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Assistance to Medical Device Clusters for Common Facilities (AMD-CF)

The Ministry of Chemicals & Fertilizers Department of Pharmaceuticals has issued the Guidelines for the Scheme for “Assistance to Medical Device Clusters for Common Facilities (AMD-CF)” on May 9 ,2023 with a proposed financial outlay of Rs. 300 crore

About AMD-CF Scheme

AMD-CF Scheme aims to strengthen the existing and new medical device clusters by providing financial assistance for setting up new testing laboratories for medical devices ensuring quality and sustainable growth for the sector

The Scheme further intends to support Central or State Government/s or Institutions or Organization to establish or strengthen the Testing Laboratories for Medical Devices to meet the needs arising due to roll out of the licensing regime of the MDR, 2017 and ensuring availability of more testing facilities for evaluation of Medical Devices on behalf of the manufacturers, as mandated under MDR, 2017 or as per the amendment thereon, from time to time

The Scheme would be implemented in a Public Private Partnership (PPP) mode through one time grant-in-aid for creation of infrastructure and common facilities. A Special Purpose Vehicles (SPVs) will be set up for this purpose. The SPVs will have a minimum of 3 pharma units (including Bulk Drug and Medical Device Units) as its shareholders. There shall be a minimum of five medical device manufacturing units as members of SPV.

The SPV should have representatives from cluster members, financial institutions, state and central government and R&D organisations and the individual manufacturing unit cannot hold more than 40 per cent in the SPV. The Medical Devices enterprises shall hold at least 51 per cent equity of the SPV

The outcomes of the Scheme will be reviewed after 2 years from the date of its initiation.

SIDBI has been appointed as Project Management Agency (PMA) for implementation of Scheme.

Components / Sub schemes of AMD – CF Scheme

There are two components / sub schemes to this AMD – CF scheme :

1. Assistance for Common Facilities (CF) : To strengthen the medical device clusters’ capacity for their sustained growth by creating Common Infrastructure Facilities.
2. Assistance for Testing Facilities (TF) : To strengthen availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices

Financial outlay of the Schemes :

The sub-schemes are designed to set up 12 common facilities and 12 testing laboratories, under which the common facilities will be supported with a financial assistance of Rs. 240 crore for the common facilities and Rs. 60 crore for the testing facilities

Tenure of the Scheme :

The tenure of the Scheme is from Financial Year 2023-24 to Financial Year 2026-27.

Incentives Under this Scheme :

For Common Infrastructure Facilities (CIF) for the Medical Device (MD) clusters: the limit of support will be 70% of the approved project cost or Rs. 20 cr., whichever is less, as per the approval of SSC (Scheme Steering Committee). In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 20 Crore per Cluster or 90% of the project cost of the CIF, whichever is less

For Testing Facilities (TF) of Medical Device (MD) products,the limit of support will be 70% of the approved Testing Facilities project cost or Rs. 5 cr., whichever is less, as per the approval of SSC.

In the case of Himalayan States and States in the North East Region, the grant-in-aid would be Rs. 5 Crore per Cluster or 90% of the project cost of the CIF, whichever is less.

Any expenditure above the prescribed limit shall be borne by the elected applicant

Benefits of the Sub Schemes are :

i. Improvement in quality standards of medical devices
ii. Improvement in regulatory compliance specified for medical device
iii.Increased availability of trained personnel for Medical Devices clusters
iv.Increased competitiveness of Medical Devices units in cluster
v. Reduction in the manufacturing cost of Medical Devices

Notice for Invitation of Applications:

The Department has now invited applications from eligible applicants under the Scheme AMDCF.

The eligible applicants may apply through online mode only. The link is https://amdcf.udyamimitra.in/.

The detailed guidelines of the Scheme is available at https://pharmaceuticals.gov.in/schemes.

The last date for filing of the application is 10.02.2024.

