Regulatory experts stressed that the Indian pharma cos should put special focus on following all the data integrity requirements to avoid crackdown by regulatory agencies. This warning comes in the wake of growing incidence of issuance of letters by the US FDA and other regulatory heads to Indian pharma cos for having data integrity issues, where inspectors have discovered glaring problems in the files.

Data integrity issues have become a mounting problem for the Indian pharma companies in the recent past as many like Sun Pharmaceutical have come under scan for flouting data integrity regulations. Ranbaxy, Canton Laboratories, USV Limited, Wockhardt Limited, Agila Specialties, Posh Chemicals, Aarti Drugs, Fresenius Kabi Oncology, RPG Life Sciences etc were also in the recent past issued warning letters for having incomplete records and lack of data integrity.

A highly placed source from the regulatory agency informed that though data integrity had been there for a long time it is only recently that the regulatory agencies have started meticulously implementing the same. The source stressed that today violation of data integrity is seen to be as grave as violations of the GMP practices which can lead to negative observations by the regulators.

“Indian pharma companies need to be sensitised on this matter at the earliest as the statistics can threaten to impact the reputation of the industry at large. Unlike manufacturing deficiencies, data integrity issues strike at the very core of good regulation, especially since the data given stands as a proof that drugs are safe, efficacious and manufactured as per appropriate quality standards required. In fact data integrity is at the root of a number of 483s issued recently by FDA,” pointed out the source.

Data integrity refers to maintaining, assuring the accuracy and consistency of data over its entire life-cycle and is a critical aspect to the design, implementation and usage of any product.  Data integrity is one of the six fundamental components of information security and its aim is to ensure the quality of correctness, completeness, wholeness, soundness and compliance with the intention of the creators of the data. It is achieved by preventing accidental or deliberate but unauthorised insertion, modification or destruction of data in a database.