By Vikas Dandekar
India / Article # 28150610001 / Posted: Jun. 11, 2015 11:55 PM GMT
An audit conducted jointly by the U.S. FDA, European Medicines Agency and a representative of the Netherlands government last September passed GVK Biosciences’ Hyderabad clinical research unit with only a few minor observations, after the Indian CRO came under fire from the European regulatory agency for alleged manipulation of ECG-related data.
MUMBAI – In what emerges as a significant divergence of views between the U.S. FDA and its European counterpart, the U.S. drug regulator in its most recent inspection of the Hyderabad site of GVK Biosciences Private Ltd. apparently raised only a few passing concerns related to ECG washout reports.
Last year, the same ECG reports were red flagged by the EMA, after ANSM – the French regulatory agency – allegedly detected data manipulation in those reports conducted by GVK as part of studies spanning several years, and led to a ban on hundreds of generic products in Europe (“Who’s Doing What On EMA Call For GVK Suspensions” — PharmAsia News, Feb. 8, 2015 11:08 PM GMT).
According to information shared by one veteran industry source, the FDA’s inspections between September 29, 2014 and October 10, 2014 reviewed over 100 ECG reports but found similarities in only four cases. The FDA’s Establishment Inspection Report was learned to have been closed and dispatched to GVK officials via a May 21 letter.
The source added that the FDA representatives did not assess the similarities in the four ECG reports as an issue of data manipulation or fraud. However, the agency is learned to have raised a few 483 observations related to routine operating procedures but that may not affect any ongoing projects related to its product filings for the U.S. markets.
The inspection was conducted as part of a joint investigative exercise between the U.S. FDA, European Medicines Agency (EMA) and a representative for the Netherlands government. Officials from the three agencies were believed to have shared their information and findings mutually before reaching conclusions.
A Rough Ride
Prior to the latest investigations conducted by the U.S. regulator, it had investigated the GVK sites in June 2012 alongside a few other international regulatory bodies including the World Health Organization and the EMA based on a complaint of fraud and data manipulation in the firm’s bio-analytical laboratory (“EC Probes India’s GVK Bio For Data Integrity Spanning Six Years” — PharmAsia News, Sep. 30, 2014 10:58 PM GMT).
Although the representatives discussed corrective measures on a few key issues, the inspection resulted in no 483 observations at that time.
Answering questions from PharmAsia News on the latest move, GVK Biosciences CEO Manni Kantipudi confirmed that the FDA made only a few minor references of the ECG reports as part of its latest site inspections, terming the development as a “major relief.” He however acknowledged that the agency served a few 483 observations on some other procedural grounds.
Although no details were available, the industry source said the 483 observations may have been related to inadequate standard operating procedures, maintenance of data and likely deviations related to a few written informed consent from trial subjects.
The FDA observations and a clearance on the controversial issue comes as a new twist in the saga that has seen the commerce ministry arm of the Indian government coming out in support of the Indian CRO and raising the issue with the European authorities.
However a few weeks ago, the EMA reemphasized its decision to impose a ban on the generic products that were launched based on studies by GVK at the Hyderabad site.