As one of the UK’s largest generics manufacturers, the suspension of Bristol Laboratories’ licence in 2017 prompted severe shortages, which the Pharmaceutical Services Negotiating Committee (PSNC) said at the time were having a “catastrophic impact” on contractors’ cashflow.
The manufacturer had its full licence reinstated on May 22, “following successful Medicines and Healthcare products Regulatory Agency (MHRA) inspections”, Bristol Laboratories said in a statement on Monday (June 3).
Despite the reinstatement of its licence, PSNC director of funding Mike Dent warned that “there continues to be ongoing generic medicine shortages” across pharmacy due to “unrelated” factors, such as other “manufacturing issues, regulatory problems, availability of raw ingredients, increased demand and product recalls”.
PSNC: Pricing problems remain
While fewer price concessions have been granted since March 2019’s record of 96, PSNC continues to receive “hundreds of reports about supply problems, the bulk of which relate to pharmacies struggling to source medicines at or below drug tariff listed prices”, Mr Dent explained.
Bristol Labs: We are Brexit ready
The MHRA first issued a partial suspension of Bristol Laboratories’ licence in 2017, after it “identified non-compliance with good manufacturing practice” during an inspection of its Luton site. The suspension was then extended following issues identified in further inspections.
In a statement on Monday, Bristol Laboratories quality and regulatory affairs director Priti Ramachandran said the manufacturer has “created enough capacity to address medicine shortages”, and it “stands ready” in the face of Brexit.
The reinstatement of the manufacturer’s licence gives “vital reassurance” to Bristol Laboratories’ customers, patients, distribution network and supply chain “as Brexit continues to present uncertainty over future medicine supply in the UK”, she added.