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MHRA will not recall generics despite concerns over efficacy

The MHRA says there are no concerns that the drugs are unsafe or ineffective

The UK's medicines watchdog has decided not to recall several generic drugs despite studies into their efficacy that were called into question.

EU medicines watchdog the European Medicines Agency (EMA) called for the suspension of “a number of nationally approved medicines”, including Brown and Burk’s tramadol/paracetamol tablets and duloxetine and pregabalin products from Lupin, last month (July 22).

The World Health Organisation found “several issues” with studies into the drugs carried out at bio-pharmaceutical service provider Semler’s research centre in India, the EMA reported.

These included concerns about the “substitution and manipulation” of clinical samples at the facility, and “serious concerns” about "data integrity". A full list of affected drugs can be found here.

But the Medicines and Healthcare Products Regulatory Agency (MHRA) told C+D last week (August 2) that it will not be recalling any drugs in the UK, because there is "no evidence" that they are unsafe or ineffective.

Suspension not binding

Despite recommending the drugs be suspended, the EMA acknowledged that some may be of "critical importance", for example due to a lack of alternatives, in a given EU state. It conceded that national authorities – such as the MHRA – could "temporarily postpone the suspension in the interest of patients".

The EMA's decision on the Semlar research will now be sent to the European Commission, who will make a “legally binding” decision on the drugs that will be valid in all EU countries, it added.

The MHRA stressed that patients should continue to take their current medicines, and should speak to their doctor if they have any questions about the drugs they are taking.

6 Comments
Question: 
Do you think the drugs should be recalled?

Do I Not Like This Dotcom, Primary care pharmacist

The MHRA/NHS need to make it a requirement that all drugs manufactured overseas are tested in an approved independent laboratory in the UK. The cost to be borne by the manufacturer. No batch deemed to have failed this test to be released onto the market. There have been concerns for many years about the poor efficacy of various medicines manufactured abroad where there is no temperature validation for the supply chain.

Ava Denuff, Locum pharmacist

Totally support this view. The MHRA wouldn't allow continued use of a product manufactured in the UK with such oncerns?... By the way, are you The 'Jas Malhi'...once lecturer (maybe you still are) at Brighton?

Do I Not Like This Dotcom, Primary care pharmacist

Hi Dave

Same one but no longer at Brighton - what you up to these days? Still following Mansfield?

Ava Denuff, Locum pharmacist

Good heavens... and I thought I had a good memory. I am still living in Mansfield, but not a follower ..always a huge Stoke City fan. I have been a locum since 1994...couple of years after finishing at Brighton. Keeps me busy !! What of you Jas?.. I will not forget nodding off during your lectures on powder technology in pharmaceutics. It was the lecture content and not you that caused the drowsiness. !

Mr CAUSTIC, Community pharmacist

If there is doubt over lab standards  they should be retested in a facility where the standards are maintained at the highest level . If the results are replicated the drugs should be withdrawn. One must be sure that the drugs we supply are made to the highest standards to ensure patient safety. 

David Kent, Community pharmacist

I am very dubious regarding the quality of many generics and they should be recalled if any doubt as to efficacy exists.

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