This is the lady responsible for helping improve USD50 billion Indian pharma’s quality

Sarah McMullen, USFDA India director

Synopsis

In the past, many within the Indian pharma industry looked at US FDA audits as motivated and a larger conspiracy against it. But this senior official, who heads the Indian operations of the US FDA, and will soon move to China, worked with Indian pharma companies to slowly change that, and bring in a culture of quality in the industry.

In a virtual presentation last year, Sarah McMullen, India director, US Food and Drug Administration (FDA), acknowledged how patients in the US largely relied on Indian generic medicines, given that nine out of 10 prescriptions written were for generic drugs. Indeed, the US needs Indian generics as much as Indian drug makers need to be in the US market. However, what McMullen didn’t mention in her presentation was that delivering high quality

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