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.
“The early signals from the Trump administration do not augur well for the pharmaceuticals,” the Indian Pharmaceutical Alliance, the trade group for India’s largest drug makers, wrote late last month in a report to a government think tank that offered suggestions on how to best appeal to the Trump administration and maintain its share of the lucrative US market.
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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. “