Archive · 7 Dec 2025
India Launches Toolkit for Diagnostics Startups
India is creating a special guide called the MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook to help local companies and research labs make and sell their diagnostic tools more easily.
Right now, India buys most of its medical devices from other countries, which is expensive and slow.
This new guide will help Indian companies follow the rules better and get their products to hospitals faster.
It will also make diagnostic tests cheaper, which is good for patients.
The guide breaks down the complicated rules into simpler steps, making it easier for new companies to bring their ideas to market.
Experts say this will help India make its own high-quality diagnostic tools and reduce the need for expensive imports.
India is launching a toolkit to help diagnostics startups commercialize their products faster.
The toolkit, MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook, is jointly prepared by ICMR, CDSCO, and NITI Aayog.
It simplifies the regulatory approval process into three stages: prototyping, clinical trials, and market licensing.
The move aims to reduce India's reliance on imported diagnostic technology, which currently stands at 80–85% by value.
The handbook is expected to reduce the final product cost by 30% to 50%, making diagnostic solutions more affordable.
- Who
- Indian government, ICMR, CDSCO, NITI Aayog, diagnostics startups, and research labs
- What
- Launch of MedTech Mitra’s In-Vitro Diagnostic Innovators Handbook to streamline commercialization of diagnostic products
- When
- Upcoming, with companies already informed
- Where
- India
- Why
- To reduce reliance on imported diagnostic technology, boost local industry, and make diagnostic solutions more affordable and accessible
- Import Dependence
- 80–85% of medical devices by value
- Import Bill FY24
- ₹68,885 crore (13% increase)
- IVD Reagents Import
- ₹6,477 crore (7% increase)
- Cost Reduction
- 30% to 50% for final products