A month after some major European nations suspended 25 generic drugs alleging “flawed clinical trials” by GVK Biosciences, the European Medicines Agency on Friday cracked its whip on the Hyderabad-based firm recommending suspension of medicines that were approved earlier.
The Committee for Medicinal Products for Human Use (CHMP) of the European Commission said that despite a re-examination for 7 drugs, suspicion remained over the reliability of their clinical studies.
The GVK Biosciences conducted trials on 700 pharmaceutical forms and strengths of medicines, which are under cloud now (See the list). Only one medicine was able to pass the test successfully and it was no longer suspended, said the CHMP.
In December 2014, France, Germany, Belgium and Luxembourg had suspended the sale of 25 generic drugs, which were made by Mylan NV and Abbott Laboratories outside India and Lupin Ltd and Dr Reddy’s Laboratories in India, based on trials conducted by GVK Biosciences.
GVK Biosciences said India may approach the World Trade Organisation (WTO) if the EU keeps the suspension despite its retrials.
In January 2015, following an inspection of GVK Biosciences’ site at Hyderabad by the French medicines agency (ANSM), concerns were raised about how GVK Biosciences conducted studies at the site on behalf of marketing authorisation holders.
“The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years,” said the agency.
“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 conduct of trials at the site generally and on the reliability of data generated,” said the agency in its statement.
The CHMP further said that there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences at Hyderabad and some medicines may remain in supply if they are critical for patients because alternatives cannot meet patients’ needs.
The CHMP’s recommendation will be taken up by the European Commission for a legal ban on these medicines, while the company may approach WTO over the issue.