Thabang Mokopanele
23 September 2008
Johannesburg — SANDOZ SA, a generics unit of Swiss pharmaceutical giant Novartis, said yesterday a warning by the World Health Organisation (WHO) against its drugs involved only a limited number of tuberculosis medications produced locally.
The WHO warned customers not to buy drugs made by Sandoz generics unit in SA after an inspection in May found more than 40 faults.
The WHO had sent an official " notice of concern" letter to Sandoz after an inspection of the unit's Kempton Park factory revealed 41 separate cases classified as "noncompliances and deviations from the WHO good manufacturing practices".
Sandoz global communications manager Chris Lewis said the WHO concerns focused mainly on maintenance issues and controls of existing policies and procedures.
"Of those issues identified by the WHO, none was classified as critical, only one as major and the rest as other," Lewis said.
He said the organisation had voiced no concern involving the quality, safety or efficacy of end products.
"Sandoz had committed to completing these changes by the first quarter of next year, partly to accommodate the longer-term actions recommended by the WHO," Lewis said.
The WHO said in its letter to Sandoz that the company failed to ensure adequate primary packaging and that interior surfaces were not smooth and free from cracks and open joints, and did not permit easy and effective cleaning and, if necessary, disinfection.
Lewis said that after talks with the WHO, the company would now find an earlier date suitable for an inspection team visit, even if some of the corrective actions would not be completed by that time.
"There is no product recall. This can be seen as equivalent to a marketing suspension.
"Our message to customers is that we always put their safety first," he said.
The WHO said Sandoz had failed to take sufficient steps to remedy the situation so it had deemed the Kempton Park site to be "operating not in compliance with WHO good manufacturing practices".
It recommended "suspension of procurement of all prequalified products manufactured at this site, (and) withhold prequalification of all new products", the WHO letter said.
These recommendations would remain in force "until satisfactory corrective actions have been implemented by the manufacturer and verified by WHO".
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