An EY (formerly Ernst & Young) survey on data integrity compliance in Indian pharmaceutical industry has found that one-third of the firms did not conduct reviews to assess the potential gaps.
Such reviews, to evaluate if the records are accurate, complete, attributable, legible and maintained properly, are critical from a perspective of the integrity.
They assume significance in the context of an increase in number of foreign regulatory inspections that in turn stems from the growing importance of the industry globally. Also, of the 19 warning letters issued by USFDA last year eight were to companies in India. Emphasising on proactive data integrity assessments, to ensure accuracy and consistency of good manufacturing practices norms, the survey report cited lack of awareness; people’s attitude that documentation is not very critical; the quantity over quality approach; and inadequate resources as root causes for the issues. Findings of the survey, conducted by EY’s Fraud Investigation and Dispute Services, were based on responses from over 170 senior executives in the industry. These included those from firms exporting to the US, Europe, Japan and Australia.
Addressing a meeting, here on Wednesday, EY LLP Partner Rajiv Joshi said work pressure and shortage of manpower were factors affecting quality compliance. “Over 57 per cent of the employees agreed [to] work pressure on the manufacturing personnel to meet key performance indicators such as volume of output, low rejection ratio and overall equipment effectiveness.”
Eighteen per cent of the respondents said quality assurance teams, to review manufacturing and testing of all the products independently, were not adequately staffed. He said shared employee login IDs and passwords for laboratory systems were not uncommon and the level of awareness of the standards prescribed by the USFDA was found wanting.
Over 30 per cent of the respondents’ companies had received inspection observations, including warning letters and import alerts, from global regulators. Stating this, Mr.Joshi said 28 per cent of respondents said their organisations did not have a fraud reporting mechanism.
