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The Indian healthcare industry has evolved at a breakneck pace, but its regulatory framework has struggled to keep up to its speed of development. 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.
Currently, India stands at a critical crossroad. On the one hand, its burgeoning med-tech sector is developing AI-driven diagnostics and sophisticated surgical robotics. On the other, the archaic law of the Drugs and Cosmetics Act presents a direct risk to patient safety and a barrier to innovation. The core flaw is that the 1940 Act classifies a ‘device’ as a type of ‘drug’. To bridge this gap there is an urgent need for a two-part transformation: one of law, the other of culture, said Dr Jagashetty.
The first, non-negotiable step is to table the Drugs, Medical Devices, and Cosmetics (DMC) Bill at the earliest. This legislation must formally break from the past by creating a completely separate chapter for medical devices. The law must move beyond approving ‘locked’ devices. It must adopt modern concepts, like the US FDA’s Predetermined Change Control Plan (PCCP), said Dr Jagashetty.
The Act must legally define cyber security as a core component of patient safety. It should empower regulators to demand a Software Bill of Materials (SBOM) and legally bind manufacturers to manage vulnerabilities and provide patches for a device’s entire lifecycle.
Secondly, a new law is useless without a new enforcement culture. The current style of functioning is ill-equipped for the technology. The traditional Drug Inspector is a pharmacist, an expert in Good Manufacturing Practices (GMP) for chemicals. They are not data scientists or biomedical engineers. CDSCO and State FDAs must build a new cadre of technical specialists who can audit an algorithm for bias or assess the validation of a software patch. Here State bodies, especially FDA Karnataka is uniquely positioned as India’s tech hub to pioneer a new approach. By running ‘Regulatory Sandboxes’ similar to the UK’s ‘Airlock’ they can allow start-ups to test new tech in a controlled setting with the regulator. This builds institutional knowledge and gets safer products to market faster, said Dr Jagashetty.
The data silos between CDSCO handling approvals and state FDAs handling on-ground enforcement are a liability. The need of the hour is a single, integrated digital platform which is essential for ‘total product lifecycle’ oversight. A state inspector in Bengaluru must have real-time access to the central approval history and post-market data of any medical device. India has the ambition to be the ‘med-tech lab of the world’. Achieving this, needs a new rulebook for the 21st century and regulators skilled enough to enforce it, said Dr Jagashetty.
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