies etc.).
    7. Address suggestions and feedback received from other government agencies and stakeholders.
    8. Educate and raise awareness amongst the stakeholders.
    9. Compile data related to GTP Clinical trials being done in the country, including international collaborative projects.