Govt invites applications from Medical device Manufacturers for this scheme

The DoP, on May 9, 2023, unveiled the guidelines for the AMD-CF scheme, signaling its commitment to the growth of the medical device sector

The Health Master

January 15, 2024

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Last Updated on January 22, 2024 by The Health Master

Medical device

In a significant move to fortify the medical device industry, the Department of Pharmaceuticals (DoP) has thrown open the doors for eligible candidates under the Assistance to Medical Device Clusters for Common Facilities (AMD-CF) scheme.

Set against the backdrop of a rapidly evolving healthcare landscape, the DoP’s initiative aims to provide financial assistance for strengthening both existing and new medical device clusters through the creation of common infrastructure facilities.

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The Genesis of AMD-CF

1. Scheme Announcement – May 9, 2023

The DoP, on May 9, 2023, unveiled the guidelines for the AMD-CF scheme, signaling its commitment to the growth of the medical device sector. The proposed financial outlay for the scheme stands at an impressive Rs. 300 crore.

2. Project Management Agency Selection

Simultaneously, the DoP announced procedures for selecting a Project Management Agency (PMA) to oversee the implementation of the scheme.

This move underlines the importance of effective project management in ensuring the success of such initiatives.

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Applying for AMD-CF Scheme

3. Online Application Process

Prospective applicants are urged to apply through online mode only, following a thorough understanding of the detailed guidelines published by the Department.

This digital application process reflects the DoP’s commitment to modern and accessible procedures.

4. Application Deadline – February 10, 2024

To ensure a streamlined application process, the Department has set the deadline for filing applications as February 10, 2024, emphasizing the need for timely submissions.

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Industry Response

5. Applauds from Industry

Industry organizations have lauded the DoP’s initiative, recognizing its potential to attract both foreign and domestic investments in the rapidly advancing MedTech space.

This collaborative effort is seen as a pivotal step in fostering innovation and growth.

Unpacking AMD-CF Scheme

6. Two Sub-Schemes – CF and TF

The AMD-CF scheme comprises two components – Assistance for Common Facilities (CF) and Assistance for Testing Facilities (TF).

These sub-schemes are structured to operate for three years, from 2023-24 to 2025-26, aligning with the overarching goal of sustainable growth.

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7. Financial Allocation

The financial allocation for the common facilities stands at Rs. 240 crore, distributed over three years.

Simultaneously, testing facilities receive Rs. 60 crore during the same period, strategically distributed for optimal impact.

8. Boosting Domestic Manufacturing

The primary objective of the CF sub-scheme is to fortify medical device clusters by creating common infrastructure facilities.

These facilities aim to enhance the manufacturing capacity of the clusters and improve their overall quality for sustained growth.

9. Eligibility Criteria

To be eligible for CF assistance, medical device manufacturing units must form a Special Purpose Vehicle (SPV) comprising a minimum of five units.

SPVs may include representatives from various stakeholders, ensuring a collaborative approach.

10. Equity Distribution in SPV

Equity distribution within the SPV is carefully structured, limiting individual manufacturing units to a maximum of 40%.

The SPV is required to have at least 51% equity held by medical devices enterprises, fostering a sense of shared responsibility.

11. Financial Support Details

Financial support for common infrastructure facilities is capped at 70% of the approved project cost or Rs. 20 crore, whichever is less.

However, Himalayan States and those in the NorthEast Region enjoy a grant of Rs. 20 crore per cluster or 90% of the project cost.

12. Release of Grant-in-Aid

Grant-in-aid is released in instalments, with 30% each in the first, second, and third stages.

The remaining 10% is disbursed in the fourth stage, contingent upon the SPV mobilizing and spending its 100% share proportionally to the first three grants.

13. Anticipated Benefits

The CF sub-scheme anticipates several benefits, including improved medical device quality, regulatory compliance, availability of trained personnel, increased competitiveness, and a reduction in manufacturing costs.

14. TF Sub-Scheme Objectives

The TF sub-scheme is dedicated to enhancing the availability of medical device testing laboratories.

Government or private institutions interested in establishing or strengthening testing facilities for a broad spectrum of medical devices, including in vitro diagnostic medical devices, can apply for assistance.

15. Application Process for TF

The application process for TF assistance is open to various legal entities that create a separate account for the funds dedicated to the project.

This inclusivity is designed to encourage diverse participation in bolstering the testing infrastructure for medical devices.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

FAQs

1. How can medical device manufacturing units apply for Assistance for Common Facilities?

Prospective units must form a Special Purpose Vehicle (SPV) and adhere to equity distribution guidelines.

2. What are the anticipated benefits of the CF sub-scheme?

Benefits include improved device quality, regulatory compliance, availability of trained personnel, increased competitiveness, and reduced manufacturing costs.