US FDA sounds alert on quality issues in Indian pharma

Warning letters might increase as 190 facilities are expected to be inspected in the next 3 years

Quality is a challenge for the Indian pharmaceutical sector, the largest supplier of drugs to the United States, according to a recent blog by the US Food and Drug Administration (US FDA). 

Of the 42 warning letters sent out by its office of manufacturing quality last year, nine — about one-fifth — were addressed to Indian facilities. The number could rise over the next three years as the US FDA would inspect 190 facilities that it could not in the past five years, wrote Edelweiss Securities. 

“Quality issues are an ongoing challenge for the Indian pharmaceutical industry,” wrote Mary Lou