Key Takeaways

• Kalam Institute of Health Technology has been approved as a Clinical Research Organisation by the Government of India.
• This approval enhances the integrated healthcare innovation ecosystem at the Andhra Pradesh MedTech Zone.
• Dr. Jitendra Sharma emphasizes that the new services will support product development for drugs and medical devices.

Approval of Clinical Research Organization

Kalam Institute of Health Technology (KIHT), a World Health Organisation Collaborating Centre for Health Innovation located in the Andhra Pradesh MedTech Zone (AMTZ) in Visakhapatnam, has received significant approval from the Government of India to operate as a Clinical Research Organisation (CRO). This designation follows the guidelines set out in the New Drugs and Clinical Trials Rules (NDCTR), 2019.

KIHT specializes in health technology assessment, clinical research, regulatory science, and healthcare innovation. With this new authorization, the institute can now carry out clinical research activities related to drugs and medical devices.

This development is an important step in expanding the integrated healthcare innovation ecosystem at AMTZ. The zone already features a variety of facilities, including medical technology manufacturing, prototyping and testing infrastructure, regulatory support systems, health technology assessment services, and pre-clinical research capabilities. The addition of government-sanctioned clinical research services will offer innovators extensive support across various stages of product development. This includes essential activities such as validation, evidence generation, regulatory approvals, manufacturing, and market adoption.

In a statement regarding this advancement, Dr. Jitendra Sharma, Executive Director of KIHT and Founder CEO of AMTZ, highlighted the approval’s role in fortifying India’s healthcare innovation ecosystem. He noted that the capability to provide clinical research support for both drugs and medical devices will significantly enhance the innovation landscape in India.

Overall, the establishment of KIHT as a CRO represents a pivotal moment for healthcare research and innovation in India, opening new avenues for product development and bolstering regulatory pathways for health technologies.

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