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India to ramp up audits of medical device makers, DCGI says
India's drug regulator will significantly increase audits of medical device manufacturing facilities across the country to check compliance with norms, the Drugs Controller General of India (DCGI) announced. Speaking at the CII…
India's drug regulator will significantly increase audits of medical device manufacturing facilities across the country to check compliance with norms, the Drugs Controller General of India (DCGI) announced. Speaking at the CII Global MedTech Summit, DCGI Dr Rajeev Raghuvanshi said the industry has had enough time to adapt to the new framework and must be prepared for inspections. The regulator has issued 30,000 product licences in the last two years.
The DCGI also said the Central Licensing Authority plans to waive the requirement for a test licence for medical devices under trial, a proposal to be discussed at the upcoming Drugs Technical Advisory Board meeting. A joint DCGI-level position has been created for greater operational independence of the medical device vertical. India's medical device industry, valued at about $16 billion (roughly Rs 1.33 lakh crore), is expected to grow to $50 billion in five years.
Indian Opinion Analysis
Until now, medical device regulation in India was a side activity of the drugs regulator, with few dedicated inspectors. The creation of a separate vertical and the recruitment of 41 officers signal a shift to full enforcement. Of the 800 domestic manufacturing units, most make low-risk class A and B devices, which already require third-party certification. The real pressure will fall on the 117 new or novel devices approved among 30,000 licences, and on importers whose processing time has been cut to 145 days. The next date to watch is the DTAB meeting later this month, where the test-licence waiver will be debated.
Source: health.economictimes.indiatimes.com
This story was synthesised by AI from the source linked above.
