UK drugs regulator halts nod for Indian clinical trials firm

MHRA may also deny other pending drug approval requests

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 UK agency said in a letter dated June 22, a copy of which was seen by Reuters.

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 drugmaker, an MHRA spokesman said.

Quest's president Yati Chugh told Reuters the company plans to appeal against the MHRA suspension as he believes the agency relied on a two-year-old 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 tore- inspectits 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 drugmaker 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 criticised 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. Drugmakers 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 United States, 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.