Lok Sabha Question No. 2126 (UNSTARRED), answered on 2025-08-01
Subject: Medical Devices
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Sribharat Mathukumilli

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

LOK SABHA UNSTARRED QUESTION No. 2126 TO BE ANSWERED ON THE 01 st  AUGUST 2025

## Medical Devices

## 2126. Shri Sribharat Mathukumilli:

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

- (a)  current  number  of  licensed  medical  device  manufacturers  in  the  country  alongwith production and export data for the past five years, year-wise, category-wise (Class A to D) and State/UT-wise;
- (b)  the  investment  inflow  (domestic  and  FDI)  in  the  medical  devices  sector  since  2018, yearwise;
- (c) the details of incentives, capital grants and approvals provided under PLI Scheme and the Promotion of Medical Device Parks Scheme, including the number of units supported and fund utilisation thereunder;
- (d) whether the Government has undertaken any assessment of India's self-reliance ratio in critical medical devices (e.g., ventilators, stents, implants) and if so, the findings thereof;
- (e)  the  steps  taken  to  improve  R&D,  quality  certification  infrastructure  and  MSME participation in the medical devices sector, including collaborations with academic or research institutions; and
- (f)  whether  the  Government  plans  to  introduce  new  medical  device  clusters  or  technology platforms, if so, the details thereof?

## ANSWER

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

(SMT. ANUPRIYA PATEL)

(a): According to the Department of Health and Family Welfare, as per data available on the online  portal  of  the  Central  Drugs  Standard  Control  Organisation,  currently  3,351  medical device  manufacturers  are  licensed  in  the  country,  out  of  which  1,721  are  licensed  for manufacture of Class A devices, 2,099 for Class B devices, 971 for Class C devices and 304 for Class D devices. Production data of all the licensed medical devices manufacturers, riskclass-wise export data and State- and Union territory-wise export data is not available.

Details of medical devices exported to various countries during the last five years, as per data maintained by the Directorate General of Commercial Intelligence and Statistics, is as follows:

(In million US$)

| S. No.   | Segment                      | Financial year (FY) 2020-21   | FY 2021- 22   | FY 2022- 23   | FY 2023- 24   | FY 2024- 25   |
|----------|------------------------------|-------------------------------|---------------|---------------|---------------|---------------|
| 1        | Consumables and disposables  | 1,290                         | 1,378         | 1,605         | 1,752         | 1,863         |
| 2        | Surgical instruments         | 54                            | 71            | 72            | 79            | 86            |
| 3        | Electromedical equipment     | 985                           | 1,163         | 1,335         | 1,472         | 1,483         |
| 4        | Implants                     | 99                            | 135           | 188           | 266           | 350           |
| 5        | In vitro diagnostic reagents | 104                           | 176           | 191           | 216           | 232           |
|          | Total                        | 2,532                         | 2,923         | 3,391         | 3,785         | 4,014         |

## (b): The financial-year-wise inflow of foreign direct investment (FDI) into the medical device sector  for  the  period  since  FY2018-19,  as  per  data  from  the  Department  for  Promotion  of Industry and Internal Trade, is as under:

| Financial year   | FDI inflows (in crore ₹)   |
|------------------|----------------------------|
| 2018-19          | 1,108                      |
| 2019-20          | 2,196                      |
| 2020-21          | 511                        |
| 2021-22          | 1,545                      |
| 2022-23          | 3,123                      |
| 2023-24          | 3,978                      |
| 2024-25          | 5,253                      |
| Total            | 17,714                     |

- (c): The Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices aims to promote domestic manufacturing of medical devices by attracting large investments for creation of domestic manufacturing capacity and incentivising domestic production. It has a total budgetary outlay of ₹3,420 crore and a five-year performance-linked incentive period from FY2022-23 to FY2026-27. Under the scheme, selected companies are eligible  for  financial  incentive  for  incremental  sales  of  domestically  manufactured  medical devices in the radiotherapy, imaging device, anaesthesia, cardio-respiratory and critical care and implant device segments, for a period of five years. A total of 31 applicants have been approved and total incentive amount of ₹133.95 crore has been disbursed to seven applicants, till  June  2025.  So  far,  21  greenfield  projects  have  been  commissioned,  and production has started for 54 products, which include high-end medical devices on which the country has been import-dependent, such as linear accelerators, MRI, Ultrasound, CT scans, Mammograms, CArm and X-ray machines. Till March 2025, cumulative eligible sales ₹10,413.40 crore have been achieved under the scheme, including exports worth ₹5,002 crore.

