Home India Ministry of Chemicals and Fertilizers : Department of Pharmaceuticals Implementation of the National Medical Devices Policy, 2023...
Date: 2025-12-05 Category: Press Release State: Union Government Country: India

Implementation of the National Medical Devices Policy, 2023

Issued by Ministry of Chemicals and Fertilizers : Department of Pharmaceuticals · Not Applicable

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

**Executive Summary** This document details the implementation of the National Medical Devices Policy, 2023, by the Department of Pharmaceuticals. It highlights measures taken to reduce import dependence and promote domestic medical device manufacturing through three central sector schemes: the Production Linked Incentive (PLI) scheme, the Scheme for Promotion of Medical Devices Parks, and the Scheme for Strengthening Medical Device Industry. Key dates mentioned include September and November 2025, and the launch date of Scheme for Strengthening Medical Device Industry as 8.11.2024. **Key Points / Main Content** * **National Medical Devices Policy, 2023:** * Aims to facilitate growth of the medical device sector through strategies in six key areas. * These areas include regulatory streamlining, enabling infrastructure, R&D, investments, human resource development, and brand positioning. * The Department of Pharmaceuticals is implementing several Central Sector schemes for promotion. * A portal has been created to monitor action taken with the stakeholder Departments/Ministries as well as the central drugs regulator. * **Production Linked Incentive (PLI) Scheme:** * Budgetary outlay of ₹3,420 crore. * Five-year performance-linked incentive period from FY2022-23 to FY2026-27. * Incentives for incremental sales of domestically manufactured devices in specific segments. * As of September 2025, 22 greenfield projects commissioned, producing 55 products. * Cumulative eligible sales of ₹12,344.37 crore, including export sales of ₹5,869.36 crore, till September 2025. * **Scheme for Promotion of Medical Devices Parks:** * Aims to provide easy access to world-class infrastructure. * Three parks approved and at an advanced stage of development in Greater Noida, Ujjain, and Kanchipuram. * Total project cost of ₹871.11 crore, with ₹100 crore Central assistance for each park. * As of November 2025, ₹180 crore out of ₹300 crore has been released for the three parks. * Civil construction for the three parks is at the final stages. * As of September 2025, 194 medical devices manufacturers have been allotted land in the three parks in a 298.58-acre area and 34 units have commenced construction of their plants. * **Scheme for Strengthening Medical Device Industry:** * Launched on 8.11.2024 with a financial outlay of ₹500 crore. * Aims to strengthen the industry by providing support in critical areas. * Includes support for manufacturing, skill development, clinical studies, infrastructure, and promotion. * Consists of five sub-schemes: Common Facilities for Medical Devices Clusters; Marginal Investment Scheme for Reducing Import Dependence; Capacity Building and Skill Development for Medical Devices; Medical Device Clinical Studies Support Scheme; and Medical Device Promotion Scheme. **Impact Analysis** **Medical Device Manufacturers:** * **Impact:** Benefit from financial incentives, improved infrastructure, and skill development programs. * **Action Required:** Participate in the PLI scheme, establish units in medical device parks, and leverage support under the Scheme for Strengthening Medical Device Industry. **Medical Device Industry:** * **Impact:** Enhanced competitiveness, reduced import dependence, increased exports, and overall growth. * **Action Required:** Collaborate with the government on policy implementation and participate in relevant schemes. **Central and State Governments:** * **Impact:** Successful implementation of national policies, economic growth, and job creation. * **Action Required:** Ensure timely release of funds, effective monitoring of schemes, and collaboration with stakeholders. **Hospitals and Healthcare Providers:** * **Impact:** Access to domestically manufactured, high-quality medical devices. * **Action Required:** Consider sourcing domestically manufactured medical devices to support local industry and reduce healthcare costs.

