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CDSCO does not use AI for drug approvals, Centre tells Parliament
The Central Drugs Standard Control Organisation does not use artificial intelligence for approving medicines or clinical trials, the Centre told the Lok Sabha on August 4. Chemicals and Fertilizers Minister Jagat Prakash…
The Story in Brief
The Central Drugs Standard Control Organisation does not use artificial intelligence for approving medicines or clinical trials, the Centre told the Lok Sabha on August 4. Chemicals and Fertilizers Minister Jagat Prakash Nadda said regulatory decisions continue to rely on scientific and technical review, including scrutiny by Subject Expert Committees.
The government is funding AI research in drug discovery and medical devices through the PRIP scheme and other programmes. New CDSCO guidance requires developers of AI-enabled medical software to disclose model methods, training data and safeguards against bias, poor explainability, model drift and hallucinations. Manufacturers must also monitor systems after approval and assess whether models trained outside India suit Indian clinical settings.
The Indian Opinion
Claims that AI is already deciding which medicines Indians can use are unsupported by the government’s reply. The opposite claim, that regulation is blocking medical innovation, is also too simple. India is funding AI research while placing added duties on software makers. The real test will be whether CDSCO can inspect compliance after launch, especially when models change or fail in Indian clinical settings.
Source: medianama.com
This story was synthesised by AI from the source linked above.
