The Department of Pharmaceuticals (DoP) has revised the incentive offered to the clinical investigations conducted through the Medical Device Clinical Studies Support (MDCSS) Scheme under the Scheme for Strengthening of Medical Devices Industry (SMDI), to enhance its support to the medical devices firms with lower average turnover for preceding two years.
The DoP has said that it is modifying the operational guidelines for the sub-scheme of MDCSS based on a decision taken in the first meeting of the Scheme Steering Committee (SSC) of this sub-scheme, held on November 21, 2025.
In the operational guidelines, where it explains the financial support provided for conducting clinical investigation, clinical performance evaluation, post market follow-up study and animal studies to the eligible applicants, the existing condition was that the Department will provide Rs. 5 crore or 25% of the expenditure incurred, whichever is less, for clinical investigations, as grant on reimbursement basis.
However, the Department has now modified this criterion to add that "... in case of an applicant who has an average turnover of not more than Rs. 10 crore in the preceding two financial years, it shall be Rs. 5 crore or 70% of the expenditure incurred, whichever is less. The same has also been included in the schedule of release of grant, in the same guidelines, to bring in clarity towards release of grant in such cases.
The other criteria related to the incentive, including for the pre-clinical studies, post market clinical follow-up, and performance evaluation of new in-vitro diagnostics (IVDs) remain the same.
According to the guidelines, for pre-clinical studies, Rs. 1 crore or 25% of the expenditure incurred - whichever is less - will be provided as grant on reimbursement, while for post market clinical follow-up and performance evaluation of new IVDs, it is Rs. 1 crore or 25% of the expenditure incurred, whichever is less.
Medical Device Clinical Studies Support Scheme is to assist both established companies and start-ups in conducting clinical studies. It is envisaged to support the medical device industry by fostering development of devices supported by clinical evidence and generation of clinical data that demonstrates the safety and efficacy of the devices manufactured in India.
This is expected to promote manufacturing of quality products with better efficacy and safety. It is also envisaged to enhance credibility of domestic manufacturers to produce high quality products, opening up opportunities for them in markets outside the country.
Recently, the DoP has invited applications under two sub-schemes - Marginal Investment Scheme for Reducing Import Dependence, and Medical Device Clinical Studies Support Scheme - to be submitted to the Life Sciences Sector Skill Development Council (LSSSDC), the authorised Project Management Agency of DoP.
The Union Budget 2026-27 has allocated Rs. 124.17 crore for SMDI, which is lower as compared to Rs. 360 crore allocated under the Budget Estimates for 2025-26. In the Revised Estimates for 2025-26, the allocation has seen over 50% reduction to Rs. 177.09 crore. The scheme has six sub-schemes, including Promotion of Medical Device Parks, Capacity Building and Skill Development for Medical Devices, Common Facilities for Medical Devices Clusters, Marginal Investment Scheme for Reducing Import Dependence, Medical Device Clinical Studies Support Scheme, and Medical Device Promotion Scheme.
The Central government introduced the scheme 'Strengthening of Medical Device Industry' on November 8, 2024, with five sub-schemes including merger of some of the prevailing schemes, with an outlay of Rs. 500 crore and tenure of the Scheme is three years from Financial Year 2024-25 to FY 2026-27.
The Common Facilities for Medical Devices Clusters, for creating common infrastructure facilities such as R&D labs, Design and Testing Centre, Animal Labs etc. for the manufacturers located in the cluster, was announced with an outlay of Rs. 110 crore, while for Marginal Investment Scheme for Reducing Import Dependence, designed to deepen the MedTech supply chain in the country by focusing on manufacturing of key components, raw materials, and accessories within the country, with an outlay of Rs. 180 crore.
The sub-scheme for Capacity Building and Skill Development for Medical Devices, focusing on capacity building and skill development for the medical device sector, and the Medical Device Clinical Studies Support Scheme were announced with an outlay of Rs. 100 crore each, while the final sub-scheme of Medical Device Promotion Scheme to support industry associations and exports councils by providing financial assistance to organize conferences and other events that promote medical device-related activities, was announced with an outlay of Rs. 10 crore.
Recently, the DoP has invited applications under two sub-schemes - Marginal Investment Scheme for Reducing Import Dependence, and Medical Device Clinical Studies Support Scheme - under the SDMI.
Proposals for the two sub-schemes are to be submitted to the Life Sciences Sector Skill Development Council (LSSSDC), the authorised Project Management Agency of DoP. Deadline for the submission of application was earlier fixed as 6 pm on January 10, 2026, which has now been extended to 6 pm on January 31, 2026. |