EMA recommends suspending drugs tested by GVK Biosciences at Hyderabad plant
Following falsification of data during the testing of some generic medicines
The European Medicines Agency (EMA) has recommended the suspension of medicines whose approval was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India.
The Agency said the recommendation is based on ‘findings from an inspection that raised concerns about how GVK Biosciences conducted studies at the Hyderabad site on behalf of marketing authorisation holders’.
At the request of the European Commission, EMA’s Committee for Medicinal Products for Human Use (CHMP) examined more than 1,000 pharmaceutical forms studied at the GVK site and found that more than 300 had sufficient data from other sources to allow them to stay on the market in the EU.
The CHMP recommended that those medicines 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 of the medicines recommended for suspension can be viewed here.
There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences
The EMA said: ‘There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences.’
The EMA recommendation follows an inspection carried out by the French medicines agency (ANSM), which raised concerns about studies conducted at the Hyderabad site following an inspection which revealed ‘data manipulations of electrocardiograms (ECGs)’ during the conduct of some studies of generic medicines.
The French regulator said these manipulations appeared to have taken place over a period of at least five years and their systematic nature, the extended period of time during which they took place and the number of members of staff involved ‘cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site’.
The CHMP’s recommendation will be sent to the European Commission for a legally binding decision, which will apply to all Member States irrespective of whether or not they have taken interim measures to suspend medicines.
