European drugs regulators have ordered the suspension of a range of generic medicines – including ten marketed in the UK – after malpractice was discovered at an Indian firm carrying out quality control checks on the drugs.
European Medicines Agency (EMA) advisors said bioequivalence studies carried out on the drugs at Semler Research Centre in Bangalore were ‘flawed’ and ‘cannot be relied on’.
GP leaders warned that CCGs must make allowances for any increase in prescribing costs resulting from a lack of alternative generics.
The move comes after inspections found ‘substitution and manipulation of subjects’ clinical samples’, and ‘serious concerns regarding data integrity and manipulation of study samples’ at Semler.
The EMA advisors concluded ‘the studies conducted at Semler cannot be accepted in marketing authorisation applications in the European Union’ and, therefore, ‘no medicines can be approved on the basis of these studies’.
The ten medicines affected in the UK are rosuvastatin, tramadol/paracetamol, irbesartan/hydrochlorothiazide, rasagiline and amoxicillin products marketed by Brown and Burk, duloxetine and pregabalin marketed by Lupin, atovaquone marketed by both Teva and Sandoz, eprosartan from Hetero Europe and celecoxib from Bristol Laboratories.
Dr Andrew Green, chair of the GPC’s clinical and prescribing subcommittee, said it was ‘difficult to know whether this will have an impact on GPs as that will depend on whether there are alternative generics available from other manufacturers’.
However he added that if alternative generics cannot easily be sourced and use of branded drugs increases as a result, ‘drug budgets should be adjusted to compensate’.
Semler were contacted for comment.