For India’s biggest drug makers, the Trump administration offers a mix of promise and peril.
On one hand, these companies supply many lower-cost generics to the United States, a key advantage as President Trump accuses most brand-name drug makers of “getting away with murder” when it comes to pricing. But Indian drug makers also fret the Trump administration will place them at a disadvantage with any policies that favor domestic jobs stemming from products made in the US.
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And such quality issues continue, as evidenced in a letter dated this month. [Warning Letter 320-17-28] That will be a hard slog:
“These findings indicate that your quality unit is not exercising its responsibilities.
In your response, you admitted that a “gap exist[ed] in the Quality Assurance department” concerning document control. “