The Kalam Institute of Health Technology (KIHT) has received government recognition to function as a Clinical Research Organisation (CRO), marking a significant milestone in India's efforts to strengthen clinical research, healthcare innovation, and evidence-based decision-making.

The approval enables KIHT, a Department of Biotechnology supported institute, to undertake and support clinical research activities across both pharmaceuticals and medical devices, creating an integrated platform for evidence generation, clinical validation, and healthcare technology assessment. 

The recognition is expected to enhance the institute's ability to bridge the gap between innovation, regulation, and patient access while supporting India's ambition to emerge as a global hub for clinical research and healthcare innovation.

As a WHO Collaborating Centre for Health Innovation, KIHT has played a key role in advancing health technology assessment, policy research, innovation management, and medical technology evaluation. 

With its CRO recognition, the institute can now expand its mandate to include clinical investigations, clinical performance studies, real-world evidence generation, and other research activities that support product development, regulatory approvals, and healthcare policy decisions.

The development is particularly significant at a time when India is witnessing rapid growth in indigenous innovation across pharmaceuticals, medical devices, diagnostics, digital health technologies, and biotechnology. The availability of a dedicated research platform capable of generating high-quality clinical evidence is expected to support innovators, healthcare institutions, startups, industry partners, and policymakers alike.

Dr. Jitendra Sharma, Executive Director, KIHT, and Managing Director & Founder CEO of AMTZ, believes 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. The recognition will further strengthen India's capacity to generate credible scientific evidence while accelerating the translation of healthcare innovations into solutions that benefit patients and healthcare systems.”

Dr. Kavita Kachroo, Chief Operating Officer, KIHT, said, "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 noted that the integrated ecosystem created through KIHT and AMTZ provides innovators with a comprehensive pathway to advance healthcare technologies from laboratory concepts to real-world implementation, while ensuring scientific rigor, regulatory compliance, and patient-centric outcomes.

The approval is expected to facilitate greater collaboration between industry, academia, healthcare providers, and government agencies while strengthening India's clinical research infrastructure. 

By combining clinical research capabilities with expertise in health technology assessment, policy advisory services, and innovation support, KIHT aims to contribute to the development of affordable, scalable, and impactful healthcare solutions for India and other emerging markets.

The recognition also reinforces India's growing focus on building a robust ecosystem for clinical research, medical technology innovation, and evidence-based healthcare, supporting the country's vision of becoming a leading global destination for research, development, and healthcare innovation.