Flawed clinical data from GVK Biosciences caused suspension of 700 pharmaceutical forms and strengths of medicines in EU
By William Chin, PhD, Scientific Coordinator, EUCRAF
It all started in September 2014 when the French medicine agency reported concerns on the reliability of the quality data from clinical studies conducted by GVK Biosciences site in India. At the request of the European Commision, under the Article 31 of Directive 2001/83/EC, EMA's Committee for Medicinal Products for Human Use (CHMP) has followed up by reviewing these finding to identify which medicines are affected by the inspection findings. After reviewing over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site, CHMP found only over 300 of them have sufficient supporting clinical data. These medicines will therefore remain on the market. For the rest of the medicines that lack data from other studies, the CHMP recommended suspension in the EU market, unless they are of critical importance for patients because alternatives will not be able to meet patients’ needs. EMA reported that there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences.
The full list of medicines for which the CHMP recommends suspension is available on the EMA website.
1. EMA Press Release, 23 January 2015, GVK Biosciences: European Medicines Agency recommends suspending medicines over flawed studies.