India's leading pharmaceutical research company GVK Bio allegedly manipulated the results of clinical trials of generic drugs it had carried out on behalf of several European manufacturers for many years, media reports have said.
Germany's drug regulators are currently examining whether to suspend the use of more than 100 medicines on suspicion that they were given marketing licences for forged medical reports of human trials supplied by the Hyderabad-based company, TV channels NDR and WDR and the Munich daily Sueddeutsche Zeitung reported on Friday.
Such studies are crucial for copy-cat drugs to gain marketing licences from the regulators. The manufacturers will have to prove that their generic copy is comparable to the original product.
GVK Bio has been conducting human trials of generic drugs on behalf of globally-operating companies. It also has been conducting tests of new medicines.
The Federal Institute for Medicines and Medical Products, which issues the licences in Germany, confirmed it has been investigating the allegations against the company. The agency said it is too early to determine the exact number of medicines involved, but they may be more than a hundred, according to the reports.
Two drugs manufactured by the German company Betapharm and anti-allergy medicine Fexofenadin by Hexal are among the medicines currently being investigated.
German authorities, so far, have no information that the drugs involved posed any health risk for the public, the reports said.
European Union's drug regulator, the European Medicines Agency (EMA), believes GVK Bio has been systematically manipulating its medical studies for a number of years, the reports said.
Documents of the EMA and the European Commission showed at least 10 GVK Bio staff members were involved in the forgery, which took place during the period between 2008 and 2013, according to the reports.
EMA had in July written to all manufacturers of generic drugs in the EU, seeking details of their cooperation with GVK Bio. The agency will decide shortly whether additional studies are needed for some medicines or they will be withdrawn completely from the market.
Meanwhile, reacting to German media reports, GVK BIO said it had addressed the concerns and had submitted independent Cardiology assessments of the ECGs indicating that the ECGs can belong to multiple volunteers and it is difficult to conclude that ECGs belonged to the same volunteer. "We also provided evidence that all key activities such as dosing, blood sampling and processing were adequately controlled, supervised and staff were qualified to do the work," the company stated in Hyderabad.
GVK BIO also strengthened its operating procedures around taking ECGs and these were accepted by the authorities.
"We are disappointed that despite providing detailed clarifications, unfortunately CHMP (Committee for Medicinal products for Human use) has concluded that though the "check-out" ECGs may have no direct relevance to the quality of the testing of drugs, the fact that the same employees were involved in other critical activities, left an element of doubt on the Bio-equivalence results," it said.
Hence, authorities have concluded that bio equivalence (BE) studies conducted at our Hyderabad clinic are not sufficient to support Marketing Authorisation Holders (MAHs) for the products approved, GVK BIO said.
"We expect the Marketing Authorisation Holders will need to repeat the studies in the next 12-15 months." "We at GVK BIO believe that the studies conducted are in accordance with the GCP guidelines while we honour the conclusion made by CHMP and are working with our clinical development customers to provide new data that meets all regulatory requirements," the statement said.