Key Entities Referenced

National Medical Devices Policy, 2023: A policy aimed at facilitating the growth and development of the medical device sector in India. Department of Pharmaceuticals: The department responsible for implementing schemes related to the promotion of domestic medical device manufacturing. Production Linked Incentive (PLI) scheme for promoting domestic manufacturing of Medical Devices: A scheme providing financial incentives for incremental sales of domestically manufactured medical devices. Scheme for Promotion of Medical Devices Parks: A scheme providing access to common infrastructure facilities for medical device units in medical device parks, with approved parks in Uttar Pradesh, Madhya Pradesh and Tamil Nadu. Scheme for Strengthening Medical Device Industry: A scheme aimed at strengthening the medical device industry through support in critical areas, including manufacturing of key components and accessories, skill development, support for clinical studies, development of common infrastructure, and industry promotion.
Official Source Record View Original Source →
See Full Document Text
Ministry of Chemicals and Fertilizers : Department of Pharmaceuticals Implementation of the National Medical Devices Policy, 2023 प्रव तथ: 05 DEC 2025 4:24PM by PIB Delhi The National Medical Devices Policy, 2023 aims to facilitate growth of the medical device sector and guide its development through a set of strategies across six key areas, namely, regulatory streamlining, enabling infrastructure, facilitating research and development and innovation, attracting investments in the sector, human resource development, and brand positioning and awareness creation. For implementation of the strategies envisaged under the National Medical Devices Policy, 2023, the Department of Pharmaceuticals is implementing several Central Sector schemes for the promotion of domestic medical device manufacturing, besides working closely with the stakeholders, within the Government, as well as the industry and academia. A portal has also been created to monitor action taken with the stakeholder Departments/Ministries as well as the central drugs regulator. As a result of these measures, the Indian medical device industry is growing rapidly in global competitiveness, and export of medical devices has increased form US$ 2.9 billion in FY2021-22 to US$ 4.1 billion in FY2024-25. Government of India has taken several measures to reduce import dependence, which includes the following: i. Production Linked Incentive (PLI) scheme for promoting domestic manufacturing of Medical Devices: This scheme has a 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. As of September 2025, 22 greenfield projects have been commissioned and production has started for 55 products, which include high-end medical devices on which the country has been highly import-dependent, such as linear accelerators, machines for MRI and CT scans and mammograms, C-arm X-ray machines, MRI coils and ultrasound machines. Till September 2025, cumulative eligible sales of ₹12,344.37 crore have been made under the scheme, including export sales worth ₹5,869.36 crore. ii. Scheme for Promotion of Medical Devices Parks: The scheme aims to provide easy access to world- class, common infrastructure facilities to medical device units set up in medical device parks. Under this 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) districts. The total project cost of these is ₹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. As of November 2025, out of a total of ₹300 crore for the three parks, a total of ₹180 crore stood released. Civil construction for the three parks is at the final stages. As of September 2025,194 medical devices manufacturers have been allotted land in the three parks in a 298.58-acre area and 34 units have commenced construction of their plants. iii. Scheme for Strengthening Medical Device Industry: This scheme has been launched on 8.11.2024 with a financial outlay of ₹500 crore. It aims to strengthen the medical device industry by providing support in critical areas, including manufacturing of key components and accessories, skill development, support for clinical studies, development of common infrastructure, and industry promotion and consists of the following sub-schemes: 1. Common Facilities for Medical Devices Clusters; 2. Marginal Investment Scheme for Reducing Import Dependence; 3. Capacity Building and Skill Development for Medical Devices; 4. Medical Device Clinical Studies Support Scheme; and 5. Medical Device Promotion Scheme. This information was given by Union Minister of State in the Ministry of Chemicals and Fertilizers, Smt. Anupriya Patel, in a written reply in Lok Sabha today. ****** PC/GS/SG (रलीज़ आईडी: 2199431) आगंतुक पटल : 388 इस वज्ञ को इन भाषाओ ंम पढ़: Urdu , ही

Continue your research