Karnataka drugs controller has stated that root cause of non-compliance issues are often linked to human errors. It is also attributed to the lackadaisical attitude of the pharma industry personnel which also include senior management officials.

Non-compliance to data integrity has resulted in global regulatory inspection failures for some Indian companies. Therefore every effort should be made by the industry to ensure adherence and should closely look at Para 15 C of Schedule L1 of Drugs and Cosmetics Rule 1945 which also mandates the requirements about data integrity and security, said Raghurama Bhandary, drugs controller, government of Karnataka.

“Data integrity calls for trust of information and records. Data should be reliable, complete and accurate. Moreover, data should be authentic and proven to be what is mentioned. This data should be usable, easily located, retrieved, presented and interpreted, he said at a recently concluded day lone International Society for Pharmaceutical Engineering (ISPE) seminar.

As per the US FDA, data integrity will focus on back backdated, postdated and missing signatures. It will also help detect fabricates or fake data, besides copying existing data as new data. Further, it will also indicate re-running samples, discarding data or omitting negative data, releasing failure product, testing information until the product is released. It will also detect hiding or obscured standard operating procedures or protocol deviations.

In addition, it will indicate not saving data electronically or even as hard copies, poor documentation control, inappropriate audit trials, inadequate access authorisation, inadequate reporting of failure and deviation management, data back up and disaster recovery, use of an invalidated software application, mismatch between reported data and actual data, he said.

India has over 300 US FDA approved manufacturing facilities which manufacture generics. The Indian pharma industry turnover of Rs. 1.38 lakh crore of which Rs. 90,000 crore is exports.

“Data integrity issue is prevalent globally and not merely India centric. If the pharma industry in the country is engaged in the production of life-saving drugs then it cannot afford to be negligent. We need to be careful and it is absolutely fair by global regulators to keep tabs on this. Therefore it is not that India pharmaceutical companies are targeted by the global regulators,” stated the Karnataka drugs controller.

Since the ISPE event also focused on need quality culture, corrective and preventive action (CAPA) , and investigation, the Karnataka drugs controller said that adherence to robust quality systems would lead to data integrity, CAPA improvements will bring in systematic processes.