The order, issued on Monday, also directed the US Food and Drug Administration (USFDA) to streamline reviews and work with domestic manufacturers to provide early support before facilities come online
The executive order to reduce the timeline for approval of pharmaceutical plants issued by the US President Donald Trump as part of new regulations to encourage domestic manufacturing will not have any impact on the Indian pharmaceutical Industry, according to experts.
The order, issued on Monday, also directed the US Food and Drug Administration (USFDA) to streamline reviews and work with domestic manufacturers to provide early support before facilities come online.
“The new executive order will not have any effect on the Indian Pharma industry on account of various factors. The US imports drugs worth $200 billion per annum and only 5 per cent of them are from India. The order encompasses all sort of drugs including those that are patented while India mainly exports only generics to US,’‘ R Uday Bhaskar, Director- General, All India Drugs Control Officers’ Confederation (AIDCOC) Training Academy and former DG of Pharmaceuticals Exports Promotion Council (Pharmexcil), told businessline.
The focus of the executive was probably more on the patented medicines imported from countries like Germany, Switzerland and Ireland, according to Bhaskar. As the order was on making speedy approvals for setting up of new manufacturing plants, it would still be a ‘costly affair’ for Indian drug-makers to set up new plants in the US compared to the investment needed to set up a plant in India, Bhaskar said.
“There is also a direction on surprise checks by the US drug regulator in the order. However, the surprise checks have been happening for a few years now and there could be nothing new on this front as well,’‘ he added.
A senior official of a Hyderabad-based pharma company which operates manufacturing plants in the US, said some players might consider shifting some production to the US if tariffs were imposed in the days to come. “However, we don’t see any immediate gains or losses out of the new executive order,’‘ he added.
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Published on May 7, 2025
