Synopsis
In the past, many within the Indian pharma industry looked at US FDA audits as motivated and a larger conspiracy against it. But Sarah McMullen, who heads the Indian operations of the US FDA, worked hard 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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