The Kalam Institute of Health Technology (KIHT), a WHO Collaborating Centre for Health Innovation located at the Andhra Pradesh MedTech Zone (AMTZ) in Visakhapatnam, has received official approval from the Government of India to operate as a Clinical Research Organization (CRO) under the New Drugs and Clinical Trials Rules (NDCTR), 2019.This development marks a significant expansion for the institute, which focuses on health technology assessment, clinical research, regulatory science, and healthcare innovation.The new certification bolsters the integrated innovation ecosystem at AMTZ, which already encompasses medical technology manufacturing, prototyping, testing facilities, and large animal pre-clinical research capabilities.By integrating these services, AMTZ aims to provide innovators with a seamless pathway from initial product development and evidence generation to regulatory approval, manufacturing, market adoption, and policy translation.Dr. Jitendra Sharma, Executive Director of KIHT and founder-CEO of AMTZ, noted that the approval serves as a crucial milestone in strengthening the nation’s healthcare innovation framework“By enabling clinical research for both drugs and medical devices, KIHT will help bridge the gap between innovation and patient access,” Dr. Sharma said.Echoing these sentiments, Dr. Kavita Kachroo, COO of KIHT, emphasised on the institute’s end-to-end support capabilities.“Together with the unique infrastructure available at AMTZ, we can now support innovators through every stage of the product journey—from concept and validation to clinical evidence generation, regulatory approval, manufacturing, market adoption, and policy translation,” she stated. Published - May 28, 2026 06:28 pm IST
KIHT gets nod to operate as Clinical Research Organisation
KIHT receives government approval to operate as a Clinical Research Organisation, enhancing India's healthcare innovation ecosystem.










