The Kalam Institute of Health Technology (KIHT), a WHO
Collaborating Centre for Health Innovation based at Andhra Pradesh MedTech Zone (AMTZ),
Visakhapatnam, is a healthcare technology institute focused on health technology assessment,
clinical research, regulatory science, and healthcare innovation, 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 milestone further strengthens AMTZ’s integrated healthcare innovation ecosystem, which
combines medical technology manufacturing, prototyping and testing facilities, regulatory
support, health technology assessment, large animal pre clinical research capabilities, and now
Government approved clinical research services. Together, these capabilities provide innovators
with a seamless pathway from product development and evidence generation to regulatory
approval, manufacturing, and market adoption, and policy translation, making AMTZ one of the
most comprehensive healthcare technology ecosystems in the country.

Speaking on the occasion, Dr. Jitendra Sharma, Executive Director, KIHT, MD & Founder,
CEO of AMTZ said, “This approval marks a significant milestone in strengthening India’s
healthcare innovation ecosystem. By enabling clinical research for both drugs and medical
devices, KIHT will help bridge the gap between innovation and patient access. “

“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.” says
Dr. Kavita Kachroo, COO- KIHT.

KIHT remains committed to advancing patient centric and ethically conducted clinical research
aligned with international standards. Through national and international collaborations, the
institute supports the development, evaluation, and adoption of healthcare technologies that
strengthen health systems, improve patient outcomes, and accelerate innovation in the healthcare
sector.