Lok Sabha Question No. 4145 (UNSTARRED), answered on 2024-12-20
Subject: Medical Equipment
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Prabhakar Reddy Vemireddy

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

LOK SABHA UNSTARRED QUESTION No. 4145 TO BE ANSWERED ON 20 th  DECEMBER, 2024

## Medical Equipment

## 4145. Shri Prabhakar Reddy Vemireddy:

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

- (a) whether the Government has issued a Memorandum indicating revised imported list of highend  and  high-value,  used  or  refurbished,  medical  equipment,  such  as  MRI  machines,  CT scanners, etc., if so, the details thereof;
- (b) whether the said Memorandum is in violation of National Medical Devices Policy 2023, if so, the details thereof;
- (c) whether the Government has also expanded the list recently; and
- (d) if so, the details of equipment allowed earlier and details of each of the equipment allowed in the expanded list along with the reasons for allowing the above mentioned equipments?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SMT. ANUPRIYA PATEL)

(a),  (c)  &  (d):      The  Ministry  of  Environment,  Forest  and  Climate  Change  (MoEFCC) has informed that initially, Directorate General of Health Services (DGHS), Ministry of Health & Family Welfare (MoHFW) vide OM dated 05.06.2023 forwarded a list of 50 numbers of High End and High Value used Medical Equipment other than critical care medical equipment for import for reuse purpose. Thereafter, OM dated 19.06.2023 was issued by MoEFCC providing list of 50 nos. of High End and High value used Medical Equipment other than critical care medical equipment ( Annexure-I ). Further, on receipt of OM dated 20.08.2024 from Director General of Health Services (DGHS), Ministry of Health & Family Welfare forwarding revised list of High End and High Value used/refurbished Medical Equipment reducing the number of equipment  to  38.  MoEFCC  in  super  session  of  OM  dated  19.06.2023,  issued  OM  dated 15.10.2024 with revised list of 38 nos. of High End and High Value used/refurbished Medical Equipment other than critical care medical equipment ( Annexure-II ).

- (b): The Union Cabinet approved the National Medical Device Policy, 2023 on 26.04.2023.  The Policy envisions to place the Indian medical devices sector on an accelerated growth path with a patient-centric approach to meet the evolving healthcare needs of patients by  building  an  innovative  and  globally  competitive  industry  in  India,  enabling  ecosystem, streamlined regulatory framework and quality manpower. This will ensure access to patentcentric, innovative and affordable healthcare products of excellent quality for better healthcare outcomes.

## Annexure referred to in reply to parts (a), (c) & (d) of Lok Sabha Unstarred Question No. 4145 for answer on 20.12.2024

|   S. No. | Name of Equipment                                                                                            |
|----------|--------------------------------------------------------------------------------------------------------------|
|        1 | MRI                                                                                                          |
|        2 | CT                                                                                                           |
|        3 | PET-CT                                                                                                       |
|        4 | SPECT/SPECT-CT/Gamma camera                                                                                  |
|        5 | Mammography                                                                                                  |
|        6 | High end X ray- Non -ICU                                                                                     |
|        7 | Ultrasound -Non-ICU                                                                                          |
|        8 | Interventional Radiology equipment                                                                           |
|        9 | C- arm (surgery)                                                                                             |
|       10 | Radiotherapy Device                                                                                          |
|       11 | Microbiology -Microbial identification &AST                                                                  |
|       12 | Microbiology -detecting systems for the presence or absence of microorganisms in Blood. Sterile body fluids. |
|       13 | Multi parametric immunoassay Analyzer based on ELFA technology                                               |
|       14 | Molecular diagnostic -molecular infectious disease diagnostics systems                                       |
|       15 | Microbiology -advanced mass spectrometry microbial identification system                                     |
|       16 | Blood cell Analyzer                                                                                          |
|       17 | Microscope slide maker / stainer                                                                             |
|       18 | Chemiluminescent immunoassay analyzer                                                                        |
|       19 | Clinical chemistry analyzer                                                                                  |
|       20 | Immunohematology Auto Analyzer                                                                               |
|       21 | URINE Analyzers                                                                                              |
|       22 | Robotic Assisted surgical system, instruments and Accessories                                                |
|       23 | Femtosecond ophthalmic solid -state laser system                                                             |
|       24 | Phacoemulsification and vitrectomy system                                                                    |
|       25 | Ophthalmic Excimer Laser system                                                                              |
|       26 | OCT posterior and anterior segment                                                                           |
|       27 | Fundus imagine system preferably ultrawide field along with FFA and ICG                                      |
|       28 | Corneal topography                                                                                           |
|       29 | Optical biometer                                                                                             |
|       30 | Clinical corneal specular microscope                                                                         |
|       31 | High end operating microscope                                                                                |
|       32 | Ablation system                                                                                              |
|       33 | Endoscopic Camera system                                                                                     |
|       34 | Endoscopes                                                                                                   |
|       35 | Orthopedic Robotic Navigation system                                                                         |
|       36 | Medical -grade monitors                                                                                      |
|       37 | Image Management system                                                                                      |
|       38 | Medical -grade electromechanical drill                                                                       |
|       39 | Flow control pump                                                                                            |
|       40 | Insufflation device                                                                                          |
|       42 | EFG system                                                                                                   |

|   43 | Repetitive transcranial magnate stimulator   |
|------|----------------------------------------------|
|   44 | Flexible video Ureterorenoscope with Monitor |
|   45 | Video Urodynamic system with chair           |
|   46 | Cryd Ablation system                         |
|   47 | 4K Advance Laparoscopy surgery system        |
|   48 | OT integration system.                       |
|   49 | High intensity Focused Ultrasound system     |
|   50 | 3D -4KLaparoscopy system                     |

## Annexure referred to in reply to parts (a), (c) & (d) of Lok Sabha Unstarred Question No. 4145 for answer on 20.12.2024

| S. No.   | Name of Equipment                                                        |
|----------|--------------------------------------------------------------------------|
| No. 1    | MRI                                                                      |
| 2        | CT                                                                       |
| 3        | PET-CT                                                                   |
| 4        | SPECT/SPECT-CT/Gamma Camera                                              |
| 5        | Mammography                                                              |
| 6        | Interventional Radiology Equipment                                       |
| 7        | Radiotherapy Devices                                                     |
| 8        | OT Integration System                                                    |
| 9        | 4K Advance Laparoscopy Surgery System                                    |
| 10       | Molecular Diagnostic -Molecular infectious disease diagnostics system    |
| 11       | Microbiology -advanced mass spectrometry microbial identification system |
| 12       | Robotic Assisted Surgical System, Instruments and Accessories            |
| 13       | Femtosecond ophthalmic solid -state laser system                         |
| 14       | , Phacoemulsification and vitrectomy system                              |
| 15       | Ophthalmic Excimer Laser system .                                        |
| 16       | OCT posterior and anterior segment                                       |
| 17       | Fundus imaging system preferably ultrawide field along with FFA and ICG  |
| 18       | Corneal topography                                                       |
| 19       | Optical Bio meter                                                        |
| 20       | High end operating microscope                                            |
| 21       | Ablation system                                                          |
| 22       | Endoscopic Camera system                                                 |
| 23       | Endoscopes                                                               |
| 24       | Orthopaedic Robotic Navigation System                                    |
| 25       | High End Medical -grade monitors                                         |
| 26       | Image Management System                                                  |
| 27       | Medical -grade electromechanical drill                                   |
| 28       | Flow control pump                                                        |
| 29       | Insufflation device                                                      |
| 30       | _ NCV/EMG system                                                         |
| 31       | EEG system                                                               |
| 32       | Repetitive transcranial magnatic stimulator                              |
| 33       | Video Urodynamic system with Chair                                       |
| 34       | Cryo Ablation system                                                     |
| 35       | High Intensity Focused Ultrasound System                                 |
| 36       | 3D -4KLaparoscopy System                                                 |
| 37       | High End Dental Chair                                                    |
| 38       | Cone-Beam Computed 'Tomography Systems (CBCT)                            |