update: Nandu confident it can resolve issues
Falsification practices: French regulators call for Nandu Chemicals' API site ban
ANSM, the French National Agency for Medicines and Health Products Safety, made the suggestion in a post on the EudraGMDP website in which it also set out its concerns about the facility.
Foremost among ANSM’s concerns are various instances of data falsification that inspectors observed.
The regulator also said systems used to control active pharmaceutical ingredient (API) manufacture are inadequate, that stability samples are poorly managed and that cleaning and training methods have not been documented.
The investigation focused on production of zinc sulphate monohydrate, which is a used to treat diarrhoea and is included on the World Health Organisation’s (WHO) essential medicines list.
However, in a section of the EudraGMDP post called “Non-Compliant Other Activities - Active Substances” ANSM also lists “other active substances routinely manufactured on the site,” indicating the problems are not limited to zinc sulphate production.
Recall and ban
In addition to suggesting APIs made at the site and drugs containing them be recalled, ANSM said the facility “should not be named in any new MAs or used in drug compounding activities.”
How many products this will impact is unclear.
The agency said: “The existence of MAs or MA variations referencing an active substance manufactured by Nandu Hubli has to be verified. Where such a MA exists, the removal of the site from the MA should be considered using QRM principles.”
A Nandu spokesman told us: "We are in touch with the concerned authorities to resolve the issues within the time-frame as stipulated.
"To overcome the non-compliance, we have started working on each point and initiated implementation of CAPA, with the help of experts in this field. We are confident to resolve the issues satisfactorily very shortly."
