The Kalam Institute of Health Technology (KIHT), a WHO Collaborating Centre for Health Innovation based at Andhra Pradesh MedTech Zone (AMTZ), has received approval from the Government of India to operate as a Clinical Research Organization (CRO) under the New Drugs and Clinical Trials Rules (NDCTR), 2019. The approval marks a significant step in strengthening India’s healthcare innovation and clinical research capabilities while further enhancing the integrated ecosystem established at AMTZ in Visakhapatnam.
KIHT is a healthcare technology institution focused on health technology assessment, clinical research, regulatory science, and healthcare innovation. With the latest authorization, the institute is now positioned to offer end-to-end clinical research support for drugs, medical devices, and healthcare technologies.
The recognition adds another critical capability to the AMTZ ecosystem, which already includes medical technology manufacturing, advanced prototyping and testing facilities, regulatory support services, health technology assessment, and large-animal pre-clinical research infrastructure. Together, these integrated services provide innovators, startups, researchers, and healthcare companies with a seamless pathway from concept development and product validation to clinical evidence generation, regulatory approval, manufacturing, commercialization, and policy adoption.
Speaking on the occasion, Dr Jitendra Sharma, Executive Director of KIHT and Managing Director & Founder CEO of AMTZ, said, “This approval marks an important 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.”
He further added that the integrated infrastructure available at AMTZ allows innovators to navigate every stage of the healthcare product journey under one ecosystem, significantly accelerating development timelines and improving accessibility to advanced healthcare solutions.
Dr Kavita Kachroo, Chief Operating Officer of KIHT, said, “With this approval, KIHT can now support innovators through every stage of product development — from concept validation and clinical evidence generation to regulatory approval, manufacturing, market adoption, and policy translation.”
KIHT reaffirmed its commitment to advancing patient-centric and ethically conducted clinical research aligned with global quality standards. Through collaborations with national and international organizations, the institute aims to support the development, evaluation, and adoption of healthcare technologies that strengthen health systems and improve patient outcomes.
The development further reinforces AMTZ’s position as one of India’s most comprehensive healthcare technology ecosystems dedicated to accelerating innovation, supporting indigenous healthcare solutions, and enabling global-quality medical technology development from India.
