The Indian pharmaceutical industry, with its talent for developing low-cost generic alternatives, is suffering a double whammy in its largest market - the US. On one hand, the industry is facing an increasing number of regulatory audits and inspections by the US Food and Drug Administration (USFDA) resulting in warning letters and import alerts; on the other it is being made to pay a fee for these inspections. Recently, this fee was raised over 48 per cent, causing an industry official to quip, "These days we are paying the USFDA to come and serve us warning letters!"
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