Bolstering Data Integrity

Pharma companies to fine-tune their security policies and implement best practices to safeguard data integrity.

- Prathiba Raju

Maintaining data to ensure traceability of a drug batch to its origin is the most important responsibility of a pharmaceutical company. Data integration asserts that medicines are accurate, complete, attributable, legible, intact and maintained within their original context, including their relationship to secondary data records. It is a worrying trend that Indian pharma companies have been regular defaulters. Between 2004 and 2012, there has been a seven-fold rise in issuance of warning letters by the US Food and Drug Administration (US FDA) to Indian companies and the trend continues even now.

The CRISIL analysis of the FDA warning letters reveals that there has been an increase in letters being issued to India which was nearly 70 per cent in 2015 and around 37 per cent till August, 2016. Additionally, 14 per cent of the FDA-approved plants in India were on import alerts. Since January 2010, there have been 65 regulatory actions such as issuance of warning letters and import alerts on domestic drug makers.

Noting that the pharma industry has to strengthen its systems and controls to address data integrity issues effectively, Akshay Chitgopekar, Director, CRISIL Ratings, said, “Analysis of warning letters in the last six years shows that data integrity issues are cited in more than 85 percent of cases relating to domestic plants compared to less than 25 percent for Canada and Germany.”

Further, the CRISIL ratings on 283 pharma companies indicated that in past three years, 16 of them have been under regulatory scrutiny. This has reduced their exports to the developed markets, leading to a slowdown in revenue growth and dipped it to single digits in two years from over 20 per cent earlier, resulting in a sharp fall in the operating profitability as well. However, ratings on more than 80 per cent of these pharma companies have remained unchanged.