Defiance In Face of EMA’s Indian CRO Data Manipulation Claims

The European Medicines Agency's recommendation that hundreds of generic medicines whose European marketing authorizations relied on clinical studies performed by Indian contract research organization GVK Biosciences be suspended in Europe has been met with defiance by the Indian government and some of the affected generics companies.

The EMA's strict stand against an Indian CRO for alleged breach of good clinical practice requirements has not gone down well. The Indian government wants the EMA to re-examine its recommended suspension, and the Indian Ministry of Commerce has threatened to take the matter to the World Trade Organization if the EMA does not rethink its decision soon, according to local Indian media reports.

Also, a number of affected marketing authorization holders have made use of the appeals procedure and have requested a re-examination of the EMA's recommendation.

gvk bioSciences Private Ltd. is accused of manipulating data in clinical studies conducted at its Hyderabad site, and the EMA had recommended that all affected drugs should be suspended in the EU. The suspension was ordered in January after the EMA conducted an EU-wide review following a referral by the European Commission (Also see "Who’s Doing What On EMA Call For GVK Suspensions" - Scrip, 8 Feb, 2015.).

Local media reports say, among other things, that the Indian government has submitted evidence to the EMA to establish that the clinical studies conducted by GVK Biosciences were not manipulated.

An EMA spokesperson confirmed to PharmAsia News’s sister publication Scrip Regulatory Affairs that it has met a delegation from the Indian government to discuss the outcomes of the referral procedure involving medicines for which clinical studies were conducted by GVK in Hyderabad "as part of the ongoing regulatory co-operation between the EU and India".

The spokesperson explained that the EMA already has a process in place to allow appeals to be filed against its recommendations. However, this so-called re-examination can only be requested by marketing authorization holders directly affected by the EMAs recommendation.

The EMA confirmed that a number of marketing authorization holders have indeed made use of this appeals procedure and have requested a re-examination of the EMA's recommendation. "The re-examination procedure is currently ongoing and [is] expected to [be] finalise[d] in May 2015.

“Measures by third parties including those reported to be contemplated by the Government of India are not part of this [re-examination] process and therefore not for EMA to comment on," the spokesperson said.

The European Commission told SRA at the end of January that it hoped to make its decision on the EMA recommendation "within roughly a month". It had not responded to a request for comment on these latest developments at the time of writing.

(This article also appeared in Scrip Regulatory Affairs.)