Government Push to Strengthen Domestic Medical Device Manufacturing
The Government of India has taken a significant step toward boosting the domestic medical device industry by establishing dedicated medical device parks across multiple states. In-principle approvals have been granted for parks in Himachal Pradesh, Madhya Pradesh (Ujjain), Tamil Nadu (Oragadam), and Uttar Pradesh.
This initiative aims to reduce dependency on imports while strengthening India’s position as a global hub for medical device manufacturing.
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Shared Infrastructure to Reduce Costs and Boost Competitiveness
These medical device parks are designed to provide world-class shared infrastructure, including:
- Advanced testing laboratories
- Common sterilization facilities
- R&D support centers
- Logistics and warehousing infrastructure
By offering these shared resources, the government intends to significantly lower manufacturing costs and create a competitive ecosystem for MedTech companies.
Key Highlights of Approved Medical Device Parks
Tamil Nadu (Oragadam): A Strategic MedTech Hub
The park in Oragadam, developed by State Industries Promotion Corporation of Tamil Nadu (SIPCOT), spans approximately 350 acres near Chennai. It focuses on:
- Medical equipment manufacturing
- Diagnostics
- Digital health and software
This park is expected to become a major investment destination for both domestic and international MedTech players.
Madhya Pradesh (Ujjain): Emerging Investment Destination
Located in Vikram Udyogpuri, the 360-acre park in Ujjain is attracting global investments. Notably, a unit has already been established by a South Korean company, signaling strong international interest in India’s MedTech sector.
Uttar Pradesh: North India’s MedTech Growth Engine
The proposed park in Uttar Pradesh is strategically positioned to serve as a major hub for medical technology manufacturing in North India, offering access to a large market and strong logistics connectivity.
Himachal Pradesh: Expanding Regional Capabilities
Himachal Pradesh is also among the selected states benefiting from the scheme, contributing to a geographically diversified manufacturing ecosystem.
Financial Support and Policy Backing
The initiative is supported by a significant financial outlay under a central government scheme (FY 2020–21 to 2024–25). The objective is to:
- Promote self-reliance in medical devices
- Encourage local manufacturing
- Attract foreign direct investment (FDI)
- Strengthen India’s export potential
How Operon Strategist Supports Medical Device Manufacturers
1. End-to-End Project Establishment
Operon Strategist assists manufacturers in setting up operations within these medical device parks through:
- Feasibility studies
- Detailed Project Reports (DPR) for bank and investor approvals
- Land acquisition and infrastructure planning
2. Regulatory Compliance & Market Entry
Navigating regulatory requirements is critical for success. Operon Strategist provides:
- Assistance with Central Drugs Standard Control Organization (CDSCO) registration
- Guidance on device classification and approval pathways
- Support for quality management systems such as ISO 13485
- Technical documentation and audit readiness
3. Infrastructure & Facility Planning
- Cleanroom design and validation
- Manufacturing layout optimization
- Equipment selection aligned with regulatory standards
4. Strategic Advisory & Investment Support
- Market entry strategies for domestic and export markets
- Partner identification and vendor development
- Financial modeling and funding support
5. Compliance Across Global Markets
Operon Strategist also helps manufacturers expand beyond India by ensuring compliance with international regulations, enabling smoother global market access.
