Industry

Govt amends guidelines for Promotion of Medical Device Parks Scheme

The prerequisite for the release of the fourth installment, amounting to 10%, remains unchanged.

The Health Master

May 23, 2023

191

Table of Contents

Last Updated on January 9, 2024 by The Health Master

Introduction: Guidelines for Promotion of Medical Device Parks Scheme

Download the amended guidelines, the link is given below: The Department of Pharmaceuticals (DoP) has recently introduced an amendment to the operational guidelines for the Scheme for Promotion of Medical Device Parks.

Download the amended guidelines

This amendment modifies the conditions for receiving subsequent fund installments from the Central government, requiring 75% utilization of the previous installment instead of the previous requirement of 60%.

This change aligns with the office memorandum issued by the Department of Expenditure on March 9, 2023.

Revised Funding Requirements:

The revised guidelines state that additional funds (up to 25% at a time) will only be released once at least 75% of the previously released funds have been utilized, and in compliance with the conditions of previous sanction.

These changes are in accordance with the advice provided in the office memorandum mentioned earlier.

Click for more on department of pharmaceuticals

Changes to Installment Prerequisites:

Under the initial guidelines issued on July 27, 2020, the second installment of 30% was to be provided after 60% utilization of the first installment and proportionate expenditure by the State Implementing Agency (SIA), along with proportionate physical progress of the Medical Device Park as per the Detailed Project Report (DPR).

Similarly, the third installment of 30% would be released after 100% utilization of the first installment and at least 60% utilization of the second installment, in addition to the same expenditure and physical progress requirements.

The corrigendum issued to the guidelines clarifies that the release of the second installment now requires 75% utilization of the first installment, and for the third installment, 100% utilization of the first installment and 75% utilization of the second installment.

Fourth Installment and Project Completion:

The prerequisite for the release of the fourth installment, amounting to 10%, remains unchanged.

It still requires 100% utilization of the second and third installments, as well as the SIA’s mobilization and complete expenditure in proportion to the grant, along with the completion of the project in all respects.

Click for more medical device parks

Scheme Overview and Project Details:

The Department of Pharmaceuticals administers the Scheme for Promotion of Medical Device Parks, which has a total financial outlay of Rs. 400 crore.

The scheme provides a maximum assistance of Rs. 100 crore for one Medical Device Park.

The scheme’s duration spans from FY 2020-2021 to FY 2024-2025, with the selected projects being implemented by the State Implementing Agency (SIA).

Among the 16 States/Union Territories that submitted proposals, final approval for financial assistance of Rs. 100 crore each has been granted to:

Uttar Pradesh,
Tamil Nadu,
Madhya Pradesh,
Himachal Pradesh.

In April 2022, the DoP announced the approved projects, including:

A 360-acre park in Ujjain district, Madhya Pradesh, with a total project cost of Rs. 222.77 crore;
A 350-acre park in Kancheepuram district, Tamil Nadu, with a total project cost of Rs. 212.40 crore;
A park in 265.75 acres in Solan district, Himachal Pradesh, with a total project cost of Rs. 349.83 crore;
A 350-acre park in Gautam Buddh Nagar District, Uttar Pradesh, with a project cost of Rs. 435.94 crore.

Assistance under the Scheme:

Financial assistance provided under the Scheme will contribute to the creation of common infrastructure facilities, including:

The component testing centre,
Electronic System Design & Manufacturing (ESDM),
Printed Circuit Boards (PCBs),
Sensors facility,
Electro-magnetic interference and electromagnetic compatibility centre,
Biomaterial/injection moulding/machining/tooling centre,
3D designing and printing for medical-grade products,
Sterilization/gamma centre,
Animal lab and toxicity testing centre,
Radiation testing centre.

Conclusion:

The recent amendment to the operational guidelines for the Scheme for Promotion of Medical Device Parks introduces changes in the funding requirements, ensuring that subsequent fund installments are issued based on a higher utilization threshold.

This amendment aligns with the Department of Expenditure’s advice on fund release practices.

The revised guidelines outline specific prerequisites for each installment, emphasizing the utilization percentages of previous installments.

The fourth installment remains unchanged, requiring full utilization of the second and third installments, along with project completion by the State Implementing Agency (SIA).

The Scheme for Promotion of Medical Device Parks aims to develop medical device infrastructure across various states and union territories.

Several projects have received final approval for financial assistance, enabling the creation of common infrastructure facilities essential for the medical device industry.

By implementing this scheme and providing financial assistance, the Department of Pharmaceuticals aims to boost the growth and development of medical device parks and related industries, ultimately enhancing healthcare infrastructure and innovation in the country.

Must read

Procedure to obtain license for manufacturing of Medical Devices

Procedure for registration of Medical Devices: CDSCO

Registration for sale of Medical Devices: Procedure and conditions

Latest Notifications: Medical Devices

Classifications of Medical Devices under the provisions of MDR 2017

Notified Bodies for Medical Devices

Updated list of Notified Bodies for Medical Devices

Updated list of Medical Device Testing Laboratories (MDTLs)

Medical Device Alert: Lists

Forms: All types of Medical Devices

Schedules: All types of Medical Devices