The UK’s healthcare regulator has suspended marketing approval for a widely used antibiotic that had won clearance based on clinical trials conducted by India’s Quest Life Sciences, due to concerns over the integrity of trial data. The Medicines and Healthcare products Regulatory Agency (MHRA) might also deny other pending drug approval requests that rely on studies conducted by Quest.
The MHRA’s decision bars the sale of a generic version of erythromycin that is being sold in the UK by Dawa Ltd, a Kenyan drug maker, an MHRA spokesman said. The MHRA said it is in contact with the involved parties, who have the right to appeal and submit new data to prove that the drugs in question meet the required standards. The agency added that it does not believe there to be any risk to public health and that its decision to suspend marketing approval is purely a precautionary measure.
The WHO’s prequalification team had visited the Chennai-based Contract Research Organisation (CRO) Quest’s facilities in October 2014 and inspected the clinical trial of Lamivudine, Zidovudine and Nevirapine, a combination of drugs for treating HIV patients.
Quest’s President Yati Chugh told that the company plans to appeal the suspension as he believes the agency
relied on a two-year-old study and the following inspection report to reach its decision, and that it did not review the company’s latest quality management systems.He said Quest had significantly improved its quality systems since 2014, and would ask the MHRA to re-inspect its site, as MHRA’s move means four other drugs Quest performed trials on that are awaiting approval with the UK regulator will not be approved until the agency clears its facility.
These drugs include the antibiotics doxycycline and cephalexin, and the diabetes drug metformin, on which Quest had conducted trials on behalf of UK drug maker Strandhaven and India’s Kopran, said Chugh. Strandhaven, Kopran and Dawa did not respond to requests for comment on the matter.
The MHRA’s move is the latest blow to India’s drug industry, whose reputation has been tainted in recent years as foreign regulators have criticized manufacturing standards and questioned the reliability of clinical data produced by some of the sector’s biggest names.
Chennai-based Quest is a contract research firm that conducts clinical trials on generic drugs on behalf of local, as well as multinational drugmakers. Drug makers in turn use clinical data produced by companies like Quest to seek approval to sell their drugs in various countries.
Data from Quest has been used to support drug approvals in the US, Europe, Australia and elsewhere, according to its website.
The MHRA said that during an inspection of Quest’s facility in February, it found several issues with data integrity in a clinical trial Quest had conducted, including discrepancies in Quest’s patient records and instances where electrocardiogram (ECG) data of patients had been deleted or manipulated.
The World Health Organization told Quest in July last year about similar ECG data manipulation issues in another drug study.
The MHRA said it believed its findings meant that the safety or well-being of patients had been jeopardized in the trial. “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,” the MHRA spokesman said, adding the problems cast “serious doubt on the integrity of any data produced.” The company has said it will conduct the entire clinical study again at its own cost, to ensure the lifting of the NoC (Notice of Concern).
