Lok Sabha Question No. 1140 (UNSTARRED), answered on 2023-12-08
Subject: Assistance under AMD CF Scheme
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Krishna Pal Singh Yadav, Heena Vijaykumar Gavit, Rita Bahuguna Joshi, Sujay Radhakrishna Vikhepatil, Shrikant Eknath Shinde

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION No. 1140

TO BE ANSWERED ON 8 TH  DECEMBER, 2023

## Assistance under AMD CF Scheme

## 1140.   DR. KRISHNA PAL SINGH YADAV:

DR. HEENA VIJAYKUMAR GAVIT: PROF.

RITA BAHUGUNA JOSHI:

DR. SUJAY RADHAKRISHNA VIKHE PATIL:

DR. SHRIKANT EKNATH SHINDE:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the Government has set up any mechanism to identify and select the medical device clusters that will be eligible for assistance under the Assistance for Medical Devices Clusters for  Common  Facilities  (AMD-CF)  scheme  and  if  so,  the  details  thereof,  State/UT-wise particularly in UP, Madhya Pradesh and Maharashtra;
- (b) whether the Government has established any specific criteria or requirements for clusters to qualify for the said scheme and if so, the details thereof;
- (c) whether the Government has undertaken/ proposes to take any measures to monitor the utilization of funds and the overall impact of such scheme and if so, the details thereof; and
- (d) whether the Government has taken/proposes to take measures to prevent the migration of manufacturing  units  from  existing  natural  clusters  to  planned  clusters  in  Medical  Devices parks, which could disrupt the ecosystem and competitiveness of the industry and if so, the details thereof?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI BHAGWANTH KHUBA)

- (a): The Department conducted a Study 'Survey of Medical Devices Clusters' to identify the Medical Device Clusters in India. Details for Uttar Pradesh, Maharashtra and Madhya Pradesh are given as Annexure.
- (b):    There are two sub-schemes under the Scheme 'Assistance to Medical Device Clusters for  Common  Facilities  (AMD-CF)'  i.e.  'Assistance  for  Common  Facilities  (ACF)'  and 'Assistance for Testing Facilities (ATF). Criteria for qualifying under these sub-schemes are as follows:-

Under  the  sub-scheme  'Assistance  for Common Facilities (ACF)' Medical Devices manufacturing units in a cluster shall form a Special Purpose Vehicle (SPV) to execute the project. There shall be a minimum of 5 Medical Device manufacturing units as members of SPV. If a cluster is promoted by the State Government, such Project Implementing Agency shall be a legal entity under the Indian law with oversight of the State Government and an

Executive  Committee  shall  be  set  up  for  implementation  of  the  project.  The  SPV  or  the Executive Committee will have representatives from Cluster Members, financial institutions, State/Central Government and R&D organization. Individual manufacturing unit cannot hold more than 40% in the SPV. Medical Devices enterprises shall hold at least 51% equity of the SPV. The combined net worth of members of SPV shall be equivalent to total grant amount applied for and each SPV member must have a net worth of at least 1.5 times of their proposed equity  contribution.  The  SPV  members  shall  be  legally  independent  entities  without  any related-party relationship with each other as described under Accounting Standard (AS) 18 of the Companies (Accounting Standard) Rules, 2006.

Under the sub-scheme 'Assistance for Testing Facilities (ATF)' any National or State level Government or Private institutions interested to establish or strengthen testing facilities for testing of Class A, B, C and D medical devices including in-vitro diagnostic medical devices under MDR, 2017 are eligible. Such legal entity under the Indian law will open a separate account for the funds to be utilized for the projects assisted under the sub-scheme.

(c): The Department set up a Scheme Steering Committee under the Chairmanship of Secretary, Department  of  Pharmaceuticals  with  Drug  Controller  General  of  India  as  a  Member  and representatives from Ministry of  Micro, Small & Medium Enterprises, Ministry of Electronics and Information Technology, Department for Promotion of Industry and Internal Trade, as Members for consideration and approval of the applications received under the 'Assistance to Medical Device Clusters for Common Facilities Scheme (AMD-CF) and also for monitoring the utilization of funds under the Scheme.

(d): The Scheme AMD-CF aims to strengthen the existing and new Medical Device Clusters by providing financial assistance for creation of Common Infrastructure Facilities which would help  in  boosting  the  domestic  manufacturing  capacity,  improving  the  quality  of clusters and sustainable growth of the Medical Device Sector.

Annexure

|   Sl. No. | State         | Medical Device Clusters   | Location of the Cluster          |
|-----------|---------------|---------------------------|----------------------------------|
|         1 | Uttar Pradesh | Agra                      | UPSIDC, Sikandra, Agra,          |
|         2 | Uttar Pradesh | Noida                     | GautamBuddha                     |
|         3 | Uttar Pradesh | Sahibabad                 | Ghaziabad Sahibabad, Ghaziabad   |
|         4 | Uttar Pradesh | Kanpur                    | Kakadeo, Kanpur                  |
|         5 | Uttar Pradesh | Lucknow                   | Hazratganj, Lucknow              |
|         6 | Uttar Pradesh | Meerut                    | Shastri Nagar, Meerut            |
|         7 | Maharashtra   | Ambarnath, Pune           | MIDC Anandnagar, Ambernath, Pune |
|         8 | Maharashtra   | Satpur, Nashik            | Malegaon Sinnar MIDC, Nashik     |
|         9 | Maharashtra   | Sinnar, Nashik            | Malegaon Sinnar MIDC, Nashik     |
|        10 | Maharashtra   | Bhiwandi                  | Kalyan-Bhiwandi Road, Bhiwandi   |

No Medical Device Cluster is identified in the State Madhya Pradesh

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