27-Jan-2015 - European Medicines Agency (EMA)

GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies

Medicines considered critically important for patients to remain available

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, says the European Medicines Agency (EMA). 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.

Upon the request of the European Commission, 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.

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.

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.

Facts, background information, dossiers
More about European Medicines Agency
More about GVK Biosciences