Trust is essential to everything we do in the pharmaceutical industry. Developing new drugs requires speaking the global language of data, which is meaningless without trust. Toxicity, efficacy, bioequivalence, and bioavailability are key measurements of drug safety and effectiveness, all spoken in the language of data. These only have meaning if there is trust.
Imagine reading an article about major concerns with a company’s application data. Worse, what if it’s your company or a partner producing some of your application data? Unfortunately, this scenario is real and has happened again. On March 27, 2025, the U.S. Food and Drug Administration (FDA) addressed significant objectionable conditions observed during a recent inspection in Navi Mumbai, India. The inspection revealed concerns regarding data integrity and the submission of falsified data to the FDA, particularly in relation to in vitro bioequivalence studies. The FDA’s findings indicate a serious breach of regulatory standards necessitating immediate corrective actions to restore confidence in the integrity of the data generated by the firm. The Agency has made it clear that all in vitro study data generated by the firm must be rejected, and further scrutiny will be applied to their in vivo studies.
The lesson from this news is that data integrity is fundamental to drug development success. Data integrity requires conscious management, much like any other significant risk in a development process. This involves adopting well-crafted governance and controls throughout all processes. These programs are designed to demonstrate that all data integrity risks are known and mitigated, and that there is strong governance, oversight, and culture that values data quality and integrity. These programs are essential to earn the trust that makes application data believable. Trust in the underlying data is pivotal to a firm’s success in developing, approving, and manufacturing safe and effective lifesaving drugs.
Additionally, recent FDA warning letters to multiple companies in China, India, and the U.S. highlight critical data integrity problems and GMP violations. Companies were found backdating QC lab documents and failing to ensure adequate control over documents, such as paper and electronic records. These issues can lead to severe consequences, including Import Alerts and product recalls, or worse, compromised patient safety.
To build more trust into the biopharma data ecosystem, the Central Licensing Authority (CLA) in India is requiring, as of April 1, that Indian CROs register to conduct clinical trials or bioavailability/bioequivalence (BA/BE) studies. This initiative seeks to improve the standards and adherence of clinical research in India, while the new registration regulations are designed to rectify previous non-compliance issues and bolster trust in Indian CROs. Non-compliance can result in severe actions, such as written warnings, rejection of study results, suspension, or cancellation of registration, and, again, the potential to compromise patient safety. A single compliance issue in a bioequivalence study can have widespread implications, affecting multiple applications and markets, underscoring the critical role of trust and data integrity in the global pharmaceutical landscape.
Do you ever lie awake at night worrying whether your company’s drug applications may be at risk because of hidden data concerns? Lachman Consultants can help. We specialize in providing leading companies around the world and their contract development partner organizations with effective data integrity and governance strategy and programs – programs essential to demonstrate the integrity of their drug applications’ data. Lachman also specializes in performing detailed reviews of existing drug application data and can help your company to be assured that your data has integrity and its applications are on solid ground. Contact us today at LCS@LachmanConsultants.com to learn more about our world-class services!
