Lok Sabha Question No. 4810 (UNSTARRED), answered on 2025-03-28
Subject: Medical Device Industry
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Bunty Vivek Sahu

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

LOK SABHA UNSTARRED QUESTION NO. 4810 TO BE ANSWERED ON 28 th  MARCH, 2025

## Medical Device Industry

## †4810. Shri Bunty Vivek Sahu:

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

the salient features and objectives of the scheme to strengthen medical equipment industry along with the financial assistance provided in this regard?

## ANSWER

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

(SMT. ANUPRIYA PATEL)

The scheme for Strengthening of Medical Device Industry, with a financial outlay of ₹500 crore, was launched on 8.11.2024 with the objective 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 and consists of the following sub-schemes:

- (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; and
- (v) Medical Device Promotion Scheme.

Details  regarding  the  objectives  of  each  sub-scheme,  along  with  its  salient  features,  are  at Annexure. As on 18.3.2025, proposals involving provision of financial assistance to the tune of ₹190 crore have been approved in-principle.

## Annexure referred to in the reply to Lok Sabha Unstarred Q. No. 4810 for answer on 28.3.2025, raised by Shri Bunty Vivek Sahu

## Objectives and salient features of the sub-schemes of the Scheme for Strengthening of Medical Devices Industry

## 1. Common Facilities for Medical Device Clusters

Objectives:

- (a) To strengthen existing infrastructure; and
- (b) To ensure availability of testing facilities/laboratories for medical devices, against the backdrop of the  bringing  of medical  devices  under  a  licensing  regime  that  requires evaluation of medical devices on behalf of manufacturers

Salient features:

- (a) Provision  of  financial  assistance  to  medical  device  clusters  for  creating  common infrastructure  facilities,  boosting  domestic  manufacturing  capacity  and  improving cluster quality
- (b) Provision of support to any national or state level government or private institution to establish or strengthen testing facilities for medical devices

## 2. Marginal Investment Scheme for Reducing Import Dependence

Objective: To reduce import of medical devices

Salient features: Provision for marginal investment support, in the form of grant, to incentivise domestic manufacturing of essential/key specialised inputs/components, upstream materials, accessories or closely related products needed for domestic manufacturing of medical devices, which cannot be produced by the general industry and are often imported by medical device manufacturers

## 3. Capacity Building and Skill Development in Medical Device Sector

Objective: To meet the requirements of rapidly innovating multidisciplinary areas of medical technology and create research and development ecosystem for the sector by generating critical mass of trained human resource

Salient  features: Provision  of  financial  assistance  to  support  quality  teaching,  training  and nurturing of excellence in medical technology education

## 4. Medical Device Clinical Studies Support Scheme

Objective: To promote manufacturing of quality products with better efficacy and safety and to enhance  credibility  of  domestic  manufacturers  to  produce  high-quality  products  and  open opportunities for them in external markets

Salient features: Provision of financial support for conducting clinical investigations or preclinical animal studies for medical devices and clinical performance evaluation of new in vitro diagnostics

## 5. Medical Device Promotion Scheme

Objective: To promote the medical device industry by bringing industry leaders, academia and policymakers together to share their knowledge and experience for the overall development of the sector

## Salient features:

- (a) Financial support, in the form of grant, for industry bodies/associations and educational institutions to conduct meetings, seminars, workshops, events, roadshows, expos etc.;
- (b) Financial support for manufacturer evaluation studies, creation of database, international  study  missions  etc.  is  available  for  promotion  and  development  of  the medical device industry; and
- (c) Expenditure by the Department on industry development activities.

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