India has appointed a 6-member panel to look into GVK BioSciences in the wake of a testing scandal that has hit drug exports to the European Union for more than 700 products and raised deeper questions on quality control for pharmaceuticals from the country.
The Times of India said the panel, assembled more than 6 months after the Central Drugs Standard Control Organization gave the Hyderabad CRO a clean chit, visited the facility this week, citing joint secretary in the department of commerce Sudhanshu Pandey.
Pandey told the newspaper the members come from several government agencies, including the All-India Institute of Medical Sciences, but declined to set a time-frame or scope of any report.
"The government is still pursuing that (GVK Bio) matter and has set up a panel. The panel visited the GVK Bio facility yesterday, interacted with the company (officials) and went into the primary data. A further view will be taken thereafter," Pandey told the newspaper on the sidelines of Pharmexcil's 11th annual meeting in Hyderabad.
"The panel wants to find out whether the allegations are true or not. We have gone through the data extensively and found no data manipulation. In fact, the allegation against the company is that the ECG data was falsified. You will be surprised that during the same period, the same data has been inspected by multiple regulators, including U.S. FDA, and even they did not find anything wrong with the ECGs."
In August, India deferred planned trade talks with the European Union as a form of protest to a EU-wide ban on the drugs bioequivalency-tested by GVK BioSciences. The ban could cost India at least $1 billion in exports by the end of the fiscal year in March 2016, reports said.
The ban came into effect on Aug. 21 in a move that New Delhi had tried to head off with diplomatic efforts, the failure of which has apparently riled India's Commerce Ministry, the Economic Times said in a July story.
The EMA issue began in May when investigators from France's Agency for Medicines and Health Products Safety examined 9 trials conducted at GVK's Hyderabad facility. The inspection found GVK employees repeatedly switched outpatient ECG scores with those of healthy volunteers.
It was followed by a separate stinging rebuke this month from the World Health Organization to CRO Quest Life Sciences over falsified ECGs in an HIV drug trial.
- here's the story from the Times of India