Lok Sabha Question No. 766 (UNSTARRED), answered on 2024-11-29
Subject: Domestic Production of Medical Devices
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Putta Mahesh Kumar

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

LOK SABHA UNSTARRED QUESTION NO. 766 TO BE ANSWERED ON THE 29 TH  NOVEMBER 2024

## Domestic Production of Medical Devices

## 766. Shri Putta Mahesh Kumar:

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

- (a) the details regarding the schemes/programmes/initiatives undertaken by the Government to increase domestic production of medical devices in the country;
- (b) the details regarding the total funds allocated and utilised by the Government over the last five  years  to  increase  domestic  production  of  medical  devices  in  the  country,  State-wise especially in Andhra Pradesh;
- (c) the status of proposed, under construction and presently functional medical device parks across India;
- (d) whether the Government has identified places to set up medical parks, if so, the details thereof and status of the same;
- (e) whether the Government has initiated any steps to incentivise the domestic production of medical devices in the country, if so, the details thereof; and
- (f) whether the Government has undertaken any activities/campaigns for promoting use and manufacture of domestically produced medical devices, if so, the details thereof?

## ANSWER

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

- (a), (c), (d) & (e):   India is one of the fastest growing markets in the global medical devices industry, expected to grow at a CAGR of about 15 per cent. India is the fourth largest Asian medical devices market after Japan, China, and South Korea and among the top twenty global medical devices markets in the world. The Government of India has taken several measures to encourage domestic manufacturing and steady supply of medical devices in the country. The schematic interventions to support domestic manufacturing of medical devices are as follows:
- (i)      Production  Linked  Incentive  Scheme  for  Promoting  Domestic  Manufacturing  of Medical Devices (PLI MD): The Union Cabinet approved proposal on 20.03.2020 with the objective of the Scheme to boost domestic manufacturing and attract large investments in the Medical Devices Sector. The production tenure of the scheme is from FY 2020-2021 to FY 2027-28 with total financial outlay of Rs. 3,420 crores. The scheme provides for  financial incentive  to  selected  companies  at  the  rate  of  5%  on  incremental  sales  of  medical  devices manufactured in India and covered under the four target segments of the scheme, for a period of  five  (5)  years.  32  applicants  have  been  selected  under  the  scheme.  Against  committed investment of Rs. 1,356.94 crore, out of which investment worth Rs 1057.47 crores has been realized. The cumulative sales made by the applicants under the scheme is Rs 8039.63 crores (which includes exports worth Rs 3,844.01 crores) upto September, 2024.

(ii)    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 2020-2021 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.  Civil works in all the other three  parks  (except  Himachal  Pradesh) has  progressed well with  most of the structures for housing equipment for Common Infrastructure Facility (CIF) constructed, while procurement of equipment is in progress.

Medical Device park at Himachal Pradesh was facing funding issues from the state government side. It appears that due to cost overrun it did not remain feasible for the state government  to  implement  the  park  within  the  framework  of  the  scheme  guidelines  of  the department,  despite  all  support  available  from  the  department  and  Rs.  30  crores  already released to the state.  Hence, the proposal for setting up of the Medical Device Park at Nalagarh has been withdrawn by the State Government.

## (iii) New scheme for Strengthening Medical Device Industry launched on 8.11.2024

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-scheme of the scheme is as given below:-

- (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
- (b) Funds  have  not  been  allocated  under  the  schemes  on  a  state-wise  basis.  Under ' Production  Linked  Incentive  Scheme  for  Promoting  Domestic  Manufacturing  of Medical Devices ', the funds allocated in five years upto 2024-25 are Rs. 160 crore and funds utilized in five years are Rs. 57.11 crore upto 2023-2024. The funds allocated is Rs. 22.50 crore and Rs. 22.50 crore are utilized under the scheme ' Assistance to Medical Device Industry for Common Facility Centre ' to AMTZ, Government of Andhra Pradesh upto 2021-2022 . The funds allocated is Rs. 367 crore upto 2024-2025 and Rs. 120 crore are utilized under the scheme ' Promotion of Medical Device Parks' upto 2023-2024 .
- (f): Initiatives have been taken to promote the sector through events, workshops, and mega events like India Medical Device 2023 and India MedTech Expo2023. The India MedTech Expo 2023 was organized by the Department of Pharmaceuticals, from 17th-19th August 2023 at the Helipad Exhibition Centre in Gandhinagar, Gujarat. With the theme 'India: The Next MedTech  Global  Hub  -  Future  of  Devices,  Diagnostics,  and  Digital'.  The  Expo  brought together key stakeholders of the medical devices ecosystem, including start-ups, MSMEs, large industries,  hospitals,  government  agencies,  R&D  institutions,  and  academia.  The  event successfully showcased India's medical device prowess and promoted the domestic medical device industry. A total of 225 companies participated in the Expo, representing sectors like Medical  Equipment,  Diagnostics, Imaging,  Home  Medical  Electronics,  Physiotherapy, Orthopedic Devices, Laboratory Equipment, and so on. International Buyer Seller meets were

organized. A total of 217 international delegates from 50 countries visited the Expo.  A total of 4909 business meetings were conducted over a span of 3-day event by the 225 exhibitors.

The new sub-scheme of the department - Medical Device Promotion Scheme aims to facilitate the  growth and development of the medical devices sector in India by supporting activities such as study and survey reports, awareness programs etc.

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