The regulator said: “A number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended.”
The EMA added that the “recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorisation holders.”
The agency explained it had examined over 1,000 pharmaceutical forms studied at the GVK site and found that 300 products had sufficient data from other sites to allow them to stay on the market.
The CHMP recommended that those lacking sufficient data should be suspended “unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs.”
The full list recommended for suspension is here.
The EMA said: “There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences.”
Germany and France
The EMA recommendation follows German regulators’ suspension of several products trialled by GVK in December and initiation of a review of alleged data manipulation.
The spotlight first fell on GVK in September when ANSM, the French Agency for the Safety of Health Products, raised concerns (here in French) about studies conducted at a site in Hyderabad between July 2008 and 2013.
At the time, ANSM said it found “falsifications of electrocardiograms” in the nine studies it examined, explaining that the ECG data appeared to have been derived from a single individual, rather than multiple volunteers.
The Paris-regulator alleged that at least 10 GVK employees were involved in manipulating the data, which it said was indicative of systemic problems.
GVK told Outsourcing-pharma.com it is "respectful of the EMA decision taken in the interest of human health" adding that it is working closely with its customers to ensure an appropriate and quick resolution to these issues.