The Assistance to Medical Device Clusters for Common Facilities Scheme (AMD-CF) was recently launched alongside the National Medical Devices Policy, 2023, marking a significant step towards achieving self-reliance in the manufacturing of medical devices in India.
Purpose and Tenure
The scheme aims to strengthen the medical device manufacturing ecosystem by promoting self-reliance and enhancing the infrastructure needed to manufacture quality medical devices. The tenure of the scheme is from 2023-24 to 2026-27.
Key Objectives
- To support the development of medical device clusters by providing financial assistance for common facilities.
- To establish and strengthen testing laboratories for medical devices to ensure high standards in production.
Salient Features of AMD-CF Scheme
1. Assistance for Common Facilities
This component focuses on the creation of common infrastructure facilities for medical device clusters.
- Incentives:
- Financial support of up to 70% of the approved project cost or ₹20 crores, whichever is less.
- For clusters in Himalayan and North East Region States, support extends to 90% of the project cost or ₹20 crores, whichever is less.
- Execution through SPV:
- A Special Purpose Vehicle (SPV) formed by at least five medical device manufacturing units within a cluster will execute the project.
- SPVs must ensure that individual manufacturing units do not hold more than 40% equity, while medical device enterprises collectively hold at least 51% equity.
- State Governments can also promote clusters under this scheme.
2. Assistance for Testing Facilities
This component is designed to enhance the availability and accessibility of medical device testing laboratories.
- Incentives:
- Financial support of up to 70% of the approved project cost or ₹5 crores, whichever is less.
- For Himalayan and North East Region States, the grant-in-aid increases to 90% of the project cost or ₹5 crores, whichever is less.
- Eligibility:
- National or state-level government or private institutions aiming to establish or strengthen facilities for testing Class A, B, C, and D medical devices, including in-vitro diagnostic devices as per the Medical Device Rules, 2017.
Project Management
The scheme is managed by the Small Industries Development Bank of India (SIDBI), which acts as the Project Management Agency.
National Medical Devices Policy, 2023
Vision
The National Medical Devices Policy, 2023, seeks to place India on an accelerated growth path, aiming to transform the country into a global leader in medical device manufacturing and innovation.
- Target: To grow the Indian medical device sector from the current $11 billion to $50 billion by 2030.
- Objective: Achieve a 10-12% share in the expanding global market over the next 25 years.
Strategic Pillars
- Regulatory Streamlining: Simplify the regulatory processes to encourage innovation and compliance.
- Infrastructure Development: Establish world-class infrastructure to support the sector.
- Facilitating R&D and Innovation: Encourage advancements in medical device technologies.
- Attracting Investments: Promote India as a hub for medical device manufacturing.
- Human Resources Development: Build skilled manpower tailored to the sector’s needs.
- Brand Positioning and Awareness Creation: Highlight India’s strengths in the global medical device market.
Significance of AMD-CF and National Medical Devices Policy
Together, these initiatives align with India’s vision under Atmanirbhar Bharat to achieve self-reliance in medical device manufacturing. By fostering innovation, attracting investment, and ensuring quality through robust testing facilities, the schemes aim to position India as a global leader in the medical devices sector, meeting both domestic and international demands.