The government’s move to bring medical devices under regulatory oversight is a step in the right direction. The Indian market for medical devices, the fourth largest in Asia, is projected to grow from $10 billion to $50 billion by 2025. A growing market, the rapid innovation and growing complexity in medical technology make regulatory oversight imperative. To this end, the health ministry has notified medical devices as drugs and brought them under the regulator, Central Drugs Standard Control Organisation (CDSCO). However, the key challenge is to endow the organisation with the requisite technical expertise to supervise complex interactions of electronics, nanotechnology, software and mechanics at the micro level.
Given the rising use of medical technology in the form of implants or in procedures, where devices effectively function as drugs, the idea of bringing devices under the CDSCO’s ambit makes sense. This is in line with the practice in developed markets. Medical devices span a range — apparatus, instruments, materials and implements, besides software. All devices cannot be treated the same, with some requiring higher levels of oversight than others. At present, medical devices are classified into four risk categories. There has to be a clear pathway for registration and approval for use and introduction to the market of existing and new devices and technologies, with legal clarity on regulatory requirements and oversight functions. The aim should be to bring all medical devices under the regulatory umbrella, roughly 6,000 at present, and not just the 37 that have been notified.
Such regulatory clarity and expertise would help strengthen the fledgling indigenous industry in medical devices, which finds a market abroad but struggles to sell at home.