The quality of pharmaceutical products from India has been this year, with regulators in Europe and the United States, citing problems ranging from data manipulation sanitation and banning the import of certain products from various companies.
"This decision is a precaution. Nothing in this stage has allowed to establish a real risk to human health or the lack of efficacy of these drugs," ANSM said on its website.
All drugs being suspended, several of which are made by Mylan and Abbott, has equivalent brand that can be used instead, so that patients do not have to stop treatment, he added.
MSNA and the German Federal Institute for Drugs and Medical Devices (BfArM) said they were investigating drug approvals based on clinical trials designed to demonstrate that these generic drugs are equivalent to the original branded versions made by GVK Bio between 2008 and 2014.
MSNA said it had alerted European authorities after they inspected the site GVK Bio in Hyderabad, India, and found "anomalies" in the way that electrocardiograms (ECG) were monitored during the bioequivalence studies.
He said the inspection raised serious concerns about whether the company studies comply with good clinical practice.
GVK Bio CEO Manni Kantipudi disputed the findings of the monitoring and ECG French said they were not an important component of drug efficacy.
GVK Bio ANSM concluded that conducts clinical research for domestic and foreign pharmaceutical, manipulated the ECG without taking into account the views of the company, said.
"We have agreed to redo the studies, I'm fine with that, but do not say it was not gross manipulation of the ECG," Kantipudi Reuters. He said the company had received board approval to spend $ 5.7- $ 6.5 million for further studies.
The European Medicines Agency (EMA) released a separate statement saying that "make a recommendation on whether the marketing authorizations for medicinal products concerned should be retained, modified, suspended or withdrawn across the EU." That recommendation is expected in January 2015.
The German control agency said it was investigating 176 approvals given 28 drug manufacturers. No name drugs or undertakings concerned.
BfArM said he was ordering pharmaceutical approvals which were found to have been based on trial data GVK stop distributing the drugs in question until they could provide details of new studies.
MSNA said several drug makers - who did not identify - had already offered to conduct new studies, if positive, could allow drugs on the market again.
Kantipudi of GVK Bio said the company has begun further studies for five to six of its customers. About 35 400 of the company's customers were affected by the regulator's decision Europoean said.
He said the Food and Drug Administration US Hyderabad inspected the plant in June, after the audit of the French regulator, and was satisfied with the data related to the ECG. No other regulator had he contacted the company since he added.
(Reporting by Maria Sheahan in Frankfurt, Ben Hirschler in London, Natalie Huet in Paris and Zeba Siddiqui in Mumbai, Editing by Mark Potter Spanish, Elaine Hardcastle, Lisa Shumaker & Kim Coghill).
