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5-Aug-2022: Medical Device Parks

The Department implements the scheme “Promotion of Medical Devices Parks”, with a total financial outlay of Rs. 400 crore and the maximum assistance under the scheme for one Medical Device Park would be limited to Rs. 100 crore. The tenure of the scheme is from FY 2020-2021 to FY 2024-2025 and the selected Medical Device Park project will be implemented by a State Implementing Agency (SIA).  Under the scheme, Department of Pharmaceuticals has received proposals from 16 States/Union Territories.  The proposals were evaluated as per the criteria given in the scheme guidelines and final approval for financial assistance of Rs. 100 crore each has been given to the States of Uttar Pradesh, Tamil Nadu, Madhya Pradesh and Himachal Pradesh.  There is no proposal to establish more medical device parks in the Country, under the scheme.

Further, the Department has provided grant-in-aid to the project of the Superconducting Magnet Testing, Validation and Integration Centre at AMTZ, Andhra Pradesh under the scheme “Assistance to Medical Device Industry for Development of Common Facility Centres”.

The Government of India has taken several measures to encourage domestic manufacturing of Pharmaceutical drugs including bulk drugs and medical devices to reduce import dependence. The Programmatic interventions to support Pharma and Medical Devices Industries are as follows;

  1. The Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) in India, with a financial outlay of Rs. 6,940 crores and the tenure from FY 2020-2021 to FY 2029-30, provides for financial incentive for 41 identified products. A total of 51 applicants have been selected under the scheme.
  2. The Production Linked Incentive Scheme for Pharmaceuticals, with a financial outlay Rs. 15,000 crores and the tenure from FY 2020- 2021 to FY 2028-29, provides for financial incentive to 55 selected applicants for manufacturing of identified products under three categories for a period of six years, including five (5) industry applicants selected for In-vitro diagnostic medical devices.
  3. The Scheme for Promotion of Bulk Drug Parks, with a financial outlay of Rs. 3,000 crores and the tenure from FY 2020-2021 to FY 2024-25, provides for financial assistance to three States for establishing Bulk Drug Parks. The proposals received are under evaluation.
  4. The Department has launched the scheme of Strengthening of Pharmaceutical Industry (SPI), with a financial outlay of Rs. 500 crores and the tenure from FY 2021-2022 to FY 2025-26 and this scheme has three components, to provide infrastructure support for pharma MSMEs in clusters and to address the issues of technology upgradation of individual pharma MSMEs.
  5. Under the scheme “Promotion of Medical Devices Parks”, final approval for financial assistance of Rs. 100 crore each, has been given to the States of Uttar Pradesh, Tamil Nadu, Madhya Pradesh and Himachal Pradesh for establishment of common facilities in their Medical Device Parks.
  6. Further, under the sub-scheme “Assistance to Medical Device Industry for Common Facility Centre”, grant-in-aid of ₹ 25 crore was provided to Andhra Pradesh MedTech Zone Ltd. (AMTZ), Andhra Pradesh for establishment of Common Facility for Super conducting magnetic coil testing and research facility.
  7. The Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of Medical Devices, with a financial outlay of Rs.3,420 Cr and with the tenure from FY 2020-21 to FY 2027-28, provides for financial incentives to selected companies at the rate of 5% of 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.  A total of 21 Applicants have been selected under the scheme.

The non-schematic interventions are as follows:

  1. In order to attract investments in this sector, the Government has allowed 100% foreign direct investments (FDI) in medical devices sector. Similarly, the Government has allowed 100% FDI in pharma sector for greenfield projects under automatic route. For the brownfield projects, upto 74%, FDI investments are allowed under automatic route and beyond 74% to 100%, FDI investments are allowed under government approval route.
  2. To redress the specific challenges of the MedTech Industry, in view of the diversity and multi-disciplinary nature of the sector, the institutional mechanism of Standing Forum of Medical Devices Associations, has been set up to deliberate on various issues with all the stakeholders including regulators.

