Data Integrity - Indian Government puts EU under pressure

One of the largest scandals with regard to data integrity and data manipulation has been detected by French Inspectors of the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) in India. On 19-23 May 2014 an inspection took place at GVK Biosciences Private Limited (GVK Bio), Swamajayanthi Commercial Complex, Ammeerpet, Hyderabad 500 038, India.

The inspection revealed that GVK falsified electrocardiograms which had been used in a clinical trial. The inspectors found a systematic nature of falsification over an extended period of time involving many employees of the company. At least 10 individuals were involved in these data falsification activities between at least July 2008 and 2013. The staff was not adequately trained and did not understand the importance of data integrity. It is obvious that clinical trials performed at GVK can no longer serve as a basis to support a marketing authorisation. Therefore, EMA had no other choice than to suspend 700 marketing authorisations in the EU in January 2015.

It is a kind of a surprise that Indian Government and Authority who failed to establish adequate controls do not take the necessary steps against GVK and other similar organisations. Moreover, as Reuters reports in a recent article, the Indian Goverment wants to take commercial and legal action against the EMA decision. This step will possibly cause the opposite of what Indian Government wants to achieve. The confidence in the Indian willingness to fight against non-compliance and falsification of data is gone. Companies in Europe and the US need to verify whether current data from India either used for clinical trials or for GMP documentation have been generated without any manipulations. Future management decisions about using regulated services from India will be impacted by the activites of Indian Government. Without Indian Authorities fighting against data manipulation and falsification the trust in data from India will not persist. For the time being not only authorities worldwide but also companies will have to establish comprehensive controls to make sure that quality, integrity and last but not least also the business will not be affected. The financial impact for all concerned companies is significant.