Dr. Reddy’s struggles to meet FDA rules

Abstract

Managers at India’s Dr. Reddy’s Laboratories do not expect to be ready for another FDA inspection of the company’s manufacturing facilities until December. Many Indian drug firms, such as Ipca Laboratories, Cadila Healthcare, and Sun Pharma, have had recent quality issues and run-ins with FDA. Reddy’s problem with FDA stems from a warning the agency issued to Reddy’s in November 2015 that three of its facilities did not meet U.S. manufacturing standards. And during a reinspection of one of those facilities in March, FDA once again discovered several shortcomings. While talking to financial analysts late last month after the announcement of the firm’s first-quarter earnings, Dr. Reddy’s chair and CEO G. V. Prasad noted that the company had to “systematically implement our new quality-management system and automate some of the critical manufacturing and quality-related processes.” Chief Operating Officer Abhijit Mukherjee added, “Optimistically, we expect to have FDA coming by year-end,