On Friday March 18 the World Health Organisation (WHO) published a Notice of Suspension (NOS) sent to Svizera Labs Private Limited on March 3.
The notice revoked prequalification status for pharmaceuticals made at its facility in Navi, Mumbai, including tuberculosis drugs supplied to the WHO via Svizera Europe.
But the letter was later removed from the WHO website after the organisation realised it had been published too soon.
Under conditions set by the WHO’s Prequalification Team, Svizera Labs should have been given 15 working days to respond. However, March 18 is only 11 working days after the firm was issued with the NOC.
WHO awaiting response
Dr Mark McDonald, coordinator of the WHO prequalification team, confirmed this, telling us “the letter was erroneously published on the website before the company was allowed the entirety of the nominated period to respond to the currently outstanding issues.”
He said “as part of the procedural fairness of the process” Svizera has been in possession of the NOS for over two weeks and the WHO has been in frequent and close discussions with the firm.
“Any further actions will depend on the company’s responses to the outstanding issues, which is expected to be received in the WHO in the coming days,” he continued, adding “the affected products are not currently suspended.”
"Damage is huge!"
Boudewijn Ploos van Amstel, the Managing Director of Svizera Europe, told us the NOS was taken down 24 hours after being circulated and a correction published only after considerable pressure from the company.
“Of course the damage is huge!” he said, adding a “lot of information [in the NOS] is not correct.”
In the NOS, which has been seen by in-Pharmatechnologist.com, the WHO described eight critical issues.
These include the submission of irregular trial injection, batch and dissolution testing data and evidence of data manipulation. The WHO also highlighted several product complaints filed since the facility was issued with a Notice of Concern (NOC) last September.
An NOC is implemented to facilities the WHO deems has violated Good Manufacturing Practices (GMP), similar to a Warning Letter issued by the US FDA.
Last September’s NOC pulled Svizera up on a number of issues, including failure to provide adequate controls to stop the contamination of products, with inspectors observing uneven floor, crumbling walls, and black mould inside a drain which also held stagnant water.