List of Technologies supported and issued by ICMR to foster Indigenous manufacturing of medical devices

The Indian Council of Medical Research (ICMR) plays a crucial role in supporting and fostering the development and indigenous manufacturing of medical devices in India. Through various initiatives and programs, ICMR aims to promote innovation, research, and technology development in the medical device sector to reduce dependency on imports, ensure better healthcare delivery, and boost the Make in India initiative.

Here’s a list of key technologies and programs supported and issued by ICMR to foster the indigenous manufacturing of medical devices:

1. ICMR – National Medical Device Promotion and Incubation Center (NMDPIC):

The NMDPIC is an initiative by the ICMR to foster and support startups, entrepreneurs, and SMEs in the medical device sector. It helps in incubating, mentoring, and accelerating the development of indigenous medical technologies. The center provides support in various stages, from concept development to commercialization.

• Key Focus Areas:
  • Support for the design and development of medical devices
  • Providing infrastructure for testing and validation of products
  • Facilitating regulatory approvals and clinical trials in collaboration with the CDSCO (Central Drugs Standard Control Organization)
  • Encouraging collaboration between academia, industry, and government bodies

2. Biomedical Devices Innovation Hub (BMDIH):

The Biomedical Devices Innovation Hub is an ICMR-supported program aimed at creating an innovation ecosystem for the development of advanced biomedical devices in India. The initiative helps in the development, testing, and certification of innovative medical devices and ensures their alignment with international standards.

• Focus Areas:
  • Encouraging research and innovation in medical technologies such as diagnostic devices, prosthetics, and therapeutic devices
  • Networking and partnerships between industry, academia, and research institutions to promote technological advancements
  • Promoting the intellectual property (IP) development of innovative devices

3. Indian Medical Devices Technology Assessment (IMDTA):

The IMDTA program focuses on assessing and evaluating new medical technologies and devices before they enter the market. ICMR works with healthcare professionals, regulatory bodies, and industry players to ensure the devices are safe, effective, and meet regulatory requirements.

• Key Objectives:
  • Provide scientific and technical assessment of innovative medical technologies
  • Assess the clinical efficacy of new devices
  • Promote the development of evidence-based medical devices tailored to local needs and conditions

4. Supporting Research for Medical Device Innovation through Funding Programs:

ICMR provides financial support to medical device startups, research organizations, and academic institutions for developing indigenous medical technologies. These programs help in fostering innovation in areas such as biomaterials, nanotechnology, AI in healthcare, and point-of-care diagnostics.

• Key Funding Programs:
  • Research grants for innovative ideas in medical device technology
  • Seed funding and early-stage investment for startups and SMEs involved in the medical device sector
  • Support for clinical trials and regulatory approvals for new devices
  • Partnerships with both private industry and government entities to co-fund R&D efforts

5. Development of Diagnostic and Imaging Technologies:

ICMR has supported the development of diagnostic devices and imaging technologies to improve the quality of healthcare. This includes low-cost diagnostic devices that can be used in remote areas to provide rapid, accurate, and affordable diagnosis.

• Technologies Supported:
  • Portable ultrasound devices
  • Smart diagnostic tools that use AI for faster diagnosis (e.g., AI-powered blood analysis devices)
  • Point-of-care diagnostics for diseases such as TB, diabetes, and cardiovascular diseases

6. Medical Device Testing and Certification Support:

ICMR has developed collaborations with testing laboratories, research organizations, and regulatory bodies to ensure that locally developed medical devices meet both Indian and international standards.

• Focus Areas:
  • Testing services for validating device safety, efficacy, and performance
  • Regulatory facilitation through the National Accreditation Board for Testing and Calibration Laboratories (NABL) and CDSCO
  • Support for clinical trials to evaluate the clinical performance of devices

7. ICMR Guidelines for Medical Device Design:

ICMR, in collaboration with Bureau of Indian Standards (BIS) and other regulatory bodies, issues guidelines for the design, development, and manufacturing of medical devices in India. These guidelines focus on safety, quality, and compliance with regulatory standards.

• Key Aspects Covered in the Guidelines:
  • Design specifications for a range of devices, including diagnostic kits, implants, and therapeutic devices
  • Clinical performance standards to ensure medical devices are effective and safe
  • Biocompatibility and environmental sustainability of medical devices

8. ICMR-Medical Device and Technology Development Fund (MDTF):

The MDTF is a dedicated fund established by ICMR to provide financial support to researchers, innovators, and companies developing advanced medical technologies. The goal of this fund is to reduce the reliance on foreign-made devices and promote the development of cost-effective and innovative solutions in the medical device sector.

• Key Support Areas:
  • Development of cost-effective diagnostic tools
  • Innovative surgical devices and implants
  • Affordable medical technologies suitable for use in resource-limited settings
  • Support for commercialization of innovative products

9. Collaboration with the Department of Biotechnology (DBT):

ICMR collaborates with the DBT to support biotechnology-based medical devices. This includes technologies like biomedical sensors, nanomedicines, and biomaterials that are being used to create next-generation medical devices.

• Technologies in Focus:
  • Nanotechnology in drug delivery systems
  • Biocompatible sensors for monitoring health conditions
  • Development of biosensors for detecting pathogens or diseases

10. Promoting Research on Personalized Medicine and Medical Devices:

ICMR is also encouraging research on personalized medicine, which requires tailored medical devices for individual patients. This includes the development of implantable devices, smart prosthetics, and personalized diagnostic tools that can be customized based on genetic, environmental, or lifestyle factors.

11. Collaborative Programs with International Agencies:

ICMR collaborates with global organizations such as the World Health Organization (WHO), USAID, and Bill & Melinda Gates Foundation to promote the development of innovative and affordable medical devices. These collaborations help in aligning Indian medical devices with global standards and ensuring their acceptance in international markets.