Medical drugs importers put on two months notice

Importers of pharmaceutical products have until September 1 to comply with Kenyan standards on medical drugs and equipment or face cancellation of their licences.

The notice affects all importers of medical devices, food supplements, medical cosmetics, herbal products and other related healthcare borderline products falling under the regulated mandate of Pharmacy and Poisons Board (PPB).

This is in an effort to protect the public against imported medical commodities that do not comply with local quality standards and technical regulations.

“A certificate of compliance must be issued to ensure public safety, without which goods must be disposed. If an importer is consistently non-compliant they would be deregistered,” said  PPB acting registrar, Dr Fred Siyoi.

“There is a danger in pharmaceutical products that have no verified origin since you will neither know their country of origin nor be assured of quality. If a food supplement is packaged in Chinese language, for instance, how do you know if it has lactose, which you could be allergic to?” he added.

Pharmaceutical manufacturers licensed by PPB to import raw materials, machinery and spares for own use are, however, exempted from the order.

Dr Siyoi said that there has been confusion over whose mandate it is to issue certificate of compliance (CoC) to parallel importers of pharmaceutical products, with traders accusing the Kenya Bureau of Standards (Kebs) for overstepping its role.

Kebs managing director Charles Ongwae said the two government agencies have agreed to use the pre-export verification of conformity (PVoC) requirement.

“Pharmaceutical products fall under PPB, but instead of them putting new systems to ensure standards, we have agreed to use what Kebs already has to become more efficient as partners,” said Mr Ongwae.

Kebs charges a minimal fee of $250 (Sh25,000) per consignment for verification.

The affected importers are required to obtain certificates of conformity for their cargo before applying for import permits from PPB through the Kenya National Single Window Electronic (Kentrade) System.