Lok Sabha Question No. 3581 (UNSTARRED), answered on 2026-03-13
Subject: Medical Devices Manufacturers
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Appalanaidu Kalisetti

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

## LOK SABHA UNSTARRED QUESTION No. 3581 TO BE ANSWERED ON THE 13 TH  MARCH 2026

## Medical Devices Manufacturers

## 3581. Shri Appalanaidu Kalisetti:

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

- (a) the current number of licensed medical device manufacturers in the country along with production and export data during the last five years, State/UT-wise, year-wise and categorywise (Class A to D);
- (b) the domestic and FDI investment inflow in the medical devices sector since 2018, yearwise; (c)  the  details  of  incentives,  capital  grants  and  approvals  provided  under  PLI  Scheme  and Promotion of Medical Device Parks Scheme, including the number of units supported and fund utilised;
- (d)  whether  the  Government  has  made  any  assessment  regarding  self-reliance  ratio  of  the country in critical medical devices such as diagnostic kits, ventilators, stents and implants and if so, the details thereof;
- (e) the steps taken to improve R&D, quality certification infrastructure and Micro, Small and Medium  Enterprises (MSME)  participation in the medical devices sector, including collaborations with academic or research institutions; and
- (f) whether the Government proposes to introduce new medical device clusters or technology platforms and if so, the details thereof?

## ANSWER

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

## (SMT. ANUPRIYA PATEL)

(a):  As  per  the  information  received  from  the  Department  of  Health  and  Family  Welfare, currently 4108 medical device manufacturers are licensed in the country. Out of 4108 medical device manufacturers, 2099 manufacturers are licensed for manufacture of Class A devices, 2560 manufacturers are licensed for manufacture of Class B devices, 1123 manufacturers are  licensed  for  manufacture  of  Class  C  devices  and  343  manufacturers  are licensed  for  manufacture  of  Class  D  devices.  Some  manufacturers  operate  across  multiple device  classes.  Production  data  is  not  maintained  by  Central  Drugs  Standard  Control Organization (CDSCO) centrally.

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:

| 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    | 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                      |
| 2025-26 (up to December, 2025) | 2,944                      |
| Total                          | 20,658                     |

Data regarding domestic investment in the medical device sector is not maintained centrally by any Ministry of the Government of India.

- (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 4 target segments, for a period of five years. A total of 28 applicants have been approved and total incentive amount of ₹157.15 crore has been disbursed to seven applicants, till December 2025. So far, 24 greenfield projects have been commissioned, and production has started for 57 products, which include high-end medical devices on which the country has been import-dependent, such as linear accelerators, MRI, Ultrasound, CT scans, Mammograms, C-Arm and X-ray machines. Till December 2025, cumulative eligible sales of Rs. 13,624.52 crore including exports sales worth Rs.6,425.48 crores have been made under the scheme.

The  Scheme  for  Promotion  of  Medical  Devices  Parks  aims  to  create  common infrastructure and testing facilities for increased competitiveness and cost reduction of medical device units 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. Till date , a total amount of ₹ 210.00 crore has been disbursed to said three parks as grant-in-aid by the Government of India.

(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) above.

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) with an  overall  financial  outlay  of ₹ 5,000 crore.  Under  the  scheme,  seven  Centres  of Excellence (CoEs) have been set up, one at each of the seven National Institutes of Pharmaceutical Education and Research (NIPERs), with total budgetary support to the tune  of ₹700 crore,  for  creating  research  infrastructure  and  promoting  R&D  in identified areas. Of these, the CoE at NIPER Ahmedabad is specializing in the area of Medical  Device.  Further,  the  scheme  also  provides  for  disbursement  of  financial assistance to support eligible research and development (R&D) projects of industry, start-ups and micro, small and medium enterprises (MSMEs) for R&D in identified priority areas which, inter-alia, include medical devices. The financial outlay for this component is ₹ 4,200 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  the  Common  Facilities  for Medical  Devices  Clusters  subscheme,  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.

(f): No plan is currently under consideration of the Department of Pharmaceuticals to introduce new medical device clusters or technology platforms.

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