Now Reading: CDSCO not using AI for drug approvals, issues AI device guidance
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CDSCO not using AI for drug approvals, issues AI device guidance
The Centre told Parliament that India's drug regulator CDSCO does not use AI for regulatory approvals, relying instead on scientific and technical review. Separately, CDSCO issued guidance for AI-enabled medical device software,…
The Story in Brief
The Centre told Parliament that India's drug regulator CDSCO does not use AI for regulatory approvals, relying instead on scientific and technical review. Separately, CDSCO issued guidance for AI-enabled medical device software, requiring developers to disclose how their models work, the datasets used, and how risks like bias and model drift are addressed.
The guidance, aligned with international principles, classifies software into risk categories and mandates post-market monitoring. It does not apply to general wellness apps. The government also funds AI research in drug discovery and has introduced AI courses at NIPERs.
The Indian Opinion
The government's refusal to use AI for approvals is both cautious and sensible, human oversight remains vital for drug safety. Yet the new guidance for AI medical devices, while welcome, raises a practical question: will CDSCO have the technical capacity to evaluate the complex AI disclosures it now demands? The number of applications for AI-based devices in the coming year will be the real test of whether the framework works, or becomes a bottleneck.
Sources (2): medianama.com, thehindu.com
This story was synthesised by AI from the 2 sources linked above.
Updated: this story now draws on 2 sources.
