Lok Sabha Question No. 3014 (UNSTARRED), answered on 2024-12-13
Subject: Medical Device Industry
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Dr. Mohammad Jawed, Dr. Amar Singh, Dr. Shashi Tharoor, Shri K Sudhakaran

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

LOK SABHA UNSTARRED QUESTION No. 3014 TO BE ANSWERED ON THE 13 th  DECEMBER, 2024

## Medical Device Industry

## 3014.   Dr. Mohammad Jawed:

Shri K Sudhakaran:

Dr. Amar Singh:

Dr. Shashi Tharoor:

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

- (a) the details of import of various high-end medical devices indicating it as a percentage of total Medical devices sale in the country in the past five years, country-wise;
- (b) whether the import of high-end devices has risen between 2019-20 and 2022-23, if so, the reasons for such an increase, despite production-linked incentives being in place;
- (c) the steps taken by the Government to promote the domestic medical devices sector;
- (d) whether the Government plans to decrease the GST on medical devices and increase the import duty on finished medical devices, which is lower than the import duty on raw materials or manufacturing components, to promote the domestic medical devices sector, if so, the details thereof and if not, the reasons therefor;
- (e)  whether  the  Government  plans  to  establish  additional  central  medical  device  testing laboratories to address the current shortfall; and
- (f) the steps taken by the Government to adopt advanced technologies such as cloud computing and  robotic  process  automation  to  enhance  the  process  of  domestic  manufacturing  in  the country?

## ANSWER

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

(a) & (b): As per DGCI&S, Ministry of Commerce and Industry, Import-Export data in respect of  five  segments  (Consumables  &  Disposables,  Electro-Medical  Equip,  Implants,  In-Vitro Diagnostics, Surgical Instruments) of medical devices for last five years is as follows:

## (USD Million)

|        |   F.Y. 2019-20 |   F.Y. 2020-21 |   FY 2021-22 |   FY 2022-23 |   FY 2023-24 |
|--------|----------------|----------------|--------------|--------------|--------------|
| Export |           2293 |           2532 |         2923 |         3391 |         3785 |
| Import |           5845 |           6242 |         8540 |         7492 |         8188 |

Between FY 2019-20 and FY 2022-23, the CAGR of imports in the said five segments is 8.63% and CAGR of exports is 13.93 % which indicates that growth of exports during this period has been more compared to imports.

FY 2022-23 was the first year of performance under the PLI Scheme for promoting domestic manufacturing of medical devices. Since then the cumulative sales made by the applicants under the scheme is Rs 8039.63 crore (which includes exports worth Rs 3,844.01 crore) up to September, 2024.

- (c): Apart from  the Production Linked  Incentive  Scheme  for  promoting  domestic manufacturing  of  medical  devices,  Government  of  India  has  taken  several  measures  to encourage domestic manufacturing of medical devices to reduce import dependence and to boost domestic manufacturing and attract large investments.
- (i) Scheme  for  Promotion  of  Medical  Devices  Parks :  The  scheme  'Promotion  of Medical Device Parks' was approved on 20th March, 2020 for providing easy access to world class common infrastructure facilities to medical device units located in the parks. The total financial outlay of the scheme is Rs. 400 crore and the implementation period is from FY 20202021 to FY 2024-2025. Under the scheme, Department had received proposals from 16 States. After evaluation of the proposals, Govt. of Uttar Pradesh, Tamil Nadu, Madhya Pradesh and Himachal  Pradesh  were  conveyed  final  approval  for  creation  of  common  infrastructure facilities in the proposed medical device parks in these four states.

## (ii) Scheme for Strengthening Medical Device Industry:

In order to provide support in critical areas of the medical device industry, covering manufacturing  of  key  components  and  accessories,  skill  development,  support  for  clinical studies,  development  of  common  infrastructure  and  industry  promotion,  a  new  scheme "Strengthening  of  Medical  Device  Industry"  with  five  sub-schemes  has  been  launched  on 8.11.2024  with  financial  outlay  of  Rs.  500  crore.  Sub-schemes  under  the  scheme  are  as follows:-

- (i) Common Facilities for Medical Devices Clusters
- (ii) Marginal Investment Scheme for Reducing Import Dependence
- (iii) Capacity Building and Skill Development for Medical Devices
- (iv) Medical Device Clinical Studies Support Scheme
- (v) Medical Device Promotion Scheme

(d):    As per Department of Revenue, the GST rates and exemptions are prescribed on the recommendations of the GST Council which consists of representation from both Union and State/UT Governments. There is no such recommendation of the GST Council.

- (e):      The  Ministry  of  Health  and  Family  Welfare  has  informed that they have notified six central medical device testing laboratories for testing of certain medical devices. Further, in order to strengthen the government medical device testing facilities in the country, Medical Devices Rules 2017 has been amended vide G.S.R 409(E) dated 02/06/2023 incorporating provisions for State Governments to notifying State Medical Device testing laboratories.
- (f):    The adoption of suitable technology by the domestic manufacturers of medical devices supported under the schemes of the department is as per their own choice. The guidelines for the PLI scheme promoting domestic manufacturing of medical devices allow investment in IT and ITES infrastructure related to manufacturing to be admissible for meeting the investment target.

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