Little Green Pharma has shifted its laboratory testing to the in-house lab of the Therapeutic Goods Administration (TGA) following the contentious publication of a TGA report identifying products which failed a potency audit.
The WA-based firm was one of four suppliers named in the audit whose products were found to have breached TGO93 requirements. The others were Althea, Spectrum Therapeutics and Bedrocan.
But the findings of the TGA, subsequent release of the report and public naming of the four suppliers appear to have exposed wider failings of the system and angered those accused of a breach.
It also reignited the thorny issue of imported medicinal cannabis amid concerns that inferior product is arriving in Australia without sufficient policing from the TGA. There is no suggestion the products named in the report failed any requirement other than the potency conditions.
ChemCentre, which conducts pre-market testing for LGP, was said to be incensed at having its analysis questioned. The facility insisted it “stands by all its results”.
Althea, LGP and Canopy Growth – the owner of Spectrum – were adamant their own test results were in line with tolerance levels. Bedrocan declined to comment until “ongoing discussions with the TGA are concluded”.
In total, the TGA said five products were in contravention of the regulations and failed to meet upper and lower limits of ingredients declared on the manufacturer’s TGO93 declaration.
Despite public backing from LGP chief executive Fleta Solomon, the discrepancy between ChemCentre’s results and that of the TGA audit has led LGP to switching its testing to NMI, the body which examined samples for the TGA.