EMA Recommends Suspending Drugs over GVK Data Integrity Issues

Regulatory NewsRegulatory News | 23 January 2015 |  By 

The European Medicines Agency (EMA) is recommending EU Member States suspend products whose approval relied on clinical trials conducted at GVK Biosciences in Hyderabad, India. The agency cites concerns over “systemic” data manipulation alleged by the French National Agency for Medicines and Health Products Safety (ANSM) following an inspection of GVK’s site in May 2014.

For more about the allegations against GVK see our December 2014 article, “EU Regulators Concerned about Drug Data Fraud by Indian Company.”

More than 700 Products Recommended for Suspension

EMA’s Committee for Medicinal Products for Human Use (CHMP) reviewed more than 1,000 forms and dosages of drugs for which GVK conducted trials. The review found more than 700 of these products lacked sufficient data from other sources to maintain marketing authorization.

The European Commission (EC) will now review CHMP’s recommendation before issuing its decision, which, if adopted, will be legally binding to all EU Member States.

CHMP recommends EU Member States suspend marketing authorization for these products except where there is a critical need. Companies whose affected products are considered critical are required to provide additional data within a year.

A Cautionary Measure

EMA is careful to point out that there has been “no evidence of harm or lack of effectiveness” for any of the products studied by GVK. The agency recommends patients continue to follow their doctors’ instructions for any medicines affected by the review.

International Reaction

Following the EMA announcement, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) put out a press release affirming that it will work with the UK Department of Health, should the EC impose CHMP’s recommendations.

A week prior to CHMP’s recommendation, the World Health Organization (WHO) issued an information note which states that two products prequalified by the organization used trial data from GVK studies in their applications. WHO is currently looking into whether the issues uncovered by ANSM affect the prequalified drugs. For the time being, Mylan Laboratories has voluntarily withdrawn two dosages of its lamivudine and stavudine tablets from the WHO List of Prequalified Medicines. The second product, ritonavir, is being reviewed by the organization using new data from different studies.

FDA Concerns over Data Integrity in India

A recent US Food and Drug Administration (FDA) inspection of GVK failed to corroborate ANSM’s allegations of data manipulation for products being marketed in the US. However, FDA has issued Warning Letters to over a dozen other Indian companies over data integrity issues in the past two years.


EMA Press Release


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