By Dr. Asawari Savant, Elets News Network (ENN)  

India’s healthcare sector is poised for a transformative leap, courtesy of the Department of Pharmaceuticals’ (DoP) recently unveiled Strengthening of Medical Device Industry (SMDI) scheme. This ambitious initiative is set to redefine India’s position in the global medical device market by fostering domestic innovation, reducing import dependence, and enhancing manufacturing capabilities. Backed by a robust financial outlay of ₹500 crore over FY 2024-25 to FY 2026-27, the scheme aligns with the government’s vision of making India self-reliant in critical healthcare technologies.

Here’s what the healthcare industry needs to know about the SMDI scheme and its potential impact on the future of Indian healthcare.

A Holistic Approach to Industry Development

The SMDI scheme builds on prior efforts, merging the Assistance to Medical Device Clusters for Common Facilities and Human Resource Development in the Medical Device Sector schemes into a comprehensive framework. With India currently importing 70% of its medical devices, this initiative aims to reverse the trend by addressing critical gaps in manufacturing, infrastructure, and skills development.

Key Objectives of the Scheme:

• Boost domestic manufacturing of key medical device components, raw materials, and accessories.
• Establish common and testing facilities to enhance manufacturing quality.
• Bridge the educational and skill gap through specialized training programs.
• Support clinical studies to improve the safety, efficacy, and marketability of medical devices.

Breaking Down the Sub-Schemes

The SMDI scheme has been divided into focused sub-schemes, each designed to address specific challenges within the medical devices value chain:

1. Marginal Investment Support for Reducing Import Dependence

This sub-scheme incentivizes the production of critical components, aiming to support 30 manufacturing facilities during the scheme period.

• Financial Outlay: ₹180 crore
• Grants: Up to ₹10 crore per project, depending on company turnover.

2. Common Facilities for Medical Device Clusters

Focusing on shared infrastructure, this sub-scheme seeks to establish 5-10 common facilities and 4-8 testing labs to ensure the availability of high-quality products.

• Financial Outlay: ₹110 crore
• Grants: Up to ₹20 crore for equipment purchase and ₹5 crore for testing labs.

3. Capacity Building and Skill Development

By supporting postgraduate courses and vocational training programs, this initiative aims to create a pipeline of skilled professionals ready to meet industry demands.

• Financial Outlay: ₹21 crore
• Target: 4-8 postgraduate institutions and 7-15 skill development institutes.

4. Medical Device Clinical Studies Support

This component emphasizes clinical research to bolster global confidence in Indian medical devices.

• Financial Outlay: ₹100 crore
• Goal: Support 30-60 projects, including preclinical and post-market studies.

5. Medical Device Promotion Activities

Aimed at increasing industry awareness, this sub-scheme will fund workshops, databases, and promotional activities to enhance knowledge sharing.

Implications for Healthcare Industry Leaders

The SMDI scheme is not just a policy initiative; it’s a strategic enabler for India’s healthcare ecosystem. Industry leaders should consider the following implications:

1. Opportunities for Investment and Collaboration
   The scheme’s focus on incentivizing manufacturing and clinical studies opens avenues for domestic and global collaborations. Companies can leverage these grants to expand operations, invest in R&D, and strengthen their market position.
2. Strengthened Ecosystem for Innovation
   By addressing gaps in infrastructure and skills, the SMDI scheme fosters a conducive environment for innovation. Common facilities and testing labs will enable startups and SMEs to scale faster while adhering to global standards.
3. Reduced Import Dependence
   With financial support targeted at critical components and accessories, the industry is poised to reduce its reliance on imports, making India a cost-effective alternative in the global supply chain.
4. Workforce Development
   The emphasis on education and skill-building will bridge the talent gap, ensuring the availability of a trained workforce capable of addressing emerging healthcare challenges.
5. Enhanced Product Safety and Efficacy
   Clinical studies support will not only improve product validation but also enhance India’s reputation as a hub for high-quality medical devices, opening doors to international markets.

Also Read :- Aligning with ‘One Nation One Standard’, NABH Inculcates FOGSI’s Manyata Standards into Programs

Driving Self-Reliance and Global Competitiveness

Union Minister for Chemicals and Fertilizers, Shri JP Nadda, hailed the SMDI scheme as a gamechanger for the industry. Beyond its immediate impact, the scheme lays a foundation for long-term growth in India’s medical device sector, aligning with the government’s broader agenda of Atmanirbhar Bharat (self-reliant India).

By addressing manufacturing bottlenecks, fostering innovation, and prioritizing skill development, the SMDI scheme positions India as a global leader in healthcare technology. As industry leaders, this is the time to align business strategies with the scheme’s objectives and leverage its benefits to drive both organizational and sectoral growth.

Together, we can create a self-sufficient, globally competitive medical device ecosystem that benefits both the industry and the nation.

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