The Drugs Controller General of India (DCGI) plans to significantly increase audits and inspections of medical device manufacturing facilities to ensure compliance with regulatory standards. Dr Rajeev Raghuvanshi, DCGI, said the industry has had sufficient time to adapt to the regulatory framework and should be prepared for inspections.
Faster Approvals and R&D Boost
Meanwhile, the regulator has issued nearly 30,000 product licences over the past two years. As per The Economic Times, the CDSCO is also considering waiving the requirement for a test licence for devices undergoing research and development, a move that could accelerate innovation.
The proposal is expected to be discussed by the Drugs Technical Advisory Board (DTAB). In addition, the regulator has reduced processing timelines for import licences and approvals for high-risk devices and in-vitro diagnostics.
Strengthening the Medical Device Regulator
Furthermore, the government has created a Joint DCGI-level position to provide greater operational independence to the medical device division. It has also promoted 21 inspectors and initiated the recruitment of 20 additional medical device officers.
These measures aim to balance stricter quality oversight with faster approvals and stronger support for innovation in India’s growing medical device sector.