The Association of Indian Medical Device Industry (AiMeD) has welcomed the Department of Pharmaceuticals’ decision to relaunch applications under the Scheme for Strengthening of Medical Device Industry (SMDI), terming it an important step towards reducing import dependence and boosting indigenous manufacturing. The two sub‑schemes- the Marginal Investment Scheme for Reducing Import Dependence and the Medical Device Clinical Studies Support Scheme (MDCSS) are aimed at supporting innovation, strengthening domestic value chains and promoting the development of high‑value medical devices.
Rajiv Nath, Forum Coordinator, AiMeD, said the relaunched SMDI would directly benefit Indian manufacturers of critical components, raw materials and high‑value finished devices such as imaging equipment, implants, diagnostic kits and accessories. He noted that subsidies of up to ₹10 crore, along with dedicated support for clinical studies, would help reduce reliance on imports, deepen local value chains and encourage innovation across the sector. AiMeD appreciates the Department of Pharmaceuticals for operationalising these key sub‑schemes within the broader SMDI framework.
AiMeD has particularly welcomed the clinical studies support scheme, describing it as pivotal for enabling Indian manufacturers to develop and export more complex, higher‑value devices such as implants. Clinical studies are essential both for securing regulatory approvals in advanced markets where high trial costs have long been a deterrent and for building credibility around patient safety and performance claims. By easing this burden, the scheme is expected to help Indian companies compete more effectively globally, expand exports and reinforce trust in the safety and efficacy of Indian‑made medical devices.
At the same time, AiMeD has stressed that the success of the relaunch will hinge on speedy implementation, transparent approvals and complementary policy measures. The association has called for predictable procurement policies that incentivise higher domestic content, rationalised regulation that clearly distinguishes packers and relabellers from actual manufacturers, faster product approvals and greater localisation of components. Sustained support for R&D, testing infrastructure, skill development, and industry‑academia collaboration will also be critical to moving beyond assembly and building deeper manufacturing capabilities.
AiMeD believes that with coordinated implementation, the SMDI sub‑schemes and related measures can help position India as a globally competitive hub for medical devices, improve healthcare security and generate high‑quality employment. The association has reaffirmed its commitment to working closely with the Department of Pharmaceuticals and other ministries to ensure effective rollout and to identify further policy interventions needed to accelerate the growth of India’s medical devices sector.
