EMA Removes BP Drug From Hyderabad Suspension List

May 22, 2015

Drug regulators in the European Union (EU) are sticking to their recommendation to suspend the sale of dozens of generic drugs because of flawed clinical trials conducted in Hyderabad, India.

However, they are restoring one drug on the list to good standing.

The EU originally had approved the drugs in question based primarily on clinical trials conducted in Hyderabad by GVK Biosciences, a contract research organization based there, on behalf of various pharmaceutical companies. These clients include Abbott Laboratories, Actavis, Dr Reddy's Laboratories, Mylan Pharmaceuticals, Sandoz, and Takeda Pharmaceuticals. The drugs are indicated for chronic conditions such as diabetes, depression, and hypertension.

In January, the European Medicines Agency (EMA) recommended suspending the sale of roughly 4 dozen of these drugs after French regulators last year uncovered widespread irregularities at the GVK Biosciences facility during an inspection. They reported that GVK staff had manipulated data from electrocardiograms, apparently for many years. The prolonged and systematic nature of these manipulations and the number of staff involved "cast doubt" on the integrity of the trial methodology and the reliability of the data, the EMA said at the time. However, the agency noted that the flawed studies did not cast doubt on the safety or effectiveness of the drugs.

GVK Biosciences has contested the EMA recommendation, saying that the EU agency has extrapolated the findings of French inspectors too broadly to other aspects of its research. Last month, Reuters reported that India's government was threatening to fight the EMA action at the World Trade Organization if the Europeans did not reconsider the matter.

The number of listed drugs technically runs to 700, because the 4 dozen or so generics involved are marketed separately in individual EU nations, in various doses, and therefore appear multiple times.

The EMA did not recommend suspending other drugs studied in Hyderabad if there were supporting data from other sources.

A number of pharmaceutical companies, none of which were identified, asked the EMA to reconsider its recommendations in regard to seven medications on the list, according to an agency news release. The EMA said that after reexamining the issue, it still found the studies conducted by GVK Biosciences problematic. However, it made an exception for one version of a hypertensive drug called nebivolol, marketed as Bivolet in Bulgaria. The EMA removed it from the suspension list.

Nebivolol is marketed in the United States by Forest Laboratories under the brand name Bystolic. Last month, the US Food and Drug Administration tentatively approved a generic version of nebivolol from Amerigen Pharmaceuticals.

In January, the FDA told Medscape Medical News it had inspected the GVK facility in Hyderabad 4 months after French regulators did and failed to find any evidence affecting the safety or efficacy products approved or awaiting approval in this country.

The EMA recommendation to suspend the drugs studied in GVK clinical trials awaits a binding decision by the European Commission, the EU's executive branch. Its ruling will apply to all EU nations, including four countries that already have suspended some of the generics in question.

Individual countries can keep a specified drug on the market, however, if it is deemed critically important because there are no therapeutic alternatives.

More information on today's EMA announcement, including an updated list of drugs recommended for suspension, is available on the agency's website.


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