Clinical trials are coming to an end for India’s Quest Life Sciences organisation after marketing approval for an antibiotic drug was suspended. The integrity of the clinic’s trial data has come under suspicion, and there is a chance that approval for other drugs that have undergone trials at the Indian centre will also be rejected.
The Medicines and Healthcare products Regulatory Agency (MHRA) has suspended the sale of erythromycin, which is being sold in the UK by Dawa Ltd. This means customers will not be able to access the drug until the MHRA removes the suspension.
The clinic may be able to appeal and submit fresh data, and after these have been assessed there is a chance the drug could be continued in the UK. The removal of the drug from the UK market is a precaution, and the MHRA insists that no patients have been put at risk. It is simply a matter of the trial data from India’s Quest Life Sciences organisation being deemed unsatisfactory. Details of the inquiry include some inconsistencies found in the patient records and occasions where ECG data had been changed or deleted.
Clinical Trials Regulation:
Other drugs that Quest has on trial include two antibiotics, doxycycline and cephalexin, and a diabetes drug called metformin. Until the MHRA has approved Quest’s trials, it is unlikely that these new drugs will make it to market in the UK. It is important for clinical trials to be conducted in a strictly professional and regulated manner. When using a contract research organization to conduct clinical trials, such as www.gandlscientific.com, it is important to ensure they have been thoroughly researched and vetted for their reliability and scientific acumen. Another concern is how Brexit might affect the drugs research market in the UK, especially if the UK leaves the EEC.
Quest Life Sciences has insisted that its clinical trials data is up to standard and that the ruling from the MHRA was based on old systems at the centre which have since been replaced. The company has requested that the MHRA inspect the premises again. Quest is concerned that their other drugs will not be approved while the current situation exists, and they want the question mark over their reliability and testing standards removed as soon as possible.