DoP Releases Rs 500 Crore Operational Guidelines for Strengthening of Medical Device Industry Scheme
New Delhi: The Department of Pharmaceuticals (DoP) has released the operational guidelines for the newly launched Strengthening of Medical Device Industry (SMDI) scheme. With an allocated budget of Rs 500 crore, the scheme will be active from FY 2024-25 to FY 2026-27.
The initiative aims to enhance domestic production, reduce import reliance, and elevate India’s standing in the global medical device market.
The SMDI scheme targets critical needs within the medical device industry across 5 key components:
1. Common Facilities for Medical Device Clusters: With a budget of Rs 110 crore, this component offers financial assistance to medical device clusters, enabling them to establish essential common facilities such as R&D labs, sterilization centers, and compliance facilities. Eligible projects can receive up to Rs 20 crore or 70% of project costs, while Rs 5 crore is designated for testing facilities. This measure aims to strengthen infrastructure and support manufacturing quality improvements.
2. Marginal Investment Scheme for Reducing Import Dependence: Allocated Rs 180 crore, this component incentivizes the domestic manufacturing of essential components, reducing reliance on imports. The scheme supports manufacturers producing medical-grade materials and other critical inputs. Grants of up to Rs 10 crore (or 20% of investment) will be awarded to private entities, while government entities will receive a 20% project cost subsidy. Exemptions from Global Tender Enquiry (GTE) requirements apply to 354 medical devices due to limited domestic production capabilities, and this sub-scheme specifically targets decreasing such dependencies.
3. Capacity Building and Skill Development: With Rs 100 crore allocated, this component aims to bridge the skills gap in the medical device industry. Through this sub-scheme, financial aid will support postgraduate, diploma, and skill development courses in medical device technology across government institutes. Component A targets postgraduate courses, covering up to 75% of expenses with a maximum of Rs 21 crore per course, while Component B funds short-term training programs, providing Rs 25,000/month per student for diploma programs and Rs 10,000/month for certificate programs. This initiative is expected to generate a workforce well-versed in medical technology, fulfilling industry needs.
4. Medical Device Clinical Studies Support Scheme: This scheme component, backed by Rs 100 crore, provides financial assistance for clinical trials and safety evaluations, including animal studies, for new medical devices. The support varies, offering up to Rs 5 crore for clinical investigations and Rs 1 crore for post-market surveillance. By aiding manufacturers in meeting clinical standards, this component aims to foster trust in Indian-made devices on global platforms.
5. Medical Device Promotion Scheme: Aimed at enhancing the “Made in India” brand in the medical devices sector, this component, with a budget of Rs 10 crore, will fund industry promotions, seminars, trade expos, and international study missions. Financial support will also be extended to industry associations for promoting collaboration and information sharing, including organizing the annual India Medical Devices Meet and Medtech Expo.
Governance and Monitoring
To ensure robust governance, the scheme includes the formation of two key committees:
- Scheme Steering Committee (SSC): This committee, chaired by the Secretary of DoP, will evaluate and approve proposals, reallocate funds across components, and provide policy guidance. Members include officials from the DoP, Ministry of MSME, and representatives from related sectors.
- Technical Committee: This committee will offer technical assessments for submitted proposals, monitor ongoing projects, and advise the SSC. It includes members from the Central Drugs Standard Control Organization (CDSCO) and experts from industry and academia.
The Project Management Agency (PMA) will oversee the scheme's implementation, ensuring projects meet their targets and deadlines. PMA responsibilities also include identifying delays, implementing corrective actions, and coordinating with the SSC for monitoring and evaluation.
The DoP envisions the SMDI scheme to create a lasting impact on India’s medical device landscape, aiming to:
- Enhance domestic manufacturing, thus lowering import dependence, which currently stands at approximately 70%.
- Increase global competitiveness of India’s medical devices by improving product quality, safety, and efficacy.
- Build an ecosystem conducive to R&D and innovation by establishing common testing and research facilities.
- Promote skill development to produce industry-ready professionals equipped for the medical device sector.
With this initiative, the DoP aims to fulfill unmet domestic demands and reduce import dependence in critical areas such as medical-grade materials, components, and testing facilities.
Application and Disbursement Process
Eligible organizations, including central/state government entities and private institutions, can apply for grants through the PMA. Funds will be released in stages, depending on project milestones. Extensions will be granted only if delays are caused by external factors.
To view the original guidelines, click on the link below:
