Written by 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.