India’s drug regulator eyes lighter oversight, more AI to boost efficiency

NEW DELHI: India’s drug regulator plans to ease processes, set fixed approval timelines and explore artificial intelligence to improve execution, its chief said on Thursday.

“We’re trying to increase our efficiency, cutting down on regulations so that we create more and more resources within our system,” the Central Drugs Standard Control Organisation’s Rajeev Raghuvanshi said in an interview at the sidelines of an industry event.

“The way for the future is to make the regulation lighter and execution is stronger,” the Drugs Controller General added, without giving details of the regulator’s plans.

On artificial intelligence, Raghuvanshi said the regulator was examining how to avoid legal infringements.

The agency said on Wednesday it has halved the processing time for drug test licences to 45 days and begun approving some studies with only an intimation, removing the need for prior licensing.

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It has also streamlined export certifications, which are now cleared in under seven days, Raghuvanshi said on Thursday.

The country’s pharmaceutical industry is exempt from U.S. President Donald Trump’s tariffs of up to 50 percent, but the sector is seeking to expand globally amid uncertainty over trade outlook.

The US, which takes just over a third of India’s drug exports, saw sales of mainly generic medicines rise 20% to about $10.5 billion in fiscal 2025.