# CDSCO not using AI for drug approvals, issues AI device guidance

2026-08-06T16:41:06+00:00 | Governance | Indian Opinion Desk

Corroboration: 1 independent outlet

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.

## Coverage

- medianama.com <https://www.medianama.com/2026/08/223-india-drug-regulator-not-adopted-ai-approvals/>
- thehindu.com <https://www.thehindu.com/news/national/cdsco-issues-guidance-clarifying-regulatory-pathway-for-ai-software-based-medical-devices/article71281400.ece>

Tags: Artificial intelligence, CDSCO, drug regulation, healthcare, medical devices
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