Now Reading: DCGI to increase audits of medical device makers
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DCGI to increase audits of medical device makers
The Drugs Controller General of India (DCGI) plans to intensify audits of medical device manufacturing facilities to check compliance with prescribed norms, Dr Rajeev Raghuvanshi announced at the CII Global MedTech Summit. Over the last two years, 30,000 product licences have been issued, but the regulator said the industry has had sufficient time to adapt and should now be ready for inspections.
The DCGI also outlined plans to waive the requirement for a test licence for under-trial devices, a proposal that will be discussed at the upcoming Drugs Technical Advisory Board (DTAB) meeting. The move aims to support innovators and encourage development of new devices, aligning with global practices. The Association of Indian Medical Device Industry welcomed the waiver.
The timeline for processing import applications has been reduced to 145 days from a charter commitment of nine months. Between April 2025 and June 2026, 1,082 import licences were issued. The government has created a joint DCGI-level position for the medical device vertical and is recruiting 20 additional officers to strengthen oversight. India's medical device market is estimated at $16 billion and is projected to reach $50 billion in five years.
Indian Opinion Analysis
The Economic Times coverage frames the DCGI's announcement primarily as an acceleration of regulatory oversight, emphasising the increase in audits and the message that the industry must be prepared. The NDTV Profit piece frames the same story as business-friendly reform, highlighting eased rules and faster market access. Neither outlet presents a critical or opposition view. The combined takeaway is that the regulator is simultaneously tightening enforcement and removing licensing hurdles for R&D, a dual approach that aims to balance compliance with innovation. The key date to watch is the DTAB meeting later this month, where the test-licence waiver will be discussed.
Coverage: 2 sources, 1 pro-government, 1 neutral
Sources (2): health.economictimes.indiatimes.com (neutral report), ndtvprofit.com (pro government)
This story was synthesised by AI from the 2 sources linked above. Methodology and corrections.
Updated: this story now draws on 2 sources.
