Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) said that India's medical device industry holds immense promise, yet it faces significant challenges. While domestic firms currently meet only a fraction of the $12 billion market demand, imports dominate, constituting 64.4% of the market. However, with strategic interventions such as streamlined regulations, India can achieve self-reliance in domestic production and global competitiveness.

Nath pointed out that by 2030, the sector could burgeon to a $50 billion industry, slashing import dependency to 35% and boosting exports to $18 billion. This expansion could generate 1.5 million new jobs, fostering economic growth and innovation. But to seize this opportunity, we must address regulatory bottlenecks.

He further said that despite government efforts to improve the business environment, regulatory streamlining remains paramount for industry vibrancy. Simplified processes can enhance efficiency, reduce bureaucratic hurdles, and accelerate affordable innovation. A transparent framework attracts investments, domestic and foreign, fostering technological advancements and job creation.

Medical electronic devices, akin to engineering products like cars, require distinct regulation. Adopting international best practices ensures patient safety throughout the product lifecycle. Strong post-market surveillance, triggered by adverse events, should focus on systemic preventive actions rather than witch-hunting.

The Parliamentary Standing Committee of Health & Family Welfare Ministry rightly advocates a separate legislation for medical devices. This legislation should establish a national regulator licensing all device classes, harmonizing standards across states and empowering qualified device officers for effective regulation.

A dedicated regulatory infrastructure, separate from CDSCO, manned by qualified personnel, is essential. Compliance with Quality Management Systems and voluntary assurance schemes like ICMED 13485 should be encouraged to prioritize patient safety and global quality competitiveness.

It's time for the aspirational younger son, the medical device industry, to have its own home, separate from pharmaceuticals and cosmetics. Let's empower this industry to soar, contributing to India's journey towards self-reliance and global leadership.