One in 10 drug companies fail quality audit
ONE in 10 Australian drug firms failed quality inspections by the federal government’s medicines watchdog last financial year.
ONE in 10 Australian drug companies failed quality inspections by the federal government’s medicines watchdog last financial year.
The Therapeutic Goods Administration yesterday said only 89 per cent of Australian pharmaceutical manufacturers “achieved satisfactory compliance’’ with quality standards during 2013-14.
The TGA said the industry’s performance had improved since 2011-12, when just 81 per cent of Australian manufacturers rated “satisfactory compliance’’.
Among foreign manufacturers audited by the TGA, satisfactory compliance levels rose from 87 per cent to 93 per cent in the two-year period.
The TGA said 10 per cent of Australian manufacturers were rated “marginally compliant’’ — down from 16 per cent two years ago, while 7 per cent of foreign manufacturers were rated as marginally compliant, down from 13 per cent.
The TGA said fewer manufacturers were now rated as unacceptable.
The TGA missed its own inspection deadlines for a third of the pharmaceutical manufacturers it audited last financial year. A spokeswoman said the demands of achieving voluntary compliance had affected its ability to hold inspections within target times.
Only 66 per cent of domestic manufacturers were audited within the “target time frames’’ in 2013-14, down from 73 per cent the year before and 87 per cent in 2010-11. And just 58 per cent of foreign manufacturers were inspected on time, down from 71 per cent the previous year and 82 per cent in 2011-12.
The Consumer Health Forum said it was “very concerning’’ the TGA had missed its own deadlines. “The decline in surveillance and monitoring is further evidence that the TGA is not being adequately resourced,’’ the forum’s chief executive Adam Stankevicius said.
The TGA is a division of the Health Department but is funded by user-pays fees and charges to the pharmaceutical industry it regulates.
The TGA spokeswoman said the TGA’s focus on high-risk manufacturers could lead to other inspections being “deferred’’.
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