Over the last decade, “data integrity” has turned out to be the most discussed and perhaps the most dreaded word for the Indian pharmaceutical companies.
Over the last decade, “data integrity” has turned out to be the most discussed and perhaps the most dreaded phrase for Indian pharmaceutical companies.
A sizeable number of units have been pummeled by the US drug regulator on issues related to data integrity, resulting in denial of access to the most lucrative market.
The importance of having unquestionable data that essentially promises safety of medicines cannot be overstated. The US Food and Drug Administration entirely relies on data and documentation through the production cycle of a drug. Any deviation from that process could be described as an “adulterated drug” within the meaning of US FDA’s regulations.
Yet, barring rare exceptions, not much seems to have changed for the Indian industry over the last several years. A few recent examples point to that grim reality.
During an inspection last December at a manufacturing site of Hetero Drugs, a privately-held Hyderabad drug maker, the US FDA investigators found a document shredder after reviewing a closed circuit TV camera. The documents that were found to be destroyed were similar to those used for batch packaging records.
The same month, Divis Labs, one of the best known and efficiently managed Indian contract manufacturing companies, was handed a set of adverse observations from the US agency, a part of which is believed to be related to data integrity issues.
Three months on, Divis Labs received an Import Alert or a ban on shipping products to the US (on Tuesday), albeit with the exception for continuing supplies of a few drugs for pain management and treatment of epilepsy and cancer.
More surprisingly, Dr. Reddy’s Labs, which has built a reputation of strong professional ethics, has also received scathing observations from the US FDA for its injectables manufacturing site in Duvvada, close to Vizag. In the initial analysis, those observations point to violations that show deviations in generation and adherence to laboratory and manufacturing and data.
As reported by CNBC-TV18 on Tuesday, US FDA investigators faulted the control systems at the site which allowed personnel to create or delete files without oversight. The issue is exacerbated further when staffers across departments were repeatedly found to be making false and misleading statements before finally admitting that they deleted files from the computers.
While the FDA’s investigations for an injectables site is known to be rigorous as compared to those of tablets or liquids, Dr. Reddy’s was expected to perform better given that it had expressed readiness for a site audit. At least three of the 13 observations or issues of concern are repeated from the time the Duvvada site was last inspected by the FDA in 2015.
What may distinguish Dr. Reddy’s from many others is that it has built a management culture that encourages freedom of expression and a free flow of ideas. Moreover, a significant portion of the senior level management's time during the last 15 months was dedicated to the remediation exercise to set right the issues raised by the US FDA.
As an industry, efforts have been made to drill deep into issues that hobble growth and risks reputation, especially the ones that stem from deliberate fabrication of data.In 2008, Ranbaxy bore the brunt for fabrication of data and that triggered a spate of inspections and import bans. A decade or so later, the industry should have learnt their lessons. As expert consultants aver, the big lesson from the FDA is “do what you say, say what you do.” That simple message will go a long way in building trust and get the recognition due to the Indian generics industry.