Medical devices import cut: Govt opens SMDI applications, ₹10 cr subsidy on offer

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Medical devices import cut: Govt opens SMDI applications, ₹10 cr subsidy on offer

Synopsis

India is putting money where its import bill is. The Department of Pharmaceuticals has opened SMDI applications offering up to ₹10 crore for manufacturers cutting medical device imports and ₹5 crore for clinical studies — with FDI in the combined pharma-medtech space already hitting ₹13,193 crore in just six months of FY26.

Key Takeaways

The Department of Pharmaceuticals has opened applications under the SMDI scheme on 29 June to reduce medical device import dependence.
The Marginal Investment Scheme offers a one-time capital subsidy of up to ₹10 crore on reimbursement for manufacturing components, raw materials, or finished devices.
The MDCSS sub-scheme provides up to ₹5 crore for clinical investigations, performance evaluations, and post-market studies.
Application deadline is 6 pm on 23 July via the Department of Pharmaceuticals' online portal.
Combined FDI in pharmaceuticals and medical devices reached ₹13,193 crore between April and September 2025 , up year-on-year.

The Department of Pharmaceuticals has invited applications under the Scheme for Strengthening of Medical Device Industry (SMDI) to boost domestic manufacturing, reduce import dependence, and deepen value chains in the medical devices sector, the Ministry of Chemicals and Fertilizers said on Monday, 29 June. The move signals a renewed push to build self-reliance in a sector that remains heavily dependent on foreign components and finished products.

Two Sub-Schemes Open for Applications

Applications are being accepted under two distinct sub-schemes. The first, the Marginal Investment Scheme for Reducing Import Dependence, offers a one-time capital subsidy of up to ₹10 crore on a reimbursement basis for manufacturing key components, raw materials, finished devices, or accessories. The second, the Medical Device Clinical Studies Support Scheme (MDCSS), provides financial support of up to ₹5 crore on reimbursement for conducting clinical investigations, clinical performance evaluations, post-market follow-up studies, and animal studies.

Deadline and Application Process

Proposals must be submitted through the official online portal by 6 pm on 23 July. Eligibility criteria, application procedures, and terms and conditions are available on the Department of Pharmaceuticals' website, according to the ministry. The department has emphasised that all submissions must be made digitally through the designated portal.

Skill Development and R&D Push

Beyond financial incentives, the SMDI also includes a sub-scheme for capacity building and skill development in the medical device sector. This component aims to address gaps in education and research, ensure quality training in medical technology, and foster an R&D ecosystem capable of supporting the sector's rapidly evolving, multidisciplinary requirements. The objective is to generate a critical mass of trained professionals equipped to handle innovations across medical technology domains.

FDI Inflows Signal Growing Investor Confidence

The announcement comes against the backdrop of rising foreign investment in the sector. FDI inflows in the pharmaceutical sector reached ₹12,753 crore during 2024-25. Combined FDI in pharmaceuticals and medical devices climbed to ₹13,193 crore between April 2025 and September 2025, up from the corresponding period of the previous year. This upward trajectory suggests that investor confidence in India's healthcare manufacturing ecosystem is strengthening, even as import dependence in medical devices remains a structural concern.

The SMDI scheme represents one of the more targeted policy instruments aimed at correcting that imbalance, with disbursements tied to actual manufacturing and clinical activity rather than mere capacity announcements.

Point of View

But one that capital subsidies alone are unlikely to fix. The ₹10 crore ceiling under the Marginal Investment Scheme is modest relative to the capital intensity of device manufacturing, particularly for complex diagnostics and implantables. The more consequential piece may be the clinical studies support, which addresses a genuine bottleneck: domestic manufacturers have historically struggled to meet regulatory evidence requirements, ceding ground to imported products with established clinical dossiers. Whether this round of SMDI applications draws serious industrial participation — or mostly smaller players seeking reimbursement on incremental investments — will be the real indicator of scheme design effectiveness.
NationPress
29 Jun 2026

Frequently Asked Questions

What is the SMDI scheme for medical devices?
The Scheme for Strengthening of Medical Device Industry (SMDI) is a government initiative run by the Department of Pharmaceuticals to promote domestic manufacturing, reduce import dependence, support innovation, and deepen value chains in India's medical devices sector. It operates through multiple sub-schemes offering capital subsidies and clinical study support.
How much subsidy is available under the SMDI Marginal Investment Scheme?
Eligible applicants can receive a one-time capital subsidy of up to ₹10 crore on a reimbursement basis for manufacturing key components, raw materials, finished medical devices, or accessories intended to reduce import dependence.
What support does the Medical Device Clinical Studies Support Scheme offer?
The MDCSS sub-scheme provides financial support of up to ₹5 crore on reimbursement for clinical investigations, clinical performance evaluations, post-market follow-up studies, and animal studies conducted by eligible applicants.
What is the deadline to apply under the SMDI scheme?
Proposals must be submitted through the Department of Pharmaceuticals' official online portal by 6 pm on 23 July. Eligibility criteria and application details are available on the department's website.
How have FDI inflows in India's pharma and medical devices sector trended?
FDI in the pharmaceutical sector stood at ₹12,753 crore in 2024-25. Combined FDI in pharmaceuticals and medical devices rose to ₹13,193 crore between April and September 2025, higher than the corresponding period of the previous year, indicating growing investor interest in the sector.
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