EY India data integrity survey flags gaps, missing processes
This article was originally published in Scrip
An EY (formerly Ernst & Young) survey around data integrity compliance issues within the Indian pharmaceutical sector has thrown up some potentially worrisome findings, including an absence of quality processes and procedures at some firms amid work pressure and manpower shortages.
You may also be interested in...
A forum on quality excellence in India saw global regulators highlight regulatory requirements and expectations in critical areas such as data integrity and the investigation of compliance-related complaints. The fostering of a quality culture was another key theme at the event, with one EMA speaker noting there are no easy fixes when trust in data is broken.
Details in US FDA’s latest warning letter for Indian site suggest that firm’s data integrity remediation efforts are not up to scratch at least yet. Agency’s observations also highlight the potential complexities that may be on hand for Cempra’s antibiotic Solithera, recently hit by a complete response letter.
India's wide-ranging drug regulation overhaul plan, including a perpetual licensing system aimed at simplifying processes and potentially delinking licensing and enforcement responsibilities may well emerge as a double-edged sword.