DoP Issues Guidelines for INR 500 Cr Medical Device Industry Scheme

The scheme, spanning FY 2024-25 to 2026-27, aims to reduce India’s import dependency—currently around 70%—while bolstering quality and safety in the medical device sector.

The Department of Pharmaceuticals (DoP) has released operational guidelines for the Strengthening of Medical Device Industry (SMDI) scheme, an INR 500 Cr initiative designed to boost domestic manufacturing of medical devices over three years.

The scheme, spanning Financial Year (FY) 2024-25 to 2026-27, aims to reduce India’s import dependency—currently around 70%—while bolstering quality and safety in the medical device sector.

The scheme consolidates two previous initiatives—Assistance to Medical Device Clusters for Common Facilities and Human Resource Development in Medical Device Sector—under one streamlined program.

With updated guidelines and a reduced budget, the scheme is expected to support increased self-reliance in medical device manufacturing, said the DoP in its announcement.

Key Support for Domestic Manufacturing

To address the dependency on imports, the scheme introduces a sub-scheme called the Marginal Investment Scheme for Reducing Import Dependence.

This sub-scheme offers grants for essential components, raw materials, and accessories for medical devices, supporting domestic manufacturers who face challenges due to limited local sourcing options.

“Strengthening domestic manufacturing of medical device components is critical for reducing imports and meeting public healthcare needs,” a DoP representative noted.

This subsidy-based assistance is expected to enhance self-sufficiency by focusing on 354 essential medical devices currently exempted from the Department of Expenditure’s Global Tender Enquiry (GTE) rule for procurements under INR 200 crore.

Eligible manufacturers will receive a one-time capital subsidy for equipment and setup costs. Companies with annual turnovers below INR 250 Cr may receive 20% of project costs or up to INR 10 Cr, while medium- and large-scale manufacturers will receive smaller proportional grants, based on turnover categories.

Emphasis on Common Facilities and Testing Labs

The scheme’s framework includes substantial support for common facilities and testing centres. With a dedicated fund of INR 110 crore, the scheme aims to establish five to ten common facilities and four to eight testing laboratories.

Government-backed institutions can access up to 70% funding, capped at INR 20 Cr for equipment, while private entities may receive up to 50% support.

DoP guidelines specify that central or state government entities will benefit from up to INR 5 Cr in grants for testing facilities, enabling enhanced testing capabilities for Indian-manufactured devices to ensure compliance with international standards.

These facilities will serve as a resource for local manufacturers, helping them achieve and maintain quality benchmarks.

Focus on Skill Development and Clinical Evidence

Another crucial aspect of the SMDI scheme is capacity-building in the medical device sector, aiming to close skill gaps through education and training. This component will support central universities and approved private institutions in offering advanced and short-term training courses.

“Building a trained workforce that meets industry standards is essential to the growth of India’s medical device sector,” the DoP said.

Further, the SMDI scheme promotes clinical evidence development through the Medical Device Clinical Studies Support Scheme. Financial assistance will cover preclinical research, clinical investigations, and post-market studies, offering up to INR 5 Cr or 25% of the project costs, whichever is lower, for clinical trials.

The department expects this support to enhance the global competitiveness of Indian-made devices. The initiative aims to assist up to 60 applicants, addressing an industry-wide need for credible clinical data to meet international market standards.

The DoP has set up a technical committee to oversee applications and provide ongoing guidance for the SMDI scheme. By bolstering domestic manufacturing, enhancing skill development, and supporting clinical research, the SMDI scheme is expected to reduce reliance on imports and promote a stronger, self-sufficient medical device sector in India.