The  Scheme  for  Promotion  of  Medical  Devices  Parks  aims  to  create  common infrastructure and testing facilities for increased competitiveness and cost reduction through optimisation of resources and economies of scale, thereby leading to better availability and affordability of medical devices in the domestic market. Under the scheme, three parks have been approved and are at an advanced stage of development in Greater Noida (Uttar Pradesh), Ujjain (Madhya Pradesh) and Kanchipuram (Tamil Nadu). The total project cost of these parks is over ₹871.11 crore, with Central assistance to the tune of ₹100 crore each, for creation of common infrastructure facilities, which is expected to enhance industry's competitiveness and reduce production costs through optimisation of resources and economies of scale. Till June 2025, a total amount of ₹180 crore has been disbursed to said three parks as grant-in-aid by the Government of India, out of which an amount of ₹127.87 crore has been utilised.

(d) and (e): No data regarding such a ratio is maintained by the Government. However, in line with the vision of Atmanirbhar Bharat, Government from time to time has assessed dependence on  imports  in  the  medical  device  sector  and  has  taken  steps  to  improve  R&D,  quality certification infrastructure and MSME participation in the medical devices sector, including collaborations with academic and research institutions.

In 2020, assessing that the domestic medical devices market was heavily dependent on imports, which contributed to more than 85% of the market, Government launched the PLI Scheme  for  Promoting  Domestic  Manufacturing  of  Medical  Devices  and  the  Scheme  for Promotion of Medical Devices Parks , details of which are given in the reply to part (c).

Subsequently, Government announced the National Medical Devices Policy, 2023 as a holistic policy framework to accelerate growth of the sector with a patient-centric approach to meet the evolving healthcare needs of patients. Pursuant to the policy, the following actions, among others, have been undertaken:

- (i) Domestic manufacturing of medical devices has been promoted under the PLI Scheme for Promoting Domestic Manufacturing of Medical Devices.
- (ii) Common infrastructure and testing facilities have been approved and are at various stages of implementation under the Scheme for Promotion of Medical Devices Parks.
- (iii) The  Promotion  of  Research  and  Innovation  in  Pharma  MedTech  Sector  (PRIP) scheme has been launched with an outlay of ₹ 5,000 crore to transform India's Pharma MedTech sector from cost- to innovation-based growth by strengthening research and to promote industry-academia linkage for research and development in priority areas that include medical devices. Under this, a Centre for Excellence in medical devices has  been  established  at  the  National  Institute  of  Pharmaceutical  Education  and Research, Ahmedabad with an outlay of ₹100 crore. Further, the scheme also provides financial  assistance  to  industry,  startups  and  micro,  small  and  medium  enterprises (MSMEs) for research and development in identified priority areas, which include medical  devices.  The  medical  device  priority  area  includes,  among  other  medical devices, artificial intelligence / machine learning based medical devices with software development,  software  as  medical  device,  software  in  medical  device,  medical diagnostics and screening devices with genetic technology, robotic medical devices for surgical procedures and medical devices with telemedicine facilities. Such medical devices  may  also  use  new  technology  platforms.  The  financial  outlay  for  this component is ₹ 4,250 crore.
- (iv) The Scheme for Strengthening Medical Device Industry has been launched with a financial outlay of ₹500 crore to provide support in manufacturing of key components and  accessories,  skill  development,  support  for  clinical  studies,  development  of common  infrastructure  and  industry  promotion.  Under  its  Common  Facilities  for Medical  Devices  Clusters  sub-scheme,  financial  assistance  of  up  to  ₹20  crore  is provided  for  creating  common  infrastructure  facilities  and  up  to  ₹5  crore  for establishing testing facilities.
- (v) Action  is  being  pursued  in  respect  of  the  six  focus  areas  of  the  policy,  namely, regulatory  streamlining,  enabling  of  infrastructure,  facilitating  of  research  and development and innovation, attracting investments in the sector, human resources development and brand positioning and awareness creation.

In November 2024, assessing that the dependence on imports continues to be about 70%, Government has launched the Scheme for Strengthening Medical Device Industry, with financial outlay of ₹500 crore and provision for support in critical areas as aforesaid.

(f): No plan is currently under consideration to introduce new medical device clusters. With regard to technology platforms, clause (iv) of the reply to parts (d) and (e) may be referred to.

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