Click here to read the AMD-CF Guidelines

Govt releases Guidelines for scheme for Assistance to Medical Devices Clusters

The Department of Pharmaceuticals (DoP) has come out with the guidelines for the scheme for Assistance to Medical Device Clusters for Common Facilities (AMD-CF) with proposed financial outlay of Rs. 300 crore to offer financial assistance to strengthen the existing and new medical device clusters through creation of common infrastructure facilities

The Scheme, with two sub-schemes, is expected to help in boosting the domestic manufacturing capacity and improving the quality of clusters for sustainable growth of the medical devices sector.

The scheme further intends to support central or state governments, institutions, or organisations to establish or strengthen the testing laboratories for medical devices to meet the needs arising due to the roll out of the licensing regime of the Medical Devices Rules (MDR), 2017.

The Scheme has two components or sub schemes – Assistance for Common Facilities (CF) and Assistance for Testing Facilities (TF) – and would be running for three years from 2023-24 to 2025-26. The tenure of the scheme is from the financial year 2023-24 to the financial year 2026-27.

Both the sub-schemes are designed to set up 12 common facilities and 12 testing laboratories, under which the common facilities will be supported with a financial assistance of Rs. 240 crore (Rs. 48 crore in the first year, Rs. 128 crore in the second and Rs 64 crore in the third year) for the common facilities and Rs. 60 crore (Rs. 18 crore for the first, Rs. 30 crore for the second and Rs. 12 crore for the third year) for the testing facilities.

Assistance for Common Facilities is planned to strengthen the medical devices clusters’ capacity for their sustained growth by creating common infrastructure facilities.

Medical devices manufacturing units in a cluster who have come together to form a Special Purpose Vehicle (SPV) to execute the project of developing common facilities and the clusters promoted by the State governments, are expected to benefit from the sub-scheme.

There shall be a minimum of five medical device manufacturing units as members of SPV. Clusters promoted by state governments may not need to form an SPV.

The SPV should have representatives from cluster members, financial institutions, state and central government and R&D organisations and the individual manufacturing unit cannot hold more than 40 per cent in the SPV. The Medical Devices enterprises shall hold at least 51 per cent equity of the SPV.

For Common Infrastructure Facilities for medical device clusters, the limit of support will be 70 per cent of the approved project cost or Rs. 20 crore, whichever is less, as per the approval of the Scheme Steering Committee (SSC).

The sub scheme is expected to have benefits including improvement in quality of medical devices, regulatory compliance specified for medical devices, increased availability of trained personnel for the clusters, increased competitiveness of units in the cluster and reduction in the manufacturing cost of the devices.

The sub scheme on assistance for Testing Facilities is aimed at strengthening availability of more Medical Device Testing Laboratories in order to boost manufacturing of quality medical devices, and national or state level government of private institutions interested to establish or strengthen testing facilities for medical devices to test Class A, B, C and D medical devices including in vitro diagnostic medical devices under MDR, 2017 can apply for the assistance.

The guideline proposes a Technical Committee constituted by the DoP to assist the SSC, which will have one representative each from the Central Drugs Standard Control Organisation (CDSCO), industry and academia, and ICMR, and two representative experts having knowledge and experience in the process development, R&D, product design, testing of medical devices or medical devices manufacturing from relevant institutes such as NIPER, IISc, IITs, Sree Chitra Thirunal Institute of Medical Sciences and Technology, and CSIR, among others.

The DoP will provide overall policy, coordination and management support for the implementation of the Scheme, while the proposals under the scheme will be considered for approval by the SSC, which will be headed by the Secretary of DoP as the Chairperson, and will have members including the Drugs Controller General of India, Financial Advisor of DoP, Joint Secretary (Schemes and Medical Devices), DoP, representatives of the Ministry of Micro, Small and Medium Enterprises (MSME), the Ministry of Electronics and Information Technology (MeitY), the Department for Promotion of Industry and Internal Trade (DPIIT), and the director or the deputy secretary (Schemes) of the DoP.

Click here to read the Guidelines

Source: https://thehealthmaster.com/2023/05/11/govt-releases-guidelines-for-scheme-for-assistance-to-medical-devices-clusters/