UP’s first MedTech Regulatory Clinic launched at GIMS

The clinic will provide guidance on regulatory approvals, clinical validation, licensing and commercialisation of medical technologies, said officials

GREATER NOIDA: The Government Institute of Medical Sciences (GIMS) has launched a dedicated MedTech Regulatory Clinic, the first of its kind initiative in Uttar Pradesh, in a move aimed at supporting healthcare startups navigating regulatory approvals, officials said.

Greater Noida, India - December 16, 2019: Government Institute of Medical Sciences (GIMS) , in Greater Noida, India, on Monday, December 16, 2019. (Photo by Sunil Ghosh / Hindustan Times) (HT Archive)

Developed in collaboration with the Biotechnology Industry Research Assistance Council (BIRAC) under its Regulatory Affairs and Policy Advocacy (RAPA) division, the clinic will provide guidance on regulatory approvals, clinical validation, licensing and commercialisation of medical technologies, said officials on Tuesday.

The clinic, officials said, has been designed as a single-window support system for startups, clinicians and researchers working on indigenous healthcare technologies. The facility was inaugurated by former Drug Controller General of India Dr G N Singh at the GIMS Centre for Medical Innovation (CMI) last week.

“India is entering a defining era in medical technology and healthcare innovation. However, innovation alone is not enough - startups also need regulatory guidance, clinical validation and policy support to translate ideas into impactful products,” Dr Singh said in a statement.

Chief executive officer, Centre for Medical Innovation at GIMS, Dr Rahul said the initiative aims to bridge the gap between innovation and implementation.

“Our vision is to create a complete ecosystem where startups can access clinical validation, regulatory mentorship and incubation support under one roof,” he said.

The development comes months after GIMS was designated a Biotechnology Industry Research Assistance Council - Regulatory Affairs and Policy Advocacy (BIRAC-RAPA) nodal centre under the Delhi-NCR circuit alongside institutions including AIIMS Delhi, IIT Delhi and the Regional Centre for Biotechnology.