In The Spotlight For New Reasons
Data integrity was one of the latest reasons over which global regulators pulled up Indian pharmaceutical companies last year.
Several Indian drug companies and contract research organisations (CROs) faced serious charges of data manipulation, and were issued warning letters and import alerts on grounds of data integrity concerns. For instance, the European Union (EU) banned marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India’s pharmaceutical research company GVK Biosciences.
The US Food and Drug Administration also accused seven companies including Wockhardt, RPG Life Sciences, Agila Specialties, with either actually or potentially tampering with their data. The Indian companies that entered US FDA’s red list for refusing regulatory inspections last year include Cheryl Laboratories and Divis Pharmaceuticals. “Data integrity issues have increased in the past. It is related to the culture of the company and could be solved only through training,” says Sujay Shetty, who leads the Pharma, Life Sciences practice for PwC India.
However, non-compliances in data weren’t limited to India. In 2016, data integrity issues triggered more than one third of all regulatory actions in pharma across the world, says PharmaCompass, a one-stop source for global pharmaceutical information. Last year, which many now refer to as the year of data integrity issues, also saw EU regulators issuing non-compliance notifications to American firms, while the US FDA complained against companies across Europe. For instance, at Teva’s Hungary plant, US FDA investigators found “quality-related documents in a waste bin”. They also found Teva’s stand-alone computer systems lacking controls to prevent analysts from deleting data. Similarly, instances of data manipulation was uncovered at a Czech-based subsidiary of Otsuka Pharmaceuticals, which received a warning letter from the US FDA.
As the US FDA’s list of Indian manufacturers accused of fabricating and falsifying data got longer, Britain’s health regulator, Medicines and Healthcare Products Regulatory Agency (MHRA) also strengthened vigilance around data integrity concerns in India and globally. Besides, last year, European operations of some major drug companies such as GlaxoSmithKline, Teva and Otsuka were found guilty of serious non-compliance issues. “MHRA is considering its response to recent data integrity concerns at a number of pharmaceutical manufacturers,” Jennifer Kyne, press officer, MHRA had said earlier.
