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PSNC in 'urgent' talks with DH over 'catastrophic' generics shortages

The Pharmaceutical Services Negotiating Committee (PSNC) is in "urgent discussions" with the Department of Health (DH) about the "catastrophic" effect of generics shortages.

PSNC is seeking “immediate action” from the DH following inspections by the European Medicines Agency (EMA), which found last month that a Bristol Laboratories manufacturing site in Luton, and a Dr Reddy’s site in India, did not “comply with good manufacturing practice”.

The supply shortage and pricing of a “large number of products” is having a “catastrophic impact on [contractors’] cashflow”, the negotiator said in a statement this afternoon (September 22).

PSNC is “aware of the very great difficulties” and “numerous market issues that pharmacy contractors and teams are facing”, it said, and alerted the DH as soon as the extent of the issues became clear.

PSNC member and independent pharmacy contractor Mark Burdon said the negotiator is “deeply frustrated and alarmed by the current medicines supply situation”.

“This is having a serious impact on all of our abilities to deliver medicines to patients,” he stressed. “We need action to ensure the resilience of the supply chain.”

PSNC has urged contractors to continue to report generic issues to help build “intelligence” to take to the DH.

Dr Reddy’s response

In a letter sent to Dr Reddy’s customers last month, the manufacturer explained that following the inspection of its site in Telangana, India, it would “not be able to dispatch any further products to the UK” until addressing the regulator’s concerns.

"We greatly value our relationship [with customers] and are committed to providing [them] with effective, high quality and safe medicines," the manufacturer added.

“Please be assured that it is our highest priority to address the concerns raised. To mitigate the disruption in supply, we are actively implementing steps to transfer the manufacture [of] certain products to an alternate, approved site.”

It included a full list of products affected (see below).

A spokesperson for Dr Reddy’s told C+D today: “We are in discussions with the DH to find a solution."

Bristol Laboratories was unavailable for comment at time of going to press.

Dr Reddy's products not available for dispatch to the UK
 
  • Amlodipine maleate 5/10mg
  • Bisacodyl 5mg
  • Cetirizine 10mg
  • Chlorpromazine 25/50/100mg
  • Ciprofloxacin 100/250/500/750mg
  • Dipyridamole 25/100mg
  • Dipyridamole retard 200mg MR (Attia)
  • Dipyridamole and aspirin 200/25mg (Molita)
  • Duloxetine 30/60mg
  • Fexofenadine 120/180mg
  • Lacidipine 2/4mg
  • Memantine 10/20mg
  • Terbinafine 250mg
  • Voriconazole 50/200mg

Source: Dr Reddy's letter to customers, August 16, 2017

 

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