The Medicines and Healthcare products Regulatory Agency (MHRA) first issued a partial suspension of the manufacturer’s licence in August 2017, after it “identified non-compliance with good manufacturing practice” during an inspection of its Luton site in July, the watchdog told C+D last week (April 12).
Two further inspections, carried out in November 2017 and January 2018, “determined that non-compliance issues remain, and so we have extended the partial suspension”, the MHRA added.
Initial shortages had “severe” impact
Pharmaceutical Services Negotiating Committee (PSNC) chief executive Sue Sharpe told C+D: “The shortages experienced by contractors following the problems at Bristol Laboratories had a severe impact and contributed to the extreme pressures of recent months.”
While Bristol Laboratories’ extended suspension “should not create new problems”, Ms Sharpe stressed, the negotiator “will continue to monitor generic supply and shortages very closely and apply for price concessions as appropriate”.
Shortages will be monitored alongside PSNC’s “ongoing work [to] ensure contractors are protected from adverse events or activity further up the supply chain”, Ms Sharpe added.
Why has the suspension been extended?
The MHRA identified two non-compliance issues with the manufacturer, relating to the “recording of key data”, and its “ongoing stability monitoring programme”, which monitors a product over its shelf life.
Bristol Laboratories told C+D it disputed information relating to the extended suspension, but did not respond to C+D’s numerous requests for further comment.
Bristol Laboratories’ manufacturing facility in Luton has the capacity to produce nine billion tablets a year, according to its website, and provides medicines used to treat conditions such as diabetes, depression and Parkinson’s.
Following the initial inspection of the facility in July 2017, the MHRA said in a statement that Bristol Laboratories had been suspended from providing “batches of non-critical product” to “EU markets while this statement of non-compliance remains in force”.
The suspension has been extended to November 22, according to the MHRA’s list of suspended licences, and will be lifted when “all the non-compliances have been addressed”, the watchdog added.
“No evidence of defective medicines”
The MHRA stressed there is “no evidence of medicines being defective and therefore patients should continue to take their medicines as necessary”.
“For those products that Bristol [Laboratories] is no longer able to supply, we are working closely with the Department of Health and Social Care and other generics suppliers to ensure supplies continue to remain available for UK patients.”