The Indian government’s “Promotion of Medical Device Parks” scheme is a strategic initiative to bolster the domestic medical device industry by establishing state-of-the-art manufacturing and testing facilities. This scheme aims to reduce dependence on imports, increase competitiveness, and foster innovation. This article will delve into the objectives, scope, and implementation framework of the scheme.
Background: Addressing Import Dependence
The medical device industry in India is characterized by high import dependence (86%) despite a high growth rate and its potential for innovation. The scheme seeks to foster an ecosystem that promotes domestic manufacturing of advanced medical devices while addressing the gaps in testing and research facilities.
Objectives: Creating World-Class Infrastructure
The primary objectives of the scheme are:
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To build world-class infrastructure for medical device manufacturing.
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To create Common Infrastructure Facilities (CIFs) that offer easy access to standard testing and manufacturing facilities.
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To lower the manufacturing costs for medical devices and improve affordability.
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To enhance the competitiveness of domestic manufacturers by providing them access to quality infrastructure.
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To enable domestic manufacturers to optimize resources by facilitating economies of scale.
Key Components: Building Shared Resources
The scheme focuses on establishing four medical device parks across India. These parks will feature the following Common Infrastructure Facilities (CIFs):
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Component Testing Centers
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Electro-magnetic Interference & Electro-Magnetic Compatibility Centers
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Biomaterial / Biocompatibility testing facilities
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Medical grade moulding/milling centers
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Sterilization facilities
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Animal labs and toxicity testing centres
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Radiology testing centers
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Solid Waste management plants
Financial Outlay: A Significant Government Investment
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The scheme has a total financial outlay of Rs. 400 crore.
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The Central Government will provide a one-time grant-in-aid to establish these CIFs.
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The financial assistance covers 70% of the project cost for most States and 90% for North-Eastern and Hilly States/UTs.
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The maximum grant-in-aid for one Medical Device Park is capped at Rs. 100 crore.
Implementation: A Central Sector Scheme
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The scheme is a Central Sector Scheme implemented by the Department of Pharmaceuticals.
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State governments act as proposers and are responsible for establishing and managing the parks.
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A Project Management Agency (PMA), nominated by the Department of Pharmaceuticals, provides secretarial, managerial, and implementation support.
Approval Process: Ensuring Feasibility and Viability
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The Department of Pharmaceuticals will evaluate and appraise proposals and put them forth to the Scheme Steering Committee (SSC) for approval.
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The Scheme Steering Committee (SSC), constituted by the DoP, approves project proposals and monitors implementation.
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The PMA assists the DoP in all aspects of scheme implementation.
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Selection is based on defined evaluation criteria, including project viability and commitment.
Key Parameters for Selection
Proposals for setting up medical device parks will be evaluated by the SSC based on several parameters:
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The state government’s commitment to providing a long term land lease at a low rate.
* Availability of uninterrupted power and water supply.
* Connectivity to various transport networks.
* Environmental suitability of the site.
* Existing ecosystem for medical devices
* Financial viability of the project.
Eligible Activities: Testing and Manufacturing Focus
The scheme encourages projects that include:
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Creation of testing and laboratory facilities.
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Common warehouse and logistic centers
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Advanced manufacturing facilities such as 3D printing
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Specialized facilities like sterilization centers
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Conclusion
The “Promotion of Medical Device Parks” scheme is a crucial initiative in making India a self reliant manufacturing hub for medical devices. By creating state-of-the-art infrastructure, reducing production costs, and providing a collaborative ecosystem, this scheme strives to improve the accessibility and affordability of quality medical devices in India