Spike in FDA Warning Letters to Slow Indian Generics in U.S.

The sharp increase in FDA warning letters to Indian facilities last year will lead to a significant delay in U.S. generic launches by Indian drugmakers, according to CRISIL, an Indian research firm.

The FDA issued more than double the number of warning letters to Indian facilities in the first ten months of 2019 compared to the previous year, said the S&P Global subsidiary — formerly known as Credit Rating Information Services of India Limited.

CRISIL estimates that the FDA’s enforcement actions will delay approximately 180 abbreviated new drug applications, or around 18 percent of total U.S. applications by India’s large drugmakers.