Context:

Recently, the Union Minister for Chemicals & Fertilizers and Health & Family Welfare launched the Scheme for Strengthening the Medical Device Industry.

About the Scheme 

• It is a comprehensive scheme, covering the manufacturing of key components and accessories, skill development, support for clinical studies, development of common infrastructure and industry promotion.
• The scheme has an initial outlay of Rs. 500 crore for three years from 2024-25 to 2026-27.
• The new scheme consists of five sub-schemes which are as follows:

Common Facilities for Medical Devices Clusters: 

• The Central Government will provide financial assistance to medical device clusters for creating common infrastructure facilities such as R&D labs, Design and Testing centres, Animal Labs etc. for the manufacturers located in the cluster.
• Grant of up to Rs. 20 Crore will be provided for Common Facilities and up to Rs. 5 crore for Testing Facilities.

Marginal Investment Scheme for Reducing Import Dependence: 

• It will strengthen the MedTech supply chain in the country. 
• It will also help to reduce dependence on imported components. Currently, most raw materials and key components are imported, making Indian manufacturers reliant on external supplies for medical device production.
• It offers a one-time capital subsidy of 10-20%, with a maximum cap of Rs 10 crore per project.

Capacity Building and Skill Development for Medical Devices:

• Its goal is to develop a skilled technical workforce capable of designing and developing MedTech products.
• It also provides financial support up to Rs.21 crore for Masters’ courses in central government institutions, Rs. 10,000 per candidate for short-term courses and Rs. 25,000 per candidate for Diploma courses to National Council for Vocational Education and Training (NCVET) approved institutes.

Medical Device Clinical Studies Support Scheme

• It will assist both established companies and start-ups in conducting clinical studies.
• Financial support of upto Rs 2.5 Crore will be provided for animal studies
• Financial support for Clinical investigation of investigational devices and post-market clinical follow-ups: Upto Rs 5 Crore 
• Upto Rs 1 Crore can be granted for clinical performance evaluations of new in-vitro diagnostic products.

Medical Device Promotion Scheme

• It aims to support industry associations and export councils by providing financial assistance to organize conferences and other events that promote medical device-related activities.

India’s Position in Medical Device Industry

• India’s medical device market is valued at approximately $14 billion and is expected to grow to $30 billion by 2030.
• India is the 4th largest Asian medical devices market after Japan, China, and South Korea, and among the top 20 medical devices markets globally.

Recent investments in the medical device sector

• In March 2024, the centre inaugurated 27 Greenfield Bulk drug park projects and 13 Greenfield Manufacturing Plants for Medical Devices under the Product Linked Incentive (PLI) scheme.
• In December 2023, MedTech Mitra, an online platform was launched to support medtech innovators with clinical assessment, regulatory help, and product adoption.