FRANKFURT (Reuters) – A German drugs regulator is suspending the marketing approval of some generic drugs due to concerns over the quality of data from clinical trials conducted by India’s GVK Biosciences.
The quality of Indian pharmaceuticals has come under fire this year, with regulators in Europe and the United States citing problems ranging from data manipulation to sanitation and banning the import of certain products from several firms.
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) said on Friday it was investigating drug approvals based on clinical trials meant to show that the generic drugs were equivalent to the original branded versions conducted by GVK between 2008 and 2014.
It said it was investigating 176 approvals given to 28 drugmakers, and that it had started suspending marketing approvals. It did not name the drugs or companies affected, did not specify what its concerns over GVK’s trials were, and did not estimate how many approvals it would end up suspending.
BfArM said that while there was no indication patients’ health was at risk, it was ordering drugmakers whose approvals were found to have been based on data from GVK trials to stop distributing the drugs concerned until they could provide data from new studies.
Its investigation was prompted by findings by French regulator ANSM, which said in August an inspection of GVK’s site in Hyderabad had raised serious concerns over whether studies by the company complied with good clinical practices.
The European Medicines Agency (EMA), Europe’s drugs watchdog, subsequently started a review to determine which medicines were affected.
GVK was not immediately available for comment.
In a statement posted on its website, it said the EMA’s Committee for Medicinal Products for Human Use (CHMP) had found that studies it conducted in Hyderabad were insufficient to support drug approvals.
“We at GVK BIO believe that the studies conducted are in accordance with the GCP (good clinical practice) guidelines while we honor the conclusion made by CHMP,” it said in the statement, which was not dated.
It said it expected affected drugmakers would need to repeat the concerned studies in the next 12-15 months.
Indian drugmakers are among the world’s biggest producers of generic medicines, or cheaper copies of drugs whose patents have expired.
Earlier this week the European Union banned imports from a Ranbaxy Laboratories factory unit that makes injectable antibiotics after the unit failed an inspection, the latest in a series of quality-related setbacks for the Indian drugmaker.
(Reporting by Maria Sheahan; Editing by Mark Potter)