Pink Sheet Quotes Howard Sklamberg on Data Integrity Issues at Indian Pharmaceutical Plants

Akin Gump health partner Howard Sklamberg has been quoted by Pink Sheet in the article “Signs Of Improving FDA Inspection Outcomes At Indian Sites But Long Road Ahead.” The article reports that India’s share of the global inspections of manufacturing sites by the U.S. Food and Drug Administration (FDA) declined last year by one percentage point to 9 percent. At the same time, outcomes improved during 2017 in comparison to previous years.

Despite some signs of improvement, the article says more needs to be done for India to meet evolving compliance requirements. There also appear to be other key shifts pertaining to the nature of inspectional observations flagged by the FDA at Indian sites, with the article noting that improvements around data reliability have been significant.

Still, Sklamberg said it would be “a mistake” to think that data integrity is only an Indian problem, as opposed to one that should concern drug manufacturers around the world. “At the extreme end of the spectrum,” he said, “everyone would recognize a data integrity issue - deliberately falsifying data. But there are more minor forms - minor GMP [good manufacturing practice] issues - that some people may consider data integrity issues.  But, I do not think data integrity is unique to India.”