New executive orders signed by former U.S. President Donald Trump could pose serious
problems for Indian pharmaceutical companies, especially those selling generic drugs in the
American market. According to a report by Nuvama Research, the policy changes are
designed to boost domestic drug production in the U.S. and could greatly impact global
supply chains.
India has long held a key role in global medicine supply, thanks to its low-cost
manufacturing. Indian companies export a large number of generic drugs to the U.S.,
benefiting from cheaper production and labor costs. But the new U.S. rules aim to move
manufacturing of drugs and essential components—like APIs (Active Pharmaceutical
Ingredients) and KSMs (Key Starting Materials)—back to America.
The report warns that if these changes are fully enforced, Indian pharma companies may lose
their pricing advantage. The executive orders also propose faster approvals for U.S.-based
plants, more inspections of foreign factories, tighter compliance standards, and higher fees
for non-U.S. manufacturers.
Another challenge for Indian companies is the possible requirement to disclose the origin of
the APIs used. Although many medicines are made in India, the industry depends heavily on
China for raw materials, which could lead to greater scrutiny from U.S. regulators.
The executive orders are also part of a wider U.S. push for national biosecurity. One order
even restricts funding for research that could increase the strength of viruses, citing safety
concerns.
Overall, these new policies—if put into action fully—could shake up the U.S. generic drug
market and create lasting changes in the global pharmaceutical supply chain.
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