Options are narrowing down for GVK Biosciences in its on-going tussle with the European Medical Agency (EMA) over alleged ‘irregularities’ in conducting clinical trials.
Last Friday, EMA had confirmed a previous recommendation of its panel to suspend a number of medicines, the authorisations of which were based on clinical trials conducted by the Hyderabad-based company.
The suspension came into effect in January 2015, after an inspection at GVK’s manufacturing plant ‘revealed’ manipulation of data from electrocardiograms (ECG) for at least five years.
When contacted on the future course of action, GVK Biosciences spokesperson told Business Line that the decision of the EMA was the culmination of a review done post the challenge by the marketing authorisation holders on the Committee for Medicinal Products for Human use (CHMP) examination procedure.
“GVK Bio has presented data from international experts and has been independently working with the EU authorities and the Government of India and will continue to do so to try and resolve the issue,” she said.
However, all the efforts done so far, in which the Ministry of Commerce and the Drugs Controller General of India (DCGI) were also involved apparently, did not bear fruit as the EMA went ahead and adopted the original recommendations of its panel with exception to a medicine on the grounds of critical care requirements.
GN Singh, the Drugs Controller General of India, told Business Line it was up to the EMA to take a final call. “I was very much involved in the process of seeking the review of the EMA decision, which of course did not yield any positive outcome. But I cannot comment on the legal options or future course at the moment,” he said.
Meanwhile, most of the drug-makers who used GVK Bio trials will have to work out a solution as the hope of a review is now gone. Some European regulators in countries such as Germany have already notified suspension of drugs over a dozen companies, including Dr Reddy’s Laboratories, Mylan Labs and Lupin, as their authorisations were based on these trials.
In a filing with the BSE, Lupin confirmed that it, along with many other companies, received communication from the EMA banning some of its drugs and it will present new bioequivalence tests.
In a recent interaction, GV Prasad, CEO of Dr Reddy’s, too said trials might have to be redone for some products.