The European Medicines Agency (EMA) today recommended suspending marketing within the European Union (EU) for some 700 medicines whose approvals were primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India.
The studies were flawed because they did not generate sufficient data to support, according to the EMA. The EMA’s recommendation sets the stage for a decision by the European Commission. That decision will be binding on all countries within the EU, whether or not they have implemented their own interim actions to suspend the medicines.
The EMA said it reached its conclusion based on an inspection by its Committee for Medicinal Products for Human Use (CHMP) of more than 1,000 pharmaceutical forms and strengths of medicines studied at the GVK Bio site.
More than 300 of the medicines studies have sufficient supporting data from other sources to satisfy EMA. Thus, the agency will allow their continued sale within the EU nations.
That leaves some 700 medicines for which EMA considers supporting data to be lacking. The agency has published a full list of the affected medicines on its website.
However, the EMA added: “There is no evidence of harm or lack of effectiveness with any of the medicines linked to studies conducted by GVK.”
And the EMA only recommends their suspension “unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs.” It is up to member states to decide whether a medicine is critical for patients.
The suspension recommendations come four months after the EMA launched a review of GVK Bio. That review came after the French medicinal products agency Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) raised concerns about the reliability of bioequivalence studies conducted at the site between 2008 and 2014.
ANSM found falsification of electrocardiogram results in all nine trials it examined, carried out “by at least 10 different individuals” between July 2008 and 2013.
“The systematic nature of the falsifications of electrocardiograms, the extended period of time during which they took place and the number of members of staff involved highlight critical deficiencies in the quality system in place at GVK Bio's clinic in Hyderabad,” ANSM concluded, according to EMA’s formal referral of the case to CHMP, dated August 1, 2014.
“They also show a lack GCP [Good Clinical Practice] training, awareness and understanding of members of GVK Bio staff, a lack of understanding by them of the importance of data integrity and of the possible consequences of their acts, as well as a lack of overview of clinical trial activities by the investigators,” ANSM also found, according to the EMA.
GVK Bio responded at the time with a statement expressing disappointment in the ANSM findings, and maintaining that its trials were conducted in accordance with GCP standards: “All key activities such as dosing, blood sampling and processing were adequately controlled, supervised and staff were qualified to do the work.”
However, GVK Bio said it expected marketing authorization holders of the affected medicines “will need to repeat their studies in the next 12-15 months.”
By December 2014, the EMA acknowledged that an undisclosed number of EU member states had begun suspending GVK Bio-tested medicines based on their own inspections.