Lok Sabha Question No. 1483 (UNSTARRED), answered on 2023-02-10
Subject: Import of High end Scan Machines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: D. M. Kathir Anand

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

LOK SABHA UNSTARRED QUESTION NO. 1483 TO BE ANSWERED ON 10 th  February, 2023

## Import of High end Scan Machines

## 1483. SHRI D.M. KATHIR ANAND:

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

- (a) whether the Government has taken any proactive steps to increase and facilitate the import of high end scan machines including the CT Scan and MRI Scan equipments from foreign countries;
- (b) if so, the details thereof;
- (c) the total number of scan machines and medical equipments imported in the last five years, year-wise origin, country-wise and the expenditure incurred for the same;
- (d) whether the Government has taken adequate measures to ensure the indigenous production and supply of high-end medical equipments and scan machines;
- (e) if so, the details thereof; and
- (f) the steps taken/proposed to be taken by the Government to establish medical equipments manufacturing hub for high-end medical equipments including the CT and MRI scan machines in the country including in Tamil Nadu?

## ANSWER

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

(a),  (b),  (d),  (e):  The  Government has taken various measures including Production Linked Incentive (PLI) scheme for Medical Devices to strengthen the domestic manufacturing capacity to ensure the indigenous production and supply of the Medical Devices, including the CT Scan and MRI Scan equipments and the same is placed at Annexure-1.  Under the PLI Scheme for Medical devices, four (4) applicants are approved for manufacturing of CT Scan and three (3) applicants are approved for MRI Scan equipment respectively.

(c): As per the data available with DoC, the details of import of medical electronic equipment which is inclusive of scan machines, along with details of top six countries of import, are given at Annexure-2.

(f):  Under  the  scheme  for  Promotion  of  Medical  Devices  Parks,  the  Government  provides support  to  the  four  States  of  Himachal  Pradesh,  Madhya  Pradesh,  Tamil  Nadu  and   Uttar Pradesh,   for  creation  of  the  world  class  common  infrastructure  facilities  in  the  Medical Devices Parks, being developed by them.  So far, first instalment of Rs.30 Cr is released to all these four states.

## Annexure-1

## Measures taken to encourage domestic manufacturing of medical devices

-  100% FDI through automatic route is allowed in the medical devices sector
-  In 2019, under the Department of Pharmaceutical's sub-scheme named 'Assistance to Medical Device industry for Common Facility Centre' , financial assistance of Rs 25 crore was approved to the Andhra Pradesh MedTech Zone (AMTZ) for setting up a common infrastructure of a superconducting magnetic coil testing facility.
-  In 2020, revised scheme named 'Scheme for Promotion of Medical Device Parks' was launched . Under this scheme, financing support of Rs 100 crore each has been approved for creation of common facilities in four medical devices parks coming up in Uttar Pradesh, Tamil Nadu, Madhya Pradesh and Himachal Pradesh , which are being developed by these State Governments. This is an infrastructure support scheme wherein the common facilities will be accessed by the industrial units in the parks. These  parks  will  come  up  as  manufacturing  hubs  and  provide  enabling  ecosystem dedicated solely for medical devices. The expected date of completion of the Parks is June, 2024. As per scheme guidelines, first tranche of grant-in-aid of Rs. 30 crore each has been released to the four States.
-  Further in 2020, a scheme named ' Production Linked Incentive Scheme for Medical devices' was introduced. The scheme has a financial outlay of Rs. 3,420 crores, over a period of FY 2020-21 to FY 2027-28. The objective of the scheme is to support the domestic manufacturing of certain identified high-technology medical devices through incentivizing domestic manufacturers. The identified medical devices under the scheme are Cancer Care /Radiotherapy medical devices; Radiology & Imaging medical devices (both  ionizing  and  non-ionizing  radiation  products)  and  nuclear  imaging  devices; Anesthetics&  Cardio-Respiratory  medical  devices  including  catheters  of  Cardio Respiratory  Category  and  Renal  Care  Medical  Devices;  and  all  Implants  including implantable  electronic  devices  like  Cochlear  implants  and  pacemakers.  Four  (4) applicants are approved for manufacturing of CT Scan and 3 applicants are approved for MRI Scan equipments respectively.
-  The Department for Promotion of Industry and Internal Trade (DPIIT) brought out the policy of ' Public Procurement (Preference to Make in India) in 2017' and designated the Department of Pharmaceuticals (DoP) as the Nodal Department for implementing the provisions related to medical devices. DoP thereafter laid out the definition of ClassI, Class-II and Non-Local supplier under the said Policy. Initiatives have been taken under the policy to give preference to domestic manufacturers in public procurement of medical  devices  done  by  the  hospitals  of  the  Central  Government.  The  Public Procurement  (Preference  to  Make  in  India)  policy  is  an  important  pillar  of  the Atmanirbhar Bharat program.
-  The Medical Devices Rules, 2017 were notified under the Drugs and Cosmetics Act, 1940  by  the  Department  of  Health  and  Family  Welfare.  These  rules  lay  out  the regulatory framework for medical devices in terms of their quality, safety and efficacy. This expanded the regulatory oversight to the entire gamut of devices and classified them into four categories based on the level of risk associated with the medical devices. Class and B Medical Devices (Low risk and medium risk) are brought into licensing under MDR 2017 from October 2022 onwards and remaining Class C and D medical devices will be brought under compulsory licensing from October 2023 onwards.

| Value of import of medical electronic equipment (USD Million)   | Value of import of medical electronic equipment (USD Million)   | Value of import of medical electronic equipment (USD Million)   | Value of import of medical electronic equipment (USD Million)   | Value of import of medical electronic equipment (USD Million)   |
|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| F.Y. 2017-18                                                    | F.Y. 2018-19                                                    | F.Y. 2019-20                                                    | F.Y. 2020-21                                                    | FY 2021-22                                                      |
| 3266.99                                                         | 3676.74                                                         | 3646.53                                                         | 3568.64                                                         | 5441                                                            |

Source: EEPC, India

| Top countries for import of medical electronic equipment (USD Million)   | Top countries for import of medical electronic equipment (USD Million)   | Top countries for import of medical electronic equipment (USD Million)   | Top countries for import of medical electronic equipment (USD Million)   |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| S.No                                                                     | Country                                                                  | 2020-21                                                                  | 2021-22                                                                  |
| 1                                                                        | China                                                                    | 768.44                                                                   | 1377                                                                     |
| 2                                                                        | USA                                                                      | 547.9                                                                    | 818.6                                                                    |
| 3                                                                        | Germany                                                                  | 493.7                                                                    | 593.7                                                                    |
| 4                                                                        | Singapore                                                                | 367.4                                                                    | 532.9                                                                    |
| 5                                                                        | Japan                                                                    | 195.3                                                                    | 281.2                                                                    |
| 6                                                                        | Malaysia                                                                 | 25.21                                                                    | 31.58                                                                    |

Source: EEPC, India

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