Data integrity is the fulcrum of pharma operations. All departments in a pharmaceutical company depend on reliable and valid results reported by its quality control laboratory. The inaccurate results and unintentional errors are attributed to lackadaisical attitude and poor comprehension of processes, stated a panel of experts at the Indian Drug Manufacturers’ Association- Karnataka State Board (IDMA-KSB) workshop on 'Laboratory Data Integrity'.

In his inaugural address, Raghurama Bhandary, Karnataka drugs controller said that data integrity was a pre-requisite for pharma industry. This was of ample importance as properly recorded data will also enable product recall and identification. The regulatory authorities are now insisting on adherence to data integrity because of a slew of waning letters, suspension of production orders with poor documentation. Pharma industry will need to invest in information technology and conduct internal audits to keep data integrity issues at bay during inspections. In fact, data integrity lapses are not just detected by global regulators but state drugs control enforcement wings are also detecting such cases, he added.

India is gaining prime importance in the global landscape with the highest number of globally audited sites, submissions of ANDAs (abbreviated new drug applications) and every fourth generic drug prescription in the US is a medicine manufactured in India. All this indicates that it is high time Indian pharma industry introspect on data integrity. This is because poor data integrity practices are noted by USFDA, UKMHRA in several Indian companies, pointed out SM Mudda, chairman, IDMA KSB and director, global strategy (technical), Micro Labs in his presentation on 'Data Integrity: Reality and Resolution'.

“Our data requirement is consistently inconsistent. Though it could be due to the misguided action of a few individuals, the causes of such failure are seen to be more behavioural than technical. It leads to low trust, tighter control, fear at all levels, blame and more errors. Therefore, now Indian companies need to scale up their data integrity efforts by winning back the trust of the regulators. We will need to ensure that all data is complete, consistent and accurate throughout the its  lifecycle,” he pointed out.

Further, breach of data integrity (BDI) is a violation. Companies should ensure that data recorded is exactly the same as it was when it was original. If the industry adheres ALCOA (attributable, legible, contemporary records, original, accurate) method, which is key to data integrity, then there would be no issues, said Mudda adding that if ALCOA is not followed then the situation would lead to BDI.

Kapil Bhargava, former deputy drugs controller, CDSCO highlighted the current challenges of data integrity. “Since medicines are only for the patient, a poor quality drug which could be a simple saline infusion or a complicated cardiac surgery where several drugs are administered indicates gravity of data integrity practices to be adhered by pharma industry.”