Non-compliance of Good Clinical Practice at GVK Biosciences in India led to suspension of marketing authorisations of concerned medicines
By William Chin, PhD, Scientific Coordinator, EUCRAF
Back in September 2014, the French medicine agency reported concerns on the reliabiity of the quality data from clinical studies conducted between 2008 and 2014 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. For precautionary measure, regulators in France, Germany, Belgium and Luxembourg are suspending the marketing approval of generic drugs that have been authorised on the basis of studies conducted at the GVK Biosciences site in Hyderabad, India.
GVK Bio has been conducting human trials of generic drugs on behalf of globally-operating companies. During an inspection, the French drug regulator ANSM discovered that GVK Bio had forged the outcome of a study of a drug for heart patients.
GVK Biosciences has issued a statement saying that it had addressed the concerns, and had submitted independent cardiology assessments of the ECGs, indicating that the ECGs could belong to multiple volunteers and it was difficult to conclude that ECGs belonged to the same volunteer. The company is disappointed at CHMP's opinion as it believes that the studies conducted are in accordance with the GCP guidelines. The company pledged to provide new data that meets all regulatory requirements as well as providing evidence that their staffs were qualified and all key activities such as dosing, blood sampling and processing were adequately controlled and supervised. GVK Biosciences expects the marketing authorisation holders will need to repeat the studies in the next 12-15 months.
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