EU pharma regulator wants drugs tested in India suspended
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 European Medicines Agency (EMA) said on Friday.india Updated: Jan 24, 2015 02:27 IST
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 European Medicines Agency (EMA) said on Friday.
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, a release from EMA said.
EMA’s Committee for Medicinal Products for Human Use (CHMP) looked at over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site. For over 300 of them, sufficient supporting data from other sources were available; these will therefore remain on the market in the EU as EMA is satisfied with the available data.
The release added that for medicines that lack data from other studies, the CHMP recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs.
“There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences”, EMA said.
The decision on whether a medicine is critical for patients lies with the national authorities of EU Member States depending on the situation in their country. For medicines that are considered critical, companies are given 12 months to submit additional data.
The list of medicines for which the CHMP recommends suspension is available on the EMA website.
The inspection of GVK that led to the CHMP’s recommendation was carried out by the French medicines agency (ANSM). The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, EMA said.
These manipulations appeared to have taken place over a period of at least five years. 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 release added.
The CHMP’s recommendation will be sent to the European Commission for a legally binding decision. This decision will apply to all Member States irrespective of whether or not they have taken interim measures to suspend medicines.