VISAKHAPATNAM: Kalam Institute of Health Technology (KIHT), a World Health Organisation 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.
KIHT focuses on health technology assessment, clinical research, regulatory science, and healthcare innovation. With the latest approval, the institute will now be authorised to undertake clinical research activities for drugs and medical devices.
The development further expands the integrated healthcare innovation ecosystem at AMTZ, which already includes medical technology manufacturing facilities, prototyping and testing infrastructure, regulatory support systems, health technology assessment services, and pre-clinical research capabilities. Officials said the addition of government-approved clinical research services would provide innovators with support across multiple stages of product development, including validation, evidence generation, regulatory approvals, manufacturing, and market adoption.
Speaking on the occasion, Dr Jitendra Sharma, Executive Director of KIHT and Founder CEO of AMTZ, said the approval would strengthen India’s healthcare innovation ecosystem by enabling clinical research support for both drugs and medical devices.
He stated that the infrastructure available at AMTZ would help innovators through different stages of product development, from concept and validation to clinical evidence generation, regulatory approval, manufacturing, market adoption, and policy translation.
Dr Kavita Kachroo, Chief Operating Officer of KIHT, noted that the approval would help bridge the gap between innovation and patient access while supporting healthcare technology developers in generating clinical evidence in line with regulatory requirements. He further mentioned that KIHT would continue to focus on patient-centric and ethically conducted clinical research aligned with international standards.
The CEO added that it would work through national and international collaborations to support the development, evaluation, and adoption of healthcare technologies aimed at strengthening health systems and improving patient outcomes.