Howard Sklamberg Interviewed by India’s CNBC on Quality Compliance by Indian Pharma Companies
Akin Gump health partner Howard Sklamberg was interviewed at the Indian Pharmaceutical Alliance conference in Mumbai, where he led a discussion on pharmaceutical quality, by India’s CNBC TV18 in a segment looking at quality compliance by Indian pharmaceutical companies.
Sklamberg said the most serious data integrity issues, including those that are willful or pervasive within a company, have decreased over time. He stated that when he was at the U.S. Food and Drug Administration, where he served as Deputy Commissioner for Global Regulatory Operations and Policy, there were some well publicized examples of data integrity problems, but he has since seen a reduction in their frequency.
Indian companies continue to lag behind the United States in terms of compliance, Sklamberg noted, and there remain some very serious issues. Some require import alerts, he said, while the less serious ones only lead to warning letters. There is still some work to do, but he added that there has been some definite progress.
To view the full video of Sklamberg's interview, please click here.