24-Sep-2021: Scheme for “Promotion of Medical Device Parks”, a key initiative to support the medical devices, notified

In a bold move that would make India ‘Aatmanirbhar’, the Government of India has taken a key initiative to support the medical devices industry to reach its potential in the coming years identifying the industry is as a sunrise sector with great potential for diversification and employment generation. Recognizing the need for higher levels of investments for the creation of proper infrastructure in the sector, the Department of Pharmaceuticals has notified the Scheme for “Promotion of Medical Device Parks” with the following objectives:

  1.  Easy access to standard testing and infrastructure facilities through creation of world class common infrastructure facilities for increased competitiveness will result into significant reduction of the cost of production of medical devices leading to better availability and affordability of medical devices in the domestic market.
  2. Reaping the benefits arising due to optimization of resources and economies of scale.

The Medical Devices Parks to be developed under the scheme will provide common infrastructure facilities at one place thereby creating a robust ecosystem for the medical device manufacturing in the country and also reducing the manufacturing cost significantly. The total financial outlay of the scheme is Rs. 400 crore and the tenure of the scheme is from FY 2020-2021 to FY 2024-2025. The financial assistance to a selected Medical Device Park would be 70% of the project cost of common infrastructure facilities. In case of North Eastern States and Hilly States, financial assistance would be 90% of the project cost. Maximum assistance under the scheme for one Medical Device Park would be limited to Rs. 100 crores.

In total, proposal from 16 States/UTs were received under the scheme. The selection of the States/UTs is based on the challenge method, which is reflected in the evaluation criteria of the scheme. The ranking methodology for States/UTs is based on the parameters prescribed in the scheme guidelines such as utility charges, State policy incentives, total area of the park, land lease rate, connectivity of the park, ease of doing business ranking, availability of technical manpower etc. Based on the evaluation, the proposals of State Government of Himachal Pradesh, Tamil Nadu, Madhya Pradesh and Uttar Pradesh have been given “in-principle” approval under the scheme. Further qualitative assessment of the said States in terms of their fiscal capability, ecosystem attractiveness and industrial presence also validated the selection of these States.

The scheme reflects the spirit of co-operative federalism where the Central Government and State Governments will partner to develop the Medial Device parks for better performance of the sector.   

22-Sep-2020: Government to set up Medical Devices Park in Kerala

Kerala will soon house one of the first medical device parks in the country, focusing on the high-risk medical device sector to provide full range of services for the medical devices industry like R&D support, testing, and evaluation.

MedSpark, the medical devices park envisaged as a joint initiative of Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), an autonomous institute of the Department of Science and Technology (DST), Govt. of India, and the Kerala State Industrial Development Corporation Ltd (KSIDC), the industrial and investment promotion agency of the Government of Kerala is going to be established in the Life Science Park, Thonnakkal, Thiruvananthapuram.

This medical device park will stand out with its emphasis on the high-risk medical device sector involving medical implants and extracorporeal devices, in which SCTIMST scores with its knowledge.

The Medical Devices Park will create an enabling support system for R&D, testing and evaluation of medical devices, manufacturing support, technology innovation, and knowledge dissemination, all of which are the full range of services that the medical devices industry seeks. These services can be utilized by the medical device industries located within the MedSpark as well from other parts of India. This will benefit small and medium-sized medical devices industries, which dominate the medical devices sector.

Pinarayi Vijayan, Chief Minister, Government of Kerala, will lay the foundation stone for Medical Devices Park on Thursday, 24th September 2020.

“Sree Chitra has made substantial contributions to the biomedical devices sector over the last 30 or more years and has established itself as a pioneer in this field. This is a milestone for biomedical devices industry in the country and is fully aligned with the Honorable Prime Minister’s Vision of Aatmanirbhar Bharat”, said Dr. VK Saraswat, NITI Aayog Member and the President of SCTIMST.

“The aspect that will distinguish this Medical Device Park from the few other similar projects proposed in the country is that it will focus on the high-risk medical device sector involving medical implants and extracorporeal devices, the domain in which SCTIMST has considerable expertise and experience,” Prof. Ashutosh Sharma, Secretary DST commented.

“The park is being established under the Technical Research Centre for Biomedical devices program of the DST, through a knowledge partnership with KSIDC, Government of Kerala, tapping the ecosystem that exists in the city with several research and academic institutions and health care centers. It was possible with the support of various departments of the Central Government and Niti Aayog,” said Dr. Asha Kishore, Director, SCTIMST.

MedSpark can leverage the existing advantage of the Kerala State in the high-risk medical device manufacture and develop it into the most sought after destination for setting up medical device industry in India.

