UK drugs regulator to halt approvals for Indian clinical trials firm (updated)

Orchid Pharma

01/07/2016 19:34

(Adds further details from MHRA spokesman) 
    By Zeba Siddiqui 
    MUMBAI, July 1 (Reuters) - The UK's healthcare regulator has 
decided to 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.  
    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 not believe there to be 
any risk to public health and that its decision to suspend 
marketing approval is purely a precautionary measure. 
    Quest's President Yati Chugh told Reuters 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 drugmaker Strandhaven and 
India's Kopran, said Chugh.  
    Strandhaven, Kopran and Dawa did not respond to requests for 
comment on the matter. 
     
    LATEST SETBACK 
    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. 
    The World Health Organisation 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 wellbeing of patients had been jeopardised 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." 
    Similar issues around data at Quest's larger rival GVK 
Biosciences led to a recall of about 700 drugs across Europe 
last year. (http://reut.rs/29dOFbW) 
 
 (Reporting by Zeba Siddiqui in Mumbai; Editing by Euan Rocha, 
Greg Mahlich) 
 ((zeba.siddiqui@thomsonreuters.com; +91-9769624550; Reuters 
Messaging: zeba.siddiqui.thomsonreuters.com@reuters.net)) 
 
Keywords: INDIA PHARMACEUTICALS/QUEST