Refutes charge of widespread data falsification/manipulation in BE studies
GVK BIO has refuted news reports that Germany’s drug regulator had banned the sale of 80 generic medicines due to ‘insufficient’ clinical trials conducted by it. In a statement released by the company, Manni Kantipudi, Chief Executive Officer, GVK BIO stated, “The regulatory authorities have themselves stated, “This decision is taken out of precaution. No element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs.”
“We believe that the conclusions of the France’s National Security Agency of Medicines and Health Products (ANSM) and the subsequent actions by the EMA are highly disproportionate to the actual risk posed to human health. At the same time, we respect and honour the conclusion made by the European regulators and are working with our clinical development customers to provide new data that meets all regulatory requirements.”
Giving further details, the statement revealed that in May 2014, a regulatory inspector from ANSM visited its clinical development facility at Hyderabad. His inspection focused on nine studies that had ‘check-out’ ECGs. Based on his inspection, he concluded that some of the employees had taken print outs of ECGs from one volunteer and used them for other volunteers. To counter this finding, GVK BIO sought the opinion of four independent cardiologists. The reports from these cardiologists indicated that the ECGs could belong to multiple volunteers and it was difficult to conclude that the ECGs belong to the same volunteer.
GVK BIO also further clarified that its employees had no operational rationale to indulge in such practices as it does not save time, money or effort. Despite all efforts and explanations, the French inspector concluded that the studies did not meet the GCP guidelines and should be rejected. The GVK BIO statement goes on to state that the company respects the conclusions of the French authority, but believes it was a matter of interpretation and was hard to conclude that ECGs were manipulated.
GVK BIO was later invited by the European Medicines Agency wherein GVK BIO presented data and evidence to demonstrate that standard operating procedures were being followed and all key activities such as dosing, blood sampling and processing were adequately controlled and supervised by qualified staff.
Unfortunately EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that though the ‘check-out’ ECGs may have no direct relevance to the quality of the testing of drugs, they believe that since some of the same employees involved in check-out ECGs could be involved in other critical activities, left an element of doubt on the Bio-equivalence results. Hence authorities have concluded that the BE studies conducted at our Hyderabad clinical development facility since 2008-20014 are not sufficient to support Marketing Authorization Holders (MAHs) for the approved products.
According to the statement, check-out ECGs are ECGs conducted before the volunteers leave the clinic merely as an additional safety test, and they do not form part of any international clinical trial guidelines; the requirement for the ECGs vary depending on the trial protocol followed for each drug. It is intended to ensure that the volunteer is safe on key health parameters and is not a drug efficacy parameter.
As a precautionary measure, the regulators have recommended suspension of marketing authorization of those products. The ANSM has said on its website: “This decision is taken out of precaution. No element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs.”
According to the statement, GVK BIO’s clinical development unit has been inspected over 25 times by various regulatory agencies including UK-MHRA, ANSM, USFDA, DCG of India, ANVISA (Brazil), WHO, MOH Turkey, with no reported critical findings.