Currently, Kerala has a number of medical device companies with an annual turnover in excess of Rs. 750 crores, most of them operating with technologies transferred from SCTIMST.

When completed, the MedSpark will have:

  • A Medical Device Testing & Evaluation Centre accredited to international agencies
  • An R&D Resource Centre for facilitating R&D in medical device domain, the services of which would be shared by the entities within the Park
  • A centralised Knowledge Centre for skill up-gradation with facilities for conducting training and providing support on regulatory issues, clinical trials, etc.
  • A Technology Business Incubation Centre for promoting start-ups and early-stage companies
  • A set of Modular Manufacturing Units for lease by the industries coming to the park or land modules for setting up manufacturing units
  • The business model for the MedSpark is self-sustaining in which its operational expenses will be generated from its revenue streams. Funding from the state and central governments (both Kerala State and Central) through various schemes will meet the capital expenditure and deficit in income against expenses during the initial stages
  • It is expected that the project would provide direct employment to 1200 people. Besides, employment generation up to 4000 – 5000 jobs through the supporting industries like OEM suppliers, service providers, and marketing/post marketing support activities.

21-Mar-2020: Cabinet approves promotion of the Domestic Manufacturing of Medical Devices in country

The Union Cabinet chaired by the Prime Minister, Shri Narendra Modi has approved the following schemes:

  1. The scheme on Promotion of Medical Device Parks for financing Common Infrastructure Facilities in 04 Medical Device Parks with financial implications of Rs. 400 crore.
  2. The   Production   Linked   Incentive (PLI) Scheme   for   promoting   domestic manufacturing of medical devices with financial implications of Rs. 3,420 crore.

The expenditure to be incurred for the above schemes will be for the next five years i.e. from 2020-21 to 2024-25.

Details:

  1. Promotion of Medical Device Parks
  2. Medical Device is a growing sector and its potential for growth is the highest among all sectors in the healthcare market. It is valued at Rs. 50,026 crore for 2018-19 and is expected to reach to Rs. 86,840 crore by 2021-22. India depends on imports up to an extent of 85% of total domestic demand of medical devices.
  3. The Scheme aims to promote Medical Device Parks in the country in partnership with the States. A maximum grant-in-aid of Rs.100 crore per park will be provided to the States.
  4. Production Linked Incentive Scheme
  5. The Medical Device sector suffers from a cost of manufacturing disability of around 12% to 15%, vis-a-vis competing economies, among other things, on account of lack of adequate infrastructure, domestic supply chain and logistics, high cost of finance, inadequate availability of quality power, limited design capabilities and low focus on R&D and skill development, etc. There is, thus, a need for a mechanism to compensate for the manufacturing disability.
  6. The Scheme aim to boost domestic manufacturing by attracting large investments in medical device sector. Under the Scheme, incentive @ 5% of incremental sales over base year 2019-20 will be provided on the segments of medical devices identified under the Scheme.

Implementation: The Scheme for Promotion of Medical Device Parks will be implemented by a State Implementing Agency(SIA). The PLI Scheme for promoting domestic manufacturing will be implemented by a Project Management Agency(PMA) to be nominated by Department of Pharmaceuticals. The target is to provide financial assistance for Common Infrastructure Facilities for 04 Medical Device parks. The target for PLI Scheme is to provide assistance to about 25-30 manufacturers under the following categories of medical devices: -

  1. Cancer care/Radiotherapy medical devices,
  2. Radiology & Imaging medical devices (both ionizing & non-ionizing   radiation products) and Nuclear Imaging Devices,
  3. Anesthetics & Cardio-Respiratory medical devices including Catheters of Cardio Respiratory Category & Renal Care Medical Devices and
  4. AII Implants including implantable electronic devices like Cochlear Implants and Pacemakers.

Impacts: Under the sub-scheme for Promotion of Medical Device Parks, Common Infrastructure Facilities would be created in 4 Medical Device Parks, which is expected to reduce manufacturing cost of medical devices in the country.

The PLI Scheme for promoting domestic manufacturing of Medical Devices would boost domestic manufacturing and attract large investments in the medical device sector, particularly in the identified target segments. It will lead to expected incremental production of Rs. 68,437 crore over a period of five years. The Schemes will lead to generation of additional employment of 33,750 jobs over a period of five years.

The Schemes will lead to substantial reduction in import of target segments of medical devices.