Sandoz, the generic drugs unit of Novartis, has lost World Health Organisation approval for drugs produced at a South African plant due to manufacturing problems, the UN agency said.
The WHO said it considered the plant was not operating in compliance with its manufacturing guidelines and so had recommended suspending procurement of all products made at the site as well as approval of any new products made there.
In a “notice of concern” letter sent to Sandoz earlier this month, the WHO said an inspection in May had revealed 41 deviations from its standards, including failure to prevent contamination and problems with cleaning and disinfection.
It had been forced to act because Sandoz had said the WHO could not conduct a follow-up inspection before the end of 2008.
A Novartis spokesman said Sandoz was working hard to solve the problems at the plant.
“We are doing everything to complete changes as quickly as possible and to reschedule a visit of the WHO by the first quarter of 2009,” the spokesman said.
Last week, US health officials banned dozens of drugs made by India's Ranbaxy Laboratories Ltd after the generic drugmaker failed to fix numerous record-keeping and other operational problems, although the drugs are considered safe. (Reuters)