Regulatory experts in India have expressly stated their opinions on adding a special focus on tailing all the data integrity requirements. They are saying that this has to be done to avoid crackdown by regulatory agencies. The warning follows a growing number of letters issued by the US FDA and other international regulatory bodies to the Indian pharmaceutical companies regarding their poor data integrity. Inspectors have discovered major errors in the Indian files.
Many firms like Sun Pharma have come under the scanner after mounting data integrity issues have cropped up in the recent times. Other companies that have also been contacted are Ranbaxy, USV Limited, Canton Laboratories, Agila Specialties, and Aarti Drugs. All the companies have recently received warnings for lack of integrity.
Sources in the regulatory agency have informed that the data integrity issues have been there for a long time and have only recently been noticed after regulatory agencies have initiated the establishment of increasingly stronger data encryption and storage methods.
Reports reveal that the companies need to be sensitized on the matter at the earliest because such statistics will threaten to affect the industry’s reputation. Data integrity issues are allegedly far more serious than manufacturing deficiencies as they affect the core of the regulation.
Data integrity is one of the six fundamental components of information security and aims to make certain the quality of precision, wholesomeness, strength and competence with the data creators’ intentions. It can be achieved by avoiding unauthorized insertion, destruction and modification of data in a database.