EXAMINING THE IMPACT AND CONSEQUENCES OF DATA INTEGRITY VIOLATIONS IN THE INDIAN PHARMACEUTICAL SECTOR

Abstract

This review examines recent data integrity issues within Indian pharmaceutical companies. Adherence to regulations regarding good documentation practices and data integrity is crucial, as both customers and regulatory agencies rely on the accuracy and reliability of data generated and stored by pharmaceutical companies. The ALCOA Plus principles are widely implemented to ensure data integrity within the industry. The objective of this study is to identify the frequency and impact of data integrity violations reported by the United State Food and Drug Administration on Indian pharmaceutical companies and to explore the consequences of these violations. The data for this analysis was sourced from the USFDA database, which included a review of 20 warning letters issued to pharmaceutical companies in India. The study also examines relevant guidelines on data integrity, including those from the WHO, USFDA, MHRA, and PIC/S. A comparison of data from 2023 and 2024 with the past 12 years reveals a noticeable increase in both warning letters and data integrity findings. Most of these issues are observed in the quality control and production departments. As a result, some companies have received IMPORT ALERT for the U.S. market barring them from supplying to the US affecting sales and the company's reputation. Further research is necessary to develop more effective solutions and strategies to prevent data integrity violations. Despite the availability of numerous guidelines, ongoing research is recommended to enhance compliance and mitigate data integrity concerns.