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Indian generics firm GVK set to be hit with European sales ban

EU regulator raises concerns on conduct of drug studies in India

GVK BiosciencesThe European Medicines Agency (EMA) has recommended suspending sales of hundreds of generic medicines produced by India-based GVK Biosciences over concerns about the conduct of clinical trials carried out by the company.

According to the regulator, of the more than 1,000 forms for pharmaceutical products studied at a site in Hyderabad around 700 lacked data from other studies to support a recommendation.

This has led the EMA's Committee for Medicinal Products for Human Use (CHMP) to back the suspension of all affected medicines unless they are of critical importance for patients.

However, despite its concerns the EMA added: “There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences.”

The EMA's recommendation will now be considered by the European Commission before a final decision is made, after which it will be up to individual EU countries to determine what medicines are considered critical and should remain available.

Responding to the EMA's statement Dr Samantha Atkinson, deputy director of the Inspection, Enforcement and Standards (IE&S) Division at the UK's Medicines and Healthcare products Regulatory Agency said: “This is a precautionary measure. There is no evidence to suggest that these medicines are not safe and effective and people should continue to take their medicines as prescribed.”

Dr Atkinson added: “If the recommendation is adopted by the Commission, we will work with our colleagues at the Department of Health to ensure people have access to the medicines they need.”

Concerns about the quality of clinical studies conducted at the Hyderabad facility were first raised by the French medicines agency (ANSM).

During an inspection of the site the ANSM uncovered data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines.

These had taken place over a period of five years and led the agency to “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”.

Article by
Thomas Meek

26th January 2015

From: Sales, Regulatory



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