'There is urgent need for tech-focused regulatory approach for med devices'

THE Indian healthcare industry has evolved at a breakneck pace, but its regulatory framework has struggled to keep up to its speed of development.

- Nandita Vijayasimha, Bengaluru

The Drugs and Cosmetics Act of 1940, designed to govern medicines in an era of syrups and tablets, is now being stretched to include sophisticated medical devices, AI-driven diagnostic tools, wearable monitors, and robotic surgical instruments that did not exist when the law was drafted, said Dr BR Jagashetty, former Karnataka State Drugs Controller.

This mismatch has created uncertainty for manufacturers, clinicians, and patients alike, highlighting the urgent need for a modern, technology-focused regulatory approach, added Dr Jagashetty, who is special resource officer, Karnataka FDA, former National Adviser (Drugs Control) to MoHFW & CDSCO.

Medical devices are not drugs. Here the Drugs & Cosmetics Act 1940, needs more than a simple update as this law is written before the invention of the microchip and requires a new regulatory operating system, he added.