Lok Sabha Question No. 751 (UNSTARRED), answered on 2025-02-07
Subject: Import of Refurbished Medical Devices
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Magunta Sreenivasulu Reddy

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

LOK SABHA UNSTARRED QUESTION NO. 751

TO BE ANSWERED ON 07 th   FEBRUARY, 2025

## Import of Refurbished Medical Devices

## 751. Shri Magunta Sreenivasulu Reddy:

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

- (a) the details regarding the total number of medical devices imported into the Country over the last five years, year-wise and country of origin-wise;
- (b) whether the Government has conducted any study/survey of refurbished/reconditioned medical devices in India over the last five years;
- (c) if so, the details regarding the total number of such refurbished/reconditioned medical devices that are presently being used in the country;
- (d)  whether the Government has considered/introduced and/or implemented any specific policy/standard for refurbished and/or reconditioned medical devices in the country over the last five years, if so, the details thereof and if not, the reasons therefor; and
- (e)  whether  the  Government  has  set  any  timeline  for  the  proper  implementation  of policy/guidelines regarding the use and sale of refurbished/reconditioned medical devices in the country, if so, the details thereof and if not, the reasons therefor?

## ANSWER

## THE  MINISTER  OF  STATE  IN  THE  MINISTRY  OF  CHEMICALS  AND FERTILIZERS

(SMT. ANUPRIYA PATEL)

(a): The details of imports and exports of medical devices over the last five years, as per data of the Directorate General of Commercial Intelligence and Statistics, are as under:

(In million US$)

|         | FY 2019- 20   | FY 2020- 21   | FY 2021- 22   | FY 2022- 23   | FY 2023- 24   |
|---------|---------------|---------------|---------------|---------------|---------------|
| Exports | 2,293         | 2,532         | 2,923         | 3,391         | 3,785         |
| Imports | 5,845         | 6,242         | 8,540         | 7,492         | 8,188         |

Country-wise details regarding the imports and exports of medical devices over the last five years, as per the data of the Directorate General of Commercial Intelligence and Statistics, in respect of major countries, are as under:

Imports

(In million US$)

Exports

| Country     | FY 2019-20   | FY 2020-21   | FY 2021-22   | FY 2022-23   | FY2023-24   |
|-------------|--------------|--------------|--------------|--------------|-------------|
| USA         | 1,190.08     | 984.08       | 1,464.73     | 1,418        | 1,519       |
| China       | 622.2        | 1,110.92     | 1,657.67     | 1,246.82     | 1,332       |
| Germany     | 732.07       | 668.5        | 782.35       | 797.49       | 908         |
| Netherlands | 347.51       | 228.51       | 398          | 416          | 460         |
| Japan       | 280.08       | 236.99       | 343.08       | 321.77       | 372         |

(In million US$)

| Country     |   FY 2019-20 |   FY 2020-21 |   FY 2021-22 |   FY 2022-23 |   FY2023-24 |
|-------------|--------------|--------------|--------------|--------------|-------------|
| USA         |       521.85 |       600.01 |       631.48 |      714.12  |      714.3  |
| Germany     |       123.74 |       133.7  |       127.29 |      176.63  |      199    |
| China       |       130.27 |       133    |       146.94 |      144.574 |      166    |
| Netherlands |        33.78 |        43.87 |        93.68 |      110.44  |      145    |
| Japan       |        30.63 |        27.21 |        31.84 |       38     |       42.17 |

(b)  and  (c):  As  informed  by  the  Ministry  of  Environment,  Forest  and  Climate  Change (MoEFCC), it has notified the Hazardous and Other Waste (Management and Transboundary Movement) Rules, 2016. The import or export of hazardous and other waste is regulated by the said rules. The import of 'Used Electrical and electronic assemblies' falls under Schedule III Part B (Basel No. B1110), and the same can be imported by the actual user only after obtaining necessary permission from MoEFCC. Further, used critical care medical equipment is covered under Basel No. B1110 of Schedule VI of the said rules and is prohibited for import for re-use.

MoEFCC amended the said rules on 23.12.2022 to allow the import of High End and High Value Used Medical Equipment other than Used Critical Care Medical Equipment by the actual user or by Original Equipment Manufacturers (OEMs) or Indian Subsidiary of OEM or Trader on behalf of actual user for re-use. These items fall under Schedule III Part B of the said rules and, therefore, import of such equipment is restricted and cannot be done without permission from MoEFCC and is subject to such conditions as may be imposed in the permission letter and the license issued by the Directorate General of Foreign Trade.

(d) and (e): The Department of Health and Family Welfare has informed that all medical devices are regulated by the Medical Devices Rules, 2017. As per Chapter V of the said rules, medical devices are imported in the country against a valid import licence issued by the Central Drugs Standard Control Organisation. Under the said rules, there is no specific provision for regulation of refurbished medical devices. Any importer possessing a valid licence is permitted to import a medical device under the Drugs and Cosmetics Act, 1940.

******