Right now, local manufacturers face a 10–15% cost handicap, and getting a factory approved can take 4 years instead of 18 months. That’s not just slow; it’s killing competitiveness. Industry groups like AiMeD are pushing for a dedicated medical devices law, faster approvals, and financial help. Why does this matter? Because if India wants to cut reliance on imports and build a self-reliant health ecosystem, fixing this bottleneck is non-negotiable. The next few months could decide whether we become a global MedTech hub; or keep playing catch-up.