Introduction

The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, Government of India, has invited proposals under two focused sub-schemes aimed at strengthening the domestic medical device manufacturing ecosystem and reducing India’s dependence on imports.

These initiatives fall under the ₹500 crore “Scheme for Strengthening of Medical Device Industry”, designed to enhance self-reliance, deepen local supply chains, and support innovation in the MedTech sector.

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Sub-Schemes Open for Applications

The DoP has called for applications from eligible stakeholders under the following sub-schemes:

1. Marginal Investment Scheme for Reducing Import Dependence

This sub-scheme offers a one-time capital subsidy of 10–20%, capped at ₹10 crore, to promote domestic manufacturing of critical medical device components, raw materials, and accessories. The objective is to reduce import reliance by incentivizing investments in upstream manufacturing and strengthening India’s medical device supply chain.

2. Medical Device Clinical Studies Support Scheme

This scheme supports the medical device industry by encouraging the generation of robust clinical evidence. It aims to facilitate clinical studies that demonstrate the safety, performance, and efficacy of medical devices manufactured in India, thereby improving market acceptance and regulatory compliance.

Application Timeline and Submission Details

Application Start Date: 10 December 2025
Last Date for Submission: 10 January 2026 (up to 6:00 PM)
Submission Authority: Life Sciences Sector Skill Development Council (LSSSDC), the authorized Project Management Agency of the DoP

Applicants are advised to refer to the detailed scheme guidelines available on the Department of Pharmaceuticals’ official website.

Role of Operon Strategist

Operon Strategist supports medical device manufacturers, component suppliers, and MedTech startups in strategically leveraging government incentive schemes to accelerate growth and regulatory readiness. Our services include:

Eligibility assessment for government medical device schemes
End-to-end proposal documentation and application support
Technical, regulatory, and compliance alignment with scheme guidelines
Advisory on import substitution strategy and domestic manufacturing roadmap
Clinical study planning and regulatory documentation support

By combining regulatory expertise with industry insight, Operon Strategist enables organizations to maximize funding opportunities while ensuring compliance and long-term sustainability.

Connect with Operon Strategist for Expert Regulatory and Strategic Guidance

About Operon Strategist

End-to-end regulatory, compliance, and market entry expertise
Specialized in turnkey medical device manufacturing projects
Support across India and global regulatory jurisdictions
Expertise in ISO 13485, CDSCO Manufacturing License, US FDA, CE, and other approvals

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