Marketing approval for generic erythromycin sold by Kenya-based drugmaker Dawa in the U.K. was suspended because of data integrity concerns over clinical studies by India's Quest Life Sciences used for approval.
Reuters reported that a June 22 letter to Quest from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA), cited the data integrity for the particular drug and also warned that other products from the Chennai-based CRO face the same fate on pending approvals.
"The MHRA inspectors identified a large number of issues which indicated that there were very serious concerns with many aspects of the company's quality system," an MHRA spokesman told Reuters.
The other products tested by Quest and pending MHRA approval are antibiotics doxycycline and cephalexin, and the generic diabetes drug metformin, on which Quest had conducted trials on behalf of U.K. drugmaker Strandhaven and India's Kopran, Reuters said, citing Quest President Yati Chugh.
In July of last year, Quest was hauled up by the World Health Organization for poor clinical practices on data and bioanalytical procedures in a clinical trial of HIV drugs.
The drugs tested by Quest were rejected by the U.N. agency in an action that came close on the heels of a European Union-wide ban on more than 700 drugs because of allegedly faked electrocardiogram bioequivalency tests that were done by Hyderabad-based GVK BioSciences, and discovered by France's Agency for Medicines and Health Products Safety--with both cases highlighting a pattern of data flaws by Indian CROs.
Both CROs perform work for drug companies around the globe.
Reuters, citing the MHRA, said the move to suspend erythromycin from Dawa, a widely used antibiotic, was "precautionary" and that Quest could appeal the findings on its data.
Chugh told the news agency that the company would file an appeal and seek a reinspection of facilities, saying that quality monitoring had significantly improved at the CRO since 2014.
- here's the Reuters story
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