VISAKHAPATNAM: The Kalam Institute of Health Technology (KIHT), a World Health Organisation (WHO) Collaborating Centre for Health Innovation based at the Andhra Pradesh MedTech Zone (AMTZ) in Visakhapatnam, has received approval from the Government of India to function as a Clinical Research Organisation (CRO) under the New Drugs and Clinical Trials Rules (NDCTR), 2019.
KIHTprimarily focuses on health technology assessment, clinical research, regulatory science, and healthcare innovation. With this newly granted central approval, the institute is now fully authorized to undertake extensive clinical research activities for both drugs and medical devices.
This development substantially expands the integrated healthcare innovation ecosystem at AMTZ, which already houses medical technology manufacturing facilities, prototyping and testing infrastructure, regulatory support systems, health technology assessment services, and pre-clinical research capabilities.
Officials stated that the inclusion of government-approved clinical research services will offer innovators comprehensive support across multiple stages of product development encompassing validation, evidence generation, regulatory approvals, manufacturing, and eventual market